Docket No. 00125/002005
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`TITLE OF THE INVENTION
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`Method and Apparatus for Health and Disease Management
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`Combining Patient Data Monitoring with Wireless Internet Connectivity
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`CROSS-REFERENCE TO RELATED APPLICATIONS
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`[0001] This is a continuation of U.S. Patent Application Serial No. 11/649,703, filed January
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`3, 2007, entitled "Method and Apparatus for Health and Disease Management Combining
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`Patient Data Monitoring with Wireless Internet Connectivity," which is a continuation of
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`U.S. Patent Application Serial No. 11/184,274, filed July 18, 2005, entitled "Method and
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`Apparatus for Health and Disease Management Combining Patient Data Monitoring with
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`Wireless Internet Connectivity," now U.S. Patent No. 7,156,808, which is a continuation of
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`U.S. Patent Application Serial No. 10/418,845, filed April 18, 2003, now U.S. Patent No.
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`6,936,007, which is a continuation of U.S. Patent Application Serial No. 09/738,270, filed
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`December 15, 2000, now U.S. Patent No. 6,602,191, which is a conversion of U.S.
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`Provisional Application Serial No. 60/172,486, filed December 17, 1999. The disclosure of
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`each of the prior applications is incorporated herein by reference in its entirety.
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`REFERENCE TO GOVERNMENTAL SUPPORT
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`(none)
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`REFERENCE TO MICROFICHE APPENDIX
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`(none)
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`FIELD OF THE INVENTION
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`[0002] The present invention relates to monitoring of living subjects, and more
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`particularly to health-monitoring of persons where measured or input health data is
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`communicated by a wireless device to and from a software application running on an
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`internet-connected server and where the same may be studied and processed by the software
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`application, a health professional, or the subject.
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`BACKGROUND OF THE INVENTION
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`[0003] Several attempts have been made in the past to achieve efficient interactive
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`communication of medical or health information between a subject or patient and a reviewer
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`or provider of that information. In particular, communication of consumer physiological
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`information has been a subject of such attempts. It is noted that in this regard the "reviewer
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`or provider of medical or health information" is understood to include not only a physician
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`but also a software application or algorithm that may analyze the information.
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`[0004] Medical or health information has been made available on a D-ROM accessible by
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`a home computer system. This passive approach had certain disadvantages. First, although
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`the personal computer is prevalent is the United States, it is generally too expensive for a
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`consumer physiological monitoring system and there are many people who find it too
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`complicated to set up and use for that purpose. High-risk, chronically ill patients, responsible
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`for more than half of health care costs in the United States and forming the fastest growing
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`segment of those requiring health care, are indeed the most likely not to be able to afford or
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`use a system built around a personal computer. In addition, such systems are limited in their
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`interactivity to the information stored on the CD.
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`[0005] Previous patents by the Inventor addressed both of these disadvantages, as well as
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`the need to reduce health care costs through providing educational health care information
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`and interactive physiological monitoring in the home environment by means of a user(cid:173)
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`friendly, interactive system (see, e.g., U.S. Patent Nos. 5,601,435, 6,144,837, and
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`continuations thereof).
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`[0006] These previous patents were based on a video game console, or a multimedia
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`player using a conventional television screen as the display device to achieve a system which
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`is simpler to use than systems based on a personal computer. An initial embodiment of the
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`previous patents utilized a compact disc to provide interactive information for disease
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`management.
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`[0007] Even with the advantages provided, these systems limited the user to location in
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`which the device was located. Even where devices are portable, as in the case of a laptop
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`computer with a modem, an ordinary POTS phone line must be found and used. Where the
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`user's computer employs a broadband connection, such as DSL or satellite, the choices of
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`location are even more limited.
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`[0008] Attempts have been made to remedy this deficiency. For example, many telemetry
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`systems allow a "wireless" distance to be placed between a health measuring unit and a
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`remote monitoring system. However, such systems are limited in their range.
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`[0009] Other systems have used cellular telephone technology to increase the wireless
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`health monitoring range. However, these systems have several deficiencies, such as
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`requiring significant modification of the mobile phone. For example, U.S. Patent No.
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`5,772,586, issued June 30, 1998 to Heinonon et al., discloses a method for monitoring the
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`health of a patient. This system uses a specialized connection between the patient health
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`measuring unit and the cellular phone, however. The patient health measuring unit is located
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`in the battery space of the mobile phone and is connected to a communication bus of the
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`mobile phone. Other systems have been proposed, but these suffer from similar deficiencies
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`in that they are not designed to be used with "off-the-shelf' wireless devices or health
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`measuring equipment.
