Ex parte MEYHACK et al. - Page 6




              Appeal No. 94-1775                                                                                        
              Application 07/488,513                                                                                    

              prior art relied upon by the examiner would have reasonably suggested that the specific                   
              yeast containing the hybrid vector required by claim 18 on appeal secrete 90% or more of                  
              the proteins with hirudin activity into the culture medium.  At the point where we need a                 
              specific, fact supported determination by the examiner, we are only left with a vague                     
              conclusion on the part of the examiner.                                                                   
                     Obvious determinations must be premised upon a consideration of the “subject                       
              matter as a whole.”  35 U.S.C. § 103.  Here, the examiner has failed to adequately come to                
              grips with the requirement of claim 18 on appeal that 90% or more of the proteins with                    
              hirudin activity produced in that method are secreted into the culture medium.  As a                      
              consequence, the examiner has failed to properly discharge his initial burden of                          
              establishing that the subject matter of claim 18, as a whole, would have been prima facie                 
              obvious to one of ordinary skill in the art.                                                              
                     The rejection of claim 18 under 35 U.S.C. § 103 premised upon Chang is reversed.                   
              2.  Claims 1 and 5 through 14                                                                             
                     Claim 1 differs from claim 18 in that claim 1 requires that “proteins with hirudin                 
              activity are predominantly secreted into the culture medium” rather than at a level of 90% or             
              more.  Thus, prior to determining whether the subject matter of claim 1 as a whole would                  
              have been obvious to one of ordinary skill in the art based upon the applied references, a                
              determination must be made as to what is meant by the requirement of claim 1 that the                     
              proteins with hirudin activity are predominantly secreted into the culture medium.                        

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