Ex Parte Fergione et al - Page 4



                  Appeal 2007-1082                                                                                           
                  Application 10/327,383                                                                                     
             1           C.  Issues                                                                                          
             2           There are two principal issues on appeal.                                                           
             3           The first issue is whether appellants have sustained their burden of                                
             4    showing that the Examiner erred in rejecting the claims on appeal as being                                 
             5    unpatentable under 35 U.S.C. § 103(a) over Tenengauzer                                                     
             6           The second issue is whether appellants have sustained their burden of                               
             7    showing that the Examiner erred in rejecting the claims on appeal as being                                 
             8    unpatentable under 35 U.S.C. § 103(a) over Singer and Curatolo.                                            
             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                                         The invention                                                          
           16            The invention relates to a method of forming non-dihydrate                                          
           17     azithromycin granules.  Specification, page 2:18-19.                                                       
           18            The method involves mixing “non-dihydrate azithromycin” particles                                   
           19     with a “granulating amount” of a “granulating liquid” to form wet granules                                 
           20     of non-dihydrate azithromycin and then drying to remove any granulating                                    
           21     liquid to form azithromycin “granules.”  Specification, page 2:20-25.                                      
           22            “Granules” are particles of azithromycin which are adhered together                                 
           23     or agglomerated.  Specification, page 3:20-23.  Good granules typically have                               
           24     few fines, uniform size and stay intact after drying and sizing.  Specification,                           
           25     page 11:15-16.                                                                                             

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