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`[0010] The deployment of the above systems also currently lacks employment of
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`full back-end server functionality with which to provide a wide range of interactive
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`communication with the patient. Instead, such systems, if internet-enabled, are often limited
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`to mere one-way non-interactive data transfer via a modem. While some systems are more
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`enhanced, including that disclosed in U.S. Patent No. 5,357,427, issued October 18, 1994 to
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`Langen, et al., and entitled "Remote Monitoring of High-Risk Patients using Artificial
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`Intelligence", these systems are limited by the wired telecommunications infrastructure.
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`[0011] Embodiments of the present invention overcome one or more of the
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`SUMMARY OF THE INVENTION
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`disadvantages of the prior art by providing a full-feature health-monitoring system that may
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`wirelessly connect to a back-end server application via the internet. The invention allows
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`wireless access to and from a wide variety of present medical or health-related instruments
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`and devices, while maintaining the capability of connecting to future such devices.
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`[0012] In particular, the invention may be embodied in several systems. Two
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`complementary such systems are described herein, although extensions to other such systems
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`can be envisioned. First, an embodiment of the invention may be employed to manage the
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`disease state or condition of a patient. In this embodiment, the patient may employ a health
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`monitoring device ("HMD"), in particular a medical device, and a wireless connection
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`provides data from the medical device for processing via the internet including a review by a
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`physician or other health care professional if required.
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`[0013] In the second embodiment, a health or lifestyle management plan may be
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`implemented. Various health parameters, such as those relating to nutrition or exercise, may
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`be entered into a health monitoring device, in this instance termed an "exercise machine",
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`and the same may be wireless communicated to a server. An application may process and
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`store the health parameters, and a health specialist may optionally review the same.
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`[0014] Wireless internet connectivity has many advantages. For example, in the
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`first embodiment, a diabetic could connect a blood glucose meter to an internet-enabled
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`wireless web device ("WWD") away from home and download data to a Diabetes
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`Management Company's server and, in response, receive guidance displayed on the screen
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`( or by voice) about choices for the next meal.
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`[0015] Alternatively, in the second embodiment, a person interested in tracking
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`an exercise program may take the WWD to the local health club and attach the same to an
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`exercise machine, send data output from various exercise machines over the Internet, and
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`receive a personalized response from the server of a company specializing in Health &
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`Lifestyle Management. The individual may input caloric content of foods eaten, and may
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`further input caloric content of exercise performed. In this way, e.g., a person in a weight(cid:173)
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`loss program may see in great detail whether they are expending more calories in the form of
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`exercise than the same individual is consuming in the form of food.
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`[0016] In general, in the health management embodiment, the system may be
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`employed to monitor the physiologic status of a healthy subject while eating, exercising, or
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`performing other activities. For clarity, such devices are termed herein "exercise machines".
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`These may include an electronic body weight scale, a body fat gauge, biofeedback devices,
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`physiotherapy or chiropractic equipment, blood pressure recorders, or the like, or any type of
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`exercise machine or monitor, including a heart rate monitor, treadmill, rowing machine,
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`stepper, or the like.
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`[0017] In more detail, the present invention provides a method and system for
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`assisting patients to manage a disease or maintain healthy lifestyle by collecting health(cid:173)
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`related data and providing information in response to those data by means of a WWD
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`designed to display interactive information through a connection to the Internet. The present
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`invention may be connected to various HMDs, both medical and exercise-related in nature,
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`and may communicate information via a wireless connection such as a wireless Internet
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`connection.
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`[0018] A major advantage of embodiments of the invention is that the same frees
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`the patient from the constraints of wired systems. The same allows users with consumer
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`"off-the-shelf' wireless devices to significantly extend the range of connectivity over that of
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`wired computer, television, or even wireless telemetry systems.
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`[0019] In a first embodiment of the present invention, the WWD is a web-enabled
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`cellular phone. Here it is noted that the term "web" or "internet" are used interchangeably to
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`refer to the internet in general. In a second embodiment, the WWD is a palm, handheld, or
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`laptop computer, or a PDA, equipped with a wireless modem. In a third embodiment, the
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`WWD may be a hybrid device that combines the functions of a computer, PDA and
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`telephone.
