Ex Parte COULTER et al - Page 4



               Appeal No.  2002-2279                                                                  Page 4                          
               Application No. 08/556,667                                                                                             
                       Currently, one approach is to utilize a plurality of magnetic microspheres,                                    
                       typically formed of a polymer based magnetic material of a relatively low                                      
                       density . . . [T]he microspheres are mixed with the bone marrow or blood                                       
                       and . . . are intended to be maintained in suspension in the sample and                                        
                       consequently are designed for very slow or substantial elimination of                                          
                       gravity settling in the sample suspension.                                                                     
                       The magnetic microspheres have at least one antibody bound thereto                                             
                       specific to the population or subpopulation desired to be removed . . . For                                    
                       purging blood or bone marrow, a sample would be mixed with a plurality of                                      
                       the antibody bound microspheres and then placed in a magnetic field.                                           
                       The remaining sample or supernatant is removed while the microspheres                                          
                       are held in the magnetic field.  This procedure typically must be repeated,                                    
                       since a single purging step generally will not deplete a sufficient                                            
                       percentage of the undesired population . . .                                                                   
                       The magnetic removal procedure . . . removes a number of cells non-                                            
                       specifically from other populations during each removal step . . . A single                                    
                       removal step results in a varying yield of a relatively low percent with each                                  
                       succeeding step also reducing the yield.                                                                       
               Specification, pages 2-3.                                                                                              
                       According to appellants, the present invention solves this problem by mixing the                               
               sample with particles “substantially more dense than the cells, at least on the order of                               
               two (2) to three (3) times more dense than the cells” and allowing “the particles and the                              
               targeted populations bound thereto [to] settle differentially through the sample [ ],                                  
               leaving the unbound/non-targeted populations in suspension” (specification, page 10).                                  
               “An advantage of the dense particles [ ] is that they differentially will gravity settle                               
               through the sample [ ] following mixing without substantial trapping of non-selected or                                
               non-targeted cells” (id., pages 9-10), “provid[ing] a high yield of the cells of interest even                         
               after multiple removal steps” (id., page 6).                                                                           
                                                          DISCUSSION                                                                  
                       The examiner rejected all of the claims as obvious over the prior art, and each of                             
               six the rejections relies, at least in part, on the examiner’s proposed combination of                                 
               Reynolds with Grenier or Pry, so we will discuss all six rejections together.                                          



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