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 .
Claim Status:
Claims 18-56 are canceled
Claims 1-17 and 57 are pending and examined below.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 03/12/2025, 03/18/2025, 06/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 4 and 9-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 is rejected because it recites the claim limitation “the total light”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is rejected because it recites the claim limitations “the position of the illumination source” and “the position of the detector”. There is insufficient antecedent basis for these limitations in the claim. Although claim 4 does recite “a point” of the illumination source and detector, claim 4 is not part of the dependency chain of claim 9. Claim 1 does not recite a position of the illumination source or a position of the detector.
Claim 10 is rejected because it recites the claim limitation “the heart”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is rejected it inherits deficiencies by nature of its dependency on claim 10. Claim 11 is also rejected because it recites “the constant component of the blood pressure gradient”, “the amplitude of the fluctuating component”, “the pulse frequency”, “the volumetric blood flow rate Q”, “the density and viscosity”, “the blood flowing through the blood vessels”, “the velocity”, " the velocity of the blood flow in the axial direction”, the z-axis is taken along the axis of the arterial blood segment”, and “the radial direction as the combination of acceleration, angular velocity; and absolute orientation”. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 is rejected because it recites the claim limitation “the density of a specific tissue type”. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is rejected because it inherits deficiencies by nature of its dependency on claim 12. Claim 13 is also rejected because it recites “the changes from tissue composition, skin thickness, surface area, tissue volume, and ambient temperature”, “the average tissue diameter”, “the average radius”, “the volumetric blood flow”, “the arterial temperature”, “the heat transfer coefficient”, “the environmental heat exchange”, and “the temperature of the surroundings”. There is insufficient antecedent basis for these limitations in the claim.
Claim 14 is rejected because it inherits deficiencies by nature of its dependency on claim 13. Claim 13 is also rejected because it recites “the thermal conductivity, density, specific heat, blood perfusion and metabolic heat generation of the respective tissue layer (N)”, and “the blood density”. There is insufficient antecedent basis for these limitation in the claim.
Claim 15 is rejected because it recites “the optical density”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 is rejected because it inherits deficiencies by nature of its dependency on claim 15. Claim 16 is also rejected because it recites “the contact force”. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is rejected because it inherits deficiencies by nature of its dependency on claim 15.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claim invention is directed to an abstract idea without significantly more.
The claims are analyzed in accordance with the two step analysis as outlined in MPEP 2106 and subsections thereof.
Statutory Category (Step 1): Claim 1 recites a method of monitoring a subject with an opto-physiological sensor system. This is a process.
Judicial Exception (Step 2A, prong 1): the claim recites determining, using the model, how the at least one physical variable affects the at least one physiological property; and determining a corrected value for the physiological property based on the determination of how the at least one physical variable affects the at least one physiological property. The determining steps are recited at such a high level of generality that it reads on a mathematical concepts type abstract idea, wherein data obtained from the sensors are calculated through the various mathematical equations 1-17 described in the instant specifications, or theoretical acquisition values are used to process a resulting value, and the resulting value is compared to the acquired data.
Additional Elements Considerations (for integration into a practical application analysis), Step 2A, prong 2: the addition elements recited are a sensor that is part of a wearable device, and the steps of obtaining a model, obtaining an indication of at least one physiological property, and obtaining an indication of at least one physical variable. The obtaining steps are all pre-solution activities of data gathering. Obtaining the indication of the physiological property and the physical variable reads as receiving the different components of data from the sensor. Obtaining the model reads on gathering the algorithms, software/code, or lookup tables needed for the determination. Additionally, the sensor, beyond being an optical sensor with a illumination source and detector, are recited at such high level of generality that it reads on using a generic optical sensing device to gather data, and processing the data using a mathematical model/calculations to then compare the collected optical data to determine if a correction is needed for the collected data. Without a specific application, and recitation at such a high level of generality, claim 1 reads on generally linking the use of the judicial exception to a particular technological environment or field of use, and thus is not indicative of integration into a practical application (See MPEP 2106.0(h)).
