For: System for Monitoring and Managing Body Weight and Other Physiological Conditions Including Iterative and
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`PATENT APPLICATION TRANSMITTAL LETTER
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`1143/111
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`COMMISSIONER FOR PATENTS
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`TE"psmitted herewith for filing under 35 U.S.C. 111 and 37 C.F.R. 1.53 is the patent application of:
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`Christopher Pacione et al.
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`EV 372577493 US
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`application.
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`10/94LcJi§'1I:IT°
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`22154
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`as filing fee.
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`A check in the amount of
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`CI Charge the issue tee set in 37 C.F.R. 1.18 at the mailing of the Notice of Allowance,
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`pursuant to 37 C.F.Fl. 1.311(b).
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`CI Payment by credit card. Form PTO-2038 is attached.
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`Dated:
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`P01SMALL/REVO8
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`1 of 1348
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`FITBIT EXHIBIT 1003
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`CERTIFICATE OF MAILING BY "EXPRESS MAIL" (37 CFR 1.10)
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`Applicant(s): Christopher Pacione et al.
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`Docket N0-
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`Filing Date
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`Examiner
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`SYSTEM FOR MONITORING AND MANAGING BODY WEIGHT AND OTHER PHYSIOLOGICAL
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`CONDITIONS INCLUDING ITERATIVE AND PERSONALIZED PLANNING, INTERVENTION AND
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`REPORTING CAPABILITY
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`I hereby certify that the following correspondence:
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`» pecification, Claims, Drawings (27 sheets), Declaration & Power of Attorney (unsigned), Check
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`is being deposited with the United States Postal Service "Express Mail Post Office to Addressee" service under 37
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`CFR 1.10 in an envelope addressed to: Commissioner for Patents. P.O. Box 1450, Alexandria, VA 22313-1450 on
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`September 13, 2004
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`-211orPrintedN2:. ailingCorrespondence)
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`EV 372577493 US
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`("Express Mail" Mailing Label Number)
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`2 of 1348
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`SYSTEM FOR MONITORING AND MANAGING BODY WEIGHT
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`AND OTHER PHYSIOLOGICAL CONDITIONS INCLUDING ITERATIVE AND
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`PERSONALIZED PLANNING, INTERVENTION AND REPORTING CAPABILITY
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`CROSS REFERENCE TO RELATED APPLICATIONS
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`This application is a continuation in part of co—pending United States Application Serial
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`No. 10/638,588, filed August 11, 2003, which is a continuation of co-pending United States
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`Application Serial No. 09/602,537, filed June 23, 2000, which is a continuation-in—part of co-
`pending United States Application Serial No. 09/595,660,'filed June 16, 2000. This application
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`also claims the benefit of United States Provisional Application No. 60/502,764 filed on
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`‘September 13, 2003 and United States Provisional Application No. 50/555,280 filed on March
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`FIELD OF THE INVENTION
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`The present invention relates to a weight control system. More specifically, the system may
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`be used as part of a behavioral modification program for calorie control, weight control or general
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`fitness.
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`In particular, the invention, according to one aspect, relates to an apparatus used in
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`conj unction with a software platform for monitoring caloric consumption and/or caloric expenditure
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`of an individual. Additionally, the invention relates to a method of tracking progress toward weight
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`3 of 1348
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`BACKGROUND OF THE INVENTION
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`Research has shown that a large number of the top health problems in society are either
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`caused in whole or in part by an unhealthy lifestyle. More and more, our society requires people to
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`lead fast-paced, achievement-oriented lifestyles that often result in poor eating habits, high stress
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`levels, lack of exercise, poor sleep habits and the inability to find the time to center the mind and
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`relax. Additionally, obesity and body weight have become epidemic problems facing a large
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`segment of the population, notably including children and adolescents. Recognizing this fact, people
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`are becoming increasingly interested in establishing a healthier lifestyle.
