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- Appeal seeks reversal of Patent Trial and Appeal Board decision terminating interference without determining priority of inventorship of CRISPR/Cas9 gene editing
- Brief asserts that the Board failed to properly apply controlling
U.S. Supreme Courtand Federal Circuit precedents, and ignored evidence of multiple groups readily applying CRISPR/Cas9 gene editing to eukaryotic cells following teachings of Charpentier-Doudna team
In its brief to the Federal Circuit (Case No. 17-1907), UC asserts that the PTAB’s
In its brief, UC sets forth multiple errors in the PTAB’s holding that the use of CRISPR/Cas9 in eukaryotes is separately patentable as alleged by Broad, including the following:
- With respect to the obviousness of applying the technology to eukaryotic cells,
U.S. Supreme Courtand Federal Circuit precedents clearly mandate that obviousness determinations be based on an “expansive and flexible approach” including consideration of “the inferences and creative steps that a person of ordinary skill in the art would employ.” In contrast, the PTAB applied a narrow and restrictive approach that ignored certain key evidence, including the steps actually employed by those of skill in the art at the time, and also effectively required a “guarantee” that UC’s CRISPR/Cas9 invention would work in eukaryotic cells, when well-established case law requires only a “reasonable expectation of success.”
- With respect to the reasonable expectation of success standard that establishes obviousness, the PTAB effectively ignored
U.S. Supreme Courtand Federal Circuit case law, which emphasize that an invention can be obvious if it is “obvious to try,” even if success is not guaranteed, “[w]hen there is a design need or market pressure to solve a problem,” “there are a finite number of identified, predictable solutions,” and experimentation leads to “the anticipated success.”
- The PTAB ignored
U.S. Supreme Courtand Federal Circuit precedent highlighting that the occurrence of what appear to be simultaneous “inventions” arising close together in time is itself strong evidence of their obviousness, and accordingly requiring that such evidence be considered in any obviousness analysis. In contrast, in terminating the interference, the PTAB essentially dismissed as “irrelevant” the evidence that six different laboratories successfully applied UC’s claimed CRISPR/Cas9 invention in eukaryotic cells using conventional techniques within months after UC publicly disclosed the invention - some of them prior to Broad’s first filing.
- The PTAB effectively ignored that Broad’s own eukaryotic application of UC’s CRISPR/Cas9 invention had simply utilized conventional prior art techniques. As a consequence, it failed to consider that Broad’s alleged invention did not reflect any significant innovation on Broad’s part, an important issue under applicable precedent.
- The PTAB failed to hold Broad to its burden of proving, among other things, the effective priority date for its patent claims, as required by the PTAB’s own rules and Federal Circuit precedent. By not requiring the Broad to meet its burden of proof, and by merely assuming that all of the Broad’s claims were entitled to their earliest possible filing date despite Broad’s failure of proof, the PTAB improperly ignored relevant intervening art that made the Broad’s claims obvious.
As explained in UC’s brief, application of the correct legal standards to the case is believed to require reversal of the PTAB’s decision. For these reasons, UC requests that the Federal Circuit instruct the PTAB to reinstate the interference proceeding so that it can properly determine priority of inventorship, as previously requested by UC. The PTAB’s failures to consider pertinent evidence and apply appropriate legal standards should at the very least require the matter to be remanded so that the PTAB can properly consider the evidence related to obviousness and Broad’s no-interference-in-fact motion using appropriate legal standards.
In the PTAB’s February decision terminating the interference proceeding prematurely, it had not yet considered the teachings of UC’s own prior-filed patent application with respect to using CRISPR/Cas9 in eukaryotic cells. Instead, the PTAB only addressed the threshold question of whether use in eukaryotic cells can be separately patentable from use in all settings as covered by UC’s claims. However, determinations on the underlying substantive matters have recently been made in parallel prosecution before the U.S. Patent & Trademark Office (“USPTO”). The USPTO has rejected a series of patent applications filed by Broad that are directed to uses of CRISPR/Cas9 technology in eukaryotic cells as being non-novel in view of UC’s prior-filed patent application, which the USPTO examiners considered to have effectively taught use of the CRISPR/Cas9 technology in eukaryotic cells. In addition, patent applications filed by Sigma-Aldrich and
Consistent with the substantive determinations reached by the USPTO regarding the broad teachings of the UC patent application, UC’s corresponding cases covering use of CRISPR/Cas9 in all settings, including in eukaryotic cells, have been advanced to grant or decisions to grant in numerous jurisdictions worldwide, including in the
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