Digest of ARIOSA DIAGNOSTICS, INC. V. SEQUENOM, INC., Nos. 2014-1139, 2014-1144 (Fed. Cir. Dec. 2, 2015) (precedential). On appeal from N.D. Cal. Before Prost, Newman, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll (en banc). Per Curiam.

Procedural Posture: The district court concluded that the claims at issue in Sequenom’s patent recited patent-ineligible subject matter. A Federal Circuit panel affirmed. The patentee petitioned the Federal Circuit for rehearing en banc, and the Court denied the petition.

Lourie and Moore, concurring in the denial:

  • Patent Eligibility (Section 101): The Supreme Court’s decision in Mayo mandates the panel’s affirmance of the district court’s decision. Judge Lourie proposes to modify the Mayo test for patent-eligibility, in which “step two” would be analyzed in conjunction with the asserted natural phenomenon in “step one.” Under the modified test, the Sequenom patent claims would be patent-eligible because they are directed to “innovative and practical uses” for the natural material of the non-cellular fraction of fetal DNA obtained from a maternal blood sample (cffDNA).

Dyk, concurring in the denial:

  • Patent Eligibility (Section 101): The framework of Mayo and Alice binds the Court to affirm the district court’s decision. Judge Dyk proposes to expand step two of the Mayo framework to allow for the “inventive concept” to come from discovery of an unknown natural phenomenon, so long as the patentee’s claims are “sufficiently limited to a specific application of the new law of nature” that it discovered and actually, not constructively, reduced to practice. Under this test, Sequenom’s claims would remain patent-ineligible because they are overbroad.

Newman, dissenting from the denial:

  • Patent Eligibility (Section 101): The Federal Circuit should rehear the case en banc and reverse the district court, because the panel’s affirmance is not mandated by Supreme Court precedent. The facts of this case diverge significantly from those in Mayo and Myriad. The claimed new diagnostic method of using cffDNA information is not ineligible under Section 101, but should instead be analyzed for compliance with other patentability requirements (e.g. Sections 102, 103, and 112).