Ariosa Diagnostics, Inc. v. Sequenom, Inc.
809 F.3d 1282
Fed. Cir.2015Background
- This en banc petition arises from the Federal Circuit panel decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court that Sequenom’s patents claiming methods to detect paternally‑inherited cell‑free fetal DNA (cffDNA) in maternal plasma are not patent‑eligible under 35 U.S.C. § 101.
- Sequenom’s representative claims recite physical steps: obtaining maternal blood, separating cellular/non‑cellular fractions, amplifying/detecting paternally‑inherited fetal nucleic acid, and diagnosing fetal conditions.
- The panel applied the two‑step Mayo/Alice framework and concluded the claims are directed to a natural phenomenon (presence of cffDNA) and add only conventional, routine laboratory steps.
- Concurring judges (Lourie joined by Moore; Dyk separately) agreed rehearing en banc should be denied but wrote separately: Lourie argued the claims should be eligible in principle and that concerns about overbreadth/indefiniteness belong to § 102/§ 112 analysis; Dyk urged that Mayo/Alice governs but suggested narrow claims that are reduced to practice could survive.
- Judge Newman dissented from the denial of rehearing en banc, arguing these claims are novel, practical diagnostic applications of a discovery and should be examined under §§ 102, 103, and 112 rather than defeated under § 101.
Issues
| Issue | Plaintiff's Argument (Ariosa/Natera) | Defendant's Argument (Sequenom) | Held |
|---|---|---|---|
| Whether claims are directed to patent‑ineligible natural phenomenon | Claims are directed to a natural phenomenon (cffDNA) and therefore ineligible under Mayo/Alice | Sequenom: claims are patent‑eligible applications of the discovery (practical diagnostic methods) | Court: claims are directed to a natural phenomenon (cffDNA); step one of Mayo satisfied (ineligible concept) |
| Whether the additional claimed steps supply an "inventive concept" beyond the natural phenomenon | Steps (separation, amplification, detection) are well‑understood, routine lab techniques and thus do not add inventive concept | Sequenom: the combination and application to non‑cellular fraction is novel and non‑routine; the discovery itself supports eligibility | Court: additional steps are routine/conventional; under Mayo/Alice they do not transform the claim into patent‑eligible subject matter |
| Whether breadth/indefiniteness (§ 112) or novelty/nonobviousness (§§ 102/103), rather than § 101, should control | Emphasize § 101: natural phenomenon + conventional steps → ineligible | Sequenom: claimed subject matter should be judged under §§ 102/103/112; § 101 is improper dismissal of meritorious diagnostics | Concurring opinions: some judges (Lourie, Newman) argue § 112/§ 103 are better tools to police overbreadth; majority bound by Supreme Court precedent (Mayo/Alice) so § 101 governs here |
| Whether discovery of a new natural phenomenon can supply the inventive concept at Mayo step two | Plaintiffs: inventive concept must appear in claimed application, not merely discovery | Sequenom: novelty of the discovery itself (presence/use of cffDNA) should supply inventive concept for a narrowly‑tailored claim | Court (panel & majority concurrences): bound by Mayo/Alice which treats discovery alone as insufficient; Dyk suggested narrow, reduced‑to‑practice claims might be treated differently in future |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (2012) (establishes two‑step test asking whether claims are directed to a law of nature and, if so, whether additional claim elements supply an inventive concept)
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (applies Mayo two‑step framework to abstract ideas and confirms unitary rule)
- Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) (genes as naturally occurring products not patentable; Court noted new applications of gene knowledge may be eligible)
- Diamond v. Diehr, 450 U.S. 175 (1981) (applications of natural laws that are transformative may be patent‑eligible)
- O’Reilly v. Morse, 56 U.S. 62 (1853) (denial of overly broad claims that would preempt future uses of a natural principle)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (panel opinion affirmed: Sequenom’s claims ineligible under § 101)