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 .
Response to Arguments
With regards to the objections to claims 1-3 the objections are withdrawn in view of the amendments.
With regards to the 101 rejection in view of the amendments amending in a camera which is activated based on the output of the previous sensor data analysis, Examiner believes this creates a practical application in line with the 101 examples provided by the office. Therefore, the 101 rejection is withdrawn in view of the amendment.
With regards to the 101 rejection under section 33 it is withdrawn in view of the amendment.
Applicant's arguments filed 7/11/25 have been fully considered but they are not persuasive. With regards to the 103 arguments, Applicants’ argument directed to the “determine, in a case . . . ” elements and to the newly amended “distinguish” elements but Examiner does not find the argument persuasive as the elements are disclosed and rendered obvious by the prior art.
The arguments are focused on claims 1 and 3, those claims encompass claiming two physiological parameters each being compared to a respective threshold; with the two physiological parameters being pulse rate (also referred to as heart rate or PR and/or HR) and blood oxygenation (Sp02). Effectively each of the parameters has an above (↑) or below the threshold (↓) state thus there are four states of (PR/HR, Sp02) compared to the readings which are: 1: (↑, ↑), 2: (↑, ↓), 3:(↓,↑) and 4:(↓,↓). For purposes of the claims only states 1, 3 and 4 are relevant. Applicants only recite determining states 3 and 4, with state 3 being the device is worn but pulse is not detected/stopped and state 4 being when the device is not worn. State 1 would be when the both the readings are above the threshold and for purposes of this Application being detected (not zero) for the PR/HR and Sp02 and the device is being worn.
The Hong reference discloses either parameter, both are optical sensing based, being used to determine when the device is not worn because the reading will not be detected or 0 respectively. While the combination with the Gu reference is recited to specifically provide state 4 determination that a secondary parameter/sensing is used to determine if the device is not worn as opposed to just one parameter as discussed in Hong. The combination with the Gaw reference is recited to show state 3 as it discloses when sensing one or more parameters it is known to use thresholds for each parameter at one or more levels to trigger alerts and further discloses triggering alerts based on one or more parameters being outside of a threshold(s). See citations below for the respective elements discussed from Hong, Gu and Gaw. The combination of references discloses the determination of the states and recite the determining of both being not worn using the combination physiological parameters as well as determining when an alarm state (such as not having a PR/HR) has occurred based on a combination of the physiological parameter(s), i.e. PR/HR has stopped (or is 0) while still getting a Sp02 reading. As such Examiner disagrees, and finds applicants argument not persuasive.
Examiner also notes to the extent the argument is directed to an intended use, such as a user’s death, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner also notes that in view of Applicants discussion of “pulse rate” stopping at death while blood oxygen can still be detected/sensed seems to be an inherent element of the body at death.
Applicants state that the Nam reference is after the priority date, however this is not persuasive as discussed in the priority section the priority date for the claims is filing date of the later PCT thus Nam is prior art.
The discussion of the dependent claim relies on the argument discussed above and is not persuasive for the same reasons.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/JP2020/032359, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Elements of claims 1-3, for example “non-wearing” and “infrared radiation”, do not seem to be present in the parent application, Application No. PCT/JP2020/032359. As such the priority for claims 1-3 is 08/25/2021 per PCT/JP2021/031225.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 has a typographical error it recites “obtained by the sensor” it should recite “obtained by the sensors”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “that receives the vital data to which an identification code of the wearable terminal is attached from the sensors” which causes confusion. The first part of this element makes sense the processor receives data and part of the data is identification code of the wearable. It’s unclear what this last part means or how it limits the claims. As such it does not clearly define the metes and bounds of the claim and the claims is indefinite. Claim 2 shares this issue by virtue of its dependency and is rejected for the same reason. Examiner notes the underlined portion is not included in the method of use from independent claim 3, so claim 3 doesn’t share this issue.
