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 .
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
Applicant argues that the Khair and the Danehorn references are not combinable. Remarks at 10-11. In one aspect, the Applicant argues that combining Khair with Danehorn would render Khair unsatisfactory for its intended purpose, in the manner of In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984), and that the combination would change Fullerton's principle of operation, in the manner of In re Ratti, 270 F.2d 810, 812-13 (CCPA 1959). See id.
According to the Applicant, Khair and Danehorn are incompatible, on account of structural and operational differences in particular embodiments disclosed in the references. According to the Applicant, Khair’s technique employs “a noninvasive wireless blood pressure data acquisition system.” Id. By contrast, the Applicant contends that Danehorn involves “blood pressure data acquired invasively.” See id. Hence, the Applicant contends the “proposal for modifying the prior art in an effort to attain the claimed invention causes the art to become inoperable or destroys its principle of operation.” Id. at 11.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, the inquiry into whether the identified features of Danehorn’s embodiments could be incorporated into those of Khair -the foundation of the Applicant’s arguments - is, in the words of the U.S. Court of Appeals for the Federal Circuit, "basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole." In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc). Notably, the Examiner's cited teachings of Danehorn, which are relied upon in the rejections, do not include the Applicant’s asserted features of invasive blood pressure data acquisition. Rather, as the Examiner explained:
in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the processor is adapted to account for an effect of respiration on a blood pressure measurement (a model is derived for respiratory artifacts and the model is subtracted from the measured blood pressure data, Abstract; data processing module, [0020]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of removing respiratory artifacts from acquired blood pressure measurements using a model to Khair’s known apparatus for acquiring blood pressure measurements to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Non-Final Rejection mailed 9/4/2025 (”NF”) at 6. None of the Applicant’s arguments are directed to the specific teachings of Danehorn relied upon and cited in the NF. The Applicant makes no argument that a PHOSITA would not find it obvious to modify the processor of Khair’s known non-invasive apparatus comprising a pressure sensor and optical blood flow detector to measure blood pressure such that the processor is further adapted to account for an effect of respiration on a blood pressure measurement. Nor, does the Applicant argue that the combination/modification of the teachings of the references,
as articulated in the rejection, render Khair unsatisfactory for its intended purpose and/or changes the principle of operation of Khair. Hence, the Applicant’s comparison of the present circumstances to those of Gordon and Ratti are inapposite.
In another aspect, the Applicant argues that the Examiner improperly combines/modifies Khair, in view of Danehorn, because Danehorn teaches away from their combination. Remarks at 11-12. The Applicant’s asserted bases for such alleged teaching away are that
such modifications would foreseeably destroy "the key to the success of the invention" and the functionality of Khair. To facilitate continuous blood pressure monitoring, the processes in Khair are specifically contemplated to improve upon prior art methods that required a patient to be at a rested state. In contrast, the techniques disclosed in Danehorn are only suited for invasive measurement processes that require a patient to be at rest.
Id. at 12.
"A reference may be said to teach away when a person of ordinary skill, upon reading the reference ... would be led in a direction divergent from the path that was taken by the applicant." In re Haruna, 249 F .3d 1327, 1335 (Fed. Cir. 2001) (quoting Tee Air, Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1360 (Fed. Cir. 1999)); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (holding that, to teach away, the prior art must "criticize, discredit, or otherwise discourage the solution claimed").
Again, none of the Applicant’s arguments are directed to the specific teachings of Danehorn relied upon and cited in the NF. The Applicant makes no argument that a PHOSITA would not find it obvious to modify the processor of Khair’s known non-invasive apparatus comprising a pressure sensor and optical blood flow detector to measure blood pressure such that the processor is further adapted to account for an effect of respiration on a blood pressure measurement. Nor, does the Applicant argue that the combination/modification of the teachings of the references, as articulated in the rejection, are criticized, discredited, or otherwise discouraged by the Khair or Danehorn references. Hence, the Applicant’s comparison of the present circumstances to those of Fulton are inapposite.
Moreover, claims 1, 12, and 18 as filed 9/16/2024 did not recite a particular apparatus or process steps to achieve the functionality of the processor “to account for an effect of respiration on a blood pressure measurement.” Therefore, Danehorn’s use of an invasive CO2 measurement to determine the respiratory cycle has no identified bearing or impact on any limitation of claims 1, 12, and 18 or any reason why the identified teachings of Khair and Danehorn would not have been combined. Thus, Applicant’s arguments do not indicate that Danehorn, per Fulton, 391 F.3d at 1201, "criticize[s], discredit[s], or otherwise discourage[s] the solution claimed" in claims 1, 12, and 18.