Step 2B: As discussed in step 2A, prong 2: claim 1 is recited at such a high level of generality that the additionally elements of data gathering do not amount to significantly more. Further, the recitation of the optical sensor seems to only link the use of the judicial exception to a particular technological environment or field of use (optical sensing of body parameters) and like in step 2A, prong 2, generally linking cannot amount to significantly more than the judicial exception. For the reasons above. Claim is not patent eligible.
Claims 2-3, are rejected under 35 U.S.C. 101 because they inherit the deficiencies of claim 1, the claimed invention being directed to an abstract idea (see 35 U.S.C. 101 analysis for claim 1), and the additional limitations of claim 2-3, such as:
determining measurements of accurate physiological parameters using the corrected value for the physiological property, the physiological parameters comprising at least one of: heart rate (HR), perfusion index (Pl), oxygen saturation (SpO2% ), respiration rate (RR), blood pressure (BP), pulse rate variability (PRY), pulse transmitted time (PTT), and pulse wave velocity (PWV), and wherein the at least one physical variable comprises at least one of: contact pressure; contact temperature; acceleration; angular velocity; and absolute orientation, do not appear to integrate the judicial exception into a practical application are not sufficient to amount to significantly more than the judicial exception. Although the limitations narrow the physiological parameters to heart or blood flow parameters, the limitations to not integrate or amount to significantly more since it provides no additional details regarding how the correction is performed based on the model, beyond the claimed, highly generalized, judicial exceptions.
Claims 4-17 are rejected under 35 U.S.C. 101 because they inherit the deficiencies of claim 1, the claimed invention being directed to an abstract idea (see 35 U.S.C. 101 analysis for claim 1), and the additional limitations of claims 4-17 are directed to the equations or variations of equations regarding the model. Although the limitations provide specific mathematical equations regarding the model, the limitations to not integrate or amount to significantly more since it provides no additional details regarding how the correction is performed based on the model. For example claim 4 provides additional elements regarding the model and defining infinitesimal optical power, and source-detector separation. However, it does not integrate, or provide additional detail beyond the judicial exceptions of claim 1, how the model results in the determination of “how the at least one physical variable affects the at least one physiological property”, or determines the corrected value. Therefore, even with the additional elements regarding the model, in claims 4-17, the additional elements of the claimed equations do not integrate with the abstract ideas of claim 1, since none of the additional elements recite how the equations are to be used to perform the abstract ideas. Therefore, the additional elements of claims 4-17 cannot be considered to integrate the abstract idea, and cannot amount to significantly more.
Claim 57 is rejected under 35 U.S.C. 101 because it inherits the deficiencies of claim 1, the claimed invention being directed to an abstract idea (see 35 U.S.C. 101 analysis for claim 1), and the additional limitations of claims 57 of a computer readable non-transitory storage medium comprising a program for a computer to cause a processor to perform the method of claim 1, reads on additional element of a generic computer. Implementing the method of claim 1 using a generic computer does not integrate the abstract ideas, and do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2016/0278646 to Hu et al. “Hu”, in view of US2021/0145297 to Kim et al. “Kim”.
Regarding claim 1, Hu discloses an opto-physiological sensor system (Paragraph 0150, Figs. 3A, 4A Ref. 40, OP system), the opto-physiological sensor system comprising at least one sensor (Paragraph 0151, Figs. 3A, 4A, OP sensor 12).
obtaining a model of the optical properties of at least one body tissue type to be monitored (Paragraph 0018, modelling the opto-physiological properties of at least one body tissue type to be monitored; inherent that by modeling, a model is obtained), and
wherein the model of the optical properties comprises a definition of static and dynamic components of transmitted optical power (Paragraph 0042) and a definition of a source-detector separation (Paragraph 0046, optimum source-detector separation) related to a normalized path length for an illumination source of the opto-physiological sensor (Paragraph 0055).
