USPTO Director Encourages Use of Declarations to Overcome Eligibility Rejections
Rejections of patent applications as being directed to patent-ineligible subject matter can be difficult to overcome, particularly for artificial intelligence or software-related applications. While arguments that a patent claim incorporates any ineligible abstract idea into a practical application or provides a technological advance over the prior art are supposed to be sufficient to overcome a rejection, they ultimately rely on the Examiner’s discretion to withdraw their own rejection – and getting someone to say they were wrong can be challenging at the best of times. Providing credible extrinsic evidence, however, can significantly strengthen those arguments.
Under 37 CFR 1.132, an Applicant can provide a declaration with supporting evidence to traverse a rejection. This tool is rarely utilized, but can be invaluable for subject matter eligibility rejections, particularly where the patent specification is light on shortcomings in the prior art and how the invention provides a concrete improvement or solution.
On December 4, USPTO Director John Squires issued a pair of memoranda – one to patent Examiners and one to Applicants – encouraging the use of evidentiary declarations under 1.132 to establish subject matter eligibility under 35 U.S.C. §101. These “Subject Matter Eligibility Declarations,” or SMEDs, represent the next phase of the USPTO’s ongoing effort to clarify examination of AI- and software-related inventions following the precedential decision in Ex parte Desjardins (Sept. 26, 2025) and Deputy Commissioner Kim’s guidance memo to Examiners on evaluating subject matter eligibility (August 4, 2025). Squires’ new memos noted the difficulty in establishing that a patent claim includes “something more” than an ineligible judicial exception as the Supreme Court instructed in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014), but emphasized that evidentiary declarations may help “demonstrate[] patent eligibility that may not be readily apparent.”
The Examiner Memo: How the USPTO Will Evaluate SMEDs
The memo to Examiners provides several key instructions on how to evaluate an SMED filed in response to a patent eligibility rejection:
Mandatory consideration – SMEDs are optional and voluntary (and Applicants cannot be penalized for declining to submit one), but when properly filed, Examiners must weigh declarations “on the merits” using a preponderance of the evidence (i.e., more likely than not) standard.
No special expertise required – any person who has knowledge of the facts being asserted may sign the declaration, including an inventor, an inventor’s co-worker, an independent expert, or others, and no special qualifications are required. However, in practice, an independent expert typically carries more weight.
Nexus required – a SMED must tie the evidence directly to the invention as claimed, and not merely to the specification, a broad “inventive concept,” or a product that embodies the invention. For example, an SMED may show how one of skill in the art would interpret a specification that describes a technological improvement.
No new matter – declarations cannot add new matter to the application, but may establish facts as of the filing date of the claimed invention, such as the state of the art, how the invention improved upon the art or solved technological problems, or how a person of skill in the art would recognize that the invention provides a technological improvement that’s reflected in the claims.
Further actions must provide explanation – whether the Examiner maintains or withdraws the eligibility rejection in a subsequent Office action, they must explain, based on all evidence of record including the declaration, why the rejection has or has not been overcome.
The memo also provides several hypothetical examples of eligibility rejections that could be overcome by a proper declaration, including that a claimed invention could not be practically performed in the human mind; that an invention improves the functioning of a computer or provides an improvement to another technology; that the patent claims include limitations that apply an abstract idea in a manner that imposes a meaningful limit on the mental process; or that a combination of elements in a claim may be conventional when considered individually, but are arranged together in an unconventional way that amounts to an inventive concept. These examples, modeled after cases such as SRI Int’I, Inc. v. Cisco Sys., 930 F.3d 1295 (Fed. Cir. 2019); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016); and McRO, Inc. v. Bandai Namco Games Am., Inc., 837 F.3d 1299 (Fed. Cir. 2016) illustrate that declarations can supply the factual underpinnings Examiners must consider when applying the Supreme Court’s Alice framework.
Practical Takeaways for Applicants
Use SMEDs Strategically and Credibly
When a §101 rejection rests on Examiner assertions about what is “routine” or “abstract,” a well-crafted declaration can shift the balance of evidence. The USPTO explicitly recognizes that expert testimony – particularly from someone other than the inventor – may be persuasive to establish the state of the art and the technological nature of an improvement. An independent declarant adds credibility and insulates against accusations of self-serving testimony.
