On December 4, 2025, the United States Patent and Trademark Office (USPTO) issued two memoranda addressing the use of Subject Matter Eligibility Declarations (“SMEDs”) during patent prosecution, both from Director John Squires.  The first, the SMED Examiner Memo, targets the Patent Examining Corps, clarifying how examiners should treat applicant-submitted evidence under 37 CFR 1.132 in traversing subject matter eligibility (SME) rejections.  The second, the Best Practices for SMEDs Memo, addresses the legal community, emphasizing strategies for maximizing the value and probative weight of SMEDs.  This article summarizes both memos, offering practical insights for innovators, patent professionals, and stakeholders navigating the Section 101 landscape.

Overview of the SMED Examiner Memo

The SMED Examiner Memo serves as comprehensive internal guidance for patent examiners regarding the treatment of SMEDs submitted during prosecution.  The SMED Examiner Memo highlights the ongoing challenges and confusion surrounding subject matter eligibility—particularly in rapidly evolving fields like artificial intelligence and medical diagnostics—and underscores the need for clear, evidence-based examination under Section 101, in line with the Ex parte Desjardins Appeals Review Panel decision.

SMED Examiner Memo Discussion of Rules and Policies

The SMED Examiner Memo provides clarification on the rules and policies governing the use of Subject Matter Eligibility Declarations (SMEDs) in patent prosecution.  Rather than introducing new procedures, the SMED Examiner Memo reinforces and elucidates longstanding practices under existing USPTO regulations, particularly 37 CFR 1.132 and related sections of the Manual of Patent Examining Procedure (MPEP).

At its core, the SMED Examiner Memo confirms that applicants have a voluntary option to submit evidentiary declarations—now referenced as SMEDs—under Rule 132 to traverse subject matter eligibility rejections.  The purpose of these submissions is to supplement the written record with facts or technical evidence demonstrating that the claimed invention meets the requirements of 35 U.S.C. § 101.

The SMED Examiner Memo anchors its discussion in MPEP § 716, which addresses the handling of affidavits or declarations submitted to overcome examiner rejections.  (While the SMED Examiner Memo references “affidavits,” the term “declaration” is used throughout because it is the more common practice under MPEP 602 and 37 CFR 1.132.)  It explains that any person with credible knowledge of the facts—such as inventors, an inventor’s co-worker, or independent experts—may submit a declaration following the formal requirements.  The declaration must meet the formal requirements outlined in MPEP 716, such as timeliness, proper signature, willful false statements clause, etc.

SMED Limitations and Requirements

The SMED Examiner Memo emphasizes key limits on the use of SMEDs:

  • A SMED cannot introduce new matter or information required to have been included at filing.  Instead, it may serve as evidence of facts existing at the time of filing, such as the state of the art or the technological improvements provided by the invention.
  • There must be a clear nexus between the facts set forth in the SMED and the claimed subject matter.  Declarations must link the provided evidence to the claims, for example, by showing how one of ordinary skill in the art would understand the technical improvement reflected in the specification and claims.
  • Mere opinions or conclusory statements regarding the ultimate question of eligibility are not entitled to weight.  However, objective, supporting facts—for example, technical test results, comparative data, or expert explanations—may be highly probative.

Examiner Obligations and Considerations

The SMED Examiner Memo outlines examiner responsibilities for reviewing SMEDs.  Examiners must evaluate the merits of a properly submitted SMED, weighing it alongside other record evidence under a preponderance of the evidence standard.  If the SMED is persuasive, the examiner must document the reasoning for withdrawing the eligibility rejection; if not, the examiner must provide a detailed explanation for maintaining the rejection.  Examiners are instructed to use specific content in office actions (MPEP form paragraphs 7.65 or 7.66) to memorialize consideration of SMED evidence.

Alignment with Existing Eligibility Guidance

The SMED Examiner Memo frames SMED practice within the broader context of the USPTO’s subject matter eligibility guidelines, including the relevant MPEP sections (2103-2106.07), recent Federal Register notices, and the 2024 and 2025 subject matter eligibility guidance updates.  It stresses that robust, well-supported factual showings can be critical in differentiating eligible technological advancements—particularly in emerging fields—within the Alice/Mayo two-step framework, and provides a pathway for applicants to directly address the factual basis underlying Section 101 rejections.

Examples Illustrating Effective Use of SMEDs

To provide practical guidance, the SMED Examiner Memo offers detailed, technology-focused examples demonstrating how SMEDs can substantively impact the outcome of Section 101 rejections.  Collectively, these examples showcase the variety of factual circumstances in which SMEDs may be leveraged to establish patent eligibility under the Alice/Mayo framework.

