Appeal 2007-0860
Application 10/148,535
19. Significantly, Evans notes: “Stimulants raise, not lower, the
seizure threshold in epileptic patients and they are frequently prescribed to
epileptic patients with ADD.” (Evans, at 31 (emphasis added).)
20. Given the teachings of Harris and Gross-Tsur (including Gross-
Tsur’s description of Wroblewski), along with other art cited by Wroblewski
demonstrating the level of skill in the art at the time of Appellants’ claimed
invention, the skilled artisan would have been motivated to treat patients
with convulsive disorders, including seizures, with MPH, and therefore with
the enantiomers of methylphenidate, with a reasonable likelihood of success.
(FFs 6-19.)
The Claims to Bipolar Disorder
21. Carlson recognizes the difficulty of distinguishing disruptive
behavior disorders from bipolar disorder because of their “considerable
phenomenological overlap” (Carlson, at 262).
22. Carlson treated children with these two disorders using
methylphenidate (MPH) and lithium and MPH alone and ran a battery of
tests to measure the effects of the drugs. (Carlson, at 265-68.)
23. Carlson notes their results were not “statistically significant” but
concludes: “Systematic studies of the efficacy and side effects of children
with both ADHD and mood symptoms are . . . needed before we can
conclude that MPH is necessarily contraindicated in such children.” (Id. at
268-69.)
24. Thus, Carlson would have suggested further testing of MPH to
treat children with bipolar disorder.
25. In that setting, El-Mallakh conducted a study of MPH is bipolar
disorder (El-Mallakh, 2 Bipolar Disorders 56-59 (2000)).
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