Ex Parte KARPF et al - Page 4


                    Appeal No. 1997-1830                                                                                                 
                    Application No. 08/389,860                                                                                           

                    long-term administration, such as that recited in the claims, was not an obvious                                     
                    dosage regimen.                                                                                                      
                            The examiner initially disparaged the Karpf declaration as “based on                                         
                    opinion without supporting data.”  Advisory Action, paper no. 9.  In the                                             
                    Examiner’s Answer, the examiner made only slightly more effort to address the                                        
                    factual contentions in the Karpf declaration, and concluded that Dr. Karpf’s                                         
                    statement that bisphosphonates were being tested for treatment of fractures                                          
                    actually supports the rejection.                                                                                     
                            The proper analysis of evidence submitted in response to a prima facie                                       
                    case of obviousness has been summarized as follows:                                                                  
                            When prima facie obviousness is established and evidence is                                                  
                            submitted in rebuttal, the decision-maker must start over.  Though                                           
                            the burden of going forward to rebut the prima facie case remains                                            
                            with the applicant, the question of whether that burden has been                                             
                            successfully carried requires that the entire path to decision be                                            
                            retraced.  An earlier decision should not . . . be considered as set in                                      
                            concrete, and applicant’s rebuttal evidence then be evaluated only                                           
                            on its knockdown ability.                                                                                    
                    In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976).  The                                             
                    facts supporting the examiner’s prima facie case are entitled to no more weight                                      
                    than the facts submitted to rebut it.                                                                                
                            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.  Though the tribunal must begin anew, a final                                             
                            finding of obviousness may of course be reached, but such finding                                            
                            will rest upon evaluation of all facts in evidence, uninfluenced by                                          
                            any earlier conclusion reached . . . upon a different record.                                                
                                                                                                                                        
                    Id.                                                                                                                  


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