USPTO Issues Memoranda on Section 101 Declarations

Patent eligibility under 35 U.S.C. § 101 has never been famous for producing calm, predictable conversations. Mention “abstract idea” in a room full of software patent lawyers and someone will eventually reach for a flowchart, a Federal Circuit opinion, or a stronger cup of coffee. The United States Patent and Trademark Office has now offered applicants another practical tool: the Subject Matter Eligibility Declaration, commonly called a SMED.

The USPTO’s December 4, 2025 memoranda explained how declarations under 37 C.F.R. § 1.132 may be used to place factual evidence into the prosecution record when an examiner rejects claims as patent-ineligible. One memorandum instructed the Patent Examining Corps; the other supplied best practices for applicants and practitioners. On April 30, 2026, the Office issued an updated applicant-and-practitioner memorandum, superseding the original best-practices memo while preserving the core approach. The message is straightforward: when eligibility turns on technical facts, do not rely on attorney argument alone if a focused evidentiary record can show what the invention actually improves.

What the USPTO Section 101 Memoranda Actually Changed

The memoranda did not rewrite Section 101, replace the Alice/Mayo framework, or create a new species of declaration. Rule 132 has long permitted applicants to submit evidence that traverses a rejection or objection. The practical change is emphasis. The USPTO formally identified a focused Rule 132 submission as a Subject Matter Eligibility Declaration and encouraged applicants to consider it when the technological significance of an invention may not be obvious from claim language alone.

The examiner memorandum says a properly submitted SMED must be considered as part of the evidentiary record. Examiners are expected to weigh relevant evidence under the preponderance-of-the-evidence standard and explain, in the next Office action, why the evidence does or does not overcome the eligibility rejection. That matters because a declaration is not supposed to vanish into the electronic file wrapper like a sock in a dryer.

The practitioner memorandum focuses on presentation. It recommends filing a standalone declaration devoted to Section 101 rather than combining eligibility testimony with evidence concerning obviousness, written description, enablement, or other statutory issues. The April 2026 update reinforced that approach, described the guidance as a living resource, and reported positive early practitioner feedback. It did not announce an across-the-board allowance shortcut, and applicants should not treat a SMED as a magic stamp marked “eligible.”

Why Evidence Matters in a Patent Eligibility Dispute

Section 101 broadly covers new and useful processes, machines, manufactures, compositions of matter, and improvements to them. Courts have also recognized judicial exceptions for laws of nature, natural phenomena, and abstract ideas. Under the familiar two-step framework, the analysis asks whether a claim is directed to a judicial exception and, if so, whether additional elements integrate that exception into a practical application or amount to significantly more.

Many eligibility disputes contain factual questions hiding beneath legal labels. Can the claimed operation practically be performed in the human mind? Would a skilled artisan understand the disclosed architecture as improving computer functionality? Was a particular arrangement conventional at the filing date? Does a diagnostic workflow produce a concrete technological result rather than merely observe a natural correlation? Lawyers can argue about those questions, but an expert or inventor may be able to support the answers with testing, technical literature, architecture diagrams, performance data, or an explanation grounded in the original specification.

A SMED is therefore most useful when it converts a vague debate into a claim-tied factual record. “This is innovative software” is advocacy. “The claimed parameter-protection method reduces stored model sets, preserves performance on prior tasks, and avoids catastrophic forgetting in the manner disclosed in paragraphs X through Y” is the beginning of evidence.

What a Strong Subject Matter Eligibility Declaration Can Show

A Technological Improvement

A declarant may explain how a person of ordinary skill would understand the specification as describing an improvement to computer operation, network security, data structures, machine learning, medical technology, or another technical field. Useful evidence can identify reduced memory use, lower latency, improved accuracy, increased throughput, fewer false positives, better signal processing, or a more efficient allocation of computing resources.

Why the Claim Is Not Merely a Mental Process

For claims characterized as mental activity, a declaration may establish that the recited operations cannot practically be performed in the human mind. A distributed cybersecurity system that analyzes high-volume packet streams across multiple machines is an obvious candidate. The key is not simply saying, “A human cannot do this.” The declaration should explain the scale, timing, architecture, and technical dependencies that make the claimed process computational rather than imaginary paperwork with a computer nearby.

