Ex Parte RUBIN - Page 2




                                     The invention                                      
                    1.   In the "Background and Prior Art" portion of                   
          the specification, we are told that (page 1, lines 18 to page 2,              
          line 12)(matter in [brackets] added):                                         
                    Parkinson's disease is associated with the depletion of             
               dopamine[3] from cells in the corpus striatum.  Since                    
               dopamine does not cross the blood brain barrier and cannot               
               therefore be used to treat Parkinson's disease, its                      
               immediate precursor, levodopa, [4] is used instead because it            
               penetrates the brain where it is decarboxylated [5] to                   
               dopamine.  But levodopa is also decarboxylated to dopamine               
               in peripheral tissues and consequently only a small portion              
               of administered levodopa is transported unchanged to the                 
               brain.  This reaction can be blocked by carbidopa [6] which              
               inhibits decarboxylation of peripheral levodopa but cannot               
               itself cross the blood brain barrier and has no effect on                
               the metabolism of levodopa in the brain.                                 
                    The combination of carbidopa and levodopa is considered             
               to be the most effective treatment for symptoms of                       
               Parkinson's disease (The Medical Letter, 35:31-34, 1993                  
               [copy in the record]).  Nevertheless, certain limitations                
               become apparent within two to five years of initiating                   
               combination therapy.  As the disease progresses, the benefit             
               from each dose becomes short ("the wearing off effect") and              


          3   The formula of dopamine is shown in entry 3479 from The Merck Index,      
          CD-ROM, Version 12:1a, ISSN 1359-2947 (12th ed. 1996).  A copy of the entry is
          found in an Appendix attached to our opinion.                                 
          4   The formula of levodopa is shown in entry 5490 from The Merck Index,      
          CD-ROM, Version 12:1a, ISSN 1359-2947 (12th ed. 1996).  A copy of the entry is
          found in an Appendix attached to our opinion.                                 
          5   Decarboxylate means remove a )COOH group.                                 
          6   The formula of carbidopa is shown in entry 1843 from The Merck Index,     
          CD-ROM, Version 12:1a, ISSN 1359-2947 (12th ed. 1996).  A copy of the entry is
          found in an Appendix attached to our opinion.                                 
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