Ex parte HEIMBURGER et al. - Page 8

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

              as a buffer.  Examiner’s Answer, page 4.  Mathews does not teach isolation, purification or                  
              pasteurization of vWF.                                                                                       
                     Costello is the only reference of record directly relating to the purification of vWF.                
              Costello indicates that vWF may be produced by a process including steps of                                  
              (i) treating a 3-4% PEG precipitate of a solubilized cryoprecipitate derived from blood with                 
              a solubilizer capable of taking up substantially all of the vWF present in the PEG                           
              precipitate, (ii) adding to the resulting solution of vWF a precipitant which is capable of                  
              preferentially precipitating fibrinogen with regard to the other components in the solution,                 
              (iii) treating the resulting supernatant with an adsorbent capable of adsorbing clotting                     
              factors II, VII, IX and X; (iv) treating the supernatant with a precipitant capable of                       
              precipitating substantially all of the protein present; and (v) solubilizing the precipitate with            
              a solubilizer capable of taking up substantially all of vWF in the precipitate.  Costello, page              
              1.  Costello does not teach pasteurization of vWF or adsorbing only Factor VIII:C to an                      
              anion exchanger while maintaining vWF in solution.                                                           
                     Mitra discloses a process for producing a high purity antihemolitic factor VIII:C                     
              (AHF) concentrate which may be subjected to pasteurization.  Mitra describes the                             
              pasteurization process as, “mixing AHF with at least one amino acid selected from glycine,                   
              lysine, arginine and alanine with at least about 30%, preferably from about 54% to                           
              saturation, on weight to volume basis of a compound selected from sugars and reduced                         


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