Appeal 2007-1082
Application 10/327,383
1 Curatolo
2 The Examiner found that Curatolo describes preparation of
3 azithromycin tablets and that granulation is a preferred step in the process of
4 formulating tablets. Examiner’s Answer, page 5.
5 The Examiner also found that Curatolo describes the use of
6 “excipients” in combination with azithromycin. Id.
7 Curatolo tells us that azithromycin is a broad spectrum antimicrobial
8 compound. Col. 1:11-13.
9 Curatolo, which predates Singer, describes an oral dosage form of
10 azithromycin. Col. 2:36-37.
11 Excipients may be combined with azithromycin. Col. 6:54-57.
12 Curatolo, which is said to be owned by appellants’ assignee Pfizer
13 Inc., tells one the following about the level of skill in the art more than one
14 year prior to the filing date of the application on appeal:
15 As known in the art, tablet blends may be dry-granulated
16 or wet granulated before tableting. Alternatively, tablet blends
17 may be directly compressed. The choice of processing
18 approach depends upon the properties of the drug and chosen
19 excipients, for example particle size, blending compatibility,
20 density and flowability. For azithromycin tablets, granulation
21 is preferred, with wet granulation being most preferred.
22 Azithromycin may be wet-granulated and then other excipients
23 may be added extragranularly. Alternatively, azithromycin and
24 one or more excipients may be wet-granulated.
25
26 Col. 7:51-61.
27
28 Curatolo confirms that wet granulating was a known technique for use
29 in the overall process of making azithromycin tablets.
11
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Last modified: September 9, 2013