Hu further discloses obtaining an indication of at least one physiological property of the subject from a wearable device comprising the at least one sensor worn by the subject (Paragraph 0049, sensor may be in the form of a wearable path or wristwatch; Paragraphs 0091-0095, wherein the opto-physiological system includes an analyser that employs an opto-physiological model to derive physiological parameter from the measured signal, wherein the physiological parameters can include blood oxygen saturation, heart rate, pulse rate velocity,
respiration rate, blood pressure, body temperature, which reads on the claimed physiological property, as described in the instant specification, Page 5, lines 4-7); and
obtaining an indication of at least one physical variable from the wearable device comprising the at least one sensor worn by the subject (Paragraph 0049, sensor may be in the form of a wearable path or wristwatch; Paragraph 0069, motion sensor (e.g. 3D accelerometer) provide an alternative description of any motion, such as degree of tilt between the sensor and tissue; additionally the device includes a temperature sensor, Paragraphs 0149 and 0158, which infers obtaining the physical variable, temperature).
However, Hu does not explicitly disclose a method of monitoring a subject with the opto-physiological sensor system, wherein the method includes determining, using the model, how the at least one physical variable affects the at least one physiological property; and determining a corrected value for the physiological property based on the determination of how the at least one physical variable affects the at least one physiological property.
Kim teaches a similar device for measuring blood flow, that includes a light source module configured to be in contact with tissue, and emit light at the tissue (Abstract), and detection module (Abstract) for detecting light that has undergone scattering, absorption, and/or reflection along the tissue (Paragraph 0019), and would read on the claimed opto-physiological sensor system.
Kim teaches a method of monitoring a subject (blood flow measuring method, Paragraph 0019) with the opto-physiological system (blood flow measuring apparatus with light source and detection module, Abstract) wherein the method includes determining, using the model, how the at least one physical variable affects the at least one physiological property (Paragraphs 0062-0065, and Figs. 6-9, wherein pressure (i.e. the pressure applied to the tissue from the probe, Abstract) is correlated with the detected intensity, Fig. 6, converting the intensity into optical density, and determining the relationship between the pressure and optical density, Fig. 8, Paragraph 0064, and 0067 determining the correction factor), and
determining a corrected value for the physiological property based on the determination of how the at least one physical variable affects the at least one physiological property (Fig. 14, S100, Paragraph 0080, acquiring the correction factor generated from the correction function; Paragraph 0092, Fig. 14, S600, applying the acquired correction function to the detection optical data to remove the effect of noise due to pressure; and Paragraph 0093, Fig. 14, S700, then transforming the corrected detection optical data into a significant result; wherein the significant result can be the oxy hemoglobin concentration and the deoxy hemoglobin concentration, Paragraph 0093).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, wherein the opto-physiological sensor system of Hu is used for a method of monitoring a subject with the opto-physiological sensor system, wherein the method includes determining, using the model, how the at least one physical variable affects the at least one physiological property; and determining a corrected value for the physiological property based on the determination of how the at least one physical variable affects the at least one physiological property, as taught by Kim, in order to correct for noise that occurs due to the effects of the physical variable, such as contact pressure, during signal acquisition, which improves accuracy and reliability of the measurement (Kim, Abstract), and therefore improve any physiological properties derived from the measurement.
Regarding claim 2, the modifications of Hu and Kim disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Kim teaches determining measurements of accurate physiological parameters using the corrected value for the physiological property, (Fig. 14, S100, Paragraph 0080, acquiring the correction factor generated from the correction function; Paragraph 0092, Fig. 14, S600, applying the acquired correction function to the detection optical data to remove the effect of noise due to pressure; and Paragraph 0093, Fig. 14, S700, then transforming the corrected detection optical data into a significant result; wherein the significant result can be the oxy hemoglobin concentration and the deoxy hemoglobin concentration, Paragraph 0093).
Su further teaches the physiological parameters comprising at least one of: heart rate (HR), perfusion index (PI), oxygen saturation (SpO2%), respiration rate (RR), blood pressure (BP), pulse rate variability (PRV), pulse transmitted time (PTT), and pulse wave velocity (PWV) (determine one or more physiological parameters therefrom (e.g. blood oxygen saturation, heart rate, pulse rate velocity, respiration rate, blood pressure, body temperature, Paragraph 0151).
