Appeal 2007-0860
Application 10/148,535
In my view, the two questions before us are:
1) At the time of Appellants’ claimed invention, would the prior art have
suggested the use of Ritalin to treat epilepsy and/or bipolar disorder,
with a reasonable likelihood of success, and thus render prima facie
obvious the use of its l-enantiomer “in substantially single enantiomer
form” for the same indications?
2) If so, have Appellants provided sufficient evidence of unexpected
results in using the l-enantiomer to treat either of these disorders?
Based on the facts in this case, as elaborated below, I conclude the
answer to the first question is “yes,” and the answer to the second is “no.”
These conclusions flow from the following facts:
Facts Relating to Question One: Prima Facie Obviousness
Appellants’ Contribution
1. Ritalin® (racemic MPH) has been widely used for more than half a
century5 to treat ADHD, particularly in children.
2. Children with ADHD frequently also have epilepsy and/or bipolar
disorder (see, e.g., Gross-Tsur & Carlson); thus, children with these
disorders have been treated with Ritalin®. (See id.)
3. Appellants did not discover Ritalin and did not resolve the
enantiomers. (See Spec. passim.)
4. According to Appellants, they found the l-threo-enantiomer
“possesses pharmacological activity broadly similar to that of the d-
enantiomer and the racemate.” (Spec. 2.)
5 Methylphenidate was first patented in 1954 by the Ciba pharmaceutical
company, a predecessor of Novartis, maker of Ritalin®.
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