1.  Refuting a Mental Process Allegation:

In the first example, an applicant facing a rejection that categorized distributed network monitoring as a “mental process” submitted a SMED to demonstrate that the claimed processes—due to the scale and distribution across multiple machines—could not practically be performed in the human mind.  The SMED included “testimony on how one of ordinary skill in the art would interpret the specification’s teaching that the network monitors are installed on multiple machines and each perform a different analysis of network packets (i.e., distributed processes), and provide[d] objective evidence showing that these teachings cannot be practically performed in the human mind.”  This approach illustrates how SMEDs can address factual misconceptions about the nature of claimed subject matter.

2.  Demonstrating Technological Improvement:

The next three examples illustrated how SMEDs can substantiate claims of improvements to computer functionality or other technical fields.

The first technological improvement example involved a claimed invention directed to a self-referential table for a computer database.  The applicant submitted a SMED providing expert testimony to establish the state of the art at the time of filing, as well as to explain how one of ordinary skill in the art would interpret the invention as an improvement to the functioning of a computer.  The declaration referenced both the specification’s discussion of prior art data structures and the claim’s specific recitation of the improved table.  

The second technological improvement example focused on a claimed neural network (NN) architecture that overcomes specific performance limitations seen in prior art NN systems.  In this scenario, while the specification described the novel NN architecture and mentioned superior results, it did not describe the specific performance improvements.  The applicant addressed this gap by submitting a SMED “present[ing] results of objective comparative testing showing that the claimed NN architecture provides superior regression performance over the prior NN systems identified in the specification.”

The third technological improvement example addressed an invention related to computer animation technology.  The applicant argued that the claimed system automated specific animation tasks that previously required subjective, manual intervention by human animators.  To support this assertion, the applicant submitted a SMED containing expert testimony and trade magazine articles establishing the state of the art at the time of filing.  The declaration “provide[d] objective evidence that, prior to the invention, animators used computers to interpolate between ‘keyframes’ (important points or frames in an animated sequence) rather than adjusting every frame of the sequence.”

3.  Proving Practical Application in Life Sciences:

Another example involved a claimed method for preventing heartworm disease in dogs.  The examiner initially rejected the claim as being directed to an abstract idea—specifically, considering the step of analyzing data to determine a disease prevention schedule as a mental process, and the act of administering booster shots to gather data as a mere extra-solution activity.  In response, the applicant submitted a SMED accompanied by arguments that the claim’s final step—administering booster shots to a second group of dogs according to the newly determined, lowest-risk schedule—meaningfully applies the analysis in a way that produces a concrete health benefit.  The SMED included evidence showing that a person of ordinary skill in the art would understand that adjusting the schedule as described indeed reduces the risk of disease in the treated animals.

4.  Showing “Significantly More” Than a Judicial Exception:

SMEDs are also illustrated as valuable tools to show that, even where individual claim elements may be conventional, their specific non-conventional arrangement can amount to an inventive concept.  In an example involving internet content filtering systems, a SMED explained how the “specific arrangement of filters provides efficient operations while allowing user-level flexibilities not seen in prior art systems.”

The Best Practices for SMED Memo

Complementing the guidance directed to examiners, the USPTO’s second memorandum—Best Practices for SMEDs Memo—is aimed at the legal community and patent practitioners.  Though brief, the Best Practices for Memo offers the following important points:

  • File SMEDs Separately: Practitioners are encouraged to submit SMEDs as stand-alone declarations—apart from declarations related to other statutory sections such as novelty or non-obviousness—to avoid confusion and enhance clarity for the record.
  • Establish Technical Context and Nexus: The memo stresses the importance of establishing a clear nexus between the evidence asserted in the SMED and the features recited in the claims.

By following these best practices, applicants improve the chances that their eligibility positions will be persuasive upon examination, help build a prosecution record that holds up on appeal, and contribute to the issuance of stronger, more defensible patents.

Conclusion

The USPTO’s coordinated release of the SMED Examiner Memo and Best Practices for SMEDs Memo marks a noteworthy step toward clarifying the use of applicant-submitted evidence in subject matter eligibility determinations.  These memoranda equip both the examining corps and the legal profession with actionable guidance on making, evaluating, and responding to factual eligibility showings under 35 U.S.C. § 101.

Ultimately, the effective use of SMEDs promises not only to enhance the clarity and transparency of the patent examination process, but also to foster the issuance of patents that are better grounded, less susceptible to later eligibility challenges, and more reflective of genuine technological progress.

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