Appeal 2007-0854
Application 10/179,463
considered a critical factor in identifying the chemical compositions that are
suitable from a patient safety perspective.” (Id. at 10.)
Appellants conclude that the “132 declaration clearly shows that the
criticality of the presently claimed formulation (not a range of formulations
as described by the Examiner, but instead a superior single species of
formulation), having particles comprising, by weight, approximately 75%
DPPC, approximately 15% 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.
at 6 (emphasis in original).)
The 132 Declaration of Jennifer Schmitke states at page 2 that the
goal of the study “was to evaluate the dose delivery (emitted dose and
aerodynamic particle size distribution) of representative formulations having
a DPPC/sodium citrate excipient base at selected temperature and humidity
conditions.” Table 1 on page 4 of the Declaration summarizes the emitted
dose results of the selected DPPC based powders at 23°C/30%RH and
30°C/80% RH.
Formulations 1 and 2 are both 60% DPPC, 10% sodium citrate, and
30% insulin; yet at 23°C/30% RH, Formulation 1 exhibited an ED of 78(3),5
while Formulation 2 showed an ED of 94(2). At 30°C/80% RH,
Formulation 1 exhibited an ED of 53(10), while Formulation 2 exhibited an
ED of 71(7). Similarly, Formulations 4 and 5 were both 87% DPPC, 10%
sodium citrate, and 10% insulin, and at 23°C/30% RH, Formulation 4
exhibited an ED of 83(2), and Formulation 5 showed an ED of 87(3). At
30°C/80% RH, Formulation 4 exhibited an ED of 48(11), while Formulation
5 Standard deviations are shown in the parenthesis.
6
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