USPTO Issues New Guidance on Subject Matter Eligibility Declarations (SMEDs)

The United States Patent and Trademark Office (USPTO) has issued new guidance on the use of Subject Matter Eligibility Declarations (SMEDs). These declarations serve as evidentiary submissions under 37 C.F.R. § 1.132 to address questions of patent eligibility under 35 U.S.C. § 101.

This guidance responds to a growing emphasis on ensuring consistent and predictable eligibility analysis, especially for rapidly evolving technologies such as artificial intelligence, distributed systems, and medical diagnostics.

On his first full day in office, Under Secretary of Commerce for Intellectual Property and USPTO Director John A. Squires demonstrated a strong commitment to robust patent protection by issuing two patents: one for distributed ledger technologies and another for medical diagnostics. This early action reflected the Office’s stance that applied technologies remain patent-eligible as long as they meet statutory requirements.

Shortly thereafter, the USPTO designated as precedential the Appeals Review Panel decision In re Desjardins, which clarified that improvements to the functioning of machine-learning models, such as reduced storage, lower system complexity, or mitigating “catastrophic forgetting,” can constitute “practical applications” under the Supreme Court’s Alice framework. The decision also warned that overly broad § 101 rejections risk excluding innovations in emerging fields from patent protection.

The new SMED memoranda build on this momentum by explaining how eligibility-related factual evidence may be presented and evaluated during examination.

The USPTO issued two complementary memoranda:

1.      A memorandum to the Patent Examining Corps explaining how examiners must evaluate SMEDs.

2.      A memorandum to applicants and practitioners describing best practices for preparing and submitting SMEDs.

Together, these documents confirm that SMEDs do not create new procedures. Instead, they clarify existing Rule 132 practice and outline how factual evidence may help establish eligibility.

Some Key Takeaways of SMED Memoranda

1. SMEDs are optional but recognized as valuable evidence

Applicants may choose to submit a SMED to provide objective factual evidence supporting eligibility. As the Examiner Memorandum notes:

• SMEDs may present evidence of technological improvement, the state of the art, or how a claimed judicial exception is integrated into a practical application.

• Examiners must consider properly submitted declarations and weigh them under the preponderance-of-the-evidence standard.

This means a well-supported SMED can materially influence an examiner’s assessment of eligibility.

2. SMEDs cannot add new disclosure

Both memoranda emphasize that declarations cannot be used to supply missing disclosures that were required at the time of filing. Instead, a SMED may:

• Explain how a person of ordinary skill would understand the original specification,

• Provide factual context regarding the state of the art,

• Offer test data or expert testimony evidence of technological improvement.

3.      Submit Eligibility-Related Testimony in a Separate Declaration

The Practitioner Memorandum strongly recommends not combining SMEDs with declarations addressing other statutory requirements (e.g., obviousness or written description). Mixing issues may dilute the evidentiary value and complicate the examiner’s analysis.

As the USPTO explains:

• Declarations should be tailored to the specific rejection they address.

• Combining § 101 testimony with § 103 secondary considerations may “intertwine issues” and reduce clarity.

4.      Examiners Are Directed to Meaningfully Engage with SMEDs

The Examiner Memorandum instructs examiners to:

• Evaluate all evidence presented in a SMED,

• Explain in the next Office action whether the evidence overcomes the rejection, and

• Cite to the declaration in withdrawing, modifying, or maintaining the rejection.

This is intended to produce a clearer, more transparent record for applicants and appeals.

Examples Highlighting How SMEDs Can Assist Eligibility

The Examiner Memorandum includes multiple hypothetical examples illustrating where SMEDs may be particularly impactful:

• Evidence that certain claim steps cannot be practicably performed in the human mind, addressing “mental process” classifications.

• Expert testimony demonstrating how a claimed data structure improves computer operation, aligning with cases such as Enfish.

• Comparative testing showing that a neural-network architecture delivers technical performance improvements.

• Evidence supporting practical application in medical prophylaxis, consistent with Classen Immunotherapies.

• Proof that an unconventional combination of elements constitutes significantly more under Alice Step 2, echoing BASCOM.

These examples help applicants understand where factual declarations can meaningfully contribute to the eligibility analysis.

Best Practices

Based on the new memoranda, the USPTO encourages applicants to:

• Use SMEDs strategically, especially in technology-heavy fields where the improvement may not be intuitively understood.

• Ensure a tight nexus between the claims and the supporting evidence.

• Avoid mixing issues; keep SMEDs separate from obviousness or other statutory-requirement declarations.

• Provide objective, fact-based support, such as comparative testing, technical explanations, or expert testimony.

• Submit evidence early, as timeliness impacts admissibility under Rule 132.

Practitioners who adopt these practices are likely to see more predictable, consistent eligibility outcomes.

As Director Squires noted, these clarifications align with the USPTO’s commitment to a “strong, robust, expansive, and resilient intellectual property system.” The memoranda take effect immediately, and additional training materials will follow on the USPTO website.