Appeal No. 2003-0913 6
Application No. 09/277,049
369-70 (CCPA 1971).
The examiner’s position is that the claimed subject matter is not enabled in the
specification, because claims 6 through 19 describe a process of making crystalline
meloxicam meglumin salt monohydrate and dihydrate by seeding the salt with the seed
crystal of the identical substance, in the absence of showing how the seed crystal is
prepared. As the examiner has stated, it is requisite that the specification provides,
“guidance on how the first crystalline salt monohydrate (or dihydrate) is made.” See
Answer, page 9.
We are persuaded however, that the specification and the art of record provide
adequate guidance and assurance that the seed crystals required by the claimed
process can be easily obtained. In this respect, the appellants have stated in the
specification that, “this condition can be met with a meloxicam-meglumin salt if, during
crystallization of the salt from a mixture of a water-miscible organic solvent and water,
seed crystals consisting of crystalline meloxicam-meglumin salt monohydrate,
preferably seed crystals of a meloxicam-meglumin salt monohydrate form previously
crystallised from acetone/water, are added to the mixture. A product is then obtained,
reproducibly and uniformly, which corresponds to the crystalline form of the seed
crystals used.” See specification page 9, lines 23-28. Accordingly, a method for the
preparation of a seed crystal is provided by the specification. Furthermore, the prior art
of record to Luger relied upon by the examiner in the art of record indicates that
meloxicam salts are customarily crystallised in the presence of solvents. In this respect,
Luger states that, “[l]ight yellow crystals of NH4+(C14H12O4N3S2)- were prepared from the
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