SLEBOEUF.010A
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`PHYSIOLOGICAL AND ENVIRONMENTAL MONITORING
`SYSTEMS, ASSESSMENTS, AND METHODS
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`RELATED APPLICATION
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`This application claims the benefit of and priority to U.S.
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`Provisional Patent Application No. 60/905,761, filed March 8, 2007, U.S.
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`Provisional Patent Application No. 60/876, 128, filed December 21, 2006, and
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`U.S. Provisional Patent Application No. 60/875,606, filed December 19, 2006,
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`the disclosures of which are incorporated herein by reference as if set forth in
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`their entireties.
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`FIELD OF THE INVENTION
`The present invention relates generally to health and, more
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`particularly, to health monitoring.
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`BACKGROUND
`There is growing market demand for personal health and
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`environmental monitors, for example, for gauging overall health and metabolism
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`during exercise, athletic training, dieting, and physical therapy. However,
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`traditional health monitors and environmental monitors may be bulky, rigid, and
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`uncomfortable - generally not suitable for use during daily physical activity.
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`There is also growing interest in generating and comparing health and
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`environmental exposure statistics of the general public and particular
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`demographic groups. For example, collective statistics enable the healthcare
`industry and medical community to direct healthcare resources to where they are
`most highly valued. However, methods of collecting these statistics may be
`expensive and laborious, often utilizing human-based recording/analysis steps at
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`2 s
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`multiple sites.
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`EXHIBIT 2113
`EXHIBIT 2113
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`SUMMARY
`In view of the above discussion, systems and methods for
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`monitoring various physiological and environmental factors, as well as systems
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`and methods for using this information for a plurality of useful purposes, are
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`s
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`provided. According to some embodiments of the present invention, real-time,
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`noninvasive health and environmental monitors include a plurality of compact
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`sensors integrated within small, low-profile devices. Physiological and
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`environmental data is collected and wirelessly transmitted into a wireless
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`network, where the data is stored and/or processed. This information is then
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`used to support a variety of useful methods, such as clinical trials, marketing
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`studies, biofeedback, entertainment, and others.
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`Though the methods herein may apply broadly to a variety of form
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`factors for a monitoring apparatus, in some embodiments of the invention an
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`earpiece functions as a physiological monitor, an environmental monitor, and a
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`1 s
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`wireless personal communicator. Because the ear region is located next to a
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`variety of "hot spots" .for physiological an environmental sensing - including the
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`tympanic membrane, the carotid artery, the paranasal sinus, etc. - in some
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`cases an earpiece monitor takes preference over other form factors. The
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`earpiece can take advantage of commercially available open-architecture, ad
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`hoc, wireless paradigms, such as Bluetooth®, Wi-Fi, or ZigBee. In some
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`embodiments, a small, compact earpiece contains at least one microphone and
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`one speaker, and is configured to transmit information wirelessly to a recording
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`device such as, for example, a cell phone, a personal digital assistant (PDA),
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`and/or a computer. The earpiece contains a plurality of sensors for monitoring
`personal health and environmental exposure. Health and environmental
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`information, sensed by the sensors is transmitted wirelessly, in real-time, to a
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`recording device, capable of processing and organizing the data into meaningful
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`displays, such as charts. In some embodiments, an earpiece user can monitor
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`health and environmental exposure data in real-time, and may also access
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`records of collected data throughout the day, week, month, etc., by observing
`charts and data through an audio-visual display.
