Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2008-07-01
2008-07-01
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S231200, C514S470000, C514S565000, C514S645000, C514S667000, C514S668000, C514S742000
Reexamination Certificate
active
07393825
ABSTRACT:
Methods for treating vascular conditions associated with localized imbalance in vascular tone, which are hypothesized to be largely due to elevated endothelin (ET) are provided. The methods involve administration of nitric oxide (NO), agents which are able to provide NO, such as NO donors, agents which activate guanyl cyclase, such as YC-1, or agents which prolong the actions of endogenous NO or cyclic guanosine monophosphate (cGMP; a 2nd messenger molecule), such as phosphodiesterase (PDE) inhibitors. According to the invention, such agents are administered in minimal doses or microdoses by any route known in the art, so as to provide dosages which are about one half to about one twentieth (½ to 1/20) of those known to induce vasodilation in “normal” circulations. The low doses of these agents effectively alleviate vascular conditions associated with a reduction in NO production or an attenuation of NO effect, by restoring balance in vascular tone while exerting almost no systemic effect in normal vasculature.
REFERENCES:
patent: 3681459 (1972-08-01), Hughes et al.
patent: 3742951 (1973-07-01), Zaffaroni
patent: 4421737 (1983-12-01), Ito et al.
patent: 4533540 (1985-08-01), Blank
patent: 4559222 (1985-12-01), Enscore et al.
patent: 4615699 (1986-10-01), Gale et al.
patent: 4654209 (1987-03-01), Leslie et al.
patent: 4655766 (1987-04-01), Theeuwes et al.
patent: 4681584 (1987-07-01), Gale et al.
patent: 4751087 (1988-06-01), Wick
patent: 4784857 (1988-11-01), Berry et al.
patent: 5059603 (1991-10-01), Rubin
patent: 5071656 (1991-12-01), Lee et al.
patent: 5284828 (1994-02-01), Hemmi et al.
patent: 5338726 (1994-08-01), Shiosaki et al.
patent: 5378715 (1995-01-01), Stein et al.
patent: 5382569 (1995-01-01), Cody et al.
patent: 5439938 (1995-08-01), Snyder et al.
patent: 5565466 (1996-10-01), Gioco et al.
patent: 5595970 (1997-01-01), Garfield et al.
patent: 5658936 (1997-08-01), Kifor et al.
patent: 5686099 (1997-11-01), Sablotsky et al.
patent: 5688499 (1997-11-01), Banting et al.
patent: 5731339 (1998-03-01), Lowrey
patent: 5859006 (1999-01-01), Daugan
patent: 5874437 (1999-02-01), Garvey et al.
patent: 5877216 (1999-03-01), Place et al.
patent: 6024976 (2000-02-01), Miranda et al.
patent: 6093709 (2000-07-01), Jirousek et al.
patent: 6165975 (2000-12-01), Adams et al.
patent: 6284763 (2001-09-01), Adams et al.
patent: 6306541 (2001-10-01), Place et al.
patent: 6410007 (2002-06-01), Banting et al.
patent: 6423683 (2002-07-01), Heaton et al.
patent: 6458797 (2002-10-01), Adams et al.
patent: 6472425 (2002-10-01), Garvey et al.
patent: 6610652 (2003-08-01), Adams et al.
patent: 6747063 (2004-06-01), Adams et al.
patent: 6787553 (2004-09-01), Adams et al.
patent: 2004/0234619 (2004-11-01), Adams et al.
patent: WO 94/18966 (1994-09-01), None
patent: WO 95/05172 (1995-02-01), None
patent: WO 95/19978 (1995-07-01), None
patent: WO 96/27372 (1996-09-01), None
patent: WO 96/32003 (1996-10-01), None
patent: WO 96/38131 (1996-12-01), None
patent: WO 97/03985 (1997-02-01), None
Medline Abstract No. 97217050, Kumar, Indian Journal of Experimental Biology, (May 1996) 34(5), 391-402.
Medline Abstract No. 96432582, Oka et al., Japanese Journal of Pharmacology, (Jun. 1996) 71(2), 89-100.
Medline Abstract No. 97074593, Smith et al., CA: A Cancer Journal for Clinicians, (Nov.-Dec. 1996), 46(6), 343-63.
Medline Abstract No. 1998029329, Rickels et al., Journal of Clinical Psychiatry, (1997) 58 Suppl. 11, 4-10.
Webster's II New Riverside University Dictionary, published 1984 by The Riverside Publishing Company, pp. 119 and 803, entries for “appreciable” and “normal”.
Adams, M.A. et al., “Vascular control mechanisms in penile erection: phylogeny and the inevitability of multiple and overlapping systems,” International Journal of Impotence Research, 1997. 9:85-91.
Adams, Michael A., “Declaration” in Response to Examination Report dated Jan. 15, 2003 in European Patent Application No. 98930577.6, Jun. 2003.
