DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
At step 1, the claim recites a device which is a statutory category of invention.
At step 2A, prong one, claim 1 recites analyz(ing) one or more medications taken by the user and determin(ing) whether the user is in compliance with a prescribed medical treatment and whether a medication of one or more medications taken by a user may interact with one or more of: a second medication of the one or more medications taken by the user; a newly prescribed medication; an over-the-counter medication; an herbal supplement; a vitamin; or a food or a beverage, and when determin(ing) that the medication of the one or more medications causes an adverse interaction, contacting an emergency center to provide a location of the user.
The limitations of “analyz(ing) one or more medications taken by the user and determin(ing) whether the user is in compliance with a prescribed medical treatment, and whether a medication of one or more medications taken by a user may interact with one or more of: a second medication of the one or more medications taken by the user; a newly prescribed medication; an over-the-counter medication; an herbal supplement; a vitamin; or a food or a beverage” and “when determin(ing) that the medication of the one or more medications causes an adverse interaction”, as drafted are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind but for the recitation of generic computer components. That is, nothing in the claim element precludes the step from practically being performed in the mind. For example, “analyzing” and “determining” in the context of this claim encompass an observation and/or evaluation.
The limitation of contacting an emergency center to provide a location of the user, as drafted, is a method that, under its broadest reasonable interpretation, covers human activity. For example, “contacting” in the context of this claim encompass managing personal behavior or interactions between people.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, and managing people behavior, then it falls within the “Mental Processes” and “Certain Methods of Organizing Human Activity” groupings of abstract idea, Accordingly, the claim recites an abstract idea.
At step 2A, prong two, this judicial exception is not integrated into a practical application. In particular, the claim recites additional elements of electronic circuitry, a first power source, a display, a thickness of 1/4" or less, a band manipulatable into a circle, and being configured to communicate with and receive data from one or more medical devices.
The electronic circuity, a first power source, a display, and a thickness of 1/4" or less and manipulatable into a circuit are recited at high level of generality and recited so generically that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer.
The limitation of communicating with and receive data from one or more medical devices represents mere data gathering and/or outputting. The communicating is recited at a high level of generality. The limitation of communicating is therefore insignificant extra-solution activity.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of electronic circuity, a first power source, a display, and a thickness of 1/4" or less amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept.
The communicating step, as discussed above, represents mere data gathering and/or outputting and is insignificant extra-solution activity. These elements are well-understood, routine and conventional.
Dependent claims 2-6 and 9-20, claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, they are ineligible.
Dependent claims 7 and 8, they are directed to an “Mental Process” grouping of abstract idea. Therefore, they are ineligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luna et al. (hereinafter Luna) (US 20160270717 A1) in view of Lettow (US 20160327979 A1) , and further in view of Vincent (US 20150288797 A1)1.
As to claim 1, Luna teaches a device [band] for being attached to a user or the user's clothing [0044: “bands 104-112 may be implemented as wearable personal data or data capture devices (e.g., data-capable devices) that are worn by a user around a wrist, ankle, arm, ear, or other appendage, or attached to the body or affixed to clothing.”], the device having a length, a width, and a thickness [band has three dimensions], the device comprising:
(a) electronic circuity, a first power source, and a display [0050: “band 200 includes bus 202, processor 204…battery 214…”] [0061: “interface module 410 may be used to manage different types of displays…”]; and
(c) a band manipulatable into a circle [FIG. 1: bands 104-112] [0043], wherein the device being configured to communicate with and receive data from one or more medical devices [0135: “FIG. 20 depicts an example of various medical devices that can communicate with a wearable device incorporating a monitoring and feedback module.”] and to analyze one or more medications taken by the user and determine whether the user is in compliance with a prescribed medical treatment [0129: “According to some implementations, a physiological reference profile is a profile for a user that defines various parameters and information related to the user's physiological well-being. For example, if a user is diagnosed as a diabetic, his or her physiological reference profile can be a data file that includes, but is not limited to, data representing a time interval between required insulin shots, a specific time for each insulin shot, how long a shot of insulin is expected to remain effective, the precise dosage of insulin required, and the like. In some cases, data of a physiological reference profile can represent a prescriptive medicine regiment designed to treat or cure one or more ailments or medical conditions.”], and whether a medication of one or more medications taken by a user may interact with one or more of: a second medication of the one or more medications taken by the user; a newly prescribed medication; an over-the-counter medication; an herbal supplement; a vitamin; or a food or a beverage [0133: “In some embodiments, remedy determinator 1950 can also be configured to determine a second amount of the remedy based on a first amount of the remedy and the physiological profile, as described below in FIG. 21A.”] [0137-0138].
