Ex Parte BURTON et al - Page 3



              Appeal No. 2003-0177                                                                 Page 3                
              Application No. 09/231,642                                                                                 

              restriction requirement, claim 1 has only been examined to the extent that the antibody                    
              is specific to carcinoembryonic antigen (CEA).  See Paper No. 8, page 3 ("The claims                       
              encompass non-elected embodiments.  These claims will be examined only to the                              
              extent they read on a targeting moiety comprising an antibody specific to CEA linked to                    
              a ligand binding region of IL-13R".").  Thus, it appears that claim 6 reflects the subject                 
              matter which has been examined by the examiner on the merits and thus before us for                        
              review in this appeal.                                                                                     
                     Eshhar describes a conjugate which also comprises an antibody and a ligand-                         
              binding region of a cellular receptor.  Specifically, the antibody portion of the Eshhar                   
              conjugate is a single-chain Fv domain (scFv) of a specific antibody.  Eshhar, page 7,                      
              lines 9-16.  A preferred embodiment of Eshhar is that the conjugate is to target tumor                     
              cells and the scFv domain is derived from an antibody specific to an epitope expressed                     
              on the tumor cell.  Id., page 19, lines 7-9.  There is no dispute on this record that CEA                  
              would have been an obvious choice to one of ordinary skill in the art in designing the                     
              conjugate of Eshhar to target tumor cells.  As set forth by appellants:                                    
                     CEA is a glycosylated cell surface protein of approximately 180 kDa,                                
                     and is a solid tumor antigen that has been extensively studied clinically,                          
                     both as a circulating tumor marker and as an antigenic target for                                   
                     radiolabeled mAbs for imaging and therapy.  A number of anti-CEA                                    
                     antibodies have been under study in phase I-III clinical diagnostic and                             
                     therapeutic trials.  Exemplary of an anti-CEA mAb is the MN-14mAb.  A                               
                     humanized version of this mAb, hMN-14, in which human constant and                                  
                     framework regions replace the corresponding mouse sequences, has                                    
                     been constructed and expressed and is the mAb and used in these                                     
                     clinical trials.  A 99mTc-labeled Fab' fragment of another, related anti-CEA                        
                     mAb, Immu-4, has received FDA approval for the detection and staging of                             
                     colon cancer.                                                                                       







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