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Section 101 eligibility remains one of the most unpredictable and frequently contested areas of U.S. patent practice, particularly for software, artificial intelligence, and machine learning. USPTO Director John Squires has identified bringing clarity to § 101 as a primary objective of his tenure, emphasizing the need to reduce inconsistent and confusing eligibility determinations that can hinder innovation.1 In furtherance of that goal, Director Squires issued two memoranda in December 2025 addressing how technical evidence can be used by applicants, and how it must be evaluated by Examiners, in the context of § 101 rejections. For applicants, the guidance provides a practical roadmap for responding to § 101 rejections by linking claim language to technological improvements disclosed in the specification.
I. Overview
On December 4, 2025, USPTO Director John Squires issued two memoranda—one to the patent examining corps ("Examiner Memo") and one to applicants and practitioners ("Practitioner Memo").2 Together, the memoranda address the use of Subject Matter Eligibility Declarations, or "SMEDs," as a mechanism for placing technical evidence of eligibility into the prosecution record. The memoranda follow Director Squires's prior comments that technologies such as machine learning, artificial intelligence, and distributed ledger systems are driving U.S. innovation,3 yet too often encounter conflicting and confusing questions regarding eligibility.4 Consistent with his stated goal of bringing greater clarity to § 101, the Examiner Memo provides six illustrative scenarios showing how SMEDs may be used to support an applicant's eligibility position during prosecution, particularly in technology areas where § 101 disputes are common.5 Although the memoranda reaffirm existing USPTO practice rather than announce new procedure, they reiterate an important point: that examiners must evaluate properly submitted declaration evidence on its merits.6 The guidance therefore signals that eligibility-focused declaration evidence, when appropriately framed, may begin to play a meaningful role in Section 101.
II. Background: Desjardins and the Evidentiary Turn in § 101 Practice
The SMED memoranda build on the Appeals Review Panel's ("ARP") precedential decision in Ex parte Desjardins, in which Director Squires served on a three-member panel that vacated a § 101 rejection the Patent Trial and Appeal Board ("PTAB") had raised sua sponte.7 In Desjardins, the ARP credited technical benefits described in the specification, including reduced storage demands and system complexity, and held that the claims, read as a whole, reflected those improvements.8 The ARP therefore concluded that the claims recited "an improvement to how the machine learning model itself operates," rather than a mere "mathematical calculation."9
In response to Desjardins,the USPTO revised the MPEP to reinforce that examiners should not dismiss claim limitations as "generic computer components" without considering, whether, in view of the specification's discussion of the technical problem and solution, the limitations provide a technological improvement.10 Taken together, Desjardins, the ensuing MPEP updates, and the SMED guidance reflect a common direction in § 101 practice: using evidence to link concrete technical improvements disclosed in the specification to what the claims actually require, particularly where eligibility is not immediately apparent from the claim language alone.11 Consistent with that approach, SMEDs should avoid legal conclusions and instead present factual, technical showings that establish a nexus between the claimed invention and how a skilled artisan would understand the specification's disclosed improvement.12
III. When SMEDs are Useful
In § 101 practice, an invention may qualify as a technological improvement when the specification provides sufficient technical detail for a person of ordinary skill in the art ("POSITA") to recognize the improvement, even if the specification does not explicitly label it as such.13 In that context, an SMED can play an important evidentiary role by documenting the state of the art as of the application's filing date and providing objective evidence that the claimed invention improved it—supporting the conclusion that a POSITA would have viewed the invention as advancing the underlying technology.14 Used appropriately, SMEDs can support arguments at Step 2 of the Alice framework, including that a claim is not directed to a judicial exception, that any judicial exception is integrated into a practical application, or that the claim recites significantly more than the judicial exception.15
At the same time, the USPTO's guidance reiterates important limits on the use of SMEDs. While an SMED may establish facts that existed at the time of filing, it cannot be used to add information that was required to appear in the application as filed.16 Accordingly, SMEDs are most effective where the specification already describes the technical problem and solution, and the declaration is used to contextualize that disclosure and explain its significance in view of the prior art.