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`[0020] An adaptor is used if necessary to convert the output signal of the medical
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`monitoring device to a suitable input signal for the WWD. The adaptor allows connection of
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`the WWD to a medical device, exercise machine or other variety of health care equipment,
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`and the connection may be made via several techniques. As for wired techniques, a standard
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`parallel bus or serial cable may be used if the input/output ports between the HMD and the
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`WWD are appropriate. Otherwise, a suitable separate adaptor may be employed.
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`[0021] The connection may also be an input such as a disk drive or other media
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`input for input of data, a USB port or phone jack or other such wired input, again employing
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`an adaptor if required.
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`[0022] As for wireless techniques, infrared (IR), microwaves, radio frequency
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`(RF), e.g., Bluetooth® or 802.11 protocols, optical techniques including lasers, and other
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`such techniques may be used. The patient or subject may also input data manually, such as
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`by a stylus, keypad, synchronization from a PC, or by various other techniques discussed
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`below.
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`[0023] A major advantage of the invention is that by use of an optional adaptor,
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`the system is compatible with current and prior HMDs as well as maintaining a capability of
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`adapting to future such systems.
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`[0024] Other advantages of the invention may include one or more of the
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`following. An embodiment of the invention may be used when a patient is traveling or
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`otherwise away from their "wired" means of communication. The invention allows wireless
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`health-monitoring to the level of accuracy previously achieved only by desktop so-called
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`"wired" computer systems. The invention is protocol-independent.
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`[0025] The interaction between a WWD and a back-end server may provide a
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`major additional advantage in certain embodiments of the invention. In particular, the
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`relatively small amount of memory currently provided on a WWD as compared to a back-end
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`server severely limits the functionality of applications running on the WWD, especially in
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`terms of computing capacity, processing power, and user interface. By providing significant
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`application functionality on the back-end, less memory and processing capabilities become
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`necessary on the WWD (i.e., on the "front-end"). Thus, memory may be used in the WWD
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`for an enhanced user interface or for other purposes, according to the user requirements.
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`[0026] In a method according to an embodiment of the invention, the patient
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`connects to a specific Internet site and a software program, resident on a remote server
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`located on the Internet, downloads an interactive user interface for that patient and an
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`application for the measurement of the physiological data. The software may also be
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`downloaded to the WWD from a personal computer via a synchronization operation in
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`known fashion. The software provides a personalized display for the user and configures the
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`WWD to control and monitor devices connected via a generic input/output port to the WWD.
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`The software may be designed to suit the constraints of the small display screens of WWDs.
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`The software, as well as inputs from the patient or other inputs, can control the manner,
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`content, and display of information presented to the patient, and measured or input data can
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`be stored for review by a health care provider or by a software algorithm or application. The
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`algorithm may be of varying complexity, from a simple program that merely acknowledges
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`receipt of information to an artificial intelligence algorithm, such as an expert system,
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`collaborative filtering system, rules based system, case-based reasoning system, or other such
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`artificial intelligence application.
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`[0027] Further information may be provided to or from the patient, including
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`information entered manually. The patient may input this information via a personal
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`computer, which then may download the input information to the WWD via a
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`synchronization operation using standard protocols, such as those for Palm PDA devices.
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`[0028] The user may also input supplemental information via a PC connected
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`independently to the server via the internet. Such supplemental information may include data
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`that is difficult or inconvenient to input on the WWD. In this way, the patient may be
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`afforded a more convenient environment in which to manipulate data to supplement the data
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`input to the WWD. The deployment of voice processing technology may be used to enable
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`an even more convenient user interface: i.e., one to which patients can talk.
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`[0029] In all of these respects, the portable aspect of the WWD is important: to
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`wit, the user may conveniently carry the WWD on their person wherever they may go,
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`allowing data entry at the time needed.
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`[0030] Other aspects, features, and advantages will be apparent from the
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`summary above, as well as from the description that follows, including the figures and the
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`claims.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0031] FIG. 1 illustrates a general embodiment of a wireless health-monitoring
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`system according to the present invention;
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`[0032] FIG. 2 illustrates an embodiment of a wireless health-monitoring
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`apparatus according to the present invention, showing the system of FIG. 1 up to a point of a
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`wireless antenna;
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`[0033] FIG. 3 illustrates an embodiment of a back end of a health-monitoring
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`system according to the present invention;
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`[0034] FIG. 4 illustrates a data flow diagram according to an embodiment of the
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`present invention;
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`[0035] FIG. 5 illustrates an embodiment of a method of use for a wireless
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`application and a server application according to the present invention, in which the same is
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`implemented for disease and patient management;
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`[0036] FIG. 6 illustrates an embodiment of a method of use for a wireless
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`application and a server application according to the present invention, in which the same is
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`implemented for health management;
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`[0037] FIG. 7 illustrates an embodiment of a wired connection between a HMD
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`and a WWD, also showing an optional adaptor; and
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`[0038] FIG. 8 illustrates an embodiment of a wireless connection between a HMD
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`and a WWD, also showing an optional adaptor.
