Subject Matter Eligibility Declarations (“SMEDs”): A New Tool For Overcoming The § 101 Patent Hurdle

Since Alice and Mayo came down, 

Software patents have started to drown. 

But a SMED’s the new way 

To keep 101 at bay— 

And turn that rejection around!

Background

Under 35 U.S.C. § 101, patent applicants must demonstrate that their inventions are directed to patent-eligible subject matter. Following the Supreme Court’s landmark decisions in Mayo Collaborative Services v. Prometheus Laboratories (2012) and Alice Corp. v. CLS Bank International (2014), applicants must show that their patent claims are directed to something significantly more than abstract ideas, laws of nature, or natural phenomena.

This “101 hurdle” poses particular challenges for inventions in fields such as software, artificial intelligence, medical diagnostics, blockchain, and quantum computing—fields where innovation often builds upon or interacts with abstract mathematical concepts or natural phenomena. Applicants in these areas have long struggled with inconsistent examiner approaches and a lack of clear guidance on what constitutes a sufficient showing of eligibility.

In response to these challenges, the USPTO issued memoranda in December 2025 and April 2026 ¹ encouraging the use of Rule 132 Subject Matter Eligibility Declarations (“SMEDs”) when addressing § 101 rejections. ² SMEDs provide a mechanism for applicants to submit factual declarations that clarify the technological contributions of their inventions and place evidence into the prosecution record. While SMEDs are voluntary, Commissioner John Squires has reported early success among voluntary submitters.

Key Advantages of SMEDs

Examiner Accountability. When a SMED is submitted during prosecution, the examiner must substantively weigh the submitted evidence and explain in writing why any rejection is maintained despite that evidence. This requirement makes it more difficult for examiners to issue conclusory rejections without meaningfully addressing the applicant’s factual showing. It also creates a clearer record for any potential appeal before the Patent Trial and Appeal Board.

Framing the Eligibility Inquiry. A proactively filed SMED allows the applicant to frame the eligibility analysis in the most favorable light before the examiner forms an initial position. Rather than reacting to a rejection, the applicant can establish the relevant technical context and direct the examiner’s attention to the most compelling aspects of the invention.

Documenting Technological Improvement. SMEDs place specific technological advancements on the record with supporting evidence, demonstrating, for example, how the claimed invention operates better, cheaper, faster, or more efficiently than the prior art. This factual foundation can be critical at both the examination and litigation stages.

Best Practices

Contents of a Well-Crafted SMED

An effective SMED should:

• Establish the state of the art at the time of filing, demonstrating what was known and what gaps existed;

• Demonstrate a specific technological improvement over that state of the art with concrete, factual support;

• Establish a clear nexus between the improvement and the pending claims; and

• Provide objective evidence such as testing data, benchmarks, or industry recognition.

Focus Exclusively on § 101

A SMED should address only subject matter eligibility and should not stray into other areas of patent law such as § 102 (novelty) and § 103 (obviousness). Avoid combining the declaration with arguments directed at other grounds for patentability.

File the SMED as a separate, stand-alone document to maintain clear boundaries between eligibility arguments and other prosecution positions.

This focus helps prevent unintended estoppel issues later in prosecution and ensures that the examiner evaluates the eligibility evidence on its own merits.

Timeliness and Coordination

Practitioners should ensure that any SMED is submitted within the applicable response period and complies with all formal requirements, including the 18 U.S.C. § 1001 willful-false-statements clause.

Practical Guidance

Selection of Declarant

While inventors can serve as declarants and offer valuable technical insight, a neutral third-party expert may carry greater weight with the examiner due to perceived objectivity. Consider selecting a declarant whose credentials and independence will be most persuasive for the specific technology at issue. The declarant should have demonstrable expertise in the relevant field and be able to speak credibly to the state of the art and the significance of the claimed improvements. Possible declarants may be academics or researchers with technical expertise in the field. Of course, the third-party declarant being compensated for their efforts should clearly identify such compensation in their submission, and as long as the fees are reasonable, there should be no concern about being a “hired gun.” The use of paid experts is routine—almost to the point of being required—in other patent proceedings, such as litigation or PTAB proceedings.

Strategic Timing

Applicants may file SMEDs at two key junctures:

• Proactive filing before first office action: Particularly advantageous in technology areas with uncertain eligibility standards, allowing the applicant to establish the technical narrative before any rejection issues.

• Responsive filing after a § 101 rejection: Permits the applicant to tailor the declaration to the examiner’s specific concerns and reasoning, directly addressing the stated grounds for rejection.

Applicants should weigh the pros and cons of “proactive” versus “responsive” filing as part of their overall prosecution strategy.

Potential Risks

Applicants should be aware that statements in a SMED become part of the prosecution history and may be cited to narrow claim scope during subsequent litigation or inter partes proceedings. Declarations should be carefully drafted to support eligibility without making unnecessary admissions about the prior art, conceding limitations on the scope of the invention, or unintentionally limiting claim breadth. Working closely with litigation-aware patent counsel helps ensure declarations are both persuasive and strategically sound.

Recommended Technology Areas for SMED Filing

Consider filing SMEDs for applications in technology areas where eligibility is particularly uncertain, including distributed ledger technology, cryptocurrency protocols, medical diagnostics, software-implemented inventions, artificial intelligence and machine learning systems, and quantum computing applications. These fields are particularly likely to benefit from the additional evidentiary support a SMED provides.

Stick to the Facts

Focus on facts rather than legal conclusions. Frame the declaration around what the technology does and how it improves upon existing solutions—not merely why it should be considered eligible. Let the factual record speak to the legal standard rather than making conclusory assertions about eligibility.

Conclusion

The USPTO’s voluntary SMED program represents a significant opportunity for patent applicants to shape the § 101 analysis by placing concrete, factual evidence before examiners early in the prosecution process. SMEDs offer a powerful evidentiary tool to overcome eligibility challenges that have historically proven difficult to address through legal argument alone. By building a robust factual record, applicants can strengthen their positions at both the examination and potential litigation stages.

Footnotes

1. Subject Matter Eligibility Declarations (December 4, 2025)

Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs) (December 4, 2025)

Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs) (April 30, 2026)

2. Rule 132 declarations derive from 37 C.F.R. § 1.132, which sets the requirements for submitting evidence via oath or declaration during patent prosecution. These declarations allow applicants to present factual evidence that may not be apparent from the application itself, including expert testimony on the state of the art, technical capabilities, and the significance of claimed improvements.