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 .
Amendment Entered
This Office action is responsive to the Amendment filed on May 15th, 2026.
Claims 1-15 and 17-20 remain pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are not persuasive.
At pages 9-10, Applicant argues that Whiting does not teach or suggest acquiring such PPG signals “based at least in part on the motion data satisfying a threshold motion metric and the temperature data satisfying a threshold temperature metric” because Whiting discloses that the motion and temperature condition thresholds are evaluated after the blood oxygen indicators are already determined (or otherwise after PPG signals for determining blood oxygen indicators have been acquired) and that Whiting would be configured to determine blood oxygen indicators, then evaluate whether or not such blood oxygen indicators are reliable or not. Examiner respectfully disagrees. Whiting discloses in para. [0037, 0041, 0079, 0108] that data coinciding with periods of relatively high motion (i.e. sufficient motion to cause the first and second light signals to be unreliable or inaccurate) can be rejected, and only data coinciding with relatively low motion can be selected for use in determining the indicator of blood oxygen saturation, that processing the motion signal may take place prior to determining an indicator of blood oxygen saturation, and processing the temperature signal may take place prior to determining an indicator of blood oxygen saturation. The claims as recited have no limitations directed to avoiding/not attempting performing measurements or preserving battery life Furthermore, in fig. 8 (see para. [0192-0200]) of Whiting, the detected light data, see step 106, is not processed/steps 108 and 110 may not be carried out unless the subject is not determined to be in a high-motion state and is not determined to be cold which can be helpful in improving the quality of the light signals and therefore the determined indicator of blood oxygen saturation.
Therefore, Whiting does disclose acquiring the first PPG signal, the second PPG signal, or both (“detected light signal … first, second, … wavelength signal”, para. [0109-0111, 0192-0200], fig. 8), is based at least in part on the motion data satisfying a threshold motion metric (“output the indicator of blood oxygen saturation in dependence on the detected motion signal only if the motion signal is below a predetermined threshold”; “processing the motion signal may take place prior to determining an indicator of blood oxygen saturation ... rejecting light signals”; “outputting the determined indicator of blood oxygen saturation in dependence on whether the calculated estimate of blood oxygen saturation of the subject is determined to be unreliable”, para. [0034-0035, 0037, 0079-0080, 0192-0200], fig. 8) and the temperature data satisfying a threshold temperature metric (“processing a temperature signal from a temperature sensor … prior to determining an indicator of blood oxygen saturation … only outputting a determined indicator of blood oxygen saturation when the temperature signal is not indicative of a subject that is cold”, para. [0059-0061, 0108-0111, 0192-0200], fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards such that the method comprises acquiring the first PPG signal, the second PPG signal, or both, is based at least in part on the motion data satisfying a threshold motion metric and the temperature data satisfying a threshold temperature metric, in view of the teachings of Whiting, as this would aid in improving the signal quality/accuracy of PPG/light signals by only carrying out the steps of processing the detected light data and determining/outputting the blood oxygen saturation indicator when the subject is not determined to be in a high-motion state and is not determined to be cold.
Examiner note: A 101 analysis was performed on the claims but concluded it was not
necessary because the claimed system/structures are not well understood, routine, and
conventional.
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.
Claims 1-7, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 20210330207 A1 - previously cited) in view of Whiting (US 20230030071 A1), and further in view of Robinson (US 20220096007 A1 - previously cited).
