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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
Response to Amendment
The amendment filed on 10/10/2025 has been entered:
Claim 39 – 52 remain pending in the application;
Claim 1 and 4 – 38 are cancelled;
Claim 39 – 52 are added as new.
Applicant’s amendments to claim overcome each and every claim objection and 112 (d) claim rejection as set forth in the Final Office Action mailed on 06/10/2025. The corresponding claim objections and 112 claim rejections are withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1, 4 – 9 and 26 – 38 under 35 U.S.C. 103 have been fully considered but they are moot in view of new grounds of rejection.
Regarding the rejection of independent claim 1 and all corresponding dependent claims, applicant canceled all claims and submitted new claims 38 – 52. In addition, applicant submitted on p.8 – 10 that “As presented in independent claim 39, the claimed method of monitoring a patient recites, among other things, calculating a plurality of ratios from combinations of at least three different colors in the video image, and then determining the oxygen saturation of the patient by adding the calculated plurality of ratios. The art of record, regardless of any hypothetical combination, fails to teach or suggest at least this feature of claim 39”; “Clifton (at [0056]) in fact does not teach that "the saturation of oxygen of the patient is determined using multiple parameters, wherein the multiple parameters comprise various frequencies of light from the video image." To the contrary, the "frequency" referred to in that paragraph is expressly described not as a frequency of light, but rather "the frequency which corresponds to the subject's heart rate." A heart rate frequency cannot qualify as the claimed "frequency signal" of a color”.
Applicant’s arguments have been fully considered but they are moot in view of new grounds of rejection for the following reasons.
First, neither the specification nor the claim defines what frequency it is related to the claimed “frequency signals”. Such frequency is a broad term. Any temporal signal contains frequency components. Further, any light signal inherently contains different frequency band. The citation of Clifton is related to temporal color signal not the hear rate as argued by applicant. Even though such color signal may contains information of heart rate, it does not prevent Clifton to use the absorption band to calculate oxygen saturation, which is well-known in the art.
Second, since applicant’s amendment changed the scope of claims, new reference, Wang et al. (Noninvasive hemoglobin measurement using unmodified smartphone camera and white flash; published on 07/15/2017) (hereinafter “Wang”), is introduced in new grounds of rejection to teach all claim limitations in combination with other cited references. See detail in later 103 rejections.
Overall, applicant’s remarks submitted on p.8 – 10 have been fully considered, but they are moot in view of new grounds of rejection. The amendments result in new grounds of rejection.
Claim Objections
Claim 42, 45 and 49 are objected to because of the following informalities:
Claim 42 line 2 – 3, limitation “the equation: SaO2 = (mRI x RRI) + (mGI x RGI) x (mBI x RBI) + (mRG x RRG) + (mRB x RRB) + (mGB x RGB) + (mλ1λ2 x R λ1λ2) + b” should read “the equation: SaO2 = (mRI * RRI) + (mGI * RGI) + (mBI * RBI) + (mRG * RRG) + (mRB * RRB) + (mGB * RGB) + (mλ1λ2 x R λ1λ2) + b”.
Claim 45 recites preamble “The method of claim 45”. A claim cannot depend on itself. Thus, for the purpose of examination, claim 45 is constructed as dependent on claim 39.
Claim 49 line 2 – 3, limitation “the equation: SaO2 = (mRI x RRI) + (mGI x RGI) x (mBI x RBI) + (mRG x RRG) + (mRB x RRB) + (mGB x RGB) + (mλ1λ2 x R λ1λ2) + b” should read “the equation: SaO2 = (mRI * RRI) + (mGI * RGI) + (mBI * RBI) + (mRG * RRG) + (mRB * RRB) + (mGB * RGB) + (mλ1λ2 x R λ1λ2) + b”.
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.
Claim 42 and 49 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 42 and claim 49 recite equations with different symbols representing different variables. Although “mxy” is annotated in the claim, mxy is not recited in the claim, and it is unclear what does “x” or “y” represent. There is no annotation of any other symbols except “b” recited in claim. It is unclear what value or unit those symbols are representing.
Thus, the above equations without annotation render claim indefinite. For the purpose of examination, those symbols in equations are interpreted as any reasonable variable.
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.
Claim 39 – 52 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton et al. (US 2014/0303454 A1; published on 10/09/2014) (hereinafter "Clifton") in view of Blanik et al. ("REMOTE PULSE OXIMETRY IMAGING – FUNDAMENTALS AND APPLICATIONS"; published on 10/01/2014) (hereinafter "Blanik") (citations of Blanik is based on the NPL in IDS filed on 08/06/2020) and Wang et al. (Noninvasive hemoglobin measurement using unmodified smartphone camera and white flash; published on 07/15/2017) (hereinafter “Wang”).
