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 Augst 10th, 2026. The examiner acknowledges the amendments to claims 1, 10, and 13.
Claims 1-19 remain pending in the application.
Response to Arguments
Applicant's arguments filed August 10th, 2026, with respect to the drawing objections have been fully considered. The drawing objections are withdrawn.
Applicant’s arguments filed August 10th, 2026, with respect to the rejections under 35 USC § 112 have been fully considered. The rejections under 35 USC § 112 are withdrawn.
Applicant’s arguments filed August 10th, 2026, with respect to the rejections under 35 USC § 101 have been fully considered and are persuasive. The rejections under 35 USC § 101 are withdrawn.
Applicant’s arguments filed August 10th, 2026, with respect to the rejections under 35 USC § 102 and 103, with respect to “caus[ing] the processor to sequentially activate the light emitting diodes in a first pattern and a second pattern different than the first pattern” have been fully 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.
Furthermore, at pages 11-12, Applicant argues that De Hann fails to disclose, teach, or even suggest a plurality of light-emitting diodes. Examiner respectfully disagrees. De Hann does teach an illumination unit comprising two radiation sources such as LEDs, that more than two radiation sources may be provided, and that the radiation sources may be controllable (para. [0027, 0054-0055]). Therefore, De Hann does teach a plurality of light-emitting diodes.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 line 3 “light from-at least one” should recite “light from at least one”.
Appropriate correction is required.
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 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over De Haan (US 20210219884 A1 – previously cited) in view of Lee (US 20220364924 A1 -previously cited), and further in view of Deane (US 20200390335 A1).
Regarding claim 1, De Haan discloses a biometric measurement device (system 1, fig. 1, para. 0054]) comprising: a photodiode array (“detection unit 4 … array of photo-diodes”, para. [0056], fig. 1) comprising a plurality of photodiodes (“16 photodiodes”; “plurality of detection elements … photodiodes”, para. [0029, 0039]) and at least one polarization filter covering at least one of the plurality of photodiodes (“polarizer 10 in front of or as part of the detection unit 4”; “polarizer a polarization filter … used”, para. [0040, 0080, 0086], figs. 2-4); and a light-emitting diode array (illumination unit 2 comprising radiation sources 20, 21, as seen in fig. 1, “LEDs”, para. [0054]) comprising a plurality of light-emitting diodes proximate to the photodiode array (radiation sources 20, 21, as seen in fig. 1, para. [0054-0055]); and a processor (“processing unit 11 … vital signs determination unit 5 … computer”, para. [0057-0058]), wherein the photodiode array (“detection unit 4 … array of photo-diodes”, para. [0056], fig. 1) is configured to (Examiner’s Note: functional language, i.e., capable of) receive a reflected waveform from light emitted from the light-emitting diode array (“detect electromagnetic radiation reflected from the skin region of the subject 50”, para. [0056]), wherein the processor (“processing unit 11 … vital signs determination unit 5 … computer”, para. [0057-0058]) is configured to determine at least one physiological parameter based on a pulsatile (AC) component and a static (DC) component of the reflected waveform (“signature vector (PBV vector) … ratio AC/DC … relative signal strength/pulsatility … PBV vector is chosen to correspond with the relative pulsatilities in the detection signals for … SpO2 value”, para. [0106-0111]).
De Haan further discloses that the present invention may also be applied in other fields such as neonate monitoring, general surveillance applications, security monitoring or so-called live style environments, such as fitness equipment, a wearable, a handheld device like a smartphone, or the like.
De Haan does not expressly disclose that the plurality of light-emitting diodes is proximate to the photodiode array; a non-volatile memory device; and that the processor is in electronic communication with the non-volatile memory device.
However, Lee directed to an electronic device for detecting whether the electronic device is worn using polarization and selectively measuring a biosignal discloses a plurality of light-emitting diodes (as least one LED 402/ LED module 1202, as seen in figs. 4 & 12, para. [0136]) proximate to a photodiode array (photodiodes 410, 420, 1210, 1220, 1230, 1240 figs. 4 & 12, para. [0137-0138]); a non-volatile memory device (non-volatile memory 134, para. [0033], fig. 1); a processor (processor 120/430, figs. 1 & 4; “processor 120”, para. [0033]); and that the processor is in electronic communication with the non-volatile memory device (as seen in fig. 1, para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan such that the plurality of light-emitting diodes are proximate to the photodiode array and such that the device comprises a non-volatile memory device, the processor is in electronic communication with the non-volatile memory device, in view of the teachings of Lee, as this would aid in integrating/arranging the system/optical sensors of De Haan into a wearable/electronic device for measuring biometric information and would aid in storing the received data from the sensor module (Lee, para. [0033, 0134]).
