In a decision on remand issued on August 15, 2016, a PTAB panel again found patentable claims 1-30 of Verinata Health’s U.S. Patent No. 8,318,430, directed to methods for determining the presence or absence of fetal aneuploidy in a fetus. This time, the PTAB specifically addressed the applicability of an exhibit to the state of the art, responding to the Federal Circuit’s concerns about whether it was considered for that purpose.

In October 2014, the PTAB issued a pair of final written decisions confirming the patentability of all claims of the ‘430 patent. On appeal, the Federal Circuit remanded, finding that the PTAB may have erred in its treatment of the exhibit (the Illumina Brochure). The Illumina Brochure was not included in the proposed grounds of unpatentability, nor was it specifically discussed as part of the Petition. Instead, it was submitted with Petitioner Ariosa’s expert declarations as evidence of the state of the art at the time of the alleged invention. For example, Ariosa’s expert stated that:

“It is my opinion that one of ordinary skill in January 2010 would not only be aware of the use of next generation, massively parallel sequencing [e.g., Ex. 1033; Ex. 1036; Ex. 1011; Ex. 1045], but would have been aware of the commercially-available indexing kit available through Illumina, Inc. in 2008 [Ex. 1010] that allowed for sequencing of 96 different samples on a single flow cell.” (Emphasis added.)

In its 2014 decisions, the PTAB rejected Ariosa’s obviousness arguments and questioned why the Illumina Brochure “could not have been presented as part of the asserted ground of unpatentability in the first instance with the Petition.” This language caused the Federal Circuit to remand the case to the PTAB to clarify whether the it meant (1) that the “development of the argument invoking [the Illumina Brochure] was not adequate (legally proper) or (2) that the Illumina Brochure could not be considered as “evidence of the background understanding of skilled artisans … because the brochure had not been identified at the petition stage as one of the pieces of prior
art defining a combination for obviousness” (legally improper). See Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015).

After permitting supplemental briefing by both parties on the question of “how [the PTAB] may have overlooked how Petitioner relied upon [the Illumina Brochure] in the record that went up to the [Federal Circuit],” the PTAB issued another decision confirming the patentability of all claims and clarified its reasons for not finding the challenged grounds of unpatentability persuasive, even in view of the Illumina Brochure.

The Illumina Brochure is marked “FOR RESEARCH USE ONLY,” which may explain why it was not used in an asserted ground of unpatentability. If it is not a “printed publication,” it cannot form the basis of a ground of unpatentability in an IPR proceeding. However, the Federal Circuit’s Ariosa opinion confirms that such background information can be useful to establish the state of the art or to show the level of skill in the art. See also Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013) (“Reversing finding of non-obviousness where court “narrowly focus[ed] on the four prior-art references” and ignored record evidence of “the knowledge and perspective of one of ordinary skill in the art” to explain motivation to combine or modify references”). Given the PTAB’s hesitancy to consider references not asserted as a ground of rejection, when relying on references for background purposes (e.g., state of the art, level of ordinary skill) careful explanation is necessary to establish exactly how the prior art fits into the story of unpatentability.