Appeal 2007-1378
Application 10/327,459
1 According to appellants, pharmaceutical manufacturers now prefer
2 the use of direct compression, over wet and dry granulation processes,
3 because of its shorter processing times and cost advantages. Specification,
4 page 1:20-23.
5 What appellants tell us about the preference for direct compression, at
6 least as of the date the application on appeal was filed (20 December 2002),
7 is not precisely the same as what appellants’ assignee said about forming
8 tablets in Curatolo, which was filed on 29 April 1994. Apparently the art
9 has evolved between 1994 and 2002, as is often the case.
10 Appellants note, in this respect, that direct compression is generally
11 limited to those situations in which the active ingredient has physical
12 characteristics suitable for forming pharmaceutically acceptable tablets via
13 direct compression. Specification, page 1:23-26.
14 Some active ingredients, which are generally unsuitable for direct
15 compression per se, can be formed into a directly compressible formulation
16 by incorporating one or more excipients before compression. Specification,
17 page 1:27-30.
18 It is known that, to form a tablet from a given formulation, the
19 formulation must have good flow properties for precise volumetic feeding of
20 the material [i.e., formulation,] to a die cavity and suitable compressibility,
21 compactability, and ejection properties to form a tablet. Specification,
22 page 2: 18-23.
23 The flow properties of powders are said to be critical for “efficient
24 tableting operation.” Specification, page 2:23-24.
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