This office action response template sets out arguments for responding to a rejection of patent claims for life sciences inventions, particularly diagnostic methods, under 35 U.S.C. ยง 101. This template includes practical guidance and drafting notes. Use this template in combination with Patent Office Action Response to prepare a complete response to an office action that rejects claims based on a lack of patent-eligible subject matter. See Office Action Responses: Arguments for Section 101 Rejections (Life Sciences), for additional arguments for responding to rejections under Section 101. For life sciences inventions generally, particularly diagnostic methods, the current framework for analyzing whether a patent claim is directed to patent-eligible subject matter under Section 101 is set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). The first step of Mayo's two-step framework is determining whether the claims are directed to a patent-ineligible ...