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`Traditional medicine, embodied in the form of an HMO or similar organization, does not
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`have the time, the training, or the reimbursement mechanism to address the needs of those
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`individuals interested in a healthier lifestyle. There have been several attempts to meet the needs of
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`these individuals, including a perfusion of fitness programs and exercise equipment, dietary plans,
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`self—help books, alternative therapies, and most recently, a plethora of health information web sites
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`on the lntemet. Each of these attempts is targeted to empower the individual to take charge and get
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`healthier lifestyle and ignores many of the real barriers that most individuals face when trying to
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`adopt a healthier lifestyle. These barriers include the fact that the individual is often left to himself
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`or herself to find motivation, to implement a plan for achieving a healthier lifestyle, to monitor
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`progress, and to brainstorm solutions when problems arise; the fact that existing programs are
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`directed to only certain aspects of a healthier lifestyle, and rarely come as a complete package; and
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`the fact that recommendations are often not targeted tothe unique characteristics of the individual or
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`4 of 1348
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`With respect to weight loss, specifically, many medical and other commercial methodologies
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`have been developed to assist individuals in losing excess body weight and maintaining an
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`appropriate weight level through various diet, exercise and behavioral modification techniques.
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`Weight Watchers is an example of a weight loss behavior modification system in which an
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`individual manages weight loss with a points system utilizing commercially available foods; All
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`food items are assigned a certain number of points based on serving size and content of fat, fiber and
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`calories. Foods that are high in fat are assigned a higher number of points. Foods that are high in
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`fiber receive a lower number of points. Healthier foods are typically assigned a lower number of
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`points, so the user is encouraged to eat these food items.
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`A user is assigned a daily points range which represents the total amount of food the user
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`should consume within each day. Instead of directing the user away from a list of forbidden foods, a
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`-user is encouraged to enjoy all foods in moderation, as long as they fit withina user's points budget.
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`The program is based on calorie reduction, portion control and modification of current eating habits.
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`Exercise activities are also assigned points which are subtracted from the points accumulated by a
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`user's daily caloric intake.
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`Weight Watchers attempts to make a user create a balance of exercise and healthy eating in
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`their life. However, because only caloric value of food is specifically tracked, the program tends to
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`fail in teaching the user about the nutritional changes they need to make to maintain weight loss.
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`Calorie content is not the only measurement that a user should take into control when determining
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`what food items to consume. Items that contain the same caloric content may not be nutritiously
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`similar. So, instead of developing healthy eating habits, a user might become dependent on counting
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`points. It is important to note that the Weight Watchers program deals essentially with caloric intake
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`only and not caloric expenditure.
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`5 of 1348
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`Similarly, Jenny Craig is also a weight loss program. Typically, an individual is assigned a
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`personal consultant who monitors weight loss progress. In addition, the individual will receive pre-
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`selected menus which are based on the Food Guide Pyramid for balanced nutrition. The menus
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`contain Jenny Craig branded food items which are shipped to the individual's home or any other
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`location chosen by the individual. The Jenny Craig program teaches portion control because the
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`food items to be consumed are pre-portioned and supplied by Jenny Craig. However, such a close
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`dietary supervision can be a problem once the diet ends because the diet plan does not teach new
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`eating habits or the value of exercise. Instead it focuses mainly on short term weight loss goals.
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`The integration of computer and diet tracking systems has created several new and more
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`automated approaches to weight loss. Available methodologies can be tailored to meet the
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`individual's specific physiological characteristics and weight loss goals.
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`BalanceLog, developed by HealtheTech, Inc. and the subject of United States Published
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`Application No. 20020133378 is a software program that provides a system for daily tracking and
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`monitoring of caloric intake and expenditure.
