Appeal No. 2002-1128 Page 2
Application No. 08/668,036
pulmonary delivery of dry powder insulin preparations for rapid systemic absorption
through the lungs. Claims 15, 20, and 24, which are illustrative of the subject matter on
appeal, read as follows:
15. A method for preparing a stable, dry powder insulin composition, said
method comprising:
dissolving insulin in an aqueous buffer at a concentration in the range from
0.01% to 1% to form a solution; and
spray drying the solution to produce substantially amorphous particles having an
average size in the range from 0.1 µm to 5 µm.
24. An insulin composition produced by the method of claim 15.
20. An insulin composition for pulmonary delivery, said composition comprising
a dry powder of individual particles which include insulin present at from 20% to 80% by
weight in a pharmaceutical carrier material, wherein the particles have an average size
in the range from 0.1 µm to 5 µm.
The Prior Art References
In rejecting the appealed claims under 35 U.S.C. § 103(a), the examiner relies
on the following prior art references:
Okada et al. (Okada) 4,211,769 Jul. 8, 1980
Hirai et al. (Hirai) 4,659,696 Apr. 21, 1987
Markussen 4,946,828 Aug. 7, 1990
Chien et al. (Chien) 5,042,975 Aug. 27, 1991
Platz et al. (Platz) 5,354,562 Oct. 11, 1994
Maniar et al. (Maniar) 5,482,927 Jan. 9, 1996
AKZO EP 0 360 340 Mar. 28, 1990
(European Patent Appln.)
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