Appeal 1997-3391
Application 08/212,578
The claims
1. The claims on appeal are claims 1-7.
2. According to applicants' reply brief, the claims
stand or fall together (page 1).
3. Claim 1 reads as following (indentation and
paragraph numbering added):
A pharmaceutical dosage unit comprising:
[1] flupirtine, its pharmaceutically acceptable salts
or mixtures thereof and
[2] a controlled-release component,
wherein 0.001 to 20 parts controlled release component
are present for each part by weight flupirtine (calculated
as flupirtine base)
which results in a release rate of flupirtine between 5
and 300 mg per hour, determined in accordance with the
method of USP XXII with apparatus 2 in an aqueous test
solution of pH 1.0 and/or pH 6.8.
The invention
4. Flupirtine is a known pharmaceutical useful as an
analgesic (specification, page 1, line 12).
5. According to applicants, its use "sometimes causes
a sedative side-effect" (specification, page 1, lines 12-13).
6. An object of applicants' invention is to provide a
solid dosage form of flupirtine in which the sedative side
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