Appeal 2007-1082
Application 10/327,383
1 A useful empirical guide to flow is given by Carr’s Compressibility
2 Index: Compressibility Index (%) = [(tapped density – initial density)
3 divided by tapped density] x 100. Specification, page 22:25-29.
4 Appellants tell us that it is preferred that the granules have a Carr’s
5 Compressibility Index of less than about 34%, more preferably less than
6 about 31%, and even more preferably less than about 28%. Specification,
7 page 22:31 through 23:2.
8 Example 6 describes a process of wet granulation of formulation of
9 Azithromycin Form F according to the invention. Specification, page 47:1
10 through end of page 48.
11 Azithromycin Form F has the empirical formula:
12 C38H72N2O12·H2O·0.5C2H5OH
13 in the single crystal structure and is referred to by appellants as being
14 azithromycin monohydrate hemi-ethanol solvate. Specification, page 7:1-3.
15 The structural formula of azithromycin is shown in Singer.
16 Col. 1:20-30.
17 Tapped density data is presented in the specification of bulk
18 azithromycin and various granulated azithromycins. Specification, page 48,
19 Table 6.
20 We will assume for the purpose of deciding the appeal that the data is
21 based on actual experimentation.
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