DETAILED ACTION
Applicant’s arguments, filed on 09/18/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 09/18/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
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 .
Specification
The amendment filed 09/18/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The addition of the paragraph before the last paragraph on page 8 saying “Fig. 2C illustrates the full scattering profiles (FSPs) in which each curve is a scattering profile of a single phantom-curve with concentrations varying to produce scattering coefficients from 8
c
m
-
1
to 26
c
m
-
1
. The angle at which the light intensity remains constant, independent of the medium’s scattering at a selected wavelength, is the IPL point 202. Therefore, measurements at the IPL point 202 provide an accurate absorption assessment while eliminating scattering dependence”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 18 is objected to because of the following informalities:
In claim 18, line 2, “at multiple angles” should read “at the multiple angles”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “a first orientation” in lines 17-18. It is unclear if this limitation is referring to the first orientation introduced earlier in the claim, or a different orientation. If it is referring to the first orientation introduced earlier in the claim, it needs to refer back to it. If it is referring to a different orientation, it needs to be distinguished from the first orientation introduced earlier in the claim. For purposes of examination, it is being interpreted as referring to the first orientation introduced earlier in the claim. Claims 208 and 17-18 are also rejected due to their dependency on claim 1.
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.
Claims 1, 3, 6, 9, 14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baek (US 20180078155) in further view of Baker (US 20110077485) and Dimaio (WO 2017074505).
Regarding independent claim 1, Baek teaches a system for detecting light scattered from a tissue for extracting oxygen saturation and pulse rate comprising ([0020]: “FIG. 3 shows a block diagram representation of an example biological signal monitoring system 300 according to some implementations”):
(i) light source for illuminating the tissue in at least two orientations, said light source having a beam alignable to pass through the tissue ([0081]: “The optical sensor 800 may include one or more light emitters 802 (also referred to herein collectively as “the light emitter,” “the light transmitter” or “the light source”)”; [0083]: “the optical sensor 800 includes one or more planar optical structures 806 (collectively referred to hereinafter as “planar optics”) configured to direct optical light emitted from the light emitter 802 into two light beams 803A and 803B”; [0085]: “the two light beams 803A and 803B output by the light emitter 802 propagate into the tissues perpendicular to the long axis of the artery 808 beneath the skin”; Fig. 8); and
(ii) a plurality of photodetectors ([0082]: “The optical sensor 800 also includes one or more light detectors 804 (also referred to herein collectively as “the light detector” or “the photodetector”)”).
However, Baek is silent on the location of the multiple photodetectors.
Baker teaches a monitoring system that may include an emission feature capable of emitting light into tissue. Specifically, Baker teaches the plurality of photodetectors placed at multiple angles with respect to the tissue for collecting the light scattered from the tissue at the multiple angles at the same time (Fig. 8; [0053]: “FIG. 8 illustrates an embodiment including multiple detectors 500 and a single emitter 502 capable of emitting and detecting photon density waves passed through tissue 504”). Baek and Baker are analogous arts as they are both related to systems that pass light through tissue and provide a measurement.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the location of the plurality of photodetectors from Baker into the system from Baek as Baek is silent on the location of the multiple photodetectors, and Baker discloses a suitable location in an analogous device.
The Baek/Baker combination teaches a processor (Abstract: “The device additionally includes one or more processors”) configured for producing from output of said plurality of photodetectors an output with said light source illuminating at a first orientation of said at least two orientations and a second FSP with said light source illuminating at a first orientation of said at least two orientations (Baek, [0083]: “the planar optics 806 can include a planar transparent structure having refractive index structures, surface relief structures, diffractive structures, or other waveguide structures known in the art to direct the light from the light emitter 802 out of the optical sensor 800 and to collect and direct backscattered light towards the light detector 804”).
However, the Baek/Baker combination does not teach producing a first scattering profile.
Dimaio discloses a system for non-invasive optical imaging. Specifically, Dimaio teaches producing a first scattering profile (FSP) ([0003]: “Optical imaging technologies can noninvasively differentiate among soft tissues, and between native soft tissues and tissue labeled with either endogenous or exogenous contrast media, using their different photon absorption or scattering profiles at different wavelengths”; [0060]: “FIG. 19 illustrates a comparison of intensity profile line between three illumination patterns”). Baek, Baker, and Dimaio are analogous devices as they are both related to non-invasive imaging devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the scattering profile from Dimaio into the Baek/Baker combination as it allows the device to determine the scattering profile, which can provide a more comprehensive analysis of the light scattering and allows for suitable analysis of the measurements to determine health parameters.