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`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
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`[0039] Various acronyms are used for clarity herein. Definitions are given below.
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`[0040] The term "HMD" may encompass not only devices with physiologic
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`sensors but also devices with a keypad, keyboard, mouse, pointer, pressure sensor, or other
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`such inputs that the patient or user may employ to perform data entry of the desired
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`parameters. In general, HMDs include some means for determining a health parameter.
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`[0041] In a disease management embodiment, an HMD may be a blood glucose
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`monitor, a blood pressure monitor, an ambulatory ECG recorder, a respiratory monitor, a
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`temperature or heart rate monitor, and so on.
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`[0042] In a healthy lifestyle management embodiment, an HMD may be an
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`exercise machine, including treadmills, rowers, steppers, exercise cycles, or other aerobic or
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`anaerobic exercisers, or a monitor, include monitors for temperature, heart rate, blood
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`pressure, amount of work or rate of work performed, etc.
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`[0043] The term "subject" as used herein primarily indicates a human subject.
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`The same may be a medical patient under physician care, a person interested in maintaining
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`health via accurate recording of nutrition and exercise, and so on. The term "user" is
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`generally used to refer to the user of the device, which may be synonymous with the subject
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`or may alternatively be a caregiver of the subject, etc. The term "patient" is used, in addition
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`to a person under the care of a physician, to also refer to a "normal" or healthy individual
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`who is interested in maintaining a healthy physiologic balance.
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`[0044] The term "signal communication" is used to mean any type of connection
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`between components where the connection is, e.g., electromagnetic, and where the
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`connection allows information to be passed from one component to another. This term may
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`be used in a similar fashion as "coupled", "connected", "information communication", "data
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`communication", etc. The following are examples of signal communication schemes. As for
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`wired techniques, a standard bus or serial cable may be used if the input/output ports are
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`compatible and an optional adaptor may be employed if they are not. As for wireless
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`techniques, IR, microwaves, RF, e.g., Bluetooth® or 802.11 protocols, optical techniques
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`including lasers, and other such techniques may be used. The patient or subject may even
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`input data manually, such as by a stylus or keypad or by various other techniques discussed
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`above and below.
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`[0045] The term "generic input/output port" is used to mean any type of
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`convention, standard, universal, stock, consumer, or "off-the-shelf' type of port for data
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`input and output. These may include both wired and wireless ports. A further description is
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`given below.
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`[0046] Various embodiments of the invention are now described in more detail.
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`[0047] Referring to FIG. 1, a system of the present invention is shown for
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`monitoring health data from a patient or subject 38. The system includes a wireless health(cid:173)
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`monitoring apparatus ("WHMA") 10 described in further detail below. WHMA 10 is linked
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`in a wireless fashion to a wireless connection point of presence ("POP") 19, the same
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`including at least a base station antenna 15 coupled to a server 17. Server 17 is in tum
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`connected to the wired, or even a wireless (not shown) Internet 21, which may include the
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`World Wide Web.
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`[0048] Referring to FIG. 2, an first embodiment ofWHMA 10 is shown. WHMA
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`10 includes an HMD 11, which may include an optional monitor screen 40, coupled via an
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`optional adaptor 42 to a WWD 12. WWD 12 connects wirelessly via an antenna 60 to base
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`station 15 (see FIG. 1). One function of WWD 12 is to provide the user interface; other
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`functions are described below.
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`[0049] As noted above, HMD 11 may include a physiologic sensor 24 or may
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`include a manual system 36 for input of physiologic data via a connection 34. Manual
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`system 36 may also be used to input data directly into WWD 12 via a connection 32. Manual
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`system 36 may include, e.g., a keyboard 30, a mouse 26, a pen-type device 28, and may also
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`employ a separate monitor (not shown). Of course, the user may also view information on
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`monitor 40 or on a screen 41 ofWWD 12. In many embodiments, the stylus-based system
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`employed by many current PDA's, such as the Palm®, may be preferred for such manual
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`data input.
