An overlapping range-based presumption of obviousness applies, if at all, only when a single reference discloses the same process or formulation as claimed, with ranges for certain variables that a POSA would have reason to optimize.

Patent Owner’s Request for Director Review swapping particular excipients in two specific combinations… that excipients and the active ingredient react differently depending on the formulation… leads the court to understand that swapping ingredients in complex chemical formulations is anything but ‘routine.’); Orexo AB, et al., v. Actavis Elizabeth LLC, 903 F.3d 1265, 1273 (Fed. Cir. 2018) (“The question is not whether the various references separately taught components of the [claimed] formulation, but whether the prior art suggested the selection and combination achieved by [the claimed invention].”).

The PVB’s interaction with the claimed formulation as-a-whole could significantly impact the viscosity, stability (chemical and physical), patient tolerability, adverse events, permeation rate, excipient compatibility, crystallization, particle size, etc. See Ex. 2057 ¶¶ 63, 67.

The Board’s failure to explicitly articulate the affirmative evidence for a motivation to combine the asserted prior art with a reasonable success is legal error, for which alone this Court should reverse the Board’s decision.

Currently, Drew Hirshfeld is “performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office