Appeal No. 2003-1126 Page 7
Application No. 08/444,285
transgenic mammal was unpredictable.” Id. at 8. Moreover, the rejection notes
further that the specification “does not teach nor provide guidance as to the
nucleic acid constructs or nucleic acid vectors to be employed in the production
of transgenic nonhuman mammals that exhibit any of the above discussed,
disclosed phenotypes.” Id.
The specification further contends that “[t]ransgenic mammals and
methods of polypeptide or protein production, to meet any of the disclosed uses,
require more than an outline of making the mammal. It requires very specific
guidance as to the promoters or expression regulatory sequences, the genetic
material or DNA sequences encoding a particular protein, and in some cases, the
tissues in which expression is to be achieved to produce a mammal with a
phenotype of the disclosure.” Id.
The rejection argues that the only guidance provided by the specification
is the production of a mouse that expresses a rabbit β-globin gene, and that
example “does not provide guidance for the production of transgenic mammals
for their entire breadth as the expression of rabbit β-globin does not fall within the
disclosed uses for the transgenic mammal.” Id. at 10. The rejection thus
concludes “that the skilled artisan would need to engage in an undue amount of
experimentation without a predictable degree of success to reach the invention
as claimed. Id. at 12.
Appellants argue that, by trying to limit the claims to the one exemplified
embodiment, the examiner is penalizing them for filing “when they had only
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