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Richards annotated fig. 1F
Regarding claim 1, Richards discloses a method for measuring blood oxygen saturation for a user (“methods … blood oxygen saturation”, Abstract) comprising: acquiring physiological data associated with the user (“motion data”; “ambient temperature or a skin temperature of the wearer”, para. [0107, 0110]) via a wearable ring device (PPG device 100, fig. 2; “worn on the outer wrist”; “ring geometry”, para. [0036, 0050] (Examiner note: the PPG device is shown as ring-shaped in fig. 2)) configured to be worn by the user (as seen in fig. 1A, “wrist-worn”, para. [0029, 0036]), the physiological data comprising at least motion data and temperature data (“motion data”; “ambient temperature or a skin temperature of the wearer”, para. [0107-0108, 0110-0111]); acquiring, during a time interval (“temporal window … no temporal gap”, para. [0073]) and using the wearable ring device (PPG device 100, fig. 2; “worn on the outer wrist”; “ring geometry”, para. [0036, 0050]) a first photoplethysmogram (PPG) signal for the user (blocks 305/405, figs. 3-4) via a first set of PPG sensors of the wearable ring device (“first PPG sensor”, para. [0061], fig. 1H) and a second PPG signal for the user (blocks 310/410, figs. 3-4) via a second set of PPG sensors that are different from the first set of PPG sensors (“second PPG sensor”; “different”, para. [0052, 0061, 0069], figs. 1H), wherein the wearable ring device comprises: a ring-shaped housing (unlabeled but as seen in fig. 2, “ring geometry”; “wrist band”, para. [0050, 0056]) having an inner curved surface (unlabeled, but as seen in fig. 2, “ underside of the PPG device 100”, para. [0056]) and an outer curved surface (unlabeled, but as seen in fig. 2, para. [0056]), wherein at least a portion of the inner curved surface is configured to contact a tissue of the user (“proximate to a user’s skin”; “worn on the user's wrist”, para. [0039, 0056], as seen in fig. 1A); the first set of PPG sensors configured to emit first light through the inner curved surface of the ring-shaped housing into the tissue of the user (“light source … emitted light has interacted with a user's skin”, para. [0052, 0068], as seen in fig. 1A) and receive the first light transmitted through the inner curved surface of the ring-shaped housing (as seen in fig. 1A; “dashed arrows, light emitted from the light sensors 102 can be reflected back to the light detectors 106”, para. [0036, 0068]), wherein the first set of PPG sensors comprises a first light source (light source 106, fig. 1H “first light source”; “center light source 102 … red … infrared” , para. [0007, 0052, 0061]) at a first position along the inner curved surface of the ring-shaped housing (unlabeled, but as seen in fig. 1A and annotated fig. 1H, “ring geometry”, para. [0050]), a first photodetector at a second position along the inner curved surface of the ring-shaped housing (first photodetector, as seen in fig. 1A & annotated fig. 1H, “ring geometry”; “outer … light detectors”, para. [0050, 0052]), and a second photodetector at a third position along the inner curved surface of the ring-shaped housing (second photodetector, as seen in fig. 1A & annotated fig. 1H, “ring geometry”; “outer … light detectors”, para. [0050, 0052]); and the second set of PPG sensors configured to emit second light through the inner curved surface of the ring-shaped housing into the tissue of the user (“light source … emitted light has interacted with a user's skin”, para. [0052, 0068], as seen in fig. 1A) and receive the second light transmitted through the inner curved surface of the ring-shaped housing (as seen in fig. 1A; “dashed arrows, light emitted from the light sensors 102 can be reflected back to the light detectors 106”, para. [0036, 0068]), wherein the second set of PPG sensors comprises a second light source(light source 106, fig. 1H “second light source”; “top and bottom light sources 102 … green light” , para. [0007, 0052, 0061]), the first photodetector (unlabeled, but as seen in annotated fig. 1H, “ring geometry”; “inner… light detectors”, para. [0050, 0052]), and the second photodetector (unlabeled, but as seen in annotated fig. 1H, “ring geometry”; “inner … light detectors”, para. [0050, 0052]); receiving, via a transceiver of a user device and from the wearable ring device (“data … transmitted … host computer 130”; “transceiver”, para. [0040, 0057, 0066]), the first PPG signal and the second PPG signal for the user (“PPG signals … communicated”, para. [0066], blocks 305/405 & 310/410, figs. 3-4); comparing (“extracts a physiological component … comparing the … signals”, para. [0081-0082]) the first PPG signal acquired via the first set of PPG sensors of the wearable ring device (outer light detectors, fig. 1H, “first PPG signals … obtained from one or more light detectors”, para. [0052, 0068]) and the second PPG signal acquired via the second set of PPG sensors of the wearable ring device (inner light detectors, fig. 1H, second PPG signals … obtained from one or more light detectors, para. [0052, 0069, 0110]); determining one or more blood oxygen saturation metrics for the user during the time interval based at least in part on comparing the first PPG signal and the second PPG signal (“extract … comparing … generate a physiological metric based on the physiological component … SpO2”, para. [0081-0083], block 420, fig. 4); and causing a graphical user interface to display an indication of the one or more blood oxygen saturation metrics (“metric … display 114 … SpO2”, para. [0071, 0083]).