Regarding claim 3, the modifications of Hu and Kim disclose all the features of claim 1 above
As disclosed in the claim 1 rejection above, Kim teaches wherein the at least one physical variable consist of at least a contact pressure.
Regarding claim 4, the modifications of Hu and Kim disclose all the features of claim 1 above.
Hu teaches wherein the model comprises defining infinitesimal optical power dP that is transmitted through to point (x, y) on a surface of the body tissue type (Paragraph 0036) as per Equation 1:
PNG
media_image1.png
37
561
media_image1.png
Greyscale
(See Eq.10, in Paragraph 0037),
wherein I0(λ, x, y) represents the total light that enters across the entire surface of the body tissue type and is subject to exponential decay, which is a function of the optical density ρ(λ) of the body tissue type (Paragraph 0038);
wherein a source-detector separation is defined in terms of an illumination source at point (xs,ys) and an arbitrary detector at point (x, y) on the surface of the body tissue type (Paragraph 0039), such that
PNG
media_image2.png
38
265
media_image2.png
Greyscale
(Paragraph 0039); and
wherein for a detector of a finite rectangular area on the surface of the body tissue type defined by vectors x and y, spanning from x- to x+ and from y- to y+ (Paragraph 0040), the optical power received by the detector is as per Equation 2:
PNG
media_image3.png
37
329
media_image3.png
Greyscale
[Eq. 2] (See Paragraph 0040 and Eq. 11).
Regarding claim 5, the modifications of Hu and Kim disclose all the features of claim 1 above.
Hu teaches wherein the model comprises defining an optical response of a dynamic and multi-layered body tissue type in terms of its dynamic optical density ρ(λ, l’, t), using a normalised physiological pulse function ψ(t) and absorption, scattering and pulsatility coefficients µai(λ), µsi(λ) and µpi(λ) respectively, where a layer number i ranges from 1 to N (Paragraph 0041) as per Equation 3:
PNG
media_image4.png
46
502
media_image4.png
Greyscale
(See Paragraph 0041, Eq. 13).
Regarding claim 6, the modifications of Hu and Kim disclose all the features of claim 4 above.
Hu teaches wherein the model comprises separation of static and dynamic components of Equation 4 as per Equations 5 to 6 (Paragraph 0042, and Eq. 14, 15, and 16, correspond to the claimed equation 4, 5, and 6, respectively) :
PNG
media_image5.png
140
602
media_image5.png
Greyscale
(See Paragraph 0042, and Eq. 14, 15, and 16).
Regarding claim 7, the modifications of Hu and Kim disclose all the features of claim 6 above.
Hu discloses wherein the model comprises using a sum rule of integration on Equations 1 and 2 to define static and dynamic components of transmitted optical power for a rectangular detector defined by vectors x and y (Paragraph 0043) as per Equations 7, 8 and 9:
PNG
media_image6.png
114
619
media_image6.png
Greyscale
(See Paragraph 0043, and Eq. 17, 19, and 21).
Regarding claim 8, the modifications of Hu and Kim disclose all the features of claim 7 above.
Hu teaches wherein the model comprises defining an optimum source-detector separation l’(λ) for an illumination source at wavelength λ (Paragraph 0046) as per Equation 10:
PNG
media_image7.png
60
582
media_image7.png
Greyscale
(See Paragraph 0046, Eq. 23).
Regarding claim 9, the modifications of Hu and Kim disclose all the features of claim 1 above.
Hu teaches wherein the model comprises assuming cylindrical symmetry and optical homogeneity of the body tissue type to be monitored such that an optimum source-detector separation l'(λ) is expressed as a circle centered on the position of the illumination source (xs,ys), or conversely centered on the position of the detector (xd,yd) (Paragraph 0047), as per Equation 11:
PNG
media_image8.png
43
574
media_image8.png
Greyscale
(See Paragraph 0047, Eq. 24).
