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(12) United States Patent (10) Patent No.: US 8,506,934 B2 Henkin (45) Date of Patent: Aug USOO8506934B2 (12) United States Patent (10) Patent No.: US 8,506,934 B2 Henkin (45) Date of Patent: Aug. 13, 2013 (54) METHODS FOR DETECTION OF Nakajima et al., Studies on cyclic nucleotides in brochopulmonary BOLOGICAL SUBSTANCES diseases with special reference to cAMP. c6MP inpatients with nasal allergy and bronchial asthma, Acta Med. Kinki Univ. 4, 257-272, (76) Inventor: Robert I. Henkin, Bethesda, MD (US) 1979.* Ajani, et al. Alcohol consumption and risk of coronary heart disease (*) Notice: Subject to any disclaimer, the term of this by diabetes status. Circulation. Aug. 1, 2000; 102(5):500-5. patent is extended or adjusted under 35 Atkinson, et al. The pathogenesis of insulin-dependent diabetes mel U.S.C. 154(b) by 12 days. litus. New Engl. J. Med. 1994:331: 1428-1436. Bakalyar, et al. Identification of a specialized adenylyl cyclase that (21) Appl. No.: 12/649,320 may mediate odorant detection. Science. Dec. 7. 1990:250(4986): 1403-6. (22) Filed: Dec. 29, 2009 Bogardus, et al. Relationships between insulin Secretion, insulin action, and fasting plasma glucose concentration in nondiabetic and (65) Prior Publication Data noninsulin-dependent diabetic subjects. J Clin Invest. Oct. 1984;74(4): 1238-46. US 2010/0227875A1 Sep. 9, 2010 Borisy, et al. High-affinity cAMP phosphodiesterase and adenosine Related U.S. Application Data localized in sensory organs. Brain Res. May 7, 1993;610(2): 199-207. Breer. Molecular reaction cascades in olfactory signal transduction. J (62) Division of application No. 1 1/415,942, filed on May Steroid Biochem Mol Biol. Oct. 1991;39(4B):621-5. 1, 2006, now Pat. No. 7,670,849. Carlsson, et al. Alcohol consumption and the increase of Type II (60) Provisional application No. 60/743,495, filed on Mar. diabetes: Finnish twin cohort study. Diabetes Care. 2003, 26: 2785 15, 2006, provisional application No. 60/676,252, 279O. Chou. Wake up and Smell the coffee. Caffeine, coffee, and the medi filed on Apr. 29, 2005. cal consequences. West J Med. Nov. 1992: 157(5):544-53. Doty, et al. Human odor intensity perception: correlation with frog (51) Int. Cl. epithelial adenylate cyclase activity and transepithelial voltage A6 IK 49/00 (2006.01) response. Brain Res. Sep. 10, 1990:527(1): 130-4. GOIN33/53 (2006.01) Franz, et al. Evidence-based nutrition principles and recommenda GOIN33/566 (2006.01) tions for diabetes and related complications. Diabetes Care. 2002, 46P II/02 (2006.01) 25:148-198. (52) U.S. Cl. Henkin, et al. Insulin receptors as well as insulin are present in Saliva USPC ............................ 424/10.1; 436/501; 435/7.1 and nasal mucus. Journal of Investingative Medicine. 2006; (58) Field of Classification Search 54(Suppl. 2):S378. None Henkin, et al. Nasal Seroproteins: a new frontier in the exploration of See application file for complete search history. physiology and pathology of nasal and sinus disese. New Frontiers in Immunobiology. 2000; pp. 127-152. (56) References Cited Henkin, et al. Treatment of abnormal chemsensation in human taste and Smell. In: Norris DM, ed. Perception of Behavioral Chemicals. U.S. PATENT DOCUMENTS Amsterdam, netherlands: Elsevier/North Holland Biomedical Press; 174.915 A 3, 1876 Lorenz 1981:227-265. 4,066.405 A 1/1978 Henkin 4,146,501 A 3, 1979 Henkin (Continued) 4,652,521 A 3, 1987 Confer et al. 4,683, 195 A 7, 1987 Mullis et al. Primary Examiner — Elly-Gerald Stoica 4,683.202 A 7, 1987 Mullis et al. (74) Attorney, Agent, or Firm — Wilson Sonsini Goodrich & 4,800,159 A 1, 1989 Mullis et al. 4,992.445 A 2f1991 Lawter et al. Rosati 5,001,139 A 3, 1991 Lawter et al. 5,023,252 A 6, 1991 HSeih (57) ABSTRACT 5,132,324 A 7/1992 Meglasson 5,384.308 A 1/1995 Henkin The invention is directed to a method of detecting a biological 5,525,329 A * 6/1996 Snyder et al. ................... 424/45 Substance in the nasal Secretion and diagnosing a disease 5,707,802 A 1/1998 Sandhu et al. following the detection of the biological substance wherein 5,788,967 A 8, 1998 Henkin 6,207,703 B1 3, 2001 Ponikau the biological Substance is not related to a respiratory disease. 6,387,639 B1 5, 2002 Posner et al. The invention also provides treatment of the diseases follow 6,929,925 B1* 8/2005 Zuker et al. ..................... 435/15 ing the detection of the biological Substance and/or diagnosis 2006/02758O1 A1 12, 2006 Henkin of the disease. In some embodiments, the diseases are cancer, FOREIGN PATENT DOCUMENTS hepatitis, Smell loss, taste loss, diabetes, and leprosy. The WO WO96,41194 A1 12, 1996 invention also provides a kit for diagnosing a disease. The WO WOO1? 