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USPTO guide

How to respond to a 35 U.S.C. 101 rejection

By , Co-founder and CEO, PatentAssist.ai
Updated

A 101 rejection says your claim is not the kind of thing a patent can cover. For software, fintech, diagnostics and AI applications it is the rejection that feels most arbitrary, yet it follows a fixed script in MPEP 2106, and the script has moved in the applicant's favor since 2024. This guide walks through what the examiner has to establish, how to read the rejection, when to argue and when to amend, and how to use a declaration. For deadlines, the reply format and options after a final rejection, see the parent guide on responding to a USPTO office action.

Quick answer

  • The test: Step 1 (statutory category), Step 2A prong one (does the claim recite an exception?), prong two (is it integrated into a practical application?), Step 2B (significantly more?). MPEP 2106.
  • Best argument: the specification describes a technical improvement and the claim contains the steps that deliver it (MPEP 2106.04(d)(1), 2106.05(a)).
  • New since 2025: Ex parte Desjardins (precedential) warns examiners against reading claims at a high level of generality and treats improvements to how an ML model operates as technological.
  • Evidence: a "well-understood, routine, conventional" finding needs support (Berkheimer, MPEP 2106.07(a)), and you can file a Rule 132 Subject Matter Eligibility Declaration.
  • Threshold: examiners should reject only if ineligibility is more likely than not.

What the examiner must show

35 U.S.C. 101 covers any new and useful process, machine, manufacture or composition of matter. The courts read in three exceptions: abstract ideas, laws of nature and natural phenomena. The Supreme Court's two-step test from Mayo v. Prometheus (2012) and Alice v. CLS Bank (2014) decides whether a claim falls into one of them, and the USPTO's version of that test, first issued as the 2019 Revised Patent Subject Matter Eligibility Guidance, now lives in MPEP 2103 to 2106.07.

The burden starts with the examiner. Under MPEP 2106.07(a) the rejection must identify the exception, explain why it falls into a recognized grouping, identify the additional elements and explain why they do not integrate the exception or add significantly more. Every patentability rejection has to be established by a preponderance of the evidence. The August 4, 2025 memo adds that in a close call the examiner should reject only when it is more likely than not (more than 50%) that the claim is ineligible, and not simply because the examiner is unsure. Once a proper rejection is made, the burden shifts to you to amend, argue or submit evidence (MPEP 2106.07(b)).

The USPTO subject matter eligibility steps
Step Question MPEP In practice
Step 1 Is the claim to a process, machine, manufacture or composition of matter? 2106.03 Rarely the problem. Watch for claims to signals, data per se or a program without a medium.
Step 2A, prong one Does the claim recite a judicial exception: an abstract idea, law of nature or natural phenomenon? 2106.04, 2106.04(a)(2) Abstract ideas must fit one of three groupings: mathematical concepts, certain methods of organizing human activity, mental processes.
Step 2A, prong two Do the additional elements, taken with the exception as a whole, integrate it into a practical application? 2106.04(d), 2106.05(a)-(c), (e)-(h) Where most software and AI rejections are won. An improvement to computer functionality or another technology ends the inquiry here.
Step 2B Do the additional elements amount to significantly more than the exception (an inventive concept)? 2106.05, 2106.05(d) Adds one question prong two does not ask: is an element well-understood, routine and conventional? That is a fact the examiner must support.

Prong one: does the claim recite an exception?

The examiner may only call something an abstract idea if it fits one of the three groupings in MPEP 2106.04(a)(2): mathematical concepts (relationships, formulas, calculations), certain methods of organizing human activity (fundamental economic practices, commercial interactions, managing personal behavior), and mental processes (observation, evaluation, judgment, opinion). Two limits on prong one are worth knowing by heart.

First, a claim must recite the exception, not merely involve it. The 2025 memo contrasts USPTO Example 39, where "training the neural network in a first stage using the first training set" does not recite math, with claim 2 of Example 47, which names backpropagation and gradient descent and therefore does. Second, the mental process grouping covers only steps that can practically be performed in the human mind or with pen and paper. The memo tells examiners not to stretch it to limitations the human mind is not equipped to perform, and says claim limitations that encompass AI in that way fall outside the grouping.

