DETAILED ACTION
This office action is in response to the communication received on March 11, 2026 concerning application No. 18/325,545 filed on May 30, 2023.
Claims 1-9 and 11-21 are currently pending.
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
Applicant's arguments filed 03/11/2026 regarding the 35 USC 112a rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112a rejection of claims 1, 13, and 21 previously set forth.
Applicant's arguments filed 03/11/2026 regarding the 35 USC 112b rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claims 1, 13, and 21 previously set forth. The amendments to the claims have led to further 35 USC 112b issues.
Applicant’s arguments with respect to claim(s) 1, 13, and 21 regarding the newly filed claim amendments, specifically, “evaluate one or more metrics measured by the wearable ring device, wherein detection of the change in the PPG data or the change in morphology is a condition for evaluation of the one or more metrics” 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.
Applicant's arguments filed 03/11/2026 regarding the prior art rejection on pgs. 13-14 have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “determine whether the change in the PPG data or the change in morphology is attributable to either a change in contact…or a physiological change of the user based at least in part on whether the change…at least partially overlap in time with the change in the one or more metrics measured by the wearable ring device”, examiner respectfully disagrees. As set forth in the previous office action, [0104]-[0105] of Aumer discloses in steps 1020 and 1120 the processed PPG sensor data is used to determine if the monitoring device is being worn or not. [0107] further discloses the output of a temperature sensor or an accelerometer is used to determine whether the device is being worn or not. [0108] discloses the methods described can be used in combination, therefore the determination of whether the device is being worn or not (change in contact) is determined using a combination of the PPG sensor data (change in PPG data) and the one or more metrics at least partially overlapping in time with one another. Also see [0088] which discloses obtaining the PPG and temperature data over the same measurement period. Therefore by determining whether the device is being worn or not the device is determining whether the change in PPG data is attributable to change in contact. For at least these reasons Aumer teaches the argued limitation recited above.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 8, “a user” should read “the user”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 11-21 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.
Claims 1, 13, and 21 recites the limitation "the change in the one or more metrics" in lines 20, 22-23, and 13 respectively. There is insufficient antecedent basis for this limitation in the claim. The claims do not previously recite a change in the one or more metrics is determined.
Claims 17-18 recite the limitation “exclude a second portion of the PPG data” in lines 3 and 3 respectively, which is considered indefinite. The claims from which claims 17-18 depend do not previously recite utilizing a first portion of the PPG data, therefore it is not clear to the examiner how a second portion can be excluded when a first portion is not first identified. For the purpose of examination and this office action, it is being interpreted that the second portion is a portion of the PPG data.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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, 4, 6-9, 11, 13, 16-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable by Aumer et al. (US 20160094899, hereinafter Aumer) in view of Shiao (US 20230200671) and Srisukh et al (US20240108233, hereinafter Srisukh).
Regarding claim 1, Aumer teaches a wearable ring device ([0065] “wearable monitoring device 10”. Also see [0067] which discloses monitoring apparatus 30 in the form of a strap or band for a finger, thereby making the apparatus 30 a ring. See fig. 3A), comprising:
a plurality of optical components ([0069]-[0070] disclose sensor modules 34 which is an “optical sensor module”. [0071] further discloses multiple (plurality) sensors are included within the device) arranged along an inner curved surface of the wearable ring device (fig. 3B shows the sensor 34 is arranged on the inner curved surface of the ring), wherein the inner curved surface is configured to at least partially contact tissue of a user when the wearable ring device is worn by the user ([0067] by being arranged on the inner surface of the ring the sensor 34 is configured to at least partially contact tissue (finger) of the user when being worn),
at least one memory ([0110] discloses a memory location for storing values), and
at least one processor ([0071] processor 14 in fig. 1), the wearable ring device configured to:
acquire, via the plurality of optical components, photoplethysmogram (PPG) data associated with a user of the wearable ring device ([0104] and [0105] discloses the “monitoring device 10 includes a PPG sensor and the method includes collecting PPG sensor data”, the PPG sensor is considered the one or more optical components. Step 1000 and 1100 in figs. 19-20 disclose the data is generated from the user);
detect a change in the PPG data or a change in morphology between cardiac pulse waveforms that are based at least in part on the PPG data and reference cardiac pulse waveforms ([0102] discloses “the output of a photodetector in a wearable PPG sensor may be processed to determine if the DC component (i.e., the DC component of a PPG signals) background is above or below a certain threshold associated with being worn or not worn”. Additionally, [0101] discloses marking the biometric reading when it is determined that the device is being worn and when the device is not being worn, therefore the device is able to detect a change in PPG signal based on whether the signal is above or below the threshold);
