As the gatekeeper of patentability, the United States Patent and Trademark Office (“USPTO”) has issued guidelines in conjunction with various court decisions in an attempt to provide patent examiners and applicants with clarity regarding the test for patent subject matter eligibility under 35 U.S.C. § 101. The USPTO admitted that this task has been challenging: “[p]roperly applying the Alice/Mayo test in a consistent manner has proven to be difficult, and has caused uncertainty in this area of the law. Among other things, it has become difficult in some cases for inventors, businesses, and other patent stakeholders to reliably and predictably determine what subject matter is patent-eligible.”1 In the latest attempt to simplify the § 101 analysis, the USPTO recently published the 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”) with the goal of increasing clarity, predictability, and consistency in patent examiners’ application of the Alice/Mayo test 2—particularly with respect to claims determined to be directed to the judicial exception of abstract ideas.3
The 2019 PEG
The revisions to Step 2A of the Alice/Mayo test in the 2019 PEG represent an attempt to bring additional structure and consistency to analysis of claims determined to be directed to abstract ideas. Under the pre-2019 PEG analysis, if the claim was found to be directed to one of the statutory categories (i.e., a process, machine, manufacture, or composition of nature) in Step 1, but was then determined to be directed to a judicial exception (under former Step 2A), the analysis proceeded directly to Step 2B in order to determine whether the claim recites additional elements that amount to “significantly more” than the judicial exception.4 Arguments that a claim was not directed to a judicial exception and should therefore be found patent-eligible at Step 2A were typically difficult to win. Furthermore, an applicant attempting to amend their claim to be found patent-eligible at Step 2B often faced an Examiner requiring the addition of more and more claim limitations in the pursuit of an undefined threshold at which the claim could be said to include “significantly more” than the abstract idea.
Revised Step 2A has been restructured as a two-pronged analysis to provide applicants with an additional avenue to a determination of eligibility without proceeding through the Step 2B analysis.5 Prong One is focused on the evaluation of whether a claim recites a judicial exception (i.e., an abstract idea, law of nature, or natural phenomenon).6 If the Examiner finds that the claim does not recite a judicial exception, then the claim will be determined to be patent-eligible under the Alice/Mayo test.7 If the claim is determined to recite a judicial exception, then the analysis proceeds to Prong Two to determine whether the claim as a whole integrates the judicial exception into a practical application.8
Revised Step 2A: Prong One
The 2019 PEG changes how abstract ideas are evaluated under Prong One.9 Prong One simplifies the process of determining whether abstract ideas are recited by a claim by enumerating three groupings of subject matter identified in judicial decisions as being directed to abstract ideas: mathematical concepts, certain methods of organizing human activity, and mental processes.10 If a claim does not recite subject matter falling within one of the groupings, the Examiner must support a determination that the claim recites an abstract idea by obtaining approval from the Technology Center director and providing a justification for why the claim should be treated as reciting an abstract idea.11
In view of this updated guidance, applicants may consider several approaches to overcome a § 101 rejection at this stage:
- Traverse the rejection if Examiner fails to identify at least one claim element as reciting an abstract idea.Under Prong One, the burden is on the Examiner to identify at least one claim element as reciting an abstract idea.
