During the week ending May 31, 2019, the Board issued four decisions in Technology Center 1600: three decisions instituting inter partes review (IPR) and one decision denying IPR, all styled Foundation Medicine, Inc. v. Caris MPI, Inc. The decisions are summarized as follows:

IPR2019-00164 (Decision—Institution of Inter Partes Review May 30, 2019); IPR2019-00165 (Decision Denying Institution of Inter Partes Review May 30, 2019); IPR2019-00170 (Decision—Institution of Inter Partes Review May 30, 2019); IPR2019-00171 (Decision—Institution of Inter Partes Review May 30, 2019). Petitioner Foundation Medicine, Inc. challenged the patentability of claims 1-14 of U.S. Patent No. 8,880,350 (“the ’350 patent”), claims 1-14 of U.S. Patent No. 9,092,392 (“the ’392 patent”), claims 1-14 of U.S. Patent No. 9,372,193 (“the ’193 patent”), and claims 1-14 of U.S. Patent 9,383,365 (“the ’365 patent”) as being obvious under 35 U.S.C. § 103(a). IPR2019-00164 at 2; IPR2019-00165 at 2; IPR2019-00170 at 2; IPR2019-00171 at 2, respectively. For the ’350, ’193, and ’365 patents, Petitioner asserted three grounds of unpatentability: claims 1-14 would have been obvious over Lu and Illumina; claims 2 and 3 would have been obvious over Lu, Illumina, and Muraca; and claims 7, 11, and 12 would have been obvious over Lu, Illumina, and McDoniels-Silvers. IPR2019-00164 at 8; IPR2019-00170 at 8; IPR2019-00171 at 8, respectively. Petitioner also asserted claims 1-14 of the ’392 patent would have been obvious over Von Hoff, Sjöblom, and Bardelli. IPR2019-00165 at 8.

The ’350, ’392, ’193, and ’365 patents relate to “a ‘system and method for determining individualized medical intervention for a particular disease state,’ such as cancer, that ‘includes the molecular profiling of a biological sample from the patient.’” See IPR2019-00164 at 3; IPR2019-00165 at 3; IPR2019-00170 at 3; IPR2019-00171 at 3, respectively. The claims of the ’350, ’193, and ’365 patents are directed to “cancer” generally (i.e., “[a] system for generating a report identifying at least one therapeutic agent with cancer”), while the ’392 patent’s claims are specific to “colorectal cancer” (i.e., “[a] system for generating a report identifying at least one therapeutic agent with colorectal cancer.”). See IPR2019-00164 at 6; IPR2019-00165 at 6; IPR2019-00170 at 3; IPR2019-00171 at 3, respectively. The patents differ with respect to the claimed group of molecular targets to be assayed. Id.

’350, ’193, and ’365 patents

Prior to evaluating unpatentability, the Board assessed Patent Owner’s argument that Petitioner failed to establish that Illumina, a technical bulletin prepared by Illumina, Inc., qualified as a prior art publication. See IPR2019-00164 at 15.[1] The Board found Petitioner made the “threshold showing,” required at the institution stage, that the Illumina reference was publicly accessible prior to the effective filing dates of the challenged patents. Id. at 15-16. First, Illumina “bears indicia that it was likely published” because it has a publication date and publication number. Id. at 16. Second, Illumina is the type of document intended for public distribution because it is “a ‘technical bulletin,’ akin to a product catalog” and bears no draft or confidentiality designations. Id. Third, the Board considered additional briefing it allowed for the parties to address a declaration from the Internet Archive’s Office Manager attesting that Illumina was archived by the Wayback Machine prior to the effective filing date of the patents, confirming it was publicly available. Id. at 16-17. Fourth, the Board rejected Patent Owner’s argument that Petitioner made no showing that skilled artisans could have found Illumina on the internet without knowing the exact URL where it was published. Relying on Jazz Pharm., Inc. v. Amneal Pharm., LLC, the Board stated, “the Federal Circuit made clear that ‘neither indexing nor searchability’ was required to determine that an online document was publicly accessible.” Id. at 18 (quoting 895 F.3d 1347, 1356 (Fed. Cir. 2018) (citations omitted)). The Board found skilled artisans would have understood that Illumina, Inc. provides research tools for gene expression assays, which would provide them a reason to review Illumina Inc.’s website where Illumina was available. Id. Finally, the Board explained it would rule in the final written decision on Patent Owner’s remaining arguments regarding whether Petitioner met its ultimate burden of establishing public accessibility. Id.

Regarding patentability of the ’350, ’193, and ’365 patents, the Board determined Petitioner established a reasonable likelihood that it would prevail in showing the claims were unpatentable as obvious over Lu and Illumina; Lu, Illumina, and Muraca; and Lu, Illumina, and McDoniels-Silvers, and instituted IPR of all challenged claims on all three grounds. Id. at 29-31.

’392 patent

Petitioner asserted a different set of references, Von Hoff, Sjöblom, and Bardelli, in its obviousness challenge against the claims of the ’392 patent directed to colorectal cancer. IPR2019-00165 at 8. The Board denied institution, finding that “Petitioner has not shown sufficiently for institution that an ordinarily skilled artisan would have had a reason to combine the prior art to obtain the claimed system wherein the molecular targets comprise BRAF, PIK3CA, EGFR, and PTEN.” Id. at 17. The Board emphasized that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Id. (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (emphasis in original)).

The Board primarily took issue with Petitioner’s reliance on Sjöblom for its disclosure of “sequencing the genes BRAF, PIK3CD, EGFR, and PTEN.” Id. at 15. Sjöblom evaluated the sequences of ~13,000 genes, including BRAF, PIK3CD, EGFR, and PTEN, for purposes of analyzing alterations in breast and colorectal cancer; however, only 189 of the genes were found to be “candidate cancer genes” (“CAN genes”), 122 in breast cancers and 69 in colorectal cancers. Id. at 13. The Board found that “Petitioner has not explained adequately for institution why an ordinarily skilled artisan would have had a reason to sequence all 13,000+ genes disclosed in Sjöblom to identify a therapeutic agent for an individual with colorectal cancer.” Id. at 17. The Board noted that “Petitioner does not discuss or mention the CAN genes in its analysis, presumably because none of the CAN genes that Sjöblom identifies for colorectal cancer include the molecular targets recited in claim 1: BRAF, PIK3CA, EGFR, and PTEN.” Id. at 18. The Board stated “[g]iven Sjöblom’s express teaching that only some of the CAN genes may be good targets for therapeutic development, it is not clear on this record why an ordinarily skilled artisan would have taken the path Petitioner alleges, i.e., performing large-scale sequencing of 13,023 genes for an individual.” Id. at 19 (emphasis in original). The Board also found that Petitioner’s expert’s testimony regarding Sjöblom was “conclusory” and that he “ignore[d] the teachings of Sjöblom.” Id. at 19-20. The Board denied institution concluding, “[a]lthough we understand that an ordinarily skilled artisan is a person of ordinary creativity, not an automaton, ‘[w]ithout any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against.’” Id. at 20-21 (quoting Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017)).

[1] Citations are to IPR2019-00164 because the institution decisions for IPR2019-00164, IPR2019-00170, and IPR2019-00171 are substantially the same.