Appeal No. 2004-2134 Page 11
Application No. 09/425,075
Publications dated after the filing date providing information publicly first
disclosed after the filing date generally cannot be used to show what was known
at the time of filing. See In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 405
(CCPA 1976). We acknowledge that Hollinger is a review article, but we could
find no citation in Hollinger to an earlier filed publication that it was known at the
time of filing of the instant application that bicistronic expression works only
poorly in Pichia (unlike E. coli), and that two chain Ab formats require that the two
chains be cloned and transformed separately.
Finally, we acknowledge Dr. Trager’s statement in paragraph 22 of his
declaration, but as his statements are based in part on the above statements in
the Pinnell and Hollinger references, which we do not find teach away from the
claimed invention for the reasons set forth above, we also find paragraph 22 of
the declaration not to be convincing on the issue of obviousness. Moreover, all
that is required is a reasonable expectation of success, not absolute predictability
of success. See In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed.
Cir. 1988). Given the teachings of the Invitrogen Catalog that a wide variety of
proteins have been expressed using the Pichia expression system, see Table 1,
one of ordinary skill would have had a reasonable expectation of success of
using a dual cassette, single vector expression system to express a functional
immunoglobulin protein in the Pichia expression system.
Citing paragraph 15 of the Trager declaration, appellants also argue that
“protein expression is unpredictable, and successful heterologous protein
expression in S. cerevisiae does not predict successful heterologous protein
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