Ex parte ESMON et al. - Page 4




                Appeal No. 1997-3951                                                                               
                Application 08/238,987                                                                             





                As can be seen, composition claim 1 of the `638 patent requires the presence of “a                 
                cytokine selected from the group consisting of tumor necrosis factor and a cytokine                
                eliciting expression of tumor necrosis factor,” while composition claim 1 on appeal                
                in relevant part requires “a compound eliciting production of cytokine in the patient.”            
                       The examiner’s enablement rejection revolves around that portion of the                     
                claimed subject matter directed to “a compound eliciting production of cytokine in                 
                the patient.”   The examiner’s reasoning in support of the rejection appears on                    
                pages 3 and 4 of the Examiner’s Answer as follows:                                                 
                              The claims encompass any compound which elicits production of any                    
                       cytokine.  The scope of the claims is not commensurate with the evidence of                 
                       enablement provided by the disclosure with regard to the extremely large                    
                       number of compounds and cytokines broadly encompassed by the claims                         
                       and the claims broadly encompass a significant number of inoperative                        
                       species.  The evidence of record is limited to a combination of TNF with a                  
                       protein C blocking antibody or a combination of endotoxin with a protein C                  
                       blocking antibody.  There is no evidence of record in this application with                 
                       respect to any other cytokines or any other compounds which broadly elicit                  
                       production of any cytokine.  In view of the diverse biological activities of the            
                       cytokines and the cytokine network there is a reasonable doubt that any                     
                       compound which elicits production of any cytokine would be effective in                     
                       tumor therapy as claimed.                                                                   
                              Thus, Applicants have not provided sufficient guidance to enable one                 
                       of ordinary skill in the art to make and use the claimed composition in a                   
                       manner reasonably correlated with the scope of the disclosure.  The scope                   
                       of the claims must bear a reasonable correlation with the scope of                          

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