USPTO Updates Its SMED Guidance — and Signals That It’s Working

On April 30, 2026, U.S. Patent and Trademark Office (USPTO) Director John A. Squires issued an updated memorandum on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs), “superseding” the December 4, 2025, memos that launched the current iteration of the SMED program. While the April 30 memo introduces no substantive changes to the underlying framework — the principles of the original SMED Examiner Memo, the relevant Manual of Patent Examining Procedure (MPEP) provisions, and the Alice/Mayo two-step analysis all remain — the update matters to practitioners for at least two reasons: it confirms that SMEDs are actually working, and it signals that the Office intends to refine the guidance over time as practitioners gain more experience with the tool.

Background: What Is a SMED?

For those who may be newer to the SMED framework, a quick recap. A Subject Matter Eligibility Declaration is a voluntary declaration submitted under 37 C.F.R. § 1.132 that provides factual evidence relevant to whether a claimed invention satisfies 35 U.S.C. § 101. Think of it as a way to put concrete, real-world evidence into the prosecution record that supports patent eligibility — evidence of technological improvement, the state of the art at the time of filing, how a claimed invention integrates an otherwise abstract concept into a practical application, or why the claimed invention is better, cheaper, faster, or more efficient than what came before.

The SMED framework traces its roots in part to a December 4, 2025 pair of memoranda from Director Squires — one directed to the Examining Corps clarifying how examiners should evaluate SMEDs, and one directed to practitioners laying out best practices for filing them. The December 2025 guidance made clear that SMEDs are not a new practice; they operate within existing Rule 132 practice as set forth in MPEP § 716. What was new was the express encouragement to use this tool, and the accompanying guidance to examiners that they must consider properly submitted SMED evidence as part of the evidentiary record.

What the April 30 Memo Actually Says

The most practically significant part of the April 30 update is the Office’s affirmative statement that early feedback from practitioners indicates that voluntary SMED submitters are having success. This is welcome news. Patent eligibility has long been treated as a pure question of law, and many practitioners have been skeptical — understandably so — about whether factual declarations would move the needle with examiners. The April 30 memo directly addresses that skepticism: the Office is telling practitioners that the evidentiary path works, and that examiners are taking SMEDs seriously.

The memo also reinforces the importance of establishing a clear nexus between the evidence submitted and the claims as written. This point deserves emphasis. A SMED’s probative value is a function of how tightly its factual assertions are tied to the claimed invention. Generic testimony about the virtues of a technological field will likely not do the job. What is apparently required — and what the memo continues to stress — is claim-linked evidence: testimony that specifically explains how the claimed elements, as recited, constitute a technological improvement or integrate an otherwise abstract concept into a practical application. The SMED must not be used as a vehicle to improperly supplement the specification; it is intended to help interpret and contextualize what is already disclosed.

The memo also revisits the question of how examiners are required to treat SMED evidence. Under In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992), the examiner bears the initial burden of establishing a prima facie case of unpatentability. The April 30 memo notes that practitioners have raised a pointed question: can an examiner merely “weigh” a SMED, or, absent contrary evidence from the examiner, does a properly submitted SMED effectively satisfy the applicant’s showing? The USPTO has acknowledged this feedback and indicated it is considering whether a revision to MPEP § 716.01(c)(III) is warranted to better reflect the full evidentiary import of a declaration. Watch this space — any revision to that section would be meaningful for prosecution strategy moving forward.

Finally, the April 30 memo expressly characterizes itself as a “living document.” So it appears that instead of issuing a one-time course correction and then stepping back, the Office is committing to an iterative approach — refining the guidance as more data comes in from practitioners and examiners about how SMEDs are being used in the field. That is a notable departure from the prior approach to Section 101 guidance, which tended to arrive as reactive responses to judicial developments rather than as practitioner-informed refinements.

What This Means in Practice

The practical implications of the April 30 memo fall into a few clear categories.

First, the core best practice for these documents remains unchanged. File your SMED as a standalone declaration under Rule 132, separate from any declaration addressing obviousness (or any other statutory ground). The rationale is straightforward: Section 101 eligibility and Section 103 obviousness are different inquiries, and addressing the two in a single declaration risks making it harder for the examiner to isolate the evidence relevant to each ground, potentially diluting the probative value of both. A clean, focused SMED is easier for the examiner to act on, results in a cleaner prosecution record, and reduces the risk of procedural confusion — particularly if the application is later appealed and the eligibility record will be considered anew.

In addition, the nexus requirement is not mere formalism. Every assertion in a SMED should map back to specific claim language. If you cannot point to a limitation in the claim that reflects the technological improvement you are referencing, the declaration is on shaky ground. Cases like Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016), and the PTAB’s Ex parte Desjardins decision are useful touchstones for what that claim-improvement connection looks like in practice: the improvement should be to the technology itself, not merely to what the technology is used for.

A Note of Caution

But I’ll end with a word of caution: SMEDs create witnesses. Before filing a SMED, practitioners should think carefully about who is signing the declaration and what they are committing to. A SMED submitted during prosecution does not disappear when the patent issues — it becomes part of the prosecution history, and the declarant becomes a potential witness in any subsequent litigation. If the patent is later asserted and the accused infringer decides to depose the inventor or technical expert who signed the SMED, that witness will need to defend, under oath and under cross-examination, every factual assertion in the declaration. An inventor who was perfectly credible in a written declaration may prove to be a difficult witness in a deposition — whether because of how they communicate, inconsistencies between the SMED and their other statements, or the difference between what they attested to during prosecution and what a well-resourced litigation team will later put in front of them at a deposition. The stronger and more specific the SMED, the more it can help during prosecution — but specificity cuts both ways. Before advising a client to submit one, it is worth having a candid conversation about who the declarant will be, how well they understand what they are signing, and how they are likely to hold up when a skilled litigator is on the other side of the table.

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