Appeal 2007-0854
Application 10/179,463
of 87 with a standard deviation of 5. Similarly, Formulation 7 exhibited an
ED of 93(1), which would also include an ED of 92. The difference
between an ED of 90 and 92, we find, is more a difference in kind than a
difference in degree, which is required to support a finding of unexpected
results. Likewise, at 30°C/80% RH, Formulation 5 has an ED of 61(6), and
Formulation 7 has an ED of 69(9). Thus, at 30°C/80% RH, the ED of
Formulations 5 and 7 overlap when the standard deviation is taken into
consideration.
Thus, given that the same formulation, i.e., Formulations 1 and 2,
gave very disparate results, and given that there is little difference between
Formulation 5, which is 10% insulin, and Formulation 7, i.e., the
formulation of claim 5, we find that Appellants’ 132 Declaration does not
demonstrate that the formulation of claim 5 exhibits properties that are
unexpected.
CONCLUSIONS OF LAW
We conclude that the Examiner has set forth a prima facie case of
obviousness that has not been contested by Appellants, and that the
Declaration of Jennifer L. Schmitke, submitted under 37 C.F.R. § 1.132,
does not demonstrate unexpected results sufficient to rebut the prima facie
case.
CLAIMS 51, 53-64, AND 66
Appellants argue that claim 51 is separately allowable, because
“Claim 51 recites simultaneous inhalation and dispersion of the particles
from a receptacle containing the particles (e.g., breath actuated
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