Ex Parte Bader et al - Page 2




              Appeal No. 2006-0182                                                                                       
              Application No. 10/254,862                                                                                 

                     The prior art references cited by the examiner are:                                                 
              Jain et al. (Jain)    5,716,609   Feb. 10, 1998                                                            
              Miyata et al. (Miyata)    5,837,735   Nov. 17, 1998                                                        
              Grounds of Rejection                                                                                       
                     1.  Claims 1-3 and 5-11 stand rejected under 35 U.S.C. §103(a) as obvious over                      
              Miyata in view of Jain.                                                                                    
                     2.  Claims 5 stands rejected under 35 U.S.C. §112, second paragraph, for                            
              indefiniteness.                                                                                            
                     We reverse these rejections.                                                                        
                                                     DISCUSSION                                                          
              Background                                                                                                 
                     Nimesulide is a known anti-inflammatory agent whose therapeutic efficacy has                        
              been proven for some time, but which has the drawback of unfavorable chemical-                             
              physical characteristics.   The main obstacle to the use of nimesulide is in fact its                      
              insolubility in water, and on the other hand, its poor solubility in solvents/raw materials                
              usually employed in such formulations.  Specification, page 1.                                             
              35 U.S.C.  § 103(a)                                                                                        
                     Claims 1-3 and 5-11 stand rejected under 35 U.S.C. §103(a) as obvious over                          
              Miyata in view of Jain.                                                                                    
                     According to the Examiner, Miyata teaches a topical nimesulide gel formulation                      
              “wherein nimesulide (0.1-5%) is dispersed in a base component that comprises 2-20%                         



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