Prong two: is the exception integrated into a practical application?

MPEP 2106.04(d) lists what can integrate an exception: an improvement in the functioning of a computer or another technology; a particular treatment or prophylaxis for a disease; use with a particular machine integral to the claim; a transformation of an article to a different state; or another meaningful limitation beyond linking the exception to a field. It also lists what does not: "apply it" or mere instructions to run the idea on a computer (2106.05(f)), insignificant extra-solution activity such as data gathering or outputting a result (2106.05(g)), and limiting the idea to a technological environment or field of use (2106.05(h)). The analysis looks at the claim as a whole, including how the additional elements interact with the exception, not at each element in isolation.

Step 2B and Berkheimer

If the claim is still "directed to" the exception, Step 2B asks whether the additional elements add an inventive concept. Most of the considerations repeat prong two. The one that is new is whether an element is well-understood, routine and conventional (MPEP 2106.05(d)). After Berkheimer v. HP (Fed. Cir. 2018) that is a factual finding, and MPEP 2106.07(a), subsection III requires the examiner to support it with one of four things: an express statement in your specification or prosecution history, a court decision noting the element is conventional, a publication, or official notice. Silence in the specification about an element's details is not enough on its own. Remember too that conventional parts can still add up: under BASCOM v. AT&T Mobility (Fed. Cir. 2016), cited in MPEP 2106.05, an inventive concept may lie in a non-conventional arrangement of individually conventional components.

What changed from 2024 to 2026

The current MPEP is still the Ninth Edition, Revision 01.2024, published November 2024. Everything since then has come out as guidance, memos and an advance notice of MPEP changes, all listed on the USPTO subject matter eligibility page (last updated September 29, 2026). Cite them by name and date in your remarks.

USPTO subject matter eligibility guidance, 2024 to 2026
Date Document Status, October 2026
July 17, 2024 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (89 FR 58128), with Examples 47 to 49. In force. The USPTO says it will be folded into the MPEP in due course.
August 4, 2025 Memo to Technology Centers 2100, 2600 and 3600: reminders on the mental process grouping, "recites" versus "involves", the claim as a whole, and the improvements consideration. In force. Restates the more-likely-than-not threshold for close calls.
September 26, 2025 Ex parte Desjardins, Appeal No. 2024-000567, Appeals Review Panel decision vacating a Board-entered 101 rejection of a machine learning training claim. Designated precedential November 4, 2025. Binding on examiners and the PTAB.
December 4, 2025 Memo to the examining corps on Subject Matter Eligibility Declarations (SMEDs) under 37 CFR 1.132. In force.
December 5, 2025 Advance notice of change to the MPEP in light of Ex parte Desjardins, rewriting parts of MPEP 2106.04(d), 2106.04(d)(1) and 2106.05(a). Applies now. Not yet in a published MPEP revision as of October 26, 2026.
April 30, 2026 Best practices memo for submitting Rule 132 SMEDs, addressed to applicants and practitioners. In force. Supersedes the December 4, 2025 best practices memo to applicants.
September 29, 2026 SMED memo from the Director with a flowchart for how examiners review a declaration, plus further best practices. In force. Addendum to the April 2026 memo.

Ex parte Desjardins, in practical terms

The claim in Desjardins trained a machine learning model on a second task while "protecting performance of the machine learning model on the first machine learning task", a fix for what the specification called catastrophic forgetting. The Appeals Review Panel agreed the claim recited a mathematical concept at prong one. It then held at prong two that the specification identified improvements to how the model itself operates (reduced storage, reduced system complexity, preserved performance on earlier tasks) and that the claim, read as a whole, reflected them. The claim was therefore not directed to the exception.

