On October 17, 2019, the USPTO issued new patent subject matter eligibility guidance, the first such memo since the January 2019 guidance on 35 U.S.C. §101. The January 2019 memo described a three step, two prong procedure for determining patent subject matter eligibility: (i) patent claims must be directed to a statutory category; (iia) the claims must not recite a judicial exception, or if it does, (iib) any exception must be integrated into a practical application; and (iii) if the claims are directed to a judicial exception and not integrated into a practical application, they must include limitations that amount to significantly more than the exception. Public comments were solicited, and ten months later, the Patent Office has responded with further explanation of how this procedure is to be applied that may help address inconsistencies in examination and provide clarity.
The updated guidance does not change the procedure laid out in the January 2019 memo, but does address comments regarding how claims are evaluated to determine whether they recite a judicial exception and how the exceptions are defined (step iia); how claims are evaluated to determine whether they integrate the exception into a practical application (step iib); and the burden of proof required of Examiners in making rejections and procedural issues around responses to rejections. The discussion of the examination procedure provides several clues to claims and arguments that will be unsuccessful and those that will be successful. For example, arguing that a claim is not abstract because it recites a physical computer or uses data from a particular industry will likely be ineffective, but claims that recite specific implementation steps that cannot be practically performed in the human mind will have a better chance at allowance. For personalized methods of treatment, the update indicates that a treatment step recited at a high level of generality or as an extra-solution data gathering step will not be sufficient, but a more specific treatment step can support eligibility even if the treatment is well-known in the art. The updated guidance is also accompanied by new examples of hypothetical ineligible and eligible claims directed to medical treatment methods and pharmaceutical compounds, machine automation, and livestock management. The examples include detailed analysis of each claim at every step of the eligibility procedure, and provide some instruction regarding what aspects of a claim meet the required threshold for patentable subject matter.
The updated guidance is binding on patent examiners and the Patent Trial and Appeals Board, but not on the federal courts. In Cleveland Clinic v. True Health Diagnostics, the Federal Circuit declined to defer to the USPTO’s previous eligibility guidance, stating that “[w]hile we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance.” (2018-1218, April 1, 2019). However, the guidance was drafted based on a review of federal court decisions and should be consistent with existing case law. The takeaway for Applicants is that well written, detailed patent claims and specifications will not only meet the PTO’s requirements, but also will likely be stronger against challenges before the courts.