Ex parte TODARO et al. - Page 4




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


                     The specification describes the hybrid cytokines as being useful in treating                        
              “indications for which their native counterparts are often employed.”  See lines 18-20 on                  
              page 17 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 4 of the                  
              specification.                                                                                             
                     In initiating and maintaining the rejection of the claims under 35 U.S.C.  112, first              
              paragraph (enablement), 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                     
              activity 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.   Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, 1366,  42                         
              USPQ2d 1001, 1005 (Fed. Cir. 1997); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802                    
              F.2d 1367, 1385, 231 USPQ 81, 94 (Fed. Cir. 1986).   As indicated the specification                        
              describes the hybrid cytokines are useful for treating the indications for which their native              
              counterparts are employed, and describes several of the known, prior art uses for the                      
              native cytokines.  The examiner has not explained why the claimed hybrid cytokines would                   
              not be useful in the same manner.                                                                          


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