Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2002-01-04
2004-03-30
Tate, Christopher (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from zingiberaceae
C424S729000, C424S094100, C424S094650, C424S464000, C424S094660, C514S062000, C514S825000
Reexamination Certificate
active
06713096
ABSTRACT:
BACKGROUND
1. Technical Field
The invention relates to dietary supplements as well as methods for reducing pain, inflammation, and stiffness associated with inflammatory conditions such as arthritis.
2. Background Information
Inflammatory conditions such as arthritis and osteoarthritis are serious medical problems that affect many Americans. In fact, arthritis is one of the nation's most prevalent chronic health problems. An estimated 43 million Americans suffer from some form of arthritis. According to the Arthritis Foundation, this figure is expected to jump to about 60 million within the next decade.
Osteoarthritis (OA), also known as degenerative joint disease, is the most common form of arthritis. By age 40, about 90 percent of all people have x-ray evidence of OA in the weight bearing joints such as the hips and knees. In addition, more than 20 million American currently have symptoms of OA. Severe involvement of the hips, knees, and spinal column can greatly limit activity and diminish the overall quality of life. The gradual breakdown of cartilage that accompanies aging is the leading cause of OA. This type of OA, called primary osteoarthritis, is caused by cartilage damage resulting mostly from stress on the joint from, for example, obesity. The first alteration in the joint, which takes place over decades, is a roughening of articular cartilage followed by pitting, ulceration, and progressive loss of cartilage surface. Primary OA most commonly involves the joints of the fingers, hips, knees, spine, base of the thumb, and big toe. It can be present in just one of these joints or in all of them.
Secondary OA, however, can affect any joint. Typically, secondary OA follows trauma or chronic joint injury due to some other type of arthritis such as rheumatoid arthritis. Alternatively, secondary OA can result from overuse of a particular joint. Although most body tissues can make repairs following an injury, cartilage repair is hampered by a limited blood supply and the lack of an effective mechanism for cartilage re-growth. The effects of joint overuse were shown in a study that revealed that subjects whose jobs required at least one hour a day of kneeling or squatting were almost twice as likely to have OA in the knees than those not commonly performing such activities. Because trauma or overuse hastens the degeneration of cartilage, symptoms of secondary OA can become apparent at a much younger age than symptoms of primary OA.
OA symptoms are usually mild at first. For example, morning stiffness that rarely lasts for more than 15 minutes is a common early symptom of OA. As the disease advances, mild pain will occur when moving the affected joint. The pain typically is made worse by greater activity and is relieved by rest. In many people, symptoms progress no further. In others, however, the pain and stiffness gradually worsen until they limit daily activities such as walking, going up stairs, or typing. Enlargement of the finger joints is common in the later stages of OA. Knobby overgrowths of the joints nearest the fingertips occur most often in women and tend to run in families.
There are number of treatments that can relive the pain, inflammation, and discomfort associated with OA. One treatment involves the use of non-steroidal anti-inflammatory drugs (NSAIDs). Although NSAIDs relieve some stiffness, inflammation, and pain associated with OA, NASIDs can lead to side effects such as gastric bleeding, liver damage, and kidney damage. In addition, long-term use of NSAIDs can lead to reduced effectiveness.
SUMMARY
The invention provides compositions (e.g., dietary supplements) for reducing pain, inflammation, and/or stiffness associated with inflammatory conditions such as arthritis or OA. Reducing pain, inflammation, or stiffness associated with an inflammatory condition can help improve joint mobility. Typically, such compositions can contain an aminosaccharide, a ginger component, and an enzyme. In addition, the compositions provided herein can contain other ingredients such as a green tea extract. The compositions provided herein can be used to help people live healthier, more active lives by reducing joint pain, inflammation, or stiffness and/or by rebuilding cartilage. The compositions of the invention also provide people suffering from joint problems with a treatment that can produce detectable benefits within a short time period (e.g., within a few days of the first administration). In addition, the compositions of the invention can provide people suffering from joint problems with a safe treatment containing natural ingredients. The invention also provides methods for reducing pain, inflammation, and/or stiffness associated with inflammatory conditions such as arthritis.
In one aspect, the invention provides a dietary supplement comprising an aminosaccharide, a ginger component, and an enzyme. An aminosaccharide can be an aminosaccharide salt. Representative aminosaccharides include glucosamine, glucosamine hydrochloride, glucosamine sulfate, glucosamine phosphate, glucosamine lactate, or glucosamine dodecanoate. Typically, 300 mg to 3000 mg (e.g., 1000 mg to 2000 mg) of the dietary supplement is the aminosaccharide. A ginger component can include ginger oil, gingerroot or gingerroot extract. Typically, 50 mg to 10 g (e.g., 100 mg to 500 mg) of the dietary supplement is the ginger component.
Representative enzymes that can be included in a dietary supplement of the invention are bromelain, papain, fungal proteases, acid stable proteases, neutral stable proteases, and alkaline stable proteases. A dietary supplement of the invention can include a single enzyme or at least two different enzymes. Typically, 50 mg to 10 g (e.g., 1000 mg to 2000 mg) of the dietary supplement is the enzyme. A dietary supplement of the invention can be in the form of a tablet, a powder, or a liquid. A dietary supplement can include a green tea extract. Typically, 50 mg to 2000 mg (e.g., 100 mg to 1000 mg) of the dietary supplement is the green tea extract.
A dietary supplement of the invention can reduce pain, stiffness, or inflammation in a mammal. Generally, administration of the dietary supplement to a mammal reduces pain, stiffness, or inflammation in the mammal within four hours of the administration. In addition, daily administration of the dietary supplement to a mammal for at least two weeks generally reduces pain, stiffness, or inflammation in the mammal.
In another aspect, the invention provides a dietary supplement comprising: (a) at least about 1500 mg of a glucosamine salt, (b) at least about 175 mg of a ginger extract, (c) at least about 125 mg of a green tea extract, and (d) at least about 50 mg of bromelain. In yet another aspect, the invention provides a tablet comprising: (a) at least about 500 mg of glucosamine hydrochloride, (b) at least about 60 mg of a ginger extract, (c) at least about 20 mg of a green tea extract, and (d) at least about 20 mg of bromelain.
In still another aspect, the invention provides a method for reducing pain, inflammation, stiffness, or discomfort in a mammal, the method comprising administering a dietary supplement, to the mammal, in an amount effective to reduce the pain, inflammation, stiffness, or discomfort, wherein the dietary supplement comprises an aminosaccharide, a ginger component, and an enzyme. A representative aminosaccharide is glucosamine. Generally, the mammal receives a daily dose of the glucosamine. A daily dose can be between 2 mg/Kg and 20 mg/Kg of body weight of the glucosamine. A representative ginger component is ginger oil. Generally, the mammal receives a daily dose of the ginger oil. A daily dose can be between 25 mg/Kg and 50 mg/Kg of body weight of the ginger oil.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods
Fish & Richardson P P.C.P.A.
Flood Michele C.
Melaleuca, Inc.
Tate Christopher
LandOfFree
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