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`Each physiological sensor is configured to detect and/or measure
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`one or more of the following types of physiological information: heart rate, pulse
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`rate, breathing rate, blood flow, heartbeat signatures, cardio-pulmonary health,
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`organ health, metabolism, electrolyte type and/or concentration, physical activity,
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`caloric intake, caloric metabolism, blood metabolite levels or ratios, blood pH
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`level, physical and/or psychological stress levels and/or stress level indicators,
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`drug dosage and/or dosimetry, physiological drug reactions, drug chemistry,
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`biochemistry, position and/or balance, body strain, neurological functioning, brain
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`activity, brain waves, blood pressure, cranial pressure, hydration level,
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`auscultatory information, auscultatory signals associated with pregnancy,
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`physiological response to infection, skin and/or core body temperature, eye
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`muscle movement, blood volume, inhaled and/or exhaled breath volume,
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`physical exertion, exhaled breath physical and/or chemical composition, the
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`presence and/or identity and/or concentration of viruses and/or bacteria, foreign
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`matter in the body, internal toxins, heavy metals in the body, anxiety, fertility,
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`ovulation, sex hormones, psychological mood, sleep patterns, hunger and/or
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`thirst, hormone type and/or concentration, cholesterol, lipids, blood panel, bone
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`density, organ and/or body weight, reflex response, sexual arousal, mental
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`and/or physical alertness, sleepiness, auscultatory information, response to
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`external stimuli, swallowing volume, swallowing rate, sickness, voice
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`characteristics, voice tone, voice pitch, voice volume, vital signs, head tilt,
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`allergic reactions, inflammation response, auto-immune response, mutagenic
`response, DNA, proteins, protein levels in the blood, water content of the blood,
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`pheromones, internal body sounds, digestive system functioning, cellular
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`regeneration response, healing response, stem cell regeneration response,
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`and/or other physiological information.
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`Each environmental sensor is configured to detect and/or measure
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`one or more of the following types of environmental information: climate,
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`humidity, temperature, pressure, barometric pressure, soot density, airborne
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`particle density, airborne particle size, airborne particle shape, airborne particle
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`identity, volatile organic chemicals (VOCs), hydrocarbons, polycyclic aromatic
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`hydrocarbons (PAHs), carcinogens, toxins, electromagnetic energy, optical
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`radiation, X-rays, gamma rays, microwave radiation, terahertz radiation,
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`ultraviolet radiation, infrared radiation, radio waves, atomic energy alpha
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`particles, atomic energy beta-particles, gravity, light intensity, light frequency,
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`light flicker, light phase, ozone, car~on monoxide, carbon dioxide, nitrous oxide,
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`sulfides, airborne pollution, foreign material in the air, viruses, bacteria,
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`signatures from chemical weapons, wind, air turbulence, sound and/or acoustical
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`energy, ultrasonic energy, noise pollution, human voices, animal sounds,
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`diseases expelled from others, exhaled breath and/or breath constituents of
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`others, toxins from others, pheromones from others, industrial and/or
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`transportation sounds, allergens, animal hair, pollen, exhaust from engines,
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`vapors and/or fumes, fuel, signatures for mineral deposits and/or oil deposits,
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`snow, rain, thermal energy, hot surfaces, hot gases, solar energy, hail, ice,
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`vibrations, traffic, the number of people in a vicinity of the person, coughing
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`and/or sneezing sounds from people in the vicinity of the person, loudness
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`and/or pitch from those speaking in the vicinity of the person, and/or other
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`environmental information.
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`In some embodiments, the signal processor is configured to
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`process signals produced by the physiological and environmental sensors into
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`signals that can be heard and/or viewed by the person wearing the apparatus. In
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`some embodiments, the signal processor is configured to selectively extract
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`environmental effects from signals produced by a physiological sensor and/or
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`selectively extract physiological effects from signals produced by an
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`environmental sensor.
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`A monitoring system, according to some embodiments of the
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`2 o
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`present invention, may be configured to detect damage to a portion of the body
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`of the person wearing the apparatus, and may be configured to alert the person
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`when such damage is detected. For example, when a person is exposed to
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`sound above a certain level that may be potentially damaging, the person is
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`notified by the apparatus to move away from the noise source. As another
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`example, the person may be alerted upon damage to the tympanic membrane
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`due to loud external noises.
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`Information from the health and environmental monitoring system
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`may be used to support a clinical trial and/or study, marketing study, dieting plan,
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`health study, wellness plan and/or study, sickness and/or disease study,
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`environmental exposure study, weather study, traffic study, behavioral and/or
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`psychosocial study, genetic study, a health and/or wellness advisory, and an
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`environmental advisory. The monitoring system may be used to support
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`interpersonal relationships between individuals or groups of individuals. The
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`monitoring system may be used to support targeted advertisements, links,
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`SLEBOEUF .01 OA
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`searches or the like through traditional media, the internet, or other
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`communication networks. The monitoring system may be integrated into a form
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`of entertainments, such as health and wellness competitions, sports, or games
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`based on health and/or environmental information associated with a user.
