Ex Parte Heller - Page 7



              Appeal No. 2003-1716                                                                   Page 7                 
              Application No. 09/946,205                                                                                    
              specification, page 2, line 23, is unclear, but may mean that a combined product was                          
              not commercially developed because it was perceived to have inadequate active                                 
              substance release and bioavailability.  But that does not constitute evidence that Lukas-                     
              Laskey is a non-enabling reference.  That does not constitute evidence that persons                           
              skilled in the art, given the disclosure of Lukas-Laskey, could not prepare a tablet                          
              comprising the active ingredients recited in claim 1 and "at least one pharmaceutically                       
              acceptable additive."                                                                                         
                     We are mindful that the subject application is a divisional of Application No.                         
              09/447,872, filed November 23, 1999, now U.S. Patent No. 6,403,579.  In the '579                              
              patent, the PTO issued claims drawn to applicant's process for producing a solid                              
              dosage form pharmaceutical combination preparation containing carvedilol, or a                                
              pharmaceutically acceptable salt thereof, and hydrochlorothiazide, or a                                       
              pharmaceutically acceptable salt thereof.  However, merely because the PTO issued                             
              claims drawn to applicant's process in the '579 patent, it does not follow that Lukas-                        
              Laskey constitutes a non-enabling reference.  Again, applicant's position to the                              
              contrary, Lukas-Laskey sufficiently describes the tablet recited in claim 1 "to have                          
              placed the public in possession of it."                                                                       
                     All in all, we find that the evidence in favor of patentability relied on by applicant                 
              does not outweigh the evidence against patentability relied on by the examiner.  On this                      
              record, applicant has failed to adduce evidence sufficient to rebut the examiner's prima                      
              facie case of anticipation of claim 1.  Accordingly, we affirm the rejection of claim 1                       
              under 35 U.S.C. § 102(b) as described by Lukas-Laskey.  As previously indicated,                              
              dependent claims 2 through 5 fall together with independent claim 1.                                          





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