Appeal 2007-0913
Application 09/888,126
In the Appeal Brief, Appellants do not contest the prima facie case of
obviousness. Instead, Appellants argue that “the evidence of record,
presented in the enclosed Rule 132 Declaration, establishes significant
unexpected results. Thus, the selection of the presently claimed approximate
amounts of 60% DPPC, 30% insulin and 10% citrate combination is
patentable over the myriad of possible combinations derived from the
combination of Patton and Edwards.” (Br. 3.)
According to Appellants,
The results pointed to the fact that DPPC concentration is not
the sole predictor of the insulin formulation, but in fact a
critical balance of insulin, DPPC and solution concentration
achieved [by] the formulation. Figure 2, for example, shows
that 10% insulin formulations “crash out” of solution rapidly,
ranging from 5 minutes to two hours depending upon the
concentration of insulin comprising the 10% formulation. On
the other hand, the 30% insulin formulation does not crash out
of solution at all. In other words, at concentrations as low as 10
g/L of the total solids (DPPC/insulin/citrate; 4 g/L DPPC), the
10% insulin containing formulation was unstable compared to
the 30% insulin containing formulation where stability was
observed even at 20 g/L of the total solids (12 g/L of DPPC).
(Id. at 5 (emphasis in original)).
Appellants assert that the above results could not have been predicted
based solely on DPPC solubility, “and results in a dramatic improvement in
manufacturability of the formulation that could have been predicted.” (Br.
5-6.) According to Appellants, “[t]he Examiner’s conclusion that these
results are not significant is simply unsubstantiated.” (Id. at 6.) Appellants
argue that the “132 declaration clearly shows the criticality of the presently
claimed formulation (not a range of formulations . . . but . . . a superior
species of formulation), having particles comprising, by weight,
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