Ex parte SIMONET et al. - Page 6


                  Appeal No.  1997-2515                                                                                     
                  Application No.  08/221,767                                                                               


                  contrary, claim 1 is drawn to a nucleic acid sequence comprising 3 elements; (1) an                       
                  HCR enhancer of SEQ ID NO:1 or biologically active                                                        
                                                                                                                           
                                                                                                                           
                  fragment thereof operably linked to, (2) a promoter, and (3) a transgene. We remind                       
                  the examiner that every limitation positively recited in a claim must be given effect in                  
                  order to determine what subject matter that claim defines.                                                
                  In re Wilder, 429 F.29 447, 450, 166 USPQ 545, 548 (CCPA 1970).                                           
                         Furthermore, the examiner improperly shifts his burden of establishing a                           
                  prima facie case of obviousness to appellants.  The examiner states (Answer, page                         
                  10):                                                                                                      
                         Appellant admits [sic] that SEQ ID NO:1 was isolated from the larger                               
                         sequence disclosed by Simonet et al.  Thus the promoter/enhancer                                   
                         constructs of Simonet et al. are sequences which comprise SEQ ID                                   
                         NO:1, and are therefore encompassed by the claims.  Even if the                                    
                         claims did not encompass the constructs of Simonet et al., Appellant                               
                         has [sic] not presented any evidence to suggest that the 774                                       
                         nucleotide HCR functions any differently when isolated from the                                    
                         remainder of the 5,700 nucleotide fragment disclosed by Simonet et                                 
                         al.  Absent any change in the functional characteristics of the HCR,                               
                         removal of extraneous sequences would have been obvious                                            
                         optimization of parameters, which one of ordinary skill in the art would                           
                         have carried out in order to reduce the size of the construct (leaving                             
                         more space in the vector for the transgene of interest) [emphasis                                  
                         original].                                                                                         
                         However, absent the examiner’s impermissible hindsight reconstruction and                          
                  reliance on appellants’ specification, the examiner fails to demonstrate that the                         
                  specific nucleotide sequence identified as SEQ ID NO:1 is present in the 5,700                            

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