Ex Parte Burns et al - Page 7


               Appeal No. 2006-3224                                                                          Page 7                   
               Application No. 10/063,656                                                                                             

               microspheres are formed in Rembaum’s process after polymerization is initiated,                                        
               without additional steps.                                                                                              
                       The Examiner argues that “Rembaum discloses emulsion aggregation.                                              
               Rembaum in column 7, lines 17-19, specifically discloses that large aggregates are                                     
               removed by centrifugation. Thus, since large aggregates are removed, then the process                                  
               has resulted in the formation of aggregates and only the large aggregates are                                          
               removed.”  Answer, page 10.  We do not agree with this reasoning.  In the example the                                  
               Examiner describes, already formed polymeric microspheres are labeled with antibody.                                   
               Rembaum, beginning at column 6, line 51.  During the labeling procedure, aggregates                                    
               are produced.  Id., column 7, lines 15-19.  These are removed by centrifugation.  Id.,                                 
               column 7, lines 17-19.  The formation of these aggregates is not part of Rembaum’s                                     
               emulsion polymerization process, but a result of the subsequent antibody labeling                                      
               process.  Consequently, we do not consider it relevant that additional aggregates may                                  
               remain in the labeling solution after the centrifugation step.  Furthermore, the Examiner                              
               has not identified a reasonable basis for presuming that the hypothetical aggregates                                   
               which remain are coalesced into individual polymeric microspheres, instead of being                                    
               separate microspheres which have aggregated together but retain their individual                                       
               identity.                                                                                                              
                       The Examiner also argues that “[c]oalescing or fusion takes place when the                                     
               polymerization mixture is heated [and] in Rembaum, [and that] the container containing                                 
               the mixture is placed in a hot water bath . . . would undergo coalescing.”  Answer, pages                              
               10-11; Rembaum, column 4, lines 60-68.  However, this step is utilized to initiate the                                 
               polymerization of the monomers, and is not accompanied by a step of “aggregating” as                                   





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