On September 2, 2014, the Patent Trial and Appeal Board (PTAB) issued a decision written by Administrative Patent Judge Green that a subset of patent claims challenged during an inter partes review (IPR) proceeding were invalid as anticipated by a prior art reference and unpatentable for claiming ineligible subject matter. Further, the PTAB denied the patent owner’s motion to amend claims because the amended claims were deemed invalid by the district court and the patent owner failed to explain how the proposed amendment addressed the district court’s validity concerns. In September 2012, Ariosa Diagnostics (Ariosa) filed an IPR petition challenging the claims of Isis Innovation Limited’s (Isis) U.S. Patent No. 6,258,540 (“the ’540 Patent”), which is directed to prenatal detection methods using non-invasive techniques. The PTAB instituted the petition for all challenged claims in March 2013.  Subsequently, Ariosa filed a second IPR petition directed to additional claims of the ’540 patent, which were joined with the instant proceeding. Prior to the issuance of this decision and Isis’s motion to amend the claims, a co-pending Northern District of California District Court proceeding (Ariosa Diagnostics Inc. v. Sequenom, Inc. Civ. No. 12-00132), the Court granted summary judgment to Ariosa on the basis that certain claims of the ’540 patent were directed to ineligible subject matter under 35 U.S.C. § 101. 

A hearing was held before three Administrative Patent Judges addressing the arguments and motions raised by both parties. The PTAB found that Ariosa had standing despite filing a civil action challenging the validity of the ’540 patent and that IPR was not barred under 35 U.S.C. § 315(b) based on Ariosa acceptance of a complaint that was later dismissed without prejudice. After construing the disputed claims of the patent, the PTAB found that Ariosa demonstrated by a preponderance of the evidence that the prior art inherently anticipates the claims 1, 4, 5, 8, 24 and 25 of the ’540 patent. However, the PTAB determined that Ariosa failed to demonstrated by a preponderance of the evidences that claims 3, 12, 13, 15 and 18 are obvious in light of the prior art. Finally, the PTAB denied Isis’s motion to amend claims 1, 24 and 25 of the ’540 patent because, despite the receiving the District Court ruling that these claims were invalid under 35 U.S.C. § 101 prior to file its Motion to Amend, Isis did not address whether its claims met the requirements for patent eligible subject matter and thus did not establish it was entitled to relief.  Therefore, the Court found that claims 1, 2, 4, 5, 8, 19, 20, 24 and 25 of the ’540 patent were demonstrated to unpatentable by the preponderance of the evidence, whereas claims 3, 12, 13, 15, 18, 21 and 22 were not shown to be unpatentable.

Ariosa Diagnostics v. Isis Innovation Ltd., IPR2012-00022, Paper No. 166 (PTAB, Sep. 2, 2014).