Animal husbandry – Confining or housing – For experimental purposes
Reexamination Certificate
2001-05-17
2003-06-03
Price, Thomas (Department: 3643)
Animal husbandry
Confining or housing
For experimental purposes
Reexamination Certificate
active
06571738
ABSTRACT:
FIELD OF INVENTION
The present invention relates to closed-system caging or storage systems for animals, biological materials, plants or the like, incorporating intake and exhaust filter membrane ports as barriers to the movement of contaminants into or out of the isolation containers. Ventilation by convection flow (passive) or mechanical (active) exhaust systems provide quality contamination-free air to the occupants and handlers.
BACKGROUND OF THE INVENTION
As described in Wolfe's U.S. Pat. No. 5,190,879 (filed 1991), millions of laboratory animals have been used every year in experimental research. These animals range from mice to non-human primates. In order to conduct valid and reliable experiments, researchers must be assured that their animals are protected from pathogens and microbial contaminants that could affect test results and conclusions.
There are presently at least 1300 research facilities and 223 federal agencies registered with the U.S. Department of Agriculture (USDA) that use registered laboratory animals. (Crawford, “A review of the animal welfare enforcement report data, 1973-1995,” AWIC Newsletter, Summer 1996) These facilities include institutions, organizations and corporations such as hospitals, colleges and universities, diagnostic and toxicology laboratories, pharmaceutical companies and biotechnology companies. In 1995, these combined organizations used a total of 1,395,463 registered animals, of which 333,379 were Guinea pigs and 248,402 were hamsters. In addition to these registered facilities, there are nearly a thousand Institutional Animal Care and use Committees (IACUC) that report to the Public Health Service (PHS), mostly the National Institutes of Health. Some 90 percent of the animals used at these institutions are mice and rats, but exact figures for mice and rats are not known, since they are not registered animals. Nevertheless, it is estimated that the United States uses between 15.3 and 18.7 million mice and rats a year. (See Mukerjee, “Trends in Animal Research,”
Scientific American
, February 1997, pp. 86-93 and Stephens, “A Current View of Vivisection Animal Research in America,”
The Animal's Agenda
, September/October 1996, pp. 20-25.) In Canada, 1.25 million mice and 650,000 rats were reported (by Mukergee, supra) to have been used in 1992 for research. These figures exclude permanent breeding populations at research institutions and commercial suppliers, which are estimated to number 1.5 million mice and 500,000 rats.
Many laboratory animals in the past have suffered subclinical infections, in which they did not demonstrate any overt signs of disease. Because more research is now being conducted at the molecular and microscopic level, these subclinical infections are being discovered and are invalidating research. Various studies have demonstrated that contamination and compromised animal integrity are pervasive problems in the United States. The loss of biological integrity results in significant losses in valuable research time and money in laboratory animal research.
Since the conditions of housing and husbandry affect animal and occupational health and safety as well as data variability, and influence an animal's well-being, the present invention relates to a biological barrier/isolator caging system for laboratory animals to permit optimum environmental conditions and animal comfort. Because of risks of contamination, biocontainment requirements, DNA hazardous issues, gene transfer technologies disease induction, allergen exposure in the workplace and animal welfare issues, current caging system technologies would appear insufficient to support the modern biotechnology industry. The objective of the invention is to attain performance standards such as the exclusion of pathogenic and opportunistic organisms, containment of biological products, hazardous materials, allergens and bioaerosols, elimination of intracage contaminants and control and maintenance of an optimal microenvironment. The invention should also have the effect of improving laboratory animal housing conditions.
The health quality of research animals has recently improved enormously, creating a need for specialized caging equipment. Animal suppliers around the world have experienced an unprecedented demand for defined pathogen-free animals, and are now committed to the production and accessibility of such animals to researchers. The needs for improvement and technological advancement for efficiently, safely and comfortably housing laboratory animals arise mainly from contemporary interests in pathogen-free, immunocompromised, immunodeficient, transgenic and induced mutant (“knockout”) animals. Transgenic technologies, which are rapidly expending, provide most of the animal populations for modeling molecular biology applications. Transgenic animals account for the continuous success of modeling mice and rats for human diseases, models of disease treatment and prevention and by advances in knowledge concerning developmental genetics. Also, the development of new immunodeficient models has seen tremendous advances in recent years due to the creation of gene targeted models using knockout technology.
The number of publications on these subjects has increased from 64 for transgenic and one for knockout in 1986 to 1726 and 496, respectively, in 1996, based upon a Medline search. Further projections through Medline search trends predict that about 2454 papers will be published in the year 2001. Estimating the numbers of animals required at 200 per report, this means an estimated 500,000 mice will need to be maintained under proper barrier caging. The pharmaceutical industry presents new trends in research, resulting in a marked shift from acute to chronic disease studies. They incorporate the technology of genetic engineering into the traditional medicinal chemistry research process.
Unfortunately, transgenic animals are very often contaminated or “dirty” animals, because of the lack of proper animal care facility resources to protect the health of the newly-created animals. The current scientific advances and opportunities raise complex questions that must be addressed by researchers and animal care professionals. These questions include how to manage risks to compromised animals, to research personnel and the society at large of animal-to-human disease transmission through genetic manipulation, and how and whether to provide adequate resources for research and breeding applications of the new mutants. It has been suggested that animals expressing pathogenic transgenes may suffer from unique diseases. In light of the risks of transmission of disease to the animal users, some mechanism is needed to ensure attention to adequate biocontainment and health protection of transgenics and knockout mutants for minimizing exposure and for continued contamination control. Also, it is essential to consider that infectious agents, opportunistic organisms, allergens, airborne contaminants, fomites and environmental factor fluctuations have the potential to induce animal stress and diseases and variability in research or testing data. Animals become more vulnerable to diseases and more susceptible to human and cross-contamination as we use immunocompromised and genetically altered mutants.
Scientists refuse to use animals that are not healthy and cared for properly. Illness, undue stress or poor living conditions would interfere with obtaining valid, useful results from scientific experiments using animals. In brief, excellent science requires excellent care. The value of the animals used in biomedical research has increased substantially with the advent of gene transfer technology. For instance, the cost of a single transgenic white mouse could easily exceed $100,000 when the time and effort required to effect a successful gene transfer is considered. (Cooper, “Design Considerations for Research Animal Facilities,”
Lab Animal
, September 1989, pp. 23-26.) These lines of animals are not only extremely valuable but also frequently irreplaceable. Therefore, the
Animal Care Systems, Inc.
Price Thomas
Sheridan & Ross P.C.
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