Appeal 2007-0854
Application 10/179,463
We find that Appellants have not demonstrated that the formulation of
claim 5 has unexpected properties so as to rebut the prima facie case of
obviousness, and the rejection is affirmed.
As set forth above, Table 1 of the 132 Declaration, Formulations 1
and 2 are identical (both 60% DPPC, 10% sodium citrate, and 30% insulin).
Yet at 23°C/30% RH, Formulation 1 exhibited an ED of 78(3), while
Formulation 2 showed an ED of 94(2), and at 30°C/80% RH, Formulation 1
exhibited an ED of 53(10), while Formulation 2 exhibited an ED of 71(7).
These results demonstrate that for the same formulation, there was
substantial variability between the tests. Given the above, Formulation 2
would meet the desired criteria of stability, yet formulation 1 would not,
even though they are both 60% DPPC, 10% sodium citrate, and 30% insulin.
In the Declaration, the Declarant states at page 4 that Formulation 1
was not considered to be representative of the formulation, so consequently
the testing was run again using clinical lot capsules, designated as
Formulation 2. The Declarant does not explain, however, how formulations
1 and 2 differ, nor does the Declarant explain why such disparate results
were obtained.
Formulation 5, which is 87% DPPC, 10% sodium citrate, and 10%
insulin, at 23°C/30% RH exhibited an ED of 87(3), and at 30°C/80% RH,
exhibited an ED of 61(6). Formulation 7, which is 75% DPPC, 10% sodium
citrate, and 15% insulin, i.e., the claimed formulation, exhibited an ED of
93(1) at 23°C/30% RH, and an ED of 69(9) at 30°C/80% RH. However, the
ED values between Formulations 5 and 6 differ very little (if at all) when the
standard deviation is taken into consideration. At 23°C/30% RH,
Formulation 5 had an ED of 87(3), and an ED of 90 would be within an ED
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