Ex Parte Morikawa et al - Page 4


                 Appeal No. 2006-3200                                                         Page 4                  
                 Application No.  10/196,428                                                                          
                 inhibitor.5  In addition, the Examiner finds that Chao teaches that the composition                  
                 comprises “well-known excipients such as binders, lubricants, and disintegrating                     
                 agents. . . .”6  Id.                                                                                 
                        The Examiner relies on Bokoch and Partridge (id.) to teach the use of                         
                 HMG-CoA reductase inhibitors, e.g., lovastatin, to treat inflammatory disorders7                     
                 and arthritis8 respectively.  Id.  Since Bokoch and Partridge appear to be                           
                 cumulative to Chao we do not discuss them further.                                                   
                        The Examiner recognizes that Chao does not teach a method of                                  
                 suppressing PTX3 gene expression.  Answer, page 6.  However, the Examiner                            
                 points out that Luchetti teaches that PTX3 gene expression is elevated in                            
                 rheumatoid arthritis patients.  Id.                                                                  
                        Based on this evidence the Examiner finds (id.), that HMG-CoA reductase                       
                 inhibitors, such as pravastatin, are well-known to be useful in treating rheumatoid                  
                 arthritis.  Therefore, the Examiner argues (id.) that it would have been prima facie                 
                 obvious to a person of ordinary skill in the art at the time the invention was made                  
                 to administer a composition comprising a HMG-CoA reductase inhibitor to a                            
                 subject suffering from rheumatoid arthritis.  As we understand the Examiner’s                        
                                                                                                                      
                 5 According to Appellants’ specification (bridging sentence, pages 9-10), “it is generally preferred 
                 to orally or parenterally administer the active ingredient at a daily dosage of from 0.01 to 1,000   
                 mg, specifically from 0.1 to 100 mg in terms of the compound represented by formula (1) at once      
                 or in several portions.”                                                                             
                 6 According to Appellants’ specification (page 9), the HMG-CoA reductase inhibitor can be            
                 formulated with one or more additives such as binders, extenders and disintegrants.                  
                 7 While Bokoch teaches the use of HMG-CoA reductase inhibitors to treat inflammatory disorders,      
                 the references does not mention rheumatoid arthritis.  Bokoch also does not address PTX3 gene        
                 expression.  See e.g., Brief, page 6.                                                                
                 8 Including rheumatoid arthritis (Partridge, column 6, line 17-21).  The Examiner recognizes,        
                 however, that Partridge does not address PTX3 gene expression.  Answer, page 6.                      




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