evaluate one or more metrics measured by the wearable ring device ([0107] discloses obtaining a temperature reading and/or motion reading which corresponds to a metric being measured. [0070] further discloses using the sensors to measure a change in motion/temperature. [0108] further discloses evaluating HRV);
determine whether the change in the PPG data or the change in morphology is attributable to either a change in contact between the wearable ring device and the tissue of the user or a physiological change of the user based at least in part on whether the change in the PPG data or the change in morphology at least partially overlap in time with the change in the one or more metrics measured by the wearable ring device, ([0104]-[0105] discloses in steps 1020 and 1120 the processed PPG sensor data is used to determine if the monitoring device is being worn or not. [0107] further discloses the output of a temperature sensor or an accelerometer is used to determine whether the device is being worn or not. [0108] discloses the methods described can be used in combination, therefore the determination of whether the device is being worn or not (change in contact) is determined using a combination of the PPG sensor data and the one or more metrics at least partially overlapping in time with one another. Also see [0088] which discloses obtaining the PPG and temperature data over the same measurement period. [0101] additionally discloses using the sensor data to determine whether the sensor is being worn or not).
Aumer does not specifically teach detection of the change in the PPG data or the change in morphology is a condition for evaluation of the one or more metrics.
Shiao in a similar field of wearing detection discloses detection of the change in the PPG data is a condition for evaluation of the one or more metrics ([0020] discloses the change in the PPG signal when the wearable device is in a worn state allows the processor to estimate the user’s heart rate (evaluation of a metric)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having detection of the change in the PPG data or the change in morphology be a condition for evaluation of the one or more metrics of Shiao to the wearable ring device of Aumer to allow for the predictable results of ensuring the one or more metrics are being produced from the intended user and not an inanimate object, thereby improving the accuracy of the evaluation.
Aumer in view of Shiao does not specifically teach adjust one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and acquire additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings.
However,
Srisukh in a similar field of endeavor teaches adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact ([0170] “at step 2106, it is determined whether or not the collected PPG signal is attributable to the device not being worn by the wearer. At step 2108…turning off a light source of the device if the collected PPG signal is attributable to the device not being worn by the wearer”, the turning on/off of the light is considered the adjusting of the setting of the optical components); and acquire additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings ([0064] and [0077] disclose when motion is detected the LED is turned back on and tuning is restarted by obtaining additional PPG signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and acquire additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings of Srisukh to the wearable device of Aumer in view of Shiao to allow for the predictable results of only acquiring data during a contact state, thereby saving energy and processing power of the device.
Regarding claim 13, Aumer teaches a system (wearable device 10 in fig. 1), comprising:
a wearable ring device ([0065] “wearable monitoring device 10”. Also see [0067] which discloses monitoring apparatus 30 in the form of a strap or band for a finger, thereby making the apparatus a ring) comprising:
a plurality of optical components ([0069]-[0070] disclose sensor modules 34 which is an “optical sensor module”. [0071] further discloses multiple (plurality) sensors are included within the device), arranged along an inner curved surface of the wearable ring device (fig. 3B shows the sensor 34 is arranged on the inner curved surface of the ring), wherein the inner curved surface is configured to at least partially contact tissue of a user when the wearable ring device is worn by the user ([0067] by being arranged on the inner surface of the ring the sensor 34 is configured to at least partially contact tissue (finger) of the user when being worn)
at least one memory ([0110] discloses a memory location for storing values), and
at least one processor ([0071] processor 14 in fig. 1), and
a user device electronically coupled with the wearable ring device ([0074] discloses remote device 40 which is in wired or wireless communication with wearable device 10” and configured ([0074] discloses “in the case where the wearable device 10 comprises only some of these components, the functionality of the remaining components may be realized all or in part by a remote device 40”, therefore the remote device is configured to perform the following) to:
receive photoplethysmogram (PPG) data acquire by the wearable ring device via the one or more optical components ([0104] and [0105] discloses the “monitoring device 10 includes a PPG sensor and the method includes collecting PPG sensor data”. [0074] discloses the remote device 40 is in communication with the wearable device and able to perform the functionality of the components of the wearable device which includes processing the PPG signal, therefore the remote device is at least configured to receive the PPG signal measured by the wearable device in order to further process the signal);
