Takeaway: Expert testimony provided after the Petition to correct errors in the expert testimony provided in the Petition will not be considered when the arguments added were not already made in the original Petition.  Further, any expert opinion of inherency must be supported by credible evidence and/or persuasive explanation that the inherent feature was necessarily present.

In its Decision, the Board denied institution of inter partes review because Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims as required 35 U.S.C. § 314(a).  The ’378 patent relates to methods for making rapid dissolve thin film drug delivery compositions for the oral administration of active components.

Petitioner asserted that claims 1-13, 15, and 23-29 are unpatentable as anticipated by Chen, and that claims 1-29 are unpatentable as obvious over Chen alone, or over the combination of Chen and Staab, or over the combination of Chen and Strobush.

The Board began its analysis with claim construction.  Patent Owner requested that the limitation of “polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105 sec-1” be construed to mean a “polymer matrix that is a non-Newtonian fluid that has a viscosity that decreases with an increasing shear rate when exposed to shear rates throughout the entire range of 10-105 sec-1.”  Specifically, Patent Owner argued, based on expert testimony, that the plain and ordinary meaning of “shear-thinning pseudoplastic fluid” is a “non-Newtonian fluid that has a viscosity that decreases with an increasing rate.”  Further, Patent Owner argued that the polymer matrix must be a shear-thinning pseudoplastic fluid over the entire range of shear rates, and not just a portion of the range, based on the use of the plural “shear rates” and the description in the specification.  The Board agreed with Patent Owner’s proposed construction, except the Board did not believe the claims required the shear-thinning pseudoplastic fluid to be a non-Newtonian fluid.  There were other disputed claim terms that the Board chose not to construe, because the shear-rates-related term was dispositive.

The Board then moved to the anticipation ground of unpatentability.  The Board determined that Petitioner failed to point to any disclosure in Chen for disclosing “polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105sec-1” as that term is construed by the Board.  Petitioner relied on inherency based on experimentations by its expert that allegedly showed that Chen’s Example 7 was a shear-thinning pseudoplastic fluid when exposed to shear rates of 10 to 103 sec-1.  Patent Owner questioned the reasoning and methodology underlying the expert’s testimony.  However, the Board did not address the methodology, because even if the testing was accurate, the expert only found that the fluid was a shear-thinning pseudoplastic fluid when exposed to shear rates of 10 to 103 sec-1, and not the entire claimed range.

Petitioner relied on a second expert in its Reply to testify that “[t]he person of ordinary skill in the art would have expected that this behavior would to [sic] continue at shear rates above 103 sec-1.”  However, because this argument was not made in the Petition, the Board declined to consider it.  The Board also determined that, even if did consider that testimony, it would fail to prove inherency, because the second expert did not cite to credible evidence or provide persuasive explanation to support his opinion and the conclusion itself (i.e., “would have expected”) constitutes probabilities or possibilities, which is insufficient to establish inherency.

In turning to the obviousness grounds, the Board noted that Petitioner relied on the same inherency argument for each of the obviousness grounds, and thus those grounds were unpersuasive for the same reasons as the anticipation ground.

BioDelivery Sciences International, Inc. v. MonoSol Rx, LLC, IPR2014-00794 Paper 7: Decision Denying Institution of Inter Partes Review 
Date: November 5, 2014
Patent 8,652,378 B1 
Before: Jacqueline Wright Bonilla, Brian P. Murphy, and Zhenyu Yang 
Written by: Yang
Related Proceedings: Reexam 90/012,098 (USP 7,357,891); Reexam 90/012,097 (USP 7,425,292); Reexam 95/002,171 (USP 7,666,337); Reexam 95/002,170 (USP 7,897,080); and Reexam 95/001,753 (USP 7,824,588)