Ahmad, S. “Scleroderma and Impotence: Response to Nitroglycerin Applied to the Fingers and Penis.” Letter, Dec. 1990, p. 1495.
Anderson, Douglas Jr., et al. “Topical Nitrate Treatment of Impotence.” The Annals of Pharmacotherapy, vol. 27, Oct. 1993, Abstract on pp. 1203-1205.
Banting, J.D. et al., “Acute hypertension after nitric oxide synthase inhibition is mediated primarily by increased endothelin vasoconstriction,” Journal of Hypertension, 1996. 14(8):975-981.
Bennett, B.M. et al., “Effect of In Vitro Organic Nitrate Tolerance on Relaxation, Cyclic GMP Accumulation, and Guanylate Cyclase Activation By Glyceryl Trinitrate and the Enantiomers of Isoidide Dinitrate,” Circulation Research, Oct. 1988. 63(4):693-701.
Berkow, R., A. Fletcher, eds. Merck Manual of Diagnosis and Therapy. Rahway, N.J.: Merck Sharp & Dohme Research Laboratories, 1987. p. 400.
Brock, G. et al., “Intracavernous Sodium Nitroprusside: Inappropriate Impotence Treatment,” The Journal of Urology, Sep. 1993. 150:864-867.
Farhy, R.D. et al., “Role of Kinins and Nitric Oxide in the Effects of Angiotensin Converting Enzyme Inhibitors on Neointima Formation,” Circulation Research, Jun. 1993. 72(60:1202-1208.
Feldman, H.A. et al., “Impotence and Its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study,” The Journal of Urology, Jan. 1994. 151:54-59.
Gardiner, S. M., et al. “Regional and cardiac haemodynamic responses to glyceryl trinitrate, acetylcholine, bradykinin and endothelin-1 in conscious rats: effects of NG-nitro-L-arginine methyl ester.” Br. Journal of Pharmacology, vol. 101, 1990, pp. 632-639.
Garg, U.C. and A. Hassid, “Nitric Oxide-generating Vasodilators and 8-Bromo-Cyclic Guanosine Monophosphate Inhibit Mitogenesis and Proliferation of Cultured Rat Vascular Smooth Muscle Cells,” J. Clin. Invest., May 1989. 83:1774-1777.
Garg, U.C. and A. Hassid, “Nitric Oxide Decreases Cytosolic Free Calcium in Balb/c 3T3 Fibroblasts by a Cyclic GMP-independent Mechanism,” The Journal of Biological Chemistry, Jan. 1991. 266(1):9-11.
Heaton, Jeremy. “Preliminary Studies, In Rabbit Penile Cavernosal Tissue, of the Role of Synthetic Nitrovasodilators in Erectile Response.” Current Therapeutic Research, vol. 45(2), Feb. 1989, pp. 278-284.
Heaton, J.P. et al., “The Characterization of a Bio-Assay of Erectile Function in a Rat Model,” The Journal of Urology, May 1991, 145:1099-1102.
Heaton, J.P. et al., “Recovery ff Erectile Function by the Oral Administration of Apomorphine,” Urology, Feb. 1995. 45(2):200-206.
Hellstrom, Wayne, et al. “Penile Erection in the Primate: Induction with Nitric-Oxide Donors.” The Journal of Urology, vol. 151, Jun. 1994, pp. 1723-1727.
Ignarro, L.J. et al., “Nitric Oxide And Cyclic GMP Formation Upon Electrical Field Stimulation Cause Relaxation Of Corpus Cavernosum Smooth Muscle,” Biochemical and Biophysical Research Communications, Jul. 1990. 170(2):843-850.
Jeremy, J. Y., et al. “Effects of sildenafil, a type-5 cGMP phosphodiesterase inhibitor, and Papaverine on cyclic GMP and cyclic AMP levels in the rabbit corpus cavernosum in vitro.” British Journal of Urology, vol. 79, 1997, pp. 958-963.
Johnson, R.A. and R.H. Freeman, “Sustained Hypertension in the Rat Induced by Chronic Blockade of Nitric Oxide Production,” American Journal of Hypertension, Inc., Dec. 1992. 5(12):919-922.
King, Robert, et al. “Low-Dose Sodium Nitroprusside Reduces Pulmonary Reperfusion Injury.” Annals of Thoracic Surgery, vol. 63, 1997, pp. 1398-1404.
Kirkeby, H. J., et al. “Role of the L-arginine
itric oxide pathway in relaxation of isolated human penile cavernous tissue and circumflex veins.” Acta Physiol. Scand., vol. 149, 1995, pp. 385-932.
Kurokawa, Hiroshi. “Portal and systemic hemodynamic responses to a very low dose of nitroglycerin in cirrhotic patients
Adams Michael A.
Banting James D.
Heaton Jeremy P. W.
Henley III Raymond J.
Strakan International Limited
Townsend and Townsend / and Crew LLP
LandOfFree
Microdose therapy does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Microdose therapy, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Microdose therapy will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2805755