Ex Parte LEON - Page 5


          Appeal No. 1999-2225                                                       
          Application No. 08/815,441                                                 



          F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).  As long           
          as "undue experimentation" is not involved, a specification would          
          comply with the enablement requirement of the statute even if a            
          reasonable amount of routine experimentation is necessary to               
          practice the claimed invention.  Enzo Biochem Inc. v. Calgene,             
          188 F.3d 1362, 1371, 52 USPQ2d 1129, 1135 (Fed. Cir. 1999).  Even          
          "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..."  Wands, 858 F.2d at           
          737, 8 USPQ2d at 1404.                                                     
               Here, the examiner has not undertaken the analytic                    
          framework, as set out in Wands, for determining whether one                
          skilled in the relevant art would be subject to "undue                     
          experimentation" in making and using the claimed invention.  For           
          this reason alone, the examiner has failed to carry the initial            
          burden of proof.                                                           
               The examiner fails to understand that a rejection under 35            
          U.S.C. § 112, first paragraph, must take into account various              


          the nature of the invention; (5) the state of the prior art; (6)           
          the relative skill of those in the art; (7) the predictability or          
          unpredictability of the art; and (8) the breadth of the claims.  In        
          re Wands, 858 F.2d 731, 735, 736-37,                                       
          8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988).                                


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