Appeal 2007-0913
Application 09/888,126
jurisdiction under 35 U.S.C. § 6(b). Claims 1 and 18 are representative of
the claims on appeal, and read as follows:
1. A formulation having particles comprising, by weight, approximately
60% DPPC, approximately 30% insulin and approximately 10% sodium
citrate.
18. A method for treating a human patient in need of insulin comprising
administering pulmonarily to the respiratory tract of a patient in need of
treatment, in a single, breath actuated step an effective amount of particles
comprising by weight, approximately 60% DPPC, approximately 30%
insulin and approximately 10% sodium citrate, wherein release of the insulin
is rapid.
The Examiner relies upon the following art in rejecting the claims:
Edwards US 5,985,309 Nov. 16, 1999
Patton US 5,997,848 Dec. 7, 1999
We affirm.
ISSUE
The Examiner contends that the invention as claimed is obvious over
the combination of Edwards and Patton, and that Appellants have not
rebutted the prima facie case.
Appellants contend that the Declaration of Jennifer L. Schmitke,
submitted under 37 C.F.R. § 1.132 and dated April 20, 2004, rebuts the
Examiner’s prima facie case of obviousness by demonstrating that the
claimed composition has unexpected properties.
The issue is thus whether Appellants have demonstrated unexpected
results as to the insulin formulation being claimed, thus rebutting the
Examiner’s case of prima facie obviousness.
2
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