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23 December 2025

Guidance On Rule 132 Declarations For Patent Eligibility

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Easier path to eligibility: The USPTO's new guidance explains how to use sworn statements (SMEDs) to provide facts showing an invention is eligible for a patent.
United States Intellectual Property
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Key Takeaways

  • Easier path to eligibility:  The USPTO's new guidance explains how to use sworn statements (SMEDs) to provide facts showing an invention is eligible for a patent.
  • Effective immediately: The memoranda apply immediately; for pending cases in eligibility‑sensitive areas, SMEDs that marshal objective, claim‑tethered proof of technological improvements or concrete application may be filed now.
  • Examiner practice changes: Examiners are instructed to weigh SMED evidence explicitly and document reasoning, promoting more predictable outcomes and stronger issued patents.

What the USPTO Issued and Why It Matters

The U.S. Patent and Trademark Office issued coordinated guidance clarifying that applicants may use Rule 132 declarations—styled as Subject Matter Eligibility Declarations (SMEDs)—to submit factual evidence supporting patent eligibility. While the Office emphasizes that SMEDs do not change existing law or procedure, they do meaningfully expand a practical avenue for applicants: targeted evidentiary submissions that can establish a “practical application” under Step 2A, Prong Two, and thereby overcome Section 101 rejections more efficiently and transparently. The USPTO issued two memoranda (one to the Examining Corps and one to applicants) and a public alert.

What Examiners Are Being Told to Do

The Examiner Memorandum advises that SMEDs must be considered on the merits if timely and compliant with formalities. Examiners are instructed to weigh the SMED's factual content alongside the full record and to document their reasons for either maintaining or withdrawing eligibility rejections in light of that evidence. The memo also provides concrete hypotheticals illustrating how SMEDs can demonstrate that processes are not “mental processes,” that processes improvement the functioning of processing elements, that claims are directed to unconventional arrangements amounting to “significantly more,” and that claims are directed to particular treatment/prophylaxis applications—each mapping to familiar Step 2A/2B pathways but with a stronger, evidence‑driven foundation.

What Applicants Are Being Advised to Do

The Public Memorandum recommends that applicants submit SMEDs as separate declarations focused solely on eligibility, rather than bundling them with testimony aimed at other statutory requirements (e.g., secondary considerations under § 103). Keeping the records distinct improves clarity and probative value and avoids confusing evidentiary relevance across different issues. The USPTO anchors this approach in the MPEP and in Federal Circuit guidance on examiner and Board consideration of evidence.

In practical terms, effective SMEDs should: identify the specific claim features that implement the improvement; provide objective, contemporaneous proof of technological benefits or constraints in the art; articulate how a skilled artisan would understand the specification as evidencing an improvement; maintain a clear nexus to the claim language; and avoid introducing new technical matter beyond the four corners of the filed disclosure.

The Key Change: A Clear, Evidence-Backed Route to “Practical Application”

Although Rule 132 declarations have long been available, the USPTO now expressly highlights SMEDs as a focused, probative mechanism to establish the factual predicates that matter most at Step 2A, Prong Two. In particular, SMEDs can supply:

  • Evidence of the state of the art at filing and how a skilled artisan would read the specification to understand the claimed improvement in technology or computer functionality.
  • Objective proof (e.g., data, comparative results, industry literature) that the claimed architecture, control flow, data structure, or workflow yields concrete technical benefits, and where those improvements are reflected in the claims.
  • Evidence that claim limitations cannot practically be performed in the human mind, supporting that the claim is not reciting a “mental process” abstract idea or that any such exception is meaningfully integrated into a practical application.
  • Evidence that applying analyzed information effects a particular medical treatment or prophylaxis—an established path to integration into a practical application in life sciences claims.

These declarations, when properly tied to the claims and the specification, are to be weighed with all other record evidence under the preponderance standard. Importantly, if an examiner maintains or withdraws a rejection after a SMED, the examiner must explain why, based on all evidence of record, the eligibility determination stands or falls—promoting transparency and consistency.

Implications Across Technologies

  • Artificial intelligence and data systems. The Desjardins framework, now precedential within the Office, supports eligibility where claims improve model function, data handling, storage, or training workflows. SMEDs can document system‑level performance improvements and architectural advantages, reinforcing integration into a practical application at Step 2A, Prong Two.
  • Software and internet technologies. Evidence showing a specific arrangement of components that confers operational benefits—such as a defined network location with user‑specific filtering features—can weigh in favor of “significantly more” or integration into a practical application, when tied closely to claim language and the specification.
  • Computer animation and media. Demonstrating that claimed rules or control flows enable automation of tasks previously subjectively performed by humans can show a computer‑function improvement and practical application, supported by industry practice evidence and specification disclosure.
  • Diagnostics and medical methods. Evidence that analyzed information is applied to effect a particular treatment or prophylaxis—such as adjusting dosing or scheduling to reduce risk—can demonstrate integration into a practical application under Step 2A, Prong Two.

This timing for this guidance is significant, arriving alongside the Appeals Review Panel's precedential designation of In re Desjardins, which recognizes that improvements in computational performance, data structures, training methods, and related features can reflect patent-eligible technological advancements. The Office's leadership links Desjardins to a broader direction: eligibility must account for how an invention is applied, how it operates, and what it accomplishes in technological terms—put differently, whether the claims integrate any judicial exception into a practical application under Step 2A, Prong Two. Importantly, SMEDs give applicants a way to provide, after filing, clear factual evidence about how the invention is actually applied in practice, which makes it easier to show a practical application and, in turn, to establish patent eligibility.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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