Regarding claim 39, Clifton teaches a method of monitoring a patient ("FIG. 1A schematically illustrates the vital-sign monitoring system ..." [0040]; "FIG. 3 sets out the process for analysing the signals from the webcam 4 to obtain a heart rate and oxygen saturation measurement." [0044]), the method comprising:
collecting a video image of the patient ("The patient 1 will be monitored by the webcam 4 while using the device 3 …" [0040]), wherein the video image comprises at least three different colors, each color corresponding to a different wavelength of light ("… which obtains the red, green and blue video output from the webcam 4 …" [0040]; "... for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) ..." [0044]);
deriving at least three frequency signals (“… a time series of these intensities is assembled for a series of frames in a time window …" [0045]; any temporal signal inherently contains frequency components, and any light signal inherently contains frequency bands, based on above fundamental physics signal in each color channel is a frequency signal), one each from the at least three colors of the video image, including a first frequency signal of a first color, a second frequency signal of a second color, and a third frequency signal of a third color ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region), one or more representative intensities from the region of interest, such as the spatial mean average or the modes of any distributions, are derived for both the ROIr and ROIs." [0044]; here three of the RGB and infra-red channels are interpreted as first, second and third frequency signals);
calculating a plurality of ratios from the at least three frequency signals ("… by calculating the ratio of the intensity of the reflected light at two different wavelengths." [0017]; "In FIG. 6F the radius of the pole, i.e. its distance from the origin, is an indication of the amplitude of the heart rate component in that (red, green or blue) channel. Thus in step 42 the radius of the heart rate pole in the green (or infra-red) channel and the red channel is obtained and the ratio of the radii is taken. This corresponds to the ratio of the reflected intensities at the red and green (or infra-red) wavelengths." [0059]); and
determining an oxygen saturation of the patient by the calculated plurality of ratios ("The oxygen saturation SpO2 measurement can be obtained by calculating the ratio of the intensity of the reflected light at two different wavelengths." [0017]; "The SpO2 value can be calculated from this ratio using calibration tables." [0059]).
Clifton fails to explicitly teach wherein calculating each ratio comprises dividing (i) a first logarithm of a first pulsatile signal intensity of one of the three frequency signals divided by a first non-pulsatile signal intensity of the one of the three frequency signals, by (ii) a second logarithm of a second pulsatile signal intensity of a different one of the three frequency signals divided by a second non-pulsatile signal intensity of the different one of the three frequency signals; and determining an oxygen saturation of the patient by adding the calculated plurality of ratios.
However, in the same field of endeavor, Blanik teaches wherein calculating each ratio comprises dividing (i) a first logarithm of a first pulsatile signal intensity of one of the three frequency signals divided by a first non-pulsatile signal intensity of the one of the three frequency signals, by (ii) a second logarithm of a second pulsatile signal intensity of a different one of the three frequency signals divided by a second non-pulsatile signal intensity of the different one of the three frequency signals (see equation (2) on Page 7; the Aλ1 part is the first logarithm, and the Aλ2 part is the second logarithm); and
determining a saturation of oxygen of the patient based on the calculated ratio (see equation (3) and (4) on Page 7).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
In addition, Wang further teaches determining an oxygen saturation of the patient by adding the calculated plurality of ratios (“By observing the different features extracted from the pulse signal, we selected the ratio of ratios RG,B rand RR,B, in particular the summation of the two, as the feature that best tracks hemoglobin concentration. A linear regression between RG,B+RR,B and the ground truth generates a model that converts PPG to hemoglobin levels.” Page 2335; considering the teaching of Blanik on Page 7, linear regression of ratio of ratios is used to approximate oxygen saturation).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
Regarding claim 40, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 39, and Clifton further teaches wherein the at least three colors comprise red (R), green (G), blue (B), infrared (I) ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) …" [0044]).
