IP Law Daily, PATENT NEWS—USPTO Director issues dual subject matter eligibility guidance memos, (Dec 5, 2025)

By Saurabh Kashyap, B.A., M.A., LL.B., LL.M.

New guidance affirms AI and software innovations as patent-eligible and encourages evidence-driven declarations to rebut § 101 rejections.

In a landmark move for U.S. patent law, the U.S. Patent and Trademark Office (USPTO) issued two complementary memoranda on December 4, 2025, aimed at clarifying and standardizing subject matter eligibility (SME) analysis under 35 U.S.C. § 101. The first memo, directed to the USPTO Patent Examining Corps, discusses the precedential Director’s decision in In re Desjardins, urging examiners to credit technological improvements in AI, machine learning, and related fields. The second, addressed to all applicants and practitioners, lays out best practices for submitting Subject Matter Eligibility Declarations (SMEDs) under Rule 132 to rebut § 101 rejections. Together, these guidances signal a decisive shift toward a more transparent, evidence-based framework for SME analysis and reinforce the agency’s commitment to protecting innovation in emerging technologies (USPTO Examiner Guidance Memorandum on Subject Matter Eligibility, No. 2025-EX101 (USPTO Dec. 4, 2025)); (USPTO Best Practices Memorandum on Rule 132 Declarations, No. 2025-BP132 (USPTO Dec. 4, 2025)).

Background. The USPTO’s latest SME guidance comes in response to years of legal uncertainty following the U.S. Supreme Court’s decisions in Alice Corp. v. CLS Bank Int’l and Mayo Collaborative Servs. v. Prometheus Labs. While those rulings introduced the two-step framework for analyzing patent eligibility, they left open critical questions about how to apply it consistently—particularly in complex technologies like artificial intelligence, medical diagnostics, and blockchain.

On his first official day as Director of the USPTO, John A. Squires issued patents in two historically difficult fields—distributed ledger technology and medical diagnostics—setting the tone for his administration. Days later, he vacated a PTAB decision in In re Desjardins (Appeal No. 2024-000567 (PTAB September 26, 2025)), emphasizing that technological improvements to machine learning architectures can constitute patent-eligible subject matter when integrated into a practical application. The case was designated as precedential on November 4, 2025.

The Desjardins memo. The first memorandum, distributed to the Patent Examining Corps, designates the Desjardins decision as binding and provides examiners with a practical roadmap for identifying “something more” under Alice Step 2. The claims in Desjardins related to training a multitask machine learning model to reduce system complexity and memory requirements while preserving prior task performance—addressing the challenge of "catastrophic forgetting." The Appeals Review Panel found that these enhancements improved the machine's functioning and were therefore patent-eligible under the Alice framework.

The memo explicitly warns against categorical exclusions of AI-related innovations and reaffirms that improvements in computational performance, data handling, or system architecture are relevant considerations in the subject matter eligibility (SME) analysis. Examiners are instructed to evaluate whether the claimed system alters how information flows through its architecture, rather than merely describing what the system does. They must also consider whether the invention addresses a technological problem with a specific technical solution, and whether it integrates an abstract idea into a practical application. Further, examiners are directed to assess whether there is probative evidence demonstrating that a person of ordinary skill in the art would regard the claimed invention as representing a technological advance.

Additionally, the memo stresses that §§ 102, 103, and 112—not § 101—should determine the scope and substance of patent protection, framing § 101 as a gatekeeper rather than a dispositive barrier to patentability.

The SMED memo. The second memorandum, titled Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations, is addressed to all patent applicants and practitioners. It encourages the submission of SMEDs as separate, targeted declarations to overcome § 101 rejections. Though applicants have long been permitted to file declarations under Rule 132, the memo formalizes their use specifically for subject-matter eligibility and cautions against combining them with declarations addressing other statutory requirements, such as obviousness under § 103.

The USPTO recommends separate SMEDs to preserve clarity and prevent evidentiary confusion. The memo cites the Manual of Patent Examining Procedure (MPEP) §§ 716 and 2106.07(b) and draws on Federal Circuit precedent, including In re Oetiker and In re Sullivan, emphasizing that evidence must be relevant to the issue at hand and fully considered by the examiner.

Importantly, SMEDs may include expert testimony, experimental data, and factual assertions about the state of the art at the time of filing. The declarations must establish a clear nexus between the evidence and the claimed invention, and must not improperly supplement the original disclosure. Instead, they should contextualize the specification in light of industry knowledge, demonstrating how a skilled artisan would interpret the claimed improvement.

Examples and application. The examiner memorandum outlines several illustrative scenarios in which Subject Matter Eligibility Declarations (SMEDs) may be effectively used to rebut rejections under 35 U.S.C. § 101. For instance, a SMED may provide evidence that claim limitations—though seemingly rooted in mental processes—are not practically performable in the human mind, thereby falling outside the judicial exceptions. In another example, an SMED may demonstrate that the claimed invention improves the functioning of a computer, such as by using enhanced data structures or more efficient memory management.

In the context of medical diagnostics or prophylactic treatments, an SMED can help establish that the claimed steps yield concrete, practical health outcomes, thereby integrating abstract ideas into a specific, useful application. Additionally, where claims recite known elements in a novel combination, an SMED may offer evidence showing that the particular arrangement produces technical advantages not present in the prior art. In all such cases, the USPTO emphasizes that SMEDs must be timely filed, factually grounded, and narrowly focused on addressing the eligibility issue at hand.

Conclusion. The two memoranda issued by the USPTO on December 4, 2025, delineate how examiners and applicants should approach subject-matter eligibility analysis after In re Desjardins and how evidentiary declarations under Rule 132 may be used to address § 101 rejections. By outlining examiner obligations, evidentiary standards, and practitioner best practices, the USPTO provides structured guidance on the role of technological improvements and factual evidence in SME determinations.

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