De Haan, as modified by Lee hereinabove, does not disclose wherein the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to sequentially activate the light emitting diodes in a first pattern and a second pattern different than the first pattern.
However, Deane directed to a nozzle head comprising at least one light emitter 42 and at least one light receiver 40 that allows for the characterization of oxygen saturation in human tissue (para. [0039]) discloses a light-emitting diode array comprising a plurality of light-emitting diodes (“array”; “LEDs”, para. [0032, 0039, 0053], fig. 6) wherein the non-volatile memory device comprises instructions which, when executed by the processor (“non-volatile memory ... code ... executed”, para. [0037]), cause the processor (controller 30 comprising processor 32 and memory 34; “controls operation of the hardware components”, para. [0037]) to sequentially activate the light emitting diodes in a first pattern and a second pattern different than the first pattern (“plurality of different wavelengths are sequentially emitted in a first sequential pattern, and then emitted in a second sequential pattern which is the reverse of the first sequential pattern”, Abstract, para. [0032, 0052-0054, 0059], fig. 6). Deane further discloses that the light source generates light in at least two wavelengths, such as 480 nm and 680 nm that allows for the characterization of oxygen saturation in human tissue (para. [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan, as modified by Lee hereinabove, such that the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to sequentially activate the light emitting diodes in a first pattern and a second pattern different than the first pattern, in view of the teachings of Deane, as this would aid in obtaining a common average time point for the reflectance data, which is the same over all color channels, resulting in fewer spectrum sampling errors and allows for the characterization of oxygen saturation in human tissue (Deane, para. [0039, 0051, 0059]).
Regarding claim 2, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1, wherein the processor (“processing unit 11 … vital signs determination unit 5 … computer”, para. [0057-0058]) is further configured to determine one or more health metrics utilizing the at least one physiological parameter, wherein the one or more health metrics are selected from the group consisting of respiratory rate, heart rate, blood oxygen saturation, blood pressure, heart rate variability, maximal oxygen consumption, systolic volume, cardiac output, cardiac index, metabolic rate, and metabolic fitness (“SpO2”; “monitoring … blood pressure, cardiac output, respiration”, para. [0058, 0106-0111, 0115-0116]).
Regarding claim 3, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1, wherein at least one of the plurality of light-emitting diodes is configured to emit polarized light (“emit electromagnetic radiation with different polarization”; “polarized light for illumination”, para. [0036, 0080]).
Regarding claim 4, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1, further comprising at least one polarization filter on at least one of the plurality of light-emitting diodes (polarizer 9, 9a, 9b, as seen in figs. 2-3, “multiple … polarization filter”, para. [0080, 0085-0086]).
Regarding claim 5, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1, wherein a first-emitting diode of the plurality of light-emitting diodes is configured to emit light having a first wavelength (“first modulation frequency for modulating the emitted electromagnetic radiation”, para. [0033, 0038, 0054-0055]), and wherein a second-emitting diode of the plurality of light-emitting diodes is configured to emit light having a second wavelength different than the first wavelength (“second modulation frequency applied by the second radiation source for modulating the emitted electromagnetic radiation”, para. [0033, 0038, 0054-0055]) (“first radiation source 20 and a second radiation source 21, which are configured to emit differently modulated electromagnetic radiation in two or more wavelength channels”; ““range from 400 nm to 1000 nm”, para. [0038, 0054-0055, 0065]).
Regarding claim 7, upon the modification of De Haan to integrate/arrange the system/optical sensors into a wearable/electronic device for measuring biometric information, as described with respect to claim 1 above, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1, wherein the plurality of photodiodes (Lee, photodiodes 1210, 1220, 1230, 1240, fig. 12) is arranged in an annular (Lee, as seen inf fig. 12) configuration around the light-emitting diode array (Lee, LED module 1202 having at least one LED, as seen in fig. 12).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view Lee and Deane, as applied to claim 1 above, and further in view of Hu (US 20260083329 A1).
