Ex Parte Donoho et al - Page 17


                 Appeal No. 2003-1794                                                       Page 17                    
                 Application No. 09/804,969                                                                            

                 defining the exon splice-junctions of a gene—do not satisfy the utility requirement                   
                 of § 101.  Such uses do not provide a specific benefit in currently available form.                   
                        For example, with regard to the asserted “DNA chip” utility, we accept for                     
                 argument’s sake that a person skilled in the art could attach one of the claimed                      
                 polynucleotides (or a part of it) to a solid substrate, in combination with other                     
                 polynucleotides, to form a DNA chip.  We can also accept that such a DNA chip                         
                 could be used to monitor changes in expression of the corresponding gene.                             
                 However, the specification provides no guidance to allow a skilled artisan to use                     
                 data relating to the expression of the putative phospholipase gene in any                             
                 practical way.  The specification provides no guidance regarding what the                             
                 phospholipase gene-specific information derived from a DNA chip would mean.                           
                        Assume, for example, that a fragment of SEQ ID NO:14 was attached to a                         
                 DNA chip and the researcher observed that expression of the corresponding                             
                 gene was increased when a cell was treated with a particular agent.  The                              
                 specification provides no basis on which a skilled worker would be able to                            
                 determine whether that result is meaningful.  Maybe the meaning in a change in                        
                 expression of the gene would depend on other factors, but again the specification                     
                 provides no hint what other factors might be important.  Would it depend on what                      
                 agent is used,  what cell type is used, the behavior of other genes (if so, which                     
                 genes and what behavior is significant), the degree of increase?  Because the                         
                 specification provides no information about the activity of the protein encoded by                    
                 the claimed polynucleotides, it provides no guidance as to how to interpret the                       







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