BERTINA et al v. REITSMA - Page 2




                Interference No. 104,021                                                                Paper No. 112                   
                Griffin v. Bertina                                                                              Page 2                  
                                                          BACKGROUND                                                                    
                        The count and involved claims                                                                                   
                        After decision on preliminary motions (Paper No. 70), the interference was redeclared                           
                (Paper No. 71) with the following count:                                                                                
                                    A method according to claim 62 of the Bertina application                                           
                                                                  OR                                                                    
                                      A kit according to claim 81 of the Bertina application.1                                          
                        Claims 62 and 81 of the Bertina application are as follows                                                      
                        62. A method for diagnosing an increased risk for thrombosis of a genetic                                       
                        defect causing thrombosis comprising the steps of:                                                              
                        (A) obtaining, from a test subject, test nucleic acid comprising codon 506                                      
                                within EXON 10 of the human Factor V gene; and                                                          
                        (B) assaying for the presence of a point mutation in the nucleotides of                                         
                                codon 506 within EXON 10 of the human Factor V gene, wherein said                                       
                                point mutation correlates to a decrease in the degree of inactivation of                                
                                human Factor V and/or human Factor Va by activated protein C,                                           
                        wherein the presence of said point mutation in said test nucleic acid indicates an                              
                        increased risk for thrombosis or a genetic defect causing thrombosis.                                           
                        81. The kit of claim 80,[2] wherein said forward primer is selected from the                                    
                        group consisting of SEQ ID NO:4, SEQ ID NO:9, and SEQ ID NO:11, and said                                        
                        reverse primer is selected from the group consisting of SEQ ID NO:5, SEQ ID                                     
                        NO:10 and SEQ ID NO:14.                                                                                         





                        1  No evidence w as presented  regarding the kit altern ative in the count, so this opinion  will focus on the method
                alternative.                                                                                                            
                        2  Claim 80, which the examiner has deemed  to be unpatentable, is:                                             
                        A kit for diagnosing an inc reased risk from thr ombosis or a genetic de fect causing throm bosis               
                        comprising a forward and a reverse primer that are capable of amplifying codon 506 within EXON 10               
                        of the human Factor V gene.                                                                                     





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