Pre-Natal Diagnostic Method Not Patent-Eligible

A district court has granted summary judgment in favor of an accused patent infringer, and has held not patent-eligible under 35 U.S.C. § 101 patent claims “relate[d] to prenatal detection methods performed on a maternal serum or plasma sample from a pregnant female, which methods comprise detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.” Ariosa Diagnostics v. Sequenom, Inc., No. C 11-06391 SI (N.D. Cal. Oct. 30, 2013).

In reaching its conclusion, the court cited both old and new Section 101 precedent, including the recent cases of Bilski v. Kappos, 130 S. Ct. 3218 (2010), Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1342 (Fed. Cir. 2013), and Accenture Global Servs. v. Guidewire Software, Inc., 2013 U.S. App. LEXIS 18446, (Fed. Cir. Sept. 5, 2013).

The court’s reached its conclusion because,

based on the undisputed facts before the Court, the only inventive part of the patent is that the conventional techniques of DNA detection known at the time of the invention are applied to paternally inherited cffDNA as opposed to other types of DNA. Thus, the only inventive concept contained in the patent is the discovery of cffDNA, which is not patentable.

The court thought that this conclusion “conforms with the relevant Supreme Court case law, in particular Flook and Myriad.”  The cases state that an “abstract idea,” or a concept that would preempt all applications of a law of nature, cannot be patented.  Just as the Pythagorean Theorem would not have been patentable, “paternally inherited cffDNA is not patentable simply because the claims contain steps indicating that it may be detected using existing DNA detection methods.”

It appeared “that the effect of issuing the ‘540 patent was to wholly preempt all known methods of detecting cffDNA at that time.” The court therefore concluded “that the claims at issue pose a substantial risk of preempting the natural phenomenon of paternally inherited cffDNA and that the preemption inquiry supports the Court’s conclusion that the claims are not drawn to patent eligible subject matter.”