Regarding claim 57, the modifications of Hu and Kim disclose all the features of claim 1 above.
Hu discloses the OP system is controllable via computer software, embodied as a wristwatch (Paragraph 0099). This reads on the computer readable non-transitory storage medium comprising a program that causes the controls the OP system (i.e. causes it to perform the method).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu, in view of Kim, as applied to claim 1 above, and further in view of US2023/0277071 to D’Mello et al. “D’Mello, and further in view of Non-Patent Literature (NPL): “Method for the Calculation of Velocity, Rate of Flow and Viscous Drag in Arteries when the Pressure Gradient is Known” to “Womersley”.
Regarding claims 10 and 11, the modification of Hu and Kim disclose all the features of claim 1 above.
However, the modifications of Hu and Kim do not disclose wherein the at least one physical variable comprises at least one of acceleration, angular velocity and absolute orientation, and wherein determining, using the model, how the at least one physical variable affects the at least one physiological property comprises modelling the pumping action of the heart.
D’Mello teaches wherein the at least one physical variable comprises at least one of acceleration, angular velocity and absolute orientation (Paragraph 0121, 0361, detecting vibrations at the sternum as linear acceleration and rotational velocity; Paragraph 0382, accelerometer and a gyroscope that measures the contraction and relaxation of the heart with each cardiac cycle as vibrations),
wherein determining, using the model, how the at least one physical variable affects the at least one physiological property comprises modelling the pumping action of the heart to determine the physiological property (D’Mello uses the relationship between pressure (which leads to vibrations) and the cardiac cycle, that reads on the pumping action of the heart, Paragraphs 0304-0309 to develop a model, Paragraph 0309, describing the relationship between cardiac pressure and the VCG waveform, i.e. the vibrational signal).
D’Mello further teaches that the vibration signal can be used to determine other hemodynamic measurements, not just blood pressure as provided in the examples (Paragraph 0141).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, and Kim, wherein the at least one physical variable comprises at least one of acceleration, angular velocity and absolute orientation, and wherein determining, using the model, how the at least one physical variable affects the at least one physiological property comprises modelling the pumping action of the heart, as taught by D’Mello, in order to determine how the ventricular pressure cycle produces the pressure to cause the valves of the heart to generate vibrational waves propagating through the chest (Paragraph 0309), which can then be correlated to blood pressure and other hemodynamic measurements (Paragraph 0141).
However, the modifications of Hu, Kim, D’Mello do not disclose using the model to determine a volumetric blood flow rate.
Womersley teaches in a similar mathematical model for determining the rate of flow in arteries based on the pressure gradient (Title). As see on Page 554, Wormsley takes a known assumption for a pressure gradient (Equation 3), and inserts the gradient formula into the formula for the rate of flow Q (Fig. 18), to which Q can then be described as shown in Equation 23 on Page 556. Additionally, in the derivation process, the density ρ, viscosity, µ, as well as the length l, pulse frequency f, and radius R, are all incorporated into the derivation (See Pages 554-556). This is very similar to what is claimed in claim 11.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, Kim, and D’Mello, wherein the model is used to determine a volumetric blood flow rate, and the model includes the claimed equations 12-14, in order to be able to determine flow rate from known pressure gradients (Womersley, Page 563, #2 of summary).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu, in view of Kim, as applied to claim 1 above, and further in view of Non-Patent Literature (NPL): “Lumped-parameter tissue temperature-blood perfusion model of a cold-stressed fingertip” to Shitzer et al. “Shitzer”.
Regarding claims 12 and 13, the modifications of Hu and Kim disclose all the features of claim 1 above.
Hu discloses modeling the density of a specific tissue type as a function of wavelength of the illumination source (Paragraph 0032, the model may be considered at one or more wavelengths; Paragraph 0037-0038, model wherein the equation 10 for the model includes the optical density of the body tissue type) of the opto-physiological sensor (Paragraph 0151, Fig. 4A, Ref. 40).
