Ex Parte Metzner et al - Page 3


                Appeal No. 2005-0192                                                                                 Page 3                    
                Application No. 09/809,021                                                                                                     

                about 5.0 to 8.0.  To achieve the desired effect on use and for stabilization, then a                                          
                soluble calcium salt, sodium chloride, a sugar or a pure alcohol and/or an amino acid                                          
                . . . is added to the preparation.  This results in good stabilities in the liquid and/or frozen                               
                state for a storage time of 12 months or more.”  Paragraph [0016].                                                             
                         “It has also emerged that addition of substances which inhibit noncovalently the                                      
                thrombin activity in vitro can seemingly only increase the stability even further,                                             
                especially at room temperature, by diminishing the autolysis of thrombin.  Suitable                                            
                substances for this purpose are compounds such as benzamidine or                                                               
                p-aminobenzamidine.”  Paragraph [0017].                                                                                        
                         “The thrombin preparations produced by the described process can be employed                                          
                inter alia as components of a fibrin glue [in combination with fibrin and optionally factor                                    
                XIII].”  Paragraph [0020].  “Finally, the thrombin concentrates produced according to the                                      
                invention can also be employed alone or in combination with carrier materials as agent                                         
                for local stoppage of bleeding.”  Paragraph [0021].                                                                            
                                                                Discussion                                                                     
                         The claims stand or fall together.  Appeal Brief, page 5.  Since the broadest claim                                   
                subject to each rejection is claim 18, we will consider that claim as representative.                                          
                Claims 19 and 35-38 will stand or fall with claim 18.                                                                          
                         Claim 18 is directed to a thrombin preparation which is “suitable for therapeutic                                     
                purposes,” comprising thrombin and “a noncovalently binding inhibitor of thrombin                                              


                                                                                                                                               
                1 The instant application’s official Image File Wrapper contains images of very poor quality; nearly every                     
                page is partially illegible.  Therefore, our citations to the specification refer to the version of the application            
                that was published on October 25, 2001 as Publication No. 2001/0033837.                                                        





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