Ex Parte Davidson et al - Page 13

                 Appeal 2007-0860                                                                                      
                 Application 10/148,535                                                                                
                        In my view, the two questions before us are:                                                   
                     1) At the time of Appellants’ claimed invention, would the prior art have                         
                        suggested the use of Ritalin to treat epilepsy and/or bipolar disorder,                        
                        with a reasonable likelihood of success, and thus render prima facie                           
                        obvious the use of its l-enantiomer “in substantially single enantiomer                        
                        form” for the same indications?                                                                
                     2) If so, have Appellants provided sufficient evidence of unexpected                              
                        results in using the l-enantiomer to treat either of these disorders?                          
                        Based on the facts in this case, as elaborated below, I conclude the                           
                 answer to the first question is “yes,” and the answer to the second is “no.”                          
                        These conclusions flow from the following facts:                                               
                 Facts Relating to Question One: Prima Facie Obviousness                                               
                 Appellants’ Contribution                                                                              
                        1.  Ritalin® (racemic MPH) has been widely used for more than half a                           
                 century5 to treat ADHD, particularly in children.                                                     
                        2.  Children with ADHD frequently also have epilepsy and/or bipolar                            
                 disorder (see, e.g., Gross-Tsur & Carlson); thus, children with these                                 
                 disorders have been treated with Ritalin®.  (See id.)                                                 
                        3.  Appellants did not discover Ritalin and did not resolve the                                
                 enantiomers.  (See Spec. passim.)                                                                     
                        4.  According to Appellants, they found the l-threo-enantiomer                                 
                 “possesses pharmacological activity broadly similar to that of the d-                                 
                 enantiomer and the racemate.”  (Spec. 2.)                                                             

                 5 Methylphenidate was first patented in 1954 by the Ciba pharmaceutical                               
                 company, a predecessor of Novartis, maker of Ritalin®.                                                

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