Appeal No. 2003-1042 Page 4
Application No. 09/019,764
Cleland is relied upon for teaching “that histidine buffers are suitable
buffers for maintaining the critical pH of vaccine formulations, including
multivalent vaccines containing multiple antigens.” Examiner’s Answer, page 3.
Cleland is also cited for teaching the use of vaccine preservatives such as benzyl
alcohol (0.7 to 1%), methyl paraben and propyl paraben. According to the
rejection, “[t]he claimed invention differs from the vaccine compositions
described by Cleland [ ] in the recitation of specific preservative concentrations
for methyl paraben and propyl paraben, in the recitation of specific combinations
of the preservatives, and in the recitation of 2-phenoxyethanol as one of the
preservatives.” Id. at 4,
Belanger is cited for teaching “an injectable pharmaceutical composition
comprising a mixture of 0.9% benzyl alcohol, 0.18% methyl paraben, and 0.02%
propyl paraben as the preservative.” Id.
Fox is cited for teaching “a commercially available preservative for use in
medical hydrogels which is a mixture of methyl paraben (at about 0.04% final
concentration in the hydrogel), propyl paraben (at about 0.015% final
concentration in the hydrogel), and 2-phenoxyethanol (at about 0.2% final
concentration in the hydrogel) . . . .” Id.
The rejection concludes:
It would have been prima facie obvious to one of ordinary
skill in the art at the time the invention was made to have
formulated stable vaccine compositions comprising histidine buffer
as taught by Cleland [ ] and a preservative according to the
teachings of Cleland [ ], in view of Belanger [ ] and Fox [ ]. One of
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