Ex Parte Seth - Page 3




              Appeal No. 2006-0139                                                                                      
              Application No. 09/583,228                                                                                
                     In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden                   
              of presenting a prima facie case of obviousness.  See In re Rijckaert, 9 F.3d 1531,                       
              1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993).   A prima facie case of obviousness is                       
              established when the teachings from the prior art itself would appear to have suggested                   
              the claimed subject matter to a person of ordinary skill in the art.  In re Bell, 991 F.2d                
              781, 783, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993).  An obviousness analysis requires                        
              that the prior art both suggest the claimed subject matter and reveal a reasonable                        
              expectation of success to one reasonably skilled in the art.  In re Vaeck, 947 F.2d 488,                  
              493, 20 USPQ2d 1438, 1442  (Fed. Cir. 1991).  With this as background, we analyze                         
              the prior art applied by the examiner in the rejection of the claims on appeal.                           
                     According to the examiner (Answer, pages 3-4)                                                      
                     Morella et al.  …  teaches a sustained release pharmaceutical composition                          
                     having a core element containing an antihypertensive agent such as                                 
                     Verapamil Hydrochloride, binding agent, such as PVD, modified                                      
                     celluloses, and other well known pharmaceutical carrier and excipients; a                          
                     coating comprising a methacrylic polymer (1-30% wt., soluble at a pH from                          
                     6-7.5 in the intestines), hydroxypropyl methylcellulose (4-20% wt.),                               
                     polyethylene glycol (15-35% wt.) and a filler such as silicon dioxide (4-30%                       
                     wt.), see, particularly, claims 1, 2, 7 and 9 as well as Col. 4, line 24.                          
                     column 11, lines 3-33.  Morella …  also teaches that the active ingredient                         
                     in the pharmaceutical composition reaches its maximum concentration                                
                     between about 4 and about 30 hours, col. 24, claim 1 and that the                                  
                     bioavailability of the active agents in the pharmaceutical pellet is not                           
                     compromised by food, col. 7, lines 34-40.  Morella discloses at least one                          
                     polymer which is substantially insoluble at acidic pH (i.e., that of the                           
                     stomach) but at least partially soluble at a less acidic to basic pH (i.e., the                    
                     pH of the intestine), see col. 6, lines 43-52[,] col. 7[,] lines 34-62 in                          
                     particular.                                                                                        
                            Morella … does not teach the particular composition containing the                          
                     specific ingredients in the amounts herein.                                                        

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