`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 1 of 20 Page ID #:1897
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`EXHIBIT 4
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`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 2 of 20 Page ID #:1898
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`U.S. PATENT DOCUMENTS
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`FOREIGN PATENT DOCUMENTS
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`5,544,649 A
`5,544,661 A
`5,549,117 A
`5,553,609 A
`5,576,952 A
`5,601,435 A
`5,626,144 A
`5,678,562 A
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`5,933,136 A
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`5,941,829 A
`5,951,300 A
`5,959,533 A
`5,964,701 A
`5,967,975 A
`5,987,352 A
`5,987,519 A
`5,997,476 A
`6,013,007 A
`6,022,315 A
`6,024,699 A
`6050940 A
`6,055,506 A
`6,057,758 A
`6,059,692 A
`6,083,156 A
`6,093,146 A
`6,101,478 A
`6,139,494 A
`6,144,837 A
`6,160,478 A
`6,168,563 B1
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`6,266,645 Bl
`6,309,342 Bl
`6,319,199 B1
`6336900 B1
`6353339 B1
`6,375,614 B1
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`6,416,471 B1
`65418346 B1
`6’440’068 B1
`2’222’333 :1
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`6,524,189 B1
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`6’529’771 B1
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`W0
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`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 4 of 20 Page ID #:1900
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`US 8,277,377 B2
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`
`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 5 of 20 Page ID #:1901
`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 5 of 20 Page ID #:1901
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`US. Patent
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`Oct. 2, 2012
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`US 8,277,377 B2
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`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 7 of 20 Page ID #:1903
`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 7 of 20 Page ID #:1903
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`US. Patent
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`Case 2:19-cv-06301-AB-KS Document 77-5 Filed 06/26/20 Page 10 of 20 Page ID #:1906
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`US 8,277,377 B2
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`1
`METHOD AND APPARATUS FOR
`MONITORING EXERCISE WITH WIRELESS
`INTERNET CONNECTIVITY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This is a continuation of US. patent application Ser. No.
`11/649,703, filed Jan. 3, 2007, entitled “Method and Appara-
`tus for Health and Disease Management Combining Patient
`Data Monitoring with Wireless Internet Connectivity,” which
`is a continuation of US. patent application Ser. No. 11/184,
`274, filed Jul. 18, 2005, entitled “Method and Apparatus for
`Health and Disease Management Combining Patient Data
`Monitoring with Wireless Internet Connectivity,” now US.
`Pat. No. 7,156,808, which is a continuation of US. patent
`application Ser. No. 10/418,845, filed Apr. 18, 2003, now
`US. Pat. No. 6,936,007, which is a continuation of US.
`patent application Ser. No. 09/738,270, filed Dec. 15, 2000,
`now US. Pat. No. 6,602,191, which is a conversion of US.
`Provisional Application Ser. No. 60/172,486, filed Dec. 17,
`1999. The disclosure of each of the prior applications is
`incorporated herein by reference in its entirety.
`
`REFERENCE TO GOVERNMENTAL SUPPORT
`
`(none)
`
`REFERENCE TO MICROFICHE APPENDIX
`
`(none)
`
`FIELD OF THE INVENTION
`
`The present invention relates to monitoring of living sub-
`jects, and more particularly to health-monitoring of persons
`where measured or input health data is communicated by a
`wireless device to and from a software application running on
`an internet-connected server and where the same may be
`studied and processed by the software application, a health
`professional, or the subject.
`
`BACKGROUND OF THE INVENTION
`
`Several attempts have been made in the past to achieve
`efficient
`interactive communication of medical or health
`information between a subject or patient and a reviewer or
`provider of that information. In particular, communication of
`consumer physiological information has been a subject of
`such attempts. It is noted that in this regard the “reviewer or
`provider of medical or health information” is understood to
`include not only a physician but also a software application or
`algorithm that may analyze the information.
`Medical or health information has been made available on
`
`a D-ROM accessible by a home computer system. This pas-
`sive approach had certain disadvantages. First, although the
`personal computer is prevalent is the United States, it is
`generally too expensive for a consumer physiological moni-
`toring system and there are many people who find it too
`complicated to set up and use for that purpose. High-risk,
`chronically ill patients, responsible for more than half of
`health care costs in the United States and forming the fastest
`growing segment of those requiring health care, are indeed
`the most likely not to be able to afford or use a system built
`around a personal computer. In addition, such systems are
`limited in their interactivity to the information stored on the
`CD.
