Ex parte VALLE et al - Page 8




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

             EXCITOTOXINS AND NEURODEGENERATIVE DISORDERS.  As correctly found by the                                 
             examiner, at the time applicants’ invention was made, the prior art did not recognize                    
             effective means of treatment for a number of disorders discussed by Olney and embraced                   
             by the appealed claims, e.g., Huntington’s Disease, Alzheimer’s Disease, neurolathyrism,                 
             Parkinson’s Disease, Wernicke/Korsakoff Syndrome, Jakob-Creutzfeldt Syndrome, and                        
             amyotrophic lateral sclerosis.  A number of these disorders have different etiologies, even              
             though “related to” or “associated with” excitatory amino acid-induced neurotoxicity.                    
                    All in all, we believe that the examiner appropriately assessed the breadth of claims             
             76 through 80, and the state of the prior art, 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.                                                                           
                    Further, as stated in In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA                      
             1970), “In cases involving unpredictable factors, such as most chemical reactions and                    
             physiological activity, the scope of enablement obviously varies inversely with the degree               
             of unpredictability of the factors involved.”  Here, we agree with the examiner that                     
             applicants’ claimed invention involves a relatively high degree of unpredictability.  The                
             claims at issue are drawn to a method of treating various neurodegenerative disorders by                 
             administering a specified pharmaceutically active ingredient to a patient in need of such                
             treatment.  The claimed invention involves unpredictable factors such as physiological                   
             activity, pharmacology, and therapeutic action of a specified N-acyl-lysoganglioside, or                 

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