Ex Parte ROLLINS et al - Page 7


                   Appeal No. 2001-0869                                                                  Page 7                       
                   Application No. 08/453,347                                                                                         

                   applicant to provide suitable proofs indicating that the specification is indeed                                   
                   enabling.”  In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed.                                       
                   Cir. 1993).                                                                                                        
                           “[E]nablement requires that the specification teach those in the art to make                               
                   and use the invention without ‘undue experimentation.’  That some                                                  
                   experimentation may be required is not fatal; the issue is whether the amount of                                   
                   experimentation required is ‘undue.’”  In re Vaeck, 947 F.2d 488, 495, 20                                          
                   USPQ2d 1438, 1444 (Fed. Cir. 1991) (citation omitted, emphasis in original).                                       
                   “Whether undue experimentation is needed is not a single, simple factual                                           
                   determination, but rather is a conclusion reached by weighing many factual                                         
                   considerations.”  In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.                                        
                   Cir. 1988).  Those considerations, see id., are well known and need not be                                         
                   repeated here.                                                                                                     
                           In this case, we agree with appellants that the examiner has not shown                                     
                   that undue experimentation would have been required to practice the claimed                                        
                   method.  The examiner’s concerns, and the evidence cited in support of the                                         
                   rejection, are directed to sources of unpredictability and experimentation involved                                
                   in gene therapy in general, rather than the claimed method in particular.                                          
                   Granted, the examiner’s references show that (at least as of 1995) gene therapy                                    
                   techniques, as a group, required further experimentation before they would be                                      
                   ready for clinical application.  This showing, however, is not enough to support a                                 
                   rejection of the instant claims for nonenablement.                                                                 







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