The United States Patent and Trademark Office (USPTO), under Director John A. Squires, has published two official memoranda that clarify the use of Subject Matter Eligibility Declarations (SMEDs). SMEDs are an evidentiary tool available under 37 C.F.R. § 1.132 (Rule 132). The guidance confirms that a SMED is a voluntary option that patent applicants may use to present factual evidence concerning areas such as technological improvement to address rejections under 35 U.S.C. § 101. The memoranda direct examiners to evaluate this evidence using the preponderance-of-the-evidence standard and outline suggested practices for submitting SMEDs as separate, focused documents.
What is a Subject Matter Eligibility Declaration (SMED)?
A SMED is a specialized document filed under Rule 132 that focuses on providing evidence to overcome a patent rejection based on 35 U.S.C. § 101 (Subject Matter Eligibility).
Essentially, it is a way for a patent applicant to submit factual proof to the USPTO that their invention is not merely an unpatentable abstract idea or law of nature.
Purpose and Key Features of a SMED
The primary goal of a SMED is to insert objective facts into the official prosecution record to challenge an examiner’s finding that the claimed invention falls under a judicial exception.
- Evidentiary Role: SMEDs provide factual evidence on technical points, such as:
- The state of the art at the time of filing.
- Objective evidence showing a technological improvement over existing systems.
- Facts demonstrating how a judicial exception is integrated into a practical application.
- Proof that the claimed steps cannot practically be performed only in the human mind.
- Voluntary Option: The USPTO confirms that submitting a SMED is voluntary. An applicant faces no penalty if they choose not to file one.
- Who Can Sign? Any person with knowledge of the facts being asserted may sign the declaration. This could be the inventor, a co-worker, or an independent technical expert.
What is the Context for the USPTO’s Clarification on SMEDs?
The analysis of subject matter eligibility under 35 U.S.C. § 101 remains a complex and critical aspect of U.S. patent examination. Eligibility focuses on whether claims are directed to a judicial exception, such as an abstract idea or a law of nature.
Notably, the USPTO issued this guidance as a procedural action supporting its stated goal of maintaining a “strong, robust, expansive, and resilient intellectual property system,” particularly for emerging technologies. Director John A. Squires reinforced this commitment by signing the first two patents of his tenure, one directed to distributed ledger technologies (U.S. Patent No. 12,419,202) and another to medical diagnostics (U.S. Patent No. 12,419,201), signaling that applied technologies remain eligible.
The guidance follows the precedential Appeals Review Panel (ARP) decision in In re Desjardins, which clarified that improvements to machine learning models may constitute a practical application within the governing eligibility framework.
The two memoranda, fulfilling a commitment Director Squires made in his remarks at the American Intellectual Property Law Association (AIPLA) Annual Meeting, address questions about how applicants and examiners use and consider evidentiary submissions (SMEDs) when a subject matter eligibility rejection occurs.
What Does the Memorandum for Examiners Require Regarding SMEDs?
The first memorandum, which directs the Examining Corps, focuses on the procedures examiners follow upon receiving a SMED. In particular, the document indicates examiners must assess eligibility consistently, giving proper consideration to asserted technological improvements.
Required Standards for Examiner Evaluation
The memorandum outlines the procedural standards examiners use when reviewing SMEDs:
| Element of the SMED | Procedure |
| Voluntary Submission Status | The SMED is a voluntary option under 37 C.F.R. § 1.132. USPTO will confirm that the declaration complies with Rule 132 to be accepted. |
| Evidentiary Content | SMED may contain evidence relevant to the eligibility inquiry. Examples include evidence of technological improvement or the state of the art. |
| Mandatory Consideration | The examiner must consider the declaration as part of the evidentiary record when properly submitted. Examiners incorporate the factual evidence into the prosecution history. |
| Standard of Review | Examiners evaluate the facts presented using the preponderance-of-the-evidence standard. The evidence must show the asserted facts are more likely than not true. |
The memorandum includes examples illustrating how such evidence may inform eligibility determinations consistently with the Manual of Patent Examining Procedure (MPEP) and applicable precedent.
Submission Practices: The Memorandum for Applicants and Practitioners
Meanwhile, the second memorandum, which directs applicants and practitioners, outlines suggested practices for preparing and submitting SMEDs. The guidance notes that combining testimony may complicate the record and hinder the examiner’s ability to evaluate the evidence and recommends submitting separate declarations for other issues.
Suggested Practices for SMED Drafting and Filing
The USPTO suggests the following practices for submitting a SMED:
Separate Declaration: Eligibility-related testimony proves most effective when applicants present it in a separate declaration focused solely on subject matter eligibility (35 U.S.C. § 101). However, the guidance notes that combining eligibility testimony with evidence for other statutory requirements (such as novelty under §102 or non-obviousness under §103) may complicate the record.
Objective Evidence: Applicants should ensure the declaration provides objective evidence directly related to the claimed invention. This evidence is important for demonstrating how a judicial exception is integrated into a practical application.
No Supplementation of Disclosure: The memorandum notes that SMEDs should not supplement the original disclosure of the patent application. The evidence presented should relate to the claimed invention as applicants originally disclosed it.
Purpose of the Clarifying Memoranda
Ultimately, the USPTO’s issuance of these memoranda reinforces that SMEDs operate within the existing evidentiary framework of Rule 132. The documents clarify how applicants may choose to provide factual evidence relevant to the eligibility analysis and how examiners evaluate such submissions under established practices.
This guidance aims to improve clarity, strengthen the record of examination, and support the consistent application of subject matter eligibility principles across technologies. The memoranda take effect immediately, and the USPTO announced it will make additional training materials available to examiners and the public.
