Appeal No. 2003-0528 Page 7
Application No. 09/314,841
According to the examiner (Answer, page 6), “[o]ne skilled in the art would
reasonably have expected success in using the beta alanine or GABA as
stabilizers in the reagent of B[rucato] and B[rown] because both B[rucato] and
B[rown] teach addition of glycine in their formulations and S[chwinn] teaches that
beta alanine and GABA are equivalent stabilizers to glycine.” However, as we
understand the Butler patent, in contrast to using glycine as a stabilizer, Butler
uses PEG, albumin and sodium propionate as stabilizers. Butler, (column 6,
lines 48-52).
In our opinion, the examiner has not provided any evidence that beta
alanine and GABA are equivalent stabilizers to PEG, albumin and sodium
propionate, as set forth in Butler. To this end, the examiner has not provided
any evidence to suggest that there would have been a reasonable expectation of
success in modifying the Butler formulation, while retaining Butler’s enhanced
shelf life.
Furthermore, as appellants point out (Brief, bridging paragraph, pages 37-
38), Schwinn (column 3, lines 45-50) is directed to blood coagulation factors II,
VIII, XIII, of antithrombin III and of plasminogen and “a process for stabilizing
coagulation factors against heat to prevent the transmission of hepatitis…. [T]he
process for the stabilization against heat includes ‘adding to the solution both an
amino acid and a monosaccharide, an oligosaccharide or a sugar alcohol.’”
Even if it were prima facia obvious to a person of ordinary skill in the art to
modify Butler’s reagent to include beta alanine or GABA, according to Schwinn
one would also include a monocaccharide, oligosaccharide or a sugar alcohol.
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