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`The user customizes the program based on
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`metabolism in addition to weight and nutrition goals. The user is able to create both exercise and
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`nutrition plans in addition to tracking progress. However, the BalanceLog system has several
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`First, a user must know their resting metabolic rate, which is the number of calories burned at
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`rest. The user can measure their resting metabolic rate. However, a more accurate rate can be
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`measured by appointment at a metabolism measurement location. A typical individual, especially
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`an individual who is beginning a weight and nutrition management plan may view this requirement
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`as an inconvenience. The system can provide an estimated resting metabolic rate based on a broad
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`population average if a more accurate measurement cannot be made. However, the resting metabolic
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`6 of 1348
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`rate can vary widely between individuals having similar physiological characteristics. Thus, an
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`estimation may not be accurate and would affect future projections of an individual's progress.
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`Second, the system is limited by the interactivity and compliance of the user. Every aspect of
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`the BalanceLog system is manual. Every item a user cats and every exercise a user does must be
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`logged in the system. If a user fails to do this, the reported progress will not be accurate. This
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`manual data entry required by BalanceLog assumes that the user will be in close proximity to a data
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`entry device, such as a personal digital assistant or a personal computer, to enter daily activities and
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`consumed meals. However, a user may not consistently or reliably be near their data entry device
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`shortly thereafter engaging in an exercise or eating activity. They may be performing the exercise
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`activity at a fitness center or otherwise away from such a device. Similarly, a user may not be eating
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`a certain meal at home, so they may not be able to log the information immediately after consuming
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`the meal. Therefore, a user must maintain a record of all food consumed and activities performed so
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`that these items can be entered into the BalanceLog system at a later time.
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`Also, the BalanceLog system does not provide for the possibility of estimation. A user must
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`select the food consumed and the corresponding portion size of the food item. If a time lapse has
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`occurred between the meal and the time of entry and the user does not remember the meal, the data
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`may not be entered accurately and the system would suffer from a lack of accuracy. Similarly, if a
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`user does not remember the details of an exercise activity, the data may not be correct.
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`Finally,
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`the BalanceLog system calculates energy expenditure based only upon the
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`information entered by the user. A user may only log an exercise activity such as running on a
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`treadmill for thirty minutes for a particular day. This logging process does not take into account the
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`actual energy expenditure of the individual, but instead relies on averages or look—up tables based
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`upon general population data, which may not be particularly accurate for any specific individual.
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`The program also ignores the daily activities of the user such as walking up stairs or running to catch
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`the bus. These dailyactivities need to be taken into account for a user to accurately determine their
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`total amount of energy expenditure.
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`Similarly FitDay, a software product developed by Cyser Software, is another system that
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`allows a user to track both nutrition and exercise activity to plan weight loss and monitor progress.
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`The FitDay software aids a user in controlling diet through the input of food items consumed. This
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`software also tracks the exercise activity and caloric expenditure through the manual data entry by
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`the user. The FitDayAsoftware also enables the user to track and graph -body measurements for
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`additional motivation to engage in exercise activity. Also, FitDay also focuses on another aspect of
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`weight loss." The system prompts a user for information regarding daily emotions for analysis ofthe
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`triggers that may affect a user's weight loss progress.
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`FitDay suffers from the same limitations of Balance Log. FitDay is dependent upon user
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`input for its calculations and weight loss progress analysis. As a result, the information may suffer
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`from a lack of accuracy or compliance because the user might not enter a meal or an activity. Also,
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`the analysis of energy expenditure is dependent on the input of the user and does not take the daily
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`activities of the user into consideration.
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`Overall, if an individual consumes fewer calories than the number of calories burned, they
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`user should experience a net weight loss. While the methods described above offer a plurality of '
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`ways to count consumed calories, they do not offer an efficient way to determine the caloric
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`expenditure. Additionally, they are highly dependent upon compliance with rigorous data entry
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`requirements. Therefore, what is lacking in the art is a management system that can accurately and
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`automatically monitor daily activity and energy expenditure ofthe user to reduce the need for strict
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`compliance with and the repetitive nature of manual data entry of information.