Regarding claim 41, , Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 40, and Blanik further teaches wherein the calculated plurality of ratios comprise two or more of: RRI=ln(ACR/DCR)/ln(ACI/DCI), Rλ1λ2=ln(AC λ1/DC λ1)/ln(AC λ2/DC λ2), wherein ln() indicates a natural logarithm function wherein ACR refers to an alternating signal from the video image in red color, DCR refers to a constant signal from the video image in red color, ACI refers to an alternating signal from the video image in infrared color, DCI refers to a constant signal from the video image in infrared color, AC λ1 refers to an alternating signal from the video image in λ1 color, DC λ1 refers to a constant signal from the video image in λ1 color, AC λ2 refers to an alternating signal from the video image in λ2 color, and DC λ2 refers to a constant signal from the video image in λ2 color; and wherein RRI refers to a ratio of signal intensities of red-light signals to infrared-light signals, R λ1λ2 refers to a ratio of signal intensities of λ1-signals to λ2-light signals (see equation (2) on Page 7; "From this the R-value can be defined, describing the ratio between the absorbance A of hemoglobin at two different wavelengths …" Page 6; "For wavelengths at 660 and 940 nm, simplifying mathematical approximations have been suggested by (amongst others) Meiyappan et al. " Page 7; here 660 nm is red light and 940 nm is infrared light, and equation (2) can be applied to any two different wavelengths).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
Regarding claim 42, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 39, and Wang further teaches wherein the oxygen saturation (SaO2) of the patient is determined, at least in part, based on the equation: SaO2 = (mRI x RRI) + (mGI x RGI) x (mBI x RBI) + (mRG x RRG) + (mRB x RRB) + (mGB x RGB) + (mλ1λ2 x R λ1λ2) + b (see 112b rejection for indefiniteness and claim interpretation; “In theory, with multiple ratio of ratios, the hemoglobin concentration can be estimated using empirically measured absorption coefficients for each compound for the wavelengths used.” Page 2335; the claimed equation is a typical multi variables linear regression approximation).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
Regarding claim 44, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 39, and Clifton further teaches wherein the at least three colors comprise four or more different light wavelengths ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) …" [0044]; R, G, B and IR, there are four different wavelengths).
Regarding claim 45, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 39, and Blanik further suggests wherein the plurality of calculated ratios comprises three or more ratios (see equation (2) on Page 7; "From this the R-value can be defined, describing the ratio between the absorbance A of hemoglobin at two different wavelengths …" Page 6; "For wavelengths at 660 and 940 nm, simplifying mathematical approximations have been suggested by (amongst others) Meiyappan et al. " Page 7; equation (2) can be applied to any two different wavelengths; Blanik does not limit the wavelength selection).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
In addition, Wang also suggest wherein the plurality of calculated ratios comprises three or more ratios (“In theory, with multiple ratio of ratios, the hemoglobin concentration can be estimated using empirically measured absorption coefficients for each compound for the wavelengths used.” Page 2335).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
In general, Wang provide a theory of using multiple ratio of ratios for linear regression approximation. The number of ratio of rations selected for linear regression would be designer’s choice, and can be optimized with routine experimentation.
Regarding claim 46, Clifton teaches a system for monitoring a patient ("FIG. 1A schematically illustrates the vital-sign monitoring system ..." [0040]), the system comprising:
one or more computer systems having at least memory for storing data and instructions (“The invention is preferably incorporated into a vital-sign monitor, which may be embodied as a computer program for running on a personal computer, tablet or laptop computer, or mobile telephone …” [0018]; memory is inherent component of any computer device for data/instructions storage);
a video capture system configured to collect video images ("The patient 1 will be monitored by the webcam 4 while using the device 3 …" [0040]);
wherein the one or more computer systems are configured to perform operations (“The invention is preferably incorporated into a vital-sign monitor, which may be embodied as a computer program for running on a personal computer, tablet or laptop computer, or mobile telephone …” [0018]) comprising:
collect a video image of the patient ("The patient 1 will be monitored by the webcam 4 while using the device 3 …" [0040]), wherein the video image comprises at least three different colors, each color corresponding to a different wavelength of light ("… which obtains the red, green and blue video output from the webcam 4 …" [0040]; "... for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) ..." [0044]);
derive at least three frequency signals (“… a time series of these intensities is assembled for a series of frames in a time window …" [0045]; any temporal signal inherently contains frequency components, and any light signal inherently contains frequency bands, based on above fundamental physics signal in each color channel is a frequency signal), one each from the at least three colors of the video image, including a first frequency signal of a first color, a second frequency signal of a second color, and a third frequency signal of a third color ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region), one or more representative intensities from the region of interest, such as the spatial mean average or the modes of any distributions, are derived for both the ROIr and ROIs." [0044]; here three of the RGB and infra-red channels are interpreted as first, second and third frequency signals);
calculate a plurality of ratios from the at least three frequency signals ("… by calculating the ratio of the intensity of the reflected light at two different wavelengths." [0017]; "In FIG. 6F the radius of the pole, i.e. its distance from the origin, is an indication of the amplitude of the heart rate component in that (red, green or blue) channel. Thus in step 42 the radius of the heart rate pole in the green (or infra-red) channel and the red channel is obtained and the ratio of the radii is taken. This corresponds to the ratio of the reflected intensities at the red and green (or infra-red) wavelengths." [0059]); and
determining an oxygen saturation of the patient by the calculated plurality of ratios ("The oxygen saturation SpO2 measurement can be obtained by calculating the ratio of the intensity of the reflected light at two different wavelengths." [0017]; "The SpO2 value can be calculated from this ratio using calibration tables." [0059]).
