Ex Parte Fergione et al - Page 8



                  Appeal 2007-1082                                                                                           
                  Application 10/327,383                                                                                     
             1                   (ii) optionally particles of one or more                                                    
             2                   pharmaceutically acceptable excipients,1 and                                                
             3                   (iii) non-dihydrate azithromycin particles                                                  
             4                   to form wet granules, wherein the wet granules comprise non-                                
             5                   dihydrate azithromycin and the non-aqueous granulating liquid;                              
             6                   and                                                                                         
             7                   b) drying the wet granules to remove the non-aqueous                                        
             8                   granulating liquid and thereby form non-dihydrate azithromycin                              
             9                   granules;                                                                                   
           10                           wherein said non-dihydrate azithromycin is selected from                             
           11                    the group consisting of substantially pure azithromycin                                     
           12                    monohydrate hemi-ethanol solvate and azithromycin                                           
           13                    sesquihydrate.                                                                              
           14                                                                                                                
           15            Claim 15 is representative of the composition claims on appeal.                                     
           16            Claim 15 reads:                                                                                     
           17                    A granule comprising non-dihydrate azithromycin and                                         
           18                    optionally, one or more excipients2 wherein said granule is                                 

                                                                                                                            
                  1  Normally in assessing the scope of a claim, every limitation in a claim                                 
                  should be given some meaning.  However, limitation a) (ii) adds absolutely                                 
                  nothing to define the scope of the claim.   A method “comprising” (1) steps                                
                  a) (i) and a) (iii) and (2) b) has precisely the same scope as a method                                    
                  including step a) (ii) due to the language “optionally” in step a) (ii) and the                            
                  transition phrase “comprising” which appears after the preamble.  We would                                 
                  recommend that step a) (ii) be deleted from claim 1 and be made the subject                                
                  of a claim depending from claim 1 in which limitation a) (ii) appears in the                               
                  dependent claim.                                                                                           
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