“Suggesting that applicants file a subject matter eligibility declaration before examination begins presents an awkward strategic choice.” – John Rogitz
The U.S. Patent and Trademark Office (USPTO) issued an updated memorandum today addressed to all patent applicants and practitioners that provides a flowchart for analyzing Subject Matter Eligibility Declarations (SMEDs) submitted under 37 C.F.R. Section 1.132 and reviews best practices for submitting them. The memo, from USPTO Director John Squires, is an addendum to an April 2026 SMED memorandum and, according to the USPTO, “this memorandum is consistent with existing USPTO guidance and does not announce any new USPTO practice or procedure.”
The USPTO released two memos on December 4, 2025, one directed to examiners and one to applicants and practitioners, on the use of SMEDs, which did not alter existing procedures and took effect immediately. The examiner memo explained that examiners must consider a properly submitted SMED, while the practitioner memo reviewed best practices.
On April 30, 2026, Squires issued an updated memorandum on best practices for submitting Rule 132 SMEDs that superseded the December 2025 practitioner memo, and the update introduced no substantive changes to the underlying framework.
The new memo opens with an overview of the USPTO’s subject matter eligibility efforts over the past year. In September 2025, Squires issued two patents as his first official act as Director, one in distributed ledger and crypto technologies and another in medical diagnostics. That same week, he authored the decision in Ex parte Desjardins and designated it precedential. The decision addressed the eligibility of an improved method of training a machine learning model to address catastrophic forgetting, which the memo describes as a concrete technical improvement to how computers function. In December 2025, the USPTO published an Advance Notice of Change to the Manual of Patent Examining Procedure (MPEP) reflecting Desjardins.
One flowchart shows how an examiner reviews a SMED for formality compliance, and the other addresses review of the merits once the formalities requirements are met. The flowchart is consistent with the USPTO guidance on declarations and affidavits under 37 C.F.R. Section 1.132, as reflected in MPEP Sections 716 and 2106.07. Each Technology Center has Subject Matter Experts available to answer examiner questions, while the ultimate determination of eligibility “resides with the Primary Examiner.” The memo does not revise the December 4, 2025 SMED memo to examiners; it describes submitting a SMED as optional but potentially useful for clarifying the record or overcoming a subject matter eligibility rejection.
Five best practices for applicants are outlined, which the USPTO describes as “not requirements” but potentially helpful in preparing and submitting a SMED. A single Rule 132 declaration may address rejections under multiple statutory requirements, but applicants are encouraged to submit a separate SMED, which may avoid intertwining enablement, written description, novelty, and nonobviousness with eligibility. Filings in the Patent Center should use the document code “AF/D.SMED” and the document description “Subject Matter Eligibility Declaration.”
A SMED may be filed at any time before prosecution closes, after which it is untimely unless filed under certain conditions. Applicants may find early filing advantageous, such as before the first action on the merits, since the examiner can then consider the SMED during the initial eligibility evaluation.
Examiners assessing an expert opinion consider the nature of the matter to be established, the strength of any opposing evidence, the expert’s interest in the outcome, and the presence of factual support. A declaration from an applicant may not be disregarded solely for that reason, but the memo describes it as less persuasive than one from a disinterested person. Neutral third-party evidence, such as a trade article outlining limitations known in a technology at the time of filing, may support an expert’s opinion that a person having ordinary skill in the art would have recognized a technological improvement disclosed in the specification.
Applicants are also encouraged to identify which aspect of the rebuttal the evidence supports, with the memo giving the example of a SMED submitted to establish under Step 2A Prong One that claim limitations cannot practically be performed in the human mind. Interviews between applicants and examiners on eligibility issues, including those relating to a SMED, are described as a means of advancing prosecution.
The memo directs readers to the USPTO’s subject matter eligibility page, which includes guidance memoranda, examples, and training, including a 101 Quick Reference Guide (101 QRG) for examiners to use with MPEP Section 2106 and applicable guidance memoranda. The USPTO states that it will share the flowchart and the 101 QRG with the patent examining corps later this week.
Potential Practice Problems
According to John Rogitz of Rogitz & Associates, SMEDs raise a number of questions from a practice standpoint. “Suggesting that applicants file a subject matter eligibility declaration before examination begins presents an awkward strategic choice,” Rogitz said. “Why would an applicant volunteer a detailed defense of eligibility before an examiner has identified a problem? Preparing the declaration the USPTO envisions also takes time and money that many corporate prosecution budgets will not support. And every declarant adds a potential fact witness whose statements may be examined years later in litigation.”
Rogitz said the flowchart “raises further questions,” particularly with respect to the third point under “Formality Review” for assessing whether a SMED is timely, which states: “after final rejection, but before or on the same date of filing an appeal, upon a showing of good and sufficient reasons why the declaration is necessary and was not earlier presented in compliance with 37 CFR 1.116(e).” He explained:
“What constitutes a ‘good and sufficient reason’ to submit a declaration after final rejection, and how consistently will that judgment be made? And an applicant seeking to strengthen an eligibility argument could instead invite scrutiny of the originally filed specification, which could create a record that complicates other issues. Practitioners will have to weigh those risks against the declaration’s uncertain benefit.”
Squires defended SMEDs as one solution to U.S. eligibility problems in an oversight hearing held today by the Senate Judiciary Committee’s Subcommittee on Intellectual Property, in response to questioning from Senator Thom Tillis (R-NC) about his support for the Patent Eligibility Restoration Act (PERA), which has been stalled this year.
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