Ex Parte CUNNINGHAM et al - Page 6


                  Appeal No. 2003-1469                                                            Page 6                     
                  Application No. 08/479,886                                                                                 

                         The examiner considered the factors set out in In re Wands, 858 F.2d 731,                           
                  737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), and concluded that “the breadth of                              
                  the instant claims is not commensurate in scope with the specification.”                                   
                  Examiner’s Answer, pages 8-9.  The examiner summed up her position as                                      
                  follows:  “Unless one has a reasonable expectation that any one material                                   
                  embodiment of the claimed invention would be more likely than not to function in                           
                  the manner disclosed or the instant specification provides sufficient guidance to                          
                  permit one to identify those embodiments which are more likely to work than not                            
                  without actually making and testing them, then the instant application does not                            
                  support the breadth of the claims.”  Examiner’s Answer, page 10.                                           
                         Appellants argue that the Wands factors do not support the examiner’s                               
                  conclusion.  See the Appeal Brief, pages 5-6.  In particular, Appellants argue that                        
                  no more than routine experimentation would have been required to make the                                  
                  claimed protein variants and to assay their binding properties.  See id., pages 7-                         
                  8.  Appellants argue that the examiner’s requirement for sufficient guidance to                            
                  predict the properties of variants within the scope of the claims is contrary to                           
                  case law, citing In re Angstadt, 537 F.2d 498, 190 USPQ 214 (CCPA 1976).  See                              
                  the Appeal Brief, pages 9-10.                                                                              
                         The examiner bears the initial burden of showing nonenablement.  See In                             
                  re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).                                  
                  That some experimentation is required does not suffice to show nonenablement;                              
                  “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).                                           





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