Appeal 2007-0913
Application 09/888,126
negatively charged therapeutic agent and a molecule of opposite charge for
delivery to the pulmonary system (Edwards, col. 3, ll. 55-60). Moreover,
Edwards also teaches that “[i]f the agent to be delivered is negatively
charged (such as insulin), protamine or other positively charged molecules
can be added to provide a lipophilic complex which results in the sustained
release of the negatively charged agent. Negatively charged molecules can
be used to render insoluble positively charged agents.” (Id. at col. 7, ll. 5-
10.) Thus, Edwards demonstrates that it was known in the art that
interactions of molecules, such as charge-charge interactions, could change
the solubilities of the molecules. Thus, the fact that the surfactant DPPC and
negatively-charged insulin interact with one another to increase the crash-out
time of higher concentration solutions containing higher levels of insulin is
not necessarily unexpected.
Second, Figure 2 is the result of testing that is well known to the
ordinary artisan that would be performed in developing and optimizing the
manufacturing process. Thus, the modification of using higher insulin
content would have been well within the skill level of the ordinary artisan.
In addition, Appellants have not presented evidence that it is unexpected in
such testing that formulations containing lower insulin concentrations would
crash out sooner than formulations containing higher insulin concentrations.
Third, each concentration of the formulations presented on Figure 2
follows a curve, from which the position of additional points on each curve
could be predicted. The only point that seems to fall outside of the curve is
the 30% insulin solution having a concentration of 15 g/l. But it is unclear if
that point is an actual outlier or merely a result of experimental error, as no
error bars are presented.
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