First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define “things” or “products” while the first category defines “actions” (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) (“The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called “judicially recognized exceptions” or simply “exceptions”) are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). See also Thales Visionix Inc. v. United States, 850 F.3d. 1343, 1349, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) (“That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction.”). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that “in applying the §101 exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more” (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo “set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts”); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found “the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,” but the Court in Gottschalk v. Benson “held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle”); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (“Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’” (quoting Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)) (emphasis in original)); Diehr, 450 U.S. at 187, 192 n.14, 209 USPQ at 10 n.14 (explaining that the process in Parker v. Flook was ineligible not because it contained a mathematical formula, but because it did not provide an application of the formula). See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972); Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978).
The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). This framework, which is referred to as the Mayo test or the Alice/Mayo test, is discussed in further detail in subsection III, below. The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
The Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims under examination. While the machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. Instead it should be considered as part of the "integration" determination or "significantly more" determination articulated in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593, 605, 95 USPQ2d 1001, 1007 (2010). See MPEP § 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP § 2106.05(b) and MPEP § 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework. Likewise, eligibility should not be evaluated based on whether the claim recites a "useful, concrete, and tangible result," State Street Bank, 149 F.3d 1368, 1374, 47 USPQ2d 1596, 1602 (Fed. Cir. 1998) (quoting In re Alappat, 33 F.3d 1526, 1544, 31 USPQ2d 1545, 1557 (Fed. Cir. 1994)), as this test has been superseded. In re Bilski, 545 F.3d 943, 959-60, 88 USPQ2d 1385, 1394-95 (Fed. Cir. 2008) (en banc), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (“It is well-settled that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea”). The programmed computer or “special purpose computer” test of In re Alappat, 33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994) (i.e., the rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim for the “special purpose” of executing the algorithm or software) was also superseded by the Supreme Court’s Bilski and Alice Corp. decisions. Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (“[W]e note that Alappat has been superseded by Bilski, 561 U.S. at 605–06, and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 110 USPQ2d 1976 (2014)”); Intellectual Ventures I LLC v. Capital One Bank (USA), N.A., 792 F.3d 1363, 1366, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) (“An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment, such as the Internet [or] a computer”). Lastly, eligibility should not be evaluated based on whether the claimed invention has utility, because “[u]tility is not the test for patent-eligible subject matter.” Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1380, 118 USPQ2d 1541, 1548 (Fed. Cir. 2016).
Examiners are reminded that 35 U.S.C. 101 is not the sole tool for determining patentability; 35 U.S.C. 112 , 35 U.S.C. 102, and 35 U.S.C. 103 will provide additional tools for ensuring that the claim meets the conditions for patentability. As the Supreme Court made clear in Bilski, 561 U.S. at 602, 95 USPQ2d at 1006:
II. ESTABLISH BROADEST REASONABLE INTERPRETATION OF CLAIM AS A WHOLEThe § 101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy ‘‘the conditions and requirements of this title.’’ § 101. Those requirements include that the invention be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112.
It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility. The BRI sets the boundaries of the coverage sought by the claim and will influence whether the claim seeks to cover subject matter that is beyond the four statutory categories or encompasses subject matter that falls within the exceptions. See MyMail, Ltd. v. ooVoo, LLC, 934 F.3d 1373, 1379, 2019 USPQ2d 305789 (Fed. Cir. 2019) (“Determining patent eligibility requires a full understanding of the basic character of the claimed subject matter”), citing Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1273-74, 103 USPQ2d 1425, 1430 (Fed. Cir. 2012); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc ), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) (“claim construction … is an important first step in a § 101 analysis”). Evaluating eligibility based on the BRI also ensures that patent eligibility under 35 U.S.C. 101 does not depend simply on the draftsman’s art. Alice, 573 U.S. 208, 224, 110 USPQ2d at 1984, 1985 (citing Parker v. Flook, 437 U.S. 584, 593, 198 USPQ 193, 198 (1978) and Mayo, 566 U.S. at 72, 101 USPQ2d at 1966). See MPEP § 2111 for more information about determining the BRI.
Claim interpretation affects the evaluation of both criteria for eligibility. For example, in Mentor Graphics v. EVE-USA, Inc., 851 F.3d 1275, 112 USPQ2d 1120 (Fed. Cir. 2017), claim interpretation was crucial to the court’s determination that claims to a “machine-readable medium” were not to a statutory category. In Mentor Graphics, the court interpreted the claims in light of the specification, which expressly defined the medium as encompassing “any data storage device” including random-access memory and carrier waves. Although random-access memory and magnetic tape are statutory media, carrier waves are not because they are signals similar to the transitory, propagating signals held to be non-statutory in Nuijten. 851 F.3d at 1294, 112 USPQ2d at 1133 (citing In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)). Accordingly, because the BRI of the claims covered both subject matter that falls within a statutory category (the random-access memory), as well as subject matter that does not (the carrier waves), the claims as a whole were not to a statutory category and thus failed the first criterion for eligibility.
With regard to the second criterion for eligibility, the Alice/Mayo test, claim interpretation can affect the first part of the test (whether the claims are directed to a judicial exception). For example, the patentee in Synopsys argued that the claimed methods of logic circuit design were intended to be used in conjunction with computer-based design tools, and were thus not mental processes. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1147-49, 120 USPQ2d 1473, 1480-81 (Fed. Cir. 2016). The court disagreed, because it interpreted the claims as encompassing nothing other than pure mental steps (and thus falling within an abstract idea grouping) because the claims did not include any limitations requiring computer implementation. In contrast, the patentee in Enfish argued that its claimed self-referential table for a computer database was an improvement in an existing technology and thus not directed to an abstract idea. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336-37, 118 USPQ2d 1684, 1689-90 (Fed. Cir. 2016). The court agreed with the patentee, based on its interpretation of the claimed “means for configuring” under 35 U.S.C. 112(f) as requiring a four-step algorithm that achieved the improvements, as opposed to merely any form of storing tabular data. See also McRO, Inc. v. Bandai Namco Games America, Inc. 837 F.3d 1299, 1314, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (the claim’s construction incorporated rules of a particular type that improved an existing technological process). Claim interpretation can also affect the second part of the Alice/Mayo test (whether the claim recites additional elements that amount to significantly more than the judicial exception). For example, in Amdocs (Israel) Ltd. v. Openet Telecom, Inc., where the court relied on the construction of the term “enhance” (to require application of a number of field enhancements in a distributed fashion) to determine that the claim entails an unconventional technical solution to a technological problem. 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016).
III. SUMMARY OF ANALYSIS AND FLOWCHART
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the following flowchart. The flowchart illustrates the steps of the subject matter eligibility analysis for products and processes that are to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter. It is recognized that under the controlling legal precedent there may be variations in the precise contours of the analysis for subject matter eligibility that will still achieve the same end result. The analysis set forth herein promotes examination efficiency and consistency across all technologies.
As shown in the flowchart, Step 1 relates to the statutory categories and ensures that the first criterion is met by confirming that the claim falls within one of the four statutory categories of invention. See MPEP § 2106.03 for more information on Step 1. Step 2, which is the Supreme Court’s Alice/Mayo test, is a two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate if additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception). See MPEP § 2106.04 for more information on Step 2A and MPEP § 2106.05 for more information on Step 2B.
The flowchart also shows three pathways (A, B, and C) to eligibility:
Claims that could have been found eligible at Pathway A (streamlined analysis), but are subjected to further analysis at Steps 2A or Step 2B, will ultimately be found eligible at Pathways B or C. Thus, if the examiner is uncertain about whether a streamlined analysis is appropriate, the examiner is encouraged to conduct a full eligibility analysis. However, if the claim is not found eligible at any of Pathways A, B or C, the claim is patent ineligible and should be rejected under 35 U.S.C. 101.
Regardless of whether a rejection under 35 U.S.C. 101 is made, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. MPEP § 2103.
35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
A process defines “actions”, i.e., an invention that is claimed as an act or step, or a series of acts or steps. As explained by the Supreme Court, a “process” is “a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.” Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (italics added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (“The Supreme Court and this court have consistently interpreted the statutory term ‘process’ to require action”); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) (“[A] process is a series of acts.”) (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in 35 U.S.C. 100(b), the term “process” is synonymous with “method.”
The other three categories (machines, manufactures and compositions of matter) define the types of physical or tangible “things” or “products” that Congress deemed appropriate to patent. Digitech Image Techs. v. Electronics for Imaging, 758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719 (Fed. Cir. 2014) (“For all categories except process claims, the eligible subject matter must exist in some physical or tangible form.”). Thus, when determining whether a claimed invention falls within one of these three categories, examiners should verify that the invention is to at least one of the following categories and is claimed in a physical or tangible form.
It is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. For example, because a microprocessor is generally understood to be a manufacture, a product claim to the microprocessor or a system comprising the microprocessor satisfies Step 1 regardless of whether the claim falls within any other statutory category (such as a machine). It is also not necessary to identify a “correct” category into which the claim falls, because although in many instances it is clear within which category a claimed invention falls, a claim may satisfy the requirements of more than one category. For example, a bicycle satisfies both the machine and manufacture categories, because it is a tangible product that is concrete and consists of parts such as a frame and wheels (thus satisfying the machine category), and it is an article that was produced from raw materials such as aluminum ore and liquid rubber by giving them a new form (thus satisfying the manufacture category). Similarly, a genetically modified bacterium satisfies both the composition of matter and manufacture categories, because it is a tangible product that is a combination of two or more substances such as proteins, carbohydrates and other chemicals (thus satisfying the composition of matter category), and it is an article that was genetically modified by humans to have new properties such as the ability to digest multiple types of hydrocarbons (thus satisfying the manufacture category).
Non-limiting examples of claims that are not directed to any of the statutory categories include:
As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed “device profile” comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category. Another example of an intangible product that does not fall within a statutory category is a paradigm or business model for a marketing company. In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009).
Even when a product has a physical or tangible form, it may not fall within a statutory category. For instance, a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, a transitory, propagating signal does not fall within any statutory category. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03.
II. ELIGIBILITY STEP 1: WHETHER A CLAIM IS TO A STATUTORY CATEGORY
As described in MPEP § 2106, subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what the inventor has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation (BRI). See MPEP § 2106, subsection II, for more information about the importance of understanding what has been invented, and MPEP § 2111 for more information about the BRI.
In the context of the flowchart in MPEP § 2106, subsection III, Step 1 determines whether:
A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason. In such a case, it is a best practice for the examiner to point out the BRI and recommend an amendment, if possible, that would narrow the claim to those embodiments that fall within a statutory category.
For example, the BRI of machine readable media can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves).
If a claim is clearly not within one of the four categories (Step 1: NO), then a rejection under 35 U.S.C. 101 must be made indicating that the claim is directed to non-statutory subject matter. Form paragraphs 7.05 and 7.05.01 should be used; see MPEP § 2106.07(a)(1). However, as shown in the flowchart in MPEP § 2106 subsection III, when a claim fails under Step 1 (Step 1: NO), but it appears from applicant’s disclosure that the claim could be amended to fall within a statutory category (Step 1: YES), the analysis should proceed to determine whether such an amended claim would qualify as eligible at Pathway A, B or C. In such a case, it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)); Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); Gottschalk v. Benson, 409 U.S. 63, 67-68, 175 USPQ 673, 675 (1972). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (“The Court’s precedents provide three specific exceptions to § 101's broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas’”) (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)).
In addition to the terms “laws of nature,” “natural phenomena,” and “abstract ideas,” judicially recognized exceptions have been described using various other terms, including “physical phenomena,” “products of nature,” “scientific principles,” “systems that depend on human intelligence alone,” “disembodied concepts,” “mental processes,” and “disembodied mathematical algorithms and formulas.” It should be noted that there are no bright lines between the types of exceptions, and that many of the concepts identified by the courts as exceptions can fall under several exceptions. For example, mathematical formulas are considered to be a judicial exception as they express a scientific truth, but have been labelled by the courts as both abstract ideas and laws of nature. Likewise, “products of nature” are considered to be an exception because they tie up the use of naturally occurring things, but have been labelled as both laws of nature and natural phenomena. Thus, it is sufficient for this analysis for the examiner to identify that the claimed concept (the specific claim limitation(s) that the examiner believes may recite an exception) aligns with at least one judicial exception.
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are “the basic tools of scientific and technological work”, and are thus excluded from patentability because “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this “exclusionary principle” is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation). See, e.g., Mayo, 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims directed to “narrow laws that may have limited applications” held ineligible); Flook, 437 U.S. at 589-90, 198 USPQ at 197 (claims that did not “wholly preempt the mathematical formula” held ineligible). This is because such a patent would “in practical effect [] be a patent on the [abstract idea, law of nature or natural phenomenon] itself.” Benson, 409 U.S. at 71- 72, 175 USPQ at 676. The concern over preemption was expressed as early as 1852. See Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852) (“A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.”).
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) (“We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection”). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal Circuit decisions, however, have noted the absence of preemption when finding claims eligible under the Alice/Mayo test. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236, 1243-44 (Fed. Cir. 2016).
The Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel or newly discovered, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were “‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” Myriad, 569 U.S. 576, 589, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes and quoting Mayo, 566 U.S. 71, 101 USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 (“the novelty of the mathematical algorithm is not a determining factor at all”); Mayo, 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that the claims embody the researcher's discoveries of laws of nature). The Supreme Court’s cited rationale for considering even “just discovered” judicial exceptions as exceptions stems from the concern that “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’” Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 (“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”). The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was “new”. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a new abstract idea is still an abstract idea”) (emphasis in original).
For a detailed discussion of abstract ideas, see MPEP § 2106.04(a); for a detailed discussion of laws of nature, natural phenomena and products of nature, see MPEP § 2106.04(b).
II. ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
As described in MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68). Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what the inventor has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation. See MPEP § 2106, subsection II for more information about the importance of understanding what has been invented, and MPEP § 2111 for more information about the broadest reasonable interpretation.
Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:
Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception. Together, these prongs represent the first part of the Alice/Mayo test, which determines whether a claim is directed to a judicial exception.
The flowchart below depicts the two-prong analysis that is performed in order to answer the Step 2A inquiry.
Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims “set forth” an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
The Supreme Court has held that Section 101 contains an implicit exception for ‘‘[l]aws of nature, natural phenomena, and abstract ideas,’’ which are ‘‘the basic tools of scientific and technological work.’’ Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (citing Mayo, 566 US at 71, 101 USPQ2d at 1965). Yet, the Court has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has cautioned ‘‘to tread carefully in construing this exclusionary principle lest it swallow all of patent law.’’ Id. See also Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. Cir. 2016) (“The ‘directed to’ inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon”). Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis).
