Appeal No. 2001-1293 Page 6
Application No. 08/464,271
specification was limited to the single embodiment specifically exemplified.
Examiner’s Answer, page 8.
The examiner has not shown, however, that undue experimentation would
have been required to practice the claimed method in species other than mice, or
to substitute other tissue-specific promoters for the exemplified lymphoid-specific
promoter in order to ablate cells of other tissues. The examiner carries the initial
burden of showing nonenablement. In re Wright, 999 F.2d 1557, 1561-62, 27
USPQ2d 1510, 1513 (Fed. Cir. 1993). (“When rejecting a claim under the
enablement requirement of section 112, the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the description of
the invention provided in the specification of the application.”).
In this case, the examiner relies heavily on “the unpredictability of the
transgenic art.” See the Examiner’s Answer, page 6 (emphasis in original): “It
was well known in the art that the expression of a transgene and the effects of its
expression on the animal as a whole are not predictable due to numerous
uncontrollable factors such as the site of integration and methylation-inactivation
of the transgene. See Kappel et al., the right column of page 549.” We can
accept for the sake of argument that the transgenic art in general is subject to a
large amount of unpredictability. Here, however, Appellants have demonstrated
that this unpredictability does not prevent the claimed method from specifically
ablating lymphoid cells in mice. Thus, the evidence shows that the sources of
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