Ex Parte DARNELL et al - Page 5


                 Appeal No.  2001-0121                                                          Page 5                    
                 Application No.  08/212,185                                                                              
                                                                                                                         
                         form or the phosphotyrisone itself (as anti-phosphotyrosine                                      
                         antibodies are well known in the art).                                                           
                         On reflection, it is our opinion that the examiner failed to provide the                         
                 evidence necessary to meet her burden of establishing a prima facie case of                              
                 non-enablement.  Instead, we agree with appellants argument (Brief, bridging                             
                 sentence, pages 12-13) that “[a]ppellants are not required to teach how to isolate                       
                 and characterize all of the receptor recognition factors that the method can be                          
                 performed on …, but rather are only required to enable the claimed methodology                           
                 such that it can be used on any given receptor recognition factor.”                                      
                         The enablement requirement of 35 U.S.C. § 112, first paragraph, requires                         
                 that the patent specification enable “those skilled in the art to make and use the                       
                 full scope of the claimed invention without ‘undue experimentation.’”  Genentech,                        
                 Inc. v. Novo Nordisk. A/S, 108 F.3d at 1365, 42 USPQ2d at 1004 (quoting In re                            
                 Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).                                     
                 Whether the disclosure is enabling, is a legal conclusion based on several                               
                 underlying factual inquiries.  To assist the fact finder in meeting his initial burden                   
                 of setting forth a reasonable explanation as to why he believes the scope of the                         
                 claimed invention is not adequately enabled by the description, our appellate                            
                 reviewing court has outlined a number of factors that should be considered.  As                          
                 set forth in In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402,                                
                 1404 (Fed. Cir. 1988), the factors to be considered in determining whether a                             
                 claimed invention is enabled throughout its scope without undue experimentation                          
                 include the quantity of experimentation necessary, the amount of direction or                            
                 guidance presented, the presence or absence of working examples, the nature                              






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