US Practice – A Green Light From the US Patent Office (USPTO) For Responding To Subject Matter Eligibility Rejections Under 35 USC § 101

On December 4, 2025, USPTO Director John A. Squires issued a Memorandum (Memorandum I) to patent applicants and patent practitioners, reminding them about the use of Subject Matter Eligibility Declarations (SMEDs) under 37 CFR § 1.132 (commonly referred to as 132 Declarations) as another tool to overcome Section 101 rejections (rejections which claimed patent ineligible subject matter).  The Memorandum (Memorandum I) was accompanied by a companion Memorandum, also of December 4, 2025, addressed to the Patent Examining Corps, entitled, “Subject Matter Eligibility Declarations” (the Companion Memorandum).

As per Memorandum I, SMEDs provide a unique evidentiary role in addressing subject matter eligibility rejections.  The Memorandum addressed both procedural and substantive aspects for SMEDs.

Procedural aspects addressed the following:

SMEDs should be submitted as separate documents.  SMED content should only address subject matter eligibility, and should not be combined with declarations or testimony addressing other issues, such as obviousness, for example, secondary considerations and motivation to combine references.  The Memorandum reinforces the separateness issue, stating that “[b]y providing testimony and objective evidence directed solely to the subject matter eligibility of the claimed invention, the applicant may avoid the risk of intertwining issues of enablement, written description, novelty and obviousness with those of subject matter eligibility.  This complicates the application file record (the record) unnecessarily.

Persons permitted to sign the SMED must have knowledge of the facts asserted in the SMED.  In this aspect, as discussed in the Companion Memorandum, SMEDS are similar to other 132 Declarations, which allow any person with personal and actual knowledge of the facts being asserted in the declaration to sign the declaration.  This is the only qualification needed to sign the SMED.  Such persons are not limited to the named inventors, but may also be an inventor’s coworker, an expert, or other person.

SMEDS may be voluntarily submitted.  Such voluntary submissions are acceptable, and will receive examiner consideration, provided the submission is timely.  A timely submitted SMED also includes a proper signature and willful false statement clause, along with satisfying any other requirements.  This SMED will receive Examiner consideration and  become part of the record, including, for example, appeals.

Substantive aspects raised included:

SMEDS must not improperly supplement the application.  The SMED may not provide subject matter which is not already in the application text and drawings, or which is in addition to the subject matter disclosed in the application.  Any later disclosed or initially missing subject matter for the application is not permitted in the SMED or any other declaration.  The Companion Memorandum instructs Examiners to evaluate this issue first upon examining the SMED.

There must be a nexus between the claim and the evidence provided in the SMED.  The facts asserted in the SMED must address the claims and the recited subject matter thereof.  Simply asserting facts not connected or not otherwise related to the claims will result in the SMED being rejected, and not entered into the record.

The SMED must assert technical facts.  SMEDs, like other 132 Declarations, must assert facts and avoid making legal conclusions.

SMEDs should be tailored to the specific rejection being traversed.  Examiners tend to be favorable to specifically focused declarations.

SMEDs are intended to clarify the record and provide objective evidence specifically relevant to patent eligibility of the claimed invention. Some examples are:

• The SMED may “demonstrate how one of ordinary skill in the art would interpret a specification that describes a technological improvement to show the claimed invention is patent eligible.”
• Additionally, from the Companion Memorandum:
  • When addressing a subject matter eligibility rejection for a mental process, the SMED should provide testimony as underlying facts on how one of ordinary skill in the art would interpret the claim limitations, in view of the specification, as being unable to be practically performed in the human mind.
  • For computer related inventions, the SMED may: 1) provide expert testimony, as underlying facts, to establish the state of the art as of the application’s filing date, and how one of ordinary skill in the art would interpret the claimed invention as improving the functioning of a computer, or 2) may present results of objective comparative testing to show superior performance of the claimed invention over the prior art.
  • When addressing a subject matter eligibility rejection for failure to “amount to significantly more”, the SMED may provide factual assertions that although claim elements are conventional individually, when considered as a whole, the claim elements are arranged unconventionally, so as to be an inventive concept, and accordingly “significantly more.”

With these points in mind, patent applicants now have another acceptable and recommended ground for traversing subject matter eligibility rejections.