Ex Parte Kozlov et al - Page 8




                Appeal No. 2005-0548                                                                                                         
                Application No. 09/839,164                                                                                                   
                Thus, since Tame and Hoffman explicitly teach each and every limitation set forth in                                         
                representative claim 30, we find that the prior art anticipates the appellants’ invention.                                   
                        We have not overlooked the appellants’ argument that human alpha globin chain                                        
                taught by both Tame and Hoffman were produced in E. coli.  Brief, p. 6.  The appellants                                      
                argue that the purification procedures disclosed in the applied prior art did not remove                                     
                endotoxin and, thus, the solutions taught therein would not be suitable for subcutaneous                                     
                administration to humans.  Id.  We find this argument to be unconvincing for several                                         
                reasons.                                                                                                                     
                        First, representative claim 30 is not directed to a pharmaceutical composition for                                   
                use in humans; i.e., no particular species is recited.  Accordingly, we find that this                                       
                argument does not address a limitation present in the claims.                                                                
                        Second, as pointed out by the examiner, the specification discloses that it is                                       
                advantageous to use a stem cell proliferation inhibitor (INPROL)(e.g., alpha globin)                                         
                which is  produced in a prokaryotic host such as E. coli.  Specification, p. 17, para. 1.                                    
                That is, the specification discloses:                                                                                        
                                 In an advantageous embodiment, INPROL is the product of prokaryotic or                                      
                        eukaryotic host expression (e.g., bacterial, yeast, higher plant, insect and                                         
                        mammalian cells in culture) of exogenous DNA sequences obtained by genomic                                           
                        or cDNA cloning or by gene synthesis.  That is, in an advantageous embodiment                                        
                        INPROL is “recombinant INPROL”.  The product of expression in typical yeast                                          
                        (e.g., Saccharomyces cerevisiae) or prokaryote (e.g., E. coli) host cells are free                                   
                        of association with any mammalian proteins.                                                                          





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