The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for supporting §101 eligibility of treatment method claims.[1] The memorandum specifically outlines a path for demonstrating “practical application” in treatment and prophylactic methods, and demonstrates how an applicant may rely on a SMED to provide evidentiary support for eligibility to categories of inventions that are found unpatentable as being directed to mental processes or abstract ideas.[2] The memorandum signals a possible recalibration in how examiners apply Alice Step 2 to treatment‑based claims when the applicant submits a SMED.[3]
The memorandum reminds applicants and practitioners that a life sciences claim can move from ineligible abstraction to eligible application when a treatment step integrates the underlying scientific discovery into a real‑world medical outcome.[4] The memorandum uses a heartworm disease prophylaxis example, modeled on Federal Circuit caselaw, to outline how subject matter eligibility in this type of case should be applied.
In the hypothetical example, the examiner initially rejected the claim on the grounds that analyzing data to determine an optimized prophylactic schedule was merely a mental process, and that administering doses to gather data was an extra‑solution activity.[5] In response, the applicant argued that “the invention applies or uses information from the analysis… to effect a particular prophylaxis for a disease in accordance with MPEP 2106.04(d)(2).”[6] In other words, applying the optimized schedule to a second group of animals materially changed their risk of disease, such that the claim did not stop at identifying a biological insight, but it had used that insight to produce a tangible physiological benefit, which “imposes a meaningful limit on the mental process.”[7] This is “a practical application” under Step 2 of the USPTO’s subject matter eligibility framework.[8] To support this, the applicant highlighted portions of the specification describing optimizing prophylaxis schedule, and submitted a SMED that provided evidentiary data showing “that a person of ordinary skill in the art would have understood that adjusting the prophylactic schedule as disclosed would lower the susceptibility of the second group of domestic canines to the disease.”[9] The memorandum reminds the examiner to evaluate this evidence, if proper to do so, and review patent eligibility based on a preponderance of the evidence standard.[10]
The memorandum emphasizes that adjusting dosing intervals, modifying treatment timing, or tailoring prophylactic regimens based on a discovered relationship is not a generic extra‑solution action.[11] When done in a specific, targeted manner, such steps can meaningfully limit a judicial exception and transform an otherwise ineligible diagnostic or analytical claim into an eligible method of treatment. Importantly, the USPTO explicitly encourages applicants to use SMEDs to provide evidence that one of ordinary skill would understand the medical significance of the claimed treatment step, including comparative data or experimental results showing the improved outcome.[12]
For the life sciences industry, these guidelines highlight a potential path for applicants to draft, support, and defend claims. Applicants and practitioners should consider the potential benefit of using SMEDs as a strategic tool in biotech prosecution. Unlike legal argument alone, a SMED can establish the state of the art at the filing date, document the technical effect of an adjusted dosing regimen, or show that a treatment step produces a non‑routine physiological change.[13] This can be important in emerging fields such as personalized medicine, where the inventive contribution often lies in how data is used to guide patient‑specific interventions. However, before submitting a SMEDs, it is important to consider the risks that submission of a subject matter eligibility declaration may pose, such as subjecting the declarant to cross-examination and contradictory expert testimony during litigation.
A possible solution to avoid the need for submission of SMEDs is for patent applications in the biotechnology and pharmaceutical sectors to expressly describe how specific treatment or prophylactic steps modify biological responses, providing the evidence needed to address §101 rejection in the applications from the start.
Editor: Brenden S. Gingrich, Ph.D.
[1] Memorandum from John A. Squires, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, U.S. Patent & Trademark Office, to Patent Examining Corps, Subject Matter Eligibility Declarations (Dec. 4, 2025); https://www.patentnext.com/wp-content/uploads/sites/990/2026/01/Jan-12-2026-Samore-Post-First-Memo.pdf.
[2] Id. at pages 6-7.
[3] Id. at page 6.
[4] Id.
[5] Id.
[6] Id.
[7] Id.
[8] Id.
[9] Id. at page 7.
[10] Id.
[11] Id. at pages 6-7.
[12] Id. at page 7.
[13] Id. at page 3 (“SMED may provide facts that describe the state of the art at the time of filing, provide objective evidence as to how the invention improved upon the state of the art, or provide a factual basis for determining that one of ordinary skill in the art would have concluded that the invention improved the underlying technology.”).
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