An example of a claim that recites a judicial exception is “A machine comprising elements that operate in accordance with F=ma.” This claim sets forth the principle that force equals mass times acceleration (F=ma) and therefore recites a law of nature exception. Because F=ma represents a mathematical formula, the claim could alternatively be considered as reciting an abstract idea. Because this claim recites a judicial exception, it requires further analysis in Prong Two in order to answer the Step 2A inquiry. An example of a claim that merely involves, or is based on, an exception is a claim to “A teeter-totter comprising an elongated member pivotably attached to a base member, having seats and handles attached at opposing sides of the elongated member.” This claim is based on the concept of a lever pivoting on a fulcrum, which involves the natural principles of mechanical advantage and the law of the lever. However, this claim does not recite these natural principles and therefore is not directed to a judicial exception (Step 2A: NO). Thus, the claim is eligible at Pathway B without further analysis.
If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two. If the claim does not recite a judicial exception (a law of nature, natural phenomenon, or abstract idea), then the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the claim is eligible at Pathway B without further analysis.
For more information how to determine if a claim recites an abstract idea, see MPEP § 2106.04(a). For more information on how to determine if a claim recites a law of nature or natural phenomenon, see MPEP § 2106.04(b). For more information on how to determine if a claim recites a product of nature, see MPEP § 2106.04(c).
2. Prong Two
Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception. If the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (Step 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility analysis. If, however, the additional elements do not integrate the exception into a practical application, then the claim is directed to the recited judicial exception (Step 2A: YES), and requires further analysis under Step 2B (where it may still be eligible if it amounts to an ‘‘inventive concept’’). For more information on how to evaluate whether a judicial exception is integrated into a practical application, see MPEP § 2106.04(d)(2).
The mere inclusion of a judicial exception such as a mathematical formula (which is one of the mathematical concepts identified as an abstract idea in MPEP § 2106.04(a)) in a claim means that the claim “recites” a judicial exception under Step 2A Prong One. However, mere recitation of a judicial exception does not mean that the claim is “directed to” that judicial exception under Step 2A Prong Two. Instead, under Prong Two, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. Prong Two thus distinguishes claims that are “directed to” the recited judicial exception from claims that are not “directed to” the recited judicial exception.
Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) (“Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract”); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.”). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must “transform the nature of the claim” into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible. In such a case, after making the appropriate rejection (see MPEP § 2106.07 for more information on formulating a rejection for lack of eligibility), it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim.
B.Evaluating Claims Reciting Multiple Judicial Exceptions
A claim may recite multiple judicial exceptions. For example, claim 4 at issue in Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) recited two abstract ideas, and the claims at issue in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012) recited two laws of nature. However, these claims were analyzed by the Supreme Court in the same manner as claims reciting a single judicial exception, such as those in Alice Corp., 573 U.S. 208, 110 USPQ2d 1976.
During examination, examiners should apply the same eligibility analysis to all claims regardless of the number of exceptions recited therein. Unless it is clear that a claim recites distinct exceptions, such as a law of nature and an abstract idea, care should be taken not to parse the claim into multiple exceptions, particularly in claims involving abstract ideas. Accordingly, if possible examiners should treat the claim for Prong Two and Step 2B purposes as containing a single judicial exception.
In some claims, the multiple exceptions are distinct from each other, e.g., a first limitation describes a law of nature, and a second limitation elsewhere in the claim recites an abstract idea. In these cases, for purposes of examination efficiency, examiners should select one of the exceptions and conduct the eligibility analysis for that selected exception. If the analysis indicates that the claim recites an additional element or combination of elements that integrate the selected exception into a practical application or that amount to significantly more than the selected exception, then the claim should be considered patent eligible. On the other hand, if the claim does not recite any additional element or combination of elements that integrate the selected exception into a practical application, and also does not recite any additional element or combination of elements that amounts to significantly more than the selected exception, then the claim should be considered ineligible. University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014) (because claims did not amount to significantly more than the recited abstract idea, court “need not decide” if claims also recited a law of nature).
In other claims, multiple abstract ideas, which may fall in the same or different groupings, or multiple laws of nature may be recited. In these cases, examiners should not parse the claim. For example, in a claim that includes a series of steps that recite mental steps as well as a mathematical calculation, an examiner should identify the claim as reciting both a mental process and a mathematical concept for Step 2A Prong One to make the analysis clear on the record. However, if possible, the examiner should consider the limitations together as a single abstract idea for Step 2A Prong Two and Step 2B (if necessary) rather than as a plurality of separate abstract ideas to be analyzed individually.
The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski v. Kappos, 561 U.S. 593, 601-602, 95 USPQ2d 1001, 1006 (2010) (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have declined to define abstract ideas. However, it is clear from the body of judicial precedent that software and business methods are not excluded categories of subject matter. For example, the Supreme Court concluded that business methods are not “categorically outside of § 101's scope,” stating that “a business method is simply one kind of ‘method’ that is, at least in some circumstances, eligible for patenting under § 101.” Bilski, 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) (“there is no categorical business-method exception”). Likewise, software is not automatically an abstract idea, even if performance of a software task involves an underlying mathematical calculation or relationship. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) (“That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction.”); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) (methods of automatic lip synchronization and facial expression animation using computer-implemented rules were not directed to an abstract idea); Enfish, 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016) (claims to self-referential table for a computer database were not directed to an abstract idea).
To facilitate examination, the Office has set forth an approach to identifying abstract ideas that distills the relevant case law into enumerated groupings of abstract ideas. The enumerated groupings are firmly rooted in Supreme Court precedent as well as Federal Circuit decisions interpreting that precedent, as is explained in MPEP § 2106.04(a)(2). This approach represents a shift from the former case-comparison approach that required examiners to rely on individual judicial cases when determining whether a claim recites an abstract idea. By grouping the abstract ideas, the examiners’ focus has been shifted from relying on individual cases to generally applying the wide body of case law spanning all technologies and claim types.
The enumerated groupings of abstract ideas are defined as:
Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above. The groupings of abstract ideas, and their relationship to the body of judicial precedent, are further discussed in MPEP § 2106.04(a)(2).
If the identified limitation(s) falls within at least one of the groupings of abstract ideas, it is reasonable to conclude that the claim recites an abstract idea in Step 2A Prong One. The claim then requires further analysis in Step 2A Prong Two, to determine whether any additional elements in the claim integrate the abstract idea into a practical application, see MPEP § 2106.04(d).
If the identified limitation(s) do not fall within any of the groupings of abstract ideas, it is reasonable to find that the claim does not recite an abstract idea. This concludes the abstract idea judicial exception eligibility analysis, except in the rare circumstance discussed in MPEP § 2106.04(a)(3), below. The claim is thus eligible at Pathway B unless the claim recites, and is directed to, another exception (such as a law of nature or natural phenomenon).
If the claims recites another judicial exception (i.e. law of nature or natural phenomenon), see MPEP §§ 2106.04(b) and 2106.04(c) for more information on Step 2A analysis.
MPEP § 2106.04(a)(1) provides examples of claims that do not recite abstract ideas (or other judicial exceptions) and thus are eligible at Step 2A Prong One.
MPEP § 2106.04(a)(2) provides further explanation on the abstract idea groupings. It should be noted that these groupings are not mutually exclusive, i.e., some claims recite limitations that fall within more than one grouping or sub-grouping. For example, a claim reciting performing mathematical calculations using a formula that could be practically performed in the human mind may be considered to fall within the mathematical concepts grouping and the mental process grouping. Accordingly, examiners should identify at least one abstract idea grouping, but preferably identify all groupings to the extent possible, if a claim limitation(s) is determined to fall within multiple groupings and proceed with the analysis in Step 2A Prong Two.
When evaluating a claim to determine whether it recites an abstract idea, examiners should keep in mind that while “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomenon, or abstract ideas”, not all claims recite an abstract idea. See Alice Corp. Pty. Ltd. v. CLS Bank, Int’l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1980-81 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 US 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Step 2A Prong One analysis articulated in MPEP § 2106.04 accounts for this cautionary principle by requiring a claim to recite (i.e., set forth or describe) an abstract idea in Prong One before proceeding to the Prong Two inquiry about whether the claim is directed to that idea, thereby separating claims reciting abstract ideas from those that are merely based on or involve an abstract idea.
Some claims are not directed to an abstract idea because they do not recite an abstract idea, although it may be apparent that at some level they are based on or involve an abstract idea. Because these claims do not recite an abstract idea (or other judicial exception), they are eligible at Step 2A Prong One (Pathway B).
Non-limiting hypothetical examples of claims that do not recite (set forth or describe) an abstract idea include:
The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Supreme Court has identified a number of concepts falling within this grouping as abstract ideas including: a procedure for converting binary-coded decimal numerals into pure binary form, Gottschalk v. Benson, 409 U.S. 63, 65, 175 USPQ2d 673, 674 (1972); a mathematical formula for calculating an alarm limit, Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ2d 193, 195 (1978); the Arrhenius equation, Diamond v. Diehr, 450 U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ 2d 1001, 1004 (2010).
The Court’s rationale for identifying these “mathematical concepts” as judicial exceptions is that a ‘‘mathematical formula as such is not accorded the protection of our patent laws,’’ Diehr, 450 U.S. at 191, 209 USPQ at 15 (citing Benson, 409 U.S. 63, 175 USPQ 673), and thus ‘‘the discovery of [a mathematical formula] cannot support a patent unless there is some other inventive concept in its application.’’ Flook, 437 U.S. at 594, 198 USPQ at 199. In the past, the Supreme Court sometimes described mathematical concepts as laws of nature, and at other times described these concepts as judicial exceptions without specifying a particular type of exception. See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at 674; Flook, 437 U.S. at 589, 198 USPQ2d at 197; Mackay Radio & Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (‘‘[A] scientific truth, or the mathematical expression of it, is not patentable invention[.]’’). More recent opinions of the Supreme Court, however, have affirmatively characterized mathematical relationships and formulas as abstract ideas. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 218, 110 USPQ2d 1976, 1981 (2014) (describing Flook as holding “that a mathematical formula for computing ‘alarm limits’ in a catalytic conversion process was also a patent-ineligible abstract idea.”); Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (noting that the claimed “concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea,”).
When determining whether a claim recites a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations), examiners should consider whether the claim recites a mathematical concept or merely limitations that are based on or involve a mathematical concept. A claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform did not merely recite “the abstract idea of using ‘mathematical equations for determining the relative position of a moving object to a moving reference frame’.”). For example, a limitation that is merely based on or involves a mathematical concept described in the specification may not be sufficient to fall into this grouping, provided the mathematical concept itself is not recited in the claim.
It is important to note that a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).
A. Mathematical Relationships
A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words or using mathematical symbols. For example, pressure (p) can be described as the ratio between the magnitude of the normal force (F) and area of the surface on contact (A), or it can be set forth in the form of an equation such as p = F/A.
Examples of mathematical relationships recited in a claim include:
A claim that recites a numerical formula or equation will be considered as falling within the “mathematical concepts” grouping. In addition, there are instances where a formula or equation is written in text format that should also be considered as falling within this grouping. For example, the phrase “determining a ratio of A to B” is merely using a textual replacement for the particular equation (ratio = A/B). Additionally, the phrase “calculating the force of the object by multiplying its mass by its acceleration” is using a textual replacement for the particular equation (F= ma).
Examples of mathematical equations or formulas recited in a claim include:
A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
Examples of mathematical calculations recited in a claim include:
The phrase “methods of organizing human activity” is used to describe concepts relating to:
The Supreme Court has identified a number of concepts falling within the “certain methods of organizing human activity” grouping as abstract ideas. In particular, in Alice, the Court concluded that the use of a third party to mediate settlement risk is a ‘‘fundamental economic practice’’ and thus an abstract idea. 573 U.S. at 219–20, 110 USPQ2d at 1982. In addition, the Court in Alice described the concept of risk hedging identified as an abstract idea in Bilski as ‘‘a method of organizing human activity’’. Id. Previously, in Bilski, the Court concluded that hedging is a ‘‘fundamental economic practice’’ and therefore an abstract idea. 561 U.S. at 611–612, 95 USPQ2d at 1010.
The term “certain” qualifies the “certain methods of organizing human activity” grouping as a reminder of several important points. First, not all methods of organizing human activity are abstract ideas (e.g., “a defined set of steps for combining particular ingredients to create a drug formulation” is not a certain "method of organizing human activity”), In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1160-61, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). Second, this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances as explained in MPEP § 2106.04(a)(3). Finally, the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings.
A.Fundamental Economic Practices or Principles
The courts have used the phrases “fundamental economic practices” or “fundamental economic principles” to describe concepts relating to the economy and commerce. Fundamental economic principles or practices include hedging, insurance, and mitigating risks.
The term “fundamental” is not used in the sense of necessarily being “old” or “well-known.” See, e.g., OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1364, 115 U.S.P.Q.2d 1090, 1092 (Fed Cir. 2015) (a new method of price optimization was found to be a fundamental economic concept); In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016) (describing a new set of rules for conducting a wagering game as a “fundamental economic practice”); In re Greenstein, 774 Fed. Appx. 661, 664, 2019 USPQ2d 212400 (Fed Cir. 2019) (non-precedential) (claims to a new method of allocating returns to different investors in an investment fund was a fundamental economic concept). However, being old or well-known may indicate that the practice is fundamental. See, e.g., Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 219-20, 110 USPQ2d 1981-82 (2014) (describing the concept of intermediated settlement, like the risk hedging in Bilski, to be a “‘fundamental economic practice long prevalent in our system of commerce’” and also as “a building block of the modern economy”) (citation omitted); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (claims to the concept of hedging are a “fundamental economic practice long prevalent in our system of commerce and taught in any introductory finance class.”) (citation omitted); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1313, 120 USPQ2d 1353, 1356 (Fed. Cir. 2016) (“The category of abstract ideas embraces ‘fundamental economic practice[s] long prevalent in our system of commerce,’ … including ‘longstanding commercial practice[s]’”).
An example of a case identifying a claim as reciting a fundamental economic practice is Bilski v. Kappos, 561 U.S. 593, 609, 95 USPQ2d 1001, 1009 (2010). The fundamental economic practice at issue was hedging or protecting against risk. The applicant in Bilski claimed “a series of steps instructing how to hedge risk,” i.e., how to protect against risk. 561 U.S. at 599, 95 USPQ2d at 1005. The method allowed energy suppliers and consumers to minimize the risks resulting from fluctuations in market demand for energy. The Supreme Court determined that hedging is “fundamental economic practice” and therefore is an “unpatentable abstract idea.” 561 U.S. at 611-12, 95 USPQ2d at 1010.
