Ex Parte Waller et al - Page 4

                Appeal 2007-0320                                                                                 
                Application 09/945,339                                                                           

                but their ability to proliferate must be reduced by more than 90% in order to                    
                substantially reduce their ability to cause graft versus host disease.                           
                The Rejection                                                                                    
                       The Examiner rejected claims 1-6 and 15-20 under 35 U.S.C. § 103(a)                       
                as unpatentable over Waller2 in view of Sykes.3                                                  
                       Waller describes “a method of transplanting hematopoietic system                          
                reconstituting cells from a donor to an antigenically matched or unmatched,                      
                genetically unrelated recipient or an antigenically unmatched, genetically                       
                related recipient with successful engraftment in the absence of GvHD”                            
                (Waller, col. 2, l. 66 to col. 3, l. 3 (emphasis added)).  Waller’s method                       
                comprises “administering to the recipient, prior to the administration of the                    
                hematopoietic . . . cells, an amount of mononuclear cells which are treated so                   
                as to render them incapable of proliferating and causing a lethal GvHD                           
                effect, but which are effective in enhancing subsequent engraftment of the                       
                hematopoietic . . . cells in the recipient” (id. at col. 3, ll. 8-14).  The                      
                mononuclear cells can be treated, “for example by exposure to a source of                        
                ionizing radiation” (id. at col. 4, ll. 43-44), or “with cytotoxic                               
                chemotherapeutic drugs” (id. at 4, ll. 66-67) including fludarabine (id. at 5, l.                
                11).                                                                                             
                       On first impression, Waller’s disclosure seems plain enough: “The                         
                mononuclear cells are ‘treated so as to render them incapable of                                 
                proliferating and causing a lethal GvHD effect’” (Waller, col. 4, ll. 40-41                      

                                                                                                                
                2  U.S. Patent 5,800,539 to Waller, issued September 1, 1998.                                    
                3  WO 99/25367, International Patent Application of Sykes, published                             
                May 27, 1999.                                                                                    
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