Ex Parte Ramakrishnan - Page 5


                Appeal No. 2006-3253                                                                            Page 5                   
                Application No. 10/276,547                                                                                               

                2.  Utility                                                                                                              
                        The examiner rejected claims 102 and 104 under 35 U.S.C. §§ 101 and 112, first                                   
                paragraph, as lacking patentable utility.  The examiner reasoned that                                                    
                        [t]he instant application does not disclose a specific biological role for this                                  
                        protein or its significance to a particular disease, disorder or physiological                                   
                        process, which one would wish to manipulate for a desired clinical effect.                                       
                        Therefore, the instant claimed method of screening for compounds that                                            
                        bind to the protein of unknown physiological significance as potential                                           
                        candidate therapeutic agents does not meet the requirements of 35 U.S.C.                                         
                        § 101 as being useful.                                                                                           
                Examiner’s Answer, page 3.                                                                                               
                        With respect to the similarity of SEQ ID NO:2 to a protein from Drosophila                                       
                melanogaster, the examiner noted that “since the specific biological role of the                                         
                Drosophila dopamine 1 receptor precursor protein is currently unknown, there appears                                     
                to be no scientific reason to assign any particular function to the instant protein of SEQ                               
                ID NO:2 based solely on their limited structural similarity.”  Id., page 5.  Finally, the                                
                examiner concluded that “[w]ithout knowledge of the natural ligand of the claimed DA-                                    
                like GPCR, one would not know the specific pathway that is regulated by this instant                                     
                GPCR, and, consequently, [would] not be able to use the claimed polypeptide [sic,                                        
                agonist or antagonist of the polypeptide] to regulate any physiological function.”  Id.,                                 
                page 6.                                                                                                                  
                        We agree with the examiner that the specification does not disclose a patentable                                 
                utility for the “candidate therapeutic agents” identified via the claimed screening method,                              
                and that, therefore, the claimed method lacks patentable utility.  The U.S. Court of                                     
                Appeals for the Federal Circuit recently addressed the utility requirement.  See In re                                   
                Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005).  The Fisher court held that                                      





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