Luna does not teach the device comprising a thickness of 1/4" or less, and when the device determines that the medication of the one or more medications causes an adverse interaction, contacting an emergency center to provide a location of the user.
Lettow teaches a wearable device having a thickness of 1/4" or less [0044: “In some cases, the device cam have a maximum thickness…or of about 6mm, or of about 4mm, or of about 2mm, or of about 1mm…”].
Thus, it would have been obvious to one ordinary skill in the art before the effective filing date of the invention to incorporate the teaching of designing the thickness of ¼’’ or less as suggested in Lettow into Luna to implement fabrication of the wearable device. One having ordinary skill in the art would have been motivated to make such modification to improve user experience by reducing the size and weight of the device.
Vincent teaches contacting emergency center to provide user location when determining an adverse interaction caused by a medication [0011: “This computer system allows a user to receives automated emergency help even id the user is unconscious…For example, if a user experiences a heart attack, stroke, seizures, drug overdose…the app alerts 911 and communicates their exact conditions and circumstances to medical personnel. That means EMTs and law enforcement can know what has happened before they arrive on the scene. Since the system has location information (preprogrammed and/or GPS) and has the option for preprogramming a host of medical and other information, it ensures that emergency responders will show up at the right address and have access to critical information.”][drug overdose (i.e., opioid] would cause adverse reaction.].
Thus, it would have been obvious to one ordinary skill in the art before the effective filing date of the invention to incorporate the teaching of contacting emergency center to provide user location when determining an adverse interaction caused by a medication as suggested in Vincent into Luna to implement health monitoring of the wearable device. One having ordinary skill in the art would have been motivated to make such modification to improve personal safety by expanding monitoring functionality.
As to claim 2, Lettow further teaches the device having a width of 2" or less, or 1 ½” or less, or 1" or less or ¾” [0015: the devices may be rings which its width is less than 2’’.].
As to claim 3, Luna teaches wherein the first power source is a battery [0050: “band 200 includes bus 202, processor 204…battery 214…”].
As to claim 4, Luna teaches wherein the electronic circuitry has a length that is 50% or less of the length of the device, or 80% or less of the length of the device [0050: “Processor 204 may be implemented using any type pf processor or microprocessor suitable for packaging within bands 104-112.”] [The processor circuitry is much smaller than the length of the device.].
As to claim 5, Luna teaches wherein the electronic circuitry has a thickness of 25% or less of the thickness of the device, or 25% - 50% of the thickness of the thickness of the device, or 75% or less of the thickness of the device [0050: “Processor 204 may be implemented using any type pf processor or microprocessor suitable for packaging within bands 104-112.”] [The processor circuitry has smaller thickness than the thickness of the device.].
As to claim 6, Luna teaches wherein: a. the electronic circuitry has a width of 90% or less of the width of the device, or between 50% and 80% of the width of the device, or between 80% and 100% the width of the device [0050: “Processor 204 may be implemented using any type pf processor or microprocessor suitable for packaging within bands 104-112.”]; and b. the display has a length that is 50% or less of the length of the device, or 80% or less of the length of the device [0052: “In some examples, the visual signal may be implemented using any available display technology, such as lights, light-emitting diodes (LEDs), interferometric modular display (IMOD), electrophoretic ink (E ink), organic light-emitting diode (OLED)…”].