Further, Applicant provides no support for the contention that the sole or key advantage that Khair’s invention provides over the prior art is that it permits acquisition when the patient is not at rest, nor that Khair’s invention does not operate when the patient is at rest. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." Again, nothing in Applicant’s allegations addresses why a PHOSITA would not find it obvious to modify the processor of Khair’s known non-invasive apparatus comprising a pressure sensor and optical blood flow detector to measure blood pressure such that the processor is further adapted to account for an effect of respiration on a blood pressure measurement. Rather, Applicant makes basically irrelevant arguments that the identified features of Danehorn’s embodiments could not be incorporated into those of Khair.
In addition, Applicant fails to address the motivation to combine cited in the NF at 6 “that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].”
In any event, as the Federal Circuit has explained: "The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another." Winner Int 'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000). In this case, even if combining Danehorn's teachings with those of Khair effected some negative consequences, as the Applicant contends, the evidence of record does not indicate that such disadvantages would undermine the reasons to combine the references' teachings.
In view of the foregoing, Applicant’s arguments are not persuasive.
Applicant’s arguments with respect to the amendment to claims 1, 12, and 18 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. As detailed in infra rejection, independent claims 1, 12, and 18 are rejected over the combination of Khair in further view of Elliot in further view of Danehorn.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Khair et al. (U.S. Patent No. 6,475,153), hereinafter “Khair,” in further view of Elliott et al. (U.S. Pub. No. 2015/0051500 as sharing the same disclosure as WO 2013/001265), hereinafter “Elliott,” in further view of Danehorn et al. (U.S. Pub. No. 2007/0073170), hereinafter “Danehorn.”
Regarding claim 1, Khair discloses a system (“a noninvasive wireless blood pressure data acquisition system”, Col.16, lines 36-45), comprising:
a processor (“acquisition apparatus for use in the present method invention is shown in FIG. 1. The blood pressure sensor apparatus 10 is suitable for application to a patient's wrist area to acquire blood pressure data. The blood pressure data is acquired via optical techniques described at length herein. In a preferred embodiment, the sensor is capable of wireless bidirectional data communication with a base unit 20, but it can alternatively be constructed as a stand-alone device with a user interface for displaying blood pressure data. In the wireless embodiment, the base unit 20 can be coupled to a computer 22 for display and analysis of blood pressure data or a wireline interface to transmit the data to a remote monitoring station 24” Khair, Col. 8, lines 21-35; “The scattering patterns acquired by the array 17… could be sent to a remote processing unit such as the base unit of FIG. 1 and there processed into useful blood pressure data… The n×m photodetector analog signals and the HDP sensor signals are multiplexed in multiplexer 104, filtered by an anti-aliasing low pass filter 106, amplified by amp 108, and sampled and converted into digital signals in an analog to digital converter 110. The digital signals are supplied to a computing platform in the form of a microcontroller and digital signal processor (DSP) unit 112” Khair, Col. 15, lines 15-51); and
a signal acquisition device (SAD) (“acquisition apparatus for use in the present method invention is shown in FIG. 1. The blood pressure sensor apparatus 10 is suitable for application to a patient's wrist area to acquire blood pressure data. The blood pressure data is acquired via optical techniques described at length herein” Khair, Col. 8, lines 21-35), the SAD comprising:
a blood flow occlusion device having an open surface available to be pressed against a body part of the subject or to have a body part of the subject pressed against it (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51);
a pressure sensor (“hold down pressure sensor 36” Khair, Col. 10, lines 35-53) adapted to provide an electrical signal indicative of the pressure applied to or by the open surface (“translate a hold down pressure to an analog voltage level” Khair, Col. 10, lines 35-53);
an optical blood flow detecting device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “The two-dimensional array of photo-sensitive elements is incorporated into an optical blood pressure sensor adapted to be placed on the surface of a patient and obtain optical information as to movement of the patient's skin in response to blood flow” Khair, Col. 5, lines 25-45) configured to detect the flow of blood in the body part of the subject when pressure is applied to or by the open surface (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51); and
