Ex parte ESSEX et al. - Page 5




                Appeal No. 95-2419                                                                                                          
                Application 07/850,770                                                                                                      


                        We understand that it is incumbent upon the Patent and Trademark Office (PTO) to                                    
                explain why one skilled in the art would reasonably doubt the objective truth of the enabling                               
                statement contained in a supporting specification.  In re Marzocchi, 439 F.2d 220, 223,                                     
                169 USPQ 367, 369 (CCPA 1971).  Here, there are no portions of the specification which                                      
                are particularly helpful in providing enablement for the vaccine aspect of the present                                      
                invention.  As seen, for example, at page 8 of the specification, the selectively                                           
                deglycosylated HIV-1 envelope proteins of the present invention are only viewed as                                          
                “candidates” for vaccines.  As explained at page 19, lines 9-19, of the supporting                                          
                specification:                                                                                                              
                                Candidate vaccine gp120 molecules should generally possess the                                              
                        following properties: 1) they should be partially deglycosylated in the                                             
                        C-terminal portion of the molecule (defined above) to a sufficient extent to                                        
                        permit immune recognition of this portion of the molecule; and 2) a sufficient                                      
                        amount of the wild type conformation of the molecular should be retained                                            
                        such that the mutant virus substantially retains infectivity.  A recombinant                                        
                        gp120 molecule which satisfies both of these criteria is likely to elicit a                                         
                        protective immune response to reduce viral infectivity.                                                             
                As seen, partially deglycosylated proteins according to the present invention which meet                                    
                these two criteria are only considered to be “candidates” for vaccine purposes.                                             
                        Other relevant information in the supporting specification in regard to the vaccine                                 
                aspect of the present invention is set forth at page 22, lines 22-30, as follows:                                           
                                The mutant envelope protein may be formulated into vaccines                                                 
                        according to standard procedures known to those in the field.  For example,                                         
                        procedures currently used to make wild-type envelope protein vaccines (e.g.,                                        

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