Ex Parte EL KHOURY et al - Page 5



              Appeal No.  2003-1765                                                              Page 5                
              Application No. 09/319,735                                                                               
              (CCPA 1977), the examiner maintains that “the burden is upon the applicant to prove                      
              that the claimed products are functionally different than those taught by the prior art and              
              to establish patentable differences” (Answer, page 5).                                                   
                     As set forth in In re Best, 562 F.2d at 1255, 195 USPQ at 433-44:                                 
                     Where . . . the claimed and prior art products are identical or substantially                     
                     identical, or are produced by identical or substantially identical processes,                     
                     the PTO can require an applicant to prove that the prior art products do                          
                     not necessarily or inherently possess the characteristics of his claimed                          
                     product . . . . Whether the rejection is based on ‘inherency’ under 35                            
                     U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly                         
                     or alternatively, the burden of proof is the same, and its fairness is                            
                     evidenced by the PTO’s inability to manufacture products or to obtain and                         
                     compare prior art products [footnote omitted].                                                    
                     Nevertheless, the examiner’s rejection would shift the burden of proof to                         
              appellant merely on the basis of a general statement that it is possible to administer                   
              antiinflammatory/analgesics “topically when treating inflammatory conditions of the skin                 
              . . . by way of creams, jellies, gels, pastes, ointments and the like, in accordance with                
              standard pharmaceutical practice” (MacLean, page 4).  The examiner has made no                           
              attempt to establish what “standard pharmaceutical practice” entails with respect to                     
              topical application of analgesics.  On this record, it is unreasonable to shift the burden               
              to appellant to establish that MacLean administers a topically effective, but systemically               
              ineffective, amount of opioid analgesic.  Accordingly, the examiner’s rejection of claims                
              1-3, 5-9 and 11-22 over MacLean is reversed.                                                             
                                                   OTHER ISSUE                                                         
                     We note that appellants have disclaimed the terminal portion of the statutory                     
              term of any patent granted on the present application which would extend beyond the                      
              term of U.S. Patent No. 5,589,480 (see paper no. 16 of the present application).                         
              However, claim 15 of the present application appears to be identical in scope with claim                 




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