Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Virus or bacteriophage
Reexamination Certificate
2000-11-22
2002-10-08
Stucker, Jeffrey (Department: 1648)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Virus or bacteriophage
C435S235100, C435S239000
Reexamination Certificate
active
06461608
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a bacteriophage composition useful in treating food products to prevent bacterial contamination by
Escherichia coli
bacteria.
BACKGROUND OF THE INVENTION
The Centers for Disease Control and Prevention (CDC) estimates that as many as 33 million people develop food poisoning each year—about one out of every ten Americans—and about 9,000 die. Since many cases of food poisoning are mistaken for a 24-hour “stomach flu,” the actual number of people with foodborn illness is probably much higher. Cerrato, P., “When food is the culprit; food poisoning,”
RN,
62(6):52 (Jun. 1, 1999). The presence of foodborn pathogens in a country's food supply not only affects the health of the local population, but also represents a potential for spread of pathogens to visitors to the country and to consumers in countries which import food products. Buzby et al., “Economic costs and trade impacts of microbial foodborne illness, ”
World Health Stat. Q.,
50(1-2):57-66 (1997).
Prevention of foodborne illnesses by microbial contamination is of major concern to the food processing industry, regulatory agencies, and consumers. Foodborne microbial contamination occurs both prior to entry into the processing facility, and by cross-contamination in the processing environment. The Food Safety & Inspection Service (FSIS) of the United States Department of Agriculture has instituted new Hazard Analysis and Critical Control Point (HACCP) requirements to reduce the occurrence and number of foodborne pathogens. These regulations must be met by food processors. Although the means of achieving this microbial reduction is left to the discretion of the processor, FSIS expects that antimicrobial treatments will be an important component of HACCP plans. The treatment methods of the present invention, which employ formulations of the bacteriophage compositions of the invention, are useful in meeting the HACCP requirements.
In their efforts to provide a product completely free of microbial contamination, poultry and meat processors have encountered major difficulties in removing microorganisms that infect poultry and meat tissues intended as food products.
E. coli
Bacteria
E. coli
bacteria are short Gram-negative rods that are part of the normal flora of the intestines of most warm-blooded animals. These organisms are the most common facultative anaerobe in the large bowel and provide protection against colonization by other harmful microbes. There are, though, five distinct groups of
E. coli
that can cause enteric disease: (1) enteroinvasive, (2) enteropathogenic, (3) enterotoxigenic, (4) enteroadherent, and (5) enterohemorrhagic. Pilot et al., “Threats from the food we eat; includes related articles; New and Emerging Pathogens, part 3,
” Medical Laboratory Observer,
28:42 (Apr. 1996).
E. coli
0157:H7 bacteria, first described in 1982, is a subset of the enterohemorrhagic variety that produces Shiga-like toxins (verotoxins) 1 and 2. Pilot et al. (Apr. 1996); and “Medical Experts Urge Radiation of Beef to Kill Deadly Bacteria,”
The New York Times,
Jul. 14, 1994, at page A15.
The toxin produced by
E. coli
0157:H7 in the intestines can cause anything from a mild diarrhea to severe hemorrhagic colitis, where the cells of the intestinal lining are damaged, allowing blood to pass into stool. In as many as 16% of all cases, the infection progresses to a more serious condition—hemolytic-uremic syndrome (HUS). Mackenzie, D. L., “When
E. coli
turns deadly,”
RN,
62(7):28 (Jul. 1, 1999). HUS, which occurs when the bacterial toxin enters the bloodstream through the damaged intestinal wall and travels to the smaller arteries that supply the kidneys, going on to damage those vessels, is characterized by hemolytic anemia, thrombocytopenia, and acute renal failure. In addition, anywhere from 10%-50% of patients with HUS develop long-term sequelae, including cardiomyopathy, pulmonary problems, pericardial effusions, end-stage renal disease, chronic hypertension, hyperglycemia, and encephalopathy. Mackenzie, D. L. (Jul. 1, 1999).
