Appeal 2007-0860
Application 10/148,535
concerns regarding the presumably innocuous nature of methylphenidate in
children whose seizures are not well controlled.” (Id. at 673-674.) Gross-
Tsur concludes that “[c]aution is warranted for children still having seizures,
but the benefits of methylphenidate on the child’s behavior and academic
achievements should be weighed against the possible risks of additional
seizures.” (Id. at 674.)
Gross-Tsur, therefore, does not relate to the treatment of epilepsy
using methylphenidate, but to looking at the possible side effects of the drug
in epileptic children who are concurrently taking antiepileptic drugs. Gross-
Tsur saw promising results with the use of methylphenidate in epileptics
with ADHD who had their seizures under control. In those, who did not,
Gross-Tsur cautioned against, and repeatedly referenced the PDR’s caution
against, giving methylphenidate to patients who experience seizures
apparently, because of the PDR’s warning that methylphenidate reduces the
seizure threshold. While Gross-Tsur reports their results indicate that
methylphenidate does not increase the frequency of seizures in epileptics
with ADHD, there is nothing in Gross-Tsur that would render obvious the
treatment of a seizure disorder, such as epilepsy, using methylphenidate. To
the contrary, Gross-Tsur specifically cautions against using methylphenidate
to treat ADHD in patients who also have a seizure disorder, stating that the
benefits as to behavior and academic achievements need to be weighed
against the risks of additional seizures.
Thus, contrary to the findings of the Examiner, Gross-Tsur does not
disclose the treatment of a convulsant state such as epilepsy using the
racemic form of methylphenidate, and in fact cautions against its use in
children whose seizures who are not under control. Combined with the
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