a device configured to receive electrical signals from the pressure sensor and the optical blood flow detecting device (“The scattering patterns acquired by the array 17… could be sent to a remote processing unit such as the base unit of FIG. 1 and there processed into useful blood pressure data… The n×m photodetector analog signals and the HDP sensor signals are multiplexed in multiplexer 104, filtered by an anti-aliasing low pass filter 106, amplified by amp 108, and sampled and converted into digital signals in an analog to digital converter 110” Khair, Col. 15, lines 15-31) and to transmit electrical signals indicative of the pressure and the blood flow to the processor (“The scattering patterns acquired by the array 17… could be sent to a remote processing unit such as the base unit of FIG. 1 and there processed into useful blood pressure data… The n×m photodetector analog signals and the HDP sensor signals are multiplexed in multiplexer 104, filtered by an anti-aliasing low pass filter 106, amplified by amp 108, and sampled and converted into digital signals in an analog to digital converter 110. The digital signals are supplied to a computing platform in the form of a microcontroller and digital signal processor (DSP) unit 112” Khair, Col. 15, lines 15-51),
wherein the processor is adapted to acquire a blood pressure measurement (“Y(t)” Col. 16, line 46-Col. 17, line 29, Col. 19, line 39-Col. 20, line 55) by (1) generating candidate optical signals (“X(t)” Col. 16, line 46-Col. 17, line 29 or “X(t)+ΔZ(t)” Col. 19, line 39-Col. 20, line 55; “measurements of the patient’s blood pressure are made with a second blood pressure device, such as an air cuff” and “systolic cuff reading was represented by Ys(t)… diastolic cuff reading by Yd(t)” Col. 16, line 46-Col. 17, line 29) using a model (“Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd” Col. 16, line 46-Col. 17, line 29 or “Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)” Col. 19, line 39-Col. 20, line 55).
However, Khair does not appear to disclose the processor is adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to account for an effect of respiration on a blood pressure measurement.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the processor (processor of the personal hand-held monitor (PHHM), [0001], [0013]; see also [0087], [0095], [0107]-[0109], [0116]-[0117], [0141]-[0151]) is adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to determine an effect of respiration on a blood pressure measurement (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of the blood photosensor and/or pressure sensor to Khair’s known apparatus configured to measure blood pressure comprising a processor, pressure sensor, and optical blood flow detecting device to achieve the predictable result that using a blood photosensor and/or pressure sensor to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, while Khair in further view of Elliott teaches the processor is adapted to use the electrical signals from the pressure senor, the optical blood flow detecting device, or both to determine an effect of respiration on a blood pressure measurement, Khair in further view of Elliott, does not appear to teach the processor is adapted to account for an effect of respiration on a blood pressure measurement.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the processor (data processing module, [0020]) is adapted to account for an effect of respiration on a blood pressure measurement (a model is derived for respiratory artifacts and the model is subtracted from the measured blood pressure data, Abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of a processor adapted to account for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known apparatus comprising a processor adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to determine an effect of the respiration cycle on a blood pressure measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Regarding claim 2, Khair in further view of Elliott does not appear to disclose the processor is adapted to account for the effect of respiration on the blood pressure measurement by generating a parametric function to represent the effect of respiration.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the processor (data processing module, [0020]) is adapted to account for the effect of respiration on the blood pressure measurement by generating a parametric function to represent the effect of respiration (the respiratory model is in the form of one or more parametric functions that each represent the effect of respiration on the blood pressure measurements, Abstract, [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of a processor adapted to account for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using one or more parametric functions to represent the effect of respiration based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known apparatus comprising a processor adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to determine an effect of the respiration cycle on a blood pressure measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Regarding claim 3, Khair discloses estimating an initial diastolic blood pressure (DBP) value and an initial systolic blood pressure (SBP) value without taking account of the effect of respiration (“Y(t)” Col. 16, line 46-Col. 17, line 29, Col. 19, line 39-Col. 20, line 55) by (1) generating candidate optical signals (“X(t)” Col. 16, line 46-Col. 17, line 29 or “X(t)+ΔZ(t)” Col. 19, line 39-Col. 20, line 55; “measurements of the patient’s blood pressure are made with a second blood pressure device, such as an air cuff” and “systolic cuff reading was represented by Ys(t)… diastolic cuff reading by Yd(t)” Col. 16, line 46-Col. 17, line 29) using a model (“Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd” Col. 16, line 46-Col. 17, line 29 or “Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)” Col. 19, line 39-Col. 20, line 55).