detect a change in the PPG data or a change in morphology between cardiac pulse waveforms that are based at least in part on the PPG data and reference cardiac pulse waveforms ([0102] discloses “the output of a photodetector in a wearable PPG sensor may be processed to determine if the DC component (i.e., the DC component of a PPG signals) background is above or below a certain threshold associated with being worn or not worn”. Additionally, [0101] discloses marking the biometric reading when it is determined that the device is being worn and when the device is not being worn, therefore the device is able to detect a change in PPG signal based on whether the signal is above or below the threshold);
evaluate one or more metrics measured by the wearable ring device ([0107] discloses obtaining a temperature reading and/or motion reading which corresponds to a metric being measured. [0070] further discloses using the sensors to measure a change in motion/temperature);
determine whether the change in the PPG data or the change in the morphology is attributable to either a change in contact between the wearable ring device and the tissue of the user or a physiological change of the user based at least in part on whether the change in the PPG data or the change in morphology at least partially overlap in time with the change in the one or more metrics measured by the wearable ring device, ([0104]-[0105] discloses in steps 1020 and 1120 the processed PPG sensor data is used to determine if the monitoring device is being worn or not. [0107] further discloses the output of a temperature sensor or an accelerometer is used to determine whether the device is being worn or not. [0108] discloses the methods described can be used in combination, therefore the determination of whether the device is being worn or not (change in contact) is determined using a combination of the PPG sensor data and the temperature or accelerometer data at least partially overlapping in time with one another. Also see [0088] which discloses obtaining the PPG and temperature data over the same measurement period. [0101] additionally discloses using the sensor data to determine whether the sensor is being worn or not).
Aumer does not specifically teach detection of the change in the PPG data or the change in morphology is a condition for evaluation of the one or more metrics.
Shiao in a similar field of wearing detection discloses detection of the change in the PPG data is a condition for evaluation of the one or more metrics ([0020] discloses the change in the PPG signal when the wearable device is in a worn state allows the processor to estimate the user’s heart rate (evaluation of a metric)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having detection of the change in the PPG data or the change in morphology be a condition for evaluation of the one or more metrics of Shiao to the system of Aumer to allow for the predictable results of ensuring the one or more metrics are being produced from the intended user and not an inanimate object, thereby improving the accuracy of the evaluation.
Aumer in view of Shiao does not specifically teach adjust one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and receive additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings.
However,
Srisukh in a similar field of endeavor teaches adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact ([0170] “at step 2106, it is determined whether or not the collected PPG signal is attributable to the device not being worn by the wearer. At step 2108…turning off a light source of the device if the collected PPG signal is attributable to the device not being worn by the wearer”, the turning on/off of the light is considered the adjusting of the setting of the optical components); and receive additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings ([0064] and [0077] disclose when motion is detected the LED is turned back on and tuning is restarted by obtaining additional PPG signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and receive additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings of Srisukh to the system of Aumer in view of Shiao to allow for the predictable results of only acquiring data during a contact state, thereby saving energy and processing power of the device.
Regarding claims 4 and 16, Aumer in view of Shiao and Srisukh teaches the device of claim 1 and the system of claim 13, as set forth above. Aumer further teaches the change in the one or more metrics comprises at least one of a change in amplitude between the cardiac pulse waveforms, a change in skin or body temperature of the user, a change in acceleration of the wearable ring device, or a change in light reflected into a laser component ([0107] discloses the output of a temperature sensor is used to determine whether the device is being worn or not based on whether the temperature is above or below a threshold. Also, an accelerometer can be used to assess motion associated with the body to determine whether the device is being worn or not. This corresponds to a change in skin or body temperature of the user and a change in acceleration of the wearable device).
Regarding claim 6, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer further teaches the wearable ring device is further configured to: determine, using at least a portion of the PPG data, a physiological metric for the user based at least in part on the change in the PPG data or the change in morphology being attributable to the change in contact ([0103]-[0104] discloses the output of the PPG sensor is used to determine a vital sign (physiological metric) of a human being. [0090] further discloses the determination of heart rate is based on signal quality and [0101] discloses that signal quality directly relates to the device being worn or not. Therefore the vital sign is determined based at least in part on the change in PPG signal being based in part on the change in contact).
