Ex Parte MALFROY-CAMINE - Page 4


                 Appeal No. 2001-2379                                                         Page 4                    
                 Application No. 08/931,666                                                                             

                 not shown, e.g., “that antibody levels in vivo could be achieved which would allow                     
                 sufficient uptake of antibody by endocytosis to achieve effective levels for                           
                 therapy.”  Id.  The examiner also cited two references showing monoclonal                              
                 antibody therapies and immune system-boosting therapies had not been                                   
                 effective in treating HIV infection.  See id., page 5.                                                 
                        We conclude that the examiner has not carried the initial burden of                             
                 showing nonenablement, by providing a reasonable explanation of why the                                
                 claimed methods are not enabled.  The examiner correctly notes that Appellant                          
                 has not shown that the claimed method actually works in vivo.  See the                                 
                 Examiner’s Answer, pages 4-5.  Appellant, however, is not required to prove that                       
                 the claimed method works.  “Section 112 does not require that a specification                          
                 convince persons skilled in the art that the assertions therein are correct.”  In re                   
                 Armbruster, 512 F.2d 676, 678, 185 USPQ 152, 153 (CCPA 1975).                                          
                        Rather, the burden is on the examiner to set forth a reasonable                                 
                 explanation as to why he believes that the scope of the claims is not adequately                       
                 enabled by the description of the invention provided in the specification.  See In                     
                 re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).                              
                 The examiner cited two prior art references to support his position that those                         
                 skilled in the art would not have expected the claimed methods to provide an                           
                 effective treatment for HIV infection.  See the Examiner’s Answer, page 5.                             
                        We do not agree that the cited references support the examiner’s                                
                 conclusion.  The examiner cites Fahey as showing that “clinical trials using                           
                 monoclonal antibody therapies have not provided any clinical benefit.”  Id.  The                       





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