USPTO Issues Memorandum Calling Renewed Attention to SMEDs

The United States Patent and Trademark Office has put a bright spotlight back on a tool that many patent applicants either overlooked, underused, or treated like that one drawer in the kitchen where the batteries, mystery keys, and expired coupons go to live forever. That tool is the Subject Matter Eligibility Declaration, better known as a SMED.

The USPTO’s memorandum on SMEDs matters because subject matter eligibility under 35 U.S.C. § 101 has long been one of the trickiest parts of U.S. patent prosecution. For inventors in software, artificial intelligence, data science, diagnostics, fintech, medical treatment methods, and other fast-moving fields, a Section 101 rejection can feel like being told, “Your invention is impressive, but maybe it is too abstract to exist legally.” Not exactly the kind of feedback that makes innovation teams high-five around the conference table.

By renewing attention to SMEDs, the USPTO is reminding applicants and patent practitioners that evidence can play a meaningful role in responding to eligibility rejections. A carefully prepared SMED may help explain how a claimed invention works in the real world, why it improves technology, and how a person of ordinary skill in the art would understand the specification and claims.

What Is a SMED?

A SMED is a Subject Matter Eligibility Declaration submitted under 37 C.F.R. § 1.132. In plain English, it is an evidentiary declaration used during patent prosecution to help address a rejection based on subject matter eligibility under 35 U.S.C. § 101.

Rule 132 declarations are not new. Patent applicants have long used declarations to submit evidence when responding to rejections or objections. What is new is the USPTO’s renewed emphasis on using this familiar procedural vehicle specifically for eligibility issues. The agency’s memoranda explain that SMEDs are voluntary, do not create a new procedure, and must fit within existing USPTO rules and Manual of Patent Examining Procedure guidance.

The key idea is simple: attorney argument can explain why an invention should be eligible, but a declaration can provide factual support. A SMED may show how the invention improves computer functionality, provides a technical benefit, applies a discovery in a practical way, or changes how a system operates. In eligibility disputes, that factual context can be the difference between “this sounds abstract” and “this is a practical technological improvement.”

Why the USPTO Memorandum Matters

The USPTO’s renewed attention to SMEDs comes at a time when patent eligibility remains difficult for applicants, examiners, and courts. Section 101 says patents may be granted for new and useful processes, machines, manufactures, compositions of matter, and improvements of those categories. However, Supreme Court decisions have created judicial exceptions for abstract ideas, laws of nature, and natural phenomena.

That framework became especially important after decisions such as Mayo and Alice. Since then, applicants in software, AI, diagnostics, personalized medicine, and business-method-adjacent technologies have often faced eligibility rejections. The challenge is not always that the invention lacks value. The challenge is that the claims may be characterized as directed to an abstract idea, mental process, natural relationship, or result rather than a patent-eligible application.

The USPTO memorandum calls attention to a practical response: build a better record. Instead of relying only on legal argument, applicants may submit objective evidence explaining why the claimed invention is more than a disembodied idea floating in the patent ether. A SMED can help connect the claims, specification, technical problem, and real-world improvement.

How SMEDs Fit Into the Alice/Mayo Eligibility Framework

The Alice/Mayo framework asks whether a claim is directed to a judicial exception and, if so, whether the claim includes additional elements that amount to significantly more. Under USPTO guidance, examiners also evaluate whether a claim integrates the exception into a practical application.

A SMED may be useful when the technical improvement is real but not immediately obvious from the claim language alone. For example, a machine learning invention may recite data processing steps that sound abstract at first glance. But if the specification describes how the model reduces storage requirements, improves training efficiency, prevents catastrophic forgetting, or enhances computational performance, a SMED can explain how a skilled person would understand those improvements.

Similarly, in medical diagnostics or treatment-related inventions, a claim may involve analyzing biological data. That can raise eligibility concerns. But if the claim applies that information to a concrete treatment, prophylaxis, or patient-specific intervention, a declaration may help show that the invention is not merely observing a natural correlation. It is using information to produce a practical medical result.

What the USPTO Wants Examiners to Do

The USPTO’s examiner-focused memorandum instructs examiners to consider properly submitted SMEDs as part of the evidentiary record. The declaration is not supposed to be tossed aside like junk mail. If an applicant submits relevant evidence, the examiner should evaluate it under the applicable standard and explain how it affects the eligibility analysis.

This point is important because eligibility rejections often turn on how the invention is understood. Is the claim merely organizing human activity? Is it just a mental process? Does it improve a computer or other technology? Does it apply a natural relationship in a meaningful way? These are not always purely legal questions in practical examination. They often depend on technical facts.

