The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430. Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy in a fetus. This is the second such decision from the PTAB. The first decision was the subject of an appeal to the Federal Circuit. Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015). In that appeal, which we previously discussed, the court vacated the PTAB’s prior conclusion of nonobviousness because the court could not discern from the appeal record that the PTAB properly considered the prior art. In its recent decision, the PTAB has considered that prior art, but nevertheless reaches the same conclusion of nonobviousness.
The prior art that is the focus of these decisions is a brochure about a commercial genome analyzer system (Exhibit 1010), and the IPR record also includes a reply declaration discussing this evidence. The Petitioner did not petition for IPR on the basis that the claims were obvious over this brochure; rather the Petitioner relied on the brochure’s description of the prior-art system as evidence of what a person having ordinary skill in the art would have understood when the application for the ’430 patent was filed. On remand, the PTAB solicited briefs from each party about how the PTAB may have overlooked the Petitioner’s reliance on this evidence in challenging the ’430 patent claims.
In its first decision (vacated by the court), the PTAB found that neither the Petitioner nor the Declarant explained “why Exhibit 1010 could not have been presented as part of the asserted ground of unpatentability in the first instance with the Petition.” According to the PTAB, the Petition referred to the brochure (Exhibit 1010) in a general manner and in supporting testimony (in the declaration of Petitioner’s expert Dr. Nussbaum) to illustrate the state of the art when the application for the ’430 patent was filed. The Petitioner’s reply was accompanied by a second declaration of the Petitioner’s expert Dr. Morton that more directly relied on the brochure to support the Petitioner’s obviousness arguments. The PTAB exercised its discretion, however, to accord that aspect of the reply testimony little weight.
In its second decision, the PTAB determined that it did not overlook the Petitioner’s reliance on this brochure in challenging the ’430 patent claims: “The inadequacy of the obviousness analysis in the Petition and accompanying Declarations is readily apparent when the disparate elements of the references are scrutinized closely, as in Patent Owner’s response, and we decline to search through the record and piece together those teachings that might support Petitioner’s position.” Further, the PTAB considered the brochure (Exhibit 1010), but accorded it little weight because the Petitioner did not explain with articulated reasoning that brochure’s importance and how the system it describes, in combination with the applied prior art, support a legal conclusion of obviousness:
[W]e did not improperly fail to consider the Illumina Brochure (Ex. 1010) as evidence of the level of skill in the art. Instead, when the challenge over Shoemaker, Dhallan, and Binladen as presented in the Petitions is considered in view of the Illumina Brochure, the Petitions fail to demonstrate the unpatentability of the challenged claims by a preponderance of the evidence for the reasons set forth in the Final Written Decisions.
This decision serves as a reminder that the original Petition must explain with particularity why all of the evidence presented is important. The PTAB has discretion to “exclude or give no weight to the evidence where a party has failed to state its relevance or to identify specific portions of the evidence that support the challenge.” 37 C.F.R. §42.104(b)(5).