Claims 1 and 3 recite versions of “wherein at least one of the watcher terminal or the management server includes first vital data processor" and later recite “wherein the first vital data processor is configured to determine, in a case where . . . generates an alert signal, and transmits the alert signal to the watcher terminal causing the watcher terminal to output an alert". The issue is the first part creates a contingency the processor is either in the “watcher terminal” or the “management server” in claim 1; claim 3 recites “watcher terminal” and/or the “management server” has the processor. Regardless, of the “or” or the “and/or”, in one version the processor is only on the watcher terminal and in that interpretation, it is unclear how the second part works because it is generating an alert signal which is being transmitted to the “watcher terminal”, phrased differently it is being transmitted to itself which doesn’t make sense. This causes confusion and lacks clarity. As such the claim does not clearly define the metes and bounds of the claim and the claims are indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140275852 to Hong et al. (hereinafter Hong) in view of US 20040015058 to Besson et al. (hereinafter Bes) in further view of US 20200004943 to Gu et al. (hereinafter Gu) in further view of US 20110202495 to Gawlick (hereinafter Gaw) in further view of US 20220354387 to Ogasawara et al. (hereinafter Oga).
Regarding Claim 1, an interpretation of Hong discloses monitoring assistance system (abstract, Fig. 1) comprising:
a wearable terminal that is configured to be worn by a person to be monitored ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, Fig. 1 see also [0109]-[0111], [0448]);
sensors provided in the wearable terminal for continuously obtaining vital data of the person to be monitored ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, [0138]-[0139], Fig. 1 see also [0109]-[0111], [0448]);
a watcher terminal associated with the wearable terminal ([0108] including “client”, Client Fig. 1 see also [0270], [0278]-[0279], [0287]-[0289], [0448]; recites numerous devices associated/connected to the wearable which are encompassed by “watcher terminal” such as laptops, smartphones etc.);
a management server communicably connected to at least one of the watcher terminal or the wearable terminal ([0108] including “server.”, Server Fig. 1 see also [0270], [0278]-[0279], [0287]-[0289], [0448]),
wherein at least one of the watcher terminal or the management server includes first vital data processor that receives the vital data ([0108], [0222] including “Signal processing may be performed on the biometric tracking devices in a distributed or centralized method . . . This signal processing may also be performed remotely and communicated back to the biometric tracking devices after processing.”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278] including “the biometric monitoring device may transmit and receive data and/or commands to and/or from a secondary electronic device.”, [0279]-[0280], [0287]-[0289] see also [0448]) and the first vital data processor performs data processing on the vital data ([0108], [0222] including “Signal processing may be performed on the biometric tracking devices in a distributed or centralized method . . . This signal processing may also be performed remotely and communicated back to the biometric tracking devices after processing.”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278] including “the biometric monitoring device may transmit and receive data and/or commands to and/or from a secondary electronic device.”, [0279]-[0280], [0287]-[0289] see also [0448]; Reference discloses the processing can be performed on one or more computing devices individually or in a distributed fashion),
wherein the vital data obtained by the sensors includes pulse rate data and blood oxygen level data ([0138]-[0139] including “optical PPG (e.g., heart rate) detection sensors and/or emitters”, [0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0180], Figs. 6A-7 see also [0448]), and
wherein the first vital data processor is configured to distinguish, when the pulse rate data is not detected, a non-wearing state in which the wearable terminal is removed from the person to be monitored ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165], [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Examiner notes that per the spec and further other claim elements recitation below discussing the thresholds, the “distinguishing” between the two recited states here both of which are when pulse rate is “not detected” is not based on the pulse rate data (because that’s the same for both) but is based on the blood oxygenation (aka SpO2) data. Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”),
wherein the first vital data processor is configured to use the blood oxygen level data for determining whether the wearable terminal is being worn or not ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is unworn the signal pattern for both would be “the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern” this would apply to both types of optical readings. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”; likewise, for the Sp02),
wherein the first vital data processor is configured to determine, in a case where the pulse rate data or the blood oxygen level data is not being detected, that a non-wearing state, where the wearable terminal is removed from the person to be monitored, has been established ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is unworn the signal pattern for both would be “the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern” this would apply to both types of optical readings. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”; likewise, for the Sp02), sensing pulse rate and blood oxygen when the device is worn ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, [0138]-[0139], [0141], [0165, [0180], Figs. 6A-7 see also [0107]-[0109], [0448]), generates an alert signal when the PR/HR has reached a certain level ([0247], [0263] including “That the user's heart rate has reached a certain level”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.” See also [0488]), transmits the alert signal to the watcher terminal causing the watcher terminal to output an alert ([0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278]-[0281] including “In some embodiments, the secondary device that acts as a user interface to the biometric monitoring device may consist of a smartphone. An app on the smart phone may facilitate and/or enable the smartphone to act as a user interface to the biometric monitoring device.”, [0287] including “The user may also be able to access the full capabilities of the smartphone app described herein (e.g., the ability to enter food logs, view dashboard, etc.) through an alternative or additional interface. In one embodiment, this alternative interface may consist of a webpage that is hosted by a server in indirect communication with the biometric monitoring device.” See also [0134], [0448]).
