Ex Parte 5955106 et al - Page 7

                Appeal No.  2006-3234                                                                           
                Application No.  90/006,410                                                                     

                       26. The ‘106 disclosure lists “inadequate or excessive moisture                          
                             content of the granulate” as a possible cause of capping.  (‘106                   
                             at 2:2-7).                                                                         
                       27. Otaya also recognizes a link between moisture content and                            
                             capping.                                                                           
                       28. Otaya “found that capping depended on the amount of moisture                         
                             and could be almost completely eliminated.”  (Otaya at 1).                         
                       29. Otaya discloses that “it is a well-known fact that when a                            
                             medicine is made into a tablet by a stamping machine, in nearly                    
                             all cases a binding agent is added to the formation” and that                      
                             “even if a binding agent is added, capping often occurs.”                          
                             (Otaya at 1).                                                                      
                       30. Otaya describes an “experiment” where the drug sulfamin was                          
                             made into tablets.  (Otaya at 1).                                                  
                       31. Otaya used sulfamin tablets having various moisture contents in                      
                             the range of .24% to 1.25%.  (Otaya at 4, Table 2).                                
                       32. Otaya concluded that “[g]ranule moisture is an important cause                       
                             of capping[,]…the greater the stamping pressure, the stronger                      
                             the capping tendency;…[t]here is no correlation between                            
                             hardness and capping;..[and] the size of sulfamin crystal                          
                             particles had little effect on capping”.  (Otaya at 4).                            
                       33. Otaya does not disclose a tablet containing metformin.                               
                                                      Evenstad                                                  
                       34. Evenstad teaches tablets formed by a wet granulation technique                       
                             using an aqueous solvent, hydroxypropyl cellulose for                              


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