Ex parte TODARO et al. - Page 7




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


                            substances....” In re Dinh-Nguyen, 492 F.2d 856, 859, 181                                    
                            USPQ 46,48 (CCPA 1974).                                                                      
                     The examiner has criticized Leung #1 on the basis that the media containing the                     
              hybrid cytokine IGGG has less activity than conditioned media from mock transfected                        
              control cells in supporting the growth of 32D cells, a cytokine-dependent cell line.  The                  
              examiner believes that the declaration does not show that hybrid cytokines encompassed                     
              by the claims have predictable activity.  However, the activity of IGGG at concentrations of               
              2.5%, 5.0% and 10.0% is greater than the activity of the mock transfected control cells at                 
              the same concentrations.  Contrary to the examiner’s opinion,  Leung #1 demonstrates that                  
              the hybrid cytokine IGGG supports the growth of 32D cells.  Thus, one skilled in the art                   
              would, at the very least, know how to use the claimed hybrids as culture reagents for                      
              maintaining in vitro cultures of cytokine-dependent cell lines, similar to their native                    
              counterparts.  Again, it is not necessary to be able to predict with absolute certainty a                  
              specific hybrid’s activity for enablement under 35 U.S.C.  112, first paragraph.                          
                     The examiner has criticized Leung #2 on the basis that all of the different hybrid                  
              cytokines tested, having different native "-helical regions, demonstrate the same activity                 
              concerning the growth of Il-6-dependent cells 7TD1.  Therefore, the examiner is of the                     
              opinion that these results underscore the unpredictability of the activity of the claimed                  
              hybrids.  However, the examiner has again misapplied the standard of enablement based                      
              solely on predictability in assessing the evidence presented in Leung #2.  This declaration                

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