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Ariosa Diagnostics, Inc. v. Sequenom, Inc. - 788 F.3d 1371 (Fed. Cir. 2015)


The Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability. For this reason, questions on preemption are inherent in and resolved by the 35 U.S.C.S. § 101 analysis. The concern is that patent law not inhibit further discovery by improperly tying up the future use of these building blocks of human ingenuity. In other words, patent claims should not prevent the use of the basic building blocks of technology—abstract ideas, naturally occurring phenomena, and natural laws. 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, preemption concerns are fully addressed and made moot.


Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA ("cffDNA") in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, Drs. Lo and Wainscoat obtained the '540 patent, which relates to this discovery. The parties agree that the patent does not claim cffDNA or paternally inherited cffDNA. Instead, the '540 patent claims certain methods of using cffDNA. Appellee Ariosa Diagnostics, Inc. makes and sells the Harmony Test, a non-invasive test used for prenatal diagnosis of certain fetal characteristics. Ariosa Diagnostics, Inc., Natera, Inc. and Diagnostics Center, Inc. each filed separate declaratory judgment actions from December 2011 through early 2012 against Sequenom alleging that they did not infringe the '540 patent. Sequenom counterclaimed alleging infringement in each case. 


Were the asserted claims of U.S. Patent No. 6,258,540 ("the '540 patent") patent-eligible?




Because patent claims were directed to the natural phenomenon of paternally inherited cell-free fetal DNA (cffDNA), and the claims merely added the steps of amplifying and detecting, which were well-understood, routine, or conventional activity when the application for the patent was filed, the patent was not directed to patentable subject matter under 35 U.S.C.S. § 101. The patentee's attempt to limit the breadth of the claims by showing alternative uses of cffDNA outside of the scope of the claims did not change the conclusion that the claims were directed to patent ineligible subject matter. Because the claims were deemed only to disclose patent ineligible subject matter, preemption concerns were moot.

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