Ex Parte SANTOLI et al - Page 2


                  Appeal No. 2001-2411                                                                                         
                  Application No. 08/879,422                                                                                   

                                 but not interfere with the cytotoxic activity of the cells, said modified                     
                                 cells characterized by irreversibly arrested cell proliferation and                           
                                 non-MHC restricted cytotoxic activity, in the absence of an                                   
                                 immunosuppressive agent.                                                                      
                          The examiner does not rely on any references.                                                        
                          Claims 1, 3, and 5-14 stand rejected under 35 U.S.C. § 112, second                                   
                  paragraph, as indefinite.                                                                                    
                          Claims 1, 3, and 5-14 also stand rejected under 35 U.S.C. § 112, first                               
                  paragraph, as lacking an adequate written description and an enabling disclosure                             
                  in the specification.                                                                                        
                          We reverse all three rejections.                                                                     
                                                        Background                                                             
                          The specification discloses that “[a]doptive transfer therapy for the                                
                  treatment of cancer has been described.  One such method makes use of a                                      
                  lethally irradiated human T cell line (TALL-104). . . .  To date, the use of this                            
                  TALL-104 cell line in such adoptive transfer has been described as requiring an                              
                  immunosuppressed patient.”  Pages 1-2.  The specification cites several                                      
                  publications as describing the use of TALL-104 cells to treat cancer in both                                 
                  immunodeficient animal models and immunocompetent animals having                                             
                  spontaneously arising cancers; in the latter experiments, the immunosuppressive                              
                  agent cyclosporin A was administered to avoid rejection of the allogeneic                                    
                  TALL-104 cells.  See page 2.  The specification discloses “a method of treating                              
                  cancer, and particularly, for preventing recurrence of cancer.  This method                                  
                  involves the step of administering an effective amount of modified TALL-104 cells                            


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