As to claim 7, Luna teaches the device of claim 1 that is configured to monitor one or more physical conditions of the user [0065: “band 519 may be configured to capture types (i.e., categories) of data such heart rate/pulse monitoring data 520, blood oxygen saturation data 522, skin temperature data 524, salinity/emission/outgassing data 526…”].
As to claim 8, Luna teaches the device of claim 7 that is configured to analyze a plurality of the one or more physical conditions of the user to determine a health attribute of the user [0045: “ Using data gathered by bands 104-112, applications may be used to perform various analyses and evaluations that can generate information as to a person's physical (e.g., healthy, sick, weakened, or other states, or activity level), emotional, or mental state (e.g., an elevated body temperature or heart rate may indicate stress, a lowered heart rate and skin temperature, or reduced movement (e.g., excessive sleeping), may indicate physiological depression caused by exertion or other factors, chemical data gathered from evaluating outgassing from the skin's surface may be analyzed to determine whether a person's diet is balanced or if various nutrients are lacking, salinity detectors may be evaluated to determine if high, lower, or proper blood sugar levels are present for diabetes management, and others).”].
As to claim 9, Luna teaches the device of claim 1 that includes one or more ports, wherein each of the one or more ports can be connected to a sensor and the device is configured to receive information from the sensor [0044: “One or more facilities, sensing elements, or sensors, both active and passive, may be implemented as part of bands 104-112 in order to capture various types of data from different sources.”] [Connection interface to the sensor is a port.].
As to claim 10, Luna teaches the device of claim 9, wherein the one or more ports comprises a plurality of ports and the sensor comprises a plurality of sensors, wherein each of the plurality of sensors is connected to a port of the plurality of ports [0044: “One or more facilities, sensing elements, or sensors, both active and passive, may be implemented as part of bands 104-112 in order to capture various types of data from different sources.”] [Connection interface to the sensor is a port.].
As to claim 11, Luna teaches the device of claim 10 that has a plurality of operating modes and the operating mode of the plurality of operating modes changes depending upon one or more of the sensors of the plurality of sensors connected to the device [0049] [1036-0137].
As to claim 12, Luna teaches wherein data is received by the device from the one or more medical devices through a connection comprising at least one of an optical fiber connection, a tip and sleeve (TS) connection, a tip, ring, and sleeve (TRS) connection, a tip, ring, ring, and sleeve (TRRS) connection, a serial peripheral interface bus (SPI) connection, a universal serial bus (USB) connection, an RS-232 serial connection, an Ethernet connection, a FireWire connection, or combinations thereof [0071: “Bands 104 and 108 may communicate with mobile communications device 118 or laptop 122 using any number of known wired communication technologies (e.g., Universal Service Bus (USB) connections, TRS/TRRS connections, telephone networks, fiber-optic networks, cable networks, etc.).”].
As to claim 13, Luna teaches wherein data is received by the device from the one or more medical devices wirelessly using at least one of a satellite communication network, a local area network (LAN), a wide area network (WAN), a wireless mobile telephone network, a General Packet Radio Service (GPRS) network, a wireless local area network (WLAN), a Global System for Mobile Communications (GSM) network, a Personal Communication Service (PCS) network, or an Advanced Mobile Phone System (AMPS) network [0046: “Regardless of the type or location of sensor used, data may be transferred to bands 104-112 by using, for example, an analog audio jack, digital adapter (e.g., USB, mini-USB), or other, without limitation, plug, or other type of connector that may be used to physically couple bands 104-112 to another device or system for transferring data and, in some examples, to provide power to recharge a battery (not shown). Alternatively, a wireless data communication interface or facility (e.g., a wireless radio that is configured to communicate data from bands 104-112 using one or more data communication protocols (e.g., IEEE 802.11a/big/n (WiFi), WiMax, ANT™, ZigBee®, Bluetooth®, Near Field Communications (“NFC”), and others)) may be used to receive or transfer data.”].
