Ex parte HART - Page 6



                 Appeal No. 1995-4717                                                                                                                   
                 Application 07/876,288                                                                                                                 
                 protein in either the cytoplasm or the periplasm of E. coli.  Cronan is also relied upon as                                            
                 teaching that the fusion protein with a cleavage site would have allowed one to purify a                                               
                 protein of interest, for example using affinity chromatography targeted towards the fusion                                             
                 protein partner, and to subsequently cleave the purified protein from the fusion protein                                               
                 partner at the cleavage site.  Scott is cited (Answer, pages 7-8) as disclosing the use of                                             
                 binding protein for screening random peptide libraries.  Maina is cited as disclosing                                                  
                 (Answer, page 8) the use of E. coli vectors to express and purify foreign fusion proteins                                              
                 and specifically exemplifies maltose binding protein as useful for this purpose.   Finally,                                            
                 Plückthun is relied upon for the disclosure that (Answer, page 7)  "general solutions of                                               
                 finding optimal ligands . . . will . . . be carried out outside the cell."   The examiner then                                         
                 concludes (Answer, pages 8-9):                                                                                                         
                          As illustrated by the cited prior art, it was generally recognized that                                                       
                          generating libraries of a random or semi-random nature would have been                                                        
                          useful for a variety of purposes; for example, in elaborating the structure of                                                
                          ligands of receptors or antibodies.  Since the art recognized the concept of                                                  
                          using expression of random peptides in heterologous systems such a                                                            
                          bacteria, it would have been obvious to one of ordinary skill in the art at the                                               
                          time the invention was made to use the expression vectors of Cronan et al.                                                    
                          to express random recombinant peptides because these vectors were                                                             
                          taught to be advantageous for purification and analysis of recombinantly                                                      
                          produced proteins.  Many methods were available for generating                                                                
                          recombinant, random peptide libraries and the particular choice of vectors                                                    
                          as claimed was known at the time of the claimed invention.                                                                    
                                                                                                                                                       
                          It is the initial burden of the patent examiner to establish that claims presented in an                                      
                 application for patent are unpatentable.  In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d                                                
                 1443, 1445 (Fed. Cir. 1992).  On the record before us, we find that the examiner has failed                                            
                 to establish a prima facie case of unpatentability of the claimed subject matter.                                                      


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