The December 5, 2025 advance notice writes three points into MPEP 2106.04(d)(1) and 2106.05(a) that you can quote back to an examiner. Claims should not be evaluated "at such a high level of generality" that meaningful technical limitations are dismissed without explanation. Additional elements should not be written off as "generic computer components" without asking whether they confer a technological improvement. And the claim does not have to state the improvement in words; it has to include the components or steps that provide it.

How to read the rejection

Before deciding anything, mark up the action against the framework. A rejection that skips a step, or takes one on assertion alone, is the easiest kind to traverse.

  1. Which words are the exception? The examiner should quote or identify the limitations said to recite it and name the grouping. "The claim is directed to collecting and analyzing data" without a grouping is a gap.
  2. Is the grouping right? For a mental process, ask whether the step can practically be done in the head. Processing thousands of sensor readings per second, or adjusting model weights, usually cannot.
  3. What was labeled "additional"? Check whether limitations that carry the invention were folded into the abstract idea so they never get weighed at prong two.
  4. Was the specification read? MPEP 2106.04(d)(1) requires the examiner to consult the specification for a described improvement. If the action never mentions it, say so.
  5. Is Step 2B supported? Look for one of the four forms of Berkheimer support for every "conventional" finding.
  6. Were dependent claims analyzed? A blanket statement that the dependent claims "do not add significantly more" often hides one that does.

Argue, amend, or both

Argue alone when the claim already contains the technical steps and the examiner has generalized them away, misplaced a step in a grouping, or made an unsupported Step 2B finding. Amend when the claim is broad enough to read on the idea of the result: "determining", "analyzing" and "outputting" with no account of how. Most strong responses do both: a narrowing amendment that pulls in the technical mechanism from the specification, and an argument tying that mechanism to the improvement.

Every amendment needs written support in the application as filed, and the same amendment usually has to answer the art rejections too. Choose limitations that do double duty: a concrete technical step the cited references lack is the best amendment for 101, 102 and 103 at once. See the guides to 102 rejections, 103 rejections and the 112 support requirements that limit what you can add.

Illustrative claim amendment (hypothetical)

Rejected claim: a method of inspecting parts, comprising receiving an image of a part, analyzing the image with a trained model to determine whether the part is defective, and outputting the determination. The examiner calls it a mental process performed on a generic computer. Underlining shows added text and strike-through deleted text, as 37 CFR 1.121(c) requires.

1. (Currently amended) A method of inspecting parts on a conveyor, comprising:
receiving, at an edge processor mounted at the conveyor, an image of a part captured at a native resolution of the camera;
dividing the image into overlapping tiles and processing each tile with an 8-bit quantized convolutional neural network stored in memory of the edge processor, without downsampling the image;
analyzing the image combining tile outputs to determine whether the part is defective; and
outputting the determination in response to determining the part is defective, actuating a diverter to remove the part from the conveyor before a next part reaches the diverter.

Each added limitation must be supported by the specification as filed. The amendment adds a particular machine and a control step (MPEP 2106.05(b) and (e)) and, more importantly, the specific way the inspection runs within the latency of the line.

Illustrative argument: Step 2A, prong two
Even if claim 1 recited a mental process, the claim as a whole integrates it into a practical application. The specification explains that cloud inspection of full-resolution images exceeded the 40 ms interval between parts, and that downsampling to meet it caused hairline cracks to be missed (paragraphs [0004]-[0006]). It then describes tiling the image at native resolution and running a quantized network on an edge processor so that inspection completes within the interval (paragraphs [0031]-[0038], FIG. 4). Amended claim 1 recites those steps and the diverter that acts on the result. Under MPEP 2106.04(d)(1), as revised by the December 5, 2025 advance notice, the claim need not state the improvement; it must include the steps that provide it, and it does. Characterizing the claim as "analyzing an image on a computer" evaluates it at the high level of generality that Ex parte Desjardins, Appeal No. 2024-000567 (precedential), cautions against.
Illustrative argument: Step 2B
The Office action finds that processing image tiles with a quantized network on an edge processor is well-understood, routine and conventional, but cites no statement in the specification, court decision, publication or official notice for that finding. Applicant requests the evidentiary support required by MPEP 2106.07(a), subsection III and Berkheimer v. HP, Inc., 881 F.3d 1360 (Fed. Cir. 2018), or withdrawal of the rejection.

