Appeal No. 2006-3234
Application No. 90/006,410
a. Schneider has been employed by the manufacturer of
Mediabet tablets since October of 1972 and was familiar with
the Mediabet preparation. (Schneider declaration at page 1 and
¶ 1).
b. As of 26 February 1993, the tablet core of Mediabet
contained, in addition to metformin, soluble
polyvinylpyrrolidone. (Schneider declaration at ¶ 3).
c. “Before tableting, the pharmaceutical composition of
MEDIABET was adjusted to a residual moisture content of no
more than 2.0 weight % (measured as drying loss) [and that]
[t]he residual moisture content also exceeded a lower threshold
of 0.5%...”. (Schneider declaration at ¶3).
14. Our own review of the Schneider declaration in combination
with the Red List shows a slight difference between the
formulation of Mediabet reported by Schneider and that
reported by the Red List.
15. For example, Schneider reports that the coating of the
metformin tablet contained “methylhydroxy propyl cellulose”
while the Red List reports a “methyl cellulose” component.
(Schneider declaration at ¶5 and Red List at entry 11 081).
16. Appellant does not note these differences nor argue that the
differences between the reported compositions of Mediabet
would affect residual moisture content.
17. Appellant has not directed us to evidence establishing that
tableting would affect residual moisture content.
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