Richards does not expressly disclose acquiring the first PPG signal, the second PPG signal, or both, is based at least in part on the motion data satisfying a threshold motion metric and the temperature data satisfying a threshold temperature metric.
However, Whiting directed to an apparatus for monitoring blood oxygen saturation of a subject comprising a motion sensor, a temperature sensor, a photosensor array 16 including first, second and third photosensors and LEDs 14A, 14B, 14C (para. [0034-0035, 0059-0061, 0174-0175]) discloses acquiring the first PPG signal, the second PPG signal, or both (“detected light signal … first, second, … wavelength signal”, para. [0109-0111]), is based at least in part on the motion data satisfying a threshold motion metric (“output the indicator of blood oxygen saturation in dependence on the detected motion signal only if the motion signal is below a predetermined threshold”; “processing the motion signal may take place prior to determining an indicator of blood oxygen saturation ... rejecting light signals”; “outputting the determined indicator of blood oxygen saturation in dependence on whether the calculated estimate of blood oxygen saturation of the subject is determined to be unreliable”, para. [0034-0035, 0037, 0079-0080, 0192-0200], fig. 8) and the temperature data satisfying a threshold temperature metric (“processing a temperature signal from a temperature sensor … prior to determining an indicator of blood oxygen saturation … only outputting a determined indicator of blood oxygen saturation when the temperature signal is not indicative of a subject that is cold”, para. [0059-0061, 0108-0111, 0192-0200], fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards such that the method comprises acquiring the first PPG signal, the second PPG signal, or both, is based at least in part on the motion data satisfying a threshold motion metric and the temperature data satisfying a threshold temperature metric, in view of the teachings of Whiting, as this would aid in improving the signal quality/accuracy of PPG/light signals by only carrying out the steps of processing the detected light data and determining/outputting the blood oxygen saturation indicator when the subject is not determined to be in a high-motion state and is not determined to be cold.
Richards, as modified by Whiting hereinabove, does not expressly disclose the first light source at a first radial position along the inner curved surface of the ring-shaped housing, the first photodetector at a second radial position along the inner curved surface of the ring-shaped housing, and the second photodetector at a third radial position along the inner curved surface of the ring-shaped housing.
However, Robinson directed to an apparatus configured as a ring to be worn on a finger (1904, fig. 19, para. [0015, 0158]) having an optical sensor system (para. [0015, 0159]), the ring comprising a ring-shaped housing (“ring”, para. [0015, 0158], as seen in fig. 19) having an inner curved surface (inner flexible surface of the ring 1921, fig. 19) and an outer curved surface (unlabeled but as seen in fig. 19) discloses a first light source (emitter 1906, fig. 19) at a first radial position along the inner curved surface of the ring-shaped housing (unlabeled, but as seen in fig. 19), a first photodetector (detector 1907, fig. 19) at a second radial position along the inner curved surface of the ring-shaped housing (unlabeled, but as seen in fig. 19), a second photodetector (detector 1908, fig. 19) at a third radial position along the inner curved surface of the ring-shaped housing (unlabeled, but as seen in fig. 19) and a second light source (emitter 1905, fig. 19). Robinson further discloses that optical sensors measure changes in blood volume, commonly referred as photoplethysmography (PPG) sensors and that the emitters can have the same emitting wavelength or different wavelengths (para. [0111])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting hereinabove, such that the first light source is at a first radial position along the inner curved surface of the ring-shaped housing, the first photodetector is at a second radial position along the inner curved surface of the ring-shaped housing, and the second photodetector is at a third radial position along the inner curved surface of the ring-shaped housing, in view of the teachings of Robinson, as such a modification would have been merely a substitution of the PPG device comprising light sources and PPG sensors of Richards for the optical sensor system comprising emitters and detectors of Robinson in order to obtain the first and second PPG signals.
