Claims Covering Basic Detection of Naturally-Occurring Compound, However Scientifically Significant, Not Patent Eligible


Ariosa Diagnostics, Inc. v. Sequenom, Inc., ___ F.3d ___, (Fed. Cir. June 12, 2015) (REYNA, Linn (concurring), Wallach) (N.D. Cal.: Illston) (4 of 5 stars)

Federal Circuit affirms summary judgment that patent claims are invalid under § 101.

The patent claimed various genetic testing methods involving paternally inherited cell-free fetal DNA occurring naturally in the blood of pregnant women. The claims included steps for "amplifying" the amount of cffDNA in a sample, and then detecting or testing for the presence of cffDNA. Some claims included further limitations addressing the method of detection, or the uses to which the detection results might be applied.

The claims are invalid as directed to natural phenomena. Under the first step of Mayo, 132 S. Ct. 1289 (2012), the claimed methods are directed to a patent-ineligible concept because each method both "begins and ends with a natural phenomenon," i.e., they are directed to the detection of naturally-occurring cffDNA. Slip op. at 9. Under the second step of Mayo's framework, the claims contain no inventive concept sufficient to transform the naturally occurring phenomenon into a patent-eligible application. They "amount[] to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional, and routine, the method of detecting paternally inherited cffDNA is not new and useful." Id. at 11.

It was irrelevant that the claimed methods did not preempt all uses of cell-free fetal DNA. "While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. . . . Where a patent's claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot." Id. at 14—15.

Moreover, it did not matter that the inventors were the first to detect cffDNA in such samples, and that prior art taught just throwing the cffDNA-containing blood away. First, to the extent the inventors discovered the presence of cffDNA in blood plasma or serum, that was not what was claimed. Second, the significance of an inventor's scientific contribution does not, without more, make claims patentable.

Concurrence: In Judge Linn's view, this result was compelled by unnecessarily broad language in Mayo dismissing all "post-solution steps" as irrelevant to patentability. Unlike this case, in which no one had tested paternally inherited cell-free fetal DNA before the inventors, in Mayo, doctors had already been testing the metabolites at issue there for years. Nevertheless, the Mayo language controlled here, which had the consequence of "excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain." Concur. at 2.