Appeal 2007-0913
Application 09/888,126
Fourth, even if we accept the validity of the data, while the 10%
insulin formulations crashed out of solution at lower concentrations than the
30% insulin formulations, we find that it is more a difference in degree, and
not a difference in kind, which is required to support a finding of unexpected
results.
CONCLUSIONS OF LAW
We conclude that the Examiner has set forth a prima facie case of
obviousness that has not been contested by Appellants, and that the
Declaration of Jennifer L. Schmitke, submitted under 37 C.F.R. § 1.132,
does not demonstrate unexpected results sufficient to rebut the prima facie
case.
CLAIMS 18, 20-39, AND 41-57
Appellants argue that claim 18 is separately allowable “because claim
18 recites that the formulation is administered to the patient in a single,
breath-actuated step, a limitation not disclosed by Patton and Edwards.”
(Br. 10.) Moreover, according to Appellants, “[c]laim 39 . . . recites
simultaneous inhalation and dispersion of the particles from a receptacle
containing the particles (e.g., breath actuated administration). Neither Patton
nor Edwards disclose or make obvious this feature which is unique to the
presently claimed particle formulation.” (Id.)
Thus, the issue as to both claim 18 and claim 39 is does the
combination of references render obvious a method of delivering the
composition of claim 1 by a breath-actuated step. According to the
Examiner, the prior art establishes that a single, breath-actuated step would
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