The USPTO’s message is that when applicants present relevant facts through a SMED, those facts deserve meaningful consideration. That does not mean every SMED will overcome a rejection. A vague declaration full of slogans such as “innovative,” “transformative,” and “next-generation” may sound nice in a pitch deck, but it will not magically convert weak claims into eligible subject matter. The evidence must be tied to the actual claims and the original disclosure.

Best Practices for Preparing a Strong SMED

1. Keep the SMED Separate

One of the clearest USPTO recommendations is that applicants should submit SMEDs as separate documents focused on subject matter eligibility. A Rule 132 declaration can technically address multiple issues, but combining Section 101 testimony with obviousness, written description, or enablement evidence can make the record messy.

A standalone SMED helps the examiner identify which facts relate to eligibility. It also creates a cleaner prosecution history, which can matter later if the patent is challenged. In patent law, clarity is not just a courtesy. It is armor.

2. Establish a Clear Nexus to the Claims

A SMED must connect the evidence to the invention as claimed. It is not enough to describe a cool feature somewhere in the product or platform. The declaration should explain how the claim limitations reflect the technological improvement described in the specification.

For example, if the claim is directed to a data compression method, the SMED should not wander into a general discussion of cloud computing trends. It should explain how the claimed steps improve compression speed, reduce memory usage, preserve data integrity, or solve a technical problem identified in the application.

3. Do Not Use a SMED to Add New Matter

A SMED cannot rescue an application by adding technical disclosure that was missing on the filing date. The declaration may explain how a skilled person would understand the specification, but it should not become a stealth rewrite of the application. The original patent document still needs to support the claimed invention.

This is a crucial distinction. A strong SMED illuminates the record; it does not repaint the record and hope nobody notices the wet brush.

4. Use Objective Evidence

The most useful SMEDs provide objective facts. These may include technical explanations, experimental data, comparative performance information, industry context, state-of-the-art evidence, or expert testimony about how the invention improves technology.

Good evidence may show that the claimed invention is faster, cheaper, more reliable, more secure, less computationally expensive, more accurate, or more efficient than existing approaches. The point is not to write a love letter to the invention. The point is to create a factual bridge between the claims and patent eligibility.

5. Match the Declaration to the Eligibility Problem

Different eligibility rejections require different evidence. If the examiner says the claim is a mental process, the SMED may need to explain why the claimed operations cannot practically be performed in the human mind or why they improve a technical system. If the examiner says the claim merely uses a computer as a tool, the declaration may need to show how the computer itself or another technology is improved.

In medical or life sciences cases, the declaration may focus on how a claimed treatment step applies information to produce a concrete physiological effect. In AI cases, it may explain model architecture, training improvements, data structures, or system performance. The best SMED is not generic. It is tailored like a good suit, not thrown over the claims like a beach towel.

Examples of Where SMEDs May Help

Artificial Intelligence and Machine Learning

AI inventions often face eligibility concerns because they involve algorithms, models, data classification, or mathematical relationships. A SMED may help show that the claim improves a technical process rather than merely automating an abstract idea.

For instance, a declaration might explain that a claimed training method reduces memory usage, preserves prior learning across tasks, improves inference speed, or solves a specific technical problem in neural network operation. Those facts can support an argument that the claim integrates any abstract idea into a practical technological application.

Software and Computer Functionality

Software patents often live under the shadow of Alice. A SMED may be helpful when software improves the functioning of a computer, database, network, cybersecurity system, user interface, or data structure.

Suppose the invention changes how a distributed database synchronizes records to reduce latency and prevent conflicts. A declaration could explain the technical problem, the state of existing systems, and how the claimed steps improve computer operation. That is much stronger than simply saying, “Our software is innovative,” which is basically the patent version of “trust me, bro.”

Medical Diagnostics and Treatment Methods

Diagnostics and treatment-related claims may be vulnerable when they appear to focus on natural correlations or data analysis. A SMED can help explain how the claimed method applies a discovery to achieve a particular treatment, prophylaxis, or clinical outcome.

For example, if a claim uses biomarker analysis to adjust a dosage schedule that reduces disease risk or improves patient response, the declaration may provide evidence of the practical medical effect. This can help distinguish a patent-eligible application from a claim that merely observes a natural phenomenon.

Risks and Strategic Considerations

SMEDs can be powerful, but they are not risk-free. A declaration becomes part of the prosecution record. That means future litigants may study it carefully, quote it aggressively, and ask whether the applicant made statements that limit claim scope or create inconsistencies.

