Appeal 2007-0860
Application 10/148,535
5. In fact, Appellants’ entire application is focused on a delivery route
other than oral, e.g., topical or subcutaneous, but Appellants have not so
limited their claims. (See Spec. 2-10 (including all examples).)
The Prior Art
6. Harris discloses the resolution of threo methylphenidate into the d
and l enantiomers. (Harris, at 1.)
7. Harris teaches that the “[s]ingle isomer methylphenidate . . . can be
used in therapy for the same purposes as the racemate.” (Id. at 2.)
8. Harris claims both of the isomers and their pharmaceutically-
acceptable salts.” (See claim 1.)
The Claims to Convulsive Disorders and Epilepsy
9. Gross-Tsur treated 30 children with both ADHD and epilepsy and
observed no increase in 26, an increase in 3, and a decrease in one. (Gross-
Tsur, at 670 (Abstract).)
10. Based on their data, Gross-Tsur concludes there was “no change
in seizure frequency” (id. at 672), yet, in spite of this conclusion suggests
“caution” when treating children having seizures with MPH (id. at 674).
11. Gross-Tsur describes the results of a study by Wroblewski et al.
in adults and children with traumatic brain injury and active seizure
disorders, noting that Wroblewski “found a trend toward a lesser incidence
of seizures during methylphenidate therapy.” (Id. at 673 (citing 53 J. Clin.
Psychiatry 86-89 (1992).)
12. Referring to the PDR warning that “Ritalin may lower the
convulsive threshold in patients with prior history of seizures,” Wroblewski
notes that “evidence for this statement appears to be lacking” (Wroblewski,
at 86).
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