Appeal No. 2003-0847 Page 8
Application No. 08/744,685
statement in a supporting disclosure and to back up assertions of its own with
acceptable evidence or reasoning which is inconsistent with the contested
statement.” Id. at 224, 169 USPQ at 370. Here, the examiner has not provided
“acceptable evidence or reasoning which is inconsistent” with the specification,
and therefore has not met the initial burden of showing nonenablement.
First, although the examiner recognized the applicability of the Forman or
Wands factors, see Paper No. 17, page 8, the rejection did not set forth a
systematic analysis of those factors. We recommend that in order to make a
clear record that is susceptible to meaningful review, that a systematic analysis
of the relevant factors be set forth in the rejection.
Second, although the rejection is concerned that the claims read on the
expression of any recombinant gene, the examiner has not provided sufficient
evidence demonstrating why it would require an undue amount of
experimentation by one skilled in the art to express genes other than those
exemplified by the specification using the claimed homologous recombination
insertional vector. The rejection makes reference to the lack of guidance as to
promoters and enhancers, but presents no evidence that it would require an
undue amount of experimentation by one skilled in the art to determine the
appropriate enhancers and promoters. Moreover, although the rejection asserts
that expression of a recombinant gene may be inhibited by expression of anti-
sense—tertiary structure formation from a constitutively expressed
complementary gene pre-existing in the cell, the examiner has not presented any
evidence that such tertiary structure formation is an issue to the expression of
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