- Traverse the rejection if the Examiner identifies at least one claim element as reciting an abstract idea falling within one of the groupings of abstract ideas listed in the 2019 PEG. Traversal may focus on an argument that the identified claim element does not recite an abstract idea. Alternatively, or in conjunction, the applicant may present an argument that the claim element(s) identified by the Examiner does not fall within any of the groupings.Such an argument is ideally supported by citation to and analysis of Federal Circuit and Supreme Court decisions, such as those cited in the 2019 PEG in discussion of the groupings of abstract ideas.12
- Amend the identified claim element(s) to avoid falling within any of the groupings of abstract ideas.The 2019 PEG states both the presumption of eligibility that is applied when a claim does not fall into one of the groupings, as well as the narrow exception to the presumption: “Claims that do not recite matter that falls within these enumerated groupings of abstract ideas should not be treated as reciting abstract ideas, except as follows: [i]n the rare circumstance in which a USPTO employee believes a claim limitation that does not fall within the enumerated groupings of abstract ideas should nonetheless be treated as reciting an abstract idea, the procedure described in Section III.C for analyzing the claim should be followed.”13
Revised Step 2A: Prong Two
In Prong Two, a claim is determined to recite patent-eligible subject matter if additional elements 14 beyond the recited judicial exception integrate the judicial exception into a “practical application” of the judicial exception.15 These additional elements must “impose a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.”16 If the additional elements integrate the judicial exception into a practical application, the claim must be found patent-eligible under the Alice/Mayo test.17 If the additional elements fail to integrate the judicial exception into a practical application, the claim may require further evaluation under Step 2B.18
The considerations for Prong Two are similar to those evaluated under Step 2B, 19 with the addition of an additional consideration rooted in a recent Federal Circuit decision. 20 One significant difference from Step 2B, however, is that the Prong Two analysis excludes the assessment of whether additional elements are well-understood, routine, conventional activities, which means that such elements may integrate the judicial exception into a practical application.21
By contrast, in Step 2B, any additional claim elements that might have served to provide “significantly more” than the judicial exception will not suffice to support a determination of patent-eligibility if they are found to be well-understood, routine, conventional activities.22 This important difference means that applicants may have more success arguing eligibility under Prong Two than under Step 2B.
In conclusion, the 2019 PEG appears to be designed to provide Examiners with a revised analytical framework with improved clarity and structure, while attempting to provide applicants with a clearer path to a determination of patent-eligibility.
2 It is important to note that the 2019 PEG is directed to USPTO personnel and is not binding on the judicial branch. The Federal Circuit warned, “While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.” Cleveland Clinic Found. v. True Health Diagnostics LLC, 2019 WL 1452697, at *6 (Fed. Cir. Apr. 1, 2019).
3 2019 PEG at 54.
4 Id. at 56 (citing Amdocs (Israel) Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300, 1303 (Fed. Cir. 2016); BASCOM Glob. Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1349–52 (Fed. Cir. 2016); DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1257–59 (Fed. Cir. 2014)).
5 Id. at 54.
9 Id. The 2019 PEG only modifies how abstract ideas are identified. Evaluating whether a claim recites a law of nature or natural phenomenon is unchanged by the 2019 PEG.
10 Id. at 52.
11 Id. at 54, 56–57.
12 Id. at 52, nn.12–15.
13 Id. at 53, 56–57. “Any rejection in which a claim limitation, which does not fall within the enumerated abstract ideas (tentative abstract idea), is nonetheless treated as reciting an abstract idea must be approved by the Technology Center Director (which approval will be indicated in the file record of the application), and must provide a justification for why such claim limitation is being treated as reciting an abstract idea.” Id. at 57 (citations omitted).
14 The term “additional elements” refers to a particular element or a combination of elements in the claims besides those identified as being directed to a judicial exception under Prong One. Furthermore, “whether an additional element or combination of elements integrate the exception into a practical application should be evaluated on the claim as a whole.” Id. 55, n.24.
15 Id. at 54. In contrast to Prong One, all three categories of judicial exceptions (laws of nature, abstract ideas, and natural phenomena) are evaluated in the same way under Prong Two.
19 Id. at 56.
20 The exemplary consideration relating to “a particular treatment or prophylaxis for a disease or medical condition” comes from one of the more recent Federal Circuit decisions, Vanda Pharm., Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). See also USPTO Memorandum of June 7, 2018, “Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals,” available at https://www.uspto.gov/sites/default/files/documents/memo-vanda-20180607.PDF (hereinafter “USPTO Vanda Memorandum”).
22 2019 PEG at 55.
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