Regarding claim 2, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1, and Richards further teaches receiving the first PPG signal and the second PPG signal (figs. 3-4) comprises: receiving a first PPG measurement utilizing a first channel between a first subset of the first set of PPG sensors (channel 1, as seen in fig. 9, para. [0115-0116], figs. 3-4); receiving a second PPG measurement utilizing a second channel between a second subset of the first set of PPG sensors (channel 2, as seen in fig. 9, para. [0115-0116], figs. 3-4), wherein the first PPG signal is based at least in part on the first PPG measurement and the second PPG measurement (“combine the signals”; “summing the probability distributions from multiple PPG channels”, para. [0109, 0116]); receiving a third PPG measurement utilizing a third channel between a first subset of the second set of PPG sensors (channel 3, as seen in fig. 9, para. [0115-0116]); and receiving a fourth PPG measurement utilizing a fourth channel between a second subset of the second set of PPG sensors (channel 4, as seen in fig. 9, para. [0115-0116]), wherein the second PPG signal is based at least in part on the third PPG measurement and the fourth PPG measurement (“combine the signals”; “summing the probability distributions from multiple PPG channels”, para. [0109, 0116]).
Regarding claim 3, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 2, and Richards further teaches the first channel comprises a channel between the first light source and the first photodetector (channel 1, as seen in fig. 9, para. [0115-0116]), and wherein the second channel comprises a channel between the first light source and the second photodetector (channel 2, as seen in fig 9, para. [0115-0116]), wherein the third channel comprises a channel between the second light source and the first photodetector (channel 3, as seen in fig. 9, para. [0115-0116]), and wherein the fourth channel comprises a channel between the second light source and the second photodetector (channel 4, as seen in fig. 9, para. [0115-0116]), wherein the second light source is configured to generate light with a different wavelength (“two or more … emitters … different center wavelength”, green, para. [0048, 0052]) as compared to light generated via the first light source (“two or more … emitters … different center wavelength”; red, para. [0048, 0052]).
Regarding claim 4, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 3, and Richards further teaches receiving the first PPG signal and the second PPG signal comprises: selectively controlling an activation state (“emission schedule … activate” para. [0073]) of the first light source and the second light source (“light sources 102”; light source A and light source B, para. [0068, 0073]) such that the first light source and the second light source are simultaneously in an active activation state (“activate … all the light sources 102”; “emit … T1 … T2 … no temporal gap between T1 and T2 (and/or T1′ and T2′)”, para. [0068, 0073] (Examiner note: if there is no temporal gap between T1/T1’ and T2/T2’ then the light sources would be activated in the same time period)).
Regarding claim 5, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 3, and Richards further teaches receiving the first PPG signal and the second PPG signal comprises: sequentially controlling an activation state (“emission schedule … activate” para. [0068, 0073]) of the first light source and the second light source (“light sources 102”; light source A and light source B, para. [0068, 0073]) such that the first light source is in an active activation state when the second light source is in an inactive activation state, and vice versa (“active … one … first light source … even seconds … second light source … odd seconds”, para. [0068, 0073]).
Regarding claim 6, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 2, and Richards further teaches combining the first PPG measurement and the second PPG measurement to generate the first PPG signal (“signals A+B”; “PPG signals are averaged together … single PPG signal”, para. [0034, 0109, 0115-0116]); and combining the third PPG measurement and the fourth PPG measurement to generate the second PPG signal (“signals B+C”; “PPG signals area averaged together … single PPG signal”, para. [0034, 0109, 0115-0116]).
