Ex Parte HOSOKAWA et al - Page 3




              Appeal No. 2002-1358                                                                                         
              Application No. 09/467,903                                                                                   
              pharmaceutical composition comprising antibody fragments.   Thus, the present claims                         
              have been limited by Appellants to a pharmaceutical composition comprising antibody                          
              fragments.                                                                                                   


              Technical Background                                                                                         
                     The claimed invention encompasses a pharmaceutical composition comprising a                           
              therapeutically effective amount of a monoclonal antibody fragment bound to the                              
              surface of a liposome enclosing an anti-cancer agent or toxin to cancer cells and a                          
              pharmaceutically acceptable carrier.  The monoclonal antibody fragment is specifically                       
              defined in the claims with reference to particular variable regions of the heavy and light                   
              chains of the antibody fragments.   Specification, pages 4, 7-8.   Anticancer agents                         
              encapsulated in the liposome include carcinostatic agents such as adriamycin,                                
              daunomycin, mitomycin, cisplatin, vincristine, toxins such as ricin A and diphtheria toxin,                  
              and antisense RNA.   Specification, page 11.  The antibody portion of the                                    
              pharmaceutical composition is provided to target and concentrate an anticancer agent                         
              to a tissue or organ to be treated.   Specification, pages 1 and 41.                                         
                     The preparation and use of Fab’ fragments bound to liposome are disclosed in                          
              the specification at pages 11-12.   The Fab’ fragments are prepared from F(ab')2                             






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