USPTO Issues Revised Patent Subject Matter Eligibility Guidance

07 January 2019 PharmaPatents Blog

Although the Department of Commerce is impacted by the partial Federal government shutdown, the USPTO has been able to continue normal operations because it has access to prior-year fee collections. Underscoring its active status, the USPTO released revised patent subject matter eligibility guidance, effective January 7, 2019. This guidance implements the changes Director Iancu announced in his keynote address at the Intellectual Property Owners Association Annual Meeting, and may lead examiners to determine that more inventions satisfy § 101 at an early stage of a Mayo/Alice analysis. The guidance is effective immediately, but the USPTO will accept written comments through March 8, 2019.

The 2019 Revised Patent Subject Matter Eligibility Guidance

According to the summary in the Federal Register Notice, the 2019 Revised Patent Subject Matter Eligibility Guidance makes two main revisions to the analytical process examiners should apply when evaluating claims for compliance with § 101:

  1. Under Step 2A, abstract ideas are to be identified with reference to enumerated categories of subject matter rather than by analogy to claims “already found to be directed to an abstract idea” in a court decision.
  2. At Step 2A, a claim should not be found to be “directed to” a judicial exception “if the claim as a whole integrates the recited judicial exception into a practical application of that exception,” without regard to whether the integration is well-understood, routine and conventional.

As Director Iancu emphasized in his address, only if a claim recites a judicial exception that is not integrated into a practical application is it “directed to” a judicial exception under Step 2A and evaluated for eligibility under Step 2B.

Step 2A: Identifying Abstract Ideas By Reference To
Enumerated Groupings Of Abstract Ideas

The revised guidance replaces the case-by-case application-of-case-law approach for identifying “abstract ideas” espoused previously with a list of categories of subject matter that itself is based on “key concepts identified by the courts as abstract ideas … when recited as such in a claim limitation(s) (that is, when recited on their own or per se).”

Under the revised guidance, “[t]o determine whether a claim recites an abstract idea … examiners are now to: (a) Identify the specific limitation(s) in the claim … the examiner believes recites an abstract idea; and (b) determine whether the identified limitation(s) falls within the [following] subject matter groupings of abstract ideas”:

(a) Mathematical concepts—mathematical relationships, mathematical formulas or equations, mathematical calculations;

(b) Certain methods of organizing human activity—fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions);

(c) Mental processes—concepts performed in the human mind (including an observation, evaluation, judgment, opinion).

If the identified limitation(s) fall within one of these subject matter groupings, the examiner should evaluate whether the claim integrates the abstract idea into a practical application, in accordance with the other major revised guidance discussed below.

If the identified limitation(s) do not fall within one of these subject matter groupings, the claim(s) “should not should not be treated as reciting abstract ideas,” except in a “rare circumstance” addressed in Section III.C of the revised guidance, which requires approval by the Technology Center Director.

Step 2A: Identifying Claims “Directed To” Judicial Exceptions

The second main revision of the revised guidance emphasizes the difference between a claim that recites a judicial exception and one that is “directed to” a judicial exception, and underscore that claims that recite but are not directed to a judicial exception should be found eligible at Step 2A of the USPTO’s analytical framework.

A claim is not “directed to” a judicial exception, and thus is patent eligible, if the claim as a whole integrates the recited judicial exception into a practical application of that exception.

Under the revised guidance, examiners should “evaluate integration into a practical application by: (a) Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.”

The guidance recognizes that aspects of the revised Step 2A analysis previously were addressed under Step 2B, but emphasizes that under Step 2A there is no consideration “of whether the additional elements represent well-understood, routine, conventional activity.”

Because revised Step 2A does not evaluate whether an additional element is well-understood, routine, conventional activity, … a claim that includes conventional elements may still integrate an exception into a practical application, thereby satisfying the subject matter eligibility requirement of Section 101.

Thus, “in revised Step 2A examiners should ensure that they give weight to all additional elements, whether or not they are conventional.”

Continued Relevance Of Step 2B

The revised guidance may lead to more inventions being found to satisfy § 101 at Step 2A, but an analysis under Step 2B still will be required for claims determined to be directed to a judicial exception at Step 2A. Under Step 2B, the consideration of whether additional claim elements are “well-understood, routine, and conventional’ can weigh in favor of eligibility. The guidance illustrates such a scenario with data gathering steps that might be determined to be “insignificant extra-solution activity” under Step 2A, but determined to relate to an “inventive concept” under Step 2B if “the combination of steps gather data in an unconventional way.”

Evaluating The Revised Guidance

Overall, the revised guidance is intended to promote the accurate, predictable, and consistent application of the subject matter eligibility requirement of § 101. As set forth in the Federal Register Notice, “[t]he USPTO is determined to continue its mission to provide predictable and reliable patent rights in accordance with this rapidly evolving area of the law,” and its “ultimate goal is to draw distinctions between claims to principles in the abstract and claims that integrate those principles into a practical application.”

The USPTO invites public comments on the revised guidance sent by email to

The Federal Register Notice also emphasizes that the guidance sets out “agency policy” with respect to the subject matter eligibility requirement of § 101, and that “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Hopefully this will prevent examiners and APJs from rejecting this guidance in favor of their own interpretations of court decisions.

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