Another example of a case identifying a claim as reciting a fundamental economic practice is Bancorp Services., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). The fundamental economic practice at issue in Bancorp pertained to insurance. The patentee in Bancorp claimed methods and systems for managing a life insurance policy on behalf of a policy holder, which comprised steps including generating a life insurance policy including a stable value protected investment with an initial value based on a value of underlying securities, calculating surrender value protected investment credits for the life insurance policy; determining an investment value and a value of the underlying securities for the current day; and calculating a policy value and a policy unit value for the current day. 687 F.3d at 1270-71, 103 USPQ2d at 1427. The court described the claims as an “attempt to patent the use of the abstract idea of [managing a stable value protected life insurance policy] and then instruct the use of well-known [calculations] to help establish some of the inputs into the equation.” 687 F.3d at 1278, 103 USPQ2d at 1433 (alterations in original) (citing Bilski).
Other examples of "fundamental economic principles or practices" include:
“Commercial interactions” or “legal interactions” include agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations.
An example of a claim reciting a commercial or legal interaction, where the interaction is an agreement in the form of contracts, is found in buySAFE, Inc. v. Google, Inc., 765 F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). The agreement at issue in buySAFE was a transaction performance guaranty, which is a contractual relationship. 765 F.3d at 1355, 112 USPQ2d at 1096. The patentee claimed a method in which a computer operated by the provider of a safe transaction service receives a request for a performance guarantee for an online commercial transaction, the computer processes the request by underwriting the requesting party in order to provide the transaction guarantee service, and the computer offers, via a computer network, a transaction guaranty that binds to the transaction upon the closing of the transaction. 765 F.3d at 1351-52, 112 USPQ2d at 1094. The Federal Circuit described the claims as directed to an abstract idea because they were “squarely about creating a contractual relationship--a ‘transaction performance guaranty’.” 765 F.3d at 1355, 112 USPQ2d at 1096.
Other examples of subject matter where the commercial or legal interaction is an agreement in the form of contracts include:
An example of a claim reciting a commercial or legal interaction in the form of a legal obligation is found in Fort Properties, Inc. v. American Master Lease, LLC, 671 F.3d 1317, 101 USPQ2d 1785 (Fed Cir. 2012). The patentee claimed a method of “aggregating real property into a real estate portfolio, dividing the interests in the portfolio into a number of deedshares, and subjecting those shares to a master agreement.” 671 F.3d at 1322, 101 USPQ2d at 1788. The legal obligation at issue was the tax-free exchanges of real estate. The Federal Circuit concluded that the real estate investment tool designed to enable tax-free exchanges was an abstract concept. 671 F.3d at 1323, 101 USPQ2d at 1789.
Other examples of subject matter where the commercial or legal interaction is a legal obligation include:
An example of a claim reciting advertising is found in Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). The patentee in Ultramercial claimed an eleven-step method for displaying an advertisement (ad) in exchange for access to copyrighted media, comprising steps of receiving copyrighted media, selecting an ad, offering the media in exchange for watching the selected ad, displaying the ad, allowing the consumer access to the media, and receiving payment from the sponsor of the ad. 772 F.3d. at 715, 112 USPQ2d at 1754. The Federal Circuit determined that the "combination of steps recites an abstraction—an idea, having no particular concrete or tangible form" and thus was directed to an abstract idea, which the court described as "using advertising as an exchange or currency." Id.
Other examples of subject matter where the commercial or legal interaction is advertising, marketing or sales activities or behaviors include:
An example of a claim reciting business relations is found in Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The business relation at issue in Credit Acceptance is the relationship between a customer and dealer when processing a credit application to purchase a vehicle. The patentee claimed a “system for maintaining a database of information about the items in a dealer’s inventory, obtaining financial information about a customer from a user, combining these two sources of information to create a financing package for each of the inventoried items, and presenting the financing packages to the user.” 859 F.3d at 1054, 123 USPQ2d at 1108. The Federal Circuit described the claims as directed to the abstract idea of “processing an application for financing a loan” and found “no meaningful distinction between this type of financial industry practice” and the concept of intermediated settlement in Alice or the hedging concept in Bilski. 859 F.3d at 1054, 123 USPQ2d at 1108.
Another example of subject matter where the commercial or legal interaction is business relations includes:
The sub-grouping “managing personal behavior or relationships or interactions between people” include social activities, teaching, and following rules or instructions.
An example of a claim reciting managing personal behavior is Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). The patentee in this case claimed methods comprising storing user-selected pre-set limits on spending in a database, and when one of the limits is reached, communicating a notification to the user via a device. 792 F.3d. at 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims were directed to the abstract idea of “tracking financial transactions to determine whether they exceed a pre-set spending limit (i.e., budgeting)”, which “is not meaningfully different from the ideas found to be abstract in other cases before the Supreme Court and our court involving methods of organizing human activity.” 792 F.3d. at 1367-68, 115 USPQ2d at 1640.
Other examples of managing personal behavior recited in a claim include:
An example of a claim reciting social activities is Voter Verified, Inc. v. Election Systems & Software, LLC, 887 F.3d 1376, 126 USPQ2d 1498 (Fed. Cir. 2018). The social activity at issue in Voter Verified was voting. The patentee claimed “[a] method for voting providing for self-verification of a ballot comprising the steps of” presenting an election ballot for voting, accepting input of the votes, storing the votes, printing out the votes, comparing the printed votes to votes stored in the computer, and determining whether the printed ballot is acceptable. 887 F.3d at 1384-85, 126 USPQ2d at 1503-04. The Federal Circuit found that the claims were directed to the abstract idea of “voting, verifying the vote, and submitting the vote for tabulation”, which is a “fundamental activity that forms the basis of our democracy” and has been performed by humans for hundreds of years. 887 F.3d at 1385-86, 126 USPQ2d at 1504-05.
Another example of a claim reciting social activities is Interval Licensing LLC, v. AOL, Inc., 896 F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue was the social activity of “’providing information to a person without interfering with the person’s primary activity.’” 896 F.3d at 1344, 127 USPQ2d 1553 (citing Interval Licensing LLC v. AOL, Inc., 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention manager for acquiring content from an information source, controlling the timing of the display of acquired content, displaying the content, and acquiring an updated version of the previously-acquired content when the information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at 1555. The Federal Circuit concluded that “[s]tanding alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is an abstract idea,” observing that the district court “pointed to the nontechnical human activity of passing a note to a person who is in the middle of a meeting or conversation as further illustrating the basic, longstanding practice that is the focus of the [patent ineligible] claimed invention.” 896 F.3d at 1344-45, 127 USPQ2d at 1559.
An example of a claim reciting following rules or instructions is In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). The patentee claimed a method of playing a dice game including placing wagers on whether certain die faces will appear face up. 911 F.3d at 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims were directed to the abstract idea of “rules for playing games”, which the court characterized as a certain method of organizing human activity. 911 F.3d at 1160-61; 129 USPQ2d at 1011.
Other examples of following rules or instructions recited in a claim include:
The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, “methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’” 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) (“‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’” (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Accordingly, the “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. A discussion of concepts performed in the human mind, as well as concepts that cannot practically be performed in the human mind and thus are not “mental processes”, is provided below with respect to point A.
The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed “conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally,” i.e., “as a person would do it by head and hand.”); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of “translating a functional description of a logic circuit into a hardware component description of the logic circuit” are directed to an abstract idea, because the claims “read on an individual performing the claimed steps mentally or with pencil and paper”). Mental processes performed by humans with the assistance of physical aids such as pens or paper are explained further below with respect to point B.
Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). Mental processes recited in claims that require computers are explained further below with respect to point C.
Because both product and process claims may recite a “mental process”, the phrase “mental processes” should be understood as referring to the type of abstract idea, and not to the statutory category of the claim. The courts have identified numerous product claims as reciting mental process-type abstract ideas, for instance the product claims to computer systems and computer-readable media in Versata Dev. Group. v. SAP Am., Inc., 793 F.3d 1306, 115 USPQ2d 1681 (Fed. Cir. 2015). This concept is explained further below with respect to point D.
The following discussion is meant to guide examiners and provide more information on how to determine whether a claim recites a mental process. Examiners should keep in mind the following points A, B, C, and D when performing this evaluation.
A. A Claim With Limitation(s) That Cannot Practically be Performed in the Human Mind Does Not Recite a Mental Process
Claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations. See SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019) (declining to identify the claimed collection and analysis of network data as abstract because “the human mind is not equipped to detect suspicious activity by using network monitors and analyzing network packets as recited by the claims”); CyberSource, 654 F.3d at 1376, 99 USPQ2d at 1699 (distinguishing Research Corp. Techs. v. Microsoft Corp., 627 F.3d 859, 97 USPQ2d 1274 (Fed. Cir. 2010), and SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 94 USPQ2d 1607 (Fed. Cir. 2010), as directed to inventions that ‘‘could not, as a practical matter, be performed entirely in a human’s mind’’).
Examples of claims that do not recite mental processes because they cannot be practically performed in the human mind include:
In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include:
If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed “conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally,” i.e., “as a person would do it by head and hand.”); Synopsys, 839 F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process of “translating a functional description of a logic circuit into a hardware component description of the logic circuit” are directed to an abstract idea, because the claims “read on an individual performing the claimed steps mentally or with pencil and paper”).
The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another. For instance, in CyberSource, the court determined that the step of “constructing a map of credit card numbers” was a limitation that was able to be performed “by writing down a list of credit card transactions made from a particular IP address.” In making this determination, the court looked to the specification, which explained that the claimed map was nothing more than a listing of several (e.g., four) credit card transactions. The court concluded that this step was able to be performed mentally with a pen and paper, and therefore, it qualified as a mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also Flook, 437 U.S. at 586, 198 USPQ at 196 (claimed “computations can be made by pencil and paper calculations”); University of Florida Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 (Fed. Cir. 2019) (relying on specification’s description of the claimed analysis and manipulation of data as being performed mentally “‘using pen and paper methodologies, such as flowsheets and patient charts’”); Symantec, 838 F.3d at 1318, 120 USPQ2d at 1360 (although claimed as computer-implemented, steps of screening messages can be “performed by a human, mentally or with pen and paper”).
C. A Claim That Requires a Computer May Still Recite a Mental Process
Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures “can be carried out in existing computers long in use, no new machinery being necessary.” 409 U.S at 67, 175 USPQ at 675. See also Mortgage Grader, 811 F.3d at 1324, 117 USPQ2d at 1699 (concluding that concept of “anonymous loan shopping” recited in a computer system claim is an abstract idea because it could be “performed by humans without a computer”).
In evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.
Examiners should keep in mind that both product claims (e.g., computer system, computer-readable medium, etc.) and process claims may recite mental processes. For example, in Mortgage Grader, the patentee claimed a computer-implemented system and a method for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The Federal Circuit determined that both the computer-implemented system and method claims were directed to “anonymous loan shopping”, which was an abstract idea because it could be “performed by humans without a computer.” 811 F.3d. at 1318, 1324-25, 117 USPQ2d at 1695, 1699-1700. See also FairWarning IP, 839 F.3d at 1092, 120 USPQ2d at 1294 (identifying both system and process claims for detecting improper access of a patient's protected health information in a health-care system computer environment as directed to abstract idea of detecting fraud); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1345, 113 USPQ2d 1354, 1356 (Fed. Cir. 2014) (system and method claims of inputting information from a hard copy document into a computer program). Accordingly, the phrase “mental processes” should be understood as referring to the type of abstract idea, and not to the statutory category of the claim.
Examples of product claims reciting mental processes include:
Examples of process claims reciting mental process-type abstract ideas are discussed in the preceding subsections (A) through (C). See, for example, the discussion of Flook, 437 U.S. 584, 198 USPQ 193; Benson, 409 U.S. 63, 175 USPQ 673; Berkheimer, 881 F.3d 1360, 125 USPQ2d 1649; Synopsys, 839 F.3d 1138, 120 USPQ2d 1473; and Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241, supra.
There may be rare circumstances in which an examiner believes a claim limitation should be treated as an abstract idea even though it does not fall within any of the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2) (i.e., mathematical concepts, certain methods of organizing human activity, mental processes). This type of claim limitation is referred to as a “tentative abstract idea.”
In such circumstances, the examiner should evaluate the claim under the subject matter eligibility framework:
The TC Director will give approval for a Step 2B subject matter eligibility rejection of a claim reciting a tentative abstract idea. The ensuing Office action will identify that the claim(s) are directed to a previously non-enumerated abstract idea via form paragraph 7.05.017 and include the TC Director’s signature. The TC Director will then inform Patents Management that this procedure has been used so that the public can be notified, for example, on USPTO.GOV at the Subject Matter Eligibility website.
In response to a Step 2B rejection of a claim reciting a tentative abstract idea, an interview with the examiner may be conducted, which may help advance prosecution and identify patent eligible subject matter. See MPEP § 713. For applications in which an abstract idea has been identified using the tentative abstract idea procedure, an interview with the TC Director that provided approval is not necessary because the examiner retains the authority to withdraw or maintain a rejection upon consideration of applicant’s reply. The examiner is not required to obtain TC Director approval to withdraw or maintain such a § 101 subject matter eligibility rejection.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including “physical phenomena,” “scientific principles”, “natural laws,” and “products of nature.”
I. LAWS OF NATURE AND NATURAL PHENOMENA, GENERALLY
The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the “manifestations of laws of nature” are “part of the storehouse of knowledge,” “free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). “Likewise, Einstein could not patent his celebrated law that E=mc 2 ; nor could Newton have patented the law of gravity.” Id. Nor can one patent “a novel and useful mathematical formula,” Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or “[t]he qualities of . bacteria, . the heat of the sun, electricity, or the qualities of metals,” Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).