E. coli
0157:H7 is a leading cause of HUS in the United States and a leading cause of acute renal failure in children. Although the overall incidence of
E. coli
0157:H7 infection is unknown, estimates based on a 1994 outbreak in the Seattle area suggest that more than 20,000 cases occur in this country each year, and that 250 of them result in death. Mackenzie, D. L. (Jul. 1, 1999); and “Ban the 0157:H7 Bomb,”
Nutrition Action Healthletter,
22:3 (Janurary 1995/Feburary 1995). Young children, the elderly, and people with weakened immune systems are most susceptible to infection and resulting complications.
There is no known treatment for
E. coli
0157:H7 infection.
Nutrition Action Healthletter,
22:3 (January 1995/Feburary 1995). Antibiotics do little to deter the infection. “Medical Experts Urge Radiation of Beef to Kill Deadly Bacteria,”
The New York Times,
Jul. 14, 1994, at page A15; and Cerrato, P. (Jun. 1, 1999).
One reason this strain of
E. coli
is so dangerous is that it can cause disease in such low doses—ingestion of less than 1,000 organisms compared to more than the 10,000,000 needed before the bacterium that causes cholera causes disease. Cerrato, P. (Jun. 1, 1999). Some reports state that
E. coli
0157:H7 can cause illness with as few as 69.
The New York Times,
Jul. 14, 1994, at page A15. As little as one-half cup of
E. coli
-contaminated cider can cause abdominal pain, bloody diarrhea, vomiting and fever. “Roadside cider may be risky; may be contaminated with
E. coli,” Environmental Nutrition,
16:8 (September 1993). Such small amounts of disease-causing bacteria cannot be detected by routine meat inspection practices, and the presence of contaminated food products cannot be identified by sight, taste or smell.
The New York Times,
Jul. 14, 1994, at page A15. Similarly, the pathogen's acid resistance gives it an advantage over other pathogens. Gastric acid, one of the gastrointestinal tract's first lines of defense against foodborne illness, has little effect on
E. coli
0157:H7. Cerrato, P. (Jun. 1, 1999).
E. coli
0157 is found regularly in the feces of healthy cattle, and is transmitted to humans through contaminated food, water, and direct contact with infected people or animals. Mead et al., “
Escherichia coli
0157:H7,
” The Lancet,
352(9135):1207-1212 (Oct. 10, 1998). Transmission of the infection is primarily linked to consumption of undercooked ground beef, contaminated drinking water, and unpasteurized milk. Hamburger is a major vehicle of foodborne outbreaks of
E. coli
0157:H7 infection. Koutkia et al., “Enterohemorrhagic
Escherichia coli
0157:H7,
” American Family Physician,
56:853 (Sep. 1, 1997).
During the slaughter process, intestinal fluid or feces of infected cattle can drip onto the surface of the meat, contaminating it. It is theorized the harmful bacteria on the surface of the raw meat become mixed throughout the meat during the grinding process, where it can better survive the heat of cooking. One hamburger patty can contain the meat from many cows.
Currently,
E. coli
0157:H7 is the most common of verotoxin-producing
E. coli
serotypes. Various sources indicate it comprises from about 60% to more than 90% of all toxin-producing isolates and has been responsible for most outbreaks when food sources have been implicated. Pilot et al. (April. 1996). Distribution of
E. coli
0157:H7 probably is worldwide; the majority of cases have been noted in North America and Europe. Pilot et al. (April 1996).
Current Methods of Treating Food Products to Eliminate Bacterial Contamination
A. Irradiation
Food irradiation is the treatment of foods by subjecting them to ionizing radiation, also called ionizing energy. The radiation used in the process comes either from radioactive isotopes of cobalt or cesium or from devices that produce controlled amounts of high-energy electrons, gamma rays, or X rays. The process does not and cannot make the food radioactive. Greenberg et al., “
Averback Paul
Gemmell Jack
Nymox Pharmaceutical Corporation
Stucker Jeffrey
LandOfFree
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