IV. Lessons from the Examiner Memo's Examples
The Examiner Memo's hypothetical examples share a theme: An SMED is most effective when it directs the examiner to the portions of the specification describing the solution to a technical problem, identifies where the claim language reflects the disclosed improvements, and supplies supporting evidence linking the two.17 Each example illustrates a different way in which SMED evidence may inform the eligibility analysis. However, it is important to note that although the examples demonstrate scenarios in which SMEDs could be effective, the memo does not suggest that these examples necessarily will be effective in every case. Instead, the memo emphasizes that an SMED constitutes one piece of evidence that examiners may weigh in their overall eligibility analysis.
A. Example for Mental Processes
In the first example, the examiner characterizes limitations directed to detecting suspicious activity and analyzing network packets across multiple machines via network monitors as a mental process.18 The applicant responds by submitting an SMED explaining how a POSITA would interpret the specification's teaching regarding the claimed network monitors.19 The SMED further explains why, under that interpretation, the claimed process cannot practically be performed in the human mind.20
B. Examples for Improvements to the Functioning of a Computer or to Any Other Technology or Technical Field
In the second example, the examiner characterizes claims related to a self-referential table for a computer database as an abstract idea lacking an inventive concept.21 The applicant responds with an SMED describing the state of the art at the time of filing and explaining how a POSITA would understand, based on the specification, that the invention improves computer functionality by improving how a computer stores and retrieves data.22 The SMED ties that improvement to specific passages in the specification and maps it to the claim language, creating a factual bridge between the specification and the claim.23
In the third example, the applicant contends that a neural network architecture improves prior systems, but the specification, while stating it offers "superior performance," does not describe the specific performance improvement.24 The SMED provides comparative testing results showing superior regression performance tied to the claimed features, supplying objective evidence to substantiate the asserted improvement.25
In the fourth example, the applicant argues that a claimed animation technique automates tasks previously performed subjectively by humans.26 The SMED offers expert testimony and trade publication evidence establishing the state of the art at the time of filing, connects the asserted improvement to disclosure in the specification, and shows how the claimed rule based approach enabled automation not previously possible.27
C. Example for Particular Treatment or Prophylaxis
In another example, the claim concerns optimizing a prophylactic dosing schedule.28 It recites administering booster shots to a first group based on a series of schedules, analyzing outcomes to determine the lowest-risk schedule, and then administering boosters to a second group using that lowest-risk schedule.29 The examiner characterizes the determining step as a mental process and treats the initial administration as mere extra-solution activity.30 The applicant responds by focusing on the later administration step, arguing that the claim does not end with analysis; instead, it uses the analysis result to implement a particular prophylactic regimen.31 The applicant supports that position with an SMED providing evidentiary data that use of the lowest-risk schedule reduces disease risk, consistent with the specification's disclosure regarding evaluating prophylaxis data and adjusting schedules accordingly.32
D. Example Addressing "Significantly More" Than a Judicial Exception
In the final example, the examiner characterizes a content-filtering method as an abstract method of organizing human activity with well-understood, routine, and conventional components.33 The applicant responds with arguments and an SMED explaining that, although the additional elements are conventional when considered individually, the claimed unconventional arrangement amounts to an inventive concept.34 The SMED includes expert testimony, supported by objective evidence, that the claimed arrangement enables efficient operation while providing user-level flexibility not seen in prior art systems.35 The SMED ties this testimony to the specification, which describes the unconventional arrangement and its advantages.36