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`s
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`According to some embodiments of the present invention, a
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`method of monitoring the health of one or more subjects includes receiving
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`physiological and/or environmental information from each subject via respective
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`portable monitoring devices associated with each subject, and analyzing the
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`received information to identify and/or predict one or more health and/or
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`environmental issues associated with the subjects. Each monitoring device has
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`at least one physiological sensor and/or environmental sensor. Each
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`physiological sensor is configured to detect and/or measure physiological
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`information from the subject, and each environmental sensor is configured to
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`detect and/or measure environmental conditions in a vicinity of the subject. The
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`physiological information and/or environmental information may be analyzed
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`locally via the monitoring device or may be transmitted to a location
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`geographically remote from the subject for analysis. The collected information
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`may undergo virtually any type of analysis. In some embodiments, the received
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`information may be analyzed to identify and/or predict the aging rate of the
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`subjects, to identify and/or predict environmental changes in the vicinity of the
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`subjects, and to identify and/or predict psychological and/or physiological stress
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`for the subjects.
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`According to some embodiments of the present invention,
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`corrective action information may be communicated to the subjects in response
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`2s
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`to identifying one or more health and/or environmental problems associated with
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`the subject. In addition or alternatively, corrective action information for the
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`subjects may be communicated to third parties.
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`In some embodiments, a geographical map illustrating health(cid:173)
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`related and/or environmental conditions associated with the subjects may be
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`created.
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`According to some embodiments of the present invention, a health
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`and environmental monitoring system includes a plurality of portable monitoring
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`devices, each comprising at least one physiological sensor and/or environmental
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`sensor, a plurality of portable communication devices, wherein each
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`communication device is in communication with a respective monitoring device
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`and is configured to transmit data from the monitoring device to remote data
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`storage, and a processor configured to analyze data within the remote data
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`storage and to identify and/or predict health and/or environmental issues
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`associated with each subject. Each physiological sensor is configured to detect
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`and/or measure physiological information from a respective subject, and each
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`environmental sensor is configured to detect and/or measure environmental
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`conditions in a vicinity of the respective subject. Each monitoring device is
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`configured to be worn by a respective subject (e.g., attached to a body of a
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`respective subject, etc.). For example, a monitoring device may be configured to
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`be attached to an ear of a respective subject.
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`In some embodiments, the processor is configured to communicate
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`corrective action information to each respective subject. Corrective action
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`information may be communicated to each subject via the monitoring device
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`associated with each respective subject, or via other methods.
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`In other embodiments, the processor communicates corrective
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`action information for a subject to a third party. The processor may be configured
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`to perform various analyses including, but not limited to, identifying and/or
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`predicting the aging rate of one or more subjects, identifying and/or predicting
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`environmental changes in the vicinity of one or more subjects, and identifying
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`and/or predicting psychological and/or physiological stress for one or more
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`subjects. In some embodiments of the present invention, the processor is
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`configured to create a geographical map illustrating health and/or environmental
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`conditions associated with one or more subjects.
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`Information collected from each monitoring device may include
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`information that is personal and private and information that can be made
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`available to the public. As such, data storage, according to some embodiments
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`of the present invention, may include a private portion and a public portion. In the
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`private portion, health and environmental data that is personalized for each
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`subject is stored. In the public portion, anonymous health and environmental
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`data is stored and is accessible by third parties.
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`In other embodiments of the present invention, a method of
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`delivering targeted advertising to a person includes collecting physiological
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`and/or environmental information from the person, selecting an advertisement for
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`SLEBOEUF.010A
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`delivery to the person based upon the collected physiological and/or
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`environmental information, and delivering the selected advertisement to the
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`person. The physiological and/or environmental information is collected via a
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`monitoring device associated with the person and that includes at least one
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`physiological sensor and/or environmental sensor, as described above. The
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`received physiological and/or environmental information is analyzed to identify a
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`physiological condition of the person and/or environmental condition in a vicinity
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`of the person, and an advertisement is selected for a product or service related
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`to an identified physiological and/or environmental condition. The selected
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`advertisement can be delivered via any of various channels including, but not
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`limited to, email, postal mail, television, radio, newspaper, magazine, the
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`internet, and outdoor advertising.
