Developing Story
USPTO SMED Guidance Update – Subject Matter Eligibility Declarations (April 2026)
USPTO Director John A. Squires issued an updated SMED memorandum on April 30, 2026, clarifying best practices for subject matter eligibility declarations without substantively changing the underlying Alice/Mayo framework. The update signals the program's institutionalization as a tool for overcoming § 101 rejections. Practitioners in AI, software, and biotech should treat SMED proficiency as a core prosecution competency.
Importance: 75%Confidence: 88%Mentions: 1Updated: June 24, 2026
## Overview
On April 30, 2026, USPTO Director John A. Squires issued an updated memorandum on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs), superseding the December 4, 2025 memos that launched the current iteration of the SMED program (IPWatchdog, June 4, 2026).
## What Changed
The April 30 memo introduces no substantive changes to the underlying framework. The principles of the original SMED Examiner Memo, the relevant MPEP provisions, and the Alice/Mayo two-step analysis all remain in place (IPWatchdog, June 4, 2026). The update is procedural and clarifying in nature.
## Why It Matters
The USPTO's characterization of the update as a signal that the program "is working" is itself a signal to practitioners — the office is affirming the SMED mechanism as a durable tool rather than an experimental one. For patent applicants in software, AI, biotech, and diagnostics — all heavily affected by Alice/Mayo eligibility rejections — the SMED process offers a structured evidentiary mechanism to overcome § 101 rejections.
## Background on SMEDs
SMEDs are declarations submitted under 37 C.F.R. § 1.132 aimed at establishing the practical utility, real-world application, or unconventional nature of claimed inventions to satisfy subject matter eligibility requirements. The program was introduced under Director Squires as part of a broader effort to provide examiners clearer guidance on how to evaluate such declarations.
## Strategic Implications
- **For applicants:** The SMED process is now effectively institutionalized. Counsel should build SMED-readiness into prosecution strategy for any application vulnerable to Alice/Mayo rejections.
- **For AI/software patents:** The SMED framework may become a critical tool for defending AI-related claims against § 101 rejections, particularly as AI patent filings surge.
- **For patent prosecutors:** Understanding SMED best practices is increasingly a core competency given the volume of eligibility rejections in key technology sectors.
## Director Squires' Role
Director John A. Squires has signaled a more applicant-friendly posture at the USPTO relative to prior administrations, consistent with the broader Trump administration approach to IP as an economic and competitiveness tool.
## Outlook
Further SMED guidance updates are possible. Practitioners should monitor MPEP revisions and examiner training materials for how the program evolves in practice, particularly for AI and biotech claims.