Appeal No. 2003-0528 Page 12
Application No. 09/314,841
serine, glycerol, and sorbitol may be added to a protein formulation to improve
storage stability….”
While the examiner points to the background section of Prestrelski to
support her finding that alanine, serine, glycerol and sorbitol may improve
storage stability of protein formulations, we note that the examiner has selected
these excipients from a very large genus of excipients. See, Prestrelski, column
2, lines 4-18. The examiner has not identified any basis for identifying a select
few of the excipients from the large genus listed. Furthermore, Prestrelski
cautions against the use of additives (see Prestrelski, column 2, lines 19-23),
“[w]hile the use of additives has improved the stability of dried proteins, many
proteins which are subject to drying and subsequent storage contain
unacceptable or undesirable amounts of inactive, aggregated protein in the
rehydrated formulation.” Thus, Prestrelski’s acknowledgement of the problem of
using additives for dried/lyophilized proteins only adds to the list of problems
associated with lyophilized proteins identified by Butler. See, Butler, (column 1,
lines 48-57).
As discussed, supra, the examiner has not provided the evidence
necessary to demonstrate that the Brucato, Butler, or Brown prothrombin
reagents could be modified in a manner that would retain shelf life disclosed by
Butler. In our opinion, Prestrelski fails to make up for the deficiencies in the
combination of Brucato, Butler and Schwinn with or without Brown. Accordingly,
we reverse the rejection of claims 4, 20, 26, 33, 36 and 52 under 35 U.S.C.
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