TAKEAWAY: While USPTO § 101 guidance following the Supreme Court’s decision on patent eligibility in Alice clarifies examiners’ analysis, district courts and the Federal Circuit are not bound by such examples provided by the USPTO. Therefore, patent applicants should still take reasonable precautions to take into account relevant case law when drafting and prosecuting applications.
The USPTO issued a Revised Patent Subject Matter Eligibility Guidance on January 7, 2019, clarifying how examiners determine whether claims are “directed to” a judicial exception for a patent eligibility analysis under 35 U.S.C. § 101. The 2019 guidance follows previous USPTO § 101 guidance, including a 2016 memo with various examples on natural products and processes.
Several months thereafter, on April 1, 2019, the United States Court of Appeals for the Federal Circuit issued a non-precedential opinion in Cleveland Clinic Found. et al. v. True Health Diagnostics LLC declining to give deference to USPTO § 101 guidelines. Patentee Cleveland Clinic pointed to the 2016 memo in support of its position regarding patentability, wherein the USPTO provided an example of a patent-eligible claim for detecting a hypothetical protein via bonding with an antibody. The Federal Circuit acknowledged the USPTO’s guidelines but held that federal courts are not bound by them. The Federal Circuit then affirmed the district court’s determination that the claims at issue were patent ineligible as claiming a natural law. The Court reasoned that the “only remaining non-conventional element of each claim is the discovery that [a] protein is present in the bodily sample, and the discovery of a natural law cannot by itself provide the requisite inventive concept.” The Federal Circuit “declined to follow the PTO’s [example]” in the 2016 memo and “conclude[d] that the district court did not err in its consideration of the PTO’s subject matter eligibility guidance.”
As Cleveland Clinic makes clear, the analysis applied by the USPTO during examination may differ from that applied by federal courts. As such, even though USPTO guidance may be beneficial during examination, it would be prudent for patent applicants to prosecute claims with a view towards both the USPTO guidance and § 101 case law provided by federal courts. For instance, patent applicants may emphasize specific technical details of the invention and include claims covering such details. In this manner, patents may be better positioned to be upheld during validity challenges.