Ex parte SHAPIRO - Page 4



                Appeal No. 1997-3329                                                                                                         
                Application No. 08/396,988                                                                                                   


                The examiner has offered no other evidence in support of the proposition that the human                                      
                macrophage elastase was known in the prior art at the time of applicant's invention.                                         
                Absent evidence establishing that the protein was known, it would not have been obvious                                      
                to use the methodology of Shapiro, Flier or Docherty in combination with the cDNA library                                    
                of Gray to isolate and characterize an unknown protein.                                                                      
                        When we weigh all of the evidence, it is not clear what the situation was at the time                                
                of the invention.  However, the initial burden of presenting a prima facie case of                                           
                obviousness rests on the examiner.  In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d                                            
                1443, 1444  (Fed. Cir. 1992).  On these circumstances, we are constrained to reach the                                       
                conclusion that the examiner has failed to provide the evidence necessary to support a                                       
                prima facie case of obviousness as to the claimed human macrophage metalloelastase                                           
                having the amino acid sequence of SEQ ID NO:2.                                                                               
                        Where the examiner fails to establish a prima facie case, the rejection is improper                                  
                and will be overturned.  In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed.                                          
                Cir.1988).  Therefore the rejection of claim 3 under 35 U.S.C. § 103 is reversed.                                            












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