As to claim 14, Luna teaches the device of claim 1 that is configured to communicate simultaneously with a plurality of medical devices [FIG. 20] [0135].
As to claim 15, Luna teaches the device of claim 1 that is configured to receive data from an apparatus implanted in the user [0134: pacemakers].
As to claim 16, Lettow further teaches wherein the electronic circuitry and display are flexible so as to be functional when manipulated into a circle having a diameter of 4" or more, 5" or more, 6" or more, 7" or more, 8" or more, 9" or more, or 10" or more [0051: “In some cases, when the entire device, a portion of the device, a display and/or input device component, etc. is bent, folded, curled, etc. the radius of curvature can be no more than about 30 cm, or about 20 cm, or about 10 cm, or about 5 cm, or about 2 cm, or about 1 cm, or about 5 mm, or about 2 mm, or about 1 mm, or about 750 micrometers, or about 500 micrometers, or about 250 micrometers, of about 100 micrometers, or about 50 micrometers, or about 10 micrometers.”].
As to claim 17, Luna teaches the device of claim 1 that is configured to transmit at least some of the data received from the one or more medical devices [0054: “Data captured by band 200 using accelerometer 210 and sensor 212 or data requested from another source (i.e., outside of band 200) may also be exchanged, transferred, or otherwise communicated using communications facility 216.”].
As to claim 18, Luna teaches wherein the data received and transmitted includes: a. at least one of a battery charge level, a an ambient temperature, a barometric pressure, a code relating to an accessory for the one or more the medical devices, a data validity measurement, an elapsed time since a previous reading by the one or more medical devices, a test result parameter, a signal-to-noise parameter, a quality of service (QoS) parameter; b. at least one of the user's: heart rate, blood oxygen level, perspiration, electrical resistance on a skin, movement, blood pressure, fall or sudden impact, calories used, calories consumed, or body temperature; and c. at least one of ambient air temperature, time, day, or location [0065: “band 519 may be configured to capture types (i.e., categories) of data such as heart rate/pulse monitoring data 520, blood oxygen saturation data 522, skin temperature data 524, salinity/emission/outgassing data 526, location/GPS data 528, environmental data 530, and accelerometer data 532.”].
As to claim 19, Luna teaches wherein its functionality changes depending upon the one or more medical devices with which the device communicates [0049: “When bands 104-112 are worn, a user may be identified and authenticated to enable a variety of other functions such as accessing or modifying data, enabling wired or wireless data transmission facilities (i.e., allowing the transfer of data from bands 104-112), modifying functionality or functions of bands 104-112, authenticating financial transactions using stored data and information (e.g., credit card. PIN, card security numbers, and the like), running applications that allow for various operations to be performed (e.g., controlling physical security and access by transmitting a security code to a reader that, when authenticated, unlocks a door by turning off current to an electromagnetic lock, and others), and others. Different functions and operations beyond those described may be performed using bands 104-112, which can act as secure, personal, wearable, data-capable devices.”] [0136: “In other embodiments, a feedback loop can be created between wearable band 2025 and any of the medical devices 2020, 2030, 2040, and 2050, among others, to monitor and to change usage and functionality of either the band or the medical devices 2020-2050, and the like. According to some embodiments, the change in usage and functionality can be initiated from either wearable band 2025 or any of the medical devices 2020, 2030, 2040, and 2050, among others.”].
As to claim 20, Luna teaches the device of claim 18 that is configured to: a. transmit or receive the user's health information; b. analyze the user's health information to identify a condition for the user [0045]; and c. alert the user or a health care professional when the condition for the user satisfies a predetermined threshold condition [0080] [FIG. 10].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XUXING CHEN whose telephone number is (571)270-3486. The examiner can normally be reached M-F 9-5:30PM.
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/XUXING CHEN/Primary Examiner, Art Unit 2176
1 Luna and Lettow were cited as prior art in the last office action mailed on 06/03/2025.