Ex Parte Morikawa et al - Page 3


                 Appeal No. 2006-3200                                                         Page 3                  
                 Application No.  10/196,428                                                                          
                                                   DISCUSSION                                                         
                        Claim 1 stands rejected under 35 U.S.C. § 103(a) as being unpatentable                        
                 over the combination of Chao, Bokoch, Partridge, and Luchetti.                                       
                        As we understand it, Appellants’ claimed invention is drawn to a method                       
                 for suppressing PTX3 gene expression in a subject suffering from rheumatoid                          
                 arthritis, which comprises the single step of administering a composition to the                     
                 subject.2  The claims require that the composition comprises two ingredients:                        
                 (a) one or more pharmaceutically acceptable additives, and (b) an effective                          
                 amount of an active ingredient, which is a compound of formula (1)3 - a HMG-                         
                 CoA reductase inhibitor4.  The claims also require that the compound of formula                      
                 (1) is not atorvastatin.                                                                             
                        According to the Examiner (Answer, page 5), Chao teaches a method of                          
                 treating rheumatoid arthritis by administering a composition comprising a                            
                 3-hydroxy-3-methylglutaryl coenxyme A (HMG-CoA) reductase inhibitor,                                 
                 e.g., pravastatin.  The Examiner finds (id.), Chao teaches that the composition                      
                 can be administered orally and comprises 0.1-100 mg of HMG-CoA reductase                             




                                                                                                                      
                 2 According to Appellants’ specification (page 1), “[t]his invention relates to a pentraxin 3 (PTX3) 
                 gene expression suppressing method useful for the treatment of autoimmune diseases,                  
                 especially rheumatoid arthritis.”                                                                    
                 3 Examples of the active ingredient having the structure of formula (1) may be lovastatin,           
                 pravastatin, simvastatin, fluvastatin, cerivastatin, rosuvastatin, mevastatin, pitavastatin, or a salt
                 thereof.  See e.g., Appellants’ specification, pages 7-8, and claim 3.                               
                 4 According to Appellants’ specification (page 4), “[c]ompounds represented by the formula (1),      
                 their lactone derivatives and salts of these compounds and lactone derivatives, all of which are     
                 usable in the present invention, are known as HMG-CoA reductase suppressors. . . .”                  





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