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`Previous patents by the Inventor addressed both of these
`disadvantages, as well as the need to reduce health care costs
`through providing educational health care information and
`interactive physiological monitoring in the home environ—
`ment by means of a user-friendly, interactive system (see,
`e.g., US. Pat. Nos. 5,601,435, 6,144,837, and continuations
`thereof).
`These previous patents were based on a video game con-
`sole, or a multimedia player using a conventional television
`screen as the display device to achieve a system which is
`simpler to use than systems based on a personal computer. An
`initial embodiment of the previous patents utilized a compact
`disc to provide interactive information for disease manage-
`ment.
`
`Even with the advantages provided, these systems limited
`the user to location in which the device was located. Even
`where devices are portable, as in the case ofa laptop computer
`with a modem, an ordinary POTS phone line must be found
`and used. Where the user’s computer employs a broadband
`connection, such as DSL or satellite, the choices of location
`are even more limited.
`
`Attempts have been made to remedy this deficiency. For
`example, many telemetry systems allow a “wireless” distance
`to be placed between a health measuring unit and a remote
`monitoring system. However, such systems are limited in
`their range.
`Other systems have used cellular telephone technology to
`increase the wireless health monitoring range. However,
`these systems have several deficiencies, such as requiring
`significant modification of the mobile phone. For example,
`US. Pat. No. 5,772,586, issued Jun. 30, 1998 to Heinonon et
`al., discloses a method for monitoring the health of a patient.
`This system uses a specialized connection between the
`patient health measuring unit and the cellular phone, how-
`ever. The patient health measuring unit is located in the bat-
`tery space of the mobile phone and is connected to a commu-
`nication bus of the mobile phone. Other systems have been
`proposed, but these suffer from similar deficiencies in that
`they are not designed to be used with “off-the-shelf” wireless
`devices or health measuring equipment.
`The deployment of the above systems also currently lacks
`employment of full back-end server functionality with which
`to provide a wide range of interactive communication with
`the patient. Instead, such systems, if intemet-enabled, are
`often limited to mere one-way non-interactive data transfer
`via a modem. While some systems are more enhanced,
`including that disclosed in US. Pat. No. 5,357,427, issued
`Oct. 18, 1994 to Langen, et al., and entitled “Remote Moni-
`toring of High-Risk Patients using Artificial Intelligence”,
`these systems are limited by the wired telecommunications
`infrastructure.
`
`SUMMARY OF THE INVENTION
`
`Embodiments of the present invention overcome one or
`more of the disadvantages of the prior art by providing a
`full-feature health-monitoring system that may wirelessly
`connect to a back-end server application via the internet. The
`invention allows wireless access to and from a wide variety of
`present medical or health-related instruments and devices,
`while maintaining the capability of connecting to future such
`devices.
`
`In particular, the invention may be embodied in several
`systems. Two complementary such systems are described
`herein, although extensions to other such systems can be
`envisioned. First, an embodiment of the invention may be
`employed to manage the disease state or condition of a
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`US 8,277,377 B2
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`3
`patient. In this embodiment, the patient may employ a health
`monitoring device (“HMD”), in particular a medical device,
`and a wireless connection provides data from the medical
`device for processing via the internet including a review by a
`physician or other health care professional if required.
`In the second embodiment, a health or lifestyle manage-
`ment plan may be implemented. Various health parameters,
`such as those relating to nutrition or exercise, may be entered
`into a health monitoring device, in this instance termed an
`“exercise machine”, and the same may be wireless commu-
`nicated to a server. An application may process and store the
`health parameters, and a health specialist may optionally
`review the same.
`
`Wireless internet connectivity has many advantages. For
`example, in the first embodiment, a diabetic could connect a
`blood glucose meter to an intemet-enabled wireless web
`device (“WWD”) away from home and download data to a
`Diabetes Management Company’s server and, in response,
`receive guidance displayed on the screen (or by voice) about
`choices for the next meal.
`
`Alternatively, in the second embodiment, a person inter-
`ested in tracking an exercise program may take the WWD to
`the local health club and attach the same to an exercise
`
`machine, send data output from various exercise machines
`over the Internet, and receive a personalized response from
`the server of a company specializing in Health & Lifestyle
`Management. The individual may input caloric content of
`foods eaten, and may further input caloric content of exercise
`performed. In this way, e.g., a person in a weight-loss pro-
`gram may see in great detail whether they are expending more
`calories in the form of exercise than the same individual is
`
`consuming in the form of food.
