On December 4, 2025, and April 30, 2026, USPTO Director Squires provided additional guidance for how applicants and practitioners can submit evidentiary declarations (also known as a Subject Matter Eligibility Declaration (SMED)) under 37 C.F.R. §1.132 during patent prosecution.
What You Need to Know:
- A §101 rejection is typically issued when the USPTO determines that an applicant for patent attempts to claim a natural phenomenon or an abstract idea—subject matter that is outside the definition of an invention.
- The greatest impact of §101 rejections have been on software and diagnostic methods.
- These rejections increased since 2010 with Supreme Court decisions that narrowed patent-eligible subject matter by broadening the scope of the judicially developed exceptions (Bilski v. Kappos, 2010; Mayo Collaborative Servs. v. Prometheus Labs, 2012; Ass’n for Molecular Pathology v. Myriad Genetics, 2013; and Alice Corp. Pty. v. CLS Bank, 2014)
- The SMED can be used to optionally submit evidence to demonstrate patent eligibility that may not be readily apparent to overcome a 35 U.S.C. §101 rejection. All other declarations under 37 C.F.R. §1.132 that address other issues, such as obviousness, should be submitted as a separate document.
- This guidance “ensure(s) the case reasoning binds all examination and appeals activity, and…underscore(s) that improvements in computational performance, learning, storage, data sets and structures…can constitute patent-eligible technological advancements under the Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (“Alice”) framework.” Memorandum to Patent Examining Corps, December 4, 2025.
- The April 30 update elaborates on the USPTOs intentions in highlighting declaration practice. Specifically, subject matter eligibility declarations should explain why the claimed invention is “better, cheaper, faster, and/or more efficient” and thus patent eligible.
- The USPTO SMED guidance will be periodically updated based on practitioner experience and knowledge gathered by the USPTO and therefore we can expect this to continue to be an actively developing area of practice.
This guidance follows and cites the Appeals Review Panel (ARP) precedential decision, Ex Parte Desjardins, Appeal No. 2024-000567, which vacated a Patent Trial and Appeal Board (PTAB) Section §101 rejection. The ARP was convened by Director Squires to review the decision. Overall, the ARP concluded that the claims reflect an improvement in computer functionality and technology and, therefore, are not directed to an abstract idea. This decision discusses that subject matter eligibility “must be assessed carefully and consistently, with proper consideration of technological improvements reflected in the claims and specification.” This guidance has not altered existing USPTO procedures, but provides clarification to both applicants and examiners on how to provide and evaluate a SMED.
Impact of the New Guidance
The memo to the Examining Corps states that when a SMED is properly submitted, examiners must consider it as part of the record and give it meaningful weight while evaluating the submission using the USPTO’s subject matter eligibility analysis (“Alice” framework). For example, if properly submitted in a SMED, examiners must consider evidence suggesting that the claim does not recite a judicial exception, identifying when a judicial exception is integrated into a practical application, or demonstrating that a claim amounts to significantly more than a judicial exception—conditions which, if present based on a preponderance of the evidence, would overcome the prima facie case of ineligibility.
Examiners should carefully consider all of the applicant’s arguments and evidence rebutting the Section §101 rejection when evaluating the applicant’s response. The Office provided examiners multiple examples in various scenarios (such as applications directed to networks, improvements to the function of a computer or to any other technology or technical field, a particular medical treatment or prophylaxis, etc.). Although these Examples are meant to guide the examiner during examination of these applications, these Examples can also be helpful to applicants and practitioners in regard to determining the best strategy to respond to the §101 rejection.
According to the April 30 update, initial feedback indicates that practitioners who submit a SMED are having success. If this trend continues, this is excellent news for innovators in fields where subject matter eligibility is an issue because the status quo has been that, given the relatively small number of examples of decisions by Article III courts in regard to subject matter eligibility, Examiners have applied subject matter eligibility rejections aggressively and then been unpersuaded by Applicant’s arguments to the contrary. With few granted patents in this area, there continue to be few court decisions and the law of subject matter eligibility cannot develop. While Examiners play a very important role in ensuring patent quality, the memoranda providing additional guidance to examiners and an additional tool for practitioners will likely result in more issued patents where subject matter eligibility is an issue and therefore more court decisions regarding patent eligibility, which will ultimately provide greater certainty and predictability in affected fields.
For Applicants and Practitioners
The SMED guidance provides applicants and practitioners best practices for preparing and submitting SMEDs. First, a declaration used to overcome a 35 U.S.C. §101 rejection should be submitted separately from any other declaration being filed (e.g., a declaration addressing an obviousness rejection should be filed separately from a declaration addressing subject matter eligibility). While applicants are permitted to address multiple grounds of rejection in a single declaration, combining a declaration that addresses different rejections may complicate the record and cause confusion during the evaluation of evidence. As a result, important evidence provided in the SMED could be misinterpreted or not fully considered by the examiner.
Next, SMEDs should not be used to supplement the original disclosure, but rather provide objective evidence tied to the claimed invention. Rather, improvements over the prior art already taught in the patent application should be framed in terms of the technical effects reflected in the claims and specification. The updated guidance elaborates that a SMED may be the equivalent of the long-ago dispensed “working model requirement” (also called patent models). The SMED may be thought of as a voluntary, “constructive model” which can highlight relevant characteristics of the claimed invention as they would be appreciated by a person of skill in the art, although a SMED is a written document, the content of the declaration may be used to highlight the less visible or tangible nuances of innovation that an Examiner may otherwise not appreciate and therefore may not be appropriately considering under the analysis set forth in the subject matter eligibility guidelines. Accordingly, an effective SMED will highlight features of the invention that overcome the subject matter eligibility rejection when considered under the existing framework and show a nexus with the claims of the application.
Finally, SMEDs provide applicants with tools to build an evidentiary record supporting eligibility. A SMED contains both benefits and risks to your application. A declaration is an affirmative act intended to be relied upon by the Office, and accordingly, a SMED may receive additional scrutiny in any future litigation of the patent, so great care should be taken to make sure no errors or misstatements are included in the declaration, which could affect patentability.
Ultimately, the memoranda issued by the USPTO provides helpful clarification on how applicants can submit factual evidence relevant to the eligibility analysis and how examiners should evaluate such submissions under longstanding practice.
Although its impact remains to be seen, the availability of SMEDs may prove a useful tool for applicants to present focused evidence in support of eligibility to a USPTO whose leadership is relatively more open to patenting in the face of Section 101. E.g., one could imagine the USPTO resolving disputed issues supported by a SMED in the applicant’s favor.
If you have questions regarding a submission of a Subject Matter Eligibility Declaration under 37 C.F.R. §1.132, please reach out to the authors of this Alert or a member of the Saul Ewing Intellectual Property Team.
