Appeal 2007-0854
Application 10/179,463
insulin formulations to the lung as taught by Edwards and to
have implemented DPPC as the carrier, since it was disclosed
that DPPC is an exemplary surfactant, naturally occurring in the
lung.
Id. at 4-5.
In the Appeal Brief, Appellants do not contest the prima facie case of
obviousness. Instead, Appellants argue that “the evidence of record
establishes significant unexpected results. Simply, the evidence establishes
that the specific amounts of these components are critical. Thus the
selection of presently claimed approximate amounts of 75% DPPC, 15%
insulin and 10% citrate combination is patentable over the myriad of
possible combinations derived from the combination of Patton and
Edwards.” (Br. 3).
Appellants refer to Table 1 of the 132 Declaration, stating that
formulations with an Emitted Dose (ED) greater than 90% are stable at
standard conditions, and that formulations 2, 3 and 74 fall into that category
(Br. 5). But when the temperature and humidity were raised to 30°C/80%
relative humidity (RH), according to Appellants, only formulations 2 and 7
met the target of an excellent ED at standard conditions and good retention
of ED at the higher temperature and humidity, while formulations 3, 5, and 6
did not (id.). Thus, Appellants assert, “[w]hat was discovered was that the
15% insulin formulation unexpectedly withstood extreme conditions as
compared to the 10% insulin formulation.” (Id. at 6.) Appellants argue that
“[t]he robustness of a formulation at different environmental conditions was
4 Formulation 7 is the formulation of the instantly claimed invention.
5
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