`In general, in the health management embodiment, the
`system may be employed to monitor the physiologic status of
`a healthy subject while eating, exercising, or performing
`other activities. For clarity, such devices are termed herein
`“exercise machines”. These may include an electronic body
`weight scale, a body fat gauge, biofeedback devices, physio-
`therapy or chiropractic equipment, blood pressure recorders,
`or the like, or any type ofexercise machine or monitor, includ-
`ing a heart rate monitor, treadmill, rowing machine, stepper,
`or the like.
`
`In more detail, the present invention provides a method and
`system for assisting patients to manage a disease or maintain
`healthy lifestyle by collecting health-related data and provid-
`ing information in response to those data by means ofa WWD
`designed to display interactive information through a connec-
`tion to the Internet. The present invention may be connected
`to various HMDs, both medical and exercise-related in
`nature, and may communicate information via a wireless
`connection such as a wireless Internet connection.
`
`A major advantage of embodiments ofthe invention is that
`the same frees the patient from the constraints of wired sys-
`tems. The same allows users with consumer “off-the-shelf”
`
`wireless devices to significantly extend the range of connec-
`tivity over that ofwired computer, television, or even wireless
`telemetry systems.
`In a first embodiment ofthe present invention, the WWD is
`a web-enabled cellular phone. Here it is noted that the term
`“we ” or “internet” are used interchangeably to refer to the
`internet in general. In a second embodiment, the WWD is a
`palm, handheld, or laptop computer, or a PDA, equipped with
`a wireless modem. In a third embodiment, the WWD may be
`a hybrid device that combines the functions of a computer,
`PDA and telephone.
`An adaptor is used ifnecessary to convert the output signal
`ofthe medical monitoring device to a suitable input signal for
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`the WWD. The adaptor allows connection of the WWD to a
`medical device, exercise machine or other variety of health
`care equipment, and the connection may be made via several
`techniques.As for wired techniques, a standard parallel bus or
`serial cable may be used if the input/output ports between the
`HMD and the WWD are appropriate. Otherwise, a suitable
`separate adaptor may be employed.
`The connection may also be an input such as a disk drive or
`other media input for input of data, a USB port or phone jack
`or other such wired input, again employing an adaptor if
`required.
`infrared (IR), microwaves,
`As for wireless techniques,
`radio frequency (RF), e.g., Bluetooth® or IEEE 802.11 pro-
`tocols, optical techniques including lasers, and other such
`techniques may be used. The patient or subject may also input
`data manually, such as by a stylus, keypad, synchronization
`from a PC, or by various other techniques discussed below.
`A major advantage of the invention is that by use of an
`optional adaptor, the system is compatible with current and
`prior HMDs as well as maintaining a capability of adapting to
`future such systems.
`Other advantages ofthe invention may include one or more
`of the following. An embodiment of the invention may be
`used when a patient is traveling or otherwise away from their
`“wired” means of communication. The invention allows
`
`wireless health-monitoring to the level of accuracy previ-
`ously achieved only by desktop so-called “wired” computer
`systems. The invention is protocol-independent.
`The interaction between a WWD and a back-end server
`
`may provide a major additional advantage in certain embodi-
`ments of the invention. In particular, the relatively small
`amount of memory currently provided 011 a WWD as com-
`pared to a back-end server severely limits the functionality of
`applications running on the WWD, especially in terms of
`computing capacity, processing power, and user interface. By
`providing significant application functionality on the back-
`end, less memory and processing capabilities become neces-
`sary on the WWD (i.e., on the “front-end”). Thus, memory
`may be used in the WWD for an enhanced user interface or for
`other purposes, according to the user requirements.
`In a method according to an embodiment of the invention,
`the patient connects to a specific Internet site and a software
`program, resident on a remote server located on the Internet,
`downloads an interactive user interface for that patient and an
`application for the measurement of the physiological data.
`The software may also be downloaded to the WWD from a
`personal computer via a synchronization operation in known
`fashion. The software provides a personalized display for the
`user and configures the WWD to control and monitor devices
`connected via a generic input/output port to the WWD. The
`software may be designed to suit the constraints of the small
`display screens of WWDs. The software, as well as inputs
`from the patient or other inputs, can control the manner,
`content, and display of information presented to the patient,
`and measured or input data can be stored for review by a
`health care provider or by a software algorithm or application.
`The algorithm may be of varying complexity, from a simple
`program that merely acknowledges receipt of information to
`an artificial intelligence algorithm, such as an expert system,
`collaborative filtering system, rules based system, case-based
`reasoning system, or other such artificial intelligence appli-
`cation.