Clifton fails to explicitly teach wherein calculating each ratio comprises dividing (i) a first logarithm of a first pulsatile signal intensity of one of the three frequency signals divided by a first non-pulsatile signal intensity of the one of the three frequency signals, by (ii) a second logarithm of a second pulsatile signal intensity of a different one of the three frequency signals divided by a second non-pulsatile signal intensity of the different one of the three frequency signals; and the one or more computer systems are configured to determine an oxygen saturation of the patient by adding the calculated plurality of ratios.
However, in the same field of endeavor, Blanik teaches wherein calculating each ratio comprises dividing (i) a first logarithm of a first pulsatile signal intensity of one of the three frequency signals divided by a first non-pulsatile signal intensity of the one of the three frequency signals, by (ii) a second logarithm of a second pulsatile signal intensity of a different one of the three frequency signals divided by a second non-pulsatile signal intensity of the different one of the three frequency signals (see equation (2) on Page 7; the Aλ1 part is the first logarithm, and the Aλ2 part is the second logarithm); and
the one or more computer systems are configured to determine a saturation of oxygen of the patient based on the calculated ratio (see equation (3) and (4) on Page 7).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
In addition, Wang further teaches the one or more computer systems are configured to determine an oxygen saturation of the patient by adding the calculated plurality of ratios (“By observing the different features extracted from the pulse signal, we selected the ratio of ratios RG,B rand RR,B, in particular the summation of the two, as the feature that best tracks hemoglobin concentration. A linear regression between RG,B+RR,B and the ground truth generates a model that converts PPG to hemoglobin levels.” Page 2335; considering the teaching of Blanik on Page 7, linear regression of ratio of ratios is used to approximate oxygen saturation).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
Regarding claim 47, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 46, and Clifton further teaches wherein the at least three colors comprise red (R), green (G), blue (B), infrared (I) ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) …" [0044]).
Regarding claim 48, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 47, and Blanik further teaches wherein the calculated plurality of ratios comprise two or more of: RRI=ln(ACR/DCR)/ln(ACI/DCI), Rλ1λ2=ln(AC λ1/DC λ1)/ln(AC λ2/DC λ2), wherein ln() indicates a natural logarithm function wherein ACR refers to an alternating signal from the video image in red color, DCR refers to a constant signal from the video image in red color, ACI refers to an alternating signal from the video image in infrared color, DCI refers to a constant signal from the video image in infrared color, AC λ1 refers to an alternating signal from the video image in λ1 color, DC λ1 refers to a constant signal from the video image in λ1 color, AC λ2 refers to an alternating signal from the video image in λ2 color, and DC λ2 refers to a constant signal from the video image in λ2 color; and wherein RRI refers to a ratio of signal intensities of red-light signals to infrared-light signals, R λ1λ2 refers to a ratio of signal intensities of λ1-signals to λ2-light signals (see equation (2) on Page 7; "From this the R-value can be defined, describing the ratio between the absorbance A of hemoglobin at two different wavelengths …" Page 6; "For wavelengths at 660 and 940 nm, simplifying mathematical approximations have been suggested by (amongst others) Meiyappan et al. " Page 7; here 660 nm is red light and 940 nm is infrared light, and equation (2) can be applied to any two different wavelengths).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
Regarding claim 49, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 46, and Wang further teaches wherein the oxygen saturation (SaO2) of the patient is determined, at least in part, based on the equation: SaO2 = (mRI x RRI) + (mGI x RGI) x (mBI x RBI) + (mRG x RRG) + (mRB x RRB) + (mGB x RGB) + (mλ1λ2 x R λ1λ2) + b (see 112b rejection for indefiniteness and claim interpretation; “In theory, with multiple ratio of ratios, the hemoglobin concentration can be estimated using empirically measured absorption coefficients for each compound for the wavelengths used.” Page 2335; the claimed equation is a typical multi variables linear regression approximation).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
Regarding claim 51, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 46, and Clifton further teaches wherein the at least three colors comprise four or more different light wavelengths ("In step 32, for each video frame, for each of the three red, green and blue channels (or from the red channel of one video camera and from a second video camera with its IR filter removed to provide a signal in the infra-red region) …" [0044]; R, G, B and IR, there are four different wavelengths).