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`[0050] Data may also be input via entry on a computer 37. This data may then be
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`synchronized to WWD 12 in known fashion. Alternatively, computer 37, or another
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`computer (see computer 37' in FIG. 4) may be used to connect to a server using the wired
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`internet. This use may be particularly advantageous when entering a large amount of data,
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`such as a patient's medical history. As noted above, in this way the patient may be afforded
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`a more convenient environment in which to manipulate data to supplement the data input to
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`theWWD.
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`[0051] It will be clear to one of skill in the art given this teaching that cable 32, as
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`10
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`well as cables 34 and 44, may be replaced with wireless circuitry to communicate signals
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`wirelessly.
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`[0052] For medical devices and applications, physiologic sensor 24 may include,
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`e.g., a sensor appropriate for measuring blood glucose levels, blood pressure, heart rate, or
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`any other desired parameter as required by the physician. Sensor 24 may connect via an
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`optional cable 44 to subject 38. Alternatively, sensor 24 may be distal ofHMD 11, i.e., at or
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`within subject 38. In other words, if cable 44 is employed, sensor 24 may be proximal or
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`distal of cable 44. If a wireless communications capability is added, sensor 24 need not
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`physically connect with HMD 11 or WWD 12 at all. That is, the same may measure a health
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`parameter and may communicate the same to wireless health-monitoring apparatus 10
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`wirelessly. The short range wireless communications schemes which may be employed
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`include infrared, radio frequency including Bluetooth or 802.11, or other such schemes.
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`[0053] As examples of sensor types, to measure blood glucose levels, sensor 24
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`may be a sensor that accepts a drop of blood, e.g., via a finger-prick. To measure heart rate,
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`sensor 24 may be placed via an adhesive sensor disposed on the chest. Other health monitors
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`may also be employed so long as the measured data may either be transferred to WWD 12,
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`e.g., via optional adaptor 42, described in further detail below, or by being read by a user,
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`e.g., from a display, and manually input to WWD 12. Alternatively, the measured data may
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`be transferred to WWD 12 via wireless communication schemes, such as RF includes
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`Bluetooth® or 802.11, infrared, optical, microwaves, etc., directly from sensor 24 or from
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`HMD 11 as described in greater detail below.
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`[0054] The user, who may or may not be the same person as subject 38, may
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`input data to WWD 12 from history or experience. For example, in a health or exercise
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`device, if subject 38 consumes a known number of calories, this information may be entered
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`via manual system 36 directly into WWD 12 or into HMD 11. Further, the user, the subject,
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`and the sensor are not necessarily the sole sources of information. Data stored on the server,
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`or on a separate server operated for health management may also be employed to result in a
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`health benefit to subject 38.
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`[0055] Referring to FIG. 3, WHMA 10 is shown communicating wirelessly with
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`11
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`the Internet. In doing so, WHMA 10 generally sends a wireless signal to a base station 14 (in
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`known fashion) that is connected to a server 18 that is in signal communication (in known
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`fashion) with the internet. Server 18 communicates via a protocol (in known fashion) to
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`Internet 20, which also communicates via a protocol (in known fashion) to a server 22
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`running an application 62. Server 22 may be accessed (in known fashion) by a client
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`computer 44 through a connection 64.
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`[0056] As noted, the protocols for data communication are known. However,
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`they currently vary amongst known techniques. The present invention is not limited to any
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`particular protocols, and may be implemented in any languages supported by the WWD and
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`server. Of course, as computing capabilities continue to increase, it is expected that the
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`capabilities ofWHMA 10, servers 18 and 22, as well as application 62 and client 44, and
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`other components, will correspondingly increase.
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`[0057] Application 62 running on server 22 may interact with WHMA 10 in a
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`number of ways. Referring to FIG. 4, WHMA 10 is shown in signal communication with
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`server 22 via a connection 72. Connection 72 schematically represents the wireless Internet
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`connection and intervening pathways. WHMA 10 includes an application that may be
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`viewed as having two components: a base wireless or device application 70 and an
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`application presentation layer or user interface 68. User interface 68 is employed to, e.g.,
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`present a menu of options to the user, to allow the user to choose inputs, and to generally
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`operate the device. User interface 68 may vary widely in sophistication, e.g., from a simple
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`data entry field to a full graphical user interface. These applications may accept as inputs
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`data from a sensor 24 as well as from a manual input 36.
