Ex parte HEIMBURGER et al. - Page 6




              Appeal No. 1997-3501                                                                                         
              Application No. 08/253,232                                                                                   



              page 5, lines 26-32.   Thus, vWF is not bound to the ion exchanger and is thus separated                     
              from FVIII:C which remains bound on the ion exchange column.                                                 
              35 U.S.C.  103                                                                                              
                     Claims 3, 6, 8-10, 16, 19, 24-25 and 30 stand rejected under 35 U.S.C.  103 as                       
              obvious over Austen, in view of Mathews, Mitra, Wang, Costello, Scopes and Harris.                           
                     It is the examiner’s position that (Answer, Paper No. 33, pages 6-7):                                 
                     [i]t would have been obvious to one with ordinary skill in the art at the time                        
                     Applicants’ invention was made to perform Austen’s anion exchange                                     
                     procedure in the presence of Mathews’ buffer components because these                                 
                     are stabilizing components that are of general usefulness in the purification                         
                     of proteins, as additionally shown by Wang, and this would insure that the                            
                     von Willebrand Factor would not become denatured during the purification                              
                     procedure.   It would also have been obvious to one with ordinary skill in the                        
                     art at the time Applicants’ invention was made to subject Austen’s purified                           
                     von Willebrand Factor to the precipitation protocols of Costello and Scopes                           
                     because these are procedures that may be used and manipulated to (sic,                                
                     so) that the desired protein is purified to the greatest extent possible, which,                      
                     for a pharmaceutical preparation is desirable,, (sic) as the more highly                              
                     purified a preparation is, the less likely there are to be contaminants present                       
                     that would cause undesirable side effects.  It would have been obvious to                             
                     one with ordinary skill in the art at the time Applicants’ invention was made to                      
                     use NaCl as a precipitant in the purification procedure of Austen as modified                         
                     by Costello, Mathews, and Scopes, because that is a salt that is known to be                          
                     effective for the precipitation of proteins, as shown by Scopes.  It would have                       
                     been obvious to one with ordinary skill in the art at the time Applicant’s                            
                     invention was made to use Mitra’s pasteurization procedure in the presence                            
                     of Mitra’s and Wang’s protein stabilizers to inactivate viral or bacterial                            
                     contaminants in the von Willebrand Factor preparation suggested by Austen                             
                     as modified  by Mathews, Costello and Scopes because it is desirable to                               
                     have a pharmaceutical preparation that does not contain unwanted materials                            
                     such as viruses, and heat treatment will inactivate these undesirable                                 

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