Ex parte WUN - Page 5


                 Appeal No. 1998-0350                                                                                     
                 Application No. 08/453,937                                                                               

                 (“VIIa”), activated factor X (“Xa”), Ca2+, and tissue factor (“TF”), together with                       
                 either or both of antithrombin IIIa and heparin.  See the legend to Figure 3.  The                       
                 composition containing heparin but not antithrombin therefore is “essentially free”                      
                 of antithrombin, as required by the claim; the question is whether the disclosed                         
                 composition “consists essentially of” LACI and heparin.                                                  
                         “By using the term ‘consisting essentially of,’ the drafter signals that the                     
                 invention necessarily includes the listed ingredients and is open to unlisted                            
                 ingredients that do not materially affect the basic and novel properties of the                          
                 invention.”  PPG Indus. Inc. v. Guardian Indus. Corp., 156 F.3d 1351, 1354,                              
                 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998).                                                                
                         Thus, the composition of claim 1 is open to the inclusion of other                               
                 ingredients that do not “materially affect the basic and novel properties” of the                        
                 composition.  One of the “basic and novel properties” of the claimed composition                         
                 is recited in the claim itself:  “provid[ing] a synergistic anticoagulation effect upon                  
                 administration to a warm-blooded mammal.”                                                                
                         The composition disclosed by Broze contains the clotting factors VIIa, Xa,                       
                 and tissue factor, which carry out enzymatic reactions that cause blood to                               
                 coagulate.  See the specification, page 1:                                                               
                         [T]he extrinsic pathway is initiated when plasma factor VII/VIIa binds                           
                         to tissue factor (TF; thromboplastin) to form a complex which                                    
                         proteolytically activates factors IX and X.  Once factor Xa is formed,                           
                         . . . it can . . . form the prothrombinase complex which converts                                
                         prothrombin to thrombin.  Ultimately, thrombin causes the fibrin clot                            
                         to form.                                                                                         




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