Ex Parte Metzner et al - Page 6


                Appeal No. 2005-0192                                                                                 Page 6                    
                Application No. 09/809,021                                                                                                     

                         Appellants point to the chromatographic procedure used by Allary and Lorne and                                        
                argue that                                                                                                                     
                         there is no evidence that the eluates from either Lorne or Allary’s columns                                           
                         are “suitable for therapeutic purposes” according to claim 18.  . . .  For                                            
                         example, they may contain unsuitable run-off from the SPHERODEX®                                                      
                         columns or unsuitable buffer ingredients.  Further, there is no evidence                                              
                         that the thrombin solutions in the chromatography procedure are suitably                                              
                         sterilized.                                                                                                           
                Id., page 18.  Appellants also point to Lorne’s disclosure that the thrombin-containing                                        
                preparation eluted from the column is subjected to two steps of dialysis or ultrafiltration                                    
                before it is in a form intended for administration to a patient.  See id., paragraph bridging                                  
                pages 17 and 18.                                                                                                               
                         We agree that claim 18 requires the thrombin preparation to be “suitable for                                          
                therapeutic purposes” and, therefore, the preparations disclosed by Lorne and Allary                                           
                must meet this limitation in order to anticipate the claim.  However, we do not agree that                                     
                the prior art compositions fail to meet this limitation.                                                                       
                         “It is axiomatic that, in proceedings before the PTO, claims in an application are                                    
                to be given their broadest reasonable interpretation consistent with the specification and                                     
                that claim language should be read in light of the specification as it would be interpreted                                    
                by one of ordinary skill in the art.”  In re Sneed, 710 F.2d 1544,1548, 218 USPQ 385,                                          
                388 (Fed. Cir. 1983) (citation omitted).                                                                                       
                         In this case, the specification does not define (or even contain) the phrase                                          
                “suitable for therapeutic purposes.”  However, the specification describes the claimed                                         
                thrombin-containing preparation as “use[ful] as local hemostatic or as component of a                                          
                tissue glue together with a fibr[in]ogen-containing component.”  Page 1, paragraph                                             






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