FETAL DiAGNOSTIC TEST method patent ineligible

On June 12, 2015, the Federal Circuit affirmed the N.D. Cal. district court's grant of summary judgment of invalidity of asserted claims of a patent directed to fetal diagnostic test method under 35 USC 101.  Sequenom's MaterniT21 test is a prenatal diagnostic test that detects cell-free fetal DNA ("cffDNA") in maternal plasma or serum to determine fetal characteristics.  U.S. Patent No. 6,258,540 claims certain methods of using cffDNA.  The asserted claim 1 of the patent includes the steps of amplifying the cffDNA contained in a sample of plasma or serum from a pregnant female and detecting the paternally inherited cffDNA.  Defendants Ariosa Diagnostics and Natera make and sell non-invasive test used for prenatal diagnosis of certain fetal characteristics.  In response to Sequenom's cease-and-desist letters, defendants filed a DJ action. In granting Ariosa's motion for summary judgment, the district court held that the asserted claims were directed to natural phenomenon of paternally inherited cffDNA; the claims didn't add enough to make them patent eligible; the steps of amplifying and detecting were well-understood, routine or conventional activity and thus, were not directed to patentable subject matter.  On appeal, the Federal Circuit applied the Supreme Court's Mayo framework and, in light of the patent specification confirming the preparation and amplification of DNA sequences in plasma as well-understood and routine, concluded that appending routine, conventional steps to a natural phenomenon does not provide the inventive concept necessary for patent eligibility.  Full text of the opinion is available here.