Ex Parte Lee - Page 10



                LINCK, Administrative Patent Judge, dissenting.                                                
                      I respectfully dissent and thus would affirm the Examiner’s § 103(a)                     
                rejection of claims 117-130.                                                                   
                      The majority finds a prima facie case of obviousness has been made                       
                (see supra p. 5) but then concludes Appellant’s Declaration has overcome                       
                the prima facie case (see supra pp. 6-7), based on data for a single dosage in                 
                a single type cancer, i.e., colon cancer.  (Declaration ¶¶ 10-13; see also                     
                Answer 10.)                                                                                    
                      I agree with the majority that the Examiner has made a prima facie                       
                case of obviousness.  And, to the extent Appellant’s data show the two-drug                    
                combination is more effective than the two drugs used separately when                          
                added together, that data may be sufficient to overcome the prima facie case                   
                for colon cancer at the particular dose used in the study.  (See Declaration ¶                 
                14.)  Such data might also support claims to a method of treating colon                        
                cancer over a modest dosage range.  But the claims are not so limited.  (See,                  
                e.g., claim 117 (reciting seven types of cancer and very broad dosage                          
                ranges).  Contrary to Appellant’s argument that all claims require “a                          
                synergistic or greater than additive effect” (Reply Br. 3), they merely                        
                require, e.g., “dosage unit[s]” that will provide a greater anti-cancer effect                 
                than the effect obtainable with either the dosage unit of capecitabine or the                  
                dosage unit of Compound (1) alone.”  (Claim 117 (emphasis added).)  As                         
                the Examiner found, the claimed dosage units likely cover “all dosage                          
                ranges” (Answer 10) and thus likely include ones that would not yield                          
                synergism or unexpected results.                                                               
                      With respect to the six types of cancers recited in the claims other                     
                than colon cancer, Appellant has not provided any evidence of unexpected                       
                results.  According to the majority, the prior art teaches the two drugs are                   




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