Ex parte MANCILLA et al. - Page 4


                     Appeal No.  1999-1281                                                                                                      
                     Application No.  08/712,249                                                                                                

                             The examiner argues (Answer, page 9) that “the specification appears to                                            
                     indicate that the order in which the cations are reacted with heparin is not critical.”                                    
                     However, as set forth in In re Ochiai, 71 F.3d 1565, 1572,                                                                 
                     37 USPQ2d 1127, 1133 (Fed. Cir. 1995) “an applicant [is entitled] to issuance of an                                        
                     otherwise proper patent unless the PTO establishes that the invention as claimed in                                        
                     the application is obvious over cited prior art, based on the specific comparison of                                       
                     that prior art with claim limitations.”  In contrast to the examiner’s argument,                                           
                     appellants argue (Reply Brief, page 3):                                                                                    
                             The claimed heparin composition is produced through a sequential                                                   
                             and selective blocking and binding of heparin reactive sites.  A first                                             
                             reaction utilizes a heavy metal, for example zinc or barium, to block                                              
                             calcium active sites on the heparin molecule.  A second reaction then                                              
                             follows wherein lithium ions are utilized to bind those active sites                                               
                             which were not previously reacted with the heavy metal.  Accordingly,                                              
                             the resultant heparin molecule so produced is “blocked” with both a                                                
                             heavy metal and e.g. a lithium salt.                                                                               
                                      As set forth in [a]ppellants’ specification, this process                                                 
                             effectively limits the interaction of the heparin composition with any                                             
                             calcium ions which may be present in a blood sample to be assayed.                                                 
                             This thereby obviates the need for added calcium or other artificial                                               
                             corrective steps to correctly assay calcium levels in an unknown                                                   
                             sample.                                                                                                            
                             Therefore, according to appellants, the order in which the cations are reacted                                     
                     with heparin is critical.  The criticality of the process steps is also discussed in                                       
                     paragraph 7a of the Fiehler Declaration4.                                                                                  

                             The examiner argues (Answer, page 6) that “[t]he claims are not deemed to                                          
                     be patentable over the prior art because appellants have merely provided a mixture                                         

                                                                                                                                                
                     4 Executed May 14, 1997, attached to the Brief as Exhibit B.                                                               

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