USPTO’s 2026 SMED Flowchart: When Evidence Can Overcome a Patent § 101 Rejection
A patent applicant facing a rejection under 35 U.S.C. § 101 often has a difficult evidentiary problem. The examiner may characterize an invention as an abstract idea even though the applicant believes its claims solve a concrete technical problem. A response that merely repeats that the technology is “innovative” or “faster” may not identify the facts necessary to bridge that gap. The U.S. Patent and Trademark Office’s latest guidance explains one way to build a more useful record: a carefully prepared declaration under 37 C.F.R. § 1.132.
On September 29, 2026, the USPTO issued a memorandum on Subject Matter Eligibility Declarations (SMEDs), accompanied by a review flowchart. It supplements an April 30 memorandum for patent applicants and practitioners. The new guidance does not change the governing patent-eligibility law, impose a declaration requirement, or create a new filing procedure. It does, however, give inventors and prosecution counsel a practical framework for deciding when evidence could make a difference.
What a subject matter eligibility declaration can—and cannot—establish
Section 101 permits patents for qualifying processes, machines, manufactures, and compositions of matter, subject to judicial exceptions such as abstract ideas, natural laws, and natural phenomena. Under the USPTO’s eligibility framework, an examiner considers whether a claim recites a judicial exception and, if so, whether additional limitations integrate it into a practical application. A separate inquiry considers whether the claim contains significantly more than the exception. The details are addressed in the USPTO’s subject matter eligibility guidance and MPEP § 2106.
A SMED is an optional sworn declaration offering objective evidence relevant to that analysis. It may help demonstrate, for example, that a claimed computer process addresses a specific technical problem, that a particular limitation cannot practically be performed in the human mind, or that a disclosed improvement has technical significance recognized by a person skilled in the relevant field. The evidence must be tied to the actual claim limitations and the legal question being disputed. A good explanation of the commercial attractiveness of a product does not, by itself, prove that every claim directed to that product is patent eligible.
That distinction matters at the outset of patent application drafting and prosecution. An invention can be valuable and technologically complex while its claims remain drafted at a level of abstraction that invites a Section 101 rejection. The declaration should illuminate the claimed technological contribution, not serve as an advertisement for the inventor’s business.
The September 29 flowchart separates formal review from the merits
The Director’s new memorandum describes a two-part examiner review. First, the examiner evaluates whether a submitted SMED satisfies the formal requirements for declarations under Rule 132 and the applicable MPEP guidance. If it does, the examiner then evaluates the declaration on the merits. The Office references MPEP §§ 716 and 2106.07 for those inquiries and notes that Technology Centers have subject matter experts available to support examiners. The ultimate eligibility determination remains with the primary examiner.
This separation is important because accepting a declaration into the record is not the same as agreeing with its conclusions. A technically qualified witness might make a declaration that is procedurally proper but too general to address the examiner’s precise rejection. Conversely, genuinely probative measurements may receive less attention if the submission fails basic evidentiary or filing requirements. Counsel needs to plan for both stages.
The Office expressly says the flowchart does not introduce a new practice or procedure. Applicants should not characterize it as a new exception to patent eligibility requirements, or assume that every examiner must allow a claim accompanied by a SMED.
Build the declaration around the actual disputed limitation
The strongest declaration generally begins not with the credentials of its author, but with the examiner’s theory of ineligibility. If the examiner asserts that a step could be performed mentally, the evidence should explain with specificity why the claimed limitation, as written, cannot practically be carried out in the human mind. If the dispute concerns integration into a practical application, the evidence should address the claimed technical implementation and its relationship to the alleged improvement.
Consider a hypothetical network-security invention. Suppose a patent application claims a narrowly defined architecture for correlating device telemetry and reallocating processing tasks to reduce detection latency under constrained bandwidth. A useful declaration might identify the relevant claim steps; describe the preexisting technological limitation; explain how the claimed arrangement operates; and present controlled testing comparing latency, false-positive rates, or processor load under defined conditions. The evidence might include contemporaneous engineering reports and a technical explanation from someone knowledgeable about the field.
That evidence may be far more helpful than a declaration stating only that a product has attracted customers or saves time. Yet the converse is equally important: even impeccable test results about a company’s product cannot supply technical limitations absent from its claims. The claimed invention, as properly construed, remains the subject of the eligibility analysis. Applicants should carefully consider whether the utility patent specification and claims actually support the technological point the declaration seeks to establish.
The September memo supplies a concrete example of specificity: an applicant may identify evidence offered to show, under Step 2A, Prong One, that one or more claim limitations cannot practically be performed in the human mind. That is much more useful than the blanket assertion that “software is technical.”
Independent evidence can make the record more persuasive
The USPTO emphasizes that evidence from disinterested parties may be more persuasive than evidence from people with a stake in the outcome. This is not a rule excluding inventors or company employees from providing declarations. The agency says an applicant’s statement about the advantages of the invention cannot be disregarded simply because the applicant is interested. But the examiner can consider that interest alongside the strength of the factual support and any conflicting evidence.