Regarding claim 6, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1. De Haan, as modified by Lee and Deane hereinabove, does not disclose wherein the plurality of light-emitting diodes is arranged in an annular configuration around the photodiode array.
However, Hu directed to an opto-physiological sensor system comprising a plurality of illumination sources 105, 107, 109, 111 (fig. 1, para. [0039]) and a plurality of photodiodes 101 (fig. 1, para. [0039]) discloses wherein the plurality of light-emitting diodes (105, 107, 109, 111, fig. 1) is arranged in an annular configuration around the photodiode array (101, fig. 1) (as seen in fig. 1, “concentric circles”, para. [0167-0168]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee and Deane hereinabove, such that the plurality of light-emitting diodes is arranged in an annular configuration around the photodiode array, in view of the teachings of Hu, as this would aid in determining SpO2 for specific tissue types by positioning light emitting diodes of longer wavelengths further away from each of the photodiodes such that the wavelength of the illumination sources increases with radial distance from the photodiode (para. [0167-0168]).
Claims 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view Lee and Deane, as applied to claim 1 above, and further in view of Schilthuizen (US 20170172476 A1).
Regarding claim 8, De Haan, as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1. De Haan, as modified by Lee and Deane hereinabove, does not disclose wherein the plurality of photodiodes and the plurality of light-emitting diodes are arranged in a linear array.
However, Schilthuizen directed to a measurement device worn on the body for measuring a signal representative of a physiological parameter of a user comprising a plurality of light receiving surfaces/photodiodes 16 (fig. 1, para. [0019, 0041]) and a plurality of light emitting sources/LEDs 12 (fig. 1, para. [0019, 0041]) discloses wherein the plurality of photodiodes (16, fig. 1) and the plurality of light-emitting diodes (12, fig. 1) are arranged in a linear array (as seen in fig. 1, “array”, para. [0032]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee and Deane hereinabove, such that the plurality of photodiodes and the plurality of light-emitting diodes are arranged in a linear array, in view of the teachings of Schilthuizen, as this would aid in arranging the lighting emitting sources and the light receiving surfaces in a position close to each other to maximize the light coupling and the light receiving and would aid in incorporating/securing the lighting emitting sources and the light receiving surfaces on a band of a wrist worn device to enable abutment against the palmar side of a wrist for measuring a physiological parameter of a user (Schilthuizen, para. [0035, 0102]).
Regarding claim 9, De Haan, as modified by Lee and Deane hereinabove, discloses biometric measurement device of claim 1. De Haan further discloses a control unit 3 configured to control the radiation sources and emitting radiation in at least two or three different wavelength intervals (RGB, or invisible wavelengths using NIR) in a modulated (frequency or phase) (para. [0055, 0067]).
De Haan, as modified by Lee and Deane hereinabove, does not disclose wherein the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to: activate a first light-emitting diode of the plurality of light-emitting diodes at a first time to emit light having a first wavelength; receive, with at least one of the plurality of photodiodes, a first reflected waveform from the first light-emitting diode; activate a second light-emitting diode of the plurality of light-emitting diodes at a second time to emit light having a second wavelength; and receive, with at least one of the plurality of photodiodes, a second reflected waveform from the second light-emitting diode.
However, Schilthuizen directed to a measurement device worn on the body for measuring a signal representative of a physiological parameter of a user comprising a plurality of light receiving surfaces/photodiodes 16 (fig. 1, para. [0019, 0041]) and a plurality of light emitting sources/LEDs 12 (fig. 1, para. [0019, 0041]) discloses the processor (control unit 4 & processing unit 6, figs. 1-2) to: activate a first light-emitting diode of the plurality of light-emitting diodes at a first time to emit light having a first wavelength (“first measurement session … at least one light source … first wavelength”, para. [0025, 0053, 0109]); receive, with at least one of the plurality of photodiodes, a first reflected waveform from the first light-emitting diode (“first measurement session”; “received light signal … at least one light receiver”; “600-660 nm”; “reflected light”, para. [0025-0026, 0053, 0088]); activate a second light-emitting diode of the plurality of light-emitting diodes at a second time to emit light having a second wavelength (“second measurement session … at least one light source … second wavelength”, para. [0026, 0053, 0109]); and receive, with at least one of the plurality of photodiodes, a second reflected waveform from the second light-emitting diode (“second measurement session”; “received light signal … at least one light receiver”; “880-940 nm”; “reflected light”, para. [0025-0026, 0053, 0088]). Schilthuizen further discloses that using light in a first wavelength range followed by light in a second wavelength range etc. allows for additional health indicators to be determined and/or to determine the heart rate parameter via two measurements (para. [0057, 0109]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee and Deane hereinabove, such that the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to: activate a first light-emitting diode of the plurality of light-emitting diodes at a first time to emit light having a first wavelength; receive, with at least one of the plurality of photodiodes, a first reflected waveform from the first light-emitting diode; activate a second light-emitting diode of the plurality of light-emitting diodes at a second time to emit light having a second wavelength; and receive, with at least one of the plurality of photodiodes, a second reflected waveform from the second light-emitting diode, in view of the teachings of Schilthuizen, as this would aid in determining additional health indicators.
