Ex Parte Stankov - Page 9

               Appeal 2007-3261                                                                             
               Application 09/854,802                                                                       
               total of release active ingredient after a specified time” (Reply Br. 12).  As               
               shown in Lee,3 provided by the Examiner, “a typical release curve . . . shows                
               that the release vs. time is computed cumulatively and is not based on a                     
               release within any period of time within the middle of the test” (Reply Br.                  
               2).                                                                                          
                      With respect to the second ground, however, we concur with the                        
               Examiner’s reasoning.  The Examiner has the initial burden of presenting                     
               evidence or reasons why a person skilled in the art would not recognize in an                
               applicant’s disclosure a description of the invention defined by the claims.                 
               In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976).  In this                     
               case, the Examiner finds that the Specification describes “volume excipients,                
               gliding and lubricating excipients” (Spec. 7: 1-2) for the slow release layer.               
               However, the Examiner states the Specification does not teach the use of                     
               these additives to obtain the rapid release profile required for the rapid                   
               release cortex. (Answer 6).  While there is no requirement that the invention                
               be claimed in the identical wording that was used in the specification, there                
               must be sufficient disclosure to show one of skill in this art that the inventor             
               “invented what is claimed.” See Union Oil Co. of California v. Atlantic                      
               Richfield Co., 208 F.3d 989, 1000, 54 USPQ2d 1227, 1235 (Fed. Cir. 2000).                    
               In view of the lack of literal support for the limitation, it is our opinion that            
               the Examiner has reason to question the written description for the recited                  
               limitation, shifting the burden to Appellant to rebut it.  Because Appellant                 
               does not address this deficiency in either the Substitute Appeal Brief or                    

                                                                                                           
               2  This is a reference to the Reply Brief dated Feb. 5, 2007.                                
               3  Lee, Int. J. Pharmacol., 188: 71-80 (1990).                                               

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