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`According to some embodiments of the present invention, a system
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`for delivering targeted advertising to people includes a plurality of portable
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`monitoring devices, each comprising at least one physiological sensor and/or
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`environmental sensor, as described above, and a remotely located
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`advertisement selection device that receives physiological and/or environmental
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`. information from the monitoring devices, selects advertisements based upon the
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`collected physiological and/or environmental information, and delivers selected
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`advertisements to the monitored persons. The advertisement selection device
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`receives physiological and/or environmental information from each monitoring
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`device via a communication device (e.g., PDA, cell phone, laptop computer, etc.)
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`associated with each respective monitoring device. In some embodiments, the
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`advertisement selection device is configured to select an advertisement for a
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`product and/or service related to a physiological condition of a person and/or for
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`a product and/or service related to an environmental condition in a vicinity of a
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`person.
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`In some embodiments, the advertisement selection device includes
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`an ad server configured to deliver online advertisements. In other embodiments,
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`the advertisement selection device includes an email server configured to deliver
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`advertisements via email. In some embodiments, the advertisement selection
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`device is configured to communicate with a third party service that can deliver
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`selected advertisements via one or more of the following delivery channels:
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`postal mail, television, radio, newspaper, magazine, the internet, and outdoor
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`SLEBOEUF.01 OA
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`advertising.
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`According to some embodiments of the present invention, a
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`method of supporting interpersonal relationships includes collecting physiological
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`and/or environmental information from a monitoring device associated with a first
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`person when the first person is in the presence of a second person, determining
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`a stress level of the first person using the collected physiological and/or
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`environmental information, and displaying the stress level to the first person. The
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`monitoring device includes at least one physiological sensor and/or
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`environmental sensor, as described above, and is configured to collect
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`physiological and/or environmental information that includes indicators
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`associated with stress experienced by the first person. The stress level of the
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`first person may also be communicated to one or more third parties.
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`In some embodiments, the physiological and/or environmental
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`information collected from the first person is analyzed to identify a source of
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`stress. A solution for reducing stress also may be recommended to the first
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`person. In some embodiments, the monitoring device can identify the second
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`person.
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`According to some embodiments of the present invention, a system
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`for supporting interpersonal relationships includes a portable monitoring device
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`that collects physiological and/or environmental information from a first person
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`when the first person is in the presence of a second person, and a processor
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`that receives physiological and/or environmental information from the monitoring
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`device. The processor determines a stress level of the first person using the
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`collected physiological and/or environmental information, and transmits and/or
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`displays the stress level to the first person. In some embodiments, the processor
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`receives physiological and/or environmental information from the monitoring
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`device via a communication device (e.g., PDA, cell phone, laptop computer, etc.)
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`associated with the monitoring device. The processor may be configured to
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`analyze the information and identify a source of stress. The processor may be
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`configured to recommend solutions for reducing stress.
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`In another embodiment of the present invention, a method of
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`supporting interpersonal relationships includes collecting physiological and/or
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`environmental information from a monitoring device associated with a first
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`person, and determining a mood of the first person using the collected
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`SLEBOEUF.010A
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`physiological and/or environmental information. The collected information
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`includes indicators associated with one or more moods of the first person. The
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`mood of the first person may be communicated to a second person, for example,
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`via a communication network (e.g., text message, email, voice message, etc.).
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`A system for supporting interpersonal relationships, according to
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`other embodiments of the present invention, includes a portable monitoring
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`device that collects physiological and/or environmental information from a first
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`person, and a processor that receives physiological and/or environmental
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`information from the monitoring device, and determines a mood of the first
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`person using the collected physiological and/or environmental information. The
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`processor receives physiological and/or environmental information from the
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`monitoring device via a communication device (e.g., PDA, cell phone, laptop
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`computer, etc.) associated with the monitoring device. The processor is
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`configured to communicate the mood of the first person to a second person, for
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`example, via a communication network (e.g., text message, email, voice
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`message, etc.).