However, Khair does not appear to disclose an estimate of the subject’s respiration cycle.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches an estimate of the subject’s respiration cycle (the state of the respiration cycle and the effect on blood pressure and pulse is estimated from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is estimated from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle are estimated using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of the blood photosensor and/or pressure sensor to Khair’s known apparatus configured to measure blood pressure comprising a processor, pressure sensor, and optical blood flow detecting device to achieve the predictable result that using a blood photosensor and/or pressure sensor to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, while Khair in further view of Elliott teaches estimating an initial diastolic blood pressure (DBP) value and an initial systolic blood pressure (SBP) value without taking account of the effect of respiration and estimating the subject’s respiration cycle using the electrical signals of the blood photosensor and/or pressure sensor, Khair in further view of Elliott does not appear to disclose the processor is further adapted to account for the effect of respiration on the blood pressure measurement by:
estimating an initial diastolic blood pressure (DBP) value and an initial systolic blood pressure (SBP) value without taking account of the effect of respiration; and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the processor (data processing module, [0020]) is further adapted to account for the effect of respiration on the blood pressure measurement by:
estimating an initial diastolic blood pressure (DBP) value and an initial systolic blood pressure (SBP) value without taking account of the effect of respiration (measured diastolic and systolic blood pressure data values, [0016], [0022], [0028], Fig. 1); and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of a processor adapted to account for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known apparatus comprising a processor adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to determine an effect of the respiration cycle on a blood pressure measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Regarding claim 5, Khair does not appear to disclose the estimate of the subject’s respiration cycle is obtained by deriving a pulse period from electrical signals received from the optical blood flow detecting device.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle is obtained by deriving a pulse period from electrical signals received from the optical blood flow detecting device (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of the blood photosensor and/or pressure sensor to Khair’s known apparatus configured to measure blood pressure comprising a processor, pressure sensor, and optical blood flow detecting device to achieve the predictable result that using a blood photosensor and/or pressure sensor to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
Regarding claim 6, Khair does not appear to disclose the estimate of the subject’s respiration cycle is further obtained by measuring the amplitude and mean values of the electrical signals received from the optical blood flow detecting device.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle is further obtained by measuring the amplitude and mean values of the electrical signals received from the optical blood flow detecting device (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of the blood photosensor and/or pressure sensor to Khair’s known apparatus configured to measure blood pressure comprising a processor, pressure sensor, and optical blood flow detecting device to achieve the predictable result that using a blood photosensor and/or pressure sensor to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
Regarding claim 7, Khair does not appear to disclose the estimate of the subject’s respiration cycle.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle (the state of the respiration cycle and the effect on blood pressure and pulse is estimated from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is estimated from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle are estimated using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of the blood photosensor and/or pressure sensor to Khair’s known apparatus configured to measure blood pressure comprising a processor, pressure sensor, and optical blood flow detecting device to achieve the predictable result that using a blood photosensor and/or pressure sensor to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, Khair in further view of Elliott does not appear to teach the processor is further adapted to calculate a relationship between the measured SBP value and the estimate of the subject’s respiration cycle.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the processor (data processing module, [0020]) is further adapted to calculate a relationship between the measured SBP value and the estimate of the subject’s respiration cycle (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of a processor adapted to account for an effect of respiration on the SBP blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model relationship based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known apparatus comprising a processor adapted to use the electrical signals from the pressure sensor, the optical blood flow detecting device, or both to determine an effect of the respiration cycle on a blood pressure measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Khair in further view of Elliott in further view of Danehorn as in claim 1 above, and further in view of Narasimhan (U.S. Patent No. 9,820,696), hereinafter "Narasimhan."
Regarding claim 8, Khair discloses the body part is in contact with the blood flow occlusion device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51).
However, Khair in further view of Elliott in further view of Danehorn do not appear to teach a camera adapted to obtain one or more images of the body part of the subject in contact with the blood flow occlusion device.
