USPTO Issues Updated Best Practices Memorandum on Subject Matter Eligibility Declarations (SMEDs) Under Rule 132

Overview

On April 30, 2026, USPTO Director John A. Squires issued an updated memorandum superseding the December 4, 2025, guidance on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs). The USPTO has also created a new position — Deputy Commissioner for Patents focusing on AI Policy, Practice, and Operations — and has welcomed longtime practitioner and private-sector AI expert Barry Schindler to this role. This alert summarizes the key updates and actionable guidance for patent applicants and practitioners.

Background: What Is a SMED?

A Subject Matter Eligibility Declaration (SMED) is a voluntary declaration that patent applicants may submit to the USPTO to help demonstrate that their invention is patent-eligible under 35 U.S.C. § 101. The concept traces back to the Patent Office's old “working model” requirement — the idea that applicants should provide the Office with a concrete, real-world picture of how their invention works. While that requirement no longer exists, the USPTO has modernized it for today’s innovations. In fields involving intangible subject matters such as software, AI, data analytics/computation, and medical diagnostics, a physical model is simply not practical, and so a SMED serves as its functional equivalent. It follows the same familiar Rule 132 declaration format practitioners already use to help overcome obviousness and written description rejections.

In substance, a SMED presents objective evidence showing how a skilled person in the relevant field would read the specification and recognize the invention as a genuine technological advance that is therefore patent-eligible, because it is better, faster, cheaper, or more efficient than existing solutions.

Key Updates in the April 30, 2026, Memorandum

1. The SMED Memo Is Now a “Living Document”

In approximately five months since the December 2025 memo, the SMED program has drawn encouraging practitioner feedback, with early submitters reporting positive results. The April 30, 2026, memorandum introduces no substantive changes to the original guidance, the SMED Examiner Memo, or the updated MPEP provisions. Rather, the USPTO intends to treat the memo as a “living document,” issuing periodic updates as practitioner experience with SMEDs continues to develop.

2. Keep SMEDs Separate from Other Rule 132 Declarations

While a single Rule 132 declaration may technically address multiple statutory rejections, the USPTO encourages practitioners to file a standalone SMED dedicated solely to subject matter eligibility. Doing so minimizes the risk of conflating § 101 eligibility issues with those arising under §§ 102, 103, or 112.

Combining these issues in a single declaration can create confusion as to the evidentiary weight of the testimony and may complicate both the examiner’s analysis and the applicant’s record.

3. Nexus Requirement and Examiner Consideration

For an evidentiary declaration to be relevant, there must be a nexus between the invention as claimed and the evidence provided in the declaration. SMEDs must not improperly supplement the specification and must be timely filed, with a clear nexus to the claimed inventions. Claims, not declarations, define the invention.

Where a SMED is combined with unrelated testimony, examiners may struggle to isolate the evidence relevant to subject matter eligibility, potentially undermining the probative value of the declaration and complicating the resulting office action.

4. Examiner's Initial Burden

Practitioner feedback has helpfully pointed out that examiners bear the initial burden upon review of all grounds presented under Rule 132 affidavits, including SMED submissions regardless of how they are filed. This is consistent with the Federal Circuit's holding in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992), where the examiner “bears the initial burden upon review of the prior art or on any other ground of presenting a prima facie case of unpatentability.”

5. MPEP § 716.01(c)(III) Under Review

The USPTO has received suggestions that the longstanding MPEP § 716.01(c)(III) may not describe the full import of a declaration as evidence. Specifically, commentators have suggested that declarations need not affirmatively “persuade,” and that absent contrary evidence, they should not be treated as subject to open-ended weighing. The USPTO is taking this feedback under advisement and considering whether a revision to this MPEP section is warranted.

Best Practices Summary

Based on the updated memorandum, practitioners should observe the following best practices when preparing and submitting SMEDs:

Best Practice	Key Consideration
Submit a separate SMED for § 101 issues.	Avoid combining with § 103 or § 112 testimony to prevent intertwining of issues.
Establish a clear nexus.	The declaration must connect the claimed invention to the evidence provided.
Demonstrate technological improvement.	Show how the invention is better, cheaper, faster, or more efficient.

Why This Matters

Filing a standalone SMED — rather than bundling § 101 eligibility arguments with testimony on obviousness or other statutory rejections — keeps the evidentiary record clean and focused. A well-targeted SMED is easier for examiners to evaluate, is less likely to generate procedural complications, and may carry greater weight in traversing a § 101 rejection. This is particularly relevant for applicants in software, AI, data analytics/computation, and medical diagnostics, where subject matter eligibility remains one of the most frequently contested issues at the USPTO.

Crowell’s patent prosecution team has been closely tracking the USPTO’s new SMED guidance and can assist in evaluating whether this approach is appropriate for pending applications.