An interpretation of Hong may not explicitly disclose an identification code of the wearable terminal is attached.
However, in the same field of endeavor (diagnostic sensor systems), Bes teaches identification codes associated with of the wearable terminal is sent with the associated physiological data ([0038] including “certain identification coees—patient code”, [0111]-[0112] including ” specific identification codes, which, for example, are stored in the evaluator unit (7)”, [0115], Fig. 1 see also [0077], [0143]-[0144], Figs. 1-2f; Recites identification codes associated with users wearable sensing device are sent along with the data to identify wearable the data came from).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis as recited by Hong to include identification codes of wearable devices as disclosed by Bes because it allows the processing elements to associate the data the particular patients and particular wearables ([0111]) allowing the system to provide analysis simultaneously for several patients ([0038]).
While Hong recites gathering pulse and blood oxygen sensors using optical sensing as well as determining a device is not worn by analyzing optical sensing data such as blood oxygenation data or PR/HR data. An interpretation of Hong may not explicitly disclose that the determining the device is not worn based on multiple sensor readings not being detected; and, in a case where the pulse rate data is not being detected and the additional optical sensor data is being detected determining the device is worn.
However, in the same field of endeavor (medical diagnostic systems), Gu teaches determining the device is not worn based on multiple sensor readings not being detected ([0037]-[0038] including “The skin sensor 110 is further configured to determine that the wearing state of the wearable device 100 is not adjacent to the skin surface when . . . a predetermined number of the detecting results of the sub-sensors indicates that the wearing state of the wearable device 100 is not adjacent to the skin surface.”, [0054] including “when at least two of the detecting results of the sub-sensors cannot indicate whether or not the wearable device 100 leaves the skin surface.” See also [0013]; Gu recites determining the device is not worn/in contact with the body when pluralities of sensing elements say is not connected); and, in a case where the pulse rate data is not being detected and the optical sensor data is being detected determining the device is worn ([0037]-[0038] including “The skin sensor 110 is further configured to determine that the wearing state of the wearable device 100 is not adjacent to the skin surface when . . . a predetermined number of the detecting results of the sub-sensors indicates that the wearing state of the wearable device 100 is not adjacent to the skin surface.”, [0054] including “when at least two of the detecting results of the sub-sensors cannot indicate whether or not the wearable device 100 leaves the skin surface.” see also [0013], [0030]; Gu recites determining the device is worn/in contact with the body if only one sensor (or a predetermined number) indicates it is not worn while other sensors data show it is worn. As such the reference teaches if only the PR/HR is not sensing a heart rate but the other sensors are gathering readings then it is worn and gathering diagnostic data and gathering diagnostic data).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis as recited by Hong in view of Bes to include determining a wearing state using multiple sensors as taught by Gu because determining when a device is not being worn based on more than one sensors provides reliability ([0038]), also determining when the device has been taken off provides protection against unauthorized access to the device ([0004]).
While Hong in view of Gu teaches sensing both PR/HR and blood oxygenation level, determining a device is being worn and to output an alert when the worn device’s users PR/HR has reached a “certain level”. Hong may not explicitly disclose wherein the processor is configured to distinguish, when the pulse rate data is not detected, a state in which the pulse of the person being monitored has stopped; or, that a pulse of the person to be monitored has stopped.
However, in the same field of endeavor (medical diagnostic systems), Gaw teaches the use of thresholds to distinguish/determine when a PR/HR reaches a certain level such as stopped/not detected/no pulse ([0021], [0055]-[0057], Figs. 10-11 see also [0061], [0063]; Gaw further discloses when monitoring one or more physiological parameters of a patient using threshold to determine when a reading is a certain level such as PR/HR being critical) and generating an alarm in response to one or more threshold(s) being crossed by one or more different physiological parameters ([0061]-[0063], Figs. 10-11 see also [0055]-[0057]; the disclosure of Gaw renders encompasses PR/HR being critical (at 0) and the Sp02 being read/normal).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis including determining a certain level of a PR/HR reading as recited by Hong in view of Bes in further view of Gu to include applying a critical threshold for the determination that the user PR/HR has reached a critical level as recited by Gaw because it is merely combining prior art elements (determination of certain level as recited by Hong in view of Bes in further view of Gu with the particular concept of a “critical” threshold from Gaw) according to known methods to yield predictable results.