Regarding claim 12, De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, discloses the biometric measurement device of claim 9. De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, does not disclose wherein the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L.
However, Lee directed to an electronic device for detecting whether the electronic device is worn using polarization and selectively measuring a biosignal comprising a plurality of light-emitting diodes (as least one LED 402/ LED module 1202, as seen in figs. 4 & 12, para. [0136]), a photodiode array (photodiodes 410, 420, 1210, 1220, 1230, 1240 figs. 4 & 12, para. [0137-0138]), and a polarizer 411/421/1211 applied to a photodiode (para. [0082, 0092, 0136]) discloses the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L (“polarizer having a polarization angle of 0 to 90 degrees … polarization angle of 90°”, para. [0092, 0136]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, such that the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L, in view of the teachings of Lee, as such a modification would have been merely a substitution of the polarization filters of De Haan for the polarizer having a polarization angle of Lee and would aid in more accurately measuring a biosignal (Lee para. [0006]) and improve light robustness or decrease sensitivity for specular reflections (De Haan, para. [0071]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view Lee, Deane, and Schilthuizen, as applied to claim 9 above, further in view of Priem (US 20220369943 A1), and further in view of Bolus (US 11660005 B1).
Regarding claim 10, De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, discloses the biometric measurement device of claim 9. De Haan further discloses the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1 and the second reflected waveform through the at least one polarization filter filters collected from the light having the second wavelength λ2 (“two or more wavelength channels and/or in two or more polarization channels”; “received light with different polarization directions”, para. [0027, 0040-0041, 0063, 0080, 0110]).
De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, does not disclose wherein the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to determine oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants, and wherein R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; DCλ1 is a static (DC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected through the at least one polarization filter from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second reflected waveform through the at least one polarization filter collected from the light having the second wavelength λ2.
However, Priem directed to a method intended for the evaluation of the quality of ratio of ratios (RR) values computed for at least two photoplethysmographic (PPG) signals discloses determining oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants (
PNG
media_image1.png
37
170
media_image1.png
Greyscale
“SpO2 value is obtained by applying a calibration model … B and C are parameters of the model that may be optimized para. [0111]). Priem further discloses calculating the ratio of ratios RR/RR value (para. [0075-0078]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee, Deane, and Schilthuizen hereinabove, such that the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to determine oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants, in view of the teachings of Priem, as this would aid in determining SpO2 values by applying a calibration model to the measured RR value.
De Haan, as modified by Lee, Deane, Schilthuizen, and Priem hereinabove, does not disclose wherein R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; DCλ1 is a static (DC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected through the at least one polarization filter from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second reflected waveform through the at least one polarization filter collected from the light having the second wavelength λ2.
However, Bolus directed to a cardiorespiratory analysis system including a PPG sensor discloses deriving SpO2 data points discloses wherein R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
(
PNG
media_image2.png
104
326
media_image2.png
Greyscale
, col. 4 lines 35-54 & col. 12 lines 7-47) where ACrms,λ1 is a root-mean-square of a pulsatile component of the first reflected waveform collected from the light having the first wavelength λ1 (“pulsatile component”; “ACrms RED is a root means square of the red AC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); DCλ1 is a static (DC) component of the first reflected waveform collected from the light having the first wavelength λ1 (“non-pulsatile component”; “DCrms RED is a root means square of the red DC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected from the light having the second wavelength λ2 (“pulsatile component”; ACrms IR is a root means square of the IR AC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); and DCλ2 is a static (DC) component of the second reflected waveform collected from the light having the second wavelength λ2 (“non-pulsatile component”; “DCrms IR is a root means square of the IR DC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Lee, Deane, Schilthuizen, and Priem hereinabove, such that R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; DCλ1 is a static (DC) component of the first reflected waveform through the at least one polarization filter collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected through the at least one polarization filter from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second reflected waveform through the at least one polarization filter collected from the light having the second wavelength λ2, in view of the teachings of Bolus, as this would aid in calculating the optical ratio for calculating oxygen saturation content.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view Lee and Deane, as applied to claim 1 above, further in view of De Haan (US 20210361203 A1) (herein De Haan 1203).
