USPTO Issues Dual Memos on Subject Matter Eligibility Declarations: A Strategic Tool for AI and Diagnostic Innovators

1. Introduction

Director John A. Squires issued two new memoranda on December 4, 2025 providing updated guidance on the use of Subject Matter Eligibility Declarations (SMEDs). These documents, effective immediately, are aimed at clarifying how examiners and applicants should use evidence to address subject matter eligibility issues, particularly in applied technologies such as artificial intelligence and medical diagnostics. For practitioners facing persistent 35 U.S.C. § 101 rejections, the memos offer a more structured path forward to resolving eligibility questions using voluntary declaration evidence to prove technical contributions.

2. Background: A More Practical Approach to Eligibility

   
   

Since taking office, Director Squires has emphasized improving consistency in subject matter eligibility analysis. His approach aims to ensure that innovations in fields like AI and diagnostics are not blocked by overly broad readings of cases such as Alice Corporation v. CLS Bank. This follows earlier 2025 initiatives, including an August memo reminding examiners to apply the Alice/Mayo framework carefully, and a precedential Appeals Review Panel decision in Ex parte Desjardins, which found an AI-based diagnostic tool eligible because it was tied to a specific practical application.

AI filings continue to grow in number, with the USPTO reporting a significant increase in machine learning applications this year. Patent eligibility rejections under 35 U.S.C. § 101 remain common, often overlapping with issues better addressed under enablement or obviousness.

SMEDs are voluntary under existing Rule 132 declaration practice. Applicants may submit a declaration to provide factual evidence relevant to the eligibility inquiry, such as evidence of technological improvement, the state of the art at the time of filing, or information demonstrating how a judicial exception is integrated into a practical application. SMEDs can be an important evidentiary tool when properly prepared and applied...and when given proper weight and consideration by the Patent Office.

Memo 1: Guidance for Examiners

The first memo (See Memorandum - Subject Matter Eligibility Declarations) instructs examiners to give proper weight to SMEDs submitted under 37 C.F.R. § 1.132. The memo reminds examiners to consider properly submitted SMEDs as part of the evidentiary record and evaluated using a preponderance-of-the-evidence standard.

Key points include:

• Examiners must evaluate declarations using the full Alice/Mayo framework. Evidence showing technical improvements, such as reduced latency or improved accuracy, can directly rebut an ineligibility position.

• The memo provides four practical scenarios illustrating how SMEDs may show technical benefits in AI tools, diagnostic methods, data processing systems, or software implementations that are close calls.

• Examiners are directed to avoid blending eligibility with unrelated issues such as written description or obviousness unless the evidence directly impacts those areas.

Memo 2: Guidance for Applicants and Practitioners

The second memo (See Memorandum - Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDSs)) focuses on how applicants can use SMEDs to strengthen the record and streamline prosecution. Highlights include:

• Use SMEDs early in prosecution when a rejection appears to be a close call or is unsupported by technical evidence.

• Declarations should use clear, factual statements tied to the specification, such as measurable performance improvements or concrete technical results.

• Avoid blurring eligibility issues with other issues and support positions with relevant precedent, including Ex parte Desjardins and recent Federal Circuit decisions addressing AI-based claims.

Effective use of SMEDs may reduce back-and-forth with the Office, particularly in AI-heavy technology centers where eligibility rejections are still common.

3. Implications for Practice

Companies developing AI and diagnostic technologies are advised of the importance of documenting technical contributions in the patent specification and preparing evidence early. Director Squires reiterated that existing law, when applied correctly, is sufficient to protect emerging technologies. These memos are a step toward more predictable and evidence-driven eligibility analysis at the USPTO.

For updates on USPTO policy and practical guidance for patent applicants, follow us or reach out. Questions about using SMEDs in your applications can be directed to admin@usaipr.com.