Regarding claim 7, Aumer in view of Shiao and Srisukh teaches the device of claim 6, as set forth above. Aumer further teaches the physiological metric comprises blood pressure, blood oxygen level, heart rate, or heart rate variability ([0103]-[0104] discloses the output of the PPG sensor is used to determine at least a heart rate of the human being).
Regarding claim 8, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer further teaches the wearable ring device is further configured to: output an indication to exclude a portion of the PPG data from a calculation to determine a physiological metric for the user based at least in part on the change in the PPG data or the change in morphology being attributable to the change in contact ([0101] “the wearable device 10 may be programmed to mark when the biometric data readings are found to be associated with the device 10 not being worn (block 930), such as the case for very low signal quality. Then an accurate assessment may be generated for the subject by factoring (weighting) sensor readings marked for periods where the wearable device 10 was determined to be worn”. An example of this is shown in [0097]-[0098] and fig. 16 where during the determination of heart rate recovery, data that is below a threshold (dotted line 702) indicting the device is not being worn correctly is not used in the determination).
Regarding claim 9, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer further teaches the wearable ring device is further configured to: output an indication to apply a weighting factor to a portion of the PPG data based at least in part on the change in the PPG data or the change in morphology being attributable to the change in contact ([0101] “the wearable device 10 may be programmed to mark when the biometric data readings are found to be associated with the device 10 not being worn (block 930), such as the case for very low signal quality. Then an accurate assessment may be generated for the subject by factoring (weighting) sensor readings marked for periods where the wearable device 10 was determined to be worn”, the indication that a period is marked as a period in which the device is worn is seen as an indication to apply a weighting factor to a portion of the signal coinciding with the change in contact to being worn. Also see [0099] which discloses weighting high and low quality data points which is based on whether the device is being worn or not).
Regarding claim 11, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer further teaches the wearable ring device is further configured to: output an indication to adjust an orientation of the wearable device based at least in part on the change in contact ([0077] discloses visual communications may be made to the user via the remote device 40 in order to communicate to the user whether the fit of the monitoring device is okay or whether the user needs to readjust the monitoring device in some way. See figs. 5A-8B. [0089] discloses the prompt to the user is in response to determining whether the device is being worn appropriately (change in contact)).
Regarding claim 17, Aumer in view of Shiao and Srisukh teaches the system of claim 13, as set forth above. Aumer further teaches the user device is further configured to: exclude a second portion of the PPG data from a calculation of a physiological metric based at least in part on the second portion of the PPG data coinciding with the change in contact ([0101] “the wearable device 10 may be programmed to mark when the biometric data readings are found to be associated with the device 10 not being worn (block 930), such as the case for very low signal quality. Then an accurate assessment may be generated for the subject by factoring (weighting) sensor readings marked for periods where the wearable device 10 was determined to be worn”. An example of this is shown in [0097]-[0098] and fig. 16 where during the determination of heart rate recovery (physiological metric), data that is below a threshold (dotted line 702) indicting the device is not being worn correctly is not used in the determination).
Regarding claim 18, Aumer in view of Shiao and Srisukh teaches the system of claim 13, as set forth above. Aumer further teaches the user device is further configured to: apply a weighting factor to a second portion of the PPG data based at least in part on the second portion of the PPG data coinciding with the change in contact ([0101] “the wearable device 10 may be programmed to mark when the biometric data readings are found to be associated with the device 10 not being worn (block 930), such as the case for very low signal quality. Then an accurate assessment may be generated for the subject by factoring (weighting) sensor readings marked for periods where the wearable device 10 was determined to be worn”, the indication that a period is marked as a period in which the device is worn is seen as an indication to apply a weighting factor to a second portion of the signal coinciding with the change in contact to being worn. Also see [0099] which discloses weighting high and low quality data points which is based on whether the device is being worn or not).