The Baek/Baker/Dimaio combination teaches the processor configured for finding an angle of an pathlength angle from said first FSP and said second FSP (Baker, [0085]: “The light scattered by moving blood cells will then be frequency-modulated and the modulation frequency f.sub.d will be given by the velocity v of the moving blood cells in conjunction with the spacing between interference fringes. This may be expressed as
f
d
=
v
λ
/
2
s
i
n
(
a
)
, where λ represents the optical wavelength and 2α represents the angle between the two transmitted beams 803A and 803B. Because the two beams 803A and 803B either originate from the same light source or at least from two mutually coherent light sources, and also are assumed to have the same optical path length from the source (at least within the coherence length of the source), the two beams form an interference pattern in the intersection region with interference fringes aligned in the direction of the bisector of the beams and at a fringe spacing of x.sub.f=λ/(2 sin α), where α is half the angle between the two light beams.”).
However, the Baek/Baker/Dimaio combination does not teach the light intensities of the beams being identical.
Dimaio teaches the light intensities being identical ([0131]: “the light sources illuminate the tissue region with substantially uniform intensity”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the light intensities being identical from Dimaio into the Baek/Baker/Dimaio combination as it allows the measurements from the beams to be easily compared and analyzed.
However, the Baek/Baker/Dimaio combination does not teach the processor configured for extracting the oxygen saturation and the pulse rate from a measurement of said light detected at said IPL angle.
Baker teaches the processor configured for extracting the oxygen saturation from a measurement of said light detected at said IPL angle ([0023]: “It should be noted that, as will be discussed further below, the correlation of certain wave characteristic (e.g., amplitude and phase) measurements to certain medium characteristics (e.g., quantity of scattering particles, path length, and blood oxygen saturation) may be based on high frequency modulation of the system's light sources”), and Dimaio teaches the processor configured for extracting the pulse rate from a measurement of said light detected at said IPL angle ([0014]: “Images generated from this information provide a method to assess pathologies involving changes to tissue blood flow and pulse rate”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the oxygen saturation and pulse rate measurement extraction from Baker and Dimaio into the Baek/Baker/Dimaio combination as it allows the system to determine more health parameters of the user from the same measurements, which can provide a more comprehensive analysis of the user and their health status.
Regarding claim 3, the Baek/Baker/Dimaio combination teaches the system of claim 1, wherein said photodetectors are selected from fixed gain silicon-type detectors and Gallium Arsenide type-detectors (Baek, [0082]: “a gallium arsenide (GaAs) photodiode or Indium phosphide (InP) photodiode may be used to detect light of longer wavelengths”).
Regarding claim 6, the Baek/Baker/Dimaio combination teaches the system of claim 1, is applied for at least one of Photoplethysmogram (PPG) signal extraction, the oxygen saturation measurement, the pulse rate measurement, blood pressure measurement, respiratory rate measurement, perfusion and blood sugar level detection (Baker, [0023]: “It should be noted that, as will be discussed further below, the correlation of certain wave characteristic (e.g., amplitude and phase) measurements to certain medium characteristics (e.g., quantity of scattering particles, path length, and blood oxygen saturation) may be based on high frequency modulation of the system's light sources”; Dimaio, [0014]: “Images generated from this information provide a method to assess pathologies involving changes to tissue blood flow and pulse rate”; [0013]: “A time-varying signal related to blood tissue perfusion, the photoplethysmography (PPG) signal, arises from a special characteristic of blood flow in the tissue”).
