Appeal 2007-0854
Application 10/179,463
5 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.
The Specification teaches ““[f]ormulations having particles
comprising, by weight, approximately 40% to approximately 60% DPPC,
approximately 30% to approximately 50% insulin and approximately 10%
sodium citrate.” (Specification 3). Also disclosed are:
Formulations having particles comprising, by weight,
approximately 75% to approximately 80% DPPC,
approximately 10% to approximately 15% insulin and
approximately 10% sodium citrate . . . . In one embodiment,
the particles comprise, by weight, 75% to 80% DPPC, 10% to
15% insulin and 10% sodium citrate. In another embodiment,
the particles comprise, by weight, 75% DPPC, 15% insulin and
10% sodium citrate. In yet another embodiment, the particles
comprise, by weight, 80% DPPC, 10% insulin, and 10%
sodium citrate.
(Id.)
In addition, in the human clinical trial described in the Specification, a
dry powder formulation of 60% DPPC, 30% insulin, and 10% citrate was
used (id. at 51-52). The Specification does not disclose the criticality of
formulations of approximately 75% DPPC, approximately 15% insulin and
approximately 10% sodium citrate.
PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
7
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