New USPTO Guidance on Declarations

New USPTO Guidance on Subject Matter Eligibility Declarations: What Software Companies and Counsel Need to Know

The United States Patent and Trademark Office (USPTO) issued new guidance clarifying how applicants may use Subject Matter Eligibility Declarations (SMEDs) under 37 C.F.R. § 1.132 to address § 101 rejections. This update is especially significant for the software industry, where eligibility concerns under Alice remain a frequent challenge.

The dual memoranda – issued December 4, 2025, by Under Secretary of Commerce and USPTO Director John A. Squires – address both the substance and process of filing SMEDs. Together, they reinforce that while § 101 remains a gatekeeper to patent protection, applicants in applied technology fields such as software can and should use objective factual evidence to demonstrate patent eligibility.

For software companies building innovative tools, algorithms, platforms, and architectures, this guidance offers a clearer procedural avenue to secure and defend valuable IP rights.

1. Background: Why SMEDs Matter for Software Inventions

As part of his first official act, Director Squires issued patents in distributed ledger and medical diagnostic technologies – two fields commonly subject to subject matter eligibility scrutiny. Soon after, he designated In re Desjardins as precedential. That decision vacated a § 101 rejection and recognized improvements to machine learning model performance as patent-eligible under Alice Step 2. The decision emphasized that technical innovations improving computational function (e.g., reduced memory use, enhanced efficiency) are not abstract ideas – they are technological advancements deserving of protection.

The USPTO’s latest SMED guidance builds on Desjardins and confirms that declarations can be a powerful vehicle for demonstrating such improvements during patent application examination.

2. Key Procedural Clarifications for Software Applicants

SMEDs are filed under existing Rule 132 procedures and are entirely voluntary. However, when used effectively, they can supply persuasive factual support for eligibility. The USPTO emphasizes the following best practices for software-related SMEDs:

• Submit as a standalone declaration. While applicants may technically combine declarations covering multiple statutory requirements (e.g., § 101 and § 103), the USPTO strongly encourages separating SMEDs from declarations addressing obviousness, novelty, or written description. Mixing legal issues risks confusing the record and undermining the impact of the eligibility evidence.
• Focus on objective evidence, not conclusory statements. Useful SMED content may include test results, performance benchmarks, architectural comparisons, and expert declarations interpreting the disclosed invention from the perspective of a person skilled in the art. Such evidence is particularly compelling when showing improvements in system efficiency, data handling, processing speed, or resource usage – common focal points in software patent claims.
• Do not use SMEDs to introduce new matter. A declaration cannot be used to supplement an inadequate original disclosure. However, it may establish how a person of ordinary skill in the art would have understood the invention at the time of filing based on what is already disclosed.

3. How Examiners Are Directed to Treat SMEDs

Once a SMED is properly submitted, examiners are required to consider it on the merits and weigh it alongside the entire record. They must apply a preponderance-of-the-evidence standard -meaning they must assess whether the totality of evidence shows it is more likely than not that the claim is directed to eligible subject matter.

Critically, examiners are also instructed to document their reasoning in the next Office Action, regardless of whether the eligibility rejection is maintained or withdrawn. This approach should lead to clearer, more predictable outcomes during prosecution.

4. Examples of Software-Specific Use Cases for SMEDs

The USPTO has provided illustrative scenarios that align closely with software inventions:

• Distributed network monitoring: A claim reciting distributed packet analysis was initially rejected as a mental process. A SMED, including expert testimony, demonstrated that the processes could not practically be performed in the human mind, overcoming the rejection.
• Database architecture: An invention involving a self-referential data structure was shown, through a SMED, to improve data retrieval and storage performance, supporting patent eligibility under Alice Step 2.
• Neural network improvements: Where the specification lacked quantitative performance data, the applicant used a SMED to submit objective test results showing superior regression outcomes. The declaration helped demonstrate a technical benefit over prior architectures.
• Animation systems: A SMED was used to show that claimed automation of facial animation previously required subjective human input, thereby reflecting a technological improvement in computer graphics processing.

Each example highlights the importance of grounding eligibility arguments in factual, rather than conclusory, evidence.

5. Recommendations for Software Clients and Counsel

In light of the USPTO’s guidance, companies operating in the software space – particularly in AI, data science, FinTech, and enterprise platforms – should take the following steps to optimize their patent strategy:

1. Identify and document technical improvements early. If your invention enhances system operation, scalability, or performance, capture this at the time of drafting the application. Consider embedding objective support directly into the specification.
2. Prepare for § 101 challenges during prosecution. When appropriate, plan proactively to submit a SMED that explains how your invention operates at a technical level and how it advances the art.
3. Use independent experts when needed. Declarations from inventors, technical staff, or third-party experts can help establish how a skilled artisan would have viewed the disclosure at filing.
4. Maintain clarity by separating eligibility evidence. Avoid combining SMEDs with declarations under § 103 or § 112. The clarity of your record can significantly impact the examiner’s analysis.
5. Leverage USPTO examples as persuasive analogies. The guidance now offers a library of model situations that can be cited or analogized to show eligibility in similar fact patterns.
6. Final Thoughts

The USPTO’s SMED guidance represents a practical step forward in aligning the patent examination process with the realities of modern software innovation. While the underlying legal standard remains unchanged, applicants now have a more clearly defined opportunity to submit eligibility evidence – and examiners are on notice that such evidence must be given proper weight.

For software clients seeking robust patent protection, the key takeaway is this: eligibility is not just a legal argument – it’s a factual question that, when properly supported, can be successfully resolved through evidence. SMEDs offer an underutilized but increasingly powerful tool to help your innovations withstand § 101 scrutiny and secure enforceable rights.  

Click HERE to learn more about Derek Fahey, Esq., the author of this article.