Regarding independent claim 9, Baek teaches a method for detecting light scattered from tissue for extracting light intensity at an iso-pathlength (IPL) angle ([0043]: “This disclosure relates generally to devices, systems and methods for estimating various characteristics of interest (also referred to herein as “properties” or “signals”) in a fluid flow system”):
conducting measurements on the tissue by illuminating the tissue with a light beam ([0081]: “The optical sensor 800 may include one or more light emitters 802 (also referred to herein collectively as “the light emitter,” “the light transmitter” or “the light source”)”; [0083]: “the optical sensor 800 includes one or more planar optical structures 806 (collectively referred to hereinafter as “planar optics”) configured to direct optical light emitted from the light emitter 802 into two light beams 803A and 803B”; [0085]: “the two light beams 803A and 803B output by the light emitter 802 propagate into the tissues perpendicular to the long axis of the artery 808 beneath the skin”; Fig. 8 ) to produce an output ([0083]: “the planar optics 806 can include a planar transparent structure having refractive index structures, surface relief structures, diffractive structures, or other waveguide structures known in the art to direct the light from the light emitter 802 out of the optical sensor 800 and to collect and direct backscattered light towards the light detector 804”).
However, Baek does not teach producing a first scattering profile.
Dimaio teaches producing a first scattering profile (FSP) ([0003]: “Optical imaging technologies can noninvasively differentiate among soft tissues, and between native soft tissues and tissue labeled with either endogenous or exogenous contrast media, using their different photon absorption or scattering profiles at different wavelengths”; [0060]: “FIG. 19 illustrates a comparison of intensity profile line between three illumination patterns”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the scattering profile from Dimaio into the method from Baek it allows the method to determine the scattering profile, which can provide a more comprehensive analysis of the light scattering and allows for suitable analysis of the measurements to determine health parameters.
The Baek/Dimaio combination teaches examining said first FSP and locating the pathlength (IPL) angle (Baek, [0085]: “The light scattered by moving blood cells will then be frequency-modulated and the modulation frequency f.sub.d will be given by the velocity v of the moving blood cells in conjunction with the spacing between interference fringes. This may be expressed as
f
d
=
v
λ
/
2
s
i
n
(
a
)
where λ represents the optical wavelength and 2α represents the angle between the two transmitted beams 803A and 803B. Because the two beams 803A and 803B either originate from the same light source or at least from two mutually coherent light sources, and also are assumed to have the same optical path length from the source (at least within the coherence length of the source), the two beams form an interference pattern in the intersection region with interference fringes aligned in the direction of the bisector of the beams and at a fringe spacing of x.sub.f=λ/(2 sin α), where α is half the angle between the two light beams.”).
However, the Baek/Dimaio combination does not teach the light intensities of the beams being identical.
Dimaio teaches the light intensities being identical ([0131]: “the light sources illuminate the tissue region with substantially uniform intensity”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the light intensities being identical from Dimaio into the Baek/Dimaio combination as it allows the measurements from the beams to be easily compared and analyzed.
The Baek/Dimaio combination teaches extracting the light intensity at the IPL angle (Dimaio, [0060]: “FIG. 19 illustrates a comparison of intensity profile line between three illumination patterns”).
However, the Baek/Dimaio combination does not teach deriving oxygen saturation and pulse rate.
Baker teaches deriving oxygen saturation ([0023]: “It should be noted that, as will be discussed further below, the correlation of certain wave characteristic (e.g., amplitude and phase) measurements to certain medium characteristics (e.g., quantity of scattering particles, path length, and blood oxygen saturation) may be based on high frequency modulation of the system's light sources”), and Dimaio teaches deriving pulse rate ([0014]: “Images generated from this information provide a method to assess pathologies involving changes to tissue blood flow and pulse rate”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the oxygen saturation and pulse rate measurement extraction from Baker and Dimaio into the Baek/Dimaio combination as it allows the method to determine more health parameters of the user from the same measurements, which can provide a more comprehensive analysis of the user and their health status.
Regarding claim 14, the Baek/Dimaio/Baker combination teaches the method of claim 9, is applied for at least one of extracting PPG signal, measuring the blood oxygen saturation, measuring the pulse rate, measuring blood pressure, measuring respiratory rate, perfusion, and detecting blood sugar level (Baker, [0023]: “It should be noted that, as will be discussed further below, the correlation of certain wave characteristic (e.g., amplitude and phase) measurements to certain medium characteristics (e.g., quantity of scattering particles, path length, and blood oxygen saturation) may be based on high frequency modulation of the system's light sources”; Dimaio, [0014]: “Images generated from this information provide a method to assess pathologies involving changes to tissue blood flow and pulse rate”; [0013]: “A time-varying signal related to blood tissue perfusion, the photoplethysmography (PPG) signal, arises from a special characteristic of blood flow in the tissue”).
