Strategies and Considerations for Optimally Using Subject Matter Eligibility Declarations Before the USPTO

On Dec. 4, 2025, U.S. Patent and Trademark Office (USPTO) Director Squires issued new guidance to patent examiners and applicants via a pair of memoranda (Guidance) encouraging the use of subject matter eligibility declarations (SMEDs) as Rule 132 evidence to rebut 35 U.S.C. §101 rejections. Given that subject matter eligibility (SME) continues to be a challenging hurdle in securing patent rights, particularly for innovations involving software, AI/ML, data processing, and computer-implemented technologies, the Guidance offers a welcome shift in promoting evidentiary declarations as a means to demonstrate patent eligibility that may not readily be apparent in the intrinsic record.  

Importantly, the Guidance encourages applicants to use SMEDs as separate, stand-alone submissions focused solely on SME. In other words, evidence such as secondary considerations of nonobviousness for §103 or enablement for §112 should be submitted in separate declarations. By keeping SME evidence isolated from non-SME evidence, technical explanations relevant to §101 are less likely of being diluted by broader arguments. SME isolation also mitigates potential estoppel of statements directed to the state of the art for non-SME purposes. Strategically, isolating SME evidence may help avoid procedural complications and preserve strength of the record should the patent application proceed to appeal or be subject to a post-grant validity challenge.

Separately, the Guidance instructs examiners to evaluate SME factual evidence solely for §101 under the preponderance-of-the-evidence standard. This is nothing new. Applicants are encouraged to build a factual record via SMEDs explaining what real-world technical problem the invention solves, how the invention works, and why its operation reflects an unconventional technological improvement. SMEDs also allow a technically knowledgeable declarant – such as the inventor or even perhaps an independent declarant such as an engineer, scientist, technical founder or expert – to explain how a person of ordinary skill in the art (POSITA) would understand an invention’s operation. The proffered testimony in SMEDs may show how the specification describes a specific technological improvement and why a POSITA would view the claimed features (e.g., nexus requirement) as implementing this improvement in a meaningful way. Rather than submitting subjective opinions, which carry little weight, consider including supporting literature, comparative results or data to back your arguments. Be mindful that presenting evidence through a formal declaration creates a record that examiners must consider and the Patent Trial and Appeal Board can later rely on during appeal.

The Guidance further reiterates patent examiners’ obligations to meaningfully evaluate factual evidence presented in a SMED and not dismiss it without explanation. This reinforces the importance of pointing directly to declaration paragraphs that rebut examiners’ findings or clarify misunderstandings about how the invention operates. Clear cross-referencing in replies allows a smoother examination and improves the likelihood of obtaining early allowance.

Strategically, the effectiveness of a SMED may depend on at least two factors – timing and support in the specification. The Guidance indicates SMEDs should be filed promptly, which generally means early in prosecution and often alongside the first substantive response to a §101 rejection. Applicants and practitioners may also benefit from discussing proposed SMED filings with examiners during interviews. Doing so may target specific gaps or factual questions identified by the examiner.

It is important to bear in mind that SMEDs cannot supplement the specification with new matter as of the filing date. That is, SMEDs may clarify but not create technical content. The Guidance effectively rewards applications having well-drafted specifications that describe measurable performance improvements, such as for example reduced processing latency, improved accuracy, lower power consumption or enhanced computational efficiency. Applicants that craft their specifications by disclosing quantifiable technical benefits demonstrating how a claimed feature operates in an unconventional manner may have an easier path substantiating SME.

Ultimately, SMEDs may help overcome §101 rejections in scenarios where the line between an “abstract idea” and a “technical improvement” is heavily fact-dependent. The Guidance confirms applicants that use SMEDs strategically and early are better positioned to show SME and possibly advance their case toward allowance.

We routinely counsel clients seeking to maximize the value of their IP portfolios to align with their strategic business needs. Please contact Tayan Patel (tpatel@bakerlaw.com) with any questions.