Appeal No. 2002-1128 Page 7
Application No. 08/668,036
composition containing substantially amorphous particles having a particle size
essentially the same as the particle size recited in claim 15. Even though the
composition of claim 24 is "produced by the method of claim 15" which requires spray
drying an aqueous solution of insulin, nevertheless, the product of claim 24 "reasonably
appears to be identical with or only slightly different than" the product disclosed by
Platz. In this regard, we invite attention to the following description in applicants'
specification, page 9, lines 20 through 31:
Insulin dry powders suitable for use in the present invention include
amorphous insulins, crystalline insulins, and mixtures of both amorphous
and crystalline insulins. Dry powder insulins are preferably prepared by
spray drying under conditions which result in a substantially amorphous
powder having a particle size within the above-stated range. Alternatively,
amorphous insulins could be prepared by lyophilization (freeze-drying),
vacuum drying, or evaporative drying of a suitable insulin solution under
conditions to produce the amorphous structure. The amorphous insulin
so produced can then be ground or milled to produce particles within the
desired size range. [Emphasis added].
We recommend that the examiner (1) take a hard look at claim 24 in light of the
foregoing discussion and relevant case law; and (2) determine whether to enter a
rejection of claim 24 over Platz, based alternatively on 35 U.S.C. § 102 or 35 U.S.C.
§ 103(a).
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