Appeal No. 2001-1293 Page 7
Application No. 08/464,271
unpredictability cited by the examiner did not prevent the method from having its
intended effect in vivo.
The examiner, in considering enablement, appears not to have given
appropriate weight to Appellants’ demonstrated success. That is, since the
claimed method has been demonstrated in mice, with a HSV-TK expression
construct under the control of a lymphoid-specific promoter, the question with
respect to enablement is: would undue experimentation have been required to
extrapolate from that successful experiment to practice the claimed method in
other organisms, with other tissue-specific promoters, or with other toxin-
converting enzymes? The examiner has not presented adequate evidence or
reasoning to show that it would have required undue experimentation to
extrapolate the exemplified method to other organisms, to identify and obtain
other tissue-specific promoters, or to substitute other tissue-specific promoters
with a reasonable expectation of causing a similar effect in other tissues. Thus,
we conclude that these factors cannot support a rejection for nonenablement.
However, we agree with the examiner that the specification does not
provide adequate guidance to enable practice of the claimed method using any
“DNA encoding and expressing an exogenous enzyme that selectively converts a
latent toxin into a cell toxin” in the targeted cells. The only gene identified in the
specification as encoding an enzyme meeting this limitation is the HSV-TK gene.
See, e.g., page 15. The working examples disclosed in the specification all use
the HSV-TK/nucleoside analog system. The specification provides no
meaningful guidance with respect to other genes that meet the criteria recited in
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