Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from citrus
Reexamination Certificate
2000-05-18
2002-01-29
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from citrus
C424S403000, C424SDIG001, C514S546000, C514S547000, C514S918000, C514S919000
Reexamination Certificate
active
06342253
ABSTRACT:
BACKGROUND FIELD OF INVENTION
This invention relates to natural compositions and methods that both repel head lice and treat
pediculosis capitis.
BACKGROUND TO THE PRESENT INVENTION AND PRIOR ART
Head lice infestation (
pediculosis capitis
) is a major problem in the United States, throughout Europe and Asia. In the United States alone 10 million cases of
pediculosis capitis
occurred in 1989. Lice are external parasites of warm blooded animals. They spread by crowding and sharing of personal items such as combs, hats, brushes and clothing.
Humans are host to three different types of lice, 1) head lice, 2) body lice, 3) crab or pubic lice.
The head louse has been among humans since their earliest origins. The louse has evolved in a highly specialized manner for survival on the haired human scalp, to the extent that its survival requires it to spend its entire life-cycle on a human host.
The life cycle of the head louse falls into three phases, egg, nymph and mature louse.
Louse eggs, some 0.5 to 0.8 by 0.3 millimeters, are usually laid at the base of hairs, within 0.5 mill of the scalp, where they hatch after seven or eight days. During incubation, the hair will grow away from the scalp by some two millimeters. The eggs are firmly glued to the hair, usually one per hair, by a clear, quick-setting substance secreted by the female. Live eggs are usually camouflaged by being the same color as the scalp.
The nymph resembles the adult louse in behavior, and in physical terms apart from size. In about ten days after hatching it is mature.
Mature head lice are 2 to 4 millimeters long, shun light, and move swiftly—10 to 20 centimeters a minute—in all lateral directions, clinging to and crawling through the hair with their six claws. Otherwise transparent, head lice camouflage themselves by darkening, after feeding, to the color of the skin and hair of the host, in the range from blond to black.
The empty egg-shell is called a nit. It is white in color, and remains firmly glued to the hair. The hair grows at a rate of some one centimeter per month, carrying any nits attached to it away from the scalp.
The characteristic feature of the group to which human head-lice belong is blood-sucking. To feed, the louse pierces the scalp with its mouth-parts, pumping in saliva and drawing out a mixture of saliva and blood. While humans are not born with the ability to react to such bites, repeated contact with the sensitizing allergens contained in the saliva creates an allergic reaction, so that each further bite evokes an itchy reaction. Wounds produced in the scalp by scratching in response to itches can become inflamed and infected. If louse infestation is allowed to persist, the wounds can develop an extreme condition, wherein successful treatment cannot be assured.
A population of head lice which is neglected will reach a steady state, where the death-rate equals the birth-rate, and some two hundred lice of all post-ovum stages are present. About five thousand eggs are laid each month and the head eventually becomes grey with drifts of empty egg shells. Such a population, when present for some months, is enough to produce the symptoms of
pediculosis capitis.
The child becomes itchy, tired, dull and sullen. The bright child becomes average, and the average child stupid.
Although they can be shown to act as transmitters of typhus and fevers in the laboratory, head lice are not responsible for the transmission of disease in the field. Lice are considered highly unlikely to transmit AIDS.
The highest incidence of
pediculosis capitis
is found in children between the ages of five and fifteen years. In the developed world head lice are most prevalent among suburban and rural children.
Even though people experience unpleasant sensations as a result of louse infestation, they often deny
pediculosis capitis
because of feelings of disgust and shame. Lice infestation used to be thought of as a problem only of the poor or poorly housed. It is now abundantly clear that the problem of head lice has extended to a very large number of middle class homes in the western world and this leads to increasing numbers of consultations with family practitioners or pharmacists who advise as to the treatment currently being recommended.
Other general recommendations include machine washing in hot water (over 54° C.) or dry cleaning all clothing, including coats, hats, scarves, pillow cases, towels, and bedding materials, which may have contacted an infested individual.
Several products for treating
pediculosis capitis
are available over the counter, the most widely used products in this category include Rid® Lice Killing Shampoo (Pfizer), Nix® Cream Rinse and A-2000® Shampoo Concentrate which contains pyrethins and piperonyl butoxide as active ingredients. Prescription drugs include Ovidem® (active ingredient 0.5% malathion) and Kwell® (containing landane 1%).
Pediculicides, selectively kill lice which invade the epidermis. Although a number of brands contain either carbaryl or malathion, lotions containing phenothrin and permethrin are now the major products. These are pyrethroid compounds are highly effective insecticidal neurotoxins, with efficacy against both adult lice and their eggs. Permethrin (3-phenoxyphenyl)methyl (+/−) cis/trans 3-(2,2-dichloroethenyl)2,2-dimethylcyclopropanecarboxylate, is used as a 0.5% preparation in a paraffin base. Other actives are benzyl benzoate and crotamiton. All are applied topically. The manufacturers claim appropriate use does not lead to resistance but evidence now would seem to suggest otherwise. Many health authorities are now advising no active treatment because of problems apparently due to resistant lice. Instead they recommend over-conditioning the hair and regular use of a specially designed lice comb.
It is clear that a repellent, which curtails infestation, is preferable. A number of insect repellents have been developed, however most are not specific for lice. Several natural repellents are specific for mosquitoes or fleas, U.S. Pat. No. 5,106,622 teaches a natural repellent effective against mosquitoes and ticks, U.S. Pat. No. 5,738,863 teaches a honey bee repellent comprising tea tree oil, U.S. Pat. No. 5,411,992 teaches a lice repellent comprising terpenoids. This survey shows that there is no teaching of the invention, which is a topical, natural composition useful as both a lice repellent and a treatment of
pediculosis capitis.
The following U.S. patents are considered relevant:
U.S. Pat. No. 4,193,986
U.S. Pat. No. 4,587,123
U.S. Pat. No. 5,591,435
U.S. Pat. No. 4,927,813
U.S. Pat. No. 5,411,992
U.S. Pat. No. 4,759,930
U.S. Pat. No. 5,208,029
U.S. Pat. No. 4,933,371
U.S. Pat. No. 4,193,986
U.S. Pat. No. 5,783,863
U.S. Pat. No. 4,379,168
U.S. Pat. No. 5,106,622
SUMMARY OF THE INVENTION
It has been discovered that the combination of three essential oils: anise, tea tree and lemon, in a concentration of between 0.01% and 50%, most preferably between 0.01% and 10%, is a very good head lice repellent and treatment of
pediculosis capitis.
The active agent can be combined with a pharmaceutically and/or cosmetically acceptable carrier for topical administration, such as an aqueous or alcohol solution, a gel, or cream, and administered with or without additives such as preservatives, antioxidents, fragrances, agents increasing solubility or delaying release of active agents.
The active agent in concentrated form can be added to personal preference shampoos, hair-sprays, rinses, styling gel or other personal preference hair care products.
The active agent can also be used to treat material such as hairbows, headbands, caps, hats, helmet linings, any object that is made of cloth and worn on the head.
The active agent can also be used as a head lice repellent and treatment of
pediculosis capitis
for animals.
Other objects, features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood however, that the detailed description and specific examples, wh
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