Regarding claim 7, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 6, and Richards further teaches the first PPG measurement and the second PPG measurement, and the third PPG measurement and the fourth PPG measurement, respectively, are combined using one or more mathematical operations (“average”; “combining the PPG signals”; “some or all of the PPG signals … may be averaged or weighted”, para. [0028, 0034, 0106]), the one or more mathematical operations comprising an averaging operation, a weighted averaging operation, or both, the one or more mathematical operations comprising an averaging operation, a weighted averaging operation, or both (“average”; “some or all of the PPG signals … may be averaged or weighted”, para. [0028, 0106, 0109]).
Regarding claim 15, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1, and Richards further teaches each of the first light source, the second light source, the first photodetector, and the second photodetector are positioned at different radial positions relative to an axis of the wearable ring device and along the inner curved surface of the wearable ring device (Richards, “arranged in the shape of a cross … along a radial direction from the center”, para. [0054], as seen in figs. 1H-1I & Robinson, as seen in fig. 19).
Regarding claim 18, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1. Richards, as modified by Whiting and Robinson hereinabove, does not expressly disclose wherein the motion data satisfies the threshold motion metric if the motion data is less than or equal to the threshold motion metric, and wherein the temperature data satisfies the threshold temperature metric if the temperature data is greater than or equal to the threshold temperature metric.
However, Whiting discloses wherein the motion data satisfies the threshold motion metric if the motion data is less than or equal to the threshold motion metric (“motion … threshold … below”, para. [0035]), and wherein the temperature data satisfies the threshold temperature metric if the temperature data is greater than or equal to the threshold temperature metric (“temperature … threshold”; “temperature … above a predetermined value”, para. [0060-0061, 0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Robinson hereinabove, such that the motion data satisfies the threshold motion metric if the motion data is less than or equal to the threshold motion metric, and the temperature data satisfies the threshold temperature metric if the temperature data is greater than or equal to the threshold temperature metric, in view of the teachings of Whiting, as this would aid in providing a reliable indicator of blood oxygen saturation by only determining and outputting the indicator of blood oxygen saturation when the motion signal is below the predetermined threshold and when the temperature is above the threshold/predetermined value.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Whiting and Robinson, as applied to claim 2 above, and further in view of Weekly (US 20170311825 A1 – previously cited).
Regarding claim 8, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 2. Richards, as modified by Whiting and Robinson hereinabove, does not expressly disclose the method further comprising: receiving a third PPG signal for the user acquired during the time interval using a third set of PPG sensors that are different from the first set of PPG sensors and the second set of PPG sensors.
However, Weekly discloses receiving a third PPG signal for the user acquired during the time interval (“third PPG signals”; “energizing … light sources … time”, para. [0109, 0113]]) using a third set of PPG sensors (additional detector 166, fig. 1F) that are different from the first set of PPG sensors (detector 162A, fig. 1F) and the second set of PPG sensors (162B, fig. 1F) (as seen in fig. 1F, para. [0075, 109]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises receiving a third PPG signal for the user acquired during the time interval using a third set of PPG sensors that are different from the first set of PPG sensors and the second set of PPG sensors, in view of the teachings of Weekly, as this would aid in generating physiological metrics based on data obtained from any one or more of first, second, and third PPG signals by incorporating the additional detector to obtain third PPG signals based on IR light sources.
Regarding claim 9, Richards, as modified by Whiting, Robinson, and Weekly hereinabove, further discloses the method of claim 8, wherein receiving the third PPG signal (“third detector”, para. [0061] & D1/D2, fig. 9) comprises: receiving a fifth PPG measurement utilizing a fifth channel between a first subset of the third set of PPG sensors (as seen in fig. 9, “channel … more than four”, para. [0044, 0115-0116]); and receiving a sixth PPG measurement utilizing a sixth channel between a second subset of the third set of PPG sensors (as seen in fig. 9, “channel … more than four”, para. [0044, 0115-0116]), wherein the third PPG signal is based at least in part on the fifth PPG measurement and the sixth PPG measurement (“combine the signals”; “summing the probability distributions from multiple PPG channels”, para. [0109, 0116]).