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`8 of 1348
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`SUMMARY OF THE INVENTION
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`A nutrition and activity management system is disclosed that can help an individual meet
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`weight loss goals and achieve an optimum energy balance of calories burned versus calories
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`consumed. The system may be automated and is also adaptable or applicable to measuring a
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`number of other physiological parameters and reporting the same and derivations of such
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`parameters. The preferred embodiment, a weight management system, is directed to achieving
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`an optimum energy balance, which is essential to progressing toward weight loss—specific goals.
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`Most programs, such as the programs discussed above, offer methods of calorie and food
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`consumption tracking, but that is only half of the equation. Without an accurate estimation of
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`energy expenditure, the optimum energy balance cannot be reached.
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`In other embodiments, the
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`system may provide additional or substitute information regarding limits on physical activity,
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`such as for a pregnant or rehabilitating user, or physiological data, such as blood sugar level, for -
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`a diabetic.
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`The management system that is disclosed provides a more accurate estimation of the total
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`energy expenditure of the user. The other programs discussed above can only track energy
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`expenditure through manual input of the user regarding specific physical activity of a certain
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`duration. The management system utilizes an apparatus on the body that continuously monitors
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`the heat given off by a user's body in addition to motion, skin temperature and conductivity.
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`Because the apparatus is continuously worn, data is collected during any physical activity
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`performed by the user, including exercise activity and daily life activity. The apparatus is
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`further designed for comfort and convenience so that long term wear is not unreasonable within a
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`wearer's lifestyle activities.
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`It is to be specifically noted that the apparatus is designed for both
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`continuous and long term wear. Continuous is intended to mean, however, nearly continuous, as
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`9 of 1348
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`the device may be removed for brief periods for hygienic purposes or other de minimus non-use.
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`Long term wear is considered to be for a substantial portion of each day of wear, typically
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`extending beyond a single day. The data collected by the apparatus is uploaded to the software
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`platform for determining the number ofcalories burned, the number of steps taken and the
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`duration of physical activity.
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`The management system that is disclosed also provides an easier process for the entry
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`and tracking of caloric consumption. The tracking of caloric consumption provided by the
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`management system is based on the recognition that current manual nutrition tracking methods
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`are too time consuming and difficult to use, which ultimately leads to a low level of compliance,
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`inaccuracy in data collection and a higher percentage of false caloric intake estimates. Most
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`users are too busy to log everything they eat for each meal and tend to forget how much they ate.
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`Therefore, in addition to manual input of consumed food items, the user may select one of
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`several other methods of caloric input which may include an estimation for a certain meal based
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`upon an average for that meal, duplication of a previous meal and a quick caloric estimate tool.
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`A user is guided through the complex task of recalling what they ate in order to increase
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`compliance and reduce the discrepancy between self—reported and actual caloric intake.
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`The combination of the information collected from the apparatus and the information
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`entered by the user is used to provide feedback information regarding the user's progress and
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`recommendations for reaching dietary goals. Because of the accuracy of the information, the
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`user can proactively make lifestyle changes to meet weight loss goals, such as adjusting diet or
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`exercising to burn more calories. The system can also predict data indicative of human
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`physiological parameters including energy expenditure and caloric intake for any given relevant
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`time period as well as other detected and derived physiological or contextual information. The
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`10 of 1348
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`user may then be notified as to their actual or predicted progress with respect to the optimum
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`energy balance or other goals for the day.
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`An apparatus is disclosed for monitoring certain identified human status parameters
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`which includes at least one sensor adapted to be worn on an individual’s body. A preferred
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`embodiment utilizes a combination of sensors to provide more accurately sensed data, with the
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`output of the multiple sensors being utilized in the derivation of additional data. The sensor or
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`sensors utilized by the apparatus may include a physiological sensor selected from the group
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`consisting of respiration sensors, temperature sensors, heat flux sensors, body conductance
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`sensors, body resistance sensors, body potential sensors, brain activity sensors, blood pressure
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`sensors, body impedance sensors, body motion sensors, oxygen consumption sensors, body
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`chemistry sensors, body position sensors, body pressure sensors, light absorption sensors, body
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`sound sensors, piezoelectric sensors, electrochemical sensors, strain gauges, and optical sensors.