Integration Into a Practical Application

A SMED can describe the real-world technological application, effect, and benefit of the claimed invention. In medical diagnostics, for example, the evidence might connect claimed sample preparation, measurement, classification, and treatment-selection steps to improved sensitivity, reduced error, or a changed prophylaxis protocol. The declaration should focus on what the claim does in practice, not merely on the discovery of a biological relationship.

An Inventive Arrangement of Otherwise Familiar Components

Sometimes individual components are conventional, but their claimed arrangement is not. Evidence may explain how a specific configuration improves operation or solves a technical problem in a nonroutine way. This is especially relevant when an examiner treats every element separately and concludes that the claim is nothing more than a pile of ordinary parts wearing a novelty trench coat.

The Connection to Ex Parte Desjardins

The SMED initiative arrived alongside the USPTO’s precedential treatment of Ex parte Desjardins, a decision involving machine-learning training across successive tasks. The claims addressed the problem of catastrophic forgetting, in which a model loses performance on earlier tasks as it learns new ones. The Appeals Review Panel credited disclosed improvements such as reduced storage, reduced system complexity, and protection of previously learned performance.

The decision is important because it warns against describing computer claims at such a high level of generality that meaningful technical limitations disappear. Software improvements may reside in logical structures and processes rather than in a shiny new physical widget. The proper question is whether the claim, read as a whole and in light of the specification, recites a particular technological solution to a technological problem.

A SMED can help build that record, but it cannot rescue drafting that never identified the technical problem or solution. The declaration must illuminate the disclosure, not quietly write a better application years after filing.

Best Practices for Preparing a Rule 132 SMED

File a Separate Eligibility Declaration

Keep Section 101 evidence in its own document. If the same expert must also address obviousness or enablement, use a separate declaration for those issues. A clean division helps the examiner identify which facts relate to eligibility and reduces the chance that statements made for one statutory test create confusion under another.

Build a Clear Nexus to the Claims

Every important factual statement should connect to specific claim language and to support in the filed specification. A practical format is to identify the disputed limitation, cite the relevant disclosure, explain how a skilled artisan would understand it, and then present objective support for the asserted technological effect.

Use Objective Evidence Where Possible

Performance benchmarks, test results, contemporaneous technical papers, system logs, comparative examples, engineering diagrams, and industry materials can strengthen the declaration. Evidence does not need to arrive with a marching band, but it should do more than repeat the specification with extra adjectives.

Choose a Qualified Declarant and Establish the Basis of Knowledge

The declaration should explain the witness’s education, experience, familiarity with the technology, and basis for each opinion. An inventor may be appropriate, particularly for system design and testing, while an independent expert may offer broader perspective on the state of the art. The best choice depends on the factual proposition being proved.

Address the Examiner’s Actual Theory

A generic declaration about innovation will not answer a rejection based on mental processes, practical application, or well-understood, routine, and conventional activity. The response should identify the examiner’s precise findings and supply evidence targeted to those findings. Patent prosecution is not improved by firing a technical encyclopedia at a one-paragraph rejection.

File Timely and Protect Against New-Matter Problems

A SMED cannot add new matter or cure an inadequate original disclosure. The technological improvement, architecture, or practical benefit must be grounded in the application as filed. Applicants should also consider declaration strategy early enough that evidence can be developed and submitted before procedural complications arise.

Risks, Limits, and Litigation Consequences

A declaration creates a public prosecution record that may later be studied by competitors, licensees, judges, juries, and litigation counsel. Overbroad statements about claim meaning, conventional technology, required operating conditions, or the scope of the invention can become awkward luggage during claim construction or validity disputes. Accuracy and restraint are therefore essential.

Cost is another consideration. Expert work, testing, and attorney preparation may be worthwhile for commercially important applications, but not every Section 101 rejection requires a declaration. A well-supported amendment, examiner interview, or written argument may resolve a misunderstanding more efficiently. The decision should turn on the quality of the specification, the examiner’s stated basis, the available evidence, portfolio value, and downstream enforcement strategy.

Applicants should also remember that eligibility is only one gate. A claim that survives Section 101 may still fail under Sections 102, 103, or 112. Desjardins itself illustrates the distinction: recognizing a technological improvement for eligibility does not automatically establish novelty or nonobviousness. Section 101 is the front door, not the entire building inspection.

