Federal Circuit Invalidates Diagnostic Method Claims For Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California ("District Court") that the method claims in U.S. Patent 6,258,540 ('540 patent) for detecting paternally-inherited cell-free DNA ("cffDNA") in maternal plasma or serum were not directed to patent eligible subject matter, and, therefore, were invalid.  See Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139, 2014-1144, slip op. at 2, 16 (Fed. Cir., June 12, 2015).

The Federal Circuit applied the two-part test as set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), and held that the method claims in the '540 patent "begins and ends with a natural phenomenon," and that the additional elements in the method steps "individually and 'as an ordered combination'" were not enough "to supply an inventive concept."  Sequenom, slip op. at 9, 11.  The Federal Circuit also relied on Parker v. Flook, 437 U.S. 584