USPTO Suggests Use of Rule 132 Declarations and Updated Examiner Guidelines to Address Patent Subject Matter Eligibility Issues

In follow up to the August 4, 2025 guidance and September 26, 2025 In re Desjardins decision, the USPTO recently took another significant step to provide patentees pursuing patent protection additional tools to address patent eligibility issues.  In two complementary memoranda—one to examiners and one to the public—the USPTO introduced the "Subject Matter Eligibility Declaration" (SMED) term to the patent examination process to highlight the existing voluntary option under 37 C.F.R. § 1.132 for addressing 35 U.S.C. § 101 (subject matter eligibility) issues.

While SMEDs should be approached as standard Rule 132 declarations, the new terminology serves a strategic purpose: it reminds both applicants and examiners of this option, while encouraging practitioners to file SMEDs separately from declarations addressing other rejections under Sections 102 (novelty requirement), 103 (not obvious requirement), or 112 (enablement/written description requirements). This categorization reflects the USPTO's approach, led by Director Squires, to position Section 101 analysis separately from other patentability issues. The USPTO reminds the examiners that, as established in In re Desjardins, Section 101 must be applied properly as a subject matter gatekeeper, while Sections 102, 103, and 112 are the appropriate tools for defining the scope of patent protection.

When a SMED Is Helpful 

An applicant may submit a SMED to provide evidence for any step of the Section 101 analysis below, conducted under the framework set forth in Alice v. CLS Bank Int’l, 
573 U.S. 208 (2014) and implemented in the MPEP: 

• Step 1 – Is the claim to a process, machine, manufacture, or composition of matter?
• Step 2A, Prong One – Does the claim recite a judicial exception (an abstract idea, law of nature, or a natural phenomenon)?
• Step 2A, Prong Two – Does the claim recite additional elements that integrate the judicial exception into a practical application?
• Step 2B – Does the claim recite additional elements that amount to significantly more than the judicial exception?

The Examiner Memo provides software and medical treatment examples demonstrating when SMEDs may be particularly effective:

• Rebutting “mental process” characterizations (Step 2A, Prong One): Provide expert testimony and objective evidence demonstrating that the claimed steps cannot be practically performed in the human mind (e.g., distributed network monitors on multiple machines, technical impossibility of manual distributed processing).
• Improvements to technology or technical field (Step 2A, Prong Two):
  • Database Self-Referential Table: Provide expert testimony establishing the prior art state and demonstrating how the invention improves computer data storage and retrieval through specific data structures, with clear nexus to claimed elements.
  • Neural Network Architecture: Present objective comparative testing results showing superior regression performance over prior art systems, addressing specification gaps in describing specific performance improvements.
  • Computer Animation Automation: Combine expert testimony with trade publications to demonstrate how the invention automates previously subjective human tasks in animation, supported by evidence of the technical transformation from manual keyframe interpolation to automated processing.
• Practical application in treatment/prophylaxis (Step 2A, Prong Two): Provide evidentiary support showing how the claimed prophylactic schedule adjustment constitutes a practical application that meaningfully limits the abstract mental process by affecting particular disease prevention in the second group of animals.
• Amounts to “significantly more” (Step 2B): Demonstrate through expert testimony and objective evidence that while individual claim elements may be conventional, their unconventional arrangement creates an inventive concept by providing a specific remote filtering solution with user-customizable features not found in prior art.

Best Practices for Applicants

1. Use a dedicated Rule 132 declaration to address the Section 101 issue (“SMED”)

• File SMED separately from other declarations, e.g., those addressing non-101 rejections, to ensure clarity and relevance, bolster probative value, and facilitate examiner review.

2. Establish a clear nexus to the claims

• Map each factual assertion (e.g., performance data, architectural change, workflow automation) to specific claim elements and specification passages.

3. Focus on objective, contemporaneous evidence; do not argue law

• Comparative testing, benchmarks, design docs, and industry publications at or before filing carry weight; avoid post hoc “new matter.”
• Focus on facts (what changed, why, how it operates, what it accomplishes); leave legal arguments and conclusions for counsel to make in the office action response.
• Anyone with personal knowledge of the facts may sign, and no special qualification is needed, but it can be important to choose knowledgeable inventors, engineers, or independent experts having appropriate backgrounds, considering future potential litigation implications.

4. Meet Rule 132 formalities and timing

• Ensure proper execution, formalities, and timely submission in accordance with the Manual of Patent Examination Procedures (e.g., MPEP 716.01).

The USPTO's introduction of Subject Matter Eligibility Declarations equip innovators, especially in high-tech and life sciences, with practical tools to overcome patent eligibility hurdles. For software, AI, and systems, SMEDs enable applicants to prove non-mental processes or technical improvements using objective metrics. For natural product-derived therapeutics, diagnostics, and treatments, SMEDs provide a structured way to demonstrate non-natural products or practical applications that go beyond natural phenomena.

The deliberate separation of Section 101 from other patentability requirements signals the USPTO's commitment to treating subject matter eligibility as the foundational gatekeeper that should not be conflated with other rejection reasonings. Consider leveraging this momentum to secure protection for innovations that merit it.