Appeal 2007-0913
Application 09/888,126
Figure 2 demonstrates that higher insulin content solutions appear to
stay in solution longer (id.). According to the Declarant,
the 10% insulin formulation experienced rapid “crash-out”
times with a DPPC concentration of 4.0 g/l, an insulin
concentration of 0.5 g/l and a citrate concentration of 0.5 g/l.
However, the 30% insulin formulation did not “crash-out” even
at concentrations of 10 g/l total solids, resulting in a DPPC
concentration of 12.0 g/l, an insulin concentration of 6 g/l and a
citrate concentration of 2 g/l. Clearly, the solubility of the
insulin formulation is not dictated solely by DPPC solubility.
Such a dramatic improvement in manufacturability could not
have been predicted.
(Id. at 5-6.)
At oral argument, Appellants stated that these results were not
appreciated until after the filing of the present application, and are part of the
routine experimentation known to the ordinary artisan in developing the
manufacturing process. In addition, Appellants also stated that what Figure
2 is demonstrating is an interaction occurring between the components of the
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