Ex parte TODARO et al. - Page 3




              Appeal No. 1996-2538                                                                                       
              Application 08/097,869                                                                                     


                                                     DISCUSSION                                                          
                     The patent examiner bears the initial burden of providing reasons why a supporting                  
              disclosure does not enable one skilled in the art to make and use a claimed invention.  In                 
              re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971).  The examiner’s                            
              position concerning the enablement of the appealed claims is two-fold.  First, the examiner                
              is of the opinion that it would require undue experimentation for one skilled in the art to                
              make the hybrid cytokines such that the hybrid cytokines possess a desired activity.                       
              Second, the examiner is of the opinion that there is an unpredictability in the activity of any            
              one hybrid cytokine encompassed by the claims on appeal.                                                   
                     Claim 1 on appeal recites a hybrid cytokine comprising first, second, third and                     
              fourth "-helical regions, wherein each of the first, second, third and fourth "-helical regions            
              is derived from the corresponding "-helical region of a factor selected from the group                     
              consisting of leukemia inhibitory factor (L), granulocyte-colony stimulating factor (G),                   
              interleukin-6 (I) and oncostatin (O), and wherein at least one of the "-helical regions of the             
              hybrid cytokine is derived from a factor different from that of the other "-helical regions.               
              Claim 20 is directed to a pharmaceutical or veterinary composition which comprises an                      
              effective amount of the hybrid cytokine in admixture with a pharmaceutically acceptable                    
              excipient.                                                                                                 




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