Focus on the Claims, Not the Concept
A SMED should address specific claim elements and how they change the functioning of a system or provide a specific improvement over the art, and not simply assert that the invention is “AI-based” or “innovative,” labels that do little to establish eligibility. Tie each technical advancement to the claim language itself (e.g., “this feature reduces memory use by altering data flow within the architecture”) rather than describing the invention at a high level of abstraction (e.g., “the invention makes computers more efficient”).
Document Objective Evidence
Declarations should include data, comparative results, or supporting literature showing how the claimed approach improves computing performance or enables tasks not feasible by humans. Subjective opinions alone carry little weight.
Special Considerations for Biotech and Pharma Applications
Applicants can use declarations to anchor §101 eligibility in claim‑tied facts rather than characterization. For diagnostics, tie specific sample‑prep, assay conditions, and analysis steps to measurable improvements (e.g., higher sensitivity or specificity, fewer false positives) to demonstrate a concrete technological improvement beyond a natural correlation. For therapeutics or formulations, point to pharmacokinetic or pharmacodynamic data, stability, or impurity profiles linked to claimed steps or excipient ranges to show non‑conventional performance. For bioinformatics, show that the claimed pipeline cannot be performed in the human mind and yields quantifiable gains (runtime, mapping accuracy, variant‑calling precision). Keep the nexus explicit, avoid new matter, and frame ‘state of the art’ carefully to the claimed context.
File SMEDs Separate From Other Declarations
Squires’ memo strongly recommends filing SMEDs as standalone documents, and explicitly warns against combining eligibility evidence with testimony traversing other rejections, such as secondary considerations of nonobviousness under §103 or enablement under §112. By keeping the SMED distinct, Applicants avoid “muddying the waters” and ensure that the Examiner or any future reviewing body evaluates the eligibility evidence in isolation, without conflating the “inventive concept” of §101 with the “unexpected results” of §103. A standalone declaration forces the Examiner to confront the eligibility evidence head-on.
Watch for Estoppel Risks
As with any sworn statement, a 1.132 declaration may be used against the patent owner in future litigation. Statements about “conventional practice” or the “state of the art” could create unintended estoppel or narrow claim scope. For example, declarations should avoid broad generalizations about what was “well-understood, routine, or conventional” unless those statements are carefully supported and narrowly framed. Applicants should also avoid defining the technological field too broadly or admitting facts that opponents might later invoke, and instead focus specifically on the claimed invention in comparison to systems lacking the inventive features. This is another reason why the USPTO’s advice to file separate declarations is sound strategy. By isolating §101 admissions in a dedicated SMED, Applicants may limit the blast radius of any statements made about the “state of the art,” preventing them from inadvertently conceding valid arguments regarding obviousness.
Declarations are Not a Substitute for Proper Application Drafting
Where a patent application does not explicitly set forth how the invention provides a technological improvement over conventional systems, addresses a particular technical problem with a specific technical solution, or improves the functioning of a computer or other technology, SMEDs can fill in the missing details (provided the specification still has enough description that such an improvement would be readily apparent to one of skill in the art). However, Squires’ memo stresses that “when applicants are aware at the time of filing that certain evidence would be favorable to eligibility, they are strongly encouraged to include the evidence in the specification.” The patent application can essentially be its own first SMED and establishes that, at the time of filing, the improvement provided by the invention was apparent.
Conclusion and Next Steps
Director Squires continues to extend policy from Desjardins into practical tools for overcoming subject matter eligibility rejections, and between that precedential decision and the guidance to Examiners, reaffirms that the USPTO is open to factual showings of technological improvement, particularly for AI and computational inventions that might otherwise be dismissed as “abstract ideas.”
Applicants should consider adding declarations in difficult eligibility cases where the specification describes a technical advance but the Examiner remains unconvinced. When done carefully, a SMED can be the difference between a final §101 rejection and allowance.
For questions regarding how the Director’s decision may affect your pending applications or portfolio strategy, please contact partner Daniel Rose, Intellectual Property Department at daniel.rose@pierferd.com.
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