Ex parte TODARO et al. - Page 4




              Appeal No. 1997-3020                                                                                           
              Application 08/149,101                                                                                         

                      Claim 1 recites a hybrid cytokine comprising 1) four "-helical regions, wherein the                    
              four "-helical regions are 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), interleukin-11 (E), ciliary neurotrophic factor (C) and             
              oncostatin-M (O), and 2) three linking sequences, the linking sequences selected from at                       
              least a portion of one or more linking sequences from any of the foregoing cytokines.  At                      
              least one of the "-helical regions of the hybrid cytokine is derived from a factor different                   
              from that of the other "-helical regions.                                                                      
                      The specification describes the hybrid cytokines as being useful in treating                           
              “indications for which their native counterparts are often employed.”  See lines 22-23 on                      
              page 13 of the specification.  The native counterparts used to make the hybrid cytokines                       
              as well as certain of their activities and uses are described on pages                                         
              1 through 3 of the specification.                                                                              
                      In initiating and maintaining the rejection of the claims under 35 U.S.C. § 112, first                 
              paragraph, it does not appear that the examiner has considered the relevant legal                              
              standards which govern the issue of enablement.  As a consequence, the requisite factual                       
              analysis has not been undertaken by the examiner.  For example, the examiner has not                           
              presented a reasoned analysis of the state of the prior art in regard to the known uses of                     
              the native cytokines which are used to make the hybrid cytokines of the invention.  Such an                    
              analysis is needed since the specification need not disclose what is well known in the art.                    

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