The courts have identified the following concepts and products as examples of laws of nature or natural phenomena:
The courts have also noted, however, that not every claim describing a natural ability or quality of a product, or describing a natural process, necessarily recites a law of nature or natural phenomenon. See Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1048-49, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims reciting process steps of fractionating, recovering, and cryopreserving hepatocytes held to be eligible, because they are not focused on merely observing or detecting the ability of hepatocytes to survive multiple freeze-thaw cycles). Thus, in a claimed method of treating cancer with chemotherapy, the cancer cells’ inability to survive chemotherapy is not considered to be a law of nature. Similarly, in a claimed method of treating headaches with aspirin, the human body’s natural response to aspirin is not considered to be a law of nature. These claims are accordingly eligible at Prong One unless they recite another exception, in which case they require further analysis in Prong Two (and Step 2B, if needed) to determine their eligibility. Similarly, a method of producing a new compound is not directed to the individual components’ ability to combine to form the new compound. Id. See also Tilghman v. Proctor, 102 U.S. 707, 729 (1881) (claims reciting process steps for manufacturing fatty acids and glycerol by hydrolyzing fat at high temperature and pressure were held to be eligible, because they are not focused on the chemical principle that fat can be hydrolyzed into its components).
Even if a claim does recite a law of nature or natural phenomenon, it may still be eligible at any of Pathways A through C. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not “directed to” that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
As explained in MPEP § 2106.04, a claim that recites a law of nature or a natural phenomenon requires further analysis in Step 2A Prong Two to determine whether the claim integrates the exception into a practical application.
A claim that does not recite a law of nature or natural phenomenon is eligible at Pathway B (Step 2A: NO) unless the claim recites, and is directed to, another exception (such as an abstract idea, or a product of nature).
II. PRODUCTS OF NATURE
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a “product of nature”. For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they “claim naturally occurring phenomena” and are “squarely within the law of nature exception”); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as “manifestations of laws of nature” and “phenomena of nature”). Step 2A of the Office’s eligibility analysis uses the terms “law of nature” and “natural phenomenon” as inclusive of “products of nature”.
It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g.,Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions. Examples of nature-based products include the isolated gene and cDNA sequences of Myriad, the cloned farm animals of Roslin, and the bacterium of Chakrabarty. As is evident from these examples, and as further discussed in MPEP § 2105, a nature-based product that is a living organism (e.g., a plant, an animal, a bacterium, etc.) is not excluded from patent protection merely because it is alive, and such a product is eligible for patenting if it satisfies the markedly different characteristics analysis.
It is important to keep in mind that under the broadest reasonable interpretation (BRI) of the claims, a nature-based product limitation may encompass both eligible and ineligible products. For example, a claim to a “cloned giraffe” may have a BRI encompassing cloned giraffes with markedly different characteristics, as well as cloned giraffes that lack markedly different characteristics and thus are products of nature. Cf. Roslin, 750 F.3d at 1338-39, 110 USPQ2d at 1673 (applicant could not rely on unclaimed features to distinguish claimed mammals from donor mammals).
Such a claim recites a product of nature, and thus requires further analysis in Prong Two. If the claim is ultimately rejected as failing to encompass an inventive concept (Step 2B: NO), it is a best practice for the examiner to point out the broadest reasonable interpretation and recommend an amendment, if possible, that would narrow the claim to those embodiments that are not directed to products of nature, or that are otherwise eligible.
For claims that recite a nature-based product limitation (which may or may not be a product of nature exception) but which are directed to inventions that clearly do not seek to tie up any judicial exception, examiners should consider whether the streamlined eligibility analysis discussed in MPEP § 2106.06 is appropriate. In such cases, it would not be necessary to conduct a markedly different characteristics analysis.
The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions. For example, Chakrabarty relied on a comparison of the claimed bacterium to naturally occurring bacteria when determining that the claimed bacterium was not a product of nature because it had “markedly different characteristics from any found in nature”. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, Roslin relied on a comparison of the claimed sheep to naturally occurring sheep when determining that the claimed sheep was a product of nature because it “does not possess ‘markedly different characteristics from any [farm animals] found in nature.’” In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ at 197 (alterations in original)).
This section sets forth guidelines for performing the markedly different characteristics analysis, including information on when to perform the analysis, and how to perform the analysis. Examiners should consult these guidelines when performing an eligibility analysis of a claim that recites a nature-based product limitation. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to “a Lactobacillus bacterium”), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, examiners should consider whether the claim recites another exception and thus requires further eligibility analysis.
If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a “product of nature” exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.
I. WHEN TO PERFORM THE MARKEDLY DIFFERENT CHARACTERISTICS ANALYSIS
Because a nature-based product can be claimed by itself (e.g., “a Lactobacillus bacterium”) or as one or more limitations of a claim (e.g., “a probiotic composition comprising a mixture of Lactobacillus and milk in a container”), care should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature-based. Instead, the markedly different characteristics analysis should be applied only to the nature-based product limitations in the claim to determine whether the nature-based products are “product of nature” exceptions.
Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception. However, if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception.
A. Product Claims
Where the claim is to a nature-based product by itself (e.g., a claim to “a Lactobacillus bacterium”), the markedly different characteristics analysis should be applied to the entire product. See, e.g., Chakrabarty, 447 U.S. at 305, 309-10, 206 USPQ at 195, 197-98 (applying analysis to entire claimed “bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway”).
Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to “a probiotic composition comprising a mixture of Lactobacillus and milk”), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. See subsection II, below, for further guidance on the markedly different characteristic analysis.
Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to “a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt”), the markedly different characteristics analysis should be applied only to the nature-based product limitation. For instance, for the yogurt starter kit example, the Lactobacillus would be analyzed for markedly different characteristics. The container and instructions would not be subject to the markedly different characteristics analysis as they are not nature-based products, but would be evaluated as additional elements in Prong Two (and Step 2B if needed) if it is determined that the Lactobacillus does not have markedly different characteristics from any naturally occurring counterpart and thus is a product of nature exception. See, e.g., Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a powder base, only the bacterial mixture was analyzed).
B. Product-by-Process Claims
For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart. See MPEP § 2113 for more information on product-by-process claims.
C. Process Claims
For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. This is because the analysis of a process claim should focus on the active steps of the process rather than the products used in those steps. For example, when evaluating a claimed process of cryopreserving hepatocyte cells comprising performing density gradient fractionation to separate viable and non-viable hepatocytes, recovering the viable hepatocytes, and cryopreserving the recovered viable hepatocytes, the court did not subject the claim to the markedly different characteristics analysis for the nature-based products (the hepatocytes) used in the process. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1049, 119 USPQ2d 1370, 1374 (Fed. Cir. 2016) (claims are directed to a process of creating a preparation of multi-cryopreserved hepatocytes, not to the preparation itself).
However, in the limited situation where a process claim reciting a nature-based product is drafted in such a way that there is no difference in substance from a product claim, the claim is subject to the markedly different analysis for the recited nature-based product. These types of claims are drafted in a way that focuses on the product rather than the process steps. For example, consider a claim that recites, in its entirety, “a method of providing an apple.” Under the broadest reasonable interpretation, this claim is focused on the apple fruit itself, which is a nature-based product. Similarly, claims to detecting naturally occurring cell-free fetal DNA (cffDNA) in maternal blood were held to be directed to the cffDNA, because the “existence and location of cffDNA is a natural phenomenon [and thus] identifying its presence was merely claiming the natural phenomena itself.” Rapid Litig. Mgmt., 827 F.3d at 1048, 119 USPQ2d at 1374, (explaining the holding in Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)).
II. HOW TO PERFORM THE MARKEDLY DIFFERENT CHARACTERISTICS ANALYSIS
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
This section sets forth guidelines for performing the markedly different characteristics analysis, including information on (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are “markedly different”.
A. Selecting The Appropriate Counterpart(s)
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. For example, assume that applicant claims deoxyacid A, which is a chemical derivative of a naturally occurring chemical called acid A. Because the inventor created the claimed nature-based product (deoxyacid A) by modifying the naturally occurring acid A, the closest natural counterpart for deoxyacid A would be the natural product from which it was derived, i.e., acid A. See, e.g.,Chakrabarty, 447 U.S. at 305 and n.1, 206 USPQ at 195 and n.1 (counterpart to genetically modified Pseudomonas bacterium containing multiple plasmids is the naturally occurring unmodified Pseudomonas bacterium from which the claimed bacterium was created); Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72 (counterparts to cloned sheep are naturally occurring sheep such as the donor ewe from which the clone was created).
Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) (comparing isolated BRCA1 genes and BRCA1 cDNA molecules to naturally occurring BRCA1 gene); Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1371, 128 USPQ2d 1221, 1227 (Fed. Cir. 2018) (comparing claimed primers to “their corresponding nucleotide sequences on the naturally occurring DNA”). Similarly, assume that applicant claims a single-stranded piece of DNA (a primer) having a nucleotide sequence derived from the sense strand of naturally occurring nucleic acid C. Although nucleic acid C occurs in nature as a double-stranded molecule having a sense and an antisense strand, the closest natural counterpart for the claimed nucleic acid is the sense strand of C only. See, e.g., University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014) (comparing single-stranded nucleic acid to the same strand found in nature, even though “single-stranded DNA cannot be found in the human body”).
When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. For example, assume that the inventor creates a cloned sheep D by transferring nuclear DNA from a Finn-Dorset sheep into an egg cell (which contains mitochondrial DNA) from a Scottish Blackface sheep. Applicant then claims sheep D. Here, because sheep D was created via combining DNA from two different naturally occurring sheep of different breeds, there is no single closest natural counterpart. The examiner should therefore select the counterpart most closely related to sheep D based on the examiner’s expertise in the particular art. For the example discussed here, the closest counterparts might be naturally occurring Finn-Dorset or Scottish Blackface sheep, as opposed to sheep of a different breed such as Bighorn sheep. Cf. Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72 (claimed sheep produced by nuclear transfer into an oocyte and subsequent manipulation of natural embryonic development processes was compared to naturally occurring sheep such as the donor ewe from which the nuclear material was obtained). When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to “naturally occurring lipid profiles of walnut oil and olive oil”). See subsection II.C.
If the claim is rejected as ineligible, it is a “best practice” for the examiner to identify the selected counterpart in the Office action if the record is not already clear. This practice assists the applicant in responding, and clarifies the record as to how the examiner is interpreting the claim.
B. Identifying Appropriate Characteristics For Analysis
Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare.
Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited. For example, in a claim to “deoxyribose”, the recited chemical name informs those in the art of the structural characteristics of the product (i.e., the “deoxy” prefix indicates that a hydroxyl group has been removed as compared to ribose). In other claims, the characteristic may be apparent from the broadest reasonable interpretation even though it is not explicitly recited in the claim. For example, in a claim to “isolated gene B,” the examiner would need to rely on the broadest reasonable interpretation of “isolated gene B” to determine what characteristics the isolated gene has, e.g., what its nucleotide sequence is, and what, if any, protein it encodes.
Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
Examples of biological or pharmacological functions or activities include, but are not limited to:
Examples of chemical and physical properties include, but are not limited to:
Examples of phenotypic characteristics include, but are not limited to:
Examples of structure and form include, but are not limited to:
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.
1. Examples of Products Having Markedly Different Characteristics
In Chakrabarty, the Supreme Court identified a claimed bacterium as a nature-based product having markedly different characteristics. This bacterium had a changed functional characteristic, i.e., it was able to degrade at least two different hydrocarbons as compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The claimed bacterium also had a different structural characteristic, i.e., it was genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The Supreme Court considered these changed characteristics to be “markedly different characteristics from any found in nature” due to the additional plasmids and resultant capacity for degrading multiple hydrocarbon components of oil. Therefore, the bacterium was eligible. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980).
In Myriad, the Supreme Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 gene as a nature-based product having markedly different characteristics. This claimed cDNA had the same functional characteristics (i.e., it encoded the same protein) as the naturally occurring gene, but had a changed structural characteristic, i.e., a different nucleotide sequence containing only exons, as compared to the naturally occurring sequence containing both exons and introns. The Supreme Court concluded that the “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, [this] cDNA is not a ‘product of nature’” and is eligible. Myriad, 569 U.S. at 595, 106 USPQ2d at 1981.
2. Examples of Products Lacking Markedly Different Characteristics
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 (“Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing”) and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.
In Ambry Genetics, the court identified claimed DNA fragments known as “primers” as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because “single-stranded DNA cannot be found in the human body”. The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence. 774 F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the primers had a different function than when they are part of the DNA strand because when isolated as a primer, a primer can be used as a starting material for a DNA polymerization process. The court disagreed, because this ability to serve as a starting material is innate to DNA itself, and was not created or altered by the patentee:
In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction--a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here--the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.
Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, because the characteristics of the claimed primers were innate to naturally occurring DNA, they lacked markedly different characteristics from nature and were thus product of nature exceptions. A similar result was reached in Marden, where the court held a claim to ductile vanadium ineligible, because the “ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics”. In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931).
In Roslin, the court concluded that claimed clones of farm animals were products of nature, because they lacked markedly different characteristics from the counterpart farm animals found in nature. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014). The inventor created its clones (which included the famous cloned sheep named Dolly) by transferring the genetic material of a donor into an oocyte (egg cell), letting the oocyte develop into an embryo, and then implanting the embryo into a surrogate animal where it developed into a baby animal. The applicant argued that the clones, including Dolly, were eligible because they were created via human ingenuity, and had phenotypic differences such as shape, size and behavior compared to their donors. The court was unpersuaded, explaining that the clones were exact genetic replicas of the donors and thus did not possess markedly different characteristics. 750 F.3d at 1337, 110 USPQ2d at 1671-72 (“Roslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.”). The court noted that the alleged phenotypic differences (e.g., the fact that Dolly may have been taller or heavier than her donor) could not make the clones markedly different because these differences were not claimed. 750 F.3d at 1338, 110 USPQ2d at 1672. See also Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. 2018) (alleged structural differences between linear primers and their counterparts on a circular chromosome were neither claimed nor relevant to the eligibility inquiry).
The Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). Similarly, in a growing body of decisions, the Federal Circuit has distinguished between claims that are ‘‘directed to’’ a judicial exception (which require further analysis to determine their eligibility) and those that are not (which are therefore patent eligible), e.g., claims that improve the functioning of a computer or other technology or technological field. See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972). See, e.g., MPEP § 2106.06(b) (summarizing Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or computer functionality instead of being directed to abstract ideas).
Accordingly, after determining that a claim recites a judicial exception in Step 2A Prong One, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. Whether or not a claim integrates a judicial exception into a practical application is evaluated using the considerations set forth in subsection I below, in accordance with the procedure described below in subsection II.
In the context of the flowchart in MPEP § 2106, subsection III, Step 2A Prong Two determines whether:
The Supreme Court and Federal Circuit have identified a number of considerations as relevant to the evaluation of whether the claimed additional elements demonstrate that a claim is directed to patent-eligible subject matter. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in MPEP § 2106.05(a) through (c) and MPEP § 2106.05(e) through (h).
