Ex Parte Harland et al - Page 10


                 Appeal No.  2007-0079                                                       Page 10                  
                 Application No.  10/159,749                                                                          
                 specification of the application.”  In re Wright, 999 F.2d 1557, 1561-62, 27                         
                 USPQ2d 1510, 1513 (Fed. Cir. 1993).  “[T]o be enabling, the specification of a                       
                 patent must teach those skilled in the art how to make and use the full scope of                     
                 the claimed invention without ‘undue experimentation.’”  Id. at 1561, 27 USPQ2d                      
                 at 1513.                                                                                             
                        “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 factors include “(1) the quantity of experimentation necessary,                   
                 (2) the amount of direction or guidance presented, (3) the presence or absence                       
                 of working examples, (4) 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.”  Id.  Accordingly, we will address the                  
                 evidence of record as it relates to the factors set forth in Wands.                                  


                 A.  Breadth of the claims:                                                                           
                        As discussed above, the claims before us on appeal are directed to a                          
                 method which uses, inter alia, a deletion mutant of a sequence selected from the                     
                 group consisting of SEQ ID NO: 2 or 8.  Accordingly, the deletion mutant may be                      
                 of any size as long as it is derived from either SEQ ID NO: 2 or 8 and has the                       
                 functional activity set forth in the claims.                                                         









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