An interpretation of Hong may not explicitly disclose a camera apparatus equipped with a camera and associated with the wearable terminal; and watcher terminal transmits the alert signal also to the camera apparatus, the camera apparatus switches the camera to a monitoring state on the basis of the reception of the alert signal.
However, in the same field of endeavor (medical devices), Oga teaches a camera apparatus equipped with a camera and associated with the wearable terminal (abstract, [0089], [0092], [0113], Fig. 1); and transmits the alert signal also to the camera apparatus, the camera apparatus switches the camera to a monitoring state on the basis of the reception of the alert signal (abstract, [0103]-[0104], [0114] see also [0098]-[0099]; wearable transmits data to smartphone which determines alert status and sends “alert signals” to the camera activating the camera in response to the alert).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis including determining a certain level of a PR/HR reading as recited by Hong in view of Bes in further view of Gu in further view of Gaw to include activating a camera in response to an alert medical alert as recited by Oga in order to better ascertain the status of the patient by visually observing the patient, but only doing so when additional monitoring is warranted thus avoiding the heavy burden on the patient of being constantly observed ([0008]).
Regarding Claim 3, an interpretation of Hong discloses a monitoring assistance method using a monitoring assistance system (abstract, Fig. 1), wherein the monitoring assistance system (abstract, Fig. 1) includes:
a wearable terminal that is configured to be worn by a person to be monitored ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, Fig. 1 see also [0109]-[0111], [0448]),
sensors provided in the wearable terminal for continuously obtaining vital data of the person to be monitored ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, Fig. 1 see also [0109]-[0111], [0448]);
a watcher terminal associated with the wearable terminal ([0108] including “client”, Client Fig. 1 see also [0270], [0278]-[0279], [0287]-[0289], [0448]; recites numerous devices associated/connected to the wearable which are encompassed by “watcher terminal” when reading the claims in view of the specification [0058] (using the PG Pub for paragraph numbers) such as laptops, smartphones etc.), and
a management server communicably connected to at least one of the watcher terminal or the wearable terminal ([0108] including “server.”, Server Fig. 1 see also [0270], [0278]-[0279], [0287]-[0289], [0448]),
a first vital data processor is included in at least one of the watcher terminal or the management server ([0108], [0222] including “Signal processing may be performed on the biometric tracking devices in a distributed or centralized method . . . This signal processing may also be performed remotely and communicated back to the biometric tracking devices after processing.”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278] including “the biometric monitoring device may transmit and receive data and/or commands to and/or from a secondary electronic device.”, [0279]-[0280], [0287]-[0289] see also [0448]) and configured to process the vital data ([0108], [0222] including “Signal processing may be performed on the biometric tracking devices in a distributed or centralized method . . . This signal processing may also be performed remotely and communicated back to the biometric tracking devices after processing.”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278] including “the biometric monitoring device may transmit and receive data and/or commands to and/or from a secondary electronic device.”, [0279]-[0280], [0287]-[0289] see also [0448]; Reference discloses the processing can be performed on one or more computing devices individually or in a distributed fashion),
wherein the monitoring assistance method comprising:
including pulse rate data and blood oxygen level data in the vital data to be obtained by the sensors ([0138]-[0139] including “optical PPG (e.g., heart rate) detection sensors and/or emitters”, [0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0180], Figs. 6A-7 see also [0448]);
distinguishing by the first vital data processor when the pulse rate data is not detected, a non-wearing state in which the wearable terminal is removed from the person to be monitored ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165], [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Examiner notes that per the spec and further other claim elements recitation below discussing the thresholds, the “distinguishing” between the two recited states here both of which are when pulse rate is “not detected” is not based on the pulse rate data (because that’s the same for both) but is based on the blood oxygenation (aka SpO2) data. Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”),
using by the first vital data processor the blood oxygen level data for determining whether the wearable terminal is being worn or not ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is unworn the signal pattern for both would be “the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern” this would apply to both types of optical readings. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”; likewise, for the Sp02),
