Ex Parte ZAVADA et al - Page 14


                    Appeal No. 2001-1970                                                                     Page 14                        
                    Application No. 08/260,190                                                                                              

                    a person of skill in the relevant field.  The enablement requirement is determined,                                     
                    of course, from the perspective of those skilled in the art.  See Amgen, Inc. v.                                        
                    Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1335, 65 USPQ2d 1385, 1400                                                 
                    (Fed. Cir. 2003). (“[T]he [enablement] requirement is satisfied if, given what they                                     
                    already know, the specification teaches those in the art enough that they can                                           
                    make and use the invention without ‘undue experimentation.’”).                                                          
                            The examiner appeared to start from the position that the claims were                                           
                    nonenabled, and then evaluate the declaration for whether it provided additional                                        
                    “factual evidence” in rebuttal.  This approach is erroneous.  “If a prima facie case                                    
                    is made in the first instance, and if the applicant comes forward with reasonable                                       
                    rebuttal, whether buttressed by experiment, prior art references, or argument, the                                      
                    entire merits of the matter are to be reweighed.”  In re Hedges, 783 F.2d 1038,                                         
                    1039, 228 USPQ 685, 686 (Fed. Cir. 1986).  See also In re Rinehart, 531 F.2d                                            
                    1048, 1052, 189 USPQ 143, 147 (CCPA 1976):                                                                              
                            When prima facie obviousness is established and evidence is                                                     
                            submitted in rebuttal, the decision-maker must start over. . . .  An                                            
                            earlier decision should not . . . be considered as set in concrete,                                             
                            and applicant’s rebuttal evidence then be evaluated only on its                                                 
                            knockdown ability.  Analytical fixation on an earlier decision can                                              
                            tend to provide that decision with an undeservedly broadened                                                    
                            umbrella effect.  Prima facie obviousness is a legal conclusion, not                                            
                            a fact.  Facts established by rebuttal evidence must be evaluated                                               
                            along with the facts on which the earlier conclusion was reached,                                               
                            not against the conclusion itself.                                                                              
                            While Hedges and Rinehart were addressed specifically to the issue of                                           
                    obviousness, the same evaluation applies to any patentability determination.                                            
                    Even if a prima facie case is made out, when evidence is submitted in rebuttal, all                                     






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