48477 A1 T 2001 present invention includes methods of analyzing samples WO WOO3,O25224 A2 3, 2003 from the nose for the detection of biological substances. In WO WOO3,O25224 A3 11, 2003 particular, nasal Secretion or nasal mucus is collected and analyzed for biological Substances. The results of this analy OTHER PUBLICATIONS sis are then Suitable for use in diagnosis, prognosis, and Henkin et al., Aberrant signaling in the olfactory system: a mecha determination of suitability of therapeutic interventions. nism forv Smell loss. FASEB Journal, vol. 18, No. 4-5, pp. Abst. 792.7, 2004.* 18 Claims, 12 Drawing Sheets US 8,506.934 B2 Page 2 (56) References Cited Vaughan. Second wind for second-messenger research. Bioscience. 1987; 37:642-646. OTHER PUBLICATIONS Velicu, et al. Insulin is present in human saliva and nasal mucus. Journal of Investigative Medicine. 2006:54:S385. Henkin. Olfaction in human disease. In: English GM, ed. Loose-leaf Weinstock, et al. Olfactory dysfunction in humans with deficient Series of Otolaryngology. New York, NY: Harper and Row: 1982:1- guanine nucleotide-binding protein. Nature. Aug. 14-20, 39. 1986:322(6080):635-6. Huque, et al. Odorant- and guanine nucleotide-stimulated Weyer, et al. The natural history of insulin secretory dysfunction and phosphoinositide turnover in olfactory cilia. Biochem Biophys Res insulin resistance in the pathogenesis of type 2 diabetes mellitus. J Commun. May 29, 1986; 137(1):36-42. Clin Invest. Sep. 1999; 104(6):787-94. Kurihara, et al. High activity of adenyl cyclase in olfactory and Will, et al. Cigarette Smoking and diabetes mellitus from a large gustatory organs. Biochem BiophyS Res Commun. Jul. 11, prospective cohort study. Int. J. Epidemiol. 2001; 30: 540-546. 1972:48(1):30-4. Williams, G. Diabetes. In Endocrine Disorder. Oxford Testbook of Lancet, et al. Molecular transduction in Smell and taste. Cold Spring Medicine vol. 2, 4th Edition, Oxford Univ. Press 2003, pp. 317-359. Harb Symp Quant Biol. 1988:53 Pt 1:343-8. Woods, et al. Effect of hyperglycaemia on glucose concentration of Law, et al. Distribution of calmodulin in taste buds. Life Sci. 1985; human nasal secretions. Clin Sci (Lond). May 2004; 106(5):527-33. 36:1189-1195. Henkin. Concepts of therapy in taste and Smell dysfunction: repair of Law, et al. Low parotid saliva calmodulin in patients with taste and sensory receptor function as primary treatment. Olfaction and Taste Smell dysfunction. Biochem Med Metab Biol. Aug. 1986:36(1):118 XI, (Kurihara, K., Suzuki, N., Ogawa, H., Eds.), Springer Verlag, 24. 1994, pp. 568-573. Law, et al. Zinc deficiency decreases the activity of calmodulin regu Henkin. Taste and Smell disorders, human. Encyclopedia of lated cyclic nucleotide phosphodiesterases in vivo in selected rat Neuroscience, 3rd Ed. (Adelman, G., Smith, B.H., Eds.), tissues. Biol Trace Elem Res. Aug. 1988; 16(3):221-6. Birkhauser, Boston, 2004. Lowe, et al. Contribution of the ciliary cyclic nucleotide-gated con Office action dated Apr. 17, 2007 for U.S. Appl. No. 1 1/415,942. ductance to olfactory transduction in the Salamander. J Physiol. Mar. Office action dated Oct. 17, 2007 for U.S. Appl. No. 11/415,942. 1993:462:175-96. Office action dated Apr. 17, 2008 for U.S. Appl. No. 1 1/415,942. Maitra, et al. The pancreas in Pathological Basis of Disease. 7th Office action dated Nov. 12, 2008 for U.S. Appl. No. 1 1/415,942. Edition. Elsevier, 2004; pp. 1155-1207. Office action dated May 26, 2009 for U.S. Appl. No. 1 1/415,942. Margolskee. The biochemistry and molecular biology of taste Agarwal, et al. A simple method for simultaneous estimation of Zinc transduction. Curr Opin Neurobiol. Aug. 1993:3(4):526-31. and copper in erythrocytes. Bio. Tr. Elem. Res. 1985:7(4): 199-208. Micauley, et al. Diagnosing insulin resistance in the general popula Cicinelli, et al. Post-stroke reorganization of brain motor output to the tion. Diabetes Care. Mar. 2001:24(3):460-4. hand: a 2-4 month follow-up with focal magnetic transcranial stimu Nakamura, et al. Proceedings of the 25th Japanese Symposium on lation. Electroencephalogr Clin Neurophysiol. Dec. Taste and Smell: 1. Current and Ca influx induced by intracellular 1997: 105(6):438-50. cAMP in the newtolfactory receptor. ChemSense. 1991; 17:85-116. Henkin, et al. A double blind study of the effects of zinc sulfate on Pelangaris, et al. Oncogenic co-operation in beta-cell tumorigenesis. taste and Smell dysfunction. Amer. J. Med. Sci. 1976:272(3): 285 Endocr Relat Cancer. Dec. 2001:8(4):307-14. 299. Philips, et al. Factors determining the appearance of glucose in upper Henkin, et al. A Zinc protein isolated from human parotid saliva. Proc. and lower respiratory tract secretions. Intensive Care Med. Dec. Nat. Acad. Sci. USA 1975:72(2):488-492. 2003:29(12):2204-10.
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