U.S. Patent & Trademark Office Issues New Guidelines on Patent Eligibility; Does Not Address Diagnostic Claims

New U.S. Patent & Trademark Office (“USPTO”) guidelines regarding the evaluation of subject matter patent-eligibility were released on December 15, 2014. 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 inclusion of a flowchart to determine subject matter eligibility. The first determination in the chart is whether the claim is directed to a process, machine, manufacture or composition of matter. If the claim is a composition and is a “nature-based product,” it is analyzed to see if the composition 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 more case law on diagnostic claims becomes available, it appears that the natural correlation will take the claims straight to the analysis described above. If the claims contain additional elements that meet a somewhat arbitrary “significantly more” test, then the diagnostic claims will qualify as eligible subject matter. Note that in reissuing the guidelines, the USPTO did not provide hypothetical examples in which a natural product or natural phenomenon passed the “markedly different” analysis criteria.

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 that help assess risk for breast, ovarian and/or related cancers and the appeal to the Federal Circuit in Ariosa Diagnostics.

In conclusion, the new guidelines unfortunately do not impose any greater certainty for diagnostic claims then the old guidelines did. While we will have to wait for the results from case law to pin down patentable material in diagnostic claims, it is good practice to have a patent application pending in the USPTO in the meantime.

If you have any questions about the latest USPTO guideline revisions described in this article, please contact Leech Tishman’s Intellectual Property Practice Group

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