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Regents of the University of California v. Broad Institute, Inc.

Doubt in Field, Skeptical Articles May Support Interference Determination of No Reasonable Expectation of Success

Regents of the University of California v. Broad Institute, Inc., __ F.3d __, 2018 WL 4288968 (Fed. Cir. Sept. 10, 2018) (Prost, Schall, MOORE) (PTAB) (3 of 5 stars)

Fed Cir affirms PTAB determination of no interference-in-fact between patent application from Cal and various patents and applications from Broad, MIT, and Harvard. The involved claims relate to “CRISPR” technology used for targeted cutting of DNA molecules. Substantial evidence supported the Board’s determination that there was a patentable distinction between Broad’s claims and Cal’s claims insofar as Broad’s claims would have been nonobvious over Cal’s (had Cal’s been prior art), as per 37 C.F.R. § 41.203(a). Specifically, there was sufficient evidence in the record—e.g., testimony from Broad’s expert, contemporaneous publications, expressions of doubt within the field—to support the Board’s determination that a person of ordinary skill in the art would not have had a reasonable expectation of success in applying Cal’s CRISPR technique in a eukaryotic cell. The opinion notes Cal’s argument that there was sufficient evidence in the record to support the opposite conclusion, but holds, “We are, however, an appellate body. We do not reweigh the evidence.” Op. at 12.

The opinion rejects Cal’s argument that the Board applied an improperly narrow test in analyzing the expectation of success. “At no point did the Board suggest it found there would not have been a reasonable expectation of success solely because there were not specific instructions in the art describing how to apply CRISPR-Cas9 in eukaryotes.” Op. at 13. It also rejects Cal’s argument that the Board treated evidence of simultaneous invention as irrelevant. The Board considered whether the fact that several research teams were exploring application of CRISPR-Cas9 in eukaryotes was evidence of a reasonable expectation of success. The Board rejected that conclusion, and such rejection was supported by substantial evidence. The opinion concludes by emphasizing that its holding addresses only the scope of the applied-for claim sets. “It is not a ruling on the validity of either set of claims.” Op. at 16.

KEYWORDS: INTERFERENCE; REASONABLE EXPECTATION OF SUCCESS (NO); OBVIOUSNESS (NO)