USPTO’s December 2025 Guidance on Subject Matter Eligibility Declarations (SMEDs) – MemorandaDecember 9, 2025

On December 4, 2025, the U.S. Patent and Trademark Office (USPTO) issued new guidance clarifying how Subject Matter Eligibility Declarations (SMEDs) can be used in patent prosecution. SMEDs are sworn declarations under 37 C.F.R. § 1.132 (commonly called Rule 132) that applicants may submit to provide evidence in support of patent eligibility. The USPTO’s guidance was delivered via two memoranda. One was addressed to patent examiners and one was addressed to practitioners. They respond to ongoing confusion over 35 U.S.C. § 101 (patentable subject matter) and offer best practices for using evidence to rebut eligibility rejections. This blog post highlight best practices for when and how to use SMEDs, and the risks of combining eligibility testimony with other issues in a single declaration.

U.S. patent law has long excluded abstract ideas, natural phenomena, and laws of nature from patentable subject matter, but the boundaries of these exclusions have been notoriously difficult to define. A series of court decisions over the past decade and beyond have shaped today’s framework. First, in Alice Corp. v. CLS Bank Int’l (2014) the Supreme Court established a now-familiar two-step test for patent eligibility under § 101. In Alice, the Court instructed examiners and courts to first determine whether a claim is “directed to” a judicial exception (e.g. an abstract idea). If so, the second step is to examine whether the claim contains an “inventive concept”, which is something more that transforms the idea into a patent-eligible practical application. Many software and business-method patents, as well as diagnostic and biotech method patents, were invalidated under this stringent test in the years following 2014. The focus shifted to whether claims recite a practical technological improvement or merely an abstract concept.

Long before Alice, the Federal Circuit established under In re Oetiker (1992) key principles about burdens of proof in patent prosecution. Specifically, the USPTO bears the initial burden to present a prima facie case for any rejection. Once that burden is met, the burden shifts to the applicant to rebut the rejection with argument or evidence relevant to the specific issue. This means that for a § 101 rejection, an applicant may introduce evidence (such as a declaration) to rebut the examiner’s prima facie ineligibility finding, but that evidence must have a clear nexus to the eligibility issue to be probative.

Then, under In re Sullivan (Fed. Cir. 2007), it was held that the USPTO must consider all evidence submitted by an applicant, even if the evidence comes in multiple declarations addressing different grounds. The Patent Trial and Appeal Board (PTAB) cannot ignore or discard evidence simply because it relates to a different aspect of patentability. In other words, if an applicant submits declarations on eligibility and on obviousness in the same case, the decision-makers must weigh both, a principle that highlights the importance of a clear record. Comprehensive, focused evidence in the record is critical, and all of it must be considered on appeal.

In re Desjardins (PTAB 2025) was a PTAB board decision that concerned AI claims were directed to training a machine learning model on multiple tasks while preventing “catastrophic forgetting” of prior tasks. The USPTO’s panel vacated a sua sponte § 101 rejection, finding the claimed invention patent-eligible because it integrated an otherwise abstract idea into a practical application, satisfying Alice step 2. The panel credited specific technological improvements recited in the application, including reduced storage requirements, lowered system complexity, and improved model performance (avoiding forgetting). In a striking admonition, the Desjardins decision warned against “overbroad Section 101 rejections” and cautioned that “categorically excluding AI innovations from patent protection in the United States jeopardize[s] America’s leadership in [] critical emerging technolog[ies]”. The Director formally designated Desjardins as precedential on Nov. 4, 2025, making its reasoning binding on examiners. Desjardins reaffirmed that genuine inventions in fields like AI should be assessed with proper weight given to technological improvements, and it stressed that patentability questions are often more appropriately addressed under § 102 (novelty), § 103 (non-obviousness), and § 112 (adequate description) rather than prematurely killing applications under § 101. As Director Squires observed, Desjardins effectively provides a framework for identifying the “something more” that Alice requires, especially in new and emerging technologies.

The USPTO’s December 2025 guidance came in two memoranda, one aimed at patent examiners and one aimed at applicants/practitioners, both focused on the use of Subject Matter Eligibility Declarations.

