The US Patent and Trademark Office (USPTO) has issued interim guidance for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. § 101, reflecting recent decisions by the US Supreme Court.
On December 10, 2014, the USPTO issued interim guidance for use by USPTO personnel in evaluating subject matter eligibility under 35 U.S.C. § 101 (79 FR 74618 (Dec. 16, 2014)).The interim guidance:
Supersedes the USPTO's March 4, 2014 procedure for subject matter eligibility analysis of claims reciting or involving laws of nature.
This interim guidance assesses recent decisions of the Supreme Court and the US Court of Appeals for the Federal Circuit, and examines how they impact the provisions contained in the Manual of Patent Examining Procedure sections 2105, 2106 and 2106.1.
The interim guidance is directed primarily to applying the two-part Mayo test for claims directed to laws of nature, natural phenomena and abstract ideas (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012)). The interim guidance provides a flowchart for evaluating a claim's subject matter eligibility. The flowchart asks:
Step 1: Whether the claim is a process, machine, manufacture or composition of matter? If so, the analysis proceeds to the Mayo two-part analysis.
Step 2(A): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (a judicially-recognized exception)? If not, the claim qualifies as eligible subject matter under 35 U.S.C. § 101. If so, the evaluation continues to the next part of the test.
Step 2(B): Does the claim recite additional elements that amount to significantly more than the judicially-recognized exception? If so, the claim qualifies as eligible subject matter under 35 U.S.C. § 101. If not, the claim is not eligible subject matter under 35 U.S.C. § 101.
The interim guidance contains two notable changes from previous guidance:
All claims, both product and process, with a judicial exception of any type are subject to the same evaluative steps.
Claims including a nature-based product are analyzed in step 2(A) to identify whether the claim is directed to a "product of nature" exception. This analysis compares the nature-based product in the claim to its naturally-occurring counterpart to identify markedly different characteristics based on structure, function and/or properties. The analysis continues to step 2(B) only when no markedly different characteristics are shown.
The interim guidance provides explanations for each of the steps in the evaluative process. It also provides sample analyses of subject matter eligibility decisions and summaries of recent Supreme Court and Federal Circuit decisions.
Written comments on the interim guidance and additional suggestions for claim examples to use for examiner training must be received within 90 days after the interim guidance is published in the Federal Register. Comments should be sent to [email protected].