Appeal 2007-0860
Application 10/148,535
26. El-Mallakh was motivated by earlier evidence that MPH was
effective in treating unipolar depression, although that evidence was
“equivocal.” (Id. at 56.)
27. El-Mallakh studied fourteen depressed subjects with bipolar
illness for twelve weeks and concluded: “methylphenidate was effective and
relatively safe in depressed bipolar subjects.” (Id.)
28. Further, “[m]ethylphenidate administered in an open fashion
significantly ameliorated psychiatric symptoms in depressed bipolar subjects
maintained on a mood stabilizer regiment. Both depressive and manic
symptoms decreased over the 12 weeks of observation.” (Id. at 58.)
29. The evidence provided by El-Mallakh’s study, combined with
Harris’ teachings, would have motivated the skilled artisan to treat bipolar
disorder with MPH (and the l-enantiomer); further the teachings would have
been sufficient for the skilled artisan to reasonably expect success in
administering such treatment (FFs 6-8, 16-19, 21-28).
Facts Relating to Question Two: Rebuttal Evidence
30. Appellants’ Specification does not provide any data showing that
the l-enantiomer provides unexpected results compared to the publicly-
available racemate in treating seizures and/or bipolar disorder; instead the
only comparative data in their application relates to narcolepsy, and even
that data are not unexpected. (See Spec. at 4-11; FF 4.)
31. Further, Appellants have not provided any evidence by
declaration or affidavit that the l-enantiomer provides unexpected results
when used to treat seizures or bipolar disorder compared to the racemate.
32. Thus, Appellants have not rebutted prima facie obviousness.
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