A technical expert unaffiliated with the applicant may be able to explain what practitioners in the field understood at the time of filing. A trade publication documenting a known technical obstacle may independently corroborate why an improvement would have mattered. Test results may be more informative when methodology, sample size, baseline, operating conditions, and limitations are disclosed rather than presented as unexplained conclusions.
Those points do not mean an inventor must hire a third-party expert for every Section 101 response. In a straightforward case, a claim amendment and carefully targeted legal argument may be sufficient. A SMED is most valuable when objective factual disputes—rather than pure legal characterization—are impeding examination. Counsel should evaluate its likely evidentiary benefit against cost, timing, and the consequences of adding sworn representations to the public prosecution history.
Timing, separate submissions, and the Patent Center document code
The September memorandum recommends submitting a SMED early when appropriate, potentially even before the first action on the merits. An early declaration gives an examiner a chance to consider the evidence while initially evaluating the claims. Rule 132 declarations can be filed before prosecution closes; after closure, timeliness is subject to additional limits and conditions. There is no blanket assurance that a late declaration will be considered simply because it concerns patent eligibility.
The USPTO also encourages applicants to submit a subject matter eligibility declaration separately from declarations addressing novelty, nonobviousness, enablement, or written description. A combined declaration can be permissible, but a separate filing may prevent distinct legal questions from becoming blurred. In Patent Center, the Office recommends document code AF/D.SMED and description “Subject Matter Eligibility Declaration” for a separately filed SMED.
These recommendations are best practices, not new mandatory requirements. The applicant still needs to comply with the governing procedural rules, office-action deadlines, and any requirements relating to after-final submissions. And a declaration should not be filed merely to use the new code: its contents must serve a legitimate evidentiary purpose.
Why an examiner interview may be more effective than another lengthy brief
The memorandum specifically encourages examiner interviews to clarify eligibility issues, including those addressed by declarations. Before preparing expensive experiments or expert testimony, counsel can attempt to identify the examiner’s actual concern. Is the dispute whether the claim recites an abstract idea at all? Whether a limitation changes how a computer system functions? Or whether the claims are so broad that the alleged improvement exists only in the specification?
Those are different issues and call for different evidence. A productive interview can help the applicant decide whether to narrow a claim, explain a technical mechanism already recited, submit a declaration, or adopt some combination of those strategies. Interviews do not replace an appropriate written record, but they can reduce the risk of preparing a detailed declaration aimed at the wrong question.
If prosecution advances toward appeal, the distinction becomes still more important. A record made before the examiner can shape what the applicant is able to argue in Patent Trial and Appeal Board proceedings. Applicants should not assume that a later appeal can cure every missed opportunity to introduce evidence during examination.
What the new guidance means for AI, software, and diagnostic inventions
Software, machine-learning, and diagnostic applications often present eligibility disputes because the boundary between a claimed technological solution and an abstract idea or natural-law application can be difficult to articulate. The September memo mentions earlier Office efforts involving AI and the precedential PTAB decision Ex parte Desjardins, addressing a machine-learning training technique intended to mitigate catastrophic forgetting. But the September SMED memorandum is not a categorical approval of AI patents, software patents, or diagnostic claims.
For an AI inventor, the key question is not whether artificial intelligence appears in the invention’s name. It is whether the claims recite an eligible application and whether the prosecution record accurately demonstrates the relevant technical facts. Evidence showing a reproducible reduction in memory consumption or an improvement in model-training behavior may help explain an asserted technological improvement when that improvement is genuinely reflected in the claimed subject matter. It cannot replace the proper statutory analysis.
Nor should applicants confuse eligibility with other patentability requirements. Novelty under § 102, nonobviousness under § 103, and the requirements of § 112 remain separate. A SMED designed to address an abstract-idea rejection should not silently become a substitute for prior-art analysis or adequate written-description support.
A more disciplined approach to a Section 101 response
The practical value of the September 29 guidance is its insistence on a logical sequence: understand the examiner’s particular Section 101 reasoning; identify which claim limitation is in dispute; determine whether objective evidence can illuminate that issue; prepare a compliant and factually supported declaration where useful; and explain explicitly how the evidence bears on the correct step of the eligibility analysis. The Office’s September 29 announcement and its eligibility resource page should be read with the underlying MPEP sections, not in place of them.
In a patent portfolio, the difference between an unsupported assertion and a useful evidentiary record can affect prosecution expense, claim scope, and the likelihood of successfully addressing an examiner’s objection. The right answer is not always to file a declaration; it is to identify what the claim and the existing record actually need.
Tucker Law advises inventors and technology businesses concerning patent protection and prosecution. If you have received a Section 101 rejection—or are preparing an application in a field where eligibility may be contested—contact Tucker Law to discuss claim strategy, objective technical evidence, and your filing deadlines.
This article provides general legal information, not advice for a particular application. The September 29, 2026 memorandum is USPTO guidance, not a statutory or judicial change to Section 101.
