Ex Parte Somerville et al - Page 3



              Appeal No. 2003-1743                                                                  Page 3                 
              Application No. 09/540,205                                                                                   

                     1.  A composition comprising a non-racemic mixture of l-methadone or a                                
              pharmaceutically acceptable salt thereof and d-methadone or a pharmaceutically                               
              acceptable salt thereof, and a pharmaceutically acceptable carrier (emphasis added).                         
                     2.  A composition according to Claim 1, comprising a non-racemic mixture of an                        
              effective amount of l-methadone or a pharmaceutically acceptable salt thereof to                             
              alleviate somatic pain and an effective amount of d-methadone or a pharmaceutically                          
              acceptable salt thereof to alleviate neuropathic pain, and a pharmaceutically acceptable                     
              carrier (emphasis added).                                                                                    
                     10.  A method for treatment of pain in a subject comprising administering the                         
              composition of Claim 1.                                                                                      
                     22.  A method for treatment of pain in a subject comprising administering a                           
              composition comprising a mixture of an opioid antagonist and dl-methadone or a                               
              pharmaceutically acceptable salt thereof or l-methadone or a pharmaceutically                                
              acceptable salt thereof to alleviate pain, and a pharmaceutically acceptable carrier.                        
                     At this juncture, we note that dependent claim 23 recites “A composition                              
              according to Claim 22, wherein the opioid antagonist is naloxone or naltrexone                               
              (emphasis added).  Independent claim 22, however, is drawn to a method.  It would                            
              appear, therefore, that recitation of a “composition” in dependent claim 23 constitutes an                   
              inadvertent error and that claim 23 should be drawn, instead, to a method.  The same                         
              infirmity appears in dependent claim 13.  On return of this application to the Examining                     
              Corps, we recommend that applicants and the examiner correct the above-noted                                 
              discrepancies in claim format.                                                                               
                                                     The Reference                                                         
                     The prior art reference relied on by the examiner is:                                                 
              Gorman et al. (Gorman), “The d- and l- isomers of methadone bind to the non-                                 
              competitive site on the N-methyl-D-aspartate (NMDA) receptor in rat forebrain and                            
              spinal cord,” Neuroscience Letters, Vol. 223, pp. 5-8 (1997)                                                 








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