Ariosa Diagnostics v. Verinata Health, Inc.

Docket Nos. 2015-1215, 2015-1226

November 16, 2015

Brief Summary:  Board decision that Ariosa did not met its burden to show obviousness during IPR found erroneous FC panel “cannot confidently discern whether the Board…was actually relying on a proper legal ground”.  The opinion also explains that “[a] petitioner in an inter partes review has the burden of proving a claim’s invalidity by a preponderance of the evidence. 35 U.S.C. § 316(e).”

Summary:   This opinion relates to IPR2013-00276 and IPR2013-00277 regarding Verinata’s US 8,318,430 directed to noninvasive prenatal testing for the presence of fetal chromosomal abnormalities.  The PTO concluded Ariosa has not met its burden of showing the contested claims would have been obvious, and Ariosa appeals here.  Ariosa argued the claims would have been obvious in view of three prior art references showing cell-free fetal DNA testing, indexing and sequencing techniques, and methods for determining aneuploidy.  The Board granted the IPR reviews but then concluded Ariosa’s burden was not met, its “central point” being that “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” (“What is lacking in the Petition and accompanying Declarations is an ‘articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.” Citing [In re] Kahn, FC 2006)  The Board also refused to consider one of Arisosa’s expert declarations (by Dr. Morton, Exhibit 1010) because it did not explain why it “could not have been presented as part of the asserted ground on unpatentablity in the first instance with the Petition” (as discussed below, it was presented as background art) (37 CFR 42.23(b):  “[a] reply may only respond to arguments raised in the corresponding…patent owner response”…and the related explanation that ‘[r]eply evidence…must be responsive and not merely new evidence that could have been presented earlier to support the movant’s motion”)    The “principal challenge” here relates to the exclusion of Exhibit 1010 and the FC panel agreed with Ariosa that the Board erred in “declining to consider Exhibit 1010, even as evidence of the background understanding of skilled artisans as of January 2010, 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.”  The FC panel concluded that it “cannot confidently discern whether the Board…was actually relying on a proper legal ground rather than [this] erroneous ground” (“the Board did not sufficiently articulate the foregoing grounds for its rejection of Ariosa’s reliance on Exhibit 1010 or other grounds independent of the incorrect grounds suggested by the Board’s language…We likewise are not prepared to find that the error we cannot rule out was non-prejudicial.”)  The Board decision was remanded for this reason.  But Ariosa also argued the Board erred in its rejection of “Ariosa’s reliance…on previously unidentified portions of a prior-art reference”; the FC panel found no error with this rejection (“[t]he Board may exclude or give no weight to the evidence where a party has failed to state its relevance or identify specific portions of the evidence that support the challenge’ in the Petition” (37 CFR 42.104(b)(5)).

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