New USPTO Guidance on Section 101 Declarations: Building a Section 101 Record in AI and Software Patents That Holds Up in Prosecution and in Court

Executive Summary

On April 30, 2026, USPTO Director John A. Squires issued updated guidance (superseding the December 4, 2025 Director’s “Best Practices” Memo) directing patent applicants and practitioners to file subject matter eligibility declarations (SMEDs) as standalone documents, separate from any declaration addressing obviousness or other rejections. This guidance is not limited to a particular technology, but may be particularly important for applicants prosecuting artificial intelligence (AI) and software related patent applications. AI patent applications frequently encounter § 101 rejections alleging that claims are directed to mathematical concepts, mental processes, or abstract ideas. SMEDs have traditionally been relatively rare but are becoming more popular with the increasing number for AI related patent applications. The updated USPTO guidance provides applicants with an additional mechanism to build a factual prosecution record demonstrating that an invention provides real world technological improvements.

If you have applications pending with Section 101 rejections in software, AI, fintech, diagnostics, or quantum computing, this guidance affects your prosecution strategy now. Critically, it also affects how you build the evidentiary record that will support your patent in district court litigation if and when that day comes.

What Is a SMED?

A SMED is a voluntary declaration filed under 37 CFR 1.132 to overcome a Section 101 rejection. It functions as a constructive model of the invention—a concept rooted in the historical “working model” requirement for letters patent, adapted to modern frontiers of innovation where the invention may not be readily tangible. A constructive model is not a physical prototype. Instead, it is a written declaration under Rule 132 that constructively demonstrates how the invention operates as a real technological solution and why it should be considered patent-eligible under Section 101. In concrete technical terms, the SMED explains how the claimed invention solves a real technological problem and why a skilled engineer or scientist would read the specification as describing a genuine improvement to technology rather than an abstract idea. Early results from voluntary submitters indicate meaningful success rates at the USPTO. Equally important, a well-constructed SMED becomes part of the prosecution history that a patent owner can deploy offensively in litigation to establish claim scope, rebut invalidity arguments (particularly under Section 101), and demonstrate the technical character of the patented invention.

The Central Directive: File Separately

Do not combine a SMED with declarations addressing obviousness or written description. Although the USPTO acknowledges it is permissible to file a single declaration under 37 CFR 1.132 addressing rejections under multiple statutory requirements, applicants are strongly encouraged to submit a separate SMED. Mixing these arguments in a single declaration risks diluting the evidentiary record, complicating the examiner's analysis, and undermining the effectiveness of all the testimony submitted. The USPTO’s reasoning is also procedural: examiners bear the initial burden of reviewing all grounds presented in Rule 132 affidavits, and a combined submission may make it difficult for the examiner to isolate the evidence relevant to subject matter eligibility, potentially diminishing the probative value of the SMED. Each declaration should be discretely focused on the specific rejection it is intended to overcome. That discipline serves you in prosecution and protects the integrity of the record in any later litigation.

What a Strong SMED Must Accomplish

1.  Establish a Direct Nexus to the Claims

The declaration must be tethered to the claims as written, not to the invention generally or the specification in the abstract. Examiners are instructed to evaluate whether the evidence is relevant to the specific rejection being traversed: “For an evidentiary declaration to be relevant, there must be a nexus between the invention as claimed and the evidence provided in the declaration.” A declaration that speaks to the invention's general utility or commercial appeal without mapping to it to the claims will receive little weight. The declarant must walk through the claims and explain how the specification supports a reading that certain limitations, and/or the invention as a whole, is a concrete technological improvement. In litigation, this same nexus argument becomes the foundation for rebutting an accused infringer's Section 101 validity challenge under Alice and its progeny.