Regarding claim 17, the Baek/Baker/Dimaio combination teaches the system of claim 1, wherein the beam of said light source is centered either on a first axis parallel to the issue or a second axis with respect to the tissue (Baek, [0084]: “the interference pattern 902 of the measurement volume 900 includes a number of interference fringes that are parallel to the bisector of the axes of the two emitted beams and transverse an arterial longitudinal axis of the artery 908”).
Regarding claim 18, the Baek/Baker/Dimaio combination teaches the system of claim 1, wherein the plurality of said photodetectors are either stationary or movable for conducting measurements at multiple angles (Baek, [0082]: “The optical sensor 800 also includes one or more light detectors 804 (also referred to herein collectively as “the light detector” or “the photodetector”). In some implementations, the light detector 804 includes one or more photodiode arrays”; [0085]: “Because the two beams 803A and 803B either originate from the same light source or at least from two mutually coherent light sources, and also are assumed to have the same optical path length from the source (at least within the coherence length of the source), the two beams form an interference pattern in the intersection region with interference fringes aligned in the direction of the bisector of the beams and at a fringe spacing of x.sub.f=λ/(2 sin α), where α is half the angle between the two light beams”).
Regarding claim 19, the Baek/Dimaio/Baker combination teaches the method of claim 9.
However, the Baek/Dimaio/Baker combination is silent on the calibration process.
Dimaio teaches the method further comprising using either solid or liquid phantoms for calibration ([0016]: “We calibrated an evaluation imaging system through a bench-top tissue phantom with tissuelike optical properties”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the calibration method from Dimaio into the Baek/Dimaio/Baker combination as the combination is silent on the calibration process and Dimaio discloses a suitable calibration process in an analogous device.
Regarding claim 20, the Baek/Dimaio/Baker combination teaches the method of claim 9, further comprising centering the light beam on a first axis parallel to the tissue for producing the first full scattering profile FSP) and on a second axis for producing a second full scattering profile (FSP) (Baek, [0084]: “the interference pattern 902 of the measurement volume 900 includes a number of interference fringes that are parallel to the bisector of the axes of the two emitted beams and transverse an arterial longitudinal axis of the artery 908”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Baker/Dimaio combination as applied to claim 1 above, and further in view of Fine (US 20180160913).
Regarding claim 2, the Baek/Baker/Dimaio combination teaches the system of claim 1.
However, the Baek/Baker/Dimaio combination does not teach wherein said light source is a continuous wave laser selected from a He—Ne gas laser, a Ti:sapphire laser, and a GaAIA s laser.
Fine discloses a system for in vivo measurement of biological parameters. Specifically, Fine teaches wherein said light source is a continuous wave laser selected from a He—Ne gas laser, a Ti:sapphire laser, and a GaAIA s laser ([0056]: “focused beam of light 12 produced by laser 10 (e.g., a He—Ne laser) is used as a localized light source”). Baek, Baker, Dimaio, and Fine are analogous devices as they are all related to using light detection to determine health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the laser type from Fine into the Baek/Baker/Dimaio combination as the lasers are similar light source types, and it would be a simple substitution to include the laser type from Fine to perform the same functions as claimed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Baker/Dimaio as applied to claim 1 above, and further in view of Tangrea (US 20170202494).
Regarding claim 4, the Baek/Baker/Dimaio combination teaches the system of claim 1.
However, the Baek/Baker/Dimaio combination is silent on the active area of the photodetectors.
Tangrea discloses an apparatus for detecting health conditions in a user. Specifically, Tangrea teaches wherein each one of said photodetectors has an active area ranging between 0.1 mm2 and 10mm2 ([0042]: “Sensitivity can be increased by coupling the diode laser to an indium gallium arsenide (InGaAs) 3V photodiode detector (3 mm2 active area; 750-1700 nm range)”). Baek, Baker, Dimaio and Tangrea are analogous arts as they are all related to systems that use light sources to measure biological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the range of the photodetectors from Tangrea into the system from the Baek/Baker/Dimaio combination as the system is silent on the range of the photodetectors, and Tangrea discloses a suitable range in an analogous device.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Baker/Dimaio combination as applied to claim 1 above, and further in view of Brumback (US 20140135631).