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`The sensor or sensors are adapted to generate data indicative of at least a first parameter of the
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`individual and a second parameter of the individual, wherein the first parameter is a
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`physiological parameter. The apparatus also includes a processor that receives at least a portion
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`of the data indicative of the first parameter and the second parameter. The processor is adapted
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`to generate derived data from at least a portion of the data indicative of a first parameter and a
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`second parameter, wherein the derived data comprises a third parameter of the individual. The
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`third parameter is an individual status parameter that cannot be directly detected by the at least
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`one sensor.
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`In an alternate embodiment, the apparatus for monitoring human status parameters is
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`disclosed that includes at least two sensors adapted to be worn on an individual’s body selected
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`from the group consisting ofphysiological sensors and contextual sensors, wherein at least one
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`11 of 1348
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`of the "sensors is a physiological sensor. The sensors are adapted to generate data indicative of at
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`least a first parameter of the individual and a second parameter of the individual, wherein the
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`first parameter is physiological. The apparatus also includes a processor for receiving at least a
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`portion of the data indicative of at least a first parameter and a second parameter, the processor
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`being adapted to generate derived data from the data indicative of at least a first parameter and a
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`second parameter. The derived data comprises a third parameter of the individual, for example
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`one selected from the group consisting of ovulation state, sleep state, calories burned, basal
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`metabolic rate, basal temperature, physical activity level, stress level, relaxation level, oxygen
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`consumption rate, rise time, time in zone, recovery time, and nutrition activity. The third
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`parameter is an individual status parameter that cannot be directly detected by any of the at least
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`tWO S€I'lSOI'S.
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`In either embodiment of the apparatus, the at least two sensors may be both physiological
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`sensors, or may be one physiological sensor and one contextual sensor. The apparatus may
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`further include a housing adapted to be worn on the individual’s body, wherein the housing
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`supports the sensors or wherein at least one of the sensors _is separately located from the housing.
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`The apparatus may further include a flexible body supporting the housing having first and
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`second members that are adapted to wrap around a portion of the individual’s body. The flexible
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`body may support one or more of the sensors. The apparatus may further include wrapping
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`means coupled to the housing for maintaining contact between the housing and the individual’s
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`body, and the wrapping means may support one or more of the sensors.
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`Either embodiment of the apparatus may further include a central monitoring unit remote
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`from the at least two sensors that includes a data storage device. The data storage device
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`receives the derived data from the processor and retrievably stores the derived data therein. The
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`12 of 1348
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`apparatus also includes means for transmitting information based on the derived data from the
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`central monitoring unit to a recipient, which recipient may include the individual or a third party
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`authorized by the individual. The processor may be supported by a housing adapted to be worn
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`on the individual’s body, or alternatively may be part of the central monitoring unit.
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`A weight—loss directed software program is disclosed that automates the tracking of the
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`energy expenditure of the individual through the use of the apparatus and reduces the repetitive
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`nature of data entry in the determination of caloric consumption in addition to providing relevant
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`feedback regarding the user's weight loss goals. The software program is based on the energy
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`balance equation which has two components: energy intake and energy expenditure. The
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`difference between these two values is the energy balance. When this value is negative, a weight
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`loss should be achieved because fewer calories were consumed than expended. A positive
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`energy balance will most likely result in no loss of wei ght or a weight gain.
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`The weight-loss directed software program may include an energy intake tracking
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`subsystem, an energy expenditure tracking subsystem, a weight tracking subsystem and an
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`energy balance and feedback subsystem.
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`The energy intake tracking subsystem preferably incorporates a food database which
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`includes an extensive list of commonly consumed foods, common branded foods available at
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`regional and national food chains, and branded off the shelf entrees and the nutrient information
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`for each item. The user also has the capability to enter custom preparations or recipes which
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`then become a part of the food in the database.
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`The energy expenditure subsystem includes a data retrieval process to retrieve the d