However, in the same field of endeavor of blood pressure measurement, Narasimhan teaches a camera (Col. 7, lines 51-67) adapted to obtain one or more images of the body part of the subject in contact with the blood flow occlusion device (fingers of the hand are in the field of view of the first and second camera when the subject’s hand is in contact with the measurement device, Col. 7, lines 51-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Narasimhan’s known technique of providing first and second cameras in which the fingers of a hand of a subject are visible to each of the first and second cameras while the measurement device is in contact with the subject’s hand to Khair in further view of Elliott in further view of Danehorn’s known apparatus of a portable blood pressure measurement device to achieve the predictable result that using more than one camera helps to cancel out common mode noise. See, e.g., Narasimhan, Coll. 7, lines 51-67.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Khair in further view of Elliott in further view of Danehorn in further view of Narasimhan as in claim 8 above, and further in view of Sakata et al. (U.S. Pub. No. 2016/0007865), hereinafter “Sakata.”
Regarding claim 9, Khair discloses the body part is in contact with the blood flow occlusion device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51).
However, Khair in further view of Elliott in further view of Danehorn in further view of Narasimhan does not appear to teach the processor is adapted to process the one or more images of the body part to analyze the relative locations of the body part of the subject and the device.
However, in the same field of endeavor of blood pressure measurement, Sakata teaches the processor is adapted to process the one or more images of the body part to analyze the relative locations of the body part of the subject and the device (image processing is used on image captured by a camera to determine the position of the hand relative to the measurement device so that a hand guide and/or instructions to adjust the position of the hand relative to the measurement device can be output, [0035]-[0037]; image processing is performed by a processing unit, [0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sakata’s known technique of performing image processing to determine the relative location of the body part relative to the measurement device to guide the body part position to Khair in further view of Elliott in further view of Danehorn in further view of Narasimhan’s known apparatus for acquiring camera images using a blood pressure measurement and blood flow occlusion device to achieve the predictable result that this allows for the improved fit of the body parts being imaged within the frame of the camera FOV. See, e.g., Sakata, [0036].
Regarding claim 10, Khair discloses the body part is in contact with the blood flow occlusion device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51).
However, Khair in further view of Elliott in further view of Danehorn in further view of Narasimhan does not appear to teach the processor is further adapted to provide the subject with guidance to optimize the relative locations of the body part and the device based on the one or more images.
However, in the same field of endeavor of blood pressure measurement, Sakata teaches the processor is further adapted to provide the subject with guidance to optimize the relative locations of the body part and the based on the one or more images (image processing is used on image captured by a camera to determine the position of the hand relative to the measurement device so that a hand guide and/or instructions to adjust the position of the hand relative to the measurement device can be output, [0035]-[0037]; image processing is performed by a processing unit, [0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sakata’s known technique of performing image processing to determine the relative location of the body part relative to the measurement device to guide the body part position to Khair in further view of Elliott in further view of Danehorn in further view of Narasimhan’s known apparatus for acquiring camera images using a blood pressure measurement and blood flow occlusion device to achieve the predictable result that this allows for the improved fit of the body parts being imaged within the frame of the camera FOV. See, e.g., Sakata, [0036].
Regarding claim 11, Khair discloses the body part is in contact with the blood flow occlusion device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51).
However, Khair in further view of Elliott in further view of Danehorn does not appear to teach a second camera, wherein the body part is in the field of view of the first camera and the second camera when the body part is in contact with the device.
However, in the same field of endeavor of blood pressure measurement, Narasimhan teaches a second camera (second camera, Col. 7, lines 51-67), wherein the body part is in the field of view of the first camera and the second camera when the body part is in contact with the device (fingers of the hand are in the field of view of the first and second camera when the subject’s hand is in contact with the measurement device, Col. 7, lines 51-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Narasimhan’s known technique of providing first and second cameras in which the fingers of a hand of a subject are visible to each of the first and second cameras while the measurement device is in contact with the subject’s hand to Khair in further view of Danehorn’s known apparatus of a portable blood pressure measurement device to achieve the predictable result that using more than one camera helps to cancel out common mode noise. See, e.g., Narasimhan, Coll. 7, lines 51-67.
Claim 12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Khair in further view of Elliott in further view of Danehorn.
