Ex Parte WELLS et al - Page 2


                 Appeal No. 2002-0091                                                         Page 2                   
                 Application No. 08/479,884                                                                            

                 from the N-terminus of 191-amino acid human growth hormone, wherein said                              
                 variant is not hGH-V.                                                                                 

                        The examiner does not rely on any references.                                                  
                        All of the pending claims stand rejected under 35 U.S.C. § 112, first                          
                 paragraph, as nonenabled.                                                                             
                        We reverse.                                                                                    
                                                      Background                                                       
                        “Human growth hormone (hGH) . . . exhibits a multitude of biological effects                   
                 including linear growth (somatogenesis), lactation, activation of macrophages,                        
                 insulin-like effects and diabetagenic effects.”  Specification, page 5.  “The three-                  
                 dimensional structure of hGH is not available.”  Id., page 6.  Attempts have been                     
                 made to map the receptor-binding site in hGH using either peptide fragments or                        
                 monoclonal antibodies, but these techniques have not produced acceptable                              
                 results.  See id., pages 6-7.                                                                         
                        The specification discloses a method for identifying active domains in                         
                 proteins by systematically replacing amino acid residues of the wild-type protein to                  
                 create protein variants, and comparing the activity of the variants to that of the                    
                 wild-type protein.  See, e.g., pages 13-14.  The method is exemplified with hGH,                      
                 among other proteins.  See pages 44-57.                                                               
                        The specification provides numerous exemplary hGH variants,1 most having                       
                 an amino acid substitution in a single position.  See, e.g., pages 76-79.  Other                      

                                                                                                                       
                 1 Appellants put the number at “over 150”, page 6 of the Appeal Brief, which the examiner does not    
                 dispute.  Not all of these embodiments are encompassed by claim 88, however.                          





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