Ex Parte MAKOWSKI et al - Page 3


                 Appeal No.  2002-0796                                                         Page 3                    
                 Application No. 09/110,994                                                                              

                                                    BACKGROUND                                                           
                        The invention, as set forth in the specification, is generally directed “to a                    
                 method for the identification of the molecular targets for drugs or toxins in an                        
                 organism or other biological system.”  Id. at 1.  As part of the “Background of the                     
                 Invention,” the specification explains that it was known that a drug or toxin                           
                 expresses its activity by binding to proteins, and that a drug may bind to a protein                    
                 other than its desired target, which may give rise to unexpected or undesired side                      
                 effects or toxicities.  The specification states that the “[i]dentification of secondary                
                 targets, the interaction with which leads to side effects, may aid initial                              
                 toxicological evaluations on humans by identifying potential biological systems to                      
                 monitor, aiding in the interpretation of observed adverse effects, or providing                         
                 information that could be used to counteract these effects.”  Id. at 1.                                 
                        The method of the claimed invention                                                              
                        is directed to a process for the identification of a protein which                               
                        binds to a ligand, the ligand having a molecular weight which is less                            
                        than 5,000 Daltons and being other than a peptide or protein.  In                                
                        the process, the ligand is screened against a library of peptides or                             
                        proteins each of which is displayed on the surface of a genetic                                  
                        package that contains the corresponding nucleic acid sequence to                                 
                        identify the members of the library which have an affinity for the                               
                        ligand which is greater than the affinity possessed by other                                     
                        members of the library.  Each member of this peptide or protein                                  
                        library is physically linked to a nucleic acid polymer which encodes                             
                        that member by a genetic packages [sic], which also allows the                                   
                        peptide or protein to interact with the ligand.  Those members of the                            
                        library which have an affinity for the ligand which is greater than the                          
                        affinity possessed by other members of the library are separated                                 
                        from the library and the nucleic acid sequences which                                            
                        encode these members are determined and translated into peptide                                  
                        sequences or consensus peptide sequences.  Proteins which                                        
                        contain the peptide sequences or which correspond to the                                         





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