Appeal No. 2006-3234
Application No. 90/006,410
would not have found it obvious to adjust moisture levels until a level
sufficient to eliminate capping is found. Dr. Vilkov’s conclusory statement
that pharmaceutical formulation is “very unpredictable” is insufficient to
persuade us that the one skilled in the art would not have had a reasonable
expectation of successfully controlling capping by optimizing residual
moisture content.
2. Unexpected results
As noted by the examiner, the testing presented in the second Vilkov
declaration does not show unexpected results for the full scope of the
claimed subject matter. Claim 1, from which claim 35 depends, cites a
residual moisture content of 0.5-3%. According to the “results and
observations” section of the Second Vilkov declaration, tablets having a
residual moisture content of 3% yielded tablets that were “soggy” and
showed “capping”. Thus, unexpected results were not demonstrated for
the full scope of the claim. Moreover, Dr. Vilkov tested a composition
having a particular “hydrocolloid forming retarding agent” (hydroxypropyl
methylcellulose) as well as other excipients (povidone, purified water,
magnesium stearate). Appellant has not explained how this particular
composition is representative of the broader claimed subject matter of
claim 1.
Appellant directs us also to example 4 of the ‘106 disclosure. (Brief
at 20 and ‘106 at 7:39-67). However, example 4 does not cure the
deficiencies of the Vilkov declaration. Appellant has not explained how
(Vilkov declaration at ¶ 4). We determine that the examiner has not shown
that ethyl cellulose can act as a hydrocolloid forming retarding agent.
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