Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
1998-05-15
2002-04-09
Saucier, Sandra E. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093400, C424S093440, C435S252400, C435S252900, C435S853000, C435S854000, C435S885000
Reexamination Certificate
active
06368591
ABSTRACT:
Throughout this application, various publications are referenced and full citations for these publications may be found in the reference at the end of the specification preceding the claims. The disclosures of these publications are hereby incorporated by reference into this application in order to more fully describe the state of the art as known to the skilled therein as of the date of the invention described and claimed herein.
BACKGROUND OF THE INVENTION
It is well known that inside the gastrointestinal tract of each human being resides a microbial flora, which is a rich ecosystem of enormous complexity containing trillions of bacteria divided into more than 400 species. In addition to the normal microbial flora (resident micro flora) already established in the gastrointestinal tract, bacteria are introduced into human body everyday as a normal part of food (transient micro flora) or as contaminants (accidental micro flora).
The bacteria in human gastrointestinal tract can be divided into two groups—the probiotics and the pathogens. The probiotics are beneficial since they participate in a wide variety of positive and health promoting activities in human physiology. The pathogens are harmful as they cause diseases. Normally the probiotics prevail and predominate. The microscopic interplay between probiotics and pathogens and the balance between the beneficial and the harmful microorganisms are essential for a properly functioning digestive tract, which is in turn crucial to the optimal health of a human being. The number and efficiency of probiotics decline as people age or decrease in health.
The major benefits probiotics render to human beings are as follows:
The presence and adherence of probiotics, especially many lactic acid producing bacteria to the mucous membrane of the intestine from ileo-caecal region downward constitute a formidable natural biologic barrier for many pathogenic bacteria. The probiotics compete with disease-causing bacteria for villi attachment sites and nutrients. In addition, many kinds of acid produced by probiotics, such as lactic acid, acetic acid and benzoic acid, create an acidic environment unfriendly to harmful bacteria, viruses and yeasts.(1) The metabolic by-products of many probiotics, called bacteriocins, such as hydrogen peroxide, lactocidin, acidophilin and bulgarican, also manifest antibiotic properties and inhibit the growth of a wide spectrum of pathogens and/or potential pathogens, such as Escherichia (particularly
E. coli
), Klebsiella, Enterobacter, Pseudomonas, Salmonella, Serratia and Bacteroides.(2)
The metabolic products of probiotics provide many useful enzymes and volatile or non-volatile fatty acids to help digestion and absorption of certain minerals, such as phosphorus, calcium and iron.(3)
Probiotics contribute to a shorter intestinal transit time as well. This effect may be useful in some cases of constipation, particularly for the elder people.
Many resident enteric probiotics also produce certain important vitamins of B complex such as niacin (B3), pyridoxine (B6), folic acid and biotin for the needs of the host human being.
The lactic acid producing bacteria confer significant protection for human beings through various immune mechanisms, that include interactions between the microbes and the host as well as interactions among microbes.(4)
Probiotics also have powerful anti-carcinogenic features, that are active against certain tumors.(5) Epidemiological reports indicate an inverse relationship between colon cancer risk and consumption of fermented milks containing certain probiotics.(6)
Bifidobacterium bifidum
and
Lactobacillus acidophilus
have been shown in human clinical studies as being able to reduce the levels of some colonic enzymes (&bgr;-glucuronidase, nitroreductase, azoreductase and glycoholic acid hydrolase), that are implicated in the conversion of procarcinogens to carcinogens such as nitrosamine or secondary bile salts.(7)
Probiotics play such an integral part in the health of human being that some leading researchers in Europe claim that as much as 80% of all degenerative diseases result from an imbalance in the intestinal flora.
Probiotics, especially certain lactic acid producing bacteria have been used to ferment food for at least 4,000 years. Without understanding the scientific basis, people used these bacteria to produce cultured food with improved preservation and different flavors and textures from the original food. A wide variety of food including sausage, ham, wine, cider, beer, sauerkraut, olives and pickles all contain beneficial bacteria. Lactic acid producing bacteria are also used for many fermented milk products from all over the world, including yogurt, cheese, butter, buttermilk, kefir and koumiss.
The health benefits associated with probiotics were first observed by Nobel prize winner Elie Metchnikoff in the early 1900's when he hypothesized that lactobacilli were important in the intestinal flora for the health and longevity of human beings.(8) At about the same time, Tissier also showed that Bifidobacteria were the predominant flora in breast-fed infants and speculated that infant diarrhea could be treated by giving large doses of Bifidobacteria orally.(9) Since then, much research has been performed in an attempt to elucidate the mechanism of action of probiotics in the intestines on good health.
Scientific interest in probiotics has increased notably in past decades as the widespread use of antibiotics such as penicillin to suppress infection also brought many side effects. Antibiotics eliminate both harmful and beneficial bacteria at the same time and disturb the balance of normal bacteria flora in human body. Patients after long period or large amount use of antibiotics are often extremely susceptible to the secondary infection. In addition, many pathogens and/or potential pathogens have acquired immunity to antibiotics over the years. Researchers all over the world are looking for a method which can suppress disease causing bacteria without disturbing the normal microbial flora in the human body. Since more and more researches have shown that probiotics have the property to inhibit the growth of pathogens and/or potential pathogens and their levels can fluctuate and be manipulated, attempts have been made to increase the number and activity of these bacteria by consuming live cultures of selected species of bacteria in milk, yogurt, or pure cultures in powder, tablet or capsule form.
In China, strain selection on certain bacteria with health benefits was undertaken in the early 1980's when a group of scientists at the Institute of Epidemiology and Microbiology of the Chinese Preventive Medical Academy succeeded in isolating various anaerobes from the feces of 1-5 years old healthy children. They compared the number of beneficial microbes in the feces of healthy people with that of those suffering from diarrhoeal conditions, finding that Bifidobacteria together with other Gram positive non-sporing rods and residential Gram negative bacteria such as Bacteroides were greatly reduced in number in diarrhoeal patients as compared with the normal ones.(10) Realizing the significance of their findings, these scientists next performed experiments in gnotobiotic gineapigs with the
Bifidobacterium bifidum
and a combination of
Bifidobacterium bifidum, Lactobacillus acidophilus
and
Sterptococcus faecalis
. Challenged with a virulent strain of
Shigella flexneri
2a, the researchers found that animals implanted and colonized with
Bifidobacterium bifidum
exhibited marked resistance to Shigella infection whereas the controls succumbed. They also discovered that
Bifidobacterium bifidum, Lactobacillus acidophilus
and
Streptococcus faecalis
, when used together, performed a synergistic action in killing
Shigella sonnei
.(11) Another study, using gnotocavy dysentery model test, also showed that the protection of
Bifidobacterium bifidum
to animal (50%) was lower than that of the three bacteria combined (75%).(12)
In the past three decades, although much progress
Chen Bin Hua
Yao Yi Qiang
Afremova Vera
Chan Albert Wai-Kit
Elkins Mark
Saucier Sandra E.
Shanghai SINE Pharmaceutical Corporation Ltd.
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