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`According to further embodiments of the present invention, a
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`method of monitoring one or more subjects includes collecting physiological
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`and/or environmental information from a monitoring device associated with each
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`respective subject, storing the collected physiological and/or environmental
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`information at a remote storage device, and comparing the stored physiological
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`and/or environmental information with benchmark physiological and/or
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`environmental information to identify at least one behavioral response of the one
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`or more subjects. Behavioral responses may include, but are not limited to,
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`behavioral responses to a product and/or service, behavioral responses to
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`product and/or service marketing, behavioral responses to medical treatment,
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`behavioral responses to a drug, etc.
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`According to some embodiments of the present invention, a system
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`for monitoring one or more subjects includes a plurality of portable monitoring
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`30
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`devices configured to collect physiological information from a subject and
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`environmental condition information in a vicinity of a subject, as described
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`above, and a processor that compares collected physiological and/or
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`environmental information with benchmark physiological and/or environmental
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`information to identify at least one behavioral response of the one or more
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`subjects. As described above, behavioral responses may include, but are not
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`limited to, behavioral responses to a product and/or service, behavioral
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`responses to product and/or service marketing, behavioral responses to medical
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`treatment, behavioral responses to a drug, etc. In some embodiments, a
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`s
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`monitoring device may include a dosimeter configured to measure a dose of a
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`drug taken by a respective subject.
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`According to further embodiments of the present invention, a
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`method of monitoring patients, includes collecting physiological and/or
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`environmental information from each patient via a monitoring device associated
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`1 o
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`with each respective patient, and analyzing the collected information to
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`determine caloric intake, health, and physical activity of each patient.
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`According to further embodiments of the present invention, an
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`entertainment system includes a gaming device, and a plurality of portable,
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`monitoring devices in communication with the gaming device, wherein each
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`1 s
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`monitoring apparatus is associated with a game participant and is configured to
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`transmit participant physiological information and/or environmental information
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`wirelessly to the gaming device. The gaming device is configured to integrate
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`into the gaming strategy physiological information and/or environmental
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`information received from each monitoring apparatus. Each monitoring
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`apparatus includes at least one physiological sensor and/or environmental
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`sensor, as described above.
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`According to further embodiments of the present invention, a
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`method of interacting with an electronic game includes collecting physiological
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`and/or environmental information from a monitoring device associated with a
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`2s
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`person, analyzing the collected information to identify one or more health and/or
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`environmental issues associated with the person, sending the identified one or
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`more health and/or environmental issues to a gaming device, and incorporating
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`the identified one or more health and/or environmental issues into a strategy of a
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`game executing on the gaming device. The monitoring device includes at least
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`one physiological sensor and/or environmental sensor, as described above.
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`In some embodiments, a gaming character may be created based
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`on the person using the identified one or more health and/or environmental
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`issues. In other embodiments, biofeedback may be provided to the person for
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`improving at least one skill associated with the electronic game.
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`According to further embodiments of the present invention, a
`method of monitoring a participant in an activity includes collecting physiological
`and/or environmental information from a monitoring device associated with the
`participant, analyzing the collected physiological and/or environmental
`information to identify one or more health-related and/or environmental issues
`associated with the participant, and providing feedback to the participant,
`wherein the feedback is relevant to a skill utilized by the participant in the
`activity.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`Fig. 1 is a block diagram of a telemetric monitoring device for
`physiological and/or environmental monitoring and personal communication,
`according to some embodiments of the present invention.
`Fig. 2 is a block diagram of a telemetric network for health and
`environmental monitoring through portable telemetric monitoring devices, such
`as the device of Fig. 1, according to some embodiments of the present
`invention.
`
`Fig. 3 illustrates a graphical user interface for displaying data,
`according to some embodiments of the present invention.
`Fig. 4 illustrates an earpiece module according to some
`embodiments of the present invention.
`Figs. 5A-5B illustrates an earpiece module with an adjustable
`mouthpiece for monitoring physiological and environmental information near the
`mouth, according to some embodiments of the present invention, wherein Fig.
`SA illustrates the mouthpiece in a stored position and wherein Fig. 5B illustrates
`the mouthpiece in an extended operative position.
`Fig. 6 illustrates an earpiece module incorporating various
`physiological and environmental sensors, according to some embodiments of the
`present invention, and being worn by a user.
