Ex Parte MIWA et al - Page 5




                Appeal No. 1997-1817                                                                                                            
                Application No. 08/139,693                                                                                                      


                para. 3) and suggests that TNF is also a suitable polyclonal growth factor (p. 26, col. 2,                                      
                para. 2); and, Matsuyama identifies several factors reported to activate HIV gene                                               
                expression, including granulocyte-macrophage colony stimulating-factor, immunological                                           
                stimuli, infection with viruses such as herpes simplex virus type 1, 12-O-                                                      
                tetradecanolyphorbol-13-acetate and lymphotoxin (p. 2504, col. 1, para. 1-2) and TNF                                            
                (p. 2507, col. 1, para. 3).                                                                                                     
                         A specification of a patent application is presumed to comply with the                                                 
                enablement requirement of 35 U.S.C. 112, first paragraph.  An examiner may reject                                               
                claims in a patent application on the basis of an alleged failure of the applicant to                                           
                comply with the enablement requirement if the examiner can establish by a                                                       
                preponderance of the evidence that there is reason  to doubt the objective truth of the                                         
                statements contained in the specification.  In re Marzocchi, 439 F.2d 220, 223-24, 169                                          
                USPQ 367, 369-70 (CCPA 1970).  In our opinion, the examiner has not sustained his                                               
                burden for making the enablement rejection, relying instead on mere conclusory                                                  
                statements.  Moreover, it appears inconsistent to assert that the claimed invention is                                          
                only enabled for "specific 'Trigger Factors'" (answer, p. 3), presumably TNF and anti-                                          
                Fas antibody, as recited in claim 8 and then to conclude that claim 8 is not enabled.                                           
                The examiner argues that while "[a]pplicants' claims read on TNF from any source,"                                              
                "TNF does not possess species cross over; that being mouse TNF fails to provide a                                               
                physiological effect in humans, with mouse TNF not effecting [sic, affecting] humans"                                           

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