Appeal No. 2002-1128 Page 4
Application No. 08/668,036
Independent claim 15 requires spray drying an aqueous solution of insulin "to
produce substantially amorphous particles having an average size in the range from
0.1 µm to 5 µm." Likewise, independent claim 26 requires spray drying an aqueous
solution of insulin and a pharmaceutical carrier "to produce amorphous particles
comprising both the insulin and the pharmaceutical carrier having an average size in
the range from 0.1 µm to 5 µm." We agree with applicants' argument (Appeal Brief,
pages 10 and 11) that the cited prior art is insufficient to support a conclusion of
obviousness of claims containing those limitations. Nor has the examiner adequately
come to grips with those specific claim limitations.
Independent claim 20 calls for 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." Again, the
insulin composition recited in claim 30 comprises "a dry powder of individual
amorphous particles including both insulin and a pharmaceutical carrier, wherein the
particles comprise from 20% to 80% insulin by weight." We agree with applicants
(Appeal Brief, page 13) that the cited prior art is insufficient to support a conclusion of
obviousness of claims containing those limitations. Nor has the examiner adequately
come to grips with those specific claim limitations.
Furthermore, in rejecting claims for want of novelty or for obviousness, the
examiner must cite the best references at his or her command. 37 CFR § 1.104(c)(2).
Here, the examiner issued what could only be described as a "shotgun" rejection of
claims 15 through 24 and 26 through 34 under 35 U.S.C. § 103(a) as unpatentable over
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