Regarding claim 11, De Haan as modified by Lee and Deane hereinabove, discloses the biometric measurement device of claim 1. De Haan as modified by Lee and Deane hereinabove, does not disclose wherein the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to calculate a physiological parameter St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
wherein f is a function; (ACλn,P) is a pulsatile (AC) component of the reflected waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P; DC(λn,P) is the static (DC) component of the reflected waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P.
However, De Haan 1203 discloses calculating a physiological parameter St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
(“determines SpO2 indirectly based on the signal quality … SpO2 ‘signatures’ …
P
b
v
→
”, para. [0092]) wherein f is a function (“APBV method … SpO2 ‘signatures’ … mathematically”, para. [0092]);
A
C
(
λ
n
,
P
)
is a pulsatile (AC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P (“first detection signal comprising reflection information in a first wavelength channel and a first polarization channel having a first polarization direction”; “ratio AC/DC … relative signal strength/pulsatility”, para. [0039, 0075. 0088]);
D
C
(
λ
n
,
P
)
is the static (DC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P (“first detection signal comprising reflection information in a first wavelength channel and a first polarization channel having a first polarization direction”; “ratio AC/DC … relative signal strength/pulsatility”, para. [0037, 0039, 0075, 0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan as modified by Lee and Deane hereinabove, such that the non-volatile memory device comprises instructions which, when executed by the processor, cause the processor to calculate a physiological parameter St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
wherein f is a function;
A
C
(
λ
n
,
P
)
is a pulsatile (AC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P;
D
C
(
λ
n
,
P
)
is the static (DC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P, in view of the teachings of De Haan 1203, as this would aid in determining SpO2 using the APBV method and exploiting various combinations of detection signals and polarization/wavelength channels.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over De Haan (US 20210219884 A1 – previously cited) in view of Deane.
Regarding claim 13, De Haan discloses a method of performing photoplethysmography (“method”, Abstract), the method comprising: emitting light from at least one light-emitting diode (“emit differently modulated electromagnetic radiation in two or more wavelength channels”, para. [0038, 0054, 0065]) of a plurality of light-emitting diodes (radiation sources 20, 21, fig. 1, para. [0054-0055]) arranged in a light-emitting diode array (illumination unit 2, as seen in fig. 1, para. [0054-0055]); receiving a polarized waveform, with at least one photodiode (“both the cross- and the parallel polarized channels can be obtained”; “signals from the individual detection elements … two signals obtained with different polarization filters”, para. [0040, 0056, 0063, 0071]) of a plurality of photodiodes (“16 photodiodes”; “plurality of detection elements … photodiodes”, para. [0029, 0039]) arranged in a photodiode array (“detection unit 4 … array of photo-diodes”, para. [0056], fig. 1), from reflected light of the light emitted by the at least one light-emitting diode (“detect electromagnetic radiation reflected from the skin region of the subject 50”, para. [0056]); and determining at least one physiological parameter based on a pulsatile (AC) component and a static (DC) component of the polarized waveform (“signature vector (PBV vector) … ratio AC/DC … relative signal strength/pulsatility … PBV vector is chosen to correspond with the relative pulsatilities in the detection signals for … SpO2 value”, para. [0106-0111]).
De Haan does not disclose that the light is emitted from the at least one light-emitting diode of the plurality of light-emitting diodes arranged in the light-emitting diode array by sequentially activating the light- emitting diodes in a first pattern and a second pattern different than the first pattern.
