Appeal 2007-1348
Application 10/650,253
1 Claim 125 requires two ingredients: (1) substantially pure crystalline
2 azithromycin Form F and (2) a carrier or diluent.
3 With respect to carriers and diluents, the following appears in the
4 specification (page 32:25-33; emphasis added):
5 The active compound may be administered alone or in
6 combination with pharmaceutically acceptable carriers or
7 diluents … and such administration may be carried out in single
8 or multiple doses. More particularly, the active compound may
9 be administered in a wide variety of different dosage forms, i.e.,
10 they may be combined with various pharmaceutically
11 acceptable insert carriers in the form of tablets, capsules,
12 lozenges, trouches, hard candies, powders, sprays, creams,
13 salves, suppositories, jellies, gels, pastes, lotions, ointments,
14 sachets, powders for oral suspension, aqueous suspensions,
15 injectable solutions, elixirs, syrups, and the like. Such carriers
16 include solid diluents or fillers, sterile aqueous media and
17 various non-toxic organic solvents, etc.
18
19 Bright
20 Bright describes azithromycin. Col. 1, lines 16-17 and col. 2,
21 lines 1-15.
22 Bright does not describe azithromycin Form F or substantially pure
23 Form F.
24 Singer
25 Singer describes an azithromycin which Singer characterizes as an
26 ethanolate of azithromycin having an ethanol content of about 1.5% to
27 about 3%. Col. 4, lines 16-17 (claim 1).
28 Li has previously sustained its burden of establishing that a Singer
29 ethanolate of azithromycin having an ethanol content of about 1.5% to about
6
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Last modified: September 9, 2013