For that reason, applicants should treat SMEDs as strategic documents, not quick attachments. The declaration should be accurate, technically sound, and consistent with the specification, claims, and broader prosecution strategy. Inventor testimony, expert opinions, and technical data should be reviewed carefully before submission.

Applicants should also consider timing. A SMED may be useful after receiving a Section 101 rejection, but in some cases the application should be drafted from the beginning with eligibility evidence in mind. The specification should describe the technical problem, the prior state of the art, the claimed improvement, and real-world benefits. A SMED is easier to prepare when the original application already gives it something solid to stand on.

Why SMEDs Signal a Bigger Shift in Patent Prosecution

The renewed attention to SMEDs suggests that the USPTO wants eligibility analysis to be less abstract about abstraction. That is good news for applicants whose inventions are technically meaningful but difficult to explain in traditional mechanical terms.

Modern innovation often does not look like a new wrench, engine part, or laboratory flask. It may look like a data structure, training method, diagnostic workflow, cryptographic protocol, quantum control process, or software architecture. These inventions can be real, useful, and technically demanding even when you cannot hold them in your hand.

The USPTO’s SMED guidance recognizes that applicants may need a way to provide a “constructive model” of the invention. In older eras, a working model could physically demonstrate how an invention operated. Today, a well-prepared declaration can serve a similar explanatory role by showing how less tangible innovation produces practical results.

Practical Experience: What Working With SMEDs Teaches Patent Teams

In practice, the most successful SMED strategy begins before the declaration is drafted. It starts with a disciplined review of the rejection, the claims, and the specification. Patent teams should ask a few hard questions: What exactly did the examiner identify as the judicial exception? Which claim elements are being treated as extra-solution activity? Where does the specification describe a technical improvement? What evidence can show that the improvement would be recognized by a skilled person?

This exercise often reveals a useful truth: eligibility problems are sometimes claim-drafting problems wearing a legal costume. If the claims are written at a high level of generality, a SMED may help, but claim amendments may also be necessary. The best response often combines focused amendments, clear attorney argument, and factual evidence. The SMED should not carry the entire piano up the stairs by itself.

Another practical lesson is that the declarant matters. An inventor may be the right person to explain how the invention works and why it solved a technical problem. An outside expert may be better positioned to describe the state of the art at the filing date or explain how a skilled person would interpret the disclosure. In some cases, a technical lead, researcher, engineer, clinician, or data scientist may provide the most useful perspective. The right declarant is the person with actual knowledge, credibility, and the ability to explain technical facts clearly.

Patent teams should also avoid turning a SMED into a mini law review article. The declaration should not merely recite eligibility buzzwords. It should present facts. A practical SMED might explain the old technical problem, identify the claimed solution, compare it with conventional approaches, and describe measurable benefits. If there is performance data, use it carefully. If there are examples from the specification, tie them to claim limitations. If the improvement is qualitative rather than numerical, explain it with enough detail that the examiner can understand why it matters.

For startups and smaller applicants, the SMED discussion is especially valuable because it encourages early documentation of technical advantages. Engineering notes, benchmark results, design decisions, and development history can become important later. Nobody enjoys reconstructing technical evidence months after the fact, especially when the people who knew the details have moved on, changed roles, or forgotten everything except where the coffee machine used to be.

Finally, applicants should remember that a SMED is part of a long-term patent asset. The goal is not only to overcome today’s rejection. The goal is to build a strong, coherent record that supports the patent in examination, appeal, licensing, investment review, and potential litigation. A rushed declaration may solve one problem while creating three new ones. A thoughtful declaration can clarify the invention, help the examiner, and strengthen the issued patent.

Conclusion

The USPTO’s memorandum calling renewed attention to SMEDs is not a dramatic rewrite of patent eligibility law. It is something more practical: a reminder that evidence matters. For applicants facing Section 101 rejections, especially in AI, software, diagnostics, and other emerging technologies, a well-prepared Subject Matter Eligibility Declaration may help show that the claimed invention is not merely an abstract idea or natural relationship, but a real-world technological application.

The strongest SMEDs are separate, focused, timely, and tied directly to the claims and specification. They provide objective evidence, avoid new matter, and explain the invention from the viewpoint of a skilled person. Used wisely, SMEDs can make patent prosecution clearer, more factual, and less dependent on abstract labels. And in the sometimes foggy world of Section 101, a little clarity is not just welcomeit is practically a superpower.

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