Appeal 2007-0854
Application 10/179,463
66-74.2 We have jurisdiction under 35 U.S.C. § 6(b). Claims 5 and 51 are
representative of the claims on appeal, and read as follows:
5. A formulation having particles comprising, by weight, 75% DPPC,
15% insulin and 10% sodium citrate.
51. A method of delivering an effective amount of insulin to the
pulmonary system, comprising:
(a) providing a mass of particles comprising by weight, 75%
DPPC, 15% insulin and 10% sodium citrate; and
b) administering via simultaneous dispersion and inhalation the
particles, from a receptacle having the mass of the particles, to a human
subject’s respiratory tract, 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.
2 This case is related to USSN 09/888,126, Appeal No. 2007-0913. Both
Appeals were heard together, and have been considered and decided
concurrently.
2
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