Ex Parte MONTAGNIER et al - Page 5



                 Appeal No. 2000-1929                                                                                 
                 Application No. 08/019,297                                                                           

                        core proteins become exposed to said sera, the immunological                                  
                        detection becomes possible.  Therefore the invention concerns all                             
                        extracts of the virus, whether it be the crudest ones – particularly                          
                        mere virus lyzates [sic] – or the more purified ones, particularly                            
                        extracts enriched in the p25 protein or even the purified p25                                 
                        protein.                                                                                      
                                                     Discussion                                                       
                 1.  The utility rejection                                                                            
                        Claims 28-30, 35, and 42 are directed to “immunological complexes”                            
                 comprising a viral protein and an antibody bound thereto.  The examiner rejected                     
                 these claims under both 35 U.S.C. § 101 and 35 U.S.C. § 112, first paragraph,                        
                 on the basis that the claimed complexes lack patentable utility.  He reasoned that                   
                 “immune complexes are the end products of the antigen-antibody interaction and                       
                 it is entirely unclear what utility(ies) reside in the immune complexes                              
                 themselves.”  Examiner’s Answer, page 4.  The examiner argues that the                               
                 complexes are not useful in immunoassays, because                                                    
                        in immunology, one skilled in the art would routinely use HIV-1                               
                        proteins to detect antibodies to HIV-1 or, conversely, use antibodies                         
                        specific for HIV-1 to detect and/or identify proteins of HIV-1.  But                          
                        one skilled in the art would not use purified immune complexes for                            
                        such identification.  This usage is repugnant to one skilled in the                           
                        art.  Immunological assays do not routinely utilize purified immune                           
                        complexes in place of purified antibodies or purified antigens for the                        
                        very basic reason that immune complexes represent the end                                     
                        product of antigen-antibody interactions, not the starting material                           
                        useful in immunological assays.                                                               
                 Examiner’s Answer, page 5.                                                                           
                        Appellants argue that the claimed complexes have utility because they are                     
                 formed during processes for isolating and detecting HIV proteins.  Appeal Brief,                     


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