Appeal 2007-1348
Application 10/650,253
1 The second issue is whether appellants have sustained their burden of
2 showing that the Examiner erred in rejecting the claims on appeal as being
3 anticipated under 35 U.S.C. § 102(b) by Bright, alternatively that the
4 claimed subject matter is unpatentable under 35 U.S.C. § 103(a) over Bright.
5 The third issue is whether appellants have sustained their burden of
6 showing that the Examiner erred in rejecting the claims on appeal as being
7 unpatentable under 35 U.S.C. § 103(a) over Singer and Curatolo.
8 Involved in the resolution of all three issues is the scope of claim 125.
9
10 D. Findings of fact
11 The following findings of fact are believed to be supported by a
12 preponderance of the evidence. To the extent that a finding of fact is a
13 conclusion of law, it may be treated as such. Additional findings as
14 necessary may appear in the Discussion portion of the opinion.
15 Claim 125
16 Claim 125 is representative of the claims on appeal.
17 According to the claims appendix accompanying the Appeal Brief,
18 claim 125 reads [matter in brackets added]:
19 A pharmaceutical dosage form comprising said [sic “a”]
20 [1] substantially pure crystalline azithromycin monohydrate
21 hemi-ethanol solvate and [2] a pharmaceutically acceptable
22 carrier or diluent; wherein said crystalline azithromycin
23 monohydrate hemi-ethanol solvate is characterized as having a
24 13C solid state NMR spectrum comprising at least one peak with
25 chemical shift of about 179.5 ppm.
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