Regarding claim 19, Aumer in view of Shiao and Srisukh teaches the system of claim 13, as set forth above. Aumer further teaches the user device is further configured to: cause, based at least in part on the change in contact, a graphical user interface to display a message prompting the user to adjust an orientation of the wearable device ([0077] discloses visual communications may be made to the user via the remote device 40 in order to communicate (message) to the user whether the fit of the monitoring device is okay or whether the user needs to readjust the monitoring device in some way. See figs. 5A-8B. [0089] discloses the prompt to the user is in response to determining whether the device is being worn appropriately (change in contact). The part of the remote device where the visuals are displayed is considered to be the graphical user interface).
Regarding claim 21, Aumer teaches a method (the methods of figs. 18-20. See [0100]-[0105]), comprising:
detecting a change in photoplethysmogram (PPG) data acquired from a user view a plurality of optical components of a wearable ring device ([0065] “wearable monitoring device 10”. Also see [0067] which discloses monitoring apparatus 30 in the form of a strap or band for a finger, thereby making the apparatus a ring. [0069]-[0070] disclose sensor modules 34 which is an “optical sensor module”. [0071] further discloses multiple (plurality) sensors are included within the device) or a change in morphology between cardiac pulse waveforms that are based at least in part on the PPG data and reference cardiac pulse waveforms ([0102] discloses “the output of a photodetector in a wearable PPG sensor may be processed to determine if the DC component (i.e., the DC component of a PPG signals) background is above or below a certain threshold associated with being worn or not worn”. Additionally, [0101] discloses marking the biometric reading when it is determined that the device is being worn and when the device is not being worn, therefore the device is able to detect a change in PPG signal based on whether the signal is above or below the threshold);
evaluate one or more metrics measured by the wearable ring device ([0107] discloses obtaining a temperature reading and/or motion reading which corresponds to a metric being measured. [0070] further discloses using the sensors to measure a change in motion/temperature);
determining whether the change in the PPG data or the change in the morphology is attributable to either a change in contact between the wearable ring device and a tissue of the user or a physiological change of the user based at least in part on whether the change in the PPG data or the change in morphology at least partially overlap in time with the change in the one or more metrics measured by the wearable ring device, ([0104]-[0105] discloses in steps 1020 and 1120 the processed PPG sensor data is used to determine if the monitoring device is being worn or not. [0107] further discloses the output of a temperature sensor or an accelerometer is used to determine whether the device is being worn or not. [0108] discloses the methods described can be used in combination, therefore the determination of whether the device is being worn or not (change in contact) is determined using a combination of the PPG sensor data and the temperature or accelerometer data at least partially overlapping in time with one another. Also see [0088] which discloses obtaining the PPG and temperature data over the same measurement period. [0101] additionally discloses using the sensor data to determine whether the sensor is being worn or not).
Aumer does not specifically teach detection of the change in the PPG data or the change in morphology is a condition for evaluation of the one or more metrics.
Shiao in a similar field of wearing detection discloses detection of the change in the PPG data is a condition for evaluation of the one or more metrics ([0020] discloses the change in the PPG signal when the wearable device is in a worn state allows the processor to estimate the user’s heart rate (evaluation of a metric)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having detection of the change in the PPG data or the change in morphology be a condition for evaluation of the one or more metrics of Shiao to the method of Aumer to allow for the predictable results of ensuring the one or more metrics are being produced from the intended user and not an inanimate object, thereby improving the accuracy of the evaluation.
Aumer in view of Shiao does not specifically teach adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and acquiring additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings.
However,
Srisukh in a similar field of endeavor teaches adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact ([0170] “at step 2106, it is determined whether or not the collected PPG signal is attributable to the device not being worn by the wearer. At step 2108…turning off a light source of the device if the collected PPG signal is attributable to the device not being worn by the wearer”, the turning on/off of the light is considered the adjusting of the setting of the optical components); and acquiring additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings ([0064] and [0077] disclose when motion is detected the LED is turned back on and tuning is restarted by obtaining additional PPG signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of adjusting one or more settings of the plurality of optical components of the wearable ring device for collection of physiological data based at least in part on a determination that the change in the PPG data or the change in morphology is attributable to the change in contact; and acquiring additional PPG data using the plurality of optical components based at least in part on adjusting the one or more settings of Srisukh to the method of Aumer in view of Shiao to allow for the predictable results of only acquiring data during a contact state, thereby saving energy and processing power of the device.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aumer in view of Shiao and Srisukh as applied to claims 1 and 13 above, and further in view of Joe et al. (US 20200146630, hereinafter Joe).