Regarding claim 5, the Baek/Baker/Dimaio combination teaches the system of claim 1.
However, the Baek/Baker/Dimaio combination does not disclose wherein said photodetectors are positioned successively in increments ranging between 2 to 10 degrees.
Brumback discloses a biometric monitoring device. Specifically, Brumback teaches wherein said photodetectors are positioned successively in increments ranging between 2 to 10 degrees (Figure 12). Baek, Baker, Dimaio, and Brumback are analogous arts as they are all related to systems that use light sources to measure biological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the placement of the photodetectors from Brumback into the system from the Baek/Baker/Dimaio combination as it allows for multiple photosensors to be used to detect the light signals at a certain angle, which can improve the sensing capabilities of the system to provide a more accurate result.
Claims 7-8 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Baker/Dimaio combination as applied to claims 1 and 9 above, and further in view of Jobsis (US 6594513).
Regarding claim 7, the Baek/Baker/Dimaio combination teaches the system of claim 1.
However, the Baek/Baker/Dimaio combination does not teach wherein the system is applied for extraction properties of scattering liquids in order to asses a quality of said scattering liquids.
Jobsis teaches a method and apparatus for determining oxygen saturation. Specifically, Jobsis teaches wherein the system is applied for extraction properties of scattering liquids in order to assess the quality of said scattering liquids (Column 13, lines 62-64: “FIG. 1 depicts the NIR absorption spectra of … water”). Baek, Baker, Dimaio and Jobsis are analogous arts as they are all related to systems that use light sources to measure biological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of water from Jobsis into the system from the Baek/Baker/Dimaio combination as it allows the system to analyze different materials, which can improve the performance of the system and allow for it to be used for multiple applications.
Regarding claim 8, the Baek/Baker/Dimaio/Jobsis combination teaches the system of claim 7, wherein said scattering liquids are selected from oil, petroleum, water, and wine (Jobsis, Column 13, lines 62-64: “FIG. 1 depicts the NIR absorption spectra of … water”).
Regarding claim 15, the Baek/Dimaio/Baker combination teaches the method of claim 9.
However, the Baek/Dimaio/Baker combination does not teach wherein the system is applied for extraction properties of scattering liquids in order to asses a quality of said scattering liquids.
Jobsis teaches wherein the system is applied for extraction properties of scattering liquids in order to assess the quality of said scattering liquids (Column 13, lines 62-64: “FIG. 1 depicts the NIR absorption spectra of … water”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis of water from Jobsis into the system from the Baek/Dimaio/Baker combination as it allows the system to analyze different materials, which can improve the performance of the system and allow for it to be used for multiple applications.
Regarding claim 16, the Baek/Dimaio/Baker combination teaches the method of claim 15, wherein said scattering liquids are selected from oil, petroleum, water, and wine (Jobsis, Column 13, lines 62-64: “FIG. 1 depicts the NIR absorption spectra of … water”).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Dimaio/Baker as applied to claim 9 above, and further in view of Breuer (“Oxygen saturation calculation procedures: a critical analysis of six equations for the determination of oxygen saturation”) and Chemistry Dictionary (“Beer-Lambert Law”).
Regarding claim 10, the Baek/Dimaio/Baker combination teaches the method of claim 9.
However, the Baek/Dimaio/Baker combination does not disclose the specific equations used to determine oxygen saturation.
Breuer and Chemistry Dictionary both disclose equations and calculations used to determine oxygen saturation (Breuer, pages 286-388; Chemistry Dictionary, pages 1-9). Baek, Dimaio, Baker, Breuer, and Chemistry dictionary are analogous arts as they are all related to calculations used to determine oxygen saturation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the equations from Breuer and Chemistry Dictionary in the method from the Baek/Dimaio/Baker combination as the method is silent on the specific calculations used to determine oxygen saturation, and Breuer and Chemistry Dictionary provide suitable calculations in analogous methods.
Regarding claim 11, the Baek/Dimaio/Baker/Breuer/Chemistry Dictionary combination teaches the method of claim 10.
