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 6, 7, 18 and 19 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 method which is a statutory category of invention.
At step 2A, prong one, claims recite monitor(ing) one or more physical conditions of the user, analyz(ing) a plurality of the one or more physical conditions of the user to determine a health attribute of the user, analyz(ing) the user’s health information to identify a condition for the user, and analyz(ing) one or more medications taken by the user and determin(ing) whether the user is in compliance with a prescribed medical treatment,
These limitations, 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, “monitoring”, “analyzing” and “determining” in the context of this claim encompass an observation and/or evaluation.
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, then it falls within the “Mental Processes” grouping 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 a band manipulated into a circle, the band comprising an electric resistance meter, electronic circuity, a first power source, a display, a thickness of 2’’ or less, being configured to communicate with and receive data from one or more medical devices, changing a functionality of the device depending upon the one or more medical devices with which the device communicates, and wherein the electric resistance meter is positioned to measure electrical resistance on a skin of the user.
The band comprising an electric resistance meter configured to measure electrical resistance on a skin of the user, the electronic circuity, a first power source, a display, a thickness of 1/4" or less, and changing a functionality of the device depending upon the one or more medical devices with which the device communicates 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, a thickness of 1/4" or less, and a functionality of the device depending upon the one or more medical devices with which the device communicates 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.
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)1.
As to claim 1, Luna teaches a method for using a device, the method comprising:
attaching the device 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.”];
communicating with and receiving data from, by the device, 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
changing, by the device, a functionality of the device 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.”],
wherein the device has a length, a width, and a thickness [band has three dimensions], and
wherein the device comprises:
a band manipulated into a circle, the band comprising an electric resistance meter [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…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.”] [0067: “band 539 may be used for sleep management purposes to track various types of data, including heart rate monitoring data 540, motion sensor data 542, accelerometer data 544, skin resistivity data 546…”], 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
wherein the circuitry has a thickness of 25% or less of the thickness of the device, or 25% - 50% 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.] and wherein the electric resistance meter is positioned to measure electrical resistance on a skin of the user [0067: “band 539 may be used for sleep management purposes to track various types of data, including heart rate monitoring data 540, motion sensor data 542, accelerometer data 544, skin resistivity data 546…”]
Luna does not teach the device comprising a thickness of 2" or less.
Lettow teaches a wearable device having a thickness of 2" 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 2’’ 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.
As to claim 2, Lettow teaches wherein the device has a width of 1 ½ " or less, or 1" or less or ¾ “ or less [0015: the devices may be rings which its width is less than 1 ½”.].
As to claim 3, Luna teaches wherein the 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 4, Luna teaches wherein the 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.”].
As to claim 5, Luna teaches wherein 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 6, Luna teaches wherein the device monitors 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 7, Luna teaches wherein the one or more physical conditions comprise a plurality of physical conditions and wherein the device analyzes the plurality of 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 8, Luna teaches wherein the device includes one or more ports, wherein each of the one or more ports can be connected to a sensor, and wherein the device receives information from at least one 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 9, Luna teaches wherein the device has a 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 10, Luna teaches wherein the device has a plurality of sensors, and wherein each of the plurality of sensors is connected to a port [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 wherein the device has a plurality of operating modes, and wherein an operating mode of the device changes depending upon one or more of the plurality of sensors attached to the device [0049] [0136-0137].
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 the device transmits 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 14, Luna teaches wherein the data received and transmitted includes: a. at least one of a battery charge level, a temperature, a barometric pressure, a code relating to an accessory for the one or more 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, or a quality of service (QoS) parameter; b. at least one of a user's: heart rate, blood oxygen level, perspiration, electrical resistance on the 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 15, Luna teaches wherein the device communicates simultaneously with a plurality of medical devices [FIG. 20] [0135].
As to claim 16, Luna teaches wherein the device also communicates with an intermediary device, or a central server [0047] [0135: “In other implementations, wearable device 2025 can communicate with a medical device via a network from a server.”].
As to claim 17, Luna teaches wherein the device receives data from an apparatus implanted in a user of the device [0134: pacemakers].
As to claim 18, Luna teaches wherein the device analyzes the user's health information to identify a condition for the user [0045], and wherein the device alerts the user or a health care professional when the user condition satisfies a predetermined threshold condition [0080] [FIG. 10].
As to claim 19, Luna teaches wherein the device analyzes one or more medications taken by the user and determines 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.”].
As to claim 20, Luna teaches wherein the one or more medical devices comprise one or more of: a blood glucose meter; a pacemaker; a blood pressure monitor; an insulin pump; a pulse oximeter; a Holter monitor; an electrocardiograph; an electroencephalograph; a blood alcohol monitor; an alcohol breathalyzer; an alcohol ignition interlock; a respiration monitor; an accelerometer; a skin galvanometer; a thermometer; a patient geolocation device; a scale; an intravenous flow regulator; a patient height measuring device; a biochip assay device; a monitor for biological agents; a hazardous chemical agent monitor; an ionizing radiation sensor; a sphygmomanometer; a loop recorder; a spirometer; an event monitor; a prothrombin time (PT) meter; an international normalized ratio (INR) meter; a tremor sensor; or a defibrillator [0134: “Examples of medical devices include, but are not limited to, glucose monitors, heart rate monitors, blood pressure monitors, CPAP machines, pacemakers, homocysteine level monitors, and intravenous (“IV”) monitors.”].
Response to Arguments
Applicant's arguments filed 09/25/2025 have been fully considered but they are not persuasive.
In the remarks, Applicant argued that the amendment would overcome the 101 and 103 rejections recited above.
The examiner respectfully traverses Applicant’s argument. Based on the analysis, the abstract idea is still exist in claims 6, 7, 18 and 19 as explained above. Also, the abstract idea is not integrated into a practical application. Therefore, the rejection under 101 is respectfully maintained for the reasons recited above. The added limitations are rejected under 103 with the reasons recited above. Therefore, the rejections under 103 are respectfully maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 06/26/2025.