Regarding claim 12, Khair discloses a method for estimating a subject’s diastolic blood pressure (DBP) and systolic blood pressure (SBP) (“Assume the systolic cuff reading was represented by Ys(t) and systolic photodetector readings were represented by Xs(t) where t is measurement number taken at a discrete instance in time t=0,1,2,3, . . . , N. N is max number of measurements taken during calibration. Similarly we represent the diastolic cuff reading by Yd(t) and the diastolic photodetector reading to be Xd(t). Then Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd where as and ad are respectively the systolic and diastolic scaling multiplication coefficients of a first order least squares polynomial line fit through the multiple calibration measurements, and the bs, and bd are respectively the systolic and diastolic offset coefficients of the straight line fit equations” Khair, Col. 16, line 46 – Col. 17, line 29), comprising:
receiving electrical signals indicative of blood flow in a body part of the subject and pressure between an open surface and the body part of the subject, wherein the pressure is applied to or by the open surface (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51; “hold down pressure sensor 36” Khair, Col. 10, lines 35-53; “translate a hold down pressure to an analog voltage level” Khair, Col. 10, lines 35-53; (“The scattering patterns acquired by the array 17… could be sent to a remote processing unit such as the base unit of FIG. 1 and there processed into useful blood pressure data… The n×m photodetector analog signals and the HDP sensor signals are multiplexed in multiplexer 104, filtered by an anti-aliasing low pass filter 106, amplified by amp 108, and sampled and converted into digital signals in an analog to digital converter 110. The digital signals are supplied to a computing platform in the form of a microcontroller and digital signal processor (DSP) unit 112” Khair, Col. 15, lines 15-51);
providing a measurement of the subject’s DBP and SBP, wherein the subject’s DBP and SBP values are estimated by: estimating an initial DBP value and an initial SBP value without taking account of the effect of respiration (“Y(t)” Col. 16, line 46-Col. 17, line 29, Col. 19, line 39-Col. 20, line 55) by (1) generating candidate optical signals (“X(t)” Col. 16, line 46-Col. 17, line 29 or “X(t)+ΔZ(t)” Col. 19, line 39-Col. 20, line 55; “measurements of the patient’s blood pressure are made with a second blood pressure device, such as an air cuff” and “systolic cuff reading was represented by Ys(t)… diastolic cuff reading by Yd(t)” Col. 16, line 46-Col. 17, line 29) using a model (“Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd” Col. 16, line 46-Col. 17, line 29 or “Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)” Col. 19, line 39-Col. 20, line 55).
However, Khair does not appear to disclose providing a measurement of the subject’s DBP and SBP that uses the electrical signals to account for an effect of respiration on the measurement.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches providing a measurement of the subject’s DBP and SBP (measure systolic and diastolic blood pressure, Table, P.5-6, [0085], [0101], [0117], [0120], [0122]) that uses the electrical signals to determine an effect of respiration on the measurement (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of blood flow and pressure to Khair’s known process of measuring DBP and SBP blood pressure using electrical signals of blood flow and pressure to achieve the predictable result that using electrical signals of blood flow and pressure to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, while Khair in further view of Elliott teaches providing a measurement of the subject’s DBP and SBP that uses the electrical signals of blood flow and pressure to determine an effect of respiration on the measurement, Khair in further view of Elliott does not appear to teach providing a measurement of the subject’s DBP and SBP that accounts for an effect of respiration on the measurement, wherein the subject’s DBP and SBP values are estimated by:
estimating an initial DBP value and an initial SBP value without taking account of the effect of respiration; and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches providing a measurement of the subject’s DBP and SBP that accounts for an effect of respiration on the measurement (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]), wherein the subject’s DBP and SBP values are estimated by:
estimating an initial DBP value and an initial SBP value without taking account of the effect of respiration (measured diastolic and systolic blood pressure data values, [0016], [0022], [0028], Fig. 1); and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of accounting for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known process of providing a measurement of the subject’s DBP and SBP that uses the electrical signals of blood flow and pressure to determine an effect of respiration on the measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Regarding claim 15, Khair does not appear to disclose the estimate of the subject’s respiration cycle is obtained by deriving a pulse period from the electrical signal indicative of the blood flow in the body part of the subject.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle is obtained by deriving a pulse period from the electrical signal indicative of the blood flow in the body part of the subject (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of blood flow and pressure to Khair’s known process of measuring DBP and SBP blood pressure using electrical signals of blood flow and pressure to achieve the predictable result that using electrical signals of blood flow and pressure to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
Regarding claim 16, Khair does not appear to disclose the estimate of the subject’s respiration cycle is further obtained by measuring the amplitude and mean values of the electrical signals indicative of the blood flow in the body part of the subject.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle is further obtained by measuring the amplitude and mean values of the electrical signals indicative of the blood flow in the body part of the subject (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of blood flow and pressure to Khair’s known process of measuring DBP and SBP blood pressure using electrical signals of blood flow and pressure to achieve the predictable result that using electrical signals of blood flow and pressure to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
Regarding claim 17, Khair does not appear to disclose the estimate of the subject’s respiration cycle.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches the estimate of the subject’s respiration cycle (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of blood flow and pressure to Khair’s known process of measuring DBP and SBP blood pressure using electrical signals of blood flow and pressure to achieve the predictable result that using electrical signals of blood flow and pressure to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, Khair in further view of Elliott does not appear to teach the step of calculating a relationship between the measured SBP value and the estimate of the subject’s respiration cycle.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches the step of calculating a relationship between the measured SBP value and the estimate of the subject’s respiration cycle (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of accounting for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known process of providing a measurement of the subject’s DBP and SBP that uses the electrical signals of blood flow and pressure to determine an effect of respiration on the measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Khair in further view of Elliott in further view of Danehorn as in claim 12 above, and as further evidenced by Karr et al. (“Genetic algorithm applied to least squares curve fitting” 1991), hereinafter “Karr.”
