Ex Parte COULTER et al - Page 5



               Appeal No.  2002-2279                                                                         Page 5                   
               Application No. 08/556,667                                                                                             
                       Reynolds describes removing neuroblastoma cells from bone marrow by                                            
               incubating neuroblastoma cells with neuroblastoma cell-specific monoclonal antibodies,                                 
               mixing the antibody-coated cells with a bone marrow sample, capturing the antibody-                                    
               coated neuroblastoma cells with goat anti-mouse immunoglobulin-coated magnetic                                         
               microbeads, removing microbead-captured neuroblastoma cells from the bone marrow                                       
               sample by passing the sample over a magnet, and recovering the remaining bone                                          
               marrow cells from the purged sample.  “The efficacy of tumor cell removal depended on                                  
               the amount of monoclonal antibody bound to tumor cells and the immunobead/tumor                                        
               cell ratio.  In addition, two cycles of purging with both monoclonal antibodies and                                    
               immunobeads was superior to one cycle.  Using a cocktail of [ ] five antibodies, 3 to 4                                
               logs of tumor cells could be depleted from marrow with good recovery of viable                                         
               hematopoietic cells.”  Pages 5882 and 5883.  While Reynold’s magnetic immunobeads                                      
               are described as “[p]olystyrene porous magnetic beads . . . 3 :m in diameter,” no                                      
               mention is made of the density of the beads.                                                                           
                       Grenier describes a diagnostic immunoassay wherein excess labeled anti-                                        
               analyte antibody is removed “by adding a solid phase material having immobilized                                       
               thereon a compound having a preferential binding affinity for the labeled anti-[analyte]                               
               antibody” (column 3, lines 60-64).  “The solid phase material can be fabricated from any                               
               number of synthetic materials . . . such as agarose, polystyrene, polyacrylamide, their                                
               derivatives or mixtures thereof” (column 4, lines 18-22) and “is present as a particle or                              
               matrix having a density greater than water” (column 4, lines 3-4), “such that a rapid                                  
               dispersal by agitation and sediment by gravity is facilitated” (column 3, line 65 to column                            
               4, line 2).  Pry’s disclosure is essentially the same as Grenier’s in this respect, and is                             
               cited by the examiner for essentially the same reasons (Answer, pages 6 and 7).                                        




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