Ex parte VALLE et al - Page 9




             Appeal No.  1999-1417                                                                                    
             Application 08/268,730                                                                                   

             derivatives or salts thereof.  Also, the very nature of applicants’ invention involves                   
             administering a pharmaceutically active ingredient to a human patient in need of treatment               
             for “disorders related to excitatory amino acid-induced neurotoxicity”  (claim 76) or                    
             “suffering from the effect of neurotoxins” (claim 80).  Each method claim before us relates              
             to a method of treating human patients.                                                                  
                    Again, we believe that the examiner appropriately assessed the unpredictability of                
             the art and the nature of the invention in determining that applicants’ specification does not           
             teach those skilled in the art how to use the full scope of the claimed invention without                
             undue experimentation.                                                                                   
                    Applicants rely on in vitro and in vivo studies, described in their specification, as             
             teaching any person skilled in the art how to practice the claimed invention.  In response,              
             the examiner argues that these studies are limited in scope because they involve only the                
             NMDA receptor (Examiner’s Answer, paragraph bridging pages 7                                             
             and 8).  The examiner notes that there are at least three types of excitatory amino acid                 
             receptors capable of mediating excitotoxic events, i.e., NMDA, Quis, and KA (Olney, page                 
             51, second paragraph).  The most studied of these and reportedly the most abundant and                   
             widely distributed in the mammalian CNS, is the NMDA receptor.  Several features                         
             distinguish the NMDA receptor from other subtypes of EAA receptor.  (Id.)  As stated in the              
             concluding passage of the Olney publication,                                                             



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