Industries Most Likely to Benefit

SMED practice is particularly relevant to artificial intelligence, machine learning, software, cybersecurity, fintech, data analytics, medical diagnostics, bioinformatics, signal processing, and other fields where the technical contribution may be expressed through information processing rather than a visibly new machine. These technologies often face rejections framed as mathematical concepts, mental processes, organizing human activity, or natural correlations.

The guidance may also influence application drafting. Patent teams should document technical bottlenecks, implementation details, measurable benefits, comparative performance, and alternative architectures before filing. A specification that clearly explains why the invention is better, faster, cheaper, more accurate, more secure, or more efficient gives both the claims and any later declaration firmer ground.

Practical Experience Lessons From Using Section 101 Declarations

Early experience with SMED-style practice suggests that the hardest work occurs before the declaration is drafted. The team must first diagnose the rejection. Is the examiner overlooking a claimed technical limitation? Treating an operation as mental without considering scale? Ignoring a disclosed improvement? Or asserting that additional elements are conventional without identifying factual support? Until that question is answered, drafting tends to produce a handsome document that proves the wrong point.

A productive workflow begins with a claim-and-specification map. Practitioners identify each limitation that carries the technological improvement, locate its original disclosure, and note the examiner’s treatment of it. The inventor or expert is then asked focused factual questions: What problem existed at the filing date? Why did prior systems struggle? What changed in the claimed design? Which measurable result followed? This interview often reveals that the strongest eligibility story is narrower and more concrete than the marketing story. “Revolutionary AI platform” may sound terrific in a pitch deck, but “one parameter set instead of several, with preserved prior-task performance” is far more useful in a prosecution record.

Another recurring lesson is that comparative evidence needs careful framing. A benchmark can be persuasive only when the comparison is technically fair, the tested implementation corresponds to the claims, and the result is tied to the disclosed improvement. A dramatic speed increase produced by unrelated hardware proves little about a claimed software architecture. The declaration should explain test conditions, datasets, baselines, and why the result would matter to a skilled artisan. Otherwise, the evidence may look less like science and more like a very enthusiastic spreadsheet.

Examiner interviews can improve the process. Before investing in extensive expert work, counsel may discuss whether the examiner views the dispute as one involving claim interpretation, a missing practical application, or conventionality. The interview cannot guarantee that a declaration will succeed, but it can help tailor the evidence and expose whether a modest claim amendment would create a clearer nexus. When an interview is productive, the later written record should still stand on its own; future readers will not have access to tone of voice, whiteboard arrows, or the moment everyone finally agreed what “adaptive” meant.

Teams also learn quickly that witness preparation is different from ordinary technical writing. Declarants should understand that their statements are evidence, not promotional copy. They must distinguish firsthand knowledge from opinion, identify supporting materials, avoid unsupported legal conclusions, and review claim language closely. Counsel, meanwhile, should resist polishing the testimony until it sounds like an attorney brief wearing a lab coat. The declaration is strongest when the technical reasoning remains clear, credible, and recognizably the witness’s own.

Finally, successful use of a SMED should feed back into future patent drafting. If a company repeatedly needs declarations to explain latency reduction, memory savings, diagnostic accuracy, or system-level effects, those facts belong in new specifications from the beginning. The best long-term experience lesson is therefore slightly ironic: the more carefully teams learn to use Section 101 declarations, the less often they may need heroic declarations later. Better disclosure creates better claims, cleaner prosecution, and fewer emergency meetings titled “Abstract Idea ResponseUrgent.”

Conclusion

The USPTO’s Section 101 memoranda give applicants a more explicit path for using Rule 132 evidence to answer subject matter eligibility rejections. A well-prepared SMED can explain how skilled artisans understand the claimed invention, establish a technological improvement, rebut an oversimplified mental-process characterization, and demonstrate real-world practical application. Its strength depends on a tight nexus to the claims, support in the original specification, objective evidence, and disciplined witness testimony.

The guidance is encouraging, especially for AI, software, and diagnostic inventions, but it is not a substitute for careful drafting or a guarantee of allowance. Used selectively, a SMED can turn an abstract legal argument into a concrete technical recordand in Section 101 practice, concrete is usually a welcome material.