Appeal 2007-0860
Application 10/148,535
compounds (infra FFs 7, 8). Thus, the only difference between the claimed
invention and what was in the prior art is reflected in the claim requirement
that treatment be with “l-threo-methylphenidate in substantially single
enantiomer form.” (Claim 7.) The level of skill in the relevant art is
reflected in an extensive body of literature, resulting from the fact Ritalin®
(racemic MPH) has been on the market for a very long time (infra FF 1), has
been a successful product, and has been widely used to treat many
indications, including those presently claimed (infra FFs 1, 2, 9, 13, 22, 25).
Given this background, one must ask, why wouldn’t it have been
obvious to use the l-enantiomer to treat epilepsy and/or bipolar disorder, in
view of the use of the racemate to treat such conditions?
As I understand the majority’s position, they find (1) Harris teaches
the value of the d-enantiomer rather than the l-enantiomer because d is
described as “preferred”; (2) the three cited references do not suggest the
racemate was effective in treating either seizures or bipolar disorder; and (3)
Gross-Tsur teaches away from such treatment (at least with respect to
seizures) by stating: “Caution is warranted for children still having seizures
. . . ” (Gross-Tsur, at 674).
These conclusions overlook (1) Harris’ clear teaching that both
enantiomers are useful pharmaceuticals (infra FFs 7, 8); (2) Gross-Tsur’s
disclosure of Wroblewski’s success in treating seizures with Ritalin (infra
FFs 11, 13); and (2) what those skilled in the art would have known about
Ritalin, i.e., that it is a stimulant and thus would have been expected to
successfully treat seizures and bipolar disorder, just like other stimulants do
(infra FFs 14-19).
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