These snippets are illustrations of structure, not language to file. The paragraph numbers and facts are invented.

Building the technological improvement argument

The improvement consideration is a two-part test, and both parts come from the record you already have. Part one is the specification: it must describe the invention so that a skilled person would recognize an improvement in computer function or another technology. A bare assertion such as "the system is faster and more efficient" does not count (MPEP 2106.04(d)(1)). Part two is the claim: it must include the components or steps that provide the improvement, which is where Intellectual Ventures v. Symantec claims failed, because the claims lacked the limitations that addressed the problems the patent owner cited.

The cases the MPEP lists as improvements are useful anchors: Enfish (a self-referential database table), McRO (rules for automated lip-sync animation), Visual Memory (a configurable memory system), Finjan (behavior-based virus scanning), SRI v. Cisco (network monitors analyzing packets), and now Desjardins. The common thread is a particular way of achieving a result, as opposed to claiming the result. The 2025 memo gives examiners three questions to ask, and your argument should answer each: does the claim recite how the solution is accomplished; is the computer a tool for an existing process or is computer capability itself improved; and how particular is the application of the exception?

For a fintech or business-method claim, the argument is harder because the improvement is often to the business, not the technology. Look for the technical constraint the invention works around (bandwidth, latency, concurrency, storage, security of a data channel) and argue that. If the specification only describes business benefits, no argument will repair it, and a continuation with narrower claims or an appeal on a cleaner record may be the realistic route.

Declarations under Rule 132 (SMEDs)

Evidence offered to traverse a rejection goes in by declaration under 37 CFR 1.132, and MPEP 2106.07(b) expressly allows it for eligibility. Since December 2025 the USPTO has called these Subject Matter Eligibility Declarations (SMEDs), and its April 30, 2026 and September 29, 2026 memos set out what it wants to see. A SMED is optional. It is useful when the dispute is about a fact rather than the law.

  • Good subjects: why a step cannot practically be performed in the human mind; what the state of the art was at filing and why a skilled reader would see the disclosed technique as a technical improvement; whether an element was in fact conventional.
  • File it separately from declarations on 103 or 112, using the Patent Center document code AF/D.SMED and the description "Subject Matter Eligibility Declaration", so the issues do not get tangled.
  • File it early. It can be filed any time before prosecution closes, even before the first action. After a final rejection it is admitted only in limited circumstances (MPEP 716.01).
  • Prefer a disinterested declarant and give factual support, such as a trade article from before the filing date describing the problem. An inventor's declaration counts, but carries less weight (MPEP 716.01(c)).
  • Say which step it answers, for example "submitted to show that limitation (c) cannot practically be performed in the human mind (Step 2A, prong one)". An interview to walk the examiner through it helps.

A declaration cannot add an improvement the specification never described. It can only help the examiner see what a skilled person would have understood from it.

Common mistakes

  • Arguing that the claim is novel or non-obvious. MPEP 2106.05 says the search for an inventive concept should not be confused with a novelty or non-obviousness determination. Keep 102 and 103 arguments in their own sections.
  • Reciting the improvement only in the remarks. Under MPEP 2106.04(d)(1) the specification has to describe it in enough detail that a skilled person would see it, and the claim has to contain the steps that deliver it.
  • Adding hardware words without changing what the claim does. "Using a processor" or "on a server" is the textbook "apply it" limitation of MPEP 2106.05(f).
  • Letting a Step 2B finding of "well-understood, routine, conventional" go unchallenged when the examiner cited nothing for it. That finding needs one of the four forms of support in MPEP 2106.07(a), subsection III.
  • Ignoring the dependent claims. Each one gets its own analysis, and a dependent claim with a concrete technical step is often the fastest route to an allowable independent claim.
  • Filing a declaration that only states the conclusion. A SMED is weighed for the facts behind the opinion, the interest of the declarant and any opposing evidence (MPEP 716.01(c)).

