On December 4, 2025, the United States Patent and Trademark Office (USPTO) issued an official memorandum clarifying a key practice recommendation for all patent applicants and practitioners. The memorandum advises that when responding to a rejection based on lack of subject matter eligibility (under 35 U.S.C. § 101), a separate Subject Matter Eligibility Declaration (SMED) should be filed. It should not be combined into a single document with declarations addressing other issues, such as obviousness (under 35 U.S.C. § 103).
This memorandum does not introduce a new rule but rather clarifies and emphasizes the current best practice. It underscores that a SMED is an evidentiary declaration submitted under 37 CFR § 1.132. Its core purpose is to provide objective evidence clarifying how the claimed invention constitutes patent-eligible subject matter, for instance, by demonstrating a specific improvement over the prior art.
Why File a Separate Declaration?
The memorandum explains that while rules permit filing a single declaration covering multiple grounds of rejection, combining a SMED with other declarations carries several risks. First, it can blur the focus of the evidence, making it difficult for the examiner to isolate the portions specifically relevant to the eligibility issue, thereby potentially diminishing the probative value of the SMED. Second, this practice complicates the examination process and deviates from the USPTO's established framework for separate evaluation. The Manual of Patent Examining Procedure (MPEP) provides distinct guidance for declarations addressing § 101 (MPEP 2106) and those addressing § 103 (MPEP 2145). Combined submissions increase the examiner's burden of disentangling the evidence and may hinder examination efficiency. Furthermore, a combined submission can lead to an unclear prosecution history, which is disadvantageous for any subsequent administrative or judicial proceedings.
Implications for Applicants
For applicants seeking patent protection in the United States, this memorandum offers clear, practical guidance. It highlights that when facing challenging § 101 rejections—particularly in technology areas frequently questioned for eligibility, such as software, business methods, and artificial intelligence—adopting the officially recommended practice of filing a separate SMED is beneficial. This approach helps build a clear, robust, and focused evidentiary record dedicated to the subject matter eligibility issue. It may enhance communication with the examiner, potentially facilitating the examination process, and lays a stronger factual foundation for any potential appeals.
Source: https://www.uspto.gov/sites/default/files/documents/smeds-applicants-practitioners.pdf
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