`Fig. 7 illustrates an earpiece module according to other
`embodiments of the present invention that includes a temple module for
`physiological and environmental monitoring.
`Fig. 8 illustrates a monitoring device having a plurality of health
`and environmental sensors and mounted onto a Bluetooth® headset module,
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`according to some embodiments of the present invention.
`Fig. 9 illustrates the display of physiological and environmental
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`information collected by a monitoring device, according to some embodiments of
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`s
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`the present invention.
`Fig. 1 O illustrates the display of demographic comparisons of
`physiological and environmental information, according to some embodiments of
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`the present invention.
`Fig. 11 illustrates the display of stress level over time as measured
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`by a monitoring device, according to some embodiments of the present
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`10
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`invention.
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`Fig. 12 illustrates the display of a healthy/stress map, according to
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`some embodiments of the present invention.
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`DETAILED DESCRIPTION
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`15
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`The present invention now is described more fully hereinafter with
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`reference to the accompanying drawings, in which preferred embodiments of the
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`invention are shown. This invention, however, may be embodied in many
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`different forms and should not be construed as limited to the embodiments set
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`forth herein; rather, these embodiments are provided so that this disclosure will
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`2 o
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`be thorough and complete, and will fully convey the scope of the invention to
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`those skilled in the art.
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`Like numbers refer to like elements throughout. In the figures, the
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`sizes of certain lines, layers, components, elements or features may be
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`exaggerated for clarity.
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`25
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`The terminology used herein is for the purpose of describing
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`particular embodiments only and is not intended to be limiting of the invention.
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`As used herein, the singular forms "a", "an" and "the" are intended to include the
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`plural forms as well, unless the context clearly indicates otherwise. It will be
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`further understood that the terms "comprises" and/or "comprising," when used in
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`30
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`this specification, specify the presence of stated features, steps, operations,
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`elements, and/or components, but do not preclude the presence or addition of
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`one or more other features, steps, operations, elements, components, and/or
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`groups thereof. As used herein, the term "and/or" includes any and all
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`combinations of one or more of the associated listed items.
`12
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`IPR2017-00318
`CONDITIONAL MOTION TO AMEND
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`VALENCELL, INC.
`EXHIBIT 2113 - PAGE 13
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`

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`SLEBOEUF.010A
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`Unless otherwise defined, all terms (including technical and
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`scientific terms) used herein have the same meaning as commonly understood
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`by one of ordinary skill in the art to which this invention belongs. It will be further
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`understood that terms, such as those defined in commonly used dictionaries,
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`s
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`should be interpreted as having a meaning that is consistent with their meaning
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`in the context of the specification and relevant art and should not be interpreted
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`in an idealized or overly formal sense unless expressly so defined herein. Well(cid:173)
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`known functions or constructions may not be described in detail for brevity
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`and/or clarity.
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`10
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`It will be understood that when an element is referred to as being
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`"on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another
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`element, it can be directly on, attached to, connected to, coupled with or
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`contacting the other element or intervening elements may also be present. In
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`contrast, when an element is referred to as being, for example, "directly on",
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`1 s
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`"directly attached" to, "directly connected" to, "directly coupled" with or "directly
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`contacting" another element, there are no intervening elements present. It will
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`also be appreciated by those of skill in the art that references to a structure or
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`feature that is disposed "adjacent" another feature may have portions that
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`overlap or underlie the adjacent feature.
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`20
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`Spatially relative terms, such as "under", "below", "lower", "over",
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`"upper" and the like, may be used herein for ease of description to describe one
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`element or feature's relationship to another element(s) or feature(s) as illustrated
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`in the figures. It will be understood that the spatially relative terms are intended
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`to encompass different orientations of a device in use or operation in addition to
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`2 s
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`the orientation depicted in the figures. For example, if a device in the figures is
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`inverted, elements described as "under" or "beneath" other elements or features
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`would then be oriented "over" the other elements or features. Thus, the
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`exemplary term "under" can encompass both an orientation of "over" and
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`"under". The device may be otherwise oriented (rotated 90 degrees or at other
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`30
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`orientations) and the spatially relative descriptors used herein interpreted
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`accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal"
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`and the like are used herein for the purpose of explanation o