Regarding claim 2, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer further teaches to detect the change in the PPG data the wearable ring device is configured to: determine that a direct current (DC) level of a PPG signal of the PPG data has changed by a threshold amount ([0102] “the output of a photodetector in a wearable PPG sensor may be processed to determine if the DC (i.e., the DC component of a PPG signal) background is above or below a certain threshold associated with being worn or not worn”. By determining whether the DC component is above or below a certain threshold, the wearable device is configured to determine whether the DC component has changed by a threshold amount, the threshold amount being the difference between the DC value and the threshold associated with being worn or not worn).
Aumer in view of Shiao and Srisukh does not specifically teach the DC level of the PPG signal has changed by a threshold amount within a threshold duration of time.
However,
Joe in a similar field of endeavor teaches determining whether a value associated with the DC level of the PPG signal has changed within a threshold duration of time ([0254]-[0255] discloses “the electronic device may measure the PPG signal for a specified period of time and may obtain the ration of an AC signal value to a DC signal value of the PPG signal” and “compare the same with the previously obtained values (stored values). According to the above comparison, the electronic device may adjust the wearing state of the electronic device to be tighter or looser”. The determination of whether the device needs to be tighter or looser is a determination that the value has changed and the specified period of time is considered the threshold duration time. [0257] further discloses “the specified period of time may be determined in consideration of the pulse period of the user. The specified period of time may be 3 seconds or 60 seconds”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of determining whether the DC level of the PPG signal has changed by a threshold amount within a threshold duration of time of Joe to the known wearable device of Aumer in view of Shiao and Srisukh in order to allow for the predictable results of more accurately detecting a change in contact of the wearable device by ensuring only DC levels that are measured during a change in contact are being analyzed, thereby avoiding interference from DC level values that occur before or after the change in contact.
Regarding claim 14, Aumer in view of Shiao and Srisukh teaches the device of claim 13, as set forth above. Aumer further teaches t to detect the change in the PPG data, the user device is configured to: determine that a direct current (DC) level of a PPG signal of the PPG data has changed by a threshold amount ([0102] “the output of a photodetector in a wearable PPG sensor may be processed to determine if the DC (i.e., the DC component of a PPG signal) background is above or below a certain threshold associated with being worn or not worn”. By determining whether the DC component is above or below a certain threshold, the wearable device is configured to determine whether the DC component has changed by a threshold amount, the threshold amount being the difference between the DC value and the threshold associated with being worn or not worn).
Aumer in view of Shiao and Srisukh does not specifically teach the DC level of the PPG signal has changed by a threshold amount within a threshold duration of time.
However,
Joe in a similar field of endeavor teaches determining whether a value associated with the DC level of the PPG signal has changed within a threshold duration of time ([0254]-[0255] discloses “the electronic device may measure the PPG signal for a specified period of time and may obtain the ration of an AC signal value to a DC signal value of the PPG signal” and “compare the same with the previously obtained values (stored values). According to the above comparison, the electronic device may adjust the wearing state of the electronic device to be tighter or looser”. The determination of whether the device needs to be tighter or looser is a determination that the value has changed and the specified period of time is considered the threshold duration time. [0257] further discloses “the specified period of time may be determined in consideration of the pulse period of the user. The specified period of time may be 3 seconds or 60 seconds”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of determining whether the DC level of the PPG signal has changed by a threshold amount within a threshold duration of time of Joe to the known user device of Aumer in view of Shiao and Srisukh in order to allow for the predictable results of more accurately detecting a change in contact of the wearable device by ensuring only DC levels that are measured during a change in contact are being analyzed, thereby avoiding interference from DC level values that occur before or after the change in contact.
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aumer in view of Shiao and Srisukh as applied to claims 1 and 13 above, and further in view of Sun et al. (US 20200146629, hereinafter Sun).
Regarding claim 3, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer in view of Shiao and Srisukh does not specifically teach the reference cardiac pulse waveforms are based at least in part on a portion of the PPG data measured by the wearable ring device before the change in contact.