However, the Baek/Dimaio/Baker/Breuer/Chemistry Dictionary combination does not teach calculating a standard deviation of said oxygen saturation value.
Dimaio teaches calculating a standard deviation of said oxygen saturation value ([0368]: “subset of samples located around the median of the sample space was taken as a subspace to calculate the mean and the standard deviation parameters for the model”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the standard deviation calculation from Dimaio into the Baek/Dimaio/Baker/Breuer/Chemistry Dictionary combination as it allows the method to further analyze the result, which can ensure the method is as accurate as possible and provide statistical analysis on the accuracy and precision of the results.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the Baek/Dimaio/Baker combination as applied to claim 9 above, and further in view of Toyota (US 20210038162).
Regarding claim 12, the Baek/Dimaio/Baker combination teaches the method of claim 9 for extracting the pulse rate.
However, the Baek/Dimaio/Baker combination is silent on the steps of extracting the pulse rate.
Dimaio teaches the method comprising: generating a Photoplethysmogram (PPG) profile at the IPL angle ([0013]: “A time-varying signal related to blood tissue perfusion, the photoplethysmography (PPG) signal, arises from a special characteristic of blood flow in the tissue”); performing a Fourier transform on the PPG profile ([0188]: “The signal is then transformed into the frequency domain. For example, in some alternatives, a fast Fourier transform (FFT) is used”); passing the Fourier transformed PPG profile through a bandpass filter ([0188]: “At block 604 the time-resolved image sequence (data subset 402 for example) is sent to the controller/classifier/processor 412 for processing, which then uses a PPG algorithm to calculate the blood flow perfusion in the tissue area. This process can involve amplification, linearization, signal averaging, correlation, and/or one or more filters (e.g., bandpass, highpass, or lowpass) to eliminate noise, isolate the portions of signal of interest, and boost signal-to-noise ratios.”); extracting a maximum frequency value,
f
m
a
x
([0474]: “the values of the heart rate corresponding to the maximum of the frequency signal are stored. The most repeated value is selected as the true heart rate of the pig for the current step. From this value, an improved SNR metric is calculated”; [0014]: “Images generated from this information provide a method to assess pathologies involving changes to tissue blood flow and pulse rate”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the method steps from Dimaio into the Baek/Dimaio/Baker combination as the combination is silent on the steps and Dimaio discloses suitable steps in an analogous method.
However, the Baek/Dimaio/Baker combination is silent on the specific calculation used to determine pulse rate.
Toyota discloses a method for estimating pulse rate. Specifically, Toyota teaches calculating pulse rate converting said maximum frequency value,
f
m
a
x
to pulse rate according to pulse rate =
f
m
a
x
*60 ([0049]: “For conversion of a frequency (Hz) into a pulse rate (bpm), the value of the frequency is multiplied by 60.”). Baek, Baker, Dimaio, and Toyota are analogous arts as they are both related to systems that use light sources to measure biological parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the calculation from Toyota into the method from the Baek/Baker/Dimaio combination as the combination is silent on the calculation used to calculate pulse rate and Toyota teaches a suitable calculation in an analogous device.
Regarding claim 13, the Baek/Dimaio/Baker/Toyota combination teaches the method of claim 12.
However, the Baek/Baker/Dimaio/Toyota combination does not teach further comprising calculating the standard deviation of the calculated pulse rate.
Dimaio teaches further comprising calculating the standard deviation of the calculated pulse rate ([0368]: “subset of samples located around the median of the sample space was taken as a subspace to calculate the mean and the standard deviation parameters for the model”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the standard deviation calculation from Dimaio into the method from the Baek/Baker/Dimaio/Toyota combination as it allows the method to further analyze the result, which can ensure the method is as accurate as possible.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to the equations form Breuer and Chemistry Dictionary have been fully considered but they are not persuasive. The combination of the Baek/Dimaio/Baker combination as well as the equations from Breuer and Chemistry Dictionary together teaches on the claimed limitations, as these methods and equations are all related to determining oxygen saturation through measured light signals, and can produce the same result as the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./ Examiner, Art Unit 3791
/RENE T TOWA/ Primary Examiner, Art Unit 3791