2.  Demonstrate Technological Improvement Through the Eyes of a Skilled Practitioner

The legal standard for overcoming a Section 101 rejection turns on whether a person of ordinary skill in the art would interpret the specification as describing an improvement to technology itself, not merely an improvement to a business method or mental process that happens to run on a computer. The SMED must provide that perspective with specificity: identify the technical problem that existed before the invention, explain why prior approaches were inadequate, and articulate precisely how the claimed invention addresses the deficiency and provides a solution or an improvement in a way that is rooted in the technical disclosure of the specification.  For AI or software patent applications this can include tying the improvement to certain computer functionality or AI system operation. Conclusory statements that the invention is innovative or novel will not move the needle at the USPTO or in court. Courts conducting Step Two of the Alice analysis ask virtually the same question (whether the claims at issue contain an "inventive concept" sufficient to transform a patent-ineligible concept, such as an abstract idea, into a patent-eligible application), making this section of the SMED potentially reusable as expert testimony supporting future Section 101 litigation challenges. 

3.  Quantify the Improvement Wherever the Specification Supports It

The USPTO guidance calls for showing that the claimed invention is better, faster, cheaper, or more efficient than prior approaches. Where the specification contains data, benchmarks, performance metrics, or comparative results, the declaration should draw those out explicitly and connect them to the claim language. Importantly, the SMED must not improperly supplement the specification; because the declaration should not introduce new technical content not already in the specification, if the specification is sparse on this point, that is a signal to evaluate whether a continuation or continuation-in-part filing with richer technical disclosure is warranted before or alongside the SMED.

Inventor vs. Technical Expert: Who Should Sign?

This is one of the more consequential decisions in SMED strategy, and there is no universal answer.

The inventor has deep familiarity with the problem the invention solves and the technical choices made during development. Inventor declarations can be compelling because they are authentic and carry the credibility of someone who lived the problem. The risk is that inventors often struggle to articulate their work from the vantage point of a hypothetical person of ordinary skill in the art, which is the legal lens that matters. An inventor declaration that reads as advocacy rather than objective technical analysis can backfire, particularly when that same prosecution record is scrutinized by litigation counsel or a federal judge years later.

A third-party technical expert brings perceived independence and can credibly speak as a person of ordinary skill in the art without the appearance of self-interest. A well-credentialed expert in the relevant field who explains why the specification discloses a genuine technological advance carries significant persuasive weight with examiners and, critically, with courts. The tradeoff is cost, preparation time, and the risk that an expert without intimate knowledge of the invention mischaracterizes a technical nuance that the inventor would have caught immediately.

In some cases, both declarations make sense: the inventor providing factual context about the problem and development history, and an independent expert providing the skilled-artisan perspective on the specification and claims. When combined, they should be filed together as a coordinated SMED submission but remain separate from any obviousness or enablement testimony.  The USPTO must consider all evidence submitted, including multiple declarations, and may not disregard any simply because they address different aspects of patentability.

The decisive factor is the nature of the technology and the litigation horizon. In highly specialized fields where the line between abstract idea and technical improvement is genuinely contested, an independent expert with strong credentials is almost always the stronger choice. For patent owners who anticipate asserting their patents, the expert selected for the SMED should be chosen mindful that they may be cross-examined over their testimony during the litigation of the patent.

What to Do Now

Review your pending portfolio for outstanding Section 101 rejections and assess the following:

• Does your specification contain sufficient technical disclosure to support a credible SMED, or does the application need to be strengthened through a continuation filing first?
• Who is the right declarant given your technology, the state of the art, and the specific examiner rejection: the inventor, an independent expert, or both?
• Is the claim language as currently drafted doing enough work to capture the technological improvement the specification discloses? A SMED cannot fix a claim drafting problem.
• Has your prosecution counsel assessed timing? Late SMED submissions create procedural risk that is avoidable with proper docketing.

For additional information, evaluating your pending applications, or developing a SMED strategy tailored to your portfolio, please contact Greg or Jaye at 949 725 4000.

This alert is provided for general informational purposes and does not constitute legal advice. Please contact us to discuss the specific circumstances of your pending applications.

https://www.uspto.gov/sites/default/files/documents/smeds-application-practitioners-4302026.pdf