Regarding claim 10, Richards, as modified by Whiting, Robinson, and Weekly hereinabove, discloses the method of claim 8, wherein the first set of PPG sensors, the second set of PPG sensors, and the third set of PPG sensors use three different wavelengths (“detector … 560 nm … 940 nm … 528 nm”, para. [0061]).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Whiting and Robinson, as applied to claim 1 above, and further in view of Verkruijsse (US 20190167124 A1 – previously cited).
Regarding claim 11, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1. Richards, as modified by Whiting and Robinson hereinabove, does not disclose the method further comprising: determining a ratio between the first PPG signal and the second PPG signal, wherein determining the one or more blood oxygen saturation metrics is based at least in part on the ratio of the first PPG signal and the second PPG signal.
However, Verkruijsse discloses determining a ratio between the first PPG signal and the second PPG signal (“ratio of ratios of the PPG signals”, para. [0031, 0046, 0109]), wherein determining the one or more blood oxygen saturation metrics is based at least in part on the ratio of the first PPG signal and the second PPG signal (“oxygen saturation (SO2) estimation algorithm … ratio of the signals”, para. [0031, 0109-0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises determining a ratio between the first PPG signal and the second PPG signal, wherein determining the one or more blood oxygen saturation metrics is based at least in part on the ratio of the first PPG signal and the second PPG signal, in view of the teachings of Verkruijsse, as this would aid in calculating the oxygen saturation by incorporating the oxygen saturation estimation algorithm.
Regarding claim 12, Richards, as modified by Whiting, Robinson and Verkruijsse hereinabove, discloses the method of claim 11. Richards, as modified by Whiting, Robinson and Verkruijsse hereinabove, does not disclose the method further comprising: determining a first perfusion index between a first amplitude and a first baseline amplitude level of the first PPG signal; and determining a second perfusion index between a second amplitude and a second baseline amplitude level of the second PPG signal, wherein determining the ratio of the first PPG signal and the second PPG signal comprises determining a ratio between the first perfusion index and the second perfusion index.
The instant application specification in para. [0134-0136] discloses that the perfusion ratio may be equal to amplitude divided by direct current (DC) and the system 200 may determine a ratio between the first perfusion index and the second perfusion index (e.g., a ratio of ratios).
However, Verkruijsse discloses determining a first perfusion index between a first amplitude and a first baseline amplitude level of the first PPG signal (“ratio of an AC component divided by a DC component of the first PPG signal”; “amplitudes defined as AC/DC”, para. [0046, 0106]); and determining a second perfusion index between a second amplitude and a second baseline amplitude level of the second PPG signal (“ratio of an AC component divided by a DC component of the second PPG signal”; “amplitudes defined as AC/DC”, para. [0046, 0106]), wherein determining the ratio of the first PPG signal and the second PPG signal comprises determining a ratio between the first perfusion index and the second perfusion index (“ratio of ratios of the PPG signals”, para. [0046, 0106, 0109]). (Examiner note: calculating the ratios of the AC components/amplitudes and the DC components/amplitudes of the PPG signals in Verkruijsse discloses calculating the perfusion index as defined in para. [0134-0136] of the instant application specification).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting, Robinson and Verkruijsse hereinabove, such that the method further comprises determining a first perfusion index between a first amplitude and a first baseline amplitude level of the first PPG signal; and determining a second perfusion index between a second amplitude and a second baseline amplitude level of the second PPG signal, wherein determining the ratio of the first PPG signal and the second PPG signal comprises determining a ratio between the first perfusion index and the second perfusion index, in view of the teachings of Verkruijsse, as this would aid in calculating the oxygen saturation based on the ratio of ratios.
Regarding claim 13, Richards, as modified by Whiting and Robinson hereinabove, discloses method of claim 1, further comprising: generating a blood oxygen saturation signal based at least in part on comparing the first PPG signal and the second PPG signal (“generate … metric based on … PPG signals …SpO2”, para. [0070, 0081-0082]). Richards, as modified by Whiting and Robinson hereinabove, does not expressly disclose identifying one or more calibration coefficients for blood oxygen saturation calculations, wherein the one or more blood oxygen saturation metrics are determined based at least in part on the blood oxygen saturation signal and the one or more calibration coefficients.
