The new USPTO guidelines on the evaluation of subject matter patent-eligibility were released yesterday. Unfortunately, the guidelines do not directly address the patent-eligibility of claims involving diagnostic tests.
The most important change in relation to the previous guidelines is the flowchart to determine subject matter eligibility. The first determination is whether the claim is directed to a process, machine, manufacture or composition of matter. If the claim is a composition is a “nature-based product,” it is analyzed in Step 2B to see if it is “markedly different” from “its naturally occurring counterpart in its natural state.” The revised guidelines do not contain the requirement that the nature-based product be structurally different. Now “markedly different characteristics can be expressed as the product’s structure, function and/or other properties and will be evaluated based on what is recited in the claim on a case-by-case basis.” Furthermore, “In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart.”
Until there is more case law on diagnostic claims, it appears that the natural correlation will take the claims straight to Step 2B. If the clams contain additional elements that meet a somewhat arbitrary “significantly more” test, then the diagnostic claims will qualify as eligible subject matter. No hypothetical examples in which a natural product or natural phenomenon passed Step 2B of the analysis are given.
The guidelines contain language that “[i]mplementation of examination guidance on eligibility will be an iterative process continuing with periodic supplements based on developments in patent subject matter eligibility jurisprudence and public feedback,” citing the pending appeals involving BRCA assays and the appeal to the Federal Circuit in Ariosa Diagnostics.
So, unfortunately, the new guidelines do not impose any greater certainty for diagnostic claims then the old guidelines did. We will have to wait for the results from case law.