Ex parte HOCK et al. - Page 6




                Appeal No. 1997-1093                                                                                                            
                Application No. 08/272,281                                                                                                      






                                                           OTHER MATTERS                                                                        
                 Upon return of the application, the examiner should consider whether the claimed                                               
                invention raises any issues under 35 U.S.C. § 112.  It appears that claimed method may                                          
                be incomplete in failing to recite all critically required method steps to obtain a fibrinogen                                  
                solution which maintains its ability to function when stored at 4-25EC for four weeks.  First,                                  
                the only disclosure in the specification of a fibrinogen solution having the claimed stability                                  
                was obtained not after treatment with two adsorbents, but after additional method steps.                                        
                According to Example 1 on specification page 5:                                                                                 
                         Cryoprecipitate from citrate plasma was dissolved in isotonic saline (2.8                                              
                         l/kg).  Subsequently, 5% (volume/volume) of an aluminum hydroxide                                                      
                         suspension (1.5% weight/volume)  was added, and the mixture was stirred                                                
                         for 15 min.  The aluminum hydroxide was removed by centrifugation, and the                                             
                         same amount of aluminum hydroxide  plus 5.25 g of QEA-Sephadex A-50                                                    
                         per kg of cryoprecipitate, was again added to the supernatant.                                                         
                         Centrifugation was repeated.  Glycine was added to the supernatant with                                                
                         stirring until the final concentration was 2.7 mol/l, and the resulting precipitate                                    
                         was removed by centrifugation and dissolved in isotonic saline (1.5 l/kg).                                             
                         The solution was mixed with glycine (final concentration 1.15 mol/l) and                                               
                         stirred for 30 min.  This was followed by centrifugation, and the residue was                                          
                         discarded.  The supernatant was mixed with glycine (final concentration 2.15                                           
                         mol/l) and stirred for 30 min.  The precipitate was removed by centrifugation,                                         
                         taken up in 0.05 mol/l NaCl, 0.005 mol/l trisodium citrate, 0.02 mol/l arginine,                                       
                         pH 7.5, and dialyzed against the same buffer.                                                                          




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