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Interference-in-Fact Decision Highlights Importance of Reasonable Expectation of Success to Find Obviousness

While the recent holding in Univ. of California v. Broad Institute, Inc.1, will certainly have long-reaching and important implications in the fight for control over CRISPR-based technology, the Federal Circuit’s opinion also provides additional confirmation that an obviousness determination must demonstrate a “reasonable expectation of success” when combining references from the prior art.

The case arises from an interference proceeding in which the United States Patent and Trademark Office, Trial and Appeal Board (“the Board”) determined that there was not an interference-in-fact between the involved claims of a University of California patent application and those of twelve patents and one application owned by Broad Institute, Inc. (“Broad”). The patents and applications all relate to the powerful gene editing technology commonly known as the CRISPR-Cas9 system. Specifically, the Board determined that as the claims of the University of California application did not anticipate or render obvious the involved claims of Broad’s patents and applications, there was not interference-in-fact.2

In it’s review of the Board’s factual findings for substantial evidence, the Federal Circuit noted that “when an interference-in-fact turns on whether one set of claims renders obvious the subject matter of another set of claims, the standard of review mirrors that in an obviousness review.”3 In order to determine if the claims would have been obvious, factual findings must demonstrate that “a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so.”4

The Federal Circuit discussed at length the Board’s findings that Broad supplied significant evidence that success in utilizing prokaryotic protein systems did not necessarily translate to success of those same systems in eukaryotic cells. 5 Based on this determination, the Federal Circuit confirmed the Board’s determination that there was no interference-in-fact between the involved applications and patents, as the involved University of California claims did not render obvious Broad’s involved claims.

The Federal Circuit was also not persuaded by University of California’s contention that evidence demonstrating simultaneous invention was sufficient to support a finding that Broad’s involved claims would have been obvious. Specifically, the court noted that evidence of simultaneous invention can support a showing of obviousness, but it cannot show obviousness alone.6 Importantly, the court noted that University of California may indeed have demonstrated “that six research groups succeeded in applying [CRISPR-Cas9] technology in eukaryotic cells within a short period of time” and that this is “certainly strong evidence that there was a motivation to combine the prior art in this manner.”7 However, the court was not persuaded that such evidence of a motivation to combine “’necessarily’ indicate[d] an expectation of success prior to completion of the experiments.”

The implications for this decision in the battle related to CRISPR-Cas9 technology are certainly far reaching. However, in the context of day-to-day patent prosecution, the Federal Circuit’s ruling also provides additional confirmation that obviousness requires more than just a mere showing of the combinability of pieces or prior art. An Examiner must demonstrate that there would have been a reasonable expectation that the combination would have been expected to work together and provide the required outcome. Simply showing that there was sufficient, and even significant motivation to “apply” a technology to a new area does not necessarily equate to the required expectation to succeed in that application.7

1 Case 2017-1907, (Fed. Cir. September 10, 2018).
2 Id. at page 2, first paragraph.
3 Id. at page 6, first full paragraph
4 Id. at paragraph bridging pages 6-7, citing In re Stepan Co., 868 F.3d 1342, 1345-1346 (Fed. Cir. 2017) (emphasis added).
5 Id. at pages 9-11, at page 11: “This substantial evidence supports the Board’s finding that the success in applying similar prokaryotic systems in eukaryotes was unpredictable and had relied on tailoring particular conditions to the technology.”
6 Id. at page 14, last paragraph
7Id. at page 15, first full paragraph
8See Id., at page 15, first full paragraph.

See the Opinion here.