Regarding claim 14, Khair discloses the step of providing the measurement of the subject’s DBP and SBP further comprises the step of calculating an error estimate that is used to weight segments of data used for calculating the measured DBP value and the measured SBP value (“The coefficients c, and d represent the scaling and offset factors respectively. For the calibration mapping into mmHg, Y(t) are affected by measured variation in HDP as follows: Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)… the translation or rotation of the sensor relative to the patient is compensated by re-mapping the calibration coefficients” Khair, Col. 19, line 39 – Col. 20, line 55; “Assume the systolic cuff reading was represented by Ys(t) and systolic photodetector readings were represented by Xs(t) where t is measurement number taken at a discrete instance in time t=0,1,2,3, . . . , N. N is max number of measurements taken during calibration. Similarly we represent the diastolic cuff reading by Yd(t) and the diastolic photodetector reading to be Xd(t). Then Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd where as and ad are respectively the systolic and diastolic scaling multiplication coefficients of a first order least squares polynomial line fit through the multiple calibration measurements, and the bs, and bd are respectively the systolic and diastolic offset coefficients of the straight line fit equations” Khair, Col. 16, line 46 – Col. 17, line 29; Additionally, least squares polynomial fit inherently and by definition is the minimization of the sum of errors between the polynomial fit, here Y(t)=aX(t)+b or Y(t)=a(X(t)+ΔZ(t))+b where Z(t)=cHDP(t)+d, i.e. the theoretical or estimated value defined by the model, and the known measured values from the strain sensor, HDP, photodetector measured values of optical signals, X, and blood pressure cuff, Y, i.e. providing estimates of the parametric function value by minimizing error between the outputs of the parametric function (estimated values) and measured values. This is evidenced by Karr, “[i]n least squares curve-fitting problems, the objective is to minimize the sum of the squares of the distances between a curve of a given form and the data points. Thus, if y is the ordinate of one of the data points, and y’ is the ordinate of the corresponding point on the theoretical curve, the objective of least squares curve fitting is to make (y-y’)2 a minimum.” (Karr, P. 4). Thus, the outputs of the polynomial function relating Y(t), X(t), and HDP(t) are the estimated systolic and diastolic pressures in mmHg at time t derived from the minimization between the polynomial function output and the measured values. This is fundamental to calibrating the system using a known standard, a Y value from a blood pressure cuff, such that it provides an estimate of the systolic and diastolic pressure, Y, from strain sensor measured values of pressure, HDP, and photodetector measured values of optical signals, X, alone, i.e. estimate future values of Y without a known Y value from the blood pressure cuff) between the candidate optical signals (“X(t)” Col. 16, line 46-Col. 17, line 29 or “X(t)+ΔZ(t)” Col. 19, line 39-Col. 20, line 55).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Khair in further view of Elliott in further view of Danehorn.
Regarding claim 18, Khair discloses a method for estimating a subject’s diastolic blood pressure (DBP) and systolic blood pressure (SBP) (“Assume the systolic cuff reading was represented by Ys(t) and systolic photodetector readings were represented by Xs(t) where t is measurement number taken at a discrete instance in time t=0,1,2,3, . . . , N. N is max number of measurements taken during calibration. Similarly we represