Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-05-15
2002-06-04
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S489000, C424S725000, C514S909000, C514S948000
Reexamination Certificate
active
06399089
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the administration of compositions and methods for balancing body weight by inhibiting re-uptake of serotonin, regulating metabolism, potentiating insulin, and inhibiting lipogenesis, in a mammal.
BACKGROUND OF THE INVENTION
Obesity is a serious heath problem both in the United States as well as world-wide. Results from the National Health and Nutrition Examination Survey III show that one in three Americans are at least twenty percent overweight. Kuczmarski et al., 272 JAMA 205-211 (1994). Other studies have shown that the prevalence of obesity increases threefold between the ages of 20 and 50, however, this varies for men and women. In particular, the weights of men appear to stabilize after age 50 and then begin to decline around age 60. Women, however, generally continue to gain weight until age 60, and it is not until after age 60 that their weight begins to decline. Kaplan and Sadock,
SYNOPSIS OF PSYCHIATRY
731 (1998).
Obesity is a condition characterized by excessive accumulation of fat on the body. Obesity can be measured by either body weight or by body mass index (BMI). By convention, obesity is said to be present when body weight exceeds by 20 percent the weight listed in typical height-weight index tables. The other measurement of obesity, BMI, is the amount of fat present in the body and is considered a reliable indication of fatness in non-athletic adults. The BMI may be calculated by using the following formula: BMI equals [body weight in kg] divided by [height in meters]
2
. In general, a normal BMI is between the range of 20 to 25, whereas the BMI of obese individuals is greater than or equal to 30.
Individuals accumulate fat by eating more calories than are expended as energy. In other words, the intake of energy exceeds its dissipation. Indeed, if fat is to be removed from the body, fewer calories must be consumed or more calories must be expended than are put in. Specifically, the energy content of food is calculated from the heat released by the total combustion of food, which is expressed in kilocalories (kcal or C). Part of the chemical energy released by the oxidation of fuel molecules is dissipated as heat, which in part is used to maintain body temperature. Approximately, 40% of the energy in food is captured in the synthesis of ATP (adenosine triphosphate) from ADP (adenosine diphosphate) and PI (phosphate). Champe and Harvey,
LIPPINCOTT's BIOCHEMISTRY REVIEWS
298 (1987).
The recommended daily allowance (RDA) for the minimal energy required for an individual has been approximated. Assuming light activity levels typical for most Americans, the recommended dietary energy intake for a 70-kg adult man is approximately 2900 kcal. For a 50-kg adult woman it is about 2100 kcal. The total energy required by an individual is the sum of three energy requiring processes that occur in the body. These include basal metabolism, specific dynamic action, and physical activity. Id., 298-299.
Basal metabolic rate (BMR) is the energy expended by an individual in a resting, postabsorptive state and represents the energy required to carry out the normal body functions. These include, respiration, blood flow, and maintenance of neuromuscular integrity. In an adult, the BMR for men is roughly 1800 kcal and 1300 kcal for women. Approximately, 50% to 70% of the daily energy expenditure in sedentary individuals is attributable to the BMR.
Specific dynamic action, also referred to diet-induced thermogenesis, is related to the amount of heat produced by the body during the digestion and absorption of food. Specifically, the body heat production of the body increases as much as 30% above the basal level. Over a 24 hour period, the thermogenic response to food may amount to 5% to 10% of the total energy expenditure. Id., 299. In particular, relatively lean individuals may generate up to 40% above the basal level, while obese individuals barely generate a 10% increase above basal level. Murray and Pizzorno,
ENCYCLOPEDIA OF NATURAL MEDICINE
684 (1998).
The final energy requiring process is physical activity. Indeed, it is physical activity that provides the greatest variation in energy expenditure. The amount of energy consumed during physical activity depends on the time and intensity of the exercise. In general, a sedentary person requires 30% to 50% more than the basal caloric requirement for energy balance, whereas a highly active individual may require 100% or more calories above BMR. Champe et al., supra.
There are a number of physiological and psychological factors that play a role in obesity. Physiological factors include genetic, chemical, physical activity, central nervous system (CNS), and other clinical factors. The presence of numerous forms of inherited obesity make it clear that genetic factors contribute to obesity. About 80% of patients who are obese have a family history of obesity. This fact, however, can be accounted for not only by genetic factors, but also by learned behavior. For example, the individual may have learned to use food as a means of coping with stress and anxiety from their parents. Kaplan et al., supra, 732-736.
A marked decrease in physical activity seems to be a major factor in the rise of obesity as a public health problem. Physical inactivity restricts energy expenditure and may contribute to increased food intake. Although food intake usually increases with increased physical activity, food intake does not necessarily decrease proportionately when physical activity falls below a minimum level. Id. at 735.
The central nervous system, specifically in the lateral and ventromedial hypothalamic areas, adjusts to food intake in response to changing energy requirements, thus maintaining fat stores at a baseline determined by a specific set point. This set point varies from person to person and is dependent upon height and body type. Id. at 733.
There are numerous other clinical factors and disease states that are associated with obesity. For example, Cushing's disease is associated with a characteristic fat distribution, which is often referred as buffalo adiposity. Other disease states associated with obesity include myxedema and adiposogenital dystrophy. Moreover, a drug or treatment regimen may also contribute to obesity. In particular, a prolonged use of serotonergic agonists in the treatment of depression is associated with weight gain. Also, depressed patients are known to have fluctuations in weight. Id.
In addition to the physiological factors that play a crucial role in the development of obesity, there are many psychological factors as well. These may include cultural, family, personality structures, and unconscious conflicts. Thus, individuals who are overweight, may suffer from numerous psychiatric disorders and come from a variety of disturbed backgrounds, and have learned to use over-eating as a means of coping with their problems. Most obese individuals report that they often over-eat when they are emotionally upset. Id. at 734. There are long-range reports supporting the link between emotional factors and obesity. In particular, the reports state that some obese people lose large amounts of weight when they fall in love and gain weight when they lose a loved one. Another study has analyzed the effects of food-use to control mood, concluding that individuals suffering from mild depression often snack on carbohydrates to elevate mood. Lieberman et al., 14(2)
INT. J. EAT. DISORD
. 171-183 (1993).
Many individuals struggling with obesity often have impaired satiety. Satiety is the feeling that results when hunger is satisfied. People generally stop eating at the end of a meal because they have replenished nutrients that had been depleted. Thus, people become hungry again once the nutrients restored at an earlier meal have been used and stored as energy by the body. Obese individuals, however, seem to have an inability to stop eating if food remains available. Kaplan et al., supra, 731.
There are a variety of methods commonly used for treating
Jiang David
Yegorova Inna
Braswell A. Glenn
Evans Charesse
Page Thurman K.
Sierra Patent Group Ltd.
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