Appeal No. 95-2662
Application 07/771,262
subject matter sought to be patented must be taken as in compliance with the enabling
requirement of the first paragraph of § 112 unless there is a reason to doubt the objective
truth of the statements contained therein which must be relied on for enabling support”).
Here, we do not find that the examiner has applied the appropriate legal standard
for determining whether a specification provides an enabling disclosure. We caution the
examiner that the initial burden lies with her to provide reasons, preferably supported with
factual evidence, as to why it would require undue experimentation for one skilled in the art
to make and use the invention as claimed. The factors to be considered in determining
whether a disclosure would require undue experimentation have been set forth by the court
in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The
examiner has not provided any reasons as to why one skilled in the art would (i) have “no
basis to conclude” that the addition of the claimed C-terminal extension would confer
similar properties to other unrelated proteins, and (ii) not have been able to make and use
the claimed invention throughout its scope, absent undue experimentation. Accordingly,
we must reverse this rejection.
Obviousness
The examiner has predicated her conclusion of obviousness on the teachings of
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