IP Law Daily, PATENT—Fed. Cir.: PTAB erred in treatment of evidence of the knowledge of skilled artisans in nonobviousness determination, (Nov 16, 2015)

By Jody Coultas, J.D.

The U.S. Patent and Trademark Office Patent Trail and Appeal Board erred in finding that Verinata Health, Inc.’s prenatal testing patent was nonobvious, according to the U.S. Court of Appeals for the Federal Circuit (Ariosa Diagnostics v. Verinata Health, Inc., November 16, 2015, Taranto, R.). Because the Board erred in its treatment of evidence submitted by Ariosa Diagnostics, the court remanded the case for further proceedings under the correct legal standard.

Verinata Health owns U.S. Patent No. 8,318,430 (the ‘430 patent), which describes and claims methods of noninvasive prenatal testing for the presence of fetal chromosomal abnormalities. Ariosa filed two petitions with the Patent Trial and Appeal Board for inter partes review of the ‘430 patent claims for obviousness in light of three prior art references.

Ariosa argued that combinations of U.S. Patent No. 7,332,277 (Dhallan) teachings about cell-free fetal DNA with indexing and sequencing techniques found in an article written by Jonas Binladen and a U.S. Patent Application No. 2008/0090239 (Shoemaker) method of determining aneuploidy. Specifically, Ariosa argued that “a scientist in this field would have known that Dhallan could be enhanced through use of the PCR amplification techniques utilizing sample indices and massively parallel sequencing of pooled samples as discussed in Binladen.”

The Board concluded that Ariosa had not met its burden of proving that the claims would have been obvious. According to the Board, “virtually no effort [wa]s made to explain how or where the references differ from the challenged claims, how one of ordinary skill in the art would go about combining their disparate elements, or what modifications one of ordinary skill in the art would necessarily have made in order to combine the disparate elements.”

Ariosa’s appeal focused on the Board’s treatment of Exhibit 1010, a brochure describing indexing and massively parallel sequencing using the commercially available Illumina Genome Analyzer System. Specifically, argued that the Board erred in refusing to consider Exhibit 1010 for what it showed about the background knowledge that a skilled artisan would have possessed, particularly about DNA indexing, at the time of the ‘430 patent priority date.

The court vacated the Board’s decisions for failure to consider certain evidence. Art may serve to document the knowledge that skilled artisans would understand in reading the prior art identified as producing obviousness. If the Board declined to consider Exhibit 1010, even as evidence of the background understanding of skilled artisans as of the patent priority date, 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, it was error. Given references to Exhibit 1010 by Ariosa’s experts, Exhibit 1010 had to be considered even though it was not one of the three pieces of prior art presented as the basis for obviousness. The court was unable to discern whether the Board, in its consideration of Exhibit 1010, relied on legally proper ground rather than the erroneous ground. Also, the court declined to make a determination about whether Exhibit 1010, if considered for what the petitions adequately presented about it, could have filled the explanatory gap that was the heart of the Board’s reason for finding Ariosa’s case unproved.

The Board on remand must determine which remand proceedings were appropriate given the governing policies, according to the court. However, the court did not direct the Board to take new evidence or accept new briefing.

Rejecting Ariosa’s reliance on previously unidentified portions of a prior-art reference to make a meaningfully distinct contention was not error, according to the court. The Board determined that teachings of Binladen and Dhallan could not be combined because “Binladen’s indexing (i.e., tagging) scheme could not be used with Dhallan’s restriction-digestible amplification primers.”

The cases are Nos. 2015-1215 and 2015-1226.

Attorneys: Mark A. Lemley (Durie Tangri LLP) for Ariosa Diagnostics. Edward R. Reines (Weil, Gotshal & Manges LLP) for Verinata Health, Inc.

Companies: Ariosa Diagnostics; Verinata Health, Inc.

Cases: Patent FedCirNews