Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
2001-04-05
2002-06-04
Gitomer, Ralph (Department: 1623)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S045000, C514S627000, C514S918000, C514S920000
Reexamination Certificate
active
06399073
ABSTRACT:
TECHNICAL BACKGROUND
The present invention concerns a liquid composition for use as a lachrymator. More particularly, the invention concerns a lachrymator produced utilizing capsicum and a nonflammable water based carrier.
BACKGROUND
The prior art provides various compositions which constitute strong irritants to the eyes, mouth and nose of a human and other animals. Such compositions are generally classified as lachrymators. Lachrymators are better known, and commonly referred to as “tear gas” or “riot gas”. Lachrymators serve a significant role in society because they allow the police, military and other authorities to control unruly or disruptive persons, including persons under the influence of alcohol or other mind-altering drugs, without having to resort to physical means that may inflict long-term or permanent bodily harm or damage.
Upon application of a lachrymator, the recipient of the lachrymator is overcome by eye, nose and mouth irritation and rendered harmless. More particularly, upon application the recipient is temporarily disabled with intense burning eye pain, blepharospasm, acute bronchitis and respiratory irritation. The prior art provides various means for dispensing or applying lachrymators, such as, for example, pressurized canisters, hand grenades, and munition cartridges.
The need for an aerosol irritant-type spray or lachrymator, for enforcement and defensive purposes, is historic as well as present day evident. Social unrest, demonstrations and rioting during the 1960's caused the extensive use of military type tear gas agents, known typically as the chemicals CN (chloroaceto-phenone) and CS (ortho-chlorobenzalmalononitrile). These tear gases are actually irritants causing pain and discomfort to the lacrimal glands (tear ducts) and the upper respiratory system. Delivery systems for these agents were comprised mainly of grenades and projectiles, commonly designed as pyrotechnic (burning) type devices. In Wortley, Jr. et al. U.S. Pat. No. 3,192,105 there is disclosed a method of combining CN with a colloidal silica to produce a solid phase form of lachrymator. As disclosed in the '105 patent, this solid phase lachrymator is well suited for use in munitions which disperse the lachrymator by an explosion or similar means.
The search began for more modern methods of delivery/dispersion of tear gas agents, with limited fire potential and more limited (controllable) area coverage. In 1966, Smith and Wesson, through acquisition of General Ordnance Equipment Company, introduced CHEMICAL MACE®. lachrymator, a liquid based CN chemical formula which was filled into pressurized aerosol spray containers.
CHEMICAL MACE® lachrymator has been the forerunner of all such products since its introduction in 1966. Its use greatly lessens the amount of physical force which might be necessarily applied by a law enforcement officer, corrections officer or security officer when attempting to detain a suspect or disperse a crowd of unruly persons. This type of product fits into the low-end of a “use of force” scale which generally begins with talking on the low side, and escalates to shooting on the high side. Thus, lachrymators are generally classified as “nonlethal weapons”.
The original CHEMICAL MACE® lachrymator formula consisted of trichlorotrifluoroethanes (CFC's 111, 113) and cosmetic kerosene as the carrier agent/solvent, blended with the active ingredient (CN), and pressurized with carbon dioxide as the propellant. This formula has successfully undergone the most extensive scientific and medical test and studies of any similar use type formulation in history. As a result, this formula was used extensively until about 1990. Specifically, beginning about 1990 there was increasing pressure on the chemical industry to phase out ozone depleting substances (i.e., chlorofluorocarbons—CFC's) under the provisions of the Clean Air Act.
The CFC's, which serve as a nonflammable carrier, provide a significant advantage for the lachrymator solution. Specifically, lachrymator solutions that employ a CFC carrier are generally less likely to ignite. More particularly, when a lachrymator is dispensed, there is always the possibility that an open flame or other source of ignition may be present that could ignite the carrier of the mixture resulting in serious bodily harm to both the user and the intended recipient of the lachrymator. Examples of some possible sources of ignition include lit cigarettes or cigars, burning candles or matches, and stoves or other heating devices employed by persons involved in illicit drug use and/or processing. A nonflammable carrier is less likely to ignite when exposed to such sources of ignition and is thus a preferred carrier for use in lachrymators.
Governmental actions in the United States, already taken as a result of the regulatory impact on CFC's, have extended to international proportions resulting for example in the complete banning of CFC's in such countries as Canada. It is likely that CFC's will be totally phased out before the year 2000, and users in the United States are already paying a federal controlled substance use tax.
Manufacturers of CFC substances have been relentless in their search for acceptable substitutes. However, to this date, manufacturers have only been able to provide solvent replacements that do not totally eliminate the problem. The most recent substitute offered is a halogenated fluorocarbon, HCFC-141b. This solvent appeared to be the solution as it complied with the mandate to reduce ozone depleting potential. However, the first danger signal was sounded on Oct. 15, 1991 in a notice which stated that the U.S. Environmental Protection Agency (EPA) did not believe that HCFC-141b was a necessary solvent replacement, and they were taking the position that they had the authority, under the Clean Air Act, to make it unlawful to use HCFC-141b as a solvent replacement. Accordingly, there is currently a need to develop a new carrier system for lachrymators which does not employ CFC's.
Capsicum (also known as cayenne pepper) and its chemical equivalents such as capsaicin (C
18
H
27
NO
2
) have also been utilized to produce lachrymators for many years. Such lachrymators are commonly utilized in the liquid phase and are dispensed from pressurized canisters or bottles. Generally, prior art capsicum containing lachrymators comprise a mixture of capsicum, soybean oil and an alcohol type solvent. Capsicum containing lachrymators are preferred by some users. More particularly, some users believe that capsicum containing lachrymators are more effective than other prior art lachrymators. Some users also believe that capsicum containing lachrymators are particularly effective for use on large animals such as bears. Additionally, some users prefer capsicum because it is a “natural” material as compared to the man-made chemicals CS and CN.
From a physiological standpoint it was noted that CN and CS did not consistently affect persons who were under the influence of alcohol or drugs. Also, from a psychological viewpoint CN and CS did not always affect those persons who were extremely outraged, emotionally disturbed or suffering from neurotic psychological symptoms.
On the other hand, some studies conducted with capsicum have concluded that, if properly dispensed, the capsicum would effect a person in all circumstances including those who were acting under the physiological and psychological influences noted above.
Unfortunately, because the prior art capsicum containing lachrymators also contain carriers which are primarily alcohol, they are considered unacceptable by some users. More particularly, some persons believe the prior art lachrymators may present too much of a fire hazard. Additionally, some persons consider the prior art capsicum containing lachrymators to be unacceptable because they believe the carrier which is primarily alcohol may have an adverse impact upon tests which are utilized to determine the blood-alcohol level of a person exposed to the lachrymator. Thus, there is a need
Defense Technology Corporation of America
Gitomer Ralph
Khare Devesh
Renner , Otto, Boisselle & Sklar, LLP
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