USPTO Puts Subject Matter Eligibility Declarations in the Spotlight

On December 4, 2025, U.S. Patent and Trademark Office (USPTO) Director John Squires issued two memoranda addressing subject matter eligibility and spotlighting an additional pathway to overcome a rejection under 35 U.S.C. § 101 by expanding the evidentiary record. The first memorandum outlines best practices for submitting a Subject Matter Eligibility Declaration (SMED) to address a subject matter eligibility rejection. The second memorandum is directed to patent examiners, reaffirming the Director’s approach in view of the recent precedential Patent Trial and Appeal Board (PTAB) decision in Ex parte Desjardins and explaining how examiners should consider the evidence presented in a SMED.

The guidance reflects the Office’s continued effort to provide greater predictability and transparency at the USPTO, particularly for computer-related, AI-driven, and/or medical diagnostic innovations.

Director Squires Reaffirms Limits on Overbroad Subject Matter Eligibility Rejections

Director Squires highlighted the recent precedential decision, Ex parte Desjardins, in which the Appeals Review Panel (ARP) vacated a PTAB decision finding claims covering a method of training a machine learning model to be ineligible subject matter. The ARP concluded that the PTAB’s application of 35 U.S.C. § 101 was overly broad, particularly in view of Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) and other Federal Circuit decisions applying the Supreme Court’s subject matter eligibility framework. Because the claimed methods properly integrated an abstract idea into a practical application, the ARP found them to be subject matter eligible. In that decision, the ARP emphasized that “[c]ategorically excluding AI innovations from patent protection in the United States jeopardizes America’s leadership in this critical emerging technology.”

The Director signaled that the USPTO will continue scrutinizing subject matter eligibility rejections that disregard technical advances reflected in the specification or claims and that are overly broad. The Desjardins decision also highlights the importance of arguments emphasizing technical improvements provided by a claimed invention to demonstrate integration of a judicial exception into a practical application. On December 5, 2025, the USPTO released an additional memorandum indicating that the Manual for Patent Examining Procedure (MPEP) will be updated to provide additional examples in view of Desjardins.

SMEDs as a Tool to Address Subject Matter Eligibility Rejections

The Director also reminded applicants of the opportunity to submit an evidentiary submission, a SMED, to overcome a subject matter eligibility rejection. While declarations under 37 C.F.R. § 1.132 can be submitted to provide evidence for traversal of any rejection, these declarations have typically been used to overcome prior art rejections. Squires’ memoranda spotlight the usefulness of these declarations when responding to a subject matter eligibility rejection.

The Director noted that anyone “who has knowledge of the facts being asserted” can submit a SMED, and no special qualifications are required. SMEDs can help explain, among other things, how a person skilled in the art would interpret the specification and establish “facts that describe the state of the art.” However, the SMED “cannot be used to supply information that was required to be present in the original disclosure.” The specification must still provide sufficient detail such that one skilled in the art would recognize the technological improvement provided by the claimed subject matter. The SMED may therefore be used to complement the specification to establish facts and understandings as of the filing date but “cannot be used to improperly supplement the original disclosure.” Further, there must be a “nexus between the invention as claimed and the evidence provided in the declaration,” rather than some unrelated feature or process.

The Director also recommended submitting SMEDs separately from other declarations, such as a declaration used to overcome rejections relating to enablement or prior art. The Director cautioned that submitting a single declaration addressing multiple issues runs the risk of the examiner confusion. It also runs the risk of “diminishing the probative value of the SMED and complicating the Office action.” By contrast, a standalone SMED can present a clearer, more persuasive evidentiary record focused on subject matter eligibility.

How Examiners Evaluate SMEDs

 Although SMEDs specifically address subject matter eligibility rejections, the Director clarified that examiners must consider all evidence of record, including information in declarations filed for other purposes. Once the examiner determines the declaration meets the formal requirements, they must evaluate all the evidence, determine whether the claims are more likely than not eligible (by a preponderance of the evidence standard), and articulate in the next Office action why the claims are—or are not—eligible in view of the full record. This framework creates meaningful opportunities for applicants to use SMEDs to strengthen the factual underpinnings of an eligibility argument.

In addition to explaining the review process, the Director also provided a few practical examples on how applicants could use SMEDs:

• A claim involving the detection of suspicious network activity using network monitors distributed on multiple machines was rejected as falling within the “mental process” judicial exception. The applicant submitted a SMED explaining that a skilled artisan would interpret the specification as teaching that the network monitors are installed on multiple machines, each providing a different analysis of network packets. Thus, the SMED explains, the claimed invention cannot be practically performed in the human mind.
• In response to an examiner rejecting claims as directed to an abstract idea without additional elements, an applicant argued the claimed invention provides improvements to neural network (NN) technology by addressing certain structural constraints of systems in the prior art. Since the specification did not describe the specific NN performance improvements, the applicant provided a SMED from the inventor with the response. The inventor presented results from “objective comparative testing showing the claimed NN architecture provides superior regression performance over the prior NN systems identified in the specification.”
• In a prophylactic method claim that includes determining a lowest-risk prophylactic schedule and administering booster shots to canines based upon the lowest-risk schedule, the examiner determined that the claims are directed to an abstract idea without additional elements that amount to an inventive concept. The applicant submitted a SMED with evidentiary data showing that one skilled in the art would have understood that adjusting the prophylactic schedule as disclosed in the specification would lower the susceptibility of the canines to the disease.
• An examiner determined that claim limitations directed to filtering content on the Internet fell within the judicial exception of “certain methods of organizing human activity,” while additional claim elements were well understood, routine, and conventional. In response, the applicant submitted a SMED with expert testimony explaining that the specific arrangement of filters and its benefits were described in the specification, and that this arrangement and the associated benefits were not seen in the prior art.

In each scenario, the examiner is required to determine that the SMED does not improperly supplement the specification and that there is a nexus between the claimed invention and the evidence provided. The examiner must then weigh the SMED evidence before issuing the next action.

Takeaways for Applicants

The Director continues to push for more flexibility in addressing subject matter eligibility rejections. SMEDs may become a more influential tool in overcoming 35 U.S.C. § 101 rejections under the new Director’s guidance.

• Consider filing SMEDs, especially for repeatedly maintained 101 rejections. They may be particularly valuable in cases where applicants have faced multiple subject matter eligibility rejections with little to no headway using traditional patent prosecution techniques.
• File SMEDs separately from other declarations. The Director emphasized that declarations addressing different patentability issues should be filed separately to help prevent the examiner from confusing the issues.
• Anchor SMEDs in the specification to support complementary nature. SMEDs should reference the disclosures in the specification and help explain and elaborate on what is already there. There must be a nexus between the evidence the SMED presents and the claimed invention.
• Be aware of potential estoppel risk. Be careful with the how claim limitations are characterized in these SMEDs, as they become part of the record and can be the basis for estoppel.
• Continue to explicitly describe technical advantages in the original specification. SMEDs can help explain these advantages but cannot replace missing disclosure.

Going forward, SMEDs may become an important and powerful tool. Applicants should consider submitting SMEDs, particularly when fighting challenging or overbroad subject matter eligibility rejections.