Ex Parte Davis et al - Page 7

                 Appeal 2007-0181                                                                                     
                 Application 10/057,323                                                                               
                 teaching as to potential drug-drug interactions, and argue that Medical Letter                       
                 at page 69 “discloses that it is unclear whether, like gemfibril and niacin,                         
                 concurrent administration of fenofibrate with a statin could increase the risk                       
                 of rhabdomyolysis.”  (Br. 12 (emphasis in original).)  Appellants assert that                        
                 “[b]ecause of the difference of the way that each component of the presently                         
                 claimed combination acts, it is respectfully submitted that the rejection is                         
                 based upon an improper combination of references.”  (Id.)                                            
                        Claim 21, which we choose as representative of claims 21 and 28, is                           
                 drawn to the composition of claim 1, further comprising niacin.  As noted                            
                 above, all three compounds are known to lower serum cholesterol, and for                             
                 the reasons already set forth with respect to the rejection of claims 1-4, 11-                       
                 13, 37-40, 42, 43, 47, 48, 83, 84, and 86, the art recognized property of each                       
                 of the described agents as a cholesterol lowering agent would have provided                          
                 one of ordinary skill in the art with ample suggestion of their combination in                       
                 the composition as claimed.                                                                          
                        We also do not find convincing Appellants’ arguments that the                                 
                 references provide no teaching as to potential drug-drug interactions, and                           
                 that Medical Letter at page 69 teaches that it is unclear whether, like                              
                 gemfibril and niacin, concurrent administration of fenofibrate with a statin                         
                 could increase the risk of rhabdomyolysis.  Medical Letter teaches that:                             
                        Like other fibrates, fenofibrate potentiates the effects of oral                              
                        anticoagulants.  Whether, like gemfibrozil and niacin, it could                               
                        increase the risk of rhabdomyolysis when taken concurrently                                   
                        with a statin is unclear.                                                                     
                 (Medical Letter 69).                                                                                 
                        Thus, the concern in Medical Letter is the combination of fenofibrate,                        
                 gemfibrozil, or niacin with statins, but statins are not required by the                             

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