Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board (PTAB) concluded that Petitioner Ariosa Diagnostics (Ariosa) failed to demonstrate the unpatentability of challenged claims 1-30. Ariosa Diagnostics, Inc. v. Verinata Health, Inc., IPR2013-0027/-00277 (PTAB Aug. 15, 2016).

U.S. Patent No. 8,318,430

The decision is the latest in a long-running challenge by Petitioner Ariosa seeking two inter partes review of the claims of U.S. Patent No. 8,318,430 (the ‘430 Patent). Ariosa initially sought review of the ‘430 Patent on the basis of three prior art documents: Shoemaker,[1] Dhallan,[2] and Binladen.[3] After trial and oral argument on the original petitions, the PTAB issued a Final Written Decision concluding that Petitioner Ariosa had failed to demonstrate by a preponderance of the evidence that all claims of the ‘430 Patent were unpatentable over the combined teachings of Shoemaker, Dhallan, and Binladen. Ariosa appealed to the Federal Circuit.[4] In Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015), the Federal Circuit noted in its review that the PTAB might have erred by failing to consider an additional piece of prior art, namely an Illumina Brochure for the Illumina Genome Analyzer, “‘simply because the brochure had not been identified at the petition stage as one of the pieces of prior art defining a combination for obviousness.'” Decision, page 4, quoting Ariosa at page 1365. The Federal Circuit vacated the PTABs finding of non-obviousness and remanded the case to allow the parties to brief how the PTAB may have overlooked the relevance of the Illumina Brochure.

Patentability of the Claims

On remand the PTAB again determined that Petitioner failed to establish the unpatentability of the ‘430 Patent claims from the combined teachings of the cited references, including the teachings of the Illumina Brochure. Importantly the PTAB stated that:

Petitioner, however, provided no further explanation of the combination in the Petition, such as a reason with rational underpinning as to why the ordinary artisan would have combined the references to arrive at the method of the challenged claims, but only presented a claim chart demonstrating where the limitations of each challenged claim could be found in the prior art.

Decision, page 16.

The decision serves as a cautionary tale to patent challengers to not only map the elements of the claims to the prior art but also to clearly articulate the rationale why the art would be combined by one of skill in the art to arrive at the claimed invention.