Appeal 2007-1348
Application 10/650,253
1 The invention
2 A review of the specification will reveal that the crystalline
3 azithromycin to which appellants make reference in claim 125 is what we
4 believe appellants call “substantially pure” azithromycin “Form F.”
5 According to the specification, the invention relates to a crystal form
6 of azithromycin where the crystal form is selected from forms C, D, E, F, G,
7 H, J, M, N, O, P, Q and R. Specification, page 2:7-8.
8 A reference to Form F per se needs to be distinguished from a
9 reference to “substantially pure” Form F vis-à-vis other possible Form F’s.
10 See specification, page 2:28 and page 5:22-29.
11 The empirical formula of Form F is:
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.
15 The structural formula of azithromycin itself is shown in the
16 specification at page 1:8.
17 Form F has a 13C solid state NMR spectrum comprising at least one
18 peak with chemical shift at about 179.5 ppm ± 0.2 ppm. Specification,
19 page 2:19 and Fig. 23 (mentioned in the specification, page 9:6).
20 Crystallographic data of Form F is set out in a table on page 11 of the
21 specification.
22 For further information concerning substantially pure azithromycin
23 Form F we refer the reader to a MEMORANDUM OPINION and ORDER
24 (Decision on Motions) entered in Li v. Singer, Interference 105,366,
25 Paper 71 (Bd. Pat. App. & Int. Nov. 8, 2006).
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