Office Action Response Argument
(Section 101) (Life Sciences)

Summary

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. § 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 35 U.S.C. § 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 35 U.S.C. § 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 concept. If the answer is yes, then the elements of each claim are considered both individually and "as an ordered combination" to determine whether additional elements "transform the nature of the claim" into a patent-eligible application. 566 U.S. at 77-78. The Supreme Court has described the second step of this analysis as a search for an "inventive concept" (i.e., an element or combination of elements that is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself"). 566 U.S at 72-73. In Mayo, the Supreme Court held that the claimed invention was directed to laws of nature, namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a particular drug would prove ineffective or cause harm. The Supreme Court noted that adding routine and conventional administration and measurement steps did not render the claims patent-eligible. Simply "appending conventional steps, specified at a high level of generality," was insufficient to supply an "inventive concept." 566 U.S. at 82-83. Following Mayo, diagnostic methods based on detecting a particular biomarker in a patient's blood and correlating it to a particular disease or condition are unlikely to be found patent-eligible unless there is something more in the claim to provide the necessary "inventive concept." The following example illustrates this. Suppose inventors discover that the detection of substance X in a patient's blood correlates with the presence of a particular medical condition Y. The inventors file a patent application with the following diagnostic method claim: 1. A method of diagnosing condition Y, comprising the steps of: obtaining a sample from a patient; analyzing the sample to detect X; and determining that the patient suffers from condition Y when X is detected in the sample Such a claim is likely to be rejected as patent-ineligible under 35 U.S.C. § 101 because there are no additional elements beyond the natural correlation of biomarker X with condition Y and routine and conventional testing steps. Here, the steps of obtaining the sample and analyzing the sample are considered "routine and conventional" which, under Mayo, is not sufficient to meet the "inventive concept" requirement. However, when additional steps or elements are included in the claim, there are arguments that can be made to overcome a rejection under 35 U.S.C. § 101. For example, such arguments may be based on additional processing or treatment steps or an unconventional analysis step. See USPTO Patent Subject Matter Eligibility Guidelines 2019 for additional guidance. For a quick reference on the sequence of inquiries under the USPTO guidelines, see USPTO Patent Subject Matter Eligibility Checklist. For additional information on responding to an office action, see Patent Office Action Response Checklist. For additional statements of law on subject-matter eligibility, see Patent-Eligible Subject Matter (Section 101) Statements of Law.