In Ariosa Diagnostics Inc. v. Sequenom Inc., a Federal Circuit panel held that certain prenatal diagnostic testing claims in U.S. patent no. 6,258,540 ("the '540 patent") were invalid under 35 U.S.C. § 101 as directed to a natural phenomenon. The court's holding rested on its conclusion that the claims failed the "inventive concept" test of Mayo v. Prometheus.
The Ariosa case raises a critical question of whether Mayo permits the interplay between a natural principle and the steps of a process claim to supply an inventive concept under § 101, or whether the inventive concept must reside in the claim elements as they stand completely independent of the natural principle.
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