However, Deane directed to a nozzle head comprising at least one light emitter 42 and at least one light receiver 40 that allows for the characterization of oxygen saturation in human tissue (para. [0039]) discloses a light-emitting diode array comprising a plurality of light-emitting diodes (“array”; “LEDs”, para. [0032, 0039, 0053], fig. 6) and emitting light from at least one light-emitting diode of the plurality of light-emitting diodes arranged in the light-emitting diode array by sequentially activate the light emitting diodes in a first pattern and a second pattern different than the first pattern (“plurality of different wavelengths are sequentially emitted in a first sequential pattern, and then emitted in a second sequential pattern which is the reverse of the first sequential pattern”, Abstract, para. [0032, 0052-0054, 0059], fig. 6). Deane further discloses that the light source generates light in at least two wavelengths, such as 480 nm and 680 nm that allows for the characterization of oxygen saturation in human tissue (para. [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan such that the light is emitted from the at least one light-emitting diode of the plurality of light-emitting diodes arranged in the light-emitting diode array by sequentially activating the light- emitting diodes in a first pattern and a second pattern different than the first pattern, in view of the teachings of Deane, as this would aid in obtaining a common average time point for the reflectance data, which is the same over all color channels, resulting in fewer spectrum sampling errors and allows for the characterization of oxygen saturation in human tissue (Deane, para. [0039, 0051, 0059]).
Regarding claim 14, De Haan, as modified by Deane hereinabove, discloses the method of claim 13, wherein the emitting the light from the at least one light-emitting diode comprises emitting polarized light (“emit electromagnetic radiation with different polarization”; “polarized light for illumination”, para. [0036, 0080]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view of Deane, as applied to claim 13 above, and further in view of Schilthuizen.
Regarding claim 15, De Haan, as modified by Deane hereinabove, discloses the method of claim 13. De Haan, as modified by Deane hereinabove, does not disclose wherein the emitting the light from the at least one light-emitting diode comprises: emitting a first light signal having a first wavelength from a first light-emitting diode of the plurality of light-emitting diodes at a first time; receiving a first polarized waveform from a first reflected signal of the first light signal; emitting a second light signal having a second wavelength from a second light-emitting diode of the plurality of light-emitting diodes at a second time different than the first time; and receiving a second polarized waveform from a second reflected signal of the second light signal.
However, Schilthuizen directed to a measurement device worn on the body for measuring a signal representative of a physiological parameter of a user comprising a plurality of light receiving surfaces/photodiodes 16 (fig. 1, para. [0019, 0041]) and a plurality of light emitting sources/LEDs 12 (fig. 1, para. [0019, 0041]) discloses wherein the emitting the light from the at least one light-emitting diode (para. [0025, 0053]) comprises: emitting a first light signal having a first wavelength from a first light-emitting diode of the plurality of light-emitting diodes at a first time (“first measurement session … at least one light source … first wavelength”; “predetermined amount of time”, para. [0025, 0053, 0109]); receiving a first polarized waveform from a first reflected signal of the first light signal (“first measurement session”; “received light signal … at least one light receiver”; “600-660 nm”; “reflected light”, para. [0025-0026, 0053, 0088]); emitting a second light signal having a second wavelength from a second light-emitting diode of the plurality of light-emitting diodes at a second time different than the first time (“second measurement session … at least one light source … second wavelength”; “predetermined amount of time”, para. [0026, 0053, 0109]); and receiving a second polarized waveform from a second reflected signal of the second light signal (“second measurement session”; “received light signal … at least one light receiver”; “880-940 nm”; “reflected light”, para. [0025-0026, 0053, 0088]). Schilthuizen further discloses that using light in a first wavelength range followed by light in a second wavelength range etc. allows for additional health indicators to be determined and/or to determine the heart rate parameter via two measurements (para. [0057, 0109]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Deane hereinabove, such that the emitting the light from the at least one light-emitting diode comprises: emitting a first light signal having a first wavelength from a first light-emitting diode of the plurality of light-emitting diodes at a first time; receiving a first polarized waveform from a first reflected signal of the first light signal; emitting a second light signal having a second wavelength from a second light-emitting diode of the plurality of light-emitting diodes at a second time different than the first time; and receiving a second polarized waveform from a second reflected signal of the second light signal, in view of the teachings of Schilthuizen, as this would aid in determining additional health indicators.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view of Deane and Schilthuizen, as applied to claim 15 above, further in view of Priem, and further in view of Bolus.
