The Federal Circuit’s recent dicta in a non-precedential decision stating that it need not give deference to the USPTO’s 35 U.S.C. § 101 patent-eligibility guidance highlights the challenges faced by patent applicants. In Cleveland Clinic Foundation v. True Health Diagnostics LLC, No. 2018-1218 (Fed. Cir. April 1, 2019), the court affirmed a District Court’s grant of a Rule 12(b)(6) motion to dismiss based on invalidity of claims of US Patent Nos. 9,575,065 and 9,581,597, as “invalid under 35 U.S.C. § 101 as directed to an ineligible natural law.”
The patent owner argued, among other things, that, under Skidmore v. Swift & Co., 323 U.S. 134 (1944), the District Court should have given “appropriate deference to subject matter eligibility guidance published by the PTO,” specifically “Example 29,” published on May 4, 2016. Judge Lourie, writing for the court, explained that
While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.
Even if Example 29 was relevant or analogous to the claims at issue in this case, controlling precedential case law “must control.” The court therefore “decline[d] to follow the PTO’s example 29 – Claim 1,” concluding “that the District Court did not err in its consideration of the PTO’s subject matter eligibility guidance.”
Others have already blogged about this opinion in detail, and the PatentlyO blog has characterized the opinion as exemplifying the ongoing “eligibility train wreck.” (It is hard to argue with that.)
I write this concurring post, as it were, to emphasize an important practice consideration: think hard before you rely on the USPTO’s § 101 guidance in prosecution. It is often tempting to do so, particularly in light of the USPTO’s January 7, 2019, patent-eligibility guidance, which provided additional arguments, and seemed to limit examiners, with respect to patent-eligibility rejections. But if arguments are not grounded in case law, they may not fly in court or in a post-grant PTAB proceeding. And overt reliance on USPTO guidance could actually hurt, i.e., if it appears that guidance was relied on instead of controlling case law.