The best 101 response is written before filing: a specification that names the technical problem, explains the mechanism in detail, and claims that recite the mechanism rather than the outcome. See how to write patent claims for structure and fallback positions.

Where PatentAssist helps

PatentAssist.ai does not draft USPTO office action responses; its office action feature covers Indian First Examination Reports only, in beta. Where it helps with 101 is earlier. It drafts USPTO-format claims and specifications from your invention disclosure, so you can make sure the technical problem, the mechanism and fallback claims are written down before filing. Its free prior-art search covers USPTO, EPO and Indian records, which helps you pick amendment language that also clears the art.

More USPTO guides

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35 U.S.C. 101 rejections: frequently asked questions

What is a 35 U.S.C. 101 rejection?

It is a finding that the claim is not to patent-eligible subject matter. Usually the examiner says the claim is directed to an abstract idea, law of nature or natural phenomenon and adds nothing that integrates it into a practical application or amounts to significantly more. The USPTO applies the Alice/Mayo test as set out in MPEP 2106.

How do I overcome an Alice rejection on a software claim?

Show that the claim, read as a whole, is a particular technical solution rather than the idea of a result. Point to the passages of the specification that explain the technical problem and how the invention improves computer function or another technology, then show which claim limitations deliver that improvement (MPEP 2106.04(d)(1) and 2106.05(a)). If the claim is too broad to carry the improvement, amend it to add the steps that do.

What did Ex parte Desjardins decide?

The USPTO's Appeals Review Panel vacated a 101 rejection of a claim to training a machine learning model on a sequence of tasks while protecting performance on earlier tasks. It accepted that the claim recited a mathematical concept, but held that the specification described an improvement to how the model itself operates and the claim reflected it, so the claim integrated the exception into a practical application at Step 2A prong two. The decision was issued on September 26, 2025 and designated precedential on November 4, 2025.

Is the 2024 AI subject matter eligibility guidance still in effect?

Yes. The July 17, 2024 update (89 FR 58128) and Examples 47 to 49 remain listed as current guidance on the USPTO eligibility page, which was last updated September 29, 2026. Later documents, including the August 2025 memo, the Desjardins advance notice and the 2025 and 2026 declaration memos, add to it rather than replace it.

What is a Berkheimer argument?

Whether an additional element is well-understood, routine and conventional is a question of fact (Berkheimer v. HP, 2018). If the examiner relies on that finding at Step 2B, MPEP 2106.07(a) requires support: a statement in your specification or prosecution, a court decision noting the element is conventional, a publication, or official notice. If none is given, say so specifically and ask for the evidence.

Can I file a declaration to overcome a 101 rejection?

Yes. A Subject Matter Eligibility Declaration under 37 CFR 1.132 can supply facts, such as why a step cannot practically be performed in the human mind or why a skilled person would read the specification as describing a technical improvement. The USPTO's April and September 2026 memos recommend filing it separately, early, under document code AF/D.SMED, and saying which step of the analysis it addresses.

Does a 101 rejection mean the examiner did not search the prior art?

No. Under compact prosecution the examiner should also examine every claim under 102, 103 and 112 in the same action, as the August 4, 2025 memo reminds examiners. Expect art rejections alongside the 101 rejection, and answer all of them.

Sources: 35 U.S.C. 101 (annotated, with the key cases, in our section 101 reference); 37 CFR 1.132; MPEP 2106 and 716 (Ninth Edition, Revision 01.2024); 2024 AI SME Update, 89 FR 58128; USPTO memo of August 4, 2025; advance notice of MPEP change in light of Ex parte Desjardins, December 5, 2025; SMED memo of April 30, 2026; SMED memo of September 29, 2026; USPTO subject matter eligibility page. Checked October 26, 2026. This guide is general information, not legal advice. Have a registered patent attorney or agent review your reply.