Ex Parte EVANS et al - Page 4


                 Appeal No. 2001-1293                                                         Page 4                    
                 Application No. 08/464,271                                                                             

                                                      Discussion                                                        
                        The claims stand or fall together.  Appeal Brief, page 6.  We will consider                     
                 independent claim 44 as representative of the claimed method.  The remaining                           
                 claims will stand or fall with claim 44.1                                                              
                        Claim 44 is directed to a method for killing cells of a particular tissue-type                  
                 or cell line in an organism, where the targeted cells comprise endogenous                              
                 thymidine kinase and exogenous DNA, linked to a tissue-specific promoter,                              
                 encoding an enzyme that converts a latent toxin to a cell toxin.  The only                             
                 manipulative step recited in claim 44 is that of “administering to said organism an                    
                 amount of said latent toxin effective to trigger generation of said cell toxin by                      
                 enzymatic conversion of the latent toxin; thereby inhibiting growth or causing                         
                 death of at least a substantial portion of said tissue-type or cell line.”                             
                        The examiner rejected the claims as nonenabled, on the basis that the                           
                 specification “does not reasonably provide enablement for a method of                                  
                 selectively inhibiting the growth or causing death of all tissue types in any and all                  
                 intact organisms comprising producing all transgenic organisms comprising DNA                          
                 encoding and expressing any and all exogenous enzymes that selectively                                 
                 convert a latent toxin into a cell toxin, wherein said DNA is operatively linked to a                  
                 promoter specific for any and all tissue types.”  Examiner’s Answer, page 4.2  The                     
                 examiner thus concluded that the claims were overly broad with respect to the                          

                                                                                                                        
                 1 We will, however, consider claims 40 and 41 separately, for reasons that are explained infra.        
                 2 The examiner also concluded that the specification does not “enable methods of selectively           
                 inhibiting the growth or causing death of all tissue types in any and all intact organisms             
                 comprising using any and all methods of gene therapy.”  Id.  For reasons that will become clear,       
                 we need address this basis of the rejection only with regard to claims 40 and 41.                      





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