However,
Sun in a similar field of determining the wearing state of a wearable device teaches reference cardiac pulse waveforms are based at least in part on a portion of a PPG data measured by a wearable device before the change in contact ([0119] “when the target PPG signal is inconsistent with a stored reference wearing parameter, the smartwatch prompts the user to adjust a wearing position of the smartwatch” and [0122] “the reference wearing parameter may be a PPG reference signal formed when the user wears the smartwatch 100 in a reference wearing position”. [0016] discloses the PPG signal is used to represent a heart rate value of the user and therefore the PPG signal is considered a cardiac waveform. Additionally, [0127] discloses the wearing position of step 602 is compared to the reference determined in step 504, meaning the reference wearing parameter was obtained before the change in contact of the wearable device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable device disclosed by Aumer in view of Shiao and Srisukh to have the reference cardiac pulse waveforms be based at least in part on a portion of the PPG data measured by the wearable ring device before the change in contact in order to improve the accuracy of the device, as recognized by Sun ([0008]).
Regarding claim 15, Aumer in view of Shiao and Srisukh teaches the device of claim 13, as set forth above. Aumer in view of Shiao and Srisukh does not specifically teach the reference cardiac pulse waveforms are based at least in part on a portion of the PPG data measured by the wearable ring device before the change in contact.
However,
Sun in a similar field of determining the wearing state of a wearable device teaches reference cardiac pulse waveforms are based at least in part on a portion of a PPG data measured by a wearable device before the change in contact ([0119] “when the target PPG signal is inconsistent with a stored reference wearing parameter, the smartwatch prompts the user to adjust a wearing position of the smartwatch” and [0122] “the reference wearing parameter may be a PPG reference signal formed when the user wears the smartwatch 100 in a reference wearing position”. [0016] discloses the PPG signal is used to represent a heart rate value of the user and therefore the PPG signal is considered a cardiac waveform. Additionally, [0127] discloses the wearing position of step 602 is compared to the reference determined in step 504, meaning the reference wearing parameter was obtained before the change in contact of the wearable device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the user device disclosed by Aumer in view of Shiao and Srisukh to have the reference cardiac pulse waveforms be based at least in part on a portion of the PPG data measured by the wearable ring device before the change in contact in order to improve the accuracy of the device, as recognized by Sun ([0008]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aumer in view of Shiao and Srisukh as applied to claim 1 above, and further in view of Gelissen et al. (WO2017190965A1, hereinafter Gelissen).
Regarding claim 5, Aumer in view of Shiao and Srisukh teaches the device of claim 1, as set forth above. Aumer in view of Shiao and Srisukh does not specifically teach the change in the one or more metrics is measured by a galvanic sensor of the wearable ring device.
However,
Gelissen in a similar field of detecting the wearing status of a device teaches detecting a change in a metric using a galvanic sensor of the wearable device in order to determine a change in contact of a wearable ring device (pg. 11, lines 17-24 discloses “a physiological characteristic sensor in the form of a skin conductivity sensor may be used, where the control unit 102 controls the skin conductivity sensor to acquire signals indicative of whether a subject is wearing a device…the signals indicative of whether a subject is wearing a device are skin conductivity signals (i.e. galvanic skin response signals)”, since the sensor is able to measure galvanic skin response signals, the sensor is considered a galvanic sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the temperature sensor or accelerometer of Aumer in view of Shiao and Srisukh for the Galvanic sensor of Gelissen because it amounts to simple substitution of one known element for another to obtain the predictable results of determining whether there is a change in contact of the wearable ring device.
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aumer in view of Shiao and Srisukh as applied to claims 11 and 19 above, and further in view of van Dinther et al. (US 20170215747, hereinafter Dinther).
Regarding claim 12, Aumer in view of Shiao and Srisukh teaches the device of claim 11, as set forth above. Aumer in view of Shiao and Srisukh does not specifically teach the PPG data is associated with the first subset of the plurality of optical components, and wherein the wearable ring device is further configured to: determine, based at least in part on the change in contact, a difference in quality between the PPG data and second PPG data associated with a second subset of the plurality of optical components, wherein the indication to adjust the orientation is based at least in part on the difference in quality.
