On Friday, June 12, 2015, the Federal Circuit ruled another molecular diagnostic invention patent-ineligible under 35 U.S.C. §101 in Ariosa Diagnostics, Inc v. Sequenom, Inc (Fed. Cir. 2015). The patent at issue (U.S. Patent No. 6,258,540) claims the use of cell-free fetal DNA (cffDNA) from maternal blood samples for predicting the gender of the baby and for diagnosing certain genetic defects. The surprising discovery claimed in this patent allows pregnant women to avoid invasive forms of paternity tests that require taking samples from the fetus or placenta. The Court applied the two-part patent-eligibility test established by the Supreme Court (citing Mayo Collaborative Services v. Promethius Laboratories, Inc) and concluded that the Ariosa method fails to disclose patent eligible subject matter.
Read more about the opinion: IHPC’s Summary of the Opinion