Regarding claim 16, De Haan, as modified by Deane and Schilthuizen hereinabove, discloses the method of claim 15. De Haan further discloses the first reflected waveform through one or more polarization filters collected from the light having the first wavelength λ1 and the second reflected waveform through one of more polarization filters collected from the light having the second wavelength λ2 (“two or more wavelength channels and/or in two or more polarization channels”; “received light with different polarization directions”, para. [0027, 0040-0041, 0063, 0080, 0110]).
De Haan, as modified by Deane and Schilthuizen hereinabove, does not disclose determining oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants, and wherein R is calculated as follows:
R
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first polarized waveform collected from the light having the first wavelength λ1; DCλ1is a static (DC) component of the first polarized waveform collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second polarized waveform collected from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second polarized waveform collected from the light having the second wavelength λ2.
However, Priem directed to a method intended for the evaluation of the quality of ratio of ratios (RR) values computed for at least two photoplethysmographic (PPG) signals discloses determining oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants (
PNG
media_image1.png
37
170
media_image1.png
Greyscale
“SpO2 value is obtained by applying a calibration model … B and C are parameters of the model that may be optimized para. [0111]). Priem further discloses calculating the ratio of ratios RR/RR value (para. [0075-0078]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Deane and Schilthuizen hereinabove, such that the method comprises determining oxygen saturation SpO2 as follows: SpO2=α-β.R wherein α and β are constants, in view of the teachings of Priem, as this would aid in determining SpO2 values by applying a calibration model to the measured RR value.
De Haan, as modified by Deane, Schilthuizen, and Priem hereinabove, does not disclose wherein R is calculated as follows:
R
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first polarized waveform collected from the light having the first wavelength λ1; DCλ1is a static (DC) component of the first polarized waveform collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second polarized waveform collected from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second polarized waveform collected from the light having the second wavelength λ2.
However, Bolus directed to a cardiorespiratory analysis system including a PPG sensor discloses deriving SpO2 data points discloses wherein R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
(
PNG
media_image2.png
104
326
media_image2.png
Greyscale
, col. 4 lines 35-54 & col. 12 lines 7-47) where ACrms,λ1 is a root-mean-square of a pulsatile component of the first reflected waveform collected from the light having the first wavelength λ1 (“pulsatile component”; “ACrms RED is a root means square of the red AC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); DCλ1 is a static (DC) component of the first reflected waveform through one or more polarization filters collected from the light having the first wavelength λ1 (“non-pulsatile component”; “DCrms RED is a root means square of the red DC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected from the light having the second wavelength λ2 (“pulsatile component”; ACrms IR is a root means square of the IR AC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47); and DCλ2 is a static (DC) component of the second reflected waveform collected from the light having the second wavelength λ2 (“non-pulsatile component”; “DCrms IR is a root means square of the IR DC data”, col. 4 lines 35-54 & col. 11 lines 49-51 & col. 12 lines 7-47).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Deane, Schilthuizen, and Priem hereinabove, such that R is calculated as follows:
=
(
A
C
r
m
s
,
λ
1
/
D
C
λ
1
)
/
A
C
r
m
s
,
λ
2
/
D
C
λ
2
)
where ACrms,λ1 is a root-mean-square of a pulsatile (AC) component of the first reflected waveform through one or more polarization filters collected from the light having the first wavelength λ1; DCλ1 is a static (DC) component of the first reflected waveform through one or more polarization filters collected from the light having the first wavelength λ1; ACrms,λ2 is a root-mean-square of a pulsatile (AC) component of the second reflected waveform collected through one or more polarization filters from the light having the second wavelength λ2; and DCλ2 is a static (DC) component of the second reflected waveform through one of more polarization filters collected from the light having the second wavelength λ2, in view of the teachings of Bolus, as this would aid in calculating the optical ratio for calculating oxygen saturation content.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view of Deane, as applied to claim 13 above, and further in view of De Haan 1203.
Regarding claim 17, De Haan, as modified by Deane hereinabove, discloses the method of claim 13. De Haan, as modified by Deane hereinabove, does not disclose wherein the determining the at least one physiological parameter comprises determining signal St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
wherein f is a function;
A
C
(
λ
n
,
P
)
is a pulsatile (AC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P;
D
C
(
λ
n
,
P
)
is the static (DC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P.
