Appeal No. 2002-1128 Page 6
Application No. 08/668,036
[I]n spite of the fact that the claim may recite only process limitations, it is
the patentability of the product claimed and not of the recited process
steps which must be established. We are therefore of the opinion that
when the prior art discloses a product which reasonably appears to be
either identical with or only slightly different than a product claimed in a
product-by-process claim, a rejection based alternatively on either section
102 or section 103 of the statute is eminently fair and acceptable. As a
practical matter, the Patent Office is not equipped to manufacture
products by the myriad of processes put before it and then obtain prior art
products and make physical comparisons therewith. [Emphasis added.]
Applying those principles of law to the facts before us, we believe that Platz
discloses a product "which reasonably appears to be either identical with or only slightly
different than" the product recited in claim 24.
Generally speaking, the Platz disclosure relates to inhalation therapy involving
the administration of a drug in aerosol form to the respiratory tract. According to Platz,
"the present invention is useful for transforming polypeptide drugs into a powder form
that is suitable for aerosol administration" (column 2, lines 13 through 15). Examples of
such polypeptides include, inter alia, insulin (column 2, line 21). Platz discloses a two-
step process where "[t]he first step in the process for forming the polypeptides into
micronized particles is lyophilization" (column 2, lines 38 through 40). Subsequently,
the lyophilized polypeptide is size reduced in a grinding mill, preferably a fluid energy
mill also known as a jet mill (column 3, lines 3 through 5). The particle size of the milled
powder disclosed by Platz appears to be essentially the same as the particle size
recited in claim 15 from which claim 24 depends (Platz, column 3, line 65 through
column 4, line 19).
On this record, it would appear that Platz discloses a stable, dry powder insulin
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