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The Federal Circuit affirmed the judgment of the district court that the claimed methods for using cell-free fetal DNA is not patent eligible as claiming a natural phenomenon.  The claimed process did not alter the natural cff-DNA and the result of the process was natural paternally inherited cff-DNA.  Further, the claims themselves do not result in an inventive concept that transforms the natural phenomenon of cff-DNA into a patentable invention.  The court rejected Sequenom’s arguments that its claims are patentable as being methods for detecting paternally inherited cff-DNA.  The methods used to detect the paternally inherited cff-DNA were “well-understood, routine, and conventional activity in 1997” making the claimed method not new or useful and making the discovery of the cff-DNA in the maternal plasma as being the only thing that is new and useful.  The court further rejected the argument that the claims were not preempting all uses of cff-DNA, because the presence of alternative uses of cff-DNA does not change the conclusion that the claims are not directed to patentable subject matter.  Judge Linn’s concurrence made clear that he is only joining the majority opinion because he is bound by the “sweeping language” of the test set out in Mayo v. Prometheus, that post-solution activity that is purely conventional or obvious is insufficient to recite an inventive concept.  Here, no one had been using these techniques on cff-DNA, and therefore they were not conventional or obvious.  

Ariosa Diagnostics, Inc. v. Sequenom, Inc., Case No. 2014-1139, 2014-1144 (June 12, 2015); Opinion by: Reyna, joined by Wallach, concurring opinion by Linn; Appealed From: District Court for the Northern District of California, Illston, J.  Read the full opinion here.

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