However, the modifications of Hu and Kim do not disclose modeling the density of a specific tissue type, also as a function of temperature comprises modelling tissue temperature as a result of blood perfusion as defined by thermoregulation as expressed per equation 15, that reflects the changes from tissue composition, skin thickness, surface area, tissue volume, and ambient temperature in presence of live tissue nature or body tissue surroundings:
PNG
media_image9.png
87
642
media_image9.png
Greyscale
where ρ(λ,t) indicates the density of a specific tissue type, Cp is the tissue specific heat, V is the specific tissue volume, and A is the tissue surface area, such that A=πD2/2, and wherein V and A are dependent on the average tissue diameter D=2R, where R is the average radius of the tissue surface area A, and wherein the density and specific heat of blood are denoted by ρb and Cpb respectively, whereas ωb is the volumetric blood flow, and wherein TA is the arterial temperature and hair is the heat transfer coefficient at the skin surface as dominated by the environmental heat exchange, and Tair represents the temperature of the surrounding.
Shitzer teaches wherein modelling the density of a specific tissue type as a function of temperature comprises modelling tissue temperature as a result of blood perfusion as defined by thermoregulation as expressed per equation 15, that reflects the changes from tissue composition, skin thickness, surface area, tissue volume, and ambient temperature in presence of live tissue nature or body tissue surroundings:
PNG
media_image9.png
87
642
media_image9.png
Greyscale
where ρ(λ,t) indicates the density of a specific tissue type, Cp is the tissue specific heat, V is the specific tissue volume, and A is the tissue surface area, such that A=πD2/2, and wherein V and A are dependent on the average tissue diameter D=2R, where R is the average radius of the tissue surface area A, and wherein the density and specific heat of blood are denoted by ρb and Cpb respectively, whereas ωb is the volumetric blood flow, and wherein TA is the arterial temperature and hair is the heat transfer coefficient at the skin surface as dominated by the environmental heat exchange, and Tair represents the temperature of the surrounding (See Page 1830, Section: Analysis, and Eq. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu and Kim, wherein modeling the density of a specific tissue type, also as a function of temperature comprises modelling tissue temperature as a result of blood perfusion as defined by thermoregulation as expressed per equation 15, that reflects the changes from tissue composition, skin thickness, surface area, tissue volume, and ambient temperature in presence of live tissue nature or body tissue surroundings, where ρ(λ,t) indicates the density of a specific tissue type, Cp is the tissue specific heat, V is the specific tissue volume, and A is the tissue surface area, such that A=πD2/2, and wherein V and A are dependent on the average tissue diameter D=2R, where R is the average radius of the tissue surface area A, and wherein the density and specific heat of blood are denoted by ρb and Cpb respectively, whereas ωb is the volumetric blood flow, and wherein TA is the arterial temperature and hair is the heat transfer coefficient at the skin surface as dominated by the environmental heat exchange, and Tair represents the temperature of the surrounding, as taught by Shitzer, in order to model temperature with blood perfusion to potentially allow prediction of blood perfusion rates from temperature (Page 1833, last paragraph, left column).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu, in view of Kim, and further in view of Shitzer, as applied to claim 13 above, and further in view of NPL: “Study of the one dimensional and transient bioheat transfer equation: Multi-layer solution development and applications” to Rodrigues et al. “Rodrigues”.
Regarding claim 14, the modifications of Hu, Kim, and Shitzer teaches all the features of claim 13 above.
As disclosed in the claim 13 rejection above, Hu and Shitzer teaches modelling the density of a specific tissue type as a function of wavelength of the illumination source of the opto-physiological sensor and temperature with multi-wavelength illuminations.
However, Hu and Shitzer do not disclose the modelling includes modelling tissue temperature as a result of blood perfusion as defined by thermoregulation as seen in Eq. 16:
PNG
media_image10.png
60
650
media_image10.png
Greyscale
where kN, ρN, CpN, ωbN, and qmN represent the thermal conductivity, density, specific heat, blood perfusion and metabolic heat generation of the respective tissue layer (N), ρb is the blood density, whereas Cpb represents the specific heat of blood and TA is the body temperature and is treated as a constant.