Regarding claim 52, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 46, and Blanik further suggests wherein the plurality of calculated ratios comprises three or more ratios (see equation (2) on Page 7; "From this the R-value can be defined, describing the ratio between the absorbance A of hemoglobin at two different wavelengths …" Page 6; "For wavelengths at 660 and 940 nm, simplifying mathematical approximations have been suggested by (amongst others) Meiyappan et al. " Page 7; equation (2) can be applied to any two different wavelengths; Blanik does not limit the wavelength selection).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Blanik. By using such classical calculation with camera based monitoring system, it would be possible to provide advantages include: "i) its easy-to-use setup, ii) functional mapping of estimated vital parameters offering an intuitive access for interpretation, and iii) the unobtrusiveness of the measurement technique that supports a wide range of possible applications" (see Blanik; Page 11).
In addition, Wang also suggest wherein the plurality of calculated ratios comprises three or more ratios (“In theory, with multiple ratio of ratios, the hemoglobin concentration can be estimated using empirically measured absorption coefficients for each compound for the wavelengths used.” Page 2335).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ratio calculation based on PPG signal as taught by Clifton with ratio calculation based on PPG signal as taught by Wang. Doing so it provides “the possibility of a purely software-based smartphone hemoglobin measurement app for a variety of use cases, ranging from at home monitoring of anemia for pregnant women to in the field testing for nutritional deficiencies in children” (see Wang; Page 2336).
In general, Wang provide a theory of using multiple ratio of ratios for linear regression approximation. The number of ratio of rations selected for linear regression would be designer’s choice, and can be optimized with routine experimentation.
Claim 43 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton in view of Blanik and Wang, as applied in claim 39 and 46 respectively, and further in view of Hong et al. (US 2017/0007137 A1; published on 01/12/2017) (hereinafter "Hong").
Regarding claim 43, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 39, except monitoring a blood pressure of the patient using the video image and an analysis of the pulsatile signal from at least one associated color.
However, in the same field of endeavor, Hong teaches monitoring a blood pressure of the patient using the video image ("FIG. 2 illustrates an example of a flowchart for describing a method of estimating a blood pressure using a video." [0022]) and an analysis of the pulsatile signal from at least one associated color ("The computer device continuously stores mean value of color data of a designated color model for two target regions in the skin region (S230) for a period of time." [0024]; "The computer device may convert the mean value of the color data of the designated color model into a pulse wave signal using a band pass filter." [0027]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the PPG signal from video as taught by Clifton to further calculate blood pressure as taught by Hong. Doing so would make it possible to provide additional vital signal from one single monitoring source, therefore making the monitoring system more simple and more efficient with fewer instruments.
Regarding claim 50, Clifton in view of Blanik and Wang teaches all claim limitations, as applied in claim 46, except wherein the one or more computer systems are further configured to monitor a blood pressure of the patient using the video image and an analysis of the pulsatile signal from at least one associated color.
However, in the same field of endeavor, Hong teaches wherein the one or more computer systems are further configured to monitor a blood pressure of the patient using the video image ("FIG. 2 illustrates an example of a flowchart for describing a method of estimating a blood pressure using a video." [0022]) and an analysis of the pulsatile signal from at least one associated color ("The computer device continuously stores mean value of color data of a designated color model for two target regions in the skin region (S230) for a period of time." [0024]; "The computer device may convert the mean value of the color data of the designated color model into a pulse wave signal using a band pass filter." [0027]), wherein a shape of the waveform, after calibration ("The equation used for estimating the blood pressure includes body information of the user in addition to the PTT ... from a database storing the body information ..." [0031]; the is a process of calibration), provides a measurement of the blood pressure ("Finally, the computer device may estimate a blood pressure using the PTT (S270). An equation used for the blood pressure estimation may be an equation used in the technology using the PPG signal and the ECG signal. Generally, the blood pressure is estimated using a regression equation." [0024]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the PPG signal from video as taught by Clifton to further calculate blood pressure as taught by Hong. Doing so would make it possible to provide additional vital signal from one single monitoring source, therefore making the monitoring system more simple and more efficient with fewer instruments.
Conclusion
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/CHAO SHENG/ Primary Examiner, Art Unit 3797