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
Step 2A Prong Two is similar to Step 2B in that both analyses involve evaluating a set of judicial considerations to determine if the claim is eligible. See MPEP §§ 2106.05(a) through (h) for the list of considerations that are evaluated at Step 2B. Although most of these considerations overlap (i.e., they are evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners should ensure that they give weight to all additional elements, whether or not they are conventional, when evaluating whether a judicial exception has been integrated into a practical application. Additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.
It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (“The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point”). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis are not “sufficient” to render claim 1 patent eligible merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) (“that the improvement is not defined by reference to ‘physical’ components does not doom the claims”). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).
In addition, a specific way of achieving a result is not a stand-alone consideration in Step 2A Prong Two. However, the specificity of the claim limitations is relevant to the evaluation of several considerations including the use of a particular machine, particular transformation and whether the limitations are mere instructions to apply an exception. See MPEP §§ 2106.05(b), 2106.05(c), and 2106.05(f). For example, in Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted that the “patent application does not purport to explain how to select the appropriate margin of safety, the weighting factor, or any of the other variables” in the claimed mathematical formula, “[n]or does it purport to contain any disclosure relating to the chemical processes at work, the monitoring of process variables, or the means of setting off an alarm or adjusting an alarm system.” 437 U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any specifics of how to use the claimed formula informative when deciding that the additional elements in the claim were insignificant post-solution activity and thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 USPQ at 197.
II. HOW TO EVALUATE WHETHER THE ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION
The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).
Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. Not all considerations will be relevant to every element, or every claim. Because the evaluation in Prong Two is not a weighing test, it is not important how the elements are characterized or how many considerations apply from the list. It is important to evaluate the significance of the additional elements relative to the invention, and to keep in mind the ultimate question of whether the exception is integrated into a practical application. If the claim as a whole integrates the judicial exception into a practical application based upon evaluation of these considerations, the additional limitations impose a meaningful limit on the judicial exception and the claim is eligible at Step 2A.
Examiners should examine each claim for eligibility separately, based on the particular elements recited therein. Claims should not be judged to automatically stand or fall with similar claims in an application. For instance, one claim may be ineligible because it is directed to a judicial exception without amounting to significantly more, but another claim dependent on the first may be eligible because it recites additional elements that do amount to significantly more, or that integrate the exception into a practical application.
For more information on how to evaluate claims reciting multiple judicial exceptions, see MPEP § 2106.04, subsection II.B.
III. EXAMPLES OF HOW THE OFFICE EVALUATES WHETHER THE CLAIM AS A WHOLE INTEGRATES THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application. Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. However, the way in which the additional elements use or interact with the exception may integrate it into a practical application. Accordingly, the additional limitations should not be evaluated in a vacuum, completely separate from the recited judicial exception. Instead, the analysis should take into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application.
Two examples of how the Office evaluates whether the claim as a whole integrates the recited judicial exception into a practical application are provided. In Solutran, Inc. v. Elavon, Inc., 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for electronically processing paper checks, all of which contained limitations setting forth receiving merchant transaction data from a merchant, crediting a merchant’s account, and receiving and scanning paper checks after the merchant’s account is credited. In part one of the Alice/Mayo test, the Federal Circuit determined that the claims were directed to the abstract idea of crediting the merchant’s account before the paper check is scanned. The court first determined that the recited limitations of “crediting a merchant’s account as early as possible while electronically processing a check” is a “long-standing commercial practice” like in Alice and Bilski. 931 F.3d at 1167, 2019 USPQ2d 281076, at *5 (Fed. Cir. 2019). The Federal Circuit then continued with its analysis under part one of the Alice/Mayo test finding that the claims are not directed to an improvement in the functioning of a computer or an improvement to another technology. In particular, the court determined that the claims “did not improve the technical capture of information from a check to create a digital file or the technical step of electronically crediting a bank account” nor did the claims “improve how a check is scanned.” Id. This analysis is equivalent to the Office’s analysis of determining that the exception is not integrated into a practical application at Step 2A Prong Two, and thus that the claims are directed to the judicial exception (Step 2A: YES).
In Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed invention was a method of virus scanning that scans an application program, generates a security profile identifying any potentially suspicious code in the program, and links the security profile to the application program. 879 F.3d at 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus screening was an abstract idea, and that merely performing virus screening on a computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. The court then continued with its analysis under part one of the Alice/Mayo test by reviewing the patent’s specification, which described the claimed security profile as identifying both hostile and potentially hostile operations. The court noted that the security profile thus enables the invention to protect the user against both previously unknown viruses and “obfuscated code,” as compared to traditional virus scanning, which only recognized the presence of previously-identified viruses. The security profile also enables more flexible virus filtering and greater user customization. 879 F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving computer functionality, and verified that the claims recite additional elements (e.g., specific steps of using the security profile in a particular way) that reflect this improvement. Accordingly, the court held the claims eligible as not being directed to the recited abstract idea. 879 F.3d at 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s analysis of determining that the additional elements integrate the judicial exception into a practical application at Step 2A Prong Two, and thus that the claims were not directed to the judicial exception (Step 2A: NO).
A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A because they are not “directed to” the recited judicial exception.
The courts have not provided an explicit test for this consideration, but have instead illustrated how it is evaluated in numerous decisions. These decisions, and a detailed explanation of how examiners should evaluate this consideration are provided in MPEP § 2106.05(a). In short, first the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification. The claim itself does not need to explicitly recite the improvement described in the specification (e.g., “thereby increasing the bandwidth of the channel”).
While the courts usually evaluate “improvements” as part of the “directed to” inquiry in part one of the Alice/Mayo test (equivalent to Step 2A), they have also performed this evaluation in part two of the Alice/Mayo test (equivalent to Step 2B). See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the improvement analysis at Step 2A Prong Two differs in some respects from the improvements analysis at Step 2B. Specifically, the “improvements” analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity. It should be noted that while this consideration is often referred to in an abbreviated manner as the “improvements consideration,” the word “improvements” in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.
Examples of claims that improve technology and are not directed to a judicial exception include: Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) (claims to a self-referential table for a computer database were directed to an improvement in computer capabilities and not directed to an abstract idea); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation were directed to an improvement in computer-related technology and not directed to an abstract idea); Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed to an improvement in computer capabilities and not an abstract idea); Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an improvement in computer technology and not directed to an abstract idea); SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1303 (Fed. Cir. 2019) (claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology and not directed to an abstract idea). Additional examples are provided in MPEP § 2106.05(a).
A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A, because they are not “directed to” the recited judicial exception.
The particular treatment or prophylaxis consideration originated as part of the other meaningful limitations consideration discussed in MPEP § 2106.05(e) and shares the same legal basis in Supreme Court jurisprudence as that consideration. However, recent jurisprudence has provided additional guidance that is especially relevant to only a subset of claims, thus warranting the elevation of the particular treatment or prophylaxis consideration to become a stand-alone consideration in the Step 2A Prong Two analysis. Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism. 887 F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: (1) performing a genotyping assay to determine if a patient has a genotype associated with poor drug metabolism; and (2) administering iloperidone to the patient in a dose range that depends on the patient’s genotype. Id. Although Vanda’s claims recited a law of nature (the naturally occurring relationship between the patient’s genotype and the risk of QTc prolongation) like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012), the Federal Circuit distinguished them from the Mayo claims based on the differences in the administration steps. In particular, the court explained that Mayo’s step of administering a drug to a patient was performed in order to gather data about the recited laws of nature, and this step was thus ancillary to the overall diagnostic focus of the claims. 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, Vanda’s claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, 126 USPQ2d at 1280. Accordingly, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not “directed to” the recited judicial exception. 887 F.3d at 1136, 126 USPQ2d at 1281.
Examples of “treatment” and prophylaxis” limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).
Examiners should keep in mind that in order to qualify as a “treatment” or “prophylaxis” limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of “administering amazonic acid to a patient” or a step of “administering a course of plasmapheresis to a patient.” If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a “pharmaceutical composition” or that a “feed dispenser is operable to dispense a mineral supplement” are not affirmative limitations because they are merely indicating how the claimed invention might be used.
When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.
The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).
An inventive concept “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.” Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, “we then ask, ‘[w]hat else is there in the claims before us?”) (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) (“Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract”). Instead, an “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Because this approach considers all claim elements, the Supreme Court has noted that “it is consistent with the general rule that patent claims ‘must be considered as a whole.’” Alice Corp., 573 U.S. at 218 n.3, 110 USPQ2d at 1981 (quoting Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 8-9 (1981)). Consideration of the elements in combination is particularly important, because even if an additional element does not amount to significantly more on its own, it can still amount to significantly more when considered in combination with the other elements of the claim. See, e.g., Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (process reciting combination of individually well-known freezing and thawing steps was “far from routine and conventional” and thus eligible); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be found in the non-conventional and non-generic arrangement of components that are individually well-known and conventional).
Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (“The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”). Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d).
A. Relevant Considerations For Evaluating Whether Additional Elements Amount To An Inventive Concept
The Supreme Court has identified a number of considerations as relevant to the evaluation of whether the claimed additional elements amount to an inventive concept. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in in MPEP § 2106.05(a) through (h).
Limitations that the courts have found to qualify as “significantly more” when recited in a claim with a judicial exception include:
Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2B. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception is not in itself an inventive concept and does not guarantee eligibility:
The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point. There is no dispute that a computer is a tangible system (in § 101 terms, a “machine”), or that many computer-implemented claims are formally addressed to patent-eligible subject matter. But if that were the end of the § 101 inquiry, an applicant could claim any principle of the physical or social sciences by reciting a computer system configured to implement the relevant concept. Such a result would make the determination of patent eligibility “depend simply on the draftsman’s art,” Flook, supra, at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451, thereby eviscerating the rule that “‘[l]aws of nature, natural phenomena, and abstract ideas are not patentable,’” Myriad, 133 S. Ct. 1289, 186 L. Ed. 2d 124, 133).
Alice Corp., 573 U.S. at 224, 110 USPQ2d at 1983-84 (alterations in original). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis “do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible” merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) (“that the improvement is not defined by reference to ‘physical’ components does not doom the claims”). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).
B. Examples Of How Courts Conduct The Search For An Inventive Concept
Alice Corp. provides an example of how courts conduct the significantly more analysis. In this case, the Supreme Court analyzed claims to computer systems, computer readable media, and computer-implemented methods, all of which described a scheme for mitigating “settlement risk,” which is the risk that only one party to an agreed-upon financial exchange will satisfy its obligation. In part one of the Alice/Mayo test, the Court determined that the claims were directed to the abstract idea of mitigating settlement risk. Alice Corp., 573 U.S. at 221, 110 USPQ2d at 1982. The Court then walked through part two of the Alice/Mayo test, in which:
Based on this analysis, the Court concluded that the claims amounted to “‘nothing significantly more’ than an instruction to apply the abstract idea of intermediated settlement using some unspecified, generic computer”, and therefore held the claims ineligible because they were directed to a judicial exception and failed the second part of the Alice/Mayo test. Alice Corp., 573 U.S. at 225-27, 110 USPQ2d at 1984.
BASCOM provides another example of how courts conduct the significantly more analysis, and of the critical importance of considering the additional elements in combination. In this case, the Federal Circuit vacated a judgment of ineligibility because the district court failed to properly perform the second step of the Alice/Mayo test when analyzing a claimed system for filtering content retrieved from an Internet computer network. BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 119 USPQ2d 1236 (Fed. Cir. 2016). The Federal Circuit agreed with the district court that the claims were directed to the abstract idea of filtering Internet content, and then walked through the district court’s analysis in part two of the Alice/Mayo test, noting that:
Based on this analysis, the Federal Circuit concluded that the district court erred by failing to recognize that when combined, an inventive concept may be found in the non-conventional and non-generic arrangement of the additional elements, i.e., the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user. 827 F.3d at 1350, 119 USPQ2d at 1242.
II. ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN “INVENTIVE CONCEPT”
As described in MPEP § 2106, subsection III, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what the inventor has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation. See MPEP § 2106, subsection II for more information about the importance of understanding what has been invented, and MPEP § 2111 for more information about the broadest reasonable interpretation.
Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
This evaluation is made with respect to the considerations that the Supreme Court has identified as relevant to the eligibility analysis, which are introduced generally in Part I.A of this section, and discussed in detail in MPEP § 2106.05(a) through (h). Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. Not all considerations will be relevant to every element, or every claim. Because the evaluation in Step 2B is not a weighing test, it is not important how the elements are characterized or how many considerations apply from this list. It is important to evaluate the significance of the additional elements relative to the invention, and to keep in mind the ultimate question of whether the additional elements encompass an inventive concept.
Although the conclusion of whether a claim is eligible at Step 2B requires that all relevant considerations be evaluated, most of these considerations were already evaluated in Step 2A Prong Two. Thus, in Step 2B, examiners should:
In the context of the flowchart in MPEP § 2106, subsection III, Step 2B determines whether:
Examiners should examine each claim for eligibility separately, based on the particular elements recited therein. Claims should not be judged to automatically stand or fall with similar claims in an application. For instance, one claim may be ineligible because it is directed to a judicial exception without amounting to significantly more, but another claim dependent on the first may be eligible because it recites additional elements that do amount to significantly more.
For more information on how to evaluate claims reciting multiple judicial exceptions, see MPEP § 2106.04, subsection II.B.
If the claim as a whole does recite significantly more than the exception itself, the claim is eligible (Step 2B: YES) at Pathway C, and the eligibility analysis is complete. If there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible (Step 2B: NO) and should be rejected under 35 U.S.C. 101. See MPEP § 2106.07 for information on how to formulate an ineligibility rejection.
In determining patent eligibility, examiners should consider whether the claim “purport(s) to improve the functioning of the computer itself” or “any other technology or technical field.” Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). This consideration has also been referred to as the search for a technological solution to a technological problem. See e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016).
While improvements were evaluated in Alice Corp. as relevant to the search for an inventive concept (Step 2B), several decisions of the Federal Circuit have also evaluated this consideration when determining whether a claim was directed to an abstract idea (Step 2A). See, e.g., Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Visual Memory, LLC v. NVIDIA Corp., 867 F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017). Thus, an examiner should evaluate whether a claim contains an improvement to the functioning of a computer or to any other technology or technical field at Step 2A Prong Two and Step 2B, as well as when considering whether the claim has such self-evident eligibility that it qualifies for the streamlined analysis. See MPEP § 2106.04(d)(1) for more information about evaluating improvements in Step 2A Prong Two, and MPEP § 2106.07(b) for more information about improvements in the streamlined analysis context.
