The Federal Circuit affirmed the district court’s dismissal based on the patent claims being directed to ineligible subject matter under Section 101.  The claims at issue were directed to a method for detecting a coding region allele of a multi-allelic genetic locus.  Applying the two-part Alice test for patent eligible subject matter, the court held that, as to the first part of the test, the claims were directed to a law of nature (i.e., a patent ineligible concept).  The law of nature in the claims is the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences.  The court analogized the present claims to those in Mayo and Ariosa, which also were directed to laws of nature.  As to the second part of the Alice test, the court held that the claimed steps of “amplifying” and “analyzing” were well-known, routine steps that were conventional in the field of molecular biology at the time of the invention and therefore were insufficient to provide the inventive concept necessary to render the claim patent eligible.  Further, the claim statement of “to detect the allele” is also insufficient to provide an inventive concept, because it recites a mental process step.

Genetic Technologies Limited v. Merial L.L.C., Case Nos. 2015-1202, -1203 (April 8, 2016); Opinion by: Dyk, joined by Prost and Taranto; Appealed From: United States District Court for the District of Delaware, Stark, J. Read the full opinion here.

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