Rodrigues teaches modelling tissue temperature as a result of blood perfusion as defined by thermoregulation for multi-layers as per equation 16:
PNG
media_image10.png
60
650
media_image10.png
Greyscale
where kN, ρN, CpN, ωbN, and qmN represent the thermal conductivity, density, specific heat, blood perfusion and metabolic heat generation of the respective tissue layer (N), ρb is the blood density, whereas Cpb represents the specific heat of blood and TA is the body temperature and is treated as a constant (See Page 154, right column, Section 2.1 Pennes bioheat transfer equation, equation 1 in view of equations 2 and 3; Page 160, Conclusion, analytical solution to the Penne’s bioheat equation is derived to calculate the heat transfer in a multi-layer perfused tissue...the biological model is enhanced by introducing an important thermoregulation mechanism, namely, the temperature dependent metabolic heat rate).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, Kim, and Shitzer, wherein the modelling includes modelling tissue temperature as a result of blood perfusion as defined by thermoregulation as seen in Eq. 16, where kN, ρN, CpN, ωbN, and qmN represent the thermal conductivity, density, specific heat, blood perfusion and metabolic heat generation of the respective tissue layer (N), ρb is the blood density, whereas Cpb represents the specific heat of blood and TA is the body temperature and is treated as a constant, as taught by, Rodrigues, in order to provide to take into account the metabolic heat generation that results from biochemical conversion of energy within tissue (Page154, right column) so that all factors of heat (input and output) are taken into account to model the tissue temperature parameter in the model.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu, in view of Kim, as applied to claim 1 above, and further in view of NPL: “Crisp-BP: Continuous Wrist PPG-based Blood Pressure Measurement” to Cao et al. “Cao”.
Regarding claim 15, the modifications of Hu and Kim disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Kim teaches wherein the at least one physical variable comprises contact pressure of the opto-physiological sensor with the subject's skin and modeling the effects of contact pressure with optical density (Paragraphs 0062-0065, and Figs. 6-9, wherein pressure (i.e. the pressure applied to the tissue from the probe, Abstract) is correlated with the detected intensity, Fig. 6, converting the intensity into optical density, and determining the relationship between the pressure and optical density, Fig. 8, Paragraph 0064, and 0067 determining the correction factor).
Hu further teaches modelling a change in the optical density of a specific tissue type based on a change in the optical path length (Paragraph 0169, determining the AC/DC ratio that gives a ratio of the static and dynamic components of the effective optical path length through the body tissue; See also Eq. 5 and 6, Paragraphs 0121-0122).
However, the modifications of Hu and Kim do not explicitly disclose determining the effects of contact pressure, through modelling a change in the optical density of a specific tissue type based on a change in the optical path length.
Cao teaches a similar PPG-based system (Title), that includes a PPG sensor (Page 379, left column) for determining blood pressure measurements. Cao teaches modeling the optical density (Pages 382-383, Section: 5.2 Arterial Pulse Extraction, Subsection: Optical Density Modeling). Cao additionally teaches determining the impact of contact pressure between the PPG sensor and human skin (Page 381, Section: 4.1 Impact of Contact Pressure). This reads on wherein the at least one physical variable comprises contact pressure of the opto-physiological sensor with the subject’s skin. Further, Cao teaches evaluating the contact pressure based on the error in the ABP (Arterial Blood Pressure) estimation (Page 386, Section: 7.4 Key Algorithm Performance), wherein the ABP is determined based on the reflected wave transit time (RWTT) (Page 383, Section: 6.1 Basic Model), and wherein the optical density model is used to determine the RWTT (Page 382-383, Section: 5.2 Arterial Pulse Extraction), and the path lengths of the two illumination sources (“L” terms in equation 6 for IR and Green) are taken into account. Therefore, this would read on the claimed determining, using the model, how the at least one physical variable affects the at least one physiological property comprises modelling a change in the optical density of a specific tissue type based on a change in the optical path length.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu and Kim, wherein the method performed by the system includes determining the effects of contact pressure, through modelling a change in the optical density of a specific tissue type based on a change in the optical path length, as taught by Cao, in order to determine the optimum contact pressure to apply to the skin with the sensor.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu, in view of Kim, and further in view of Cao, as applied to claim 15 above, and further in view of Shitzer, and further view of NPL: “Effects of Contact Pressure in Reflectance Photoplethysmography in an In Vitro Tissue-Vessel Phantom” to May et al. “May”.
