Drug – bio-affecting and body treating compositions – Topical body preparation containing solid synthetic organic...
Reexamination Certificate
2002-05-08
2003-06-10
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Topical body preparation containing solid synthetic organic...
C424S048000, C514S456000
Reexamination Certificate
active
06576229
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to synthetic soil extract substances comprised of phenolic polymers, and to compositions and methods for employing these synthetic phenolic polymers for preventing, reducing, treating, or eliminating influenza viral diseases.
2. Description of Related Art
Soil extract materials, particularly the classes of substances known collectively as “humus,” “humics,” “humic acid(s),” or “humates,” have been widely used in a number of applications for many years, as reviewed by F. J. Stevenson,
Humus Chemistry. Genesis Composition Reactions;
New York: Wiley, 1964; and, more recently, by A. Piccolo,
Humic Substances in Terrestrial Ecosystems;
New York: Elsevier, 1996.
Humic substances have long been known to exhibit anti-viral properties (H. Schultz,
Dtsch. Tierarztl. Wochenschr.
1962, 69, 613; 1965, 72(13), 294-297; R. Klocking and M. Sprossig,
Experientia
1972, 28(5), 607-608), particularly retroviruses (G. Sydow, V. Wunderlich, R. Klocking, and B. Helbig,
Pharmazie
1986, 41(12), 865-868). Viral pathogens for which soil-extract materials have been shown to be effective include in particular Coxsackie virus A9 (Griggs-Baylor) (R. Klocking and M. Sprossig,
Experientia
1972, 28(5), 607-608), herpes simplex virus type 1 (B. T. Rouse (Ed.), Herpes Simplex Virus; Berlin: Springer-Verlag, 1992; R. Klocking, K. D. Thiel, P. Wutzler, B. Helbig, and P. Drabke,
Pharmazie
1978, 33(8), 539; F. Schiller, R. Klocking, P. Wutzler, and I. Farber,
Dermatol. Monatsschr.
1979, 165(7), 505-509; B. Helbig, A. Sauerbrei, R. Klocking, P. Wutzler, N. Wicht, U. Wiedemann, and G. Herrmann,
J. Med. Virol.
1987, 23(3), 303-309; R. Klocking and B. Helbig, in
Humic Substances in the Aquatic and Terrestrial Environment;
Berlin: Springer-Verlag, 1991; 407-412;) and type 2 (anon.
Zentralbl. Bakteriol [Orig. A]
1976, 234(2), 159-169; K. D. Thiel, R. Klocking, H. Schweizer, and M. Sprossig,
Zentralbl. Bakteriol [Orig. A]
1977, 239(3), 304-321; K. D. Thiel, B. Helbig, R. Klocking, P. Wutzler, M. Sprossig, and H. Schweizer,
Pharmazie
1981, 36(1), 50-53; K. D. Thiel, B. Helbig, M. Sprossig, R. Klocking, and P. Wutzler,
Acta Virol.
1983, 27(3), 200-208; K. D. Thiel, P. Wutzler, B. Helbig, R. Klocking, M. Sprossig, and H. Schweizer,
Pharmazie
1984, 39(11), 781-782); human immunodeficiency virus (HIV) (M. Cushman, P. Wang, S. H. Chang, C. Wild, E. De Clercq, D. Schols, M. E. Goldman, and J. A. Bowen,
J. Med. Chem.
1991, 34(1), 329-337; M. Cushman, S. Kanamathareddy, E. De Clercq, D. Schols, M. E. Goldman, and J. A. Bowen,
J. Med. Chem.
1991, 34(1), 337-342; D. Schols, P. Wutzler, R. Klocking, B. Helbig, and E. De Clercq,
J. Acquir. Immune Defic. Syndr.
1991, 4(7), 677-685; S. Loya, R. Tal, A. Hizi, S. Issacs, Y. Kashman, and Y. Loya,
J. Nat. Prod.
1993, 56(12), 2120-2125; J. Schneider, R. Weis, C. Manner, B, Kary, A. Werner, B. J. Seubert, and U. N. Riede,
Virology
1996, 218(2), 389-395; influenza virus type A (Krasnodar/101/59/H2N2) (R. Mentel, B. Helbig, R. Klocking, L. Dohner, and M. Sprossig,
Biomed. Biochim. Acta
1983, 42(10), 1353-1356); and type B (J. Hils, A. May, M. Sperber, R. Klocking, B. Helbig, and M. Sprossig,
Biomed. Biochim. Acta
1986, 45(9), 1173-1179); as well as other respiratory tract infectious agents (A. Jankowski, B. Nienartowicz, B. Polanska, and A. Lewandowicz-Uszyuska,
Arch. Immunol. Ther. Exp.
(
Warsz
) 1993, 41(1), 95-97).
The mechanisms whereby humic substances inhibit the cytopathicity of a number of viruses have been studied in some detail. It is thought that the materials prevent viral replication in part by sorbing onto the viral envelope protein (gp120 in the case of HIV), and thereby block the sorption of viral particles to cell surfaces: K. D. Thiel, R. Klocking, H. Schweizer, and M. Sprossig,
Zentralbl. Bakteriol. [Orig. A]
1977, 239(3), 304-321; D. Schols, P. Wutzler, R. Klocking, B. Helbig, and E. De Clercq,
J. Acquir. Immune Defic. Syndr.
1991, 4(7), 677-685; anon.,
Fortschr. Med.