However, Verkruijsse discloses identifying one or more calibration coefficients for blood oxygen saturation calculations (“calibration factor”, para. [0109]), wherein the one or more blood oxygen saturation metrics are determined based at least in part on the blood oxygen saturation signal and the one or more calibration coefficients (“oxygen saturation … based on the ratio … in conjunction with … calibration curve … corresponding blood oxygen saturation para. [0038, 0109, 0153-0156]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises identifying one or more calibration coefficients for blood oxygen saturation calculations, wherein the one or more blood oxygen saturation metrics are determined based at least in part on the blood oxygen saturation signal and the one or more calibration coefficients, in view of the teachings of Verkruijsse, as this would aid in determining the oxygen saturations based on the ratio of ratios and the lookup table/calibration curve that provides the correspondence between such a ratio and the corresponding blood oxygen saturation.
Regarding claim 14, Richards, as modified by Whiting, Robinson and Verkruijsse hereinabove, discloses the method of claim 13, further comprising: acquiring the temperature data during the time interval (“biometric sensors … temperature”, para. [0110]); and modifying the first PPG signal and the second PPG signal based at least in part on the temperature data (“based on changes in temperature values … energize or de-energize different arrangements of light sources 102”, para. [0110]), wherein determining the one or more blood oxygen saturation metrics is based at least in part on modifying the first PPG signal and the second PPG signal (“generating HR, SpO2 … based on the combined signals”, para. [0110]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Whiting and Robinson, as applied to claim 1 above, and further in view of Lisogurski (US 20110034783 A1 – previously cited).
Regarding claim 17, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1. Richards, as modified by Whiting and Robinson hereinabove, does not expressly disclose the method further comprising: determining a breathing rate for the user based at least in part on the motion data, the first PPG signal, the second PPG signal, or a combination thereof, and updating the one or more blood oxygen saturation metrics for the user based at least in part on determining the breathing rate for the user.
However, Lisogurski discloses determining a breathing rate for the user based at least in part on the motion data, the first PPG signal, the second PPG signal, or a combination thereof (“photoplethysmographic … respiration rate”, para. [0035-0036]), and updating the one or more blood oxygen saturation metrics for the user based at least in part on determining the breathing rate for the user (“update factors … respiration rate, blood oxygen saturation, … threshold … update interval”, para. [0035-0037, 0040], figs. 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises determining a breathing rate for the user based at least in part on the motion data, the first PPG signal, the second PPG signal, or a combination thereof, and updating the one or more blood oxygen saturation metrics for the user based at least in part on determining the breathing rate for the user, in view of the teachings of Lisogurski, as this would aid in providing the appropriate quantity and rate of data to send to the patient monitor based on the update factors.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Whiting and Robinson, as applied to claim 1 above, and further in view of Chen (US 20180132789 A1 – previously cited).
Regarding claim 19, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1. Richards, as modified by Whiting and Robinson hereinabove, does not disclose the method further comprising: receiving physiological data associated with the user via the wearable ring device, the physiological data comprising at least heart rate data or PPG signal feature data, or both, wherein receiving the first PPG signal, the second PPG signal, or both, is based at least in part on the heart rate data satisfying a threshold heart rate metric and the PPG signal feature data satisfying a threshold PPG signal feature metric.
However, Chen discloses receiving physiological data associated with the user via the wearable device, the physiological data comprising at least heart rate data or PPG signal feature data, or both (“heart rate”; “features”, para. [0061-0063, 0077]), wherein receiving the first PPG signal, the second PPG signal, or both, is based at least in part on the heart rate data satisfying a threshold heart rate metric and the PPG signal feature data satisfying a threshold PPG signal feature metric (“light … physiological signal … threshold”; “heart rate … threshold … oxygen saturation”, para. [0031, 0061-0063]). Chen further discloses that an abnormal condition of the blood oxygen saturation occurs in connection with a sudden increase in the heart rate (para. [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises receiving physiological data associated with the user via the wearable ring device, the physiological data comprising at least heart rate data or PPG signal feature data, or both, wherein receiving the first PPG signal, the second PPG signal, or both, is based at least in part on the heart rate data satisfying a threshold heart rate metric and the PPG signal feature data satisfying a threshold PPG signal feature metric, in view of the teachings of Chen, as this would aid in minimizing power consumption by only measuring the blood oxygen saturation when the heart rate is higher than the threshold since an abnormal condition of the blood oxygen saturation occurs in connection with a sudden increase in the heart rate.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Richards in view of Whiting and Robinson, as applied to claim 1 above, and further in view of Baker, Jr. (US 7706852 B2 – previously cited).