Regarding claims 16 and 17, the modifications of Hu, Kim, and Cao disclose all the features of claim 15 above.
As disclosed in the claim 1 rejection above, Kim teaches modeling the effects of contact pressure with optical density (Paragraphs 0062-0065, and Figs. 6-9, wherein pressure (i.e. the pressure applied to the tissue from the probe, Abstract) is correlated with the detected intensity, Fig. 6, converting the intensity into optical density, and determining the relationship between the pressure and optical density, Fig. 8, Paragraph 0064, and 0067 determining the correction factor).
Additionally, Hu discloses modeling the density of a specific tissue type as a function of wavelength of the illumination source (Paragraph 0032, the model may be considered at one or more wavelengths; Paragraph 0037-0038, model wherein the equation 10 for the model includes the optical density of the body tissue type) of the opto-physiological sensor (Paragraph 0151, Fig. 4A, Ref. 40).
However, the modifications of Hu, Kim, and Cao do not disclose modeling the optical density of a specific tissue type as a function of temperature.
Shitzer teaches wherein modelling the density of a specific tissue type as a function of temperature (See Page 1830, Section: Analysis, and Eq. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, Kim, and Cao, wherein modeling the density of a specific tissue type, also includes modeling as a function of temperature, as taught by Shitzer, in order to model temperature with blood perfusion to potentially allow prediction of blood perfusion rates from temperature (Page 1833, last paragraph, left column).
However, Hu, Kim, Cao, and Shitzer do not disclose the modeling as being proportional to the contact force when the contact force is within a selected range, and modelling the optical density of a specific tissue type as a function of wavelength and temperature as being proportional to the inverse of the contact force when the contact force is outside of the selected range as shown in Eq. 17:
PNG
media_image11.png
107
474
media_image11.png
Greyscale
May teaches in a similar method of determining the effects of contact pressure in reflectance photoplethysmography (Title).
As seen in Fig. 4 of May, the PPG signal is increasing until approximately 50 mmHg of sensor is applied, then the signal amplitude beings to decrease, as the vessel is slowly becoming more restricted, until there is a sudden drop off that corresponds with the vessel being completely occluded (Page 8, Section 3.1). May teaches that the pressure exerted by the PPG probe (approximately between 10 and 50 mm Hg) does not significantly affect the ability to detect and measure PPG morphological features. Using the conversion equation 1 of May, the range of 10 to 50 mmHg, converted to force measured in Newtons would result in a range of 0.133 to 0.665. The would be similar to the claimed range of 0.15 to 1.5, when the optical density is proportional to the contact force. Additionally, outside the range of 10 to 50 mmHg (or 0.133 to 0.665 N) the signal amplitude is decreasing, and would be similar to the second claimed relationship of the optical density is proportional to the inverse of the contact force, when outside of the optimum contact force range.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Hu, Kim, and Cao, wherein the modeling is proportional to the contact force when the contact force is within a selected range, and modelling the optical density of a specific tissue type as a function of wavelength and temperature as being proportional to the inverse of the contact force when the contact force is outside of the selected range, as taught by May, in order to take into the account effect of contact force on the collected sensor signal when the contact force within an optimum range, and to also take into account the effect on the signal collected by the sensor, when the contact force is not in the optimum range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Milton Truong whose telephone number is (571)272-2158. The examiner can normally be reached 9AM - 5PM, MON-FRI.
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, Keith Raymond can be reached at (571) 270-1790. 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.
/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798