determining by the first vital data processor, in a case where the pulse rate data or the blood oxygen level data is not being detected, that a non-wearing state, where the wearable terminal is removed from the person to be monitored, has been established ([0141] including “These optical sensors may sample, acquire and/or detect physiological data which may then be processed or analyzed (for example, by resident processing circuitry) to obtain data that is representative of, for example, a user's heart rate, respiration, heart rate variability, oxygen saturation (SpO2), blood volume, blood glucose, skin moisture, and/or skin pigmentation level.”, [0165] including “These may be included in addition to or in lieu of a heart rate sensor and include sensors such as a skin temperature sensor . . . pulse oximeter, blood pressure sensor, EMG, or galvanic skin response (GSR) sensor.”, [0415] including “Typically when the device is worn by the user, the emitted light will interact with the skin and/or other tissue of the user, and then be detected by the photodetector of the heart rate monitor. If the device is not worn by the user, the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern. The difference in detected light provides data that the heart rate monitor may analyze to determine whether the device is being worn by the user on not.” See also [0448]; Hong discloses the optical sensing for both pulse rate(PR)/HR and Sp02. If the device is unworn the signal pattern for both would be “the emitted light will not be detected by the photodetector, or will be detected with a different intensity or pattern” this would apply to both types of optical readings. If the device is not worn the PR/HR sensed will be 0 BPM since there are no PR/HR being measured which is encompassed in the claimed “not detected”; likewise, for the Sp02); and
sensing pulse rate and blood oxygen when the device is worn ([0101] including “may be generally described as wearable devices, typically of a small size, that are designed to be worn relatively continuously by a person. When worn, such biometric monitoring devices gather data regarding activities performed by the wearer or the wearer's physiological state.”, [0138]-[0139], [0141], [0165, [0180], Figs. 6A-7 see also [0107]-[0109], [0448]),
generating an alert signal when the PR/HR has reached a certain level ([0247], [0263] including “That the user's heart rate has reached a certain level”, [0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.” See also [0488]), transmitting the alert signal to the watcher terminal causing the watcher terminal to output an alert ([0270] including “The biometric monitoring device itself may determine whether the criteria or conditions for an alert have been met. Alternatively, a computing device in communication with the biometric monitoring device (e.g., a server and/or a mobile phone) may determine when the alert should occur.”, [0278]-[0281] including “In some embodiments, the secondary device that acts as a user interface to the biometric monitoring device may consist of a smartphone. An app on the smart phone may facilitate and/or enable the smartphone to act as a user interface to the biometric monitoring device.”, [0287] including “The user may also be able to access the full capabilities of the smartphone app described herein (e.g., the ability to enter food logs, view dashboard, etc.) through an alternative or additional interface. In one embodiment, this alternative interface may consist of a webpage that is hosted by a server in indirect communication with the biometric monitoring device.” See also [0134], [0448]).
An interpretation of Hong may not explicitly disclose an identification code of the wearable terminal is attached to the vital data.
However, in the same field of endeavor (diagnostic sensor systems), Bes teaches identification codes associated with of the wearable terminal is sent with the associated vital data ([0038] including “certain identification coees—patient code”, [0111]-[0112] including ” specific identification codes, which, for example, are stored in the evaluator unit (7)”, [0115], Fig. 1 see also [0077], [0143]-[0144], Figs. 1-2f; Recites identification codes associated with users wearable sensing device are sent along with the data to identify wearable the data came from).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis as recited by Hong to include identification codes of wearable devices as disclosed by Bes because it allows the processing elements to associate the data the particular patients and particular wearables ([0111]) allowing the system to provide analysis simultaneously for several patients ([0038]).
While Hong recites gathering pulse and blood oxygen sensors using optical sensing as well as determining a device is not worn by analyzing optical sensing data such as blood oxygenation data or PR/HR data. An interpretation of Hong may not explicitly disclose that the determining the device is not worn based on multiple sensor readings not being detected; and, in a case where the pulse rate data is not being detected and the additional optical sensor data is being detected determining the device is worn.
