Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Milk or colostrum
Reexamination Certificate
1999-08-06
2001-07-10
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Milk or colostrum
C454S195000, C454S178000, C454S178000
Reexamination Certificate
active
06258383
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the field of natural dietary supplements. It relates particularly to dietary supplements that are able to aid the prevention or inhibition of infection, promote immunological stimulation or increase tissue repair or healing. It is directed particularly towards the supplementation of human diets, and provides for enhanced absorption of the proteinaceous active ingredients in the oral cavity.
2. Background of the Invention
Nutrition is a critical determinant of immunological competence and of the individual's ability to resist infection and physiological stresses. The health of individuals is affected by poor decisions in society's management of new technology over the past five decades. In particular, the routine use of antibiotics, the consumption of processed foods and the pollution of the environment have resulted in multiple adverse influences upon health. Among these may be included the proliferation of new strains of bacteria and viruses that are resistant to existing antibiotic and antiviral agents, compromised immune systems resulting from chemical pollutants in food, water and air, as well as impaired ability to repair tissue and muscle. Additionally, emotional and physical stresses from employment, family, exercise and the natural effects of aging reduce the effectiveness of the immune system and tissue repair processes.
The continuing widespread use of antibiotics in medicine and agriculture reinforces the selective pressures that increase the types and extent of antibiotic-resistant microbes in the environment, which then substantially increases the cost of treating infection. Moreover, administration of antibiotics frequently causes disruption of the normal bacterial flora colonizing the individual's digestive tract, with results that are particularly undesirable in weakened patients.
The physiological rigors to which an individual's body is exposed in the modern environment, which include the chemical pollutants and antibiotic-resistant microbes discussed above, indicate the advisability of boosting the immune system to facilitate the body's abilities to resist and cope with infection, and to assist the natural, self-healing processes. Two groups of individuals are particularly susceptible to infection and the side effects of treatment: young children and the aged. These individuals may respond poorly to physiological or environmental challenges because they typically possess immune systems that are, in young children and in the aged respectively, immature or damaged. Consequently, natural stimulation of these individuals' immune systems is particularly desirable.
3. Description of the Prior Art
Stimulation of the immune system may occur if the appropriate proteins are absorbed into an individual's bloodstream. Yet these proteins are not only degraded rapidly by the acidic and enzymatic conditions of the stomach and intestine but they are also expensive to obtain, even in the quantities and formats used for experimental demonstrations: Lonnerdal & Iyer, 1995,
Annu. Rev. Nutr.,
15: 93-110. Thus attempts to formulate an effective dietary supplement able to generate and maintain a state of immune stimulation in an individual have been unsuccessful.
If the components of a dietary supplement were to possess, in addition to nutritional characteristics, abilities that aid the body's capacity to resist fresh infection, to suppress existing infection or to increase tissue repair and healing, such abilities would naturally prove advantageous for achieving the general health enhancing purposes outlined above. As indicated below, those skilled in the art of the respective fields recognize that each of the two proteinaceous products colostrum and lactoferrin is able to perform beneficial activities of this type: see, for example, Wang, et al., 1995,
J. Leuk. Biol.,
75: 865-874, and Burrin et al., 1995,
Pediatr. Res.,
37: 593-599.
Colostrum is the pre-milk produced immediately after birth before the breast secretions stabilize into milk. Prime colostrum from cows is obtained within the first six hours after calving and contains more than twice the milk solids and four times the protein found in milk from the same cow obtained forty-eight hours later. The concentrations of digestive enzymes, immunoglobulins, cytokines, interferons, glycoproteins, proline-rich peptides and vitamins A, D, E and K are all higher in prime colostrum than in the later breast secretions. The immunoglobulin fraction of the prime colostrum provides the newborn with antibodies, lactoferrin and immune enhancers. These components offer the newborn protection against viruses, bacteria, allergens and toxins, assisting desirable Acidophilus bacteria to start the colonization of the newborn's intestine and help prevent the development of gastrointestinal infection. Proline-rich peptides (e.g. colostrinin) are immunomodulatory peptide components of colostrum: Janusz and Lisowski, 1993,
Arch. Immunol. Therap. Experiment.,
41: 275-279. These proline-rich peptides are regulators of the thymus gland, which in turn produces T-lymphocytes that neutralize antigens, including infectious agents such as bacteria and viruses. Colostrum also contains a combination of growth factors that combat disease, reduce infection and enable the newborn to grow healthily and to heal rapidly: see, for example, Oda et al., 1989,
Comp. Biochem. Physiol.,
94A: 805-808 and Xu et al., 1994,
Biol. Neonate,
66: 280-287. That even healthy adults may benefit from the administration of colostrum is suggested by studies showing that bovine colostrum whey increases serum levels of insulin-like growth factor (IGF-I) in athletes undergoing training: Mero et al., 1997,
J. Appl. Physiol.,
1997, 83: 1144-1151. Colostrum balances blood sugars during periods of hyperglycemia or hypoglycemia, slows catabolism and the breakdown of muscle protein, and it stimulates fat utilization.
In sum, prime colostrum contains powerful healing, growth and repair factors that activate numerous immune, healing, growth and repair systems and assist in synthesis, retention and repair of muscle, bone, nerve and cartilage. As the body ages, becomes weakened by illness, or is subjected to physical stresses, it produces less and less of the growth, healing and repair factors that are needed to overcome illness and to heal quickly.
Ettinger, U.S. Pat. No. 4,762,822 (expired) describes the use of human colostrum as a source for extracting ganglioside, with human milk or mammalian brain being alternative sources. As one of several alternative components of young mammals' dietary supplements the extracted ganglioside is used to improve mother's milk substitute foods or for reducing the numbers of gastrointestinal disease-producing organisms in a young mammal.
Lactoferrin is a protein that is secreted in milk, tears, mucus and saliva, and is expressed by white cells at the site of attack by numerous pathogens. A primary function of lactoferrin is to bind iron at the molecular level and thereby act as a highly effective antimicrobial agent. Iron is an essential growth factor for virtually every cell and microorganism, and free iron promotes the growth of pathogens in the intestines (bacteria, viruses and fungi), permitting invasion of the rest of the body through the intestinal walls: Gillon Ward et al., 1996,
J. Trauma, Inj. Inf. Critical Care,
41: 356-364. Lactoferrin is released by cells to absorb free iron that would otherwise be available to bacteria, viruses and fungi for growth. Unlike synthetic antibiotics, to which bacteria may develop resistance through mutation, lactoferrin exerts its bacteriostatic effect as long as the bacteria require iron for growth.
Additionally, lactoferrin is recognized by specific receptors in mammalian tissues to release iron to the body for normal, healthy cell growth. Unlike synthetic antibiotics, lactoferrin has the ability to bind iron, transport it and then release the iron specifically to the
Cockrum Richard H.
Gohlke Marcus B.
Baker & Botts L.L.P.
Coe Susan D.
Lactoferrin Products Company
Prats Francisco
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