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., “thereby increasing the bandwidth of the channel”). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim “as a whole,” in other words, the claim should be evaluated “as an ordered combination, without ignoring the requirements of the individual steps.” When performing this evaluation, examiners should be “careful to avoid oversimplifying the claims” by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
During examination, the examiner should analyze the “improvements” consideration by evaluating the specification and the claims to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. Generally, examiners are not expected to make a qualitative judgement on the merits of the asserted improvement. If the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification. See, e.g.MPEP § 716.09 on 37 CFR 1.132 practice with respect to rejections under 35 U.S.C. 112(a). For example, in response to a rejection under 35 U.S.C. 101, an applicant could submit a declaration under § 1.132 providing testimony on how one of ordinary skill in the art would interpret the disclosed invention as improving technology and the underlying factual basis for that conclusion.
I. IMPROVEMENTS TO COMPUTER FUNCTIONALITY
In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification’s discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691.
Examples that the courts have indicated may show an improvement in computer-functionality:
It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology. See RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122 USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data using image codes assigned to particular facial features held ineligible because the process did not require a computer).
Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality:
The courts have also found that improvements in technology beyond computer functionality may demonstrate patent eligibility. In McRO, the Federal Circuit held claimed methods of automatic lip synchronization and facial expression animation using computer-implemented rules to be patent eligible under 35 U.S.C. 101, because they were not directed to an abstract idea. McRO, 837 F.3d at 1316, 120 USPQ2d at 1103. The basis for the McRO court's decision was that the claims were directed to an improvement in computer animation and thus did not recite a concept similar to previously identified abstract ideas. Id. The court relied on the specification's explanation of how the claimed rules enabled the automation of specific animation tasks that previously could not be automated. 837 F.3d at 1313, 120 USPQ2d at 1101. The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process. 837 F.3d at 1314, 120 USPQ2d at 1102. The McRO court also noted that the claims at issue described a specific way (use of particular rules to set morph weights and transitions through phonemes) to solve the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome, and thus were not directed to an abstract idea. 837 F.3d at 1313, 120 USPQ2d at 1101.
Consideration of improvements is relevant to the eligibility analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management v. CellzDirect, Inc., 827 F.3d 1042, 119 USPQ2d 1370 (Fed. Cir. 2016), in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural. Notably, the court did not distinguish between the types of technology when determining the invention improved technology. However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.
Examples that the courts have indicated may be sufficient to show an improvement in existing technology include:
To show that the involvement of a computer assists in improving the technology, the claims must recite the details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology. See MPEP § 2106.05(f) for more information about mere instructions to apply an exception.
Examples that the courts have indicated may not be sufficient to show an improvement to technology include:
When determining whether a claim integrates a judicial exception, into a practical application in Step 2A Prong Two and whether a claim recites significantly more than a judicial exception in Step 2B, examiners should consider whether the judicial exception is applied with, or by use of, a particular machine. "The machine-or-transformation test is a useful and important clue, and investigative tool” for determining whether a claim is patent eligible under § 101. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).
It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Id.
All claims must be evaluated for eligibility using the two-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exception at Step 2A, or amounts to significantly more than any recited exception in Step 2B), then the claim is eligible even if it fails the machine-or-transformation test ("M-or-T test"). Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not satisfy the M-or-T test); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (“[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable”). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) (“[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an 'inventive concept.'”).
Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether an element (or combination of elements) is a particular machine. For information on the definition of the term “machine,” see MPEP § 2106.03.
When determining whether a machine recited in a claim provides significantly more, the following factors are relevant.
I. THE PARTICULARITY OR GENERALITY OF THE ELEMENTS OF THE MACHINE OR APPARATUS
The particularity or generality of the elements of the machine or apparatus, i.e., the degree to which the machine in the claim can be specifically identified (not any and all machines). One example of applying a judicial exception with a particular machine is Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86, 40 USPQ 199 (1939). In this case, a mathematical formula was employed to use standing wave phenomena in an antenna system. The claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged. 306 U.S. at 95-96; 40 USPQ at 203. Another example is Eibel Process, in which gravity (a law of nature or natural phenomenon) was applied by a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web. Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923).
II. WHETHER THE MACHINE OR APPARATUS IMPLEMENTS THE STEPS OF THE METHOD
Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. See CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) ("We are not persuaded by the appellant's argument that the claimed method is tied to a particular machine because it ‘would not be necessary or possible without the Internet.’ . . . Regardless of whether "the Internet" can be viewed as a machine, it is clear that the Internet cannot perform the fraud detection steps of the claimed method"). For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must “play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly”).
III. WHETHER ITS INVOLVEMENT IS EXTRA-SOLUTION ACTIVITY OR A FIELD-OF-USE
Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) (“[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’” 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively.
Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two and whether a claim recites significantly more in Step 2B is whether the claim effects a transformation or reduction of a particular article to a different state or thing. "[T]ransformation and reduction of an article ‘to a different state or thing’ is the clue to patentability of a process claim that does not include particular machines." Bilski v. Kappos, 561 U.S. 593, 658, 95 USPQ2d 1001, 1007 (2010) (quoting Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972)). If such a transformation exists, the claims are likely to be significantly more than any recited judicial exception or to integrate any recited judicial exception into a practical application.
It is noted that while the transformation of an article is an important clue, it is not a stand-alone test for eligibility. Id.
All claims must be evaluated for eligibility using the two-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exception at Step 2A, or amounts to significantly more than any recited exception in Step 2B), then the claim is eligible even if it “fails” the M-or-T test. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010) (explaining that a claim may be eligible even if it does not satisfy the M-or-T test); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (“[T]here is nothing that requires a method ‘be tied to a machine or transform an article’ to be patentable”). And if a claim fails the Alice/Mayo test (i.e., is directed to an exception at Step 2A and does not amount to significantly more than the exception in Step 2B), then the claim is ineligible even if it passes the M-or-T test. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014) (“[I]n Mayo, the Supreme Court emphasized that satisfying the machine-or-transformation test, by itself, is not sufficient to render a claim patent-eligible, as not all transformations or machine implementations infuse an otherwise ineligible claim with an “inventive concept.”).
Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a claim satisfies the particular transformation consideration.
An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. “Transformation” of an article means that the “article” has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Purely mental processes in which thoughts or human based actions are “changed” are not considered an eligible transformation. For data, mere “manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’” has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994)).
Tilghman v. Proctor, 102 U.S. 707 (1881), provides an example of effecting a transformation of a particular article to a different state or thing. In that case, the claim was directed to a process of subjecting a mixture of fat and water to a high degree of heat and included additional parameters relating to the level of heat, the quantities of fat and water, and the strength of the mixing vessel. The claimed process, which used the natural principle that the elements of neutral fat require that they be severally united with an atomic equivalent of water in order to separate and become free, resulted in the transformation of the fatty bodies into fat acids and glycerine. Id. at 729.
Where a transformation is recited in a claim, the following factors are relevant to the analysis:
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry. This consideration is only evaluated in Step 2B of the eligibility analysis.
If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility. If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 113 USPQ2d 1097 (Fed. Cir. 2014), provides an example of additional elements that favored eligibility because they were more than well-understood, routine conventional activities in the field. The claims in DDR Holdings were directed to systems and methods of generating a composite webpage that combines certain visual elements of a host website with the content of a third-party merchant. 773 F.3d at 1248, 113 USPQ2d at 1099. The court found that the claim had additional elements that amounted to significantly more than the abstract idea, because they modified conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, which differed from the conventional operation of Internet hyperlink protocol that transported the user away from the host’s webpage to the third party’s webpage when the hyperlink was activated. 773 F.3d at 1258-59, 113 USPQ2d at 1106-07. Thus, the claims in DDR Holdings were eligible.
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were “well known” and, thus, did not amount to a patentable application of the mathematical formula)). In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists “routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds.” 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
I. EVALUATING WHETHER THE ADDITIONAL ELEMENTS ARE WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY
When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity. In this respect, the well-understood, routine, conventional consideration overlaps with other Step 2B considerations, particularly the improvement consideration (see MPEP § 2106.05(a)), the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a particular element or combination of elements is well-understood, routine, conventional activity.
In addition, examiners should keep in mind the following points when determining whether additional elements define only well-understood, routine, conventional activity.
A rejection should only be made if an examiner relying on the examiner's expertise in the art can conclude in the Step 2B inquiry that the additional elements do not amount to significantly more (Step 2B: NO). If the elements or functions are beyond those recognized in the art or by the courts as being well‐understood, routine, conventional activity, then the elements or functions will in most cases amount to significantly more (Step 2B: YES). For more information on formulating a subject matter eligibility rejection involving well-understood, routine, conventional activity, see MPEP § 2106.07(a).
II. ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS
Because examiners should rely on what the courts have recognized, or those of ordinary skill in the art would recognize, as elements that describe well‐understood, routine activities, the following section provides examples of elements that have been recognized by the courts as well-understood, routine, conventional activity in particular fields. It should be noted, however, that many of these examples failed to satisfy other considerations (e.g., because they were recited at a high level of generality and thus were mere instructions to apply an exception, or were insignificant extra-solution activity). Thus, examiners should carefully analyze additional elements in a claim with respect to all relevant Step 2B considerations, including this consideration, before making a conclusion as to whether they amount to an inventive concept.
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
This listing is not meant to imply that all computer functions are well‐understood, routine, conventional activities, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible. See e.g. Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1316, 120 USPQ2d 1527, 1549 (Fed. Cir. 2016), BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed. Cir. 2016). Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). On the other hand, courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1257-59, 113 USPQ2d 1097, 1105-07 (Fed. Cir. 2014).
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
Below are examples of other types of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
The analysis of whether the claim includes other meaningful limitations may be relevant for both eligibility analysis Step 2A Prong Two, and Step 2B.
The claim should add meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment to transform the judicial exception into patent-eligible subject matter. The phrase “meaningful limitations” has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole. The considerations described in MPEP § 2106.05(a)-(d) are meaningful limitations when they amount to significantly more than the judicial exception, or when they integrate a judicial exception into a practical application. This broad label signals that there can be other considerations besides those described in MPEP § 2106.05(a)-(d) that when added to a judicial exception amount to meaningful limitations that can transform a claim into patent-eligible subject matter.
Diamond v. Diehr provides an example of a claim that recited meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. 450 U.S. 175, 209 USPQ 1 (1981). In Diehr, the claim was directed to the use of the Arrhenius equation (an abstract idea or law of nature) in an automated process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The Court evaluated additional elements such as the steps of installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time, and found them to be meaningful because they sufficiently limited the use of the mathematical equation to the practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at 7, 8. In contrast, the claims in Alice Corp. v. CLS Bank International did not meaningfully limit the abstract idea of mitigating settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court concluded that the additional elements such as the data processing system and communications controllers recited in the system claims did not meaningfully limit the abstract idea because they merely linked the use of the abstract idea to a particular technological environment (i.e., “implementation via computers”) or were well-understood, routine, conventional activity recited at a high level of generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85.
Classen Immunotherapies Inc. v. Biogen IDEC provides another example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the lower court’s prior holding of ineligibility in view of Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In Classen, the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune-mediated disorders in mammals in order to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at 1495-96. Although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application.” 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. In contrast, in OIP Technologies, Inc. v. Amazon.com, Inc., the court determined that the additional steps to “test prices and collect data based on the customer reactions” did not meaningfully limit the abstract idea of offer-based price optimization, because the steps were well-understood, routine, conventional data-gathering activities. 788 F.3d 1359, 1363-64, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015).
With respect to treatment or prophylaxis limitations, such as the immunization step in Classen, examiners should note that the other meaningful limitations consideration overlaps with the particular treatment or prophylaxis consideration that is evaluated in Step 2A Prong Two (see MPEP § 2106.04(d)(2)).
When evaluating whether additional elements meaningfully limit the judicial exception, it is particularly critical that examiners consider the additional elements both individually and as a combination. When an additional element is considered individually by an examiner, the additional element may be enough to qualify as “significantly more” if it meaningfully limits the judicial exception, and may also add a meaningful limitation by integrating the judicial exception into a practical application. However, even in the situation where the individually-viewed elements do not add significantly more or integrate the exception, those additional elements when viewed in combination may render the claim eligible. See Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ2d 1, 9 (1981) (“a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made”); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It is important to note that, when appropriate, an examiner may explain on the record why the additional elements meaningfully limit the judicial exception.
Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do “‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’”. Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a § 101 analysis that turns on “the draftsman’s art”).
The Supreme Court has identified additional elements as mere instructions to apply an exception in several cases. For instance, in Mayo, the Supreme Court concluded that a step of determining thiopurine metabolite levels in patients’ blood did not amount to significantly more than the recited laws of nature, because this additional element simply instructed doctors to apply the laws by measuring the metabolites in any way the doctors (or medical laboratories) chose to use. 566 U.S. at 79, 101 USPQ2d at 1968. In Alice Corp., the claim recited the concept of intermediated settlement as performed by a generic computer. The Court found that the recitation of the computer in the claim amounted to mere instructions to apply the abstract idea on a generic computer. 573 U.S. at 225-26, 110 USPQ2d at 1984. The Supreme Court also discussed this concept in an earlier case, Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972), where the claim recited a process for converting binary-coded-decimal (BCD) numerals into pure binary numbers. The Court found that the claimed process had no meaningful practical application except in connection with a computer. Benson, 409 U.S. at 71-72, 175 USPQ at 676. The claim simply stated a judicial exception (e.g., law of nature or abstract idea) while effectively adding words that “apply it” in a computer. Id.
Requiring more than mere instructions to apply an exception does not mean that the claim must be narrow in order to be eligible. The courts have identified some broad claims as eligible see, e.g.,McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016); Thales Visionix Inc. v. United States, 850 F.3d. 1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and some narrow claims as ineligible see e.g.,Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 112 USPQ2d 1750 (Fed. Cir. 2014); Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016). Thus, examiners should carefully consider each claim on its own merits, as well as evaluate all other relevant considerations, before making a determination of whether an element (or combination of elements) is more than mere instructions to apply an exception. For example, because this consideration often overlaps with the improvement consideration (see MPEP § 2106.05(a)), the particular machine and particular transformation considerations (see MPEP § 2106.05(b) and (c), respectively), and the well-understood, routine, conventional consideration (see MPEP § 2106.05(d)), evaluation of those other considerations may assist examiners in making a determination of whether an element (or combination of elements) is more than mere instructions to apply an exception. Note, however, that examiners should not evaluate the well-understood, routine, conventional consideration in the Step 2A Prong Two analysis, because that consideration is only evaluated in Step 2B.
