This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition.  This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite its failure to present expert declaration until its Reply brief).  However, a petitioner should strongly consider submitting an expert declaration to support their arguments in technology areas that are considered complex. 

On April 6, 2016, the PTAB denied Benitec Biopharma Ltd.’s (Benitec) petition for IPR (IPR2016-000017) against a patent owned by Cold Spring Harbor Laboratory (CSHL). Benitec’s petition sought cancellation of claims 1-10 of U.S. Patent No. 8,829,264, asserting that the claims lacked novelty and/or were obvious in view of numerous references.  The ‘264 patent claims are generally directed to RNA interference (RNAi), and more specifically to transgenic mice that express a transgene encoding a short hairpin RNA (shRNA) molecule that is capable of attenuating expression of a target gene.

This denial serves as a warning to petitioners in complex fields such as biotechnology where the Board often relies on reasoned explanations from experts.

Benetic did not present an expert declaration supporting its arguments that one of ordinary skill in the art would understand a prior art reference to expressly or inherently disclose each limitation of the challenged claims.  The Board emphasized this lack of testimonial evidence in rejecting petitioner’s challenge:

Petitioner, however, points to no evidence indicating that such constructs were introduced into mammalian cells; nor do we discern in Graham any evidence that the disclosed constructs were successfully expressed in mammalian cells, or that they subsequently produced a measurable effect on a target gene in accord with the claim language…Based on our review of the record to date, we acknowledge the substantial complexity of the subject matter and unpredictability of the art…. Given this subject matter, and Petitioner’s lack of testimonial evidence, we do not find that Petitioner has established that Graham expressly or inherently discloses a transgenic mouse comprising a germline or somatic cell molecule wherein an shRNA molecule is “stably expressed in said germline or somatic cell in an amount sufficient to attenuate expression of [a] target gene in a sequence specific manner” as required by claims 1 and 6. For at least this reason, Petitioner has not established that Graham anticipates the challenged claims.

The Board similarly faulted Benitec’s “kitchen sink” obviousness arguments which relied on twelve references in various combinations, finding  that Benitec again failed to sufficiently explain the teachings and suggestions of the cited art.

Unlike the earlier IPR proceedings mentioned at the beginning of this Blog, here the Board noted that the field of RNAi is complex and that Benitec failed to provide sufficient explanations and particularly noted the lack of expert testimony accompanying their petition.  This denial serves as a warning to petitioners in complex fields such as biotechnology where the Board often relies on reasoned explanations from experts.  To that end, this Blog has also highlighted the importance of (correctly) using expert declarations.