1995, 113(7), 10; J. Schneider, R. Weis, C. Manner, B. Kary, A. Werner, B. J. Seubert, and U. N. Riede,
Virology
1996, 218(2), 389-395. [Extracellular interception of pathogens by chemical agents that bind to them is a well-known means of immunological defense (D. M. Shankel, S. Kuo, C. Haines, and L. A. Mitscher, in
Antimutagenesis and Anticarcinogenesis Mechanisms III;
G. Bronzetti, H. Hayatsu, S. De Flora, M. D. Waters, and D. M. Shankel (Eds.); New York: Plenum, 1993; 65-74). Such materials might well be termed “despathogens”, following the terminology proposed by T. Kada and K. Shimoi,
Bioessays
1987, 7, 113-116, regarding “desmutagens”.] It has also been found that naturally-occurring humic acid preparations can stimulate the production of cytokines, including interferon-gamma, interferon-alpha, and tumor necrosis factor-alpha (A. D. Inglot, J. Zielinksa-Jenczylik, and E. Piasecki,
Arch. Immunol. Ther. Exp.
(
Warsz
) 1993, 41(1), 73-80); as well as interferon-beta (Z. Blach-Olszewska, E. Zaczynksa, E. Broniarek, and A. D. Inglot,
Arch. Immunol. Ther. Exp.
(
Warsz
), 1993, 41(1), 81-85).
The toxicity of naturally-occurring humic acids is remarkably low (K. D. Thiel, B. Helbig, R. Klocking, P. Wutzler, M. Sprossig, and H. Schweizer,
Pharmazie
1981, 36(1), 50-53; U. N. Riede, I. Jonas, B. Kim, U. H. Usener, W. Kreutz, and W. Schlickewey,
Arch. Orthop. Trauma Surg.
1992, 111(5), 259-264; H. Czyzewska-Szafran, Z. Jastrzebski, D. Soltysiak-Pawluczak, M. Wutkiewicz, A. Jedrych, and M. Riemiszewska,
Acta Pol. Pharm.
1993, 50(4-5), 373-377; H. L. Yang, F. J. Lu, S. L. Wung, and H. C. Chiu,
Thromb. Haemost.
1994, 71(3), 325-330). [Cytotoxic effects of anti-viral substances, including humic acids, are usually evaluated via biological (viability and alterations of cell morphology) and biochemical testing methods (
51
Cr release), as described by K. D. Thiel, U. Eichhom, H. Schweizer, and R. Klocking,
Arch. Toxicol. Suppl.
1980, 4, 428-430.] The cytotoxicity (CD
50
) of a naturally-occurring humic acid for human peripheral blood leukocytes (PBL) was found to be 1-9 milligrams per milliliter. In addition, J. Schneider, R. Weis, C. Manner, B. Kary, A. Werner, B. J. Seubert, and U. N. Riede,
Virology
1996, 218(2), 389-395, reported that the cytotoxicity of a synthetic humic acid prepared from hydroquinone for MT-2 cells was approximately 600 micrograms per milliliter. It has also been found that medicaments prepared from humic acids isolated from naturally-occurring soil materials are neither carcinogenic (Syrian hamster embryo cell transformation test: J. Koziorowska and E. Anuszewska,
Acta Pol. Pharm.
1994, 51(1), 101-102) nor mutagenic (T. Sato, Y. Ose, and H. Hagase,
Mutat. Res.
1986, 162(2), 173-178; V. M. Sui, A. I. Kiung, and T. I. Veidebaum,
Vopr. Kurortol. Fiozioter. Lech. Fiz. Kult.
1986, 2(3-4), 34-37; J. Koziorowska, B. Chlopkiewicz, and E. Anuszewska,
Acta Pol. Pharm.
1993, 50(4-5), 379-382). Prenatal (S. Golbs, V. Fuchs, M. Kuhnert, and C. Polo,
Arch. Exp. Veterinarmed.
1982, 36(2), 179-185) and embryotoxic and teratogenic effects (T. Juszkiewicz, M. Minta, B. Wlodarczyk, B. Biernacki, and J. Zmudzki,
Acta Pol. Pharm.
1993, 50(4-5),383-388) are also not observed with humic preparations at daily dose levels from 5-50 milligrams per kilogram body weight. Topical preparations are tolerated even better (V. V. Soldatov and M. N. Cherepanova,
Vopr. Kurortol. Fizioter. Lech. Fiz. Kult.
1970, 35(3), 256-259; H. Czyzewska-Szafran, Z. Jastrzebski, D. Soltysiak-Pawluczuk, M. Wutkiewicz, A. Jedrych, and M. Remiszewska,
Acta Pol. Pharm.
1993, 50(4-5), 373-377) when applied dermally in aqueous solution in amounts as high as 10 percent weight-by-volume (K. Wiegleb, N. Lange, and M. Kuhnert,
Dtsch. Tierarztl. Wochenschr.
1993, 100(10), 412-416).
Because humic substances are not chemically well-defined, the preparation of synthetic humic acids whose physicochemical properties mimic naturally-occurring materia
Fubara Blessing
Knobbe Martens Olson & Bear LLP
Laub BioChemicals Corp.
Page Thurman K.
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