CSG Law Alert: USPTO Issues New Guidance on Subject Matter Eligibility Declarations
In a previous CSG Law client alert, USPTO Directed Signals Shift Towards Broader Patent Eligibility for AI Inventions, the recent Ex parte Desjardins decision was described as signaling a more expansive interpretation of patent eligibility under 35 U.S.C. §101. The United States Patent and Trademark Office (USPTO) has now issued two important memoranda clarifying the role of so-called Subject Matter Eligibility Declarations (SMEDs). These updates describe SMEDs as a tool to respond to subject matter eligibility rejections.
A SMED is a declaration by someone knowledgeable about the facts asserted to address a subject matter eligibility rejection. The SMED provides an applicant with an opportunity to provide factual evidence—such as proof of technological improvements, the state of the art at the time of filing, or explanations showing how a judicial exception is integrated into a practical application—to strengthen the record and support patent eligibility arguments.
The first memo is directed to the USPTO Examining Corps and emphasizes that SMEDs—when properly submitted—must be considered as part of the evidentiary record and evaluated under a preponderance-of-the-evidence standard. Examiners are instructed in the first memo to consider these declarations when applying the existing subject matter eligibility framework, ensuring that factual evidence is given appropriate consideration.
The second memo offers best practices for applicants. It instructs applicants to submit SMEDs as standalone documents, to clearly link the evidence to the claimed invention, and to avoid improper supplementation of the specification. Timely filing of a SMED describing a strong link between the evidence and the claims is critical to convincing an Examiner.
These developments are significant because they provide an additional means for applicants to demonstrate technological improvements and show how judicial exceptions are integrated into a practical application under the existing framework. For inventions in fields such as artificial intelligence, medical diagnostics, and other emerging technologies, SMEDs can help overcome eligibility hurdles and reduce prosecution delays.
The USPTO’s recent guidance concerning SMEDs and the Desjardins decision represents a broader trend toward a more inclusive subject matter eligibility standard. Applicants should consider incorporating SMEDs into their prosecution strategies, where appropriate, to strengthen the record and improve outcomes.
If your applications involve technologies frequently challenged under §101, CSG Law’s Patent Group can assist with preparing declarations, developing supporting evidence, and navigating USPTO guidance to improve the chances of allowance. For more information, please contact the authors of this alert or the Patent Group at CSG Law.