V. Formal Requirements for SMEDs and Examiner Obligations to Respond
There are formal requirements that must be observed for SMEDs. For example, they must be signed by a person with knowledge of the facts asserted, including an inventor, a co-worker, an independent expert, or another knowledgeable individual,37 they must be timely under MPEP § 716.01, and they must comply with applicable formalities, including the required willful-false-statements acknowledgment under 18 U.S.C. § 1001.38
However, when these requirements are satisfied and an SMED is entered into the record, the USPTO's guidance makes clear that the examiner must consider the SMED on the merits, weigh it with the other evidence of record, and apply the preponderance-of-the-evidence standard.39 If the § 101 rejection is maintained in the next Office Action, the examiner must explain, in view of the full record including the SMED, why the rejection has not been overcome.40 If the rejection is withdrawn, the examiner must likewise explain why the evidence is sufficient to overcome the rejection.41
VI. Takeaways
SMEDs can be an effective way to place technical, record evidence before the USPTO that links the claim limitations to the technological improvement described in the specification. The USPTO's guidance reflects a preference for presenting § 101-focused declaration evidence in a clear, dedicated submission, rather than combining SMEDs with other Rule 132 declarations directed to issues such as novelty or non-obviousness.42
At the same time, applicants should bear in mind that an SMED becomes part of the prosecution record. Statements in the declaration may later be cited in litigation, including in claim-construction disputes or for impeachment if later testimony is inconsistent with positions taken during prosecution. SMEDs should be carefully drafted to present factual, technical explanations grounded in the specification, while avoiding unnecessary legal conclusions or overstatements.
When used with those considerations in mind, the USPTO's guidance makes clear that SMEDs can play a meaningful role in shaping §101 outcomes, particularly in for AI, machine learning and software, where eligibility disputes are most common.
Finally, it should be appreciated that when information appropriate for inclusion in an SMED is known as of the filing date, it is preferable for the specification itself to contain that material. In this sense, the information in Director Squires's December 4 memoranda provides guidance not only for preparing SMEDs, but also for drafting robust specifications that clearly articulate the technical character of the claimed inventions.
Footnotes
1. See Remarks by Director Squires at the 2025 AIPLA Annual Meeting, USPTO, accessible via https://www.uspto.gov/about-us/news-updates/remarks-director-squires-2025-aipla-annual-meeting?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term= (Oct. 31, 2025).
2. Subject Matter Eligibility Declarations, USPTO, accessible via https://www.uspto.gov/sites/default/files/documents/smeds-corps.pdf (Dec. 4, 2025); Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs), USPTO, accessible via https://www.uspto.gov/sites/default/files/documents/smeds-applicants-practitioners.pdf (Dec. 4, 2025).
3. See Remarks, supra note 1.
4. Examiner Memo, 1.
5. See id. at 4-7.
6. See id. at 2; see generally Practitioner Memo.
7. See Ex parte Desjardins, Appeal No. 2024-000567 (application no. 16/319,040), Appeals Review Panel Decision, 4, 9-10 (Sept. 26, 2025).
8. See id. at 8-9.
9. Id. at 9.
10. See Advance Notice of Change to the MPEP in Light of Ex Parte Desjardins, USPTO, accessible via https://www.uspto.gov/sites/default/files/documents/memo-desjardins.pdf (Dec. 5, 2025).
11. See generally Examiner Memo, 2-3.
12. See id. at 3.
13. See MPEP § 2106.05(a).
14. See Examiner Memo, 3.
15. See id. at 4.
16. Id.
17. See id.
18. Id.
19. See id.
20. See id.
21. Id. at 5.
22. See id.
23. See id.
24. Id.
25. See id.
26. Id. at 5-6.
27. See id.
28. Id. at 6.
29. Id.
30. Id. at 5-6.
31. See id.
32. See id. at 6.
33. Id. at 7.
34. See id.
35. See id.
36. See id.
37. Id. at 2.
38. MPEP § 716.01; 18 U.S.C. § 1001.
39. Examiner Memo, 3-4.
40. Id. at 4.
41. Id.
42. See Practitioner Memo, 2.
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