In ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC., Appeal No. 2014-1139, 2014-1144, the Federal Circuit held that claims are directed to patent-ineligible subject matter under 35 U.S.C. § 101 where the claimed method begins and ends with pre-existing natural phenomena and uses only well-understood, routine, and conventional techniques as intermediate elements.

Sequenom accused Ariosa’s noninvasive, prenatal testing of patent infringement. The disputed patent claims methods of prenatal diagnostics requiring the detection and analysis of cell-free, fetal DNA (cffDNA).  On cross-motions for summary judgment, the district court determined Sequenom’s claims were not drawn to patent-eligible subject matter. 

The Federal Circuit agreed “the method reflects a significant human contribution in that [the inventors] combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care” but nevertheless affirmed the district court’s decision invalidating the claims.  Following the framework of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), the Federal Circuit first observed the patented method begins with the recognition cffDNA exists in maternal blood and ends with detecting paternally inherited cffDNA.  Both of these are pre-existing natural phenomena, which the inventors did not create or alter.  Because the “method therefor begins and ends with a natural phenomenon, . . . the claims are directed to matter that is naturally occurring.”

The Federal Circuit next examined “whether the claim contains an inventive concept sufficient to transform the claimed naturally occurring phenomenon into a patent-eligible application.”  The Federal Circuit concluded the claim effectively stated the natural phenomenon while adding the words “apply it” because the claim elements used well-understood, routine, and conventional techniques when detecting paternally inherited cffDNA from maternal blood.  The Federal Circuit next addressed Sequenom’s preemption argument.  The Federal Circuit observed that, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.” The Federal Circuit concluded that, “[w]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, . . . preemption concerns are fully addressed and made moot.” 

Here, the “only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.”  The Federal Circuit did “not disagree that detecting cffDNA in maternal plasma . . . is a positive and valuable contribution to science.” Nevertheless, this valuable contribution fell short of statutory patentable subject matter.