Ex Parte Vandendriessche et al - Page 2

                Appeal No. 2006-1036                                                                          
                Application No. 10/191,760                                                                    

                      6. A method to obtain therapeutic levels of Factor VIII in a                            
                      mammal comprising:                                                                      
                             administering less than 1010 infectious units of a                               
                      recombinant high capacity adenoviral vector per kg of body                              
                      weight or less than 1012 viral particles of the recombinant high                        
                      capacity adenoviral vector per kg of body weight intravenously                          
                      to the mammal’s liver;                                                                  
                             wherein the recombinant high capacity adenoviral vector                          
                      comprises:                                                                              
                      an Ad5 left terminus;                                                                   
                      a human or canine Factor VIII cDNA under the control of a                               
                      liver specific promoter, wherein the B-domain of the Factor                             
                      VIII cDNA has been deleted; and                                                         
                      an Ad5 right terminus.                                                                  
                13. A method of treating hemophilia A in a mammal,                                            
                      comprising:                                                                             
                         administering less than 1010 infectious units of a                                   
                      recombinant high capacity adenoviral vector per kg of body                              
                      weight or less than 1012 viral particles of the recombinant high                        
                      capacity viral vector per kg of body weight intravenously to the                        
                      mammal’s liver, said recombinant high capacity adenoviral                               
                      vector comprising:                                                                      
                      an Ad5 left terminus;                                                                   
                      a human or canine Factor VIII cDNA under the control of a                               
                      liver specific promoter, wherein the B-domain of the                                    
                      Factor VIII cDNA has been deleted; and                                                  
                      an Ad5 right terminus;                                                                  
                             thus generating therapeutic amounts of Factor VIII in                            
                      said mammal to substantially ameliorate the effects of                                  
                      hemophilia A.                                                                           
                      Claims 6, 12, 13, and 17 stand rejected under 35 U.S.C. § 112, first                    
                paragraph, on the grounds that the specification fails to enable the full scope               
                of the claimed subject matter.  We reverse.                                                   



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