The preferred compositional weight percent range for 12 Garrett does not assert that topical dapsone formulations for treating acne were new as of its disclosure, and it identifies and incorporates by reference in its entirety, inter alia, U.S. Patent 5,863,560 to Osborne (Ex. 1016, “Osborne ’560”).
Petitioner asserts that the prior art informed the skilled artisan that the claimed dapsone, water, DGME, and methyl paraben were compatible components for a topical formulation, and that a hydrophilic or hydroalcoholic thickening agent, such as carbomer, could also be included.
In particular, as explained below, we find that a person of ordinary skill in the art would have found it obvious to substitute the A/SA copolymer taught by Nadau-Fourcade for the carbomer gelling agent disclosed in Garrett’s formulations to arrive at the claimed composition.
Although the example in Garret only studied a 5% dapsone topical formulation, we find that a POSA would have nonetheless considered it relevant in determining whether higher concentrations of the active agent within Garrett’s disclosed range of 5–10% were also safe and effective based on Garrett’s teaching that 5% to 10%
Regarding the “grittiness” rationale of Ground 2, Patent Owner argues that, although the Aczone 5%’s FDA-approved labeling indicates the presence of grittiness, with visible drug particles, this really was not the case and would not have motivated the skilled artisan to substitute Carbopol with Sepineo.