Ex Parte Bunick et al - Page 5


                  Appeal No. 2006-0204                                                              Page 5                     
                  Application No. 09/896,052                                                                                   

                  well within the purview of one of ordinary skill in the art” (id., page 5), “[t]herefore,                    
                  claim limitations drawn to such features are not considered by the examiner to                               
                  impart a patentable quality unto the instantly claimed invention” (id.).                                     
                          Appellants argue essentially that Lee does not “disclose[ ] any particle size                        
                  for anything, much less the claimed average particle size of the active agent                                
                  particles” (Appeal Brief, page 6), and that Friend does nothing to make up this                              
                  deficiency because Lee and Friend are not properly combinable (id., page 7).                                 
                  Appellants point out that the “excellent stability” of Lee’s chewable tablets is                             
                  attributed to the fact that the medicaments in the soft core are not subjected to                            
                  high temperatures, but are combined with the core materials at room temperature                              
                  (i.e., 25°C) (id., pages 7-8; Lee, column 3, lines 32-41).  Friend’s microcapsules,                          
                  on the other hand, are formed by mixing a drug, a solvent and two polymeric                                  
                  materials, heating the mixture to 70°C or more to dissolve the polymeric                                     
                  materials in the solvent, and cooling the mixture at a rate and temperature                                  
                  sufficient to effect phase separation and microencapsulation of the drug (Appeal                             
                  Brief, page 8; Friend, column 4, line 66 to column 5, line 50).                                              
                          The examiner argues that “there is nothing in the Friend [ ] patent that                             
                  requires that the incorporation of the disclosed encapsulated drug particles into                            
                  oral dosage forms takes place at the same elevated temperature (80°C) at which                               
                  the particles were prepared” (Examiner’s Answer, page 6).                                                    
                          Maybe so, but as we understand appellants’ position, it is that the drug in                          
                  Friend’s preparation is heated together with a solvent and two polymeric                                     
                  materials in order to form the microcapsules in the first place.  We agree with                              





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