Appeal No. 2004-2134 Page 12
Application No. 09/425,075
expression in Pichia.” Appeal Brief, page 13. Moreover, according to the
declarant, “[e]ven if a reference was cited that actually showed a working method
for the expression of functional antibodies in S. cerevisiae using a dual
expression cassette vector, it is my unequivocal opinion that a Skilled Person
would have no reasonable expectation of success in practicing such a method in
Pichia.” Id. at 14 (quoting Trager Declaration, ¶16). Appellants thus conclude
that a person of ordinary skill in the art must make three leaps from the
disclosure of Robinson—the first being that yeast as used in Robinson means
something other than S. cerevisiae, the second being that evidence of a single
expression cassette vector for antibody production in S. cerevisaiae is predictive
of success using a dual cassette system, and the third being that expression in
S. cerevisaiae is predictive of success in Pichia—and the Pinnell and the
Hollinger references, as well as the Trager declaration, “provides ample evidence
that none of these leaps are trivial, and that the ordinary skilled artisan would not
make these leaps.” Appeal Brief, page 14.
We do not find appellants’ arguments convincing for the same reasons as
set forth supra. As noted above, obviousness only requires a reasonable
expectation of success, not an absolute predictability. If we were to accept
declarant’s arguments that protein expression is unpredictable, and successful
heterologous protein expression in S. cerevisiae does not predict successful
heterologous protein expression in Pichia, an obviousness rejection would never
be appropriate anytime one changed to a new expression system. With respect
to the statements in paragraph 17 of the Trager declaration, the problems
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