Method and specific diagnostic system for objectively...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

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C436S501000, C436S518000

Reexamination Certificate

active

06333160

ABSTRACT:

TECHNICAL FIELD
The present invention relates generally to a method for the assessment of the relative health and homeostatic status of animals and specifically to an objective method for assessing and monitoring the relative health and homeostatic balance of animals as a basis for effective animal management and to a specific diagnostic system for conducting the assessment and monitoring method.
BACKGROUND OF THE INVENTION
Veterinarians, live stock breeders, herd managers and others involved in the field of animal management have long sought an efficient objective way to monitor the relative health and disease states and homeostatic balance of groups of animals and to assess the relative health and homeostatic balance of a group of animals or individual animals as a basis for effective animal management decisions. Groups of animals, whether a newborn litter of piglets or a herd of dairy cattle, must be effectively managed to maintain the group in the healthiest condition possible. In addition, it is highly desirable to maintain animals intended for the commercial market as stress-free and as homeostatically balanced as possible. If the health and homeostatic balance of the group is not maintained, at best, the animals in the group will not provide commercially usable products and, at worst, the animals in the group will die. Neither situation is desirable.
The health and homeostatic balance of individual animals also provides important information required for effective animal management. Consequently, an objective method for quickly determining the relative health homeostatic status of individual animals and of the individual animals in a group so that the changes necessary to ensure that the health and homeostatic balance of both the individual animals and the group is maintained at an optimum level would be a helpful animal management tool. In the past, animal managers have been required to rely on their own experience to evaluate an animal subjectively. Such a subjective evaluation is almost always based on the observation of symptoms indicative of some clinical disease process. However, by the time observable symptoms have appeared, it is often too late to implement management decisions that will promote or maintain the optimum health and homeostatic balance of either the group or the individual animals in the group.
Livestock, such as cattle, pigs, horses, sheep, goats, fowl and the like must be kept healthy by the producer to maintain the quality of the meat, milk, eggs and other products both at levels required by various regulatory agencies and at levels acceptable to consumers so that these products meet standards for human consumption and commercial salability. From the time such animals are born until they reach the stage where they are able to produce milk or eggs or they can be slaughtered for their meat, the optimum health and homeostatic balance of the animals should be maintained. A group of healthy, homeostatically balanced animals will grow and thrive and respond positively to shipping, environmental changes, routine vaccinations and other potentially stressful situations. A group of animals which includes animals that are not healthy or which has had its homeostatic balance upset will not respond positively to these stress inducers or disease. An efficient way to assess objectively the relative health and homeostatic balance of the individual animals in a group would provide the animal manager with a basis for making decisions that will promote optimum animal health and homeostatic balance and, in turn, produce high quality animal products.
In the past, veterinarians and animal managers such as herdsmen and breeders have not had an objective method for evaluating animal health or homeostatic balance, but have been required initially to evaluate their animals' health subjectively based on their own experience and then consult with a veterinarian to obtain an accurate assessment of an animal's health. Not only is this a time-consuming and costly method, but a disease condition or response to stress is highly unlikely even to be noticed until it has advanced enough to produce observable symptoms. By this time the health of other animals in the group may have been compromised, and information relating to the relative health status of the group has been obtained too late to permit the most effective action to be taken to maintain the optimum health of the group.
Animals, such as rabbits, guinea pigs, mice, dogs, cats and rats, used for experimental investigation have also been evaluated subjectively to ascertain relative health status prior to use in a study. Typically, a change in body weight is the primary indication of an experimental animal's relative health. However, this is not the most accurate indication of relative health. An efficient and accurate objective evaluation has not heretofore been proposed for determining the health or homeostatic balance of experimental animals. Such an evaluation would both prevent the unexpected premature death of unhealthy experimental animals and insure that the animals selected for a study would remain healthy during the course of an experiment so that meaningful data will be produced.
There is, moreover, no currently available efficient method for objectively evaluating the relative health of animals kept as pets.
The presence of a disease or other abnormal condition in humans and animals generally causes changes in various components of the blood, including cell count and the distribution or concentration of serum proteins, enzymes and hormones. Changes in plasma or serum proteins called acute phase reactants have been observed in several human disease conditions. The concentrations of such proteins may increase or decrease, depending on the type of disease or abnormal condition. This information has been useful in the diagnosis and treatment of certain human disease states.
One of the acute phase reactants, &agr;
1
-acid glycoprotein, usually increases in some disease conditions, most notably in inflammatory diseases. When a human or animal host is infected with a microbion, the host reaction is primarily an inflammatory reaction process. This process produces immunocytes, including T cells and macrophages, in response to such inducers as lipopolysaccharides, bacteria and viruses. Mediators, including tissue necrosis factor (TNF) and cytokines are produced. These mediators affect the production of serum proteins and enzymes by the hepatocytes. Some serum proteins and enzymes kill cells, while others suppress overactive immune activity. &agr;
1
-acid glycoprotein affects T cells or macrophages to suppress immune response. The resulting immunosuppression and reduced immunity may eventually produce observable clinical symptoms of a disease condition. However, the immune system may be suppressed and symptoms never observed because of the action of active portions of the immune system, including killer cells and macrophages.
Elevated serum &agr;
1
-acid glycoprotein levels have been found to accompany certain human disease conditions, such as, for example, ischemic cardiac events (U.S. Pat. No. 4,492,753 to Shell) and Alzheimer's Disease, cancer and pregnancy (U.S. Pat. No. 4,801,533 to Fudenberg and European Patent Publication No. 199,196 to Kuraray Co., Ltd.). The prior art has also suggested a relationship between artificially induced and naturally occurring inflammatory conditions and elevated serum &agr;
1
-acid glycoprotein levels in some animals. U.S. Pat. No. 4,215,109 to Ruhenstroth-Bauer et al, for example, discloses that the serum concentrations of several plasma proteins, including &agr;
1
-acid glycoprotein, increased in response to the injection of inflammation-producing compounds into rats. However, Ruhenstroth-Bauer et al is concerned primarily with the therapeutic potential of the plasma proteins in response to an inflammatory condition. Belpaire et al, in
Biological Abstracts
No. 18333, 1987, Vol. 84(2), p. AB825, describes a study of healthy dogs and dogs with inflammatory disea

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