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 thatPage: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 NextLast modified: November 3, 2007