Regarding claim 20, Richards, as modified by Whiting and Robinson hereinabove, discloses the method of claim 1, further comprising: transmitting, to the user device, the indication of the one or more blood oxygen saturation metrics (“transmit data … computer, mobile phone, … SpO2”, para. [0046]).
Richards, as modified by Whiting and Robinson hereinabove, does not expressly disclose determining a variation of the one or more blood oxygen saturation metrics for the user during the time interval; transmitting, to the user device, the indication of the one or more blood oxygen saturation metrics based at least in part on the variation exceeding a threshold, wherein displaying the indication of the one or more blood oxygen saturation metrics is based at least in part on the transmitting; and causing the graphical user interface to display a sleep disturbance alert based at least in part on the variation of the one or more blood oxygen saturation metrics exceeding the threshold.
However Baker, Jr. discloses determining a variation of the one or more blood oxygen saturation metrics for the user during the time interval (“saturation variations”, col. 5 lines 20-26, figs. 2-4, Abstract); transmitting, to the user device (“deliver data”; “display 18 … separate independent components operatively coupled”, col. 3 lines 35-46 & col. 4 lines 45-54, fig. 1A), the indication of the one or more blood oxygen saturation metrics based at least in part on the variation exceeding a threshold (“oxygen saturation values … output is provided … exceeds a threshold value … variations”, col. 3 line 47 - col. 4 line 46), wherein displaying the indication of the one or more blood oxygen saturation metrics is based at least in part on the transmitting (“deliver data … display screen 18”; “output is provided … exceeds a threshold value”, col. 3 line 35 - col. 4 line 46); and causing the graphical user interface (display 18, fig. 1A) to display a sleep disturbance alert based at least in part on the variation of the one or more blood oxygen saturation metrics exceeding the threshold (“sleep apnea … output … exceeds a threshold”; “visual alert”, col. 3 line 47 - 4 line 15). Baker, Jr. further discloses that average saturation changes and that small changes are disregarded, and remaining ones with a ratio above a threshold slope indicate possible sleep apnea or hypopnea (col. 2 lines 3-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richards, as modified by Whiting and Robinson hereinabove, such that the method further comprises determining a variation of the one or more blood oxygen saturation metrics for the user during the time interval; transmitting, to the user device, the indication of the one or more blood oxygen saturation metrics based at least in part on the variation exceeding a threshold, wherein displaying the indication of the one or more blood oxygen saturation metrics is based at least in part on the transmitting; and causing the graphical user interface to display a sleep disturbance alert based at least in part on the variation of the one or more blood oxygen saturation metrics exceeding the threshold, in view of the teachings of Baker, Jr., as this would aid in informing the patient, nurse, or physician of the detected unstable saturation variations indicating possible sleep apnea or hypopnea by displaying a visual alert.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Pantelopoulos (US 20170209055 A1) directed to a process 200 for determining arterial stiffness comprising determining whether one or more user conditions suitable for collecting PPG data to obtain pulse waveforms are satisfied, the one or more conditions including motion of the user below a motion threshold and a body temperature of the user meeting a criterion (fig. 2, para. [0024, 0113-0114, 0117]); Dua (US 12635958 B1) directed to pulse oximetry systems and methods for background sensing of peripheral oxygen saturation and discloses criteria used as a prerequisite for beginning measurement of the physiological signals (fig. 4, col. 16 lines 7-20 & col. 27 lines 20-57).
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/A.E.H./Examiner, Art Unit 3791 /AURELIE H TU/Primary Examiner, Art Unit 3791
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