Ex Parte Hogan - Page 14


              Appeal No. 2006-1517                                                                  Page 14                 
              Application No. 09/976,423                                                                                    

                                                       Other Issue                                                          
                     This application is said to be “a continuation-in-part of co-pending U.S.                              
              application serial number 09/613,887” (specification, page 1), which is the subject of                        
              appeal number 2006-1560.  The claims in that application are directed to a method,                            
              rather than a kit, for perioperative screening.  The examiner rejected the claims as                          
              obvious in view of, among other references, Pharmacogenetics6 and AAS.7                                       
                     AAS discloses that different alleles of the BChE gene affect patients’ reactions to                    
              succinylcholine (page 139, left-hand column), that “careful DNA analysis is really the                        
              only way to establish individual BChE genotypes” (page 140, right-hand column), that                          
              “[w]e have been able to sequence the entire BCHE coding region and consider all the                           
              possible structural mutations using PCR amplification” (id.), and that “anesthesiologists                     
              need to keep up to date about” the application of molecular biology tests to BChE                             
              variants (sentence bridging pages 140 and 141).                                                               
                     Pharmacogenetics discloses that cytochrome P4502D6 (CYP2D6) in involved in                             
              mediating drug biotransformation (page 309), including the transformation of codeine to                       
              its active form (page 317, left-hand column), and that by combining “rapid and specific                       
              PCR-based allele-specific amplification tests . . . [with] XbaI RFLP analysis, about 95                       
              percent of all mutant alleles of CYP2D6 could be identified, allowing for the prediction of                   
              over 90 percent of PM [poor metabolizer] phenotypes”  (page 314, right-hand column).                          



                                                                                                                            
              6 The reference is cited as “Pharmacogen[e]tics, Chapter 4, pp. 309-326” in the Information Disclosure        
              Statement received in application 09/613,887 on April 6, 2001 (reference number 202 in the IDS).              
              7 La Du, “Butyrylcholinesterase variants and the new methods of molecular biology,” Acta                      
              Anaesthesiologica Scandinavica, Vol. 39, pp. 139-141 (1995)                                                   





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