Surgery – Male reproductory tract shields or birth control devices – Condoms
Reexamination Certificate
1999-11-08
2001-11-27
Brown, Michael A. (Department: 3764)
Surgery
Male reproductory tract shields or birth control devices
Condoms
C128S918000
Reexamination Certificate
active
06321750
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is in the fields of biochemistry, pharmacology, and anti-viral agents. It relates to the use of zinc salts in lubricants used during sexual intercourse, to reduce the risk of infection by sexually transmitted diseases such as AIDS or genital herpes.
The background information of interest herein is discussed in a series of five US patents that have already been issued, designating Patrick Kelly (the inventor herein) as sole inventor. Those five US patents are U.S. Pat. No. 5,208,031 (issued May 4, 1993, claiming gel-type genital lubricants with anti-viral zinc salts, in certain types of useful packagings); U.S. Pat. No. 5,482,053 (issued Jan. 9, 1996, claiming condoms that are prepackaged with lubricants containing anti-viral zinc salts); U.S. Pat. No. 5,545,673 (issued Aug. 13, 1996, with method claims); U.S. Pat. No. 5,599,551 (issued Feb. 4, 1997, claiming gel-type lubricants in additional types of packaging); and U.S. Pat. No. 5,624,675 (issued Apr. 29, 1997, with claims directed specifically at the human immunodeficiency virus, HIV, the causative agent for AIDS). The disclosures of these five issued patents are incorporated herein by reference. Briefly, the above-cited patents all relate to the use of water-soluble salts of zinc (such as zinc acetate, lactate, gluconate, etc.) as anti-viral additives in topical genital lubricants (this term includes condom lubricants).
One object of this invention is to disclose that genital lubricants containing a water-soluble salt of zinc offer anti-viral protection, when incorporated into genital lubricant formulations that are applied topically to one or more genital surfaces during sexual intercourse. These lubricants are useful for reducing the risk of viral infection from a sexual partner.
Another object of this invention is to disclose that water-soluble salts of zinc offer anti-viral protection, when incorporated into genital lubricant formulations that also may contain a potentially irritating or semi-toxic compound, such as a spermicide or microbicide.
Another object of this invention is to disclose genital lubricants containing two or more active agents in addition to a carrier fluid. One active agent is a water-soluble anti-viral zinc salt. The second active agent is a spermicide (such as nonoxynol or other suitable surfactant), microbicide, or other active agent.
Another object of this invention is to disclose that certain water-soluble inorganic salts of zinc, such as zinc chloride and/or zinc sulfate, can offer anti-viral protection in genital lubricant formulations.
Another object of this invention is to disclose an article of manufacture comprising a condom which is enclosed within a watertight package with a hydrophilic lubricant containing a water-soluble zinc salt at a concentration that reduces the risk that a person will become infected by a sexually transmitted virus such as herpes or HIV.
SUMMARY OF THE INVENTION
This invention relates to the use of water-soluble zinc salts as anti-viral agents in genital lubricants (such as condom lubricants or stand-alone gels). Such zinc-containing anti-viral lubricants can be spread on the shaft of the penis or inside the vagina before sexual intercourse, or applied in other suitable manners that causes the lubricant fluid to be coated on one or more genital surfaces during intercourse. Such zinc-containing anti-viral lubricants also can be coated onto condoms during manufacture and enclosed in sealed watertight packages containing the lubricated condoms, or packaged and sold as “stand-alone” lubricants in watertight containers without condoms. Preferred lubricants contain at least one water-soluble lubricating agent, such as glycerin or polyethylene glycol, and a suitable zinc salt, as well as some quantity of water to promote ionization of the salt and release of zinc ions (Zn
++
). If water is used, such lubricants may also contain a thickening or suspending agent, such as a cellulose derivative, a natural gum compound, or a hydrophilic polymer, to provide a gel; alternately, the carrier may be a different type of water-containing formulation, such as a cream, emulsion, or ointment. Suitable zinc salts include water-soluble organic salts having relatively low molecular weights (including zinc acetate, butyrate, gluconate, glycerate, glycolate, lactate, propionate, etc.). Highly ionizing inorganic salts, such as zinc chloride or sulfate, can also be used in some formulations. Preferred salts are those which cause no detectable irritation. The zinc-containing lubricants described herein are intended to reduce the risk of infection by a sexually transmitted pathogen, in a user who may be at risk.
REFERENCES:
patent: 4465666 (1984-08-01), Luke et al.
patent: 4503070 (1985-03-01), Eby
Brown Michael A.
Hamilton Lalita M
Kelly Patrick D.
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