However,
Dinther in a similar field of detecting a contact state of a device teaches a PPG data is associated with a first subset of a plurality of optical components ([0039] “in step S1, the PPG sensor 100 is activated and light is emitted by the light units at a first wavelength P1”. [0036]-[0037] discloses the first wavelength is associated with light emitting diode 111 and photodetector 121, which are considered the first set of optical components), and wherein a wearable ring device is further configured to: determine, based at least in part on a change in contact, a difference in quality between the PPG data and second PPG data associated with a second subset of the plurality of optical components ([0047] discloses “the off-skin detection unit 130 compares the DC component of the output signals of the photo detector 120 at the first and second wavelength P1, P2” to determine whether the sensor is in contact with the skin. P1 is considered the first PPG signal and P2 is considered the second PPG signal and by comparing the signals to determine a contact state, a difference in quality is being determined based on a change in contact of the wearable device. [0036]-[0037] further discloses the second wavelength P2 is associated with light emitting diode 112 and photodetector 122, which are considered the second set of optical components), wherein the indication to adjust the orientation is based at least in part on the difference in quality (applying the contact determination of Dinther, where the contact is determined based on the difference in quality of the signals associated with the first and second wavelengths to the outputting of an indication to adjust an orientation of the wearable device based on the change in contact of Aumer, would result in the indication to adjust the orientation being output being based at least in part on the difference in quality).
The invention of Aumer in view of Shiao and Srisukh can be considered a “base” device upon which the claimed invention can be seen as an “improvement”. The invention of Dinther discussed above can be considered a “comparable” device such as a wearable device that detects a contact state of the wearable device based on PPG data that has been improved in the same way as the claimed invention by determining, based at least in part on a change in contact, a difference in quality between the PPG data and second PPG data associated with a second subset of the plurality of optical components. One of ordinary skill in the art would have been motivated to apply the known improvement of determining, based at least in part on a change in contact, a difference in quality between the PPG data and second PPG data associated with a second subset of the plurality of optical components of Dinther to the device of Aumer in view of Shiao and Srisukh because the improvements allow for a predictable result of more accurately determining the contact state of the wearable device by adding a second PPG data, thereby allowing for the use of the known technique recited above to improve similar devices in the same way.
Regarding claim 20, Aumer in view of Shiao and Srisukh teaches the device of claim 19, as set forth above. Aumer in view of Shiao and Srisukh does not specifically teach the PPG data is associated with a first subset of optical components, and wherein the user device is further configured to: determine a difference in quality between the PPG data and second PPG data associated with a second subset of optical components, wherein the message to adjust the orientation is based at least in part on the difference in quality.
However,
Dinther in a similar field of detecting a contact state of a device teaches a PPG signal is associated with a first subset of optical components ([0039] “in step S1, the PPG sensor 100 is activated and light is emitted by the light units at a first wavelength P1”. [0036]-[0037] discloses the first wavelength is associated with light emitting diode 111 and photodetector 121, which are considered the first set of optical components), and wherein a wearable device is further configured to: determine a difference in quality between the PPG data and second PPG data associated with a second subset of optical components ([0047] discloses “the off-skin detection unit 130 compares the DC component of the output signals of the photo detector 120 at the first and second wavelength P1, P2” to determine whether the sensor is in contact with the skin. P1 is considered the first PPG signal and P2 is considered the second PPG signal and by comparing the signals to determine a contact state, a difference in quality is being determined based on a change in contact of the wearable device. [0036]-[0037] further discloses the second wavelength P2 is associated with light emitting diode 112 and photodetector 122, which are considered the second set of optical components), wherein the message to adjust the orientation is based at least in part on the difference in quality (applying the contact determination of Dinther, where the contact is determined based on the difference in quality of the signals associated with the first and second wavelengths to the outputting of an indication to adjust an orientation of the wearable device based on the change in contact of Aumer, would result in the indication to adjust the orientation being output being based at least in part on the difference in quality).
The invention of Aumer in view of Shiao and Srisukh can be considered a “base” device upon which the claimed invention can be seen as an “improvement”. The invention of Dinther discussed above can be considered a “comparable” device such as a user device that detects a contact state of the wearable device based on PPG data that has been improved in the same way as the claimed invention by determine a difference in quality between the PPG data and a second PPG data associated with a second subset of optical components. One of ordinary skill in the art would have been motivated to apply the known improvement of determine a difference in quality between the PPG data and second PPG data associated with a second subset of optical components of Dinther to the device of Aumer in view of Shiao and Srisukh because the improvements allow for a predictable result of more accurately determining the contact state of the wearable device by adding a second PPG data, thereby allowing for the use of the known technique recited above to improve similar devices in the same way.
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.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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