Ex Parte Fergione et al - Page 10



                  Appeal 2007-1082                                                                                           
                  Application 10/327,383                                                                                     
             1    hydroxytoluene—col. 2:41-42] ... was dissolved in ethanol and the solution                                 
             2    was sprayed onto the azithromycin with thorough mixing.”  Col. 10:4-8.                                     
             3           According to Formulation 1, “[s]tabilized azithromycin resulting                                    
             4    from Preparation 7 was formulated into a wet granulated tablet ....”                                       
             5    Col. 11:51-53.                                                                                             
             6           The process of making Formulation 1 is described as mixing                                          
             7    Preparation 7 with denatured alcohol to form granules and then drying the                                  
             8    granules.  See steps 2-5 in col. 12:35-40.                                                                 
             9           The description of making Formulation 1 from Preparation 7 is                                       
           10     consistent with the Examiner’s finding that “Tenengauzer ... teach[es] that                                
           11     formulation containing azithromycin can be formed into granules ... by wet                                 
           12     granulation ....”  Examiner’s Answer, page 4.                                                              
           13                                             Singer                                                             
           14            The Examiner found that Singer describes “azithromycin ethanolate                                   
           15     which can be formed into tablets ... but do[es] not disclose a method of                                   
           16     forming azithromycin ethanolate into granules by wet granulation.”                                         
           17     Examiner’s Answer, page 5:1-3.                                                                             
           18            A review of Singer will confirm the Examiner’s finding.                                             
           19            For example, Singer teaches that oral forms of administering                                        
           20     azithromycin includes “tablets.”  Col. 3:24-25.                                                            
           21            An Example in Singer describes preparation of azithromycin                                          
           22     ethanolate.  Col. 3:54.                                                                                    





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