Ex parte HEIMBURGER et al. - Page 12

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

                     In the case before us, it is clear that the field and scope of the prior art, protein                 
              purification, remains unpredictable.  As acknowledged by Harris at page 60, a universal                      
              purification strategy for all proteins cannot be given since the materials available and the                 
              requirements for each application differ.  Harris, also, states that there is no substitute for              
              trial and error.  Wang recognizes that many variables affect protein stabilization and                       
              denaturation, including solvents, hydrophobic interactions, oxidation potential, temperature                 
              and pH, to name a few.  Thus, the purification and pasteurization procedures for Factor                      
              VIII:C, provided in the cited references, would not necessarily provide one of ordinary skill                
              in the art with the purification procedures for vWF, a different protein having different                    
                     While Costello appears most relevant to the claimed method as it deals with                           
              purification of vWF, it does not address specifically the pasteurization conditions for vWF,                 
              and does not disclose the claimed purification process steps.  The process of Costello                       
              starts with a precipitate of solubilized cryoprecipitate by product formed in the production                 
              of Factor VIII which includes vWF, and then solubilizes, precipitates, and resolubilizes vWF                 
              to effect purification.  In contrast, the claimed method isolates vWF from solution only after               
              having removed Factor VIII:C and other proteins and does not appear to require                               
              precipitation and resolubilization of vWF.                                                                   


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