The 2019 Revised Subject Matter Eligibility Guidance published on January 7th purported to revise the procedures for determining whether a patent claim or patent application claim is “directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under step 2A” of the USPTO’s Mayo/Alice Rule Guidance in two ways. First, the Revised Guidance seeks to clarify just what an abstract idea is by stated that abstract ideas can be grouped as, e.g., mathematical concepts, mental processes and the like. More important to life sciences patenting, the Revised Guidance explains that a patent claim that recited a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.” If the claim is [[not]] directed to a judicial exception, the dreaded 2B analysis must be carried out.
The majority of the Fed. Cir. panel clearly disagrees with this Revision in the case of any diagnostic claim that recites a naturally occurring correlation, along with the manipulative steps required to reach a diagnosis. The majority of the panel in Athena v. Mayo – and perhaps a majority of the Fed. Cir. Judges – inevitably find that a diagnostic claim that recites the application of a naturally occurring correlation reach a diagnostic conclusion is directed to a natural law, despite the presence in the claim of the steps wherein the “hand of man” is applied to convert the discovery of the in vivo correlation into a practical application of the natural law. Once the claim is found to be directed to a such a correlation, which is a natural law, the court moves on the Step 2B, in which it examines the remaining steps – sampling, measuring the biomarkers in question and comparing them to a reference amount of the biomarker, and drawing a diagnostic conclusion from the data – in isolation, to see if they represent an “inventive step” apart from their application to reach a diagnostic conclusion. In other words, the recognition of the utility of the in vivo correlation cannot provide the required “inventive step” when applied in vitro, unless there is a second “invention” that arises when the in vitro assay is carried out.