By Donald Zuhn --
Last month, in Ariosa Diagnostics v. Verinata Health, Inc., the Federal Circuit vacated the decisions of the Patent Trial and Appeal Board concluding that Appellant Ariosa Diagnostics had not met its burden of proving that claims 1–30 of U.S. Patent No. 8,318,430 would have been obvious and remanded for for further consideration. The '430 patent, which is directed to methods of noninvasive prenatal testing for the presence of fetal chromosomal abnormalities, is owned by Appellee Verinata Health, Inc.
The Federal Circuit described the claimed methods (claim 1 is some 58 lines long) as involving "obtaining blood samples from several pregnant women; isolating from the samples genomic DNA molecules not contained in cells; choosing particular DNA sequences -- some on a chromosome of concern, some not; indexing by maternal source the chromosomes or regions containing those sequences; amplifying (making many copies of) the group of chromosomes or regions; performing massively parallel sequencing on the resulting pool; using the indexing to count, for a particular maternal source, the number of sequences from chromosomes of concern versus the number from reference chromosomes or regions; and determining based on the comparison whether there are fetal chromosomal abnormalities, such as an extra copy of a chromosome of concern." The Court also characterized the '430 patent as being directed to a method for determining a presence or absence of a fetal aneuploidy in a fetus by amplifying target and reference sequences, pooling samples from several women and indexing them for later identification, and using massively parallel sequencing.
In separate inter partes review petitions, Ariosa had challenged claims 1-18 and claims 19-30 of the '430 patent for obviousness in view of three references: (1) U.S. Patent Application No. 2008/0090239 (Shoemaker et al.), which discloses a method of determining fetal aneuploidy by isolating fetal cells, not cell-free DNA; (2) U.S. Patent No. 7,332,277 (Dhallan), which discloses a method of detecting fetal genetic disorders using a maternal blood sample to obtain a mixture of cell-free fetal and maternal DNA; and (3) an article by Jonas Binladen et al., which describes a study that involved tagging and sequencing DNA samples from multiple sources simultaneously. In its petitions, Ariosa argued for obviousness based on combining Dhallan's teachings about cell-free fetal DNA with Binladen's PCR amplification techniques utilizing sample indices and massively parallel sequencing of pooled samples and Shoemaker's method of determining aneuploidy.
While the Board instituted both of Ariosa's reviews, it ultimately upheld all of the challenged claims, concluding that Ariosa did not carry its burden of showing that the claims would have been obvious because Ariosa failed to adequately 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. The Board also discussed testimony presented by one of Ariosa's experts regarding a brochure that describes indexing and massively parallel sequencing using the commercially available Illumina Genome Analyzer System (Exhibit 1010), stating that:
This testimony, in effect, replaces the tagging and sequencing techniques of Dhallan and Binladen with the Illumina indexing kit and sequencing platform, but neither Petitioner nor Dr. Morton explains why Exhibit 1010 could not have been presented as part of the asserted ground of unpatentability in the first instance with the Petition. Therefore we accord this aspect of Dr. Morton's testimony no weight.
Ariosa appealed the Board's determinations of nonobviousness to the Federal Circuit, arguing 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, during the relevant time. In an opinion authored by Circuit Judge Taranto, the panel "agree[d] with Ariosa up to a point," stating that "the Board's language leaves open the distinct possibility that the Board incorrectly limited its consideration of Exhibit 1010." In particular, the Court indicated that:
The Board's language on its face supports Ariosa's interpretation of what the Board meant -- that the Board was 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. If that is what the Board meant, the Board erred. Art can legitimately serve to document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness.
The opinion then discusses how Ariosa used Exhibit 1010, determining that Ariosa used the exhibit in the manner it had suggested (i.e., to show background knowledge possessed by the skilled artisan) and concluding that given the references to the exhibit in its petitions and supporting declarations, "Exhibit 1010 had to be considered by the Board even though it was not one of the three pieces of prior art presented as the basis for obviousness." However, because the Court could not "confidently discern whether the Board, in its consideration of Exhibit 1010, was actually relying on a legally proper ground," rather than its finding that Ariosa failed to adequately explain how the skilled artisan would combine the disparate elements of the cited references, and because the Court must not make factual and discretionary determinations that are for the Board to make, the Board vacated the Board's decisions and remanded.
Ariosa Diagnostics v. Verinata Health, Inc. (Fed. Cir. 2015)
Panel: Chief Judge Prost and Circuit Judges Wallach and Taranto
Opinion by Circuit Judge Taranto
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