Appeal 2007-0913
Application 09/888,126
approximately 60% DPPC, approximately 30% insulin and approximately
10% sodium citrate possesses unexpected properties as compared to
formulations that are even closer than those of the combination of prior art
cited by the Examiner.” (Id. (emphasis in original).) Appellants conclude
that their “showing of unexpected enhanced stability and manufacturability
of the presently claimed specific formulation is sufficient to overcome any
prima facie case of obviousness in view of the potentially infinite
combinations of formulations provided by the excipients and ranges
disclosed in the cited combination of Patton and Edwards.” (Id. at 7.)
The 132 Declaration of Jennifer Schmitke states on page 1 that the
claimed invention “results from substantial experimentation that necessitated
the selection of a formulation that achieves serum insulin levels similar to
that achieved by injectable insulin, good to excellent bioavailability, good to
excellent physical stability and good to excellent manufacturability.”
Figure 2 of the Declaration is a graph of “crash-out” time, i.e., the
time before particles start to come out of solution, versus the percent insulin
composition, with the different curves representing different concentrations
(Declaration, 5). Figure 2 is reproduced below:
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