However, in the same field of endeavor (medical diagnostic systems), Gu teaches determining the device is not worn based on multiple sensor readings not being detected ([0037]-[0038] including “The skin sensor 110 is further configured to determine that the wearing state of the wearable device 100 is not adjacent to the skin surface when . . . a predetermined number of the detecting results of the sub-sensors indicates that the wearing state of the wearable device 100 is not adjacent to the skin surface.”, [0054] including “when at least two of the detecting results of the sub-sensors cannot indicate whether or not the wearable device 100 leaves the skin surface.” See also [0013]; Gu recites determining the device is not worn/in contact with the body when pluralities of sensing elements say is not connected); and, in a case where the pulse rate data is not being detected and the optical sensor data is being detected determining the device is worn ([0037]-[0038] including “The skin sensor 110 is further configured to determine that the wearing state of the wearable device 100 is not adjacent to the skin surface when . . . a predetermined number of the detecting results of the sub-sensors indicates that the wearing state of the wearable device 100 is not adjacent to the skin surface.”, [0054] including “when at least two of the detecting results of the sub-sensors cannot indicate whether or not the wearable device 100 leaves the skin surface.” see also [0013], [0030]; Gu recites determining the device is worn/in contact with the body if only one sensor (or a predetermined number) indicates it is not worn while other sensors data show it is worn. As such the reference teaches if only the PR/HR is not sensing a heart rate but the other sensors are gathering readings then it is worn and gathering diagnostic data and gathering diagnostic data).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis as recited by Hong in view of Bes to include determining a wearing state using multiple sensors as taught by Gu because determining when a device is not being worn based on more than one sensors provides reliability ([0038]), also determining when the device has been taken off provides protection against unauthorized access to the device ([0004]).
While Hong in view of Gu teaches sensing both PR/HR and blood oxygenation level, determining a device is being worn and to output an alert when the worn device’s users PR/HR has reached a “certain level”. Hong may not explicitly disclose wherein the processor is configured to distinguish, when the pulse rate data is not detected, a state in which the pulse of the person being monitored has stopped; or, that a pulse of the person to be monitored has stopped.
However, in the same field of endeavor (medical diagnostic systems), Gaw teaches the use of thresholds to distinguish/determine when a PR/HR reaches a certain level such as stopped/not detected/no pulse ([0021], [0055]-[0057], Figs. 10-11 see also [0061], [0063]; Gaw recites using threshold to determine to determine when PR/HR reading is a certain level such as critical) and generating an alarm in response to one or more threshold(s) being crossed by one or more different physiological parameters ([0061]-[0063], Figs. 10-11 see also [0055]-[0057]; which encompasses PR/HR being critical (at 0) and the Sp02 being read/normal).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis including determining a certain level of a PR/HR reading as recited by Hong in view of Bes in further view of Gu to include applying a critical threshold for the determination that the user PR/HR has reached a critical level as recited by Gaw because it is merely combining prior art elements (determination of certain level as recited by Hong in view of Bes in further view of Gu with the particular concept of a “critical” threshold from Gaw) according to known methods to yield predictable results.
An interpretation of Hong may not explicitly disclose a camera apparatus equipped with a camera and associated with the wearable terminal; and transmitting the alert signal also to the camera apparatus, and switching, by the camera apparatus, the camera to a monitoring state on the basis of the reception of the alert signal.
However, in the same field of endeavor (medical devices), Oga teaches a camera apparatus equipped with a camera and associated with the wearable terminal (abstract, [0089], [0092], [0113], Fig. 1); watcher terminal transmitting the alert signal also to the camera apparatus, and switching, by the camera apparatus, the camera to a monitoring state on the basis of the reception of the alert signal (abstract, [0103]-[0104], [0114] see also [0098]-[0099]; wearable transmits data to smartphone which determines alert status and sends “alert signals” to the camera activating the camera in response to the alert).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, worn/unworn analysis, diagnostic analysis of physiological data and generating alerts based on the diagnostic analysis including determining a certain level of a PR/HR reading as recited by Hong in view of Bes in further view of Gu in further view of Gaw to include activating a camera in response to an alert medical alert as recited by Oga in order to better ascertain the status of the patient by visually observing the patient, but only doing so when additional monitoring is warranted thus avoiding the heavy burden on the patient of being constantly observed ([0008]).
Claim Rejections