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Following the introduction of the “Subject Matter Eligibility Declaration” (SMED) term in December 2025, the United States Patent and Trademark Office (“USPTO”) has updated its best practices guidance on SMEDs, describing the memorandum as a “living document” that will be periodically updated based on practitioner feedback and Office experience.

The SMED is a voluntary evidentiary submission under a Rule 132 Declaration (37 C.F.R. § 1.132) that an applicant may file during U.S. patent prosecution to address patent eligibility issues under 35 U.S.C. § 101. The Office describes SMEDs as a “constructive model,” a modern analog to the historical “working model” requirement, enabling applicants to communicate less visible and tangible nuances of innovation, particularly in fields such as software, AI, quantum, and diagnostics, where a physical model is impracticable.  

The updated memorandum underscores Director Squire’s push to clarify the “technological improvement” aspect of claimed inventions when § 101 issues arise. The Office emphasizes that an SMED may demonstrate how one of ordinary skill in the art would interpret a specification that describes a technological improvement—how the claimed invention is better, cheaper, faster, and/or more efficient, and thus is patent eligible.

The “technological improvement” evidence submitted by SMEDs can address eligibility at Step 2A, Prong Two and/or Step 2B of the Alice analysis framework as described 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?

By encouraging applicants to demonstrate how a claimed invention provides a real-world technological improvement, the Office charts a practical path forward for overcoming § 101 rejections for inventions falling under a judicial exception. As “§ 103 is the other side of the coin from § 101,” the Office encourages filing SMEDs as eligibility focused declarations separate from testimony on other statutory issues such as novelty (§ 102), obviousness (§ 103), enablement (§ 112), or written description (§ 112), to avoid the risk of intertwining the issues and to preserve a clear and properly focused evidentiary record.  

According to the Office, strong SMEDs should:

  • Explain how the claimed invention provides real‑world technological application, effect, and benefit, including why it is better, cheaper, faster, or more efficient than existing technology;
  • Provide objective, factual evidence about the state of the art and technological improvements, not legal conclusions;
  • Establish a clear nexus between the declaration and the claims, tying evidence directly to claim limitations, without improperly supplementing the specification; and
  • Focus exclusively on § 101 eligibility.

The update reflects input from newly appointed Deputy Commissioner for Patents Barry Schindler, focused on AI Policy, Practice, and Operations. The Office invites continued practitioner engagement and plans periodic updates as feedback and experience develop.

SMEDs provide a useful and strategic tool that may help patent applicants secure protection for certain innovations. If you have any questions about these developments, please contact the authors of this alert or the Womble Bond Dickinson attorneys with whom you normally work.

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