However, De Haan 1203 discloses wherein the determining the at least one physiological parameter comprises determining signal St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
(“determines SpO2 indirectly based on the signal quality … SpO2 ‘signatures’ …
P
b
v
→
”, para. [0092]) wherein f is a function (“APBV method … SpO2 ‘signatures’ … mathematically”, para. [0092]);
A
C
(
λ
n
,
P
)
is a pulsatile (AC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P (“first detection signal comprising reflection information in a first wavelength channel and a first polarization channel having a first polarization direction”; “ratio AC/DC … relative signal strength/pulsatility”, para. [0039, 0075. 0088]);
D
C
(
λ
n
,
P
)
is the static (DC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P (“first detection signal comprising reflection information in a first wavelength channel and a first polarization channel having a first polarization direction”; “ratio AC/DC … relative signal strength/pulsatility”, para. [0037, 0039, 0075, 0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Haan, as modified by Deane hereinabove, such that the determining the at least one physiological parameter comprises determining signal St at a time t as follows:
S
t
=
f
A
C
(
λ
n
,
P
)
D
C
(
λ
n
,
P
)
wherein f is a function;
A
C
(
λ
n
,
P
)
is a pulsatile (AC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and a polarization state P;
D
C
(
λ
n
,
P
)
is the static (DC) component of the polarized waveform collected with light from a light-emitting diode n having a wavelength λn and the polarization state P, in view of the teachings of De Haan 1203, as this would aid in determining SpO2 using the APBV method and exploiting various combinations of detection signals and polarization/wavelength channels.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view of Deane and De Haan 1203, as applied to claim 17 above, and further in view of Lee.
Regarding claim 18, De Haan, as modified by Deane and De Haan 1203 hereinabove, discloses the method of claim 17. De Haan, as modified by Deane and De Haan 1203 hereinabove, does not disclose wherein the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L.
However, Lee directed to an electronic device for detecting whether the electronic device is worn using polarization and selectively measuring a biosignal comprising a plurality of light-emitting diodes (as least one LED 402/ LED module 1202, as seen in figs. 4 & 12, para. [0136]), a photodiode array (photodiodes 410, 420, 1210, 1220, 1230, 1240 figs. 4 & 12, para. [0137-0138]), and a polarizer 411/421/1211 applied to a photodiode (para. [0082, 0092, 0136]) discloses the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L (“polarizer having a polarization angle of 0 to 90 degrees … polarization angle of 90°”, para. [0092, 0136]).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Deane and De Haan 1203 hereinabove, such that the polarization state P is selected from the group consisting of 0°, 30°, 45°, 60°, 90°, 120°, 135°, 150°, R, and L, in view of the teachings of Lee, as such a modification would have been merely a substitution of the polarization filters of De Haan for the polarizer having a polarization angle of Lee and would aid in more accurately measuring a biosignal (Lee para. [0006]) and improve light robustness or decrease sensitivity for specular reflections (De Haan, para. [0071]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over De Haan in view of Deane, as applied to claim 13 above, and further in view of Dashevsky (US 10561863 B1).
Regarding claim 19, De Haan, as modified by Deane hereinabove, discloses the method of claim 13. De Haan, as modified by Deane hereinabove, does not disclose the method further comprising processing the polarized waveform with an artificial neural network model to improve accuracy and a wider range of healthcare metric prediction.
However, Dashevsky directed to a wearable device for comprehensive bio-monitoring of physiologic metrics discloses processing the signals with an artificial neural network model to improve accuracy and a wider range of healthcare metric prediction (“processor … algorithm … identifying or predicting dangerous health conditions … signals received from the connected sensors … calculates … oxygen saturation … artificial neural network”, col. 31 line 33-col. 32 line 42).
It would have been obvious to one of ordinary skill in the art prior to the claimed invention being made to modify De Haan, as modified by Deane hereinabove, such that the method further comprises processing the polarized waveform with an artificial neural network model to improve accuracy and a wider range of healthcare metric prediction, in view of the teachings of Dashevsky, as this would aid in calculating physiological metrics and identifying or predicting dangerous health conditions by incorporating the algorithm/artificial neural network of Dashevsky.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jang (US 20200041342 A1) directed to a method and an apparatus for analyzing a component of an object – see para. [0061, 0080-0086];
Saito (US 20220225865 A1) directed to an endoscope system that obtains the oxygen saturation of an object – see para. [0040, 0044].
Heikkinen (US 20230114269 A1) directed to devices for blood oxygen measurement – see para. [0124, 0144];
Bhat (US 20170337413 A1) directed to a bio-sensor device – see para [0047, 0102].
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
