BRAKE v. SINGH - Page 35




                Interference 102,728                                                                                                          
                determining obviousness.  W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d                                             
                1540, 1550, 220 USPQ 303, 311 (Fed. Cir. 1983).  The issue here, however, is                                                  
                enablement and whether one skilled in the art would have been able to “make and use”                                          
                the invention defined by the count without undue experimentation at the time the                                              
                application was filed.  The factors to be considered in determining whether a disclosure                                      
                would require undue experimentation were set forth by the court more than four (4)                                            
                years prior to the filing of Singh’s Opposition in In re Wands, 858 F.2d 731, 8 USPQ2d                                        
                1400 (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.  In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.                                                         

                We find that Singh’s Opposition conspicuously lacks any analysis of the Brake 1                                               
                application in view of the Wand’s factors.                                                                                    
                         Second, we find Dr. Falkinham’s declaration insufficient to support Singh’s                                          
                position that based on the formula TR-L-(R-R(GAXYCX)n-W-(Gene*)d)y, one skilled in                                            
                the art would have determined that a construct which included two to three “glu-ala” or                                       
                “asp-ala” sequences was preferred over one lacking these sequences.  It is not clear                                          
                where Dr. Falkinham mentions the referenced formula in his declaration.  In fact, it is                                       
                not clear to us, which formula he is discussing in the paragraph (para. 9) of his                                             
                declaration relied upon by Singh.                                                                                             



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