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`[0058] Server 22 has a base server application 62 with which the same calculates
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`or provides a response based at least in part on data from WHMA 10. Application 62 may
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`include an algorithm 63 for analyzing data from the HMD, and either application 62 or
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`algorithm 63 may optionally access data from an external data source 74 and may further
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`consult an artificial intelligence system 76.
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`[0059] External data source 74 may be a memory or disk or other such storage
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`12
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1010 Page 0012
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`

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`Docket No. 00125/002005
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`that stores health data, such as healthy and unhealthy weight/height ranges, healthy and
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`unhealthy cholesterol counts, the patient's or subject's prior medical or health history,
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`healthy and unhealthy blood pressure values, information corresponding to the caloric and
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`other nutritional content of foods, information corresponding to the caloric expenditure
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`values of various exercises, algorithms for calculating various health parameters, etc. In
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`general, any data that may benefit the health of a subject or patient may be stored in external
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`data source 74. External data source 74 may also include online access of health information
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`from external web sites, ftp servers, or other sources.
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`[0060] Due to the current relatively small amount of memory and storage available on
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`current WWDs, such external application processing as by application 62 and external data
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`storage as by external data 74 may be particularly important.
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`[0061] As noted, application 62 or algorithm 63 may also consult AI system 76
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`for suggestions as to health benefits. AI system 76 may even interact with external data
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`source 74 to extract useful information from the same. AI system 76 may employ, e.g., case(cid:173)
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`based reasoning, rules-based systems, collaborative filtering, neural networks, expert
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`systems, or other such systems as are known.
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`[0062] It should also be noted that each of application 62, algorithm 63, external
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`data source 74, or AI system 76, may physically reside on more than one server, e.g., on an
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`array of servers for, e.g., storage or multiple processing purposes. Each of application 62,
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`algorithm 63, external data source 74, or AI system 76, or combinations of each, may also
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`respectively reside on different servers.
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`[0063] The extent to which server application 62 interacts with wireless
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`application 70 depends on the use to which the system is put. For example, in a less
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`interactive embodiment, device application 70 may act to measure a diabetic patient's blood
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`glucose level and report the same to server application 62. In this case, a physician may
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`simply review the measured value and send the patient an email reporting that the value is
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`acceptable or not. In a highly interactive embodiment, a patient may have numerous HMDs
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`11 connected via optional adaptors to a WWD 12, and wireless application 70 may
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`correspondingly send a large amount of health data to server application 62. The physician,
`
`13
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1010 Page 0013
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`

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`Docket No. 00125/002005
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`accessing server application 62, may in tum send detailed care plans to a caregiver via
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`connection 72. The received data may be analyzed using algorithm 63, external data source
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`74, and AI system 76. In this sense, the two applications may be highly interactive.
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`[0064] It is noted that an Application Service Provider (ASP) may operate
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`application 62. That is, application 62 may be leased by an ASP to the health care provider,
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`and the ASP may perform all necessary upgrades and maintenance to application 62 and its
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`associated components.
`
`[0065] To initialize the system, the program starts and a wireless application is
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`loaded into the WWD. The loading of the wireless application may occur via
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`synchronization from a desktop or via downloading from a server over the internet. The
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`server application may be loaded into an appropriate internet-connected server. Subject data
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`may be loaded into the WWD or into the server. In the latter case, the subject information
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`may later be transferred to the WWD or transferred to the server from the WWD, as called
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`for by the application. The initialization scheme then ends.
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`[0066] The wireless application may access the server and server application, or
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`vice-versa, as determined by the respective program instructions. Examples are now given
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`for (1) a system of disease and patient management and (2) a system for health management
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`employing an exercise machine.
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`EXAMPLE EMPLOYING SYSTEM FOR DISEASE MANAGEMENT
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`[0067] Referring to FIG. 5, an example is given for a system of disease and
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`patient management. In this figure, as well as in FIG. 6, boxes in dotted lines may generally
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`be considered optional.
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`[0068] In FIG. 5, a medical device may determine health parameters and an
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`optional physician review is provided. Health parameters may also be determined by user
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`manual input.
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`[0069] The program is started (step 142) and a sensor measures a health
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`parameter (step 116). The sensor may send the parameter to a medical device (step 118). The
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`medical device then sends the parameter to the WWD (step 120). The WWD then