`
`Further information may be provided to or from the patient,
`including information entered manually. The patient may
`input this information via a personal computer, which then
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`US 8,277,377 B2
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`5
`may download the input information to the WWD Via a syn-
`chronization operation using standard protocols, such as
`those for Palm PDA devices.
`
`The user may also input supplemental information Via a PC
`connected independently to the server Via the internet. Such
`supplemental information may include data that is difficult or
`inconvenient to input on the WWD. In this way, the patient
`may be afforded a more convenient environment in which to
`manipulate data to supplement the data input to the WWD.
`The deployment ofvoice processing technology may be used
`to enable an even more convenient user interface: i.e., one to
`which patients can talk.
`In all of these respects, the portable aspect of the WWD is
`important: to with, the user may conveniently carry the WWD
`on their person wherever they may go, allowing data entry at
`the time needed.
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`Other aspects, features, and advantages will be apparent
`from the summary above, as well as from the description that
`follows, including the figures and the claims.
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 illustrates a general embodiment of a wireless
`health-monitoring system according to the present invention;
`FIG. 2 illustrates an embodiment of a wireless health-
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`monitoring apparatus according to the present invention,
`showing the system of FIG. 1 up to a point of a wireless
`antenna;
`FIG. 3 illustrates an embodiment of a back end of a health-
`
`monitoring system according to the present invention;
`FIG. 4 illustrates a data flow diagram according to an
`embodiment of the present invention;
`FIG. 5 illustrates an embodiment of a method of use for a
`
`wireless application and a server application according to the
`present invention, in which the same is implemented for
`disease and patient management;
`FIG. 6 illustrates an embodiment of a method of use for a
`
`wireless application and a server application according to the
`present invention, in which the same is implemented for
`health management;
`FIG. 7 illustrates an embodiment of a wired connection
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`between a HMD and a WWD, also showing an optional
`adaptor; and
`FIG. 8 illustrates an embodiment of a wireless connection
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`between a HMD and a WWD, also showing an optional
`adaptor.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Various acronyms are used for clarity herein. Definitions
`are given below.
`The term “HMD” may encompass not only devices with
`physiologic sensors but also devices with a keypad, keyboard,
`mouse, pointer, pressure sensor, or other such inputs that the
`patient or user may employ to perform data entry of the
`desired parameters. In general, HMDs include some means
`for determining a health parameter.
`In a disease management embodiment, an HMD may be a
`blood glucose monitor, a blood pressure monitor, an ambula-
`tory ECG recorder, a respiratory monitor, a temperature or
`heart rate monitor, and so on.
`In a healthy lifestyle management embodiment, an HMD
`may be an exercise machine, including treadmills, rowers,
`steppers, exercise cycles, or other aerobic or anaerobic exer-
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`cisers, or a monitor, include monitors for temperature, heart
`rate, blood pressure, amount of work or rate of work per-
`formed, etc.
`The term “subject” as used herein primarily indicates a
`human subject. The same may be a medical patient under
`physician care, a person interested in maintaining health Via
`accurate recording of nutrition and exercise, and so on. The
`term “user” is generally used to refer to the user of the device,
`which may be synonymous with the subject or may altema-
`tively be a caregiver of the subject, etc. The term “patient” is
`used, in addition to a person under the care of a physician, to
`also refer to a “normal” or healthy individual who is inter-
`ested in maintaining a healthy physiologic balance.
`The term “signal communication” is used to mean any type
`of connection between components where the connection is,
`e.g., electromagnetic, and where the connection allows infor-
`mation to be passed from one component to another. This
`term may be used in a similar fashion as “coupled”, “con-
`nected”, “information communication”, “data communica-
`tion”, etc. The following are examples of signal communica-
`tion schemes.As for wired techniques, a standard bus or serial
`cable may be used ifthe input/output ports are compatible and
`an optional adaptor may be employed if they are not. As for
`wireless techniques, IR, microwaves, RF, e.g., Bluetooth® or
`IEEE 802.11 protocols, optical techniques including lasers,
`and other such techniques may be used. The patient or subject
`may even input data manually, such as by a stylus or keypad
`or by various other techniques discussed above and below.
`The term “generic input/output port” is used to mean any
`type of convention, standard, universal, stock, consumer, or
`“off-the-shelf” type of port for data input and output. These
`may include both wired and wireless ports. A further descrip-
`tion is given below.
`Various embodiments ofthe invention are now described in
`more detail.
`
`Referring to FIG. 1, a system of the present invention is
`shown for monitoring health data f