Ex parte TODARO et al. - Page 5

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

                     In the Examiner’s Answer (Paper No. 31, April 5, 1995), the examiner states on                      
              page 4 that “it would require undue experimentation for one of ordinary skill in the art to                
              make the hybrid cytokines such that the hybrid cytokines possess a desired activity and                    
              can be used in a beneficial manner.  Each hybrid cytokine would have to be tested for all of               
              the activities attributed to each native cytokine from which it is derived, as well as for any             
              'unique' property.”  Again, in making this statement, it does not appear that the examiner                 
              has taken into consideration the proper legal standards concerning issues of enablement                    
              under 35 U.S.C.  112, first paragraph, in that the examiner has not presented a fact-                     
              based analysis concerning how and why any experimentation needed to practice the                           
              invention would be “undue.”   As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75                
              F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996),                                                    
                            The fact that some experimentation is necessary does not preclude                            
                     enablement; what is required is that the amount of experimentation “must not                        
                     be unduly extensive”.  Atlas Powder Co. v. E.I. DuPont de Nemours & Co.,                            
                     750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).  The Patent                                
                     and Trademark Office Board of Appeals summarized the point well when it                             
                            The test is not merely quantitative, since a considerable amount of                          
                     experimentation is permissible, if it is merely routine, or if the specification                    
                     in question provides a reasonable amount of guidance with respect to the                            
                     direction in which the experimentation should proceed to enable the                                 
                            determination of how to practice a desired embodiment of the invention                       
                     Ex Parte Jackson, 217 USPQ 804, 807 (1982).                                                         


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