Ex parte BAUGH et al. - Page 4


                 Appeal No.  2000-1906                                                                                  
                 Application No. 09/063,338                                                                             

                        Claims 1-66 stand rejected under 35 U.S.C. § 103 as obvious over                                
                 Antanavich ‘007, Antanavich ‘662, Hirsh, Cochrum, Barrow, and Suzuki.  We                              
                 reverse.                                                                                               
                                                     Background                                                         
                        “[F]ibrin glue is a relatively new technological advance which duplicates                       
                 the biological process of the final stage of blood coagulation.”  Specification,                       
                 page 2.  Fibrin glue is made by mixing fibrinogen with thrombin; the mixture                           
                 forms a clot which can be used to control bleeding during surgery in cases where                       
                 ordinary sutures cannot be used or where the patient suffers from a coagulation                        
                 disorder.  Id.  Fibrin glue is used in Europe but has not been approved by the                         
                 U.S. Food and Drug Administration, because fibrinogen concentrate or thrombin                          
                 prepared from pooled blood donors carries a risk of transmitting viruses.  Id.                         
                        The specification discloses a method for making fibrin glue autologously,                       
                 i.e., based on components derived from the patient to be treated with the fibrin                       
                 glue.  The disclosed method comprises                                                                  
                        forming a platelet rich plasma or platelet poor plasma containing an                            
                        anticoagulant.  The platelet rich plasma or platelet poor plasma is                             
                        then divided into two portions and the first portion is restored so                             
                        that it can coagulate thus forming a clot.  The clot is then triturated                         
                        and the resulting serum is collected.  The bioadhesive sealant                                  
                        composition is then prepared by combining a defined volume of the                               
                        second portion of platelet rich plasma or platelet poor plasma with a                           
                        sufficient volume of serum causing the fibrinogen in the second                                 
                        portion of platelet rich p lasma or platelet poor plasma to be                                  
                        converted to fibrin which then solidifies in the form of a gel.                                 
                 Specification, page 6.                                                                                 




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