Appeal No. 1997-3122
Application No. 08/082,848
With respect to the ineffectiveness of rapamycin in Sharkey’s model, we note that
Sharkey reasons that “[calcineurin involvement would explain the lack of rapamycin efficacy
because a complex of FK506-FKBP12, but not rapamycin-FKBP12, inhibits calcineurin”
(page 338). This is consistent with the present specification, which implicates calcineurin
in appellants’ proposed mechanism of neurotoxicity, and indicates that rapamycin would
not be effective in the present method because it does not inhibit calcineurin (Example 2).
Finally, with respect to the ineffectiveness of cyclosporin (which does inhibit calcineurin) in
Sharkey’s model, Sharkey suggests that “the lack of efficacy in this study may reflect the
low blood-brain barrier permeability of cyclosporin following a single injection.” Again, this
is entirely consistent with the present specification, which teaches that “some
immunophilin-binding drugs, like cyclosporin A, do not readily penetrate into the brain” but
“can be effectively administered by, for example, an intraventricular route of delivery” (page
7).
CONCLUSION
In our judgment, the reasons cited in support of the examiner’s rejection do not
provide a reasonable basis to question the adequacy of the disclosure provided for the
claimed invention. Thus, in our opinion, the PTO has failed to meet the initial burden of
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