For claim limitations that do not amount to more than a recitation of the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners should explain why they do not meaningfully limit the claim in an eligibility rejection. For example, an examiner could explain that implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. For more information on formulating a subject matter eligibility rejection. See MPEP § 2106.07(a).
When determining whether a claim simply recites a judicial exception with the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners may consider the following:
(1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). In contrast, claiming a particular solution to a problem or a particular way to achieve a desired outcome may integrate the judicial exception into a practical application or provide significantly more. See Electric Power, 830 F.3d at 1356, 119 USPQ2d at 1743.
By way of example, in Intellectual Ventures I v. Capital One Fin. Corp., 850 F.3d 1332, 121 USPQ2d 1940 (Fed. Cir. 2017), the steps in the claims described “the creation of a dynamic document based upon ‘management record types’ and ‘primary record types.’” 850 F.3d at 1339-40; 121 USPQ2d at 1945-46. The claims were found to be directed to the abstract idea of “collecting, displaying, and manipulating data.” 850 F.3d at 1340; 121 USPQ2d at 1946. In addition to the abstract idea, the claims also recited the additional element of modifying the underlying XML document in response to modifications made in the dynamic document. 850 F.3d at 1342; 121 USPQ2d at 1947-48. Although the claims purported to modify the underlying XML document in response to modifications made in the dynamic document, nothing in the claims indicated what specific steps were undertaken other than merely using the abstract idea in the context of XML documents. The court thus held the claims ineligible, because the additional limitations provided only a result-oriented solution and lacked details as to how the computer performed the modifications, which was equivalent to the words “apply it”. 850 F.3d at 1341-42; 121 USPQ2d at 1947-48 (citing Electric Power Group., 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims “so result focused, so functional, as to effectively cover any solution to an identified problem”)).
Other examples where the courts have found the additional elements to be mere instructions to apply an exception, because they recite no more than an idea of a solution or outcome include:
In contrast, other cases have found that additional elements are more than “apply it” or are not “mere instructions” when the claim recites a technological solution to a technological problem. In DDR Holdings, the court found that the additional elements did amount to more than merely instructing that the abstract idea should be applied on the Internet. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed. Cir. 2014). The claims at issue specified how interactions with the Internet were manipulated to yield a desired result—a result that overrode the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. 773 F.3d at 1258; 113 USPQ2d at 1106. In BASCOM, the court determined that the claimed combination of limitations did not simply recite an instruction to apply the abstract idea of filtering content on the Internet. BASCOM Global Internet Servs. v. AT&T Mobility, LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016). Instead, the claim recited a “technology based solution” of filtering content on the Internet that overcome the disadvantages of prior art filtering systems. 827 F.3d at 1350-51, 119 USPQ2d at 1243. Finally, in Thales Visionix, the particular configuration of inertial sensors and the particular method of using the raw data from the sensors was more than simply applying a law of nature. Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The court found that the claims provided a system and method that “eliminate[d] many ‘complications’ inherent in previous solutions for determining position and orientation of an object on a moving platform.” In other words, the claim recited a technological solution to a technological problem. Id.
(2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In contrast, a claim that purports to improve computer capabilities or to improve an existing technology may integrate a judicial exception into a practical application or provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See MPEP §§ 2106.04(d)(1) and 2106.05(a) for a discussion of improvements to the functioning of a computer or to another technology or technical field.
TLI Communications provides an example of a claim invoking computers and other machinery merely as a tool to perform an existing process. The court stated that the claims describe steps of recording, administration and archiving of digital images, and found them to be directed to the abstract idea of classifying and storing digital images in an organized manner. 823 F.3d at 612, 118 USPQ2d at 1747. The court then turned to the additional elements of performing these functions using a telephone unit and a server and noted that these elements were being used in their ordinary capacity (i.e., the telephone unit is used to make calls and operate as a digital camera including compressing images and transmitting those images, and the server simply receives data, extracts classification information from the received data, and stores the digital images based on the extracted information). 823 F.3d at 612-13, 118 USPQ2d at 1747-48. In other words, the claims invoked the telephone unit and server merely as tools to execute the abstract idea. Thus, the court found that the additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a telephone network without any recitation of details of how to carry out the abstract idea.
Other examples where the courts have found the additional elements to be mere instructions to apply an exception, because they do no more than merely invoke computers or machinery as a tool to perform an existing process include:
(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words “apply it” to the judicial exception. See Internet Patents Corporation v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an online form without restriction on how the state is maintained and with no description of the mechanism for maintaining the state describes “the effect or result dissociated from any method by which maintaining the state is accomplished” and does not provide a meaningful limitation because it merely states that the abstract idea should be applied to achieve a desired result). See also O’Reilly v. Morse, 56 U.S. 62 (1854) (finding ineligible a claim for “the use of electromagnetism for transmitting signals at a distance”); The Telephone Cases, 126 U.S. 1, 209 (1888) (finding a method of “transmitting vocal or other sound telegraphically . by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sounds,” to be ineligible, because it “monopolize[d] a natural force” and “the right to avail of that law by any means whatever.”).
In contrast, limitations that confine the judicial exception to a particular, practical application of the judicial exception may amount to significantly more or integrate the judicial exception into a practical application. For example, in BASCOM, the combination of additional elements, and specifically “the installation of a filtering tool at a specific location, remote from the end‐users, with customizable filtering features specific to each end user” where the filtering tool at the ISP was able to “identify individual accounts that communicate with the ISP server, and to associate a request for Internet content with a specific individual account,” were held to be meaningful limitations because they confined the abstract idea of content filtering to a particular, practical application of the abstract idea. 827 F.3d at 1350-51, 119 USPQ2d at 1243.
Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term “extra-solution activity” can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent. An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent.
As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that “[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula”. 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was “post-solution activity”). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity).
Examiners should carefully consider each claim on its own merits, as well as evaluate all other relevant considerations, before making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. In particular, evaluation of the particular machine and particular transformation considerations (see MPEP § 2106.05(b) and (c), respectively), the well-understood, routine, conventional consideration (see MPEP § 2106.05(d)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)) may assist examiners in making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. Note, however, that examiners should not evaluate the well-understood, routine, conventional consideration in the Step 2A Prong Two analysis, because that consideration is only evaluated in Step 2B.
This consideration is similar to factors used in past Office guidance (for example, the now superseded Bilski and Mayo analyses) that were described as mere data gathering in conjunction with a law of nature or abstract idea. When determining whether an additional element is insignificant extra-solution activity, examiners may consider the following:
(1) Whether the extra-solution limitation is well known. See Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the inputs of an equation were token extra-solution activity); Flook, 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only indicating that is could be usefully applied to existing surveying techniques); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to form an index was deemed token extra-solution activity). Because this overlaps with the well-understood, routine, conventional consideration, it should not be considered in the Step 2A Prong Two extra-solution activity analysis.
(2) Whether the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention). See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B.
Below are examples of activities that the courts have found to be insignificant extra-solution activity:
Some cases have identified insignificant computer implementation as an example of insignificant extra-solution activity. See e.g., Fort Props., Inc. v. Am. Master Lease LLC, 671 F.3d 1317, 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada, 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as mere instructions to apply a judicial exception. See MPEP § 2106.05(f) for more information about insignificant computer implementation.
For claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), examiners should explain in an eligibility rejection why they do not meaningfully limit the claim. For example, an examiner could explain that adding a final step of storing data to a process that only recites computing the area of a space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. For more information on formulating a subject matter eligibility rejection, see MPEP § 2106.07(a).
Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible “simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use.” Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
The courts often cite to Parker v. Flook as providing a classic example of a field of use limitation. See, e.g., Bilski v. Kappos, 561 U.S. 593, 612, 95 USPQ2d 1001, 1010 (2010) (“Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable”) (citing Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978)). In Flook, the claim recited steps of calculating an updated value for an alarm limit (a numerical limit on a process variable such as temperature, pressure or flow rate) according to a mathematical formula “in a process comprising the catalytic chemical conversion of hydrocarbons.” 437 U.S. at 586, 198 USPQ at 196. Processes for the catalytic chemical conversion of hydrocarbons were used in the petrochemical and oil-refining fields. Id. Although the applicant argued that limiting the use of the formula to the petrochemical and oil-refining fields should make the claim eligible because this limitation ensured that the claim did not preempt all uses of the formula, the Supreme Court disagreed. 437 U.S. at 588-90, 198 USPQ at 197-98. Instead, the additional element in Flook regarding the catalytic chemical conversion of hydrocarbons was not sufficient to make the claim eligible, because it was merely an incidental or token addition to the claim that did not alter or affect how the process steps of calculating the alarm limit value were performed. Further, the Supreme Court found that this limitation did not amount to an inventive concept. 437 U.S. at 588-90, 198 USPQ at 197-98. The Court reasoned that to hold otherwise would “exalt[] form over substance”, because a competent claim drafter could attach a similar type of limitation to almost any mathematical formula. 437 U.S. at 590, 198 USPQ at 197.
In contrast, the additional elements in Diamond v. Diehr as a whole provided eligibility and did not merely recite calculating a cure time using the Arrhenius equation “in a rubber molding process”. Instead, the claim in Diehr recited specific limitations such as monitoring the elapsed time since the mold was closed, constantly measuring the temperature in the mold cavity, repetitively calculating a cure time by inputting the measured temperature into the Arrhenius equation, and opening the press automatically when the calculated cure time and the elapsed time are equivalent. 450 U.S. at 179, 209 USPQ at 5, n. 5. These specific limitations act in concert to transform raw, uncured rubber into cured molded rubber. 450 U.S. at 177-78, 209 USPQ at 4.
A more recent example of a limitation that does no more than generally link a judicial exception to a particular technological environment is Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016). In Affinity Labs, the claim recited a broadcast system in which a cellular telephone located outside the range of a regional broadcaster (1) requests and receives network-based content from the broadcaster via a streaming signal, (2) is configured to wirelessly download an application for performing those functions, and (3) contains a display that allows the user to select particular content. 838 F.3d at 1255-56, 120 USPQ2d at 1202. The court identified the claimed concept of providing out-of-region access to regional broadcast content as an abstract idea, and noted that the additional elements limited the wireless delivery of regional broadcast content to cellular telephones (as opposed to any and all electronic devices such as televisions, cable boxes, computers, or the like). 838 F.3d at 1258-59, 120 USPQ2d at 1204. Although the additional elements did limit the use of the abstract idea, the court explained that this type of limitation merely confines the use of the abstract idea to a particular technological environment (cellular telephones) and thus fails to add an inventive concept to the claims. 838 F.3d at 1259, 120 USPQ2d at 1204.
Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include:
Examiners should be aware that the courts often use the terms “technological environment” and “field of use” interchangeably, and thus for purposes of the eligibility analysis examiners should consider these terms interchangeable. Examiners should also keep in mind that this consideration overlaps with other considerations, particularly insignificant extra-solution activity (see MPEP § 2106.05(g)). For instance, a data gathering step that is limited to a particular data source (such as the Internet) or a particular type of data (such as power grid data or XML tags) could be considered to be both insignificant extra-solution activity and a field of use limitation. See, e.g., Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (limiting use of abstract idea to the Internet); Electric Power, 830 F.3d at 1354, 119 USPQ2d at 1742 (limiting application of abstract idea to power grid data); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017) (limiting use of abstract idea to use with XML tags). Thus, examiners should carefully consider each claim on its own merits, as well as evaluate all other relevant considerations, before making a determination on this consideration.
For claim limitations that generally link the use of the judicial exception to a particular technological environment or field of use, examiners should explain in an eligibility rejection why they do not meaningfully limit the claim. For example, an examiner could explain that employing generic computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient. For more information on formulating a subject matter eligibility rejection, see MPEP § 2106.07(a).
For purposes of efficiency in examination, examiners may use a streamlined eligibility analysis (Pathway A) when the eligibility of the claim is self-evident, e.g., because the claim clearly improves a technology or computer functionality. However, if there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself, the full eligibility analysis (the Alice/Mayo test described in MPEP § 2106, subsection III) should be conducted to determine whether the claim integrates the judicial exception into a practical application or recites significantly more than the judicial exception.
The results of the streamlined analysis will always be the same as the full analysis, thus the streamlined analysis is not a means of avoiding a finding of ineligibility that would occur if a claim were to undergo the full eligibility analysis. Similarly, a claim that qualifies as eligible after Step 2A (Pathway B) or Step 2B (Pathway C) of the full analysis would also be eligible if the streamlined analysis (Pathway A) were applied to that claim. It may not be apparent that an examiner employed the streamlined analysis because the result is a conclusion that the claim is eligible, and there will be no rejection of the claim on eligibility grounds. In practice, the record may reflect the conclusion of eligibility simply by the absence of an eligibility rejection or may include clarifying remarks, when appropriate.
In the context of the flowchart in MPEP § 2106, subsection III, if, when viewed as a whole, the eligibility of the claim is self-evident (e.g., because the claim clearly improves a technology or computer functionality), the claim is eligible at Pathway A, thereby concluding the eligibility analysis.
A streamlined eligibility analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it. Such claims do not need to proceed through the full analysis herein as their eligibility will be self-evident. On the other hand, a claim that does not qualify as eligible after Step 2B of the full analysis would not be suitable for the streamlined analysis, because the claim lacks self‐evident eligibility.
For instance, a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with a judicial exception may sufficiently limit its practical application so that a full eligibility analysis is not needed. As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is clearly not an attempt to tie up use of the mathematical relationships and would not require a full analysis to determine eligibility. Also, a claim that recites a nature-based product, but clearly does not attempt to tie up the nature-based product, does not require a markedly different characteristics analysis to identify a “product of nature” exception. As an example, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral is not an attempt to tie up the mineral. Similarly, claimed products that merely include ancillary nature-based components, such as a claim that is directed to a cellphone with an electrical contact made of gold or a plastic chair with wood trim, would not require analysis of the nature-based component to determine whether the claims are directed to a “product of nature” exception because such claims do not attempt to improperly tie up the nature-based product.
As explained by the Federal Circuit, some improvements to technology or to computer functionality are not abstract when appropriately claimed, and thus claims to such improvements do not always need to undergo the full eligibility analysis. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). MPEP § 2106.05(a) provides details regarding improvements to a technology or computer functionality.