The Examiner focused memo raises awareness within the examining corps of the voluntary option for applicants to submit a declaration under Rule 132 specifically to address a § 101 rejection. In other words, it reminds examiners that applicants may introduce factual evidence into the record to rebut an eligibility rejection. It is an option that has existed but, until now, was rarely utilized in practice. The memo emphasizes that such SMEDs can contain evidence of technological improvements, details about the state of the art at the time of filing, or facts showing how a purported abstract idea is actually integrated into a practical application of technology. Notably, the USPTO instructs that when a SMED is properly submitted, examiners must consider it as part of the record and evaluate the evidence under the normal “preponderance of the evidence” standard (the usual evidentiary standard in examination). Examiners are cautioned to weigh all relevant evidence and carefully consider the applicant’s arguments and factual showings rebutting a 101 rejection. If a SMED is in the record, an examiner’s next Office Action must explicitly discuss why the evidence does or does not overcome the eligibility rejection, based on a preponderance analysis. The memo even provides concrete examples demonstrating how a SMED might prove useful. For example, an affidavit can be used to evidence that certain claim steps (e.g., a distributed network monitoring in a cybersecurity invention) “cannot practically be performed in the human mind,” thereby countering an “abstract mental process” rejection. Importantly, the examiner memo reiterates that submitting a SMED is optional and “does not announce any new USPTO practice or procedure,” but rather highlights an underutilized path available to applicants to strengthen their case on eligibility.

The companion memo addressed to applicants and practitioners lays out best practices for preparing and filing SMEDs. A central point is that eligibility-related evidence is most effective when presented in a standalone declaration focused solely on § 101. While Rule 132 permits a single declaration to address multiple issues (e.g. one could theoretically combine arguments about § 101 and § 103 in one affidavit), the USPTO strongly discourages combining eligibility testimony with other statutory issues in the same document. Mixing § 101 evidence with, say, obviousness or enablement evidence can “complicate the record and hinder an examiner’s ability to evaluate the evidence”. The guidance cites the Manual of Patent Examining Procedure (MPEP) § 716, which instructs that any Rule 132 declaration “must be relevant to the specific rejection traversed.” In parallel, MPEP § 2106 (the USPTO’s subject matter eligibility guidance) confirms that applicants can submit declarations to traverse a 101 rejection, for example by providing evidence of how a person of ordinary skill in the art views the invention as a technological improvement (see MPEP § 2106 and §2106.07(b)).

Procedurally, a proper SMED should still: (1) be timely submitted (e.g. with a response to a pending Office Action), (2) be signed by someone with personal knowledge of the facts (inventor, technical expert, etc.), (3) include the required attestations (per 37 C.F.R. 1.132 and 35 U.S.C. § 25) regarding truthfulness, (4) focus on factual evidence showing why the claimed invention is not “just” an abstract idea or natural phenomenon, but rather an applied technology or improvement, and (5) maintain a clear nexus between the evidence and the claim elements at issue. Examiners are instructed to fully consider such evidence under the usual examination standards (weighing all evidence for and against patentability under a prima facie and rebuttal framework). The new guidance does not change the law on eligibility or the burdens of proof. It simply illuminates a pathway for applicants to make a stronger factual record when confronting a challenging § 101 rejection.

A SMED can be a powerful tool if you face a § 101 rejection that cannot be overcome by legal argument alone and there are facts in dispute. An effective SMED will root the testimony in the technical realities of the invention and the state of the art. That said, be sure to include critical technical evidence in the patent application itself, whenever possible.

Finally, it is worth noting that if an inventor or expert provided a declaration during prosecution, that individual (or another with similar expertise) can be tapped in litigation to maintain a consistent story about the invention’s contribution. The SMED essentially previews the arguments that the patentee would make to a judge or jury to defend the patent’s validity. By having that in the file, the patentee’s litigation counsel can show that “the Patent Office considered these very facts and still allowed the patent.” While not legally binding on a court, this can be persuasive evidence. Additionally, since the inventor’s own words or an expert’s testimonial statements are part of the record, a patent owner should also ensure those statements are accurate. Any exaggeration or overstatement in a SMED could be used to impeach credibility later. The statements made might also be used as admissions that negatively affect claim construction.

Gregory Lars Gunnerson is a Partner, Intellectual Property Attorney in the Mechanical and Electrical Patent Practice Groups, and Chair of the Design Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit www.ipmvs.com or contact Lars directly via email at gregory.gunnerson@ipmvs.com.