For instance, claims directed to clear improvements to computer-related technology do not need the full eligibility analysis. Enfish, 822 F.3d at 1339, 118 USPQ2d at 1691-92 (claims to a self-referential table for a computer database held eligible at step 1 of the Alice/Mayo test as not directed to an abstract idea). Claims directed to improvements to other technologies or technological processes, beyond computer improvements, may also avoid the full eligibility analysis. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1316, 120 USPQ2d 1091, 1103 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation found eligible at Step 1 of the Alice/Mayo test as directed to an improvement in computer-related technology). In these cases, when the claims were viewed as a whole, their eligibility was self-evident based on the clear improvement, so no further analysis was needed. Although the Federal Circuit held these claims eligible at Step 2A as not being directed to abstract ideas, it would be reasonable for an examiner to have found these claims eligible at Pathway A based on the clear improvement, or at Pathway B (Step 2A) as not being directed to an abstract idea.
If the claims are a “close call” such that it is unclear whether the claims improve technology or computer functionality, a full eligibility analysis should be performed to determine eligibility. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349, 119 USPQ2d 1236, 1241 (Fed Cir. 2016). Only when the claims clearly improve technology or computer functionality, or otherwise have self-evident eligibility, should the streamlined analysis be used. For example, because the claims in BASCOM described the concept of filtering content, which is a method of organizing human behavior previously found to be abstract, the Federal Circuit considered them to present a “close call” in the first step of the Alice/Mayo test (Step 2A), and thus proceeded to the second step of the Alice/Mayo test (Step 2B) to determine their eligibility. Id. Although the Federal Circuit held these claims eligible at Step 2B (Pathway C) because they presented a “technology-based solution” of filtering content on the Internet that overcame the disadvantages of prior art filtering systems and that amounted to significantly more than the recited abstract idea, it also would be reasonable for an examiner to have found these claims eligible at Pathway A or B if the examiner had considered the technology-based solution to be an improvement to computer functionality.
Eligibility rejections must be based on failure to comply with the substantive law under 35 U.S.C. 101 as interpreted by judicial precedent. The substantive law on eligibility is discussed in MPEP §§ 2106.03 through 2106.06. Examination guidance, training, and explanatory examples discuss the substantive law and establish the policies and procedures to be followed by examiners in evaluating patent applications for compliance with the substantive law, but do not serve as a basis for a rejection. Accordingly, while it would be acceptable for applicants to cite training materials or examples in support of an argument for finding eligibility in an appropriate factual situation, applicants should not be required to model their claims or responses after the training materials or examples to attain eligibility.
When evaluating a claimed invention for compliance with the substantive law on eligibility, examiners should review the record as a whole (e.g., the specification, claims, the prosecution history, and any relevant case law precedent or prior art) before reaching a conclusion with regard to whether the claimed invention sets forth patent eligible subject matter. The evaluation of whether the claimed invention qualifies as patent-eligible subject matter should be made on a claim-by-claim basis, because claims do not automatically rise or fall with similar claims in an application. For example, even if an independent claim is determined to be ineligible, the dependent claims may be eligible because they add limitations that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception recited in the independent claim. And conversely, even if an independent claim is determined to be eligible, a dependent claim may be ineligible because it adds a judicial exception without also adding limitations that integrate the judicial exception or provide significantly more. Thus, each claim in an application should be considered separately based on the particular elements recited therein.
If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claim as a whole does not satisfy both criteria for eligibility (Step 1: NO and/or Step 2B: NO), then examiners should formulate an appropriate rejection of that claim under Step 1 and/or Step 2B. The rejection should set forth a prima facie case of ineligibility under the substantive law. The concept of the prima facie case is a procedural tool of patent examination, which allocates the burdens going forward between the examiner and applicant. In particular, the initial burden is on the examiner to explain why a claim or claims are ineligible for patenting clearly and specifically, so that applicant has sufficient notice and is able to effectively respond.
When an examiner determines a claim does not fall within a statutory category (Step 1: NO), the rejection should provide an explanation of why the claim does not fall within one of the four statutory categories of invention. See MPEP § 2106.03 for a discussion of Step 1 and the statutory categories of invention.
When an examiner determines that a claim is directed to a judicial exception (Step 2A: YES) and does not provide an inventive concept (Step 2B: NO), the rejection should provide an explanation for each part of the Step 2 analysis. For example, the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception, identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception, and explain the reason(s) that the additional elements taken individually, and also taken as a combination, 1) do not integrate the judicial exception into a practical application and 2) do not result in the claim as a whole amounting to significantly more than the judicial exception. See MPEP § 2106.04et seq. for a discussion of Step 2A and the judicial exceptions, MPEP § 2106.05et seq. for a discussion of Step 2B and the search for an inventive concept, and MPEP § 2106.07(a) for more information on formulating an ineligibility rejection.
If the evaluation of the claimed invention results in a conclusion that it is more likely than not that the claimed invention falls within a statutory category (Step 1: YES) and is either not directed to a judicial exception (Step 2A: NO) or is directed to a judicial exception and amounts to significantly more than the judicial exception (Step 2B: YES), then the examiner should not reject the claim. When evaluating a response by applicant to a subject matter eligibility rejection, examiners must carefully consider all of applicant’s arguments and evidence presented to rebut the rejection. If applicant properly challenges the examiner’s findings, the rejection should be withdrawn or, if the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the next Office action. This is discussed in greater detail in MPEP § 2106.07(b).
After determining what has been invented and establishing the broadest reasonable interpretation of the claimed invention (see MPEP § 2111), the eligibility of each claim should be evaluated as a whole using the analysis detailed in MPEP § 2106. If it is determined that the claim does not recite eligible subject matter, a rejection under 35 U.S.C. 101 is appropriate. When making the rejection, the Office action must provide an explanation as to why each claim is unpatentable, which must be sufficiently clear and specific to provide applicant sufficient notice of the reasons for ineligibility and enable the applicant to effectively respond.
Subject matter eligibility rejections under Step 1 are discussed in MPEP § 2106.03.
A subject matter eligibility rejection under Step 2 should provide an explanation for each part of the Step 2 analysis:
Under the principles of compact prosecution, regardless of whether a rejection under 35 U.S.C. 101 is made based on lack of subject matter eligibility, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. Thus, examiners should state all non-cumulative reasons and bases for rejecting claims in the first Office action.
I. WHEN MAKING A REJECTION, IDENTIFY AND EXPLAIN THE JUDICIAL EXCEPTION RECITED IN THE CLAIM (STEP 2A PRONG ONE)
A subject matter eligibility rejection should point to the specific claim limitation(s) that recites (i.e., sets forth or describes) the judicial exception. The rejection must explain why those claim limitations set forth or describe a judicial exception (e.g., a law of nature). Where the claim describes, but does not expressly set forth, the judicial exception, the rejection must also explain what subject matter those limitations describe, and why the described subject matter is a judicial exception. See MPEP § 2106.04 for more information about Step 2A of the eligibility analysis.
When the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it falls within one of the groupings of abstract ideas (i.e., mathematical concepts, mental processes, or certain methods of organizing human activity) enumerated in MPEP § 2106.04(a)(2). Alternatively, the examiner should provide justification for why a specific limitation(s) recited in the claim is being treated as an abstract idea if it does not fall within the groupings of abstract ideas in accordance with the “tentative abstract idea” procedure (see MPEP § 2106.04(a)(3)). While not required, this explanation or justification may include citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea within one of the groupings. Examiners should be familiar with any cited decision relied upon in making or maintaining a rejection to ensure that the rejection is reasonably tied to the facts of the case and to avoid relying upon language taken out of context. Examiners should not go beyond those concepts that are enumerated as abstract ideas in MPEP § 2106.04, unless they are identifying a tentative abstract idea in the claim, and should avoid relying upon or citing non-precedential decisions unless the facts of the application under examination uniquely match the facts at issue in the non-precedential decisions. Examiners are reminded that a chart of court decisions is available on the USPTO’s Internet website (www.uspto.gov/ PatentEligibility).
Sample explanation: The claim recites the step of comparing collected information to a predefined threshold, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping.
When the examiner has determined the claim recites a law of nature or a natural phenomenon, the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain using a reasoned rationale why it is considered a law of nature or natural phenomenon. See MPEP § 2106.04(b) for more information about laws of nature and natural phenomena.
Sample explanation: The claim recites the correlation of X, and X is a law of nature because it describes a consequence of natural processes in the human body, e.g., the naturally-occurring relationship between the presence of Y and the manifestation of Z.
Sample explanation: The claim recites X, which is a natural phenomenon because it occurs in nature and exists in principle apart from any human action.
When the examiner has determined the claim recites a product of nature, the rejection should identify the exception as it is recited (i.e., set forth or described) in the claim, and explain using a reasoned rationale why the product does not have markedly different characteristics from its naturally occurring counterpart in its natural state. See MPEP § 2106.04(b) for more information about products of nature, and MPEP § 2106.04(c) for more information about the markedly different characteristics analysis.
Sample explanation: The claim recites X, which as explained in the specification was isolated from naturally occurring Y. X is a nature-based product, so it is compared to its closest naturally occurring counterpart (X in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of X has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, X is a product of nature exception.
II. WHEN MAKING A REJECTION, EXPLAIN WHY THE ADDITIONAL CLAIM ELEMENTS DO NOT RESULT IN THE CLAIM AS A WHOLE INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND STEP 2B)
After identifying the judicial exception in the rejection, identify any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception and explain why they do not integrate the judicial exception into a practical application and do not add significantly more to the exception. The explanation should address the additional elements both individually and as a combination when determining whether the claim as whole recites eligible subject matter. It is important to remember that a new combination of steps in a process may be patent eligible even though all the steps of the combination were individually well known and in common use before the combination was made. Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 9 (1981). Thus, it is particularly critical to address the combination of additional elements, because while individually-viewed elements may not appear to integrate an exception into a practical application or add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception. See MPEP § 2106.05 for more information about Step 2B of the eligibility analysis.
A rejection should be made only if it is readily apparent to an examiner relying on the examiner's expertise in the art in the Step 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. When making a rejection, it is important for the examiner to explain the rationale underlying the conclusion so that applicant can effectively respond. On the other hand, when appropriate, the examiner should explain why the additional elements integrate an exception into a practical application or provide an inventive concept by adding a meaningful limitation to the claimed exception. See MPEP §§ 2106.04(d) and 2106.05 for a listing of considerations that qualify, and to not qualify, as integrating an exception or providing significantly more than an exception, and MPEP § 2106.07(c) for more information on clarifying the record when a claim is found eligible.
In the Step 2B inquiry, if the examiner has concluded that particular claim limitations are well understood, routine, conventional activities (or elements) to those in the relevant field, the rejection should support this conclusion in writing with a factual determination in accordance with Subsection III below. See MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements, and Subsection III below for more information about how to support a conclusion that a claim limitation is well understood, routine, conventional activity.
For claim limitations that recite a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, examiners can explain why these generic computing functions do not meaningfully limit the claim. Examiners should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. DDR Holdings, LLC v. Hotels.com, LP, 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See MPEP § 2106.05(f) for more information about generic computing functions that the courts have found to be mere instructions to implement a judicial exception on a computer, and MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements (a relevant consideration only in Step 2B).
For claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), or that generally link the use of the judicial exception to a particular technological environment or field of use, examiners should explain why they do not meaningfully limit the claim. For example, adding a final step of storing data to a process that only recites computing the area of a two dimensional space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. As another example, employing well-known computer functions to execute an abstract idea, even when limiting the use of the idea to one particular environment, does not integrate the exception into a practical application or add significantly more, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient. See e.g., Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (limiting use of mathematical formula to use in particular industries did not amount to an inventive concept). See MPEP § 2106.05(g) for more information about insignificant extra-solution activity, and MPEP § 2106.05(h) for more information about generally linking use of a judicial exception to a particular technological environment or field of use.
In the event a rejection is made, it is a best practice for the examiner to consult the specification to determine if there are elements that could be added to the claim to make it eligible. If so, the examiner should identify those elements in the Office action and suggest them as a way to overcome the rejection.
III. EVIDENTIARY REQUIREMENTS IN MAKING A § 101 REJECTION
The courts consider the determination of whether a claim is eligible (which involves identifying whether an exception such as an abstract idea is being claimed) to be a question of law. Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 (Fed. Cir. 2016); OIP Techs. v. Amazon.com, 788 F.3d 1359, 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); DDR Holdings v. Hotels.com, 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014); In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335, 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc), aff’d by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). Thus, the court does not require “evidence” that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues. FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) (citing Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1373, 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); OIP Techs., 788 F.3d at 1362, 115 USPQ2d at 1092; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue of whether additional elements are well-understood, routine, conventional activity as an underlying factual issue upon which the legal conclusion of eligibility may be based. See, e.g., Interval Licensing LLC v. AOL, Inc., 896 F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a question of law that may contain underlying issues of fact), Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018) (issue of whether additional elements are well-understood, routine, conventional activity is factual).
When performing the analysis at Step 2A Prong One, it is sufficient for the examiner to provide a reasoned rationale that identifies the judicial exception recited in the claim and explains why it is considered a judicial exception (e.g., that the claim limitation(s) falls within one of the abstract idea groupings). Therefore, there is no requirement for the examiner to rely on evidence, such as publications or an affidavit or declaration under 37 CFR 1.104(d)(2), to find that a claim recites a judicial exception. Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc., 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming district court decision that identified an abstract idea in the claims without relying on evidence); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. 2014) (same).
At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B.
Examiners should not assert that an additional element (or combination of elements) is well-understood, routine, or conventional unless the examiner finds, and expressly supports the rejection in writing with one or more of the following:
Use form paragraphs 7.04.01, 7.05, and 7.05.01 for rejections based on a failure to claim an invention that falls within the statutory categories of invention (i.e., the claim is not to one of the four statutory categories of invention and is thus rejected at Step 1 of the eligibility analysis).
Use form paragraphs 7.04.01, 7.05, and 7.05.016 for rejections based on a failure to claim an invention that is directed to patent-eligible subject matter, i.e., the claim is directed to a judicial exception without providing an inventive concept/significantly more, and is thus rejected at Step 2B of the eligibility analysis. If the judicial exception to which the claim is directed is a "tentative abstract idea," i.e., an abstract idea that does not fall within any of the groupings of abstract ideas discussed in MPEP § 2106.04(a)(2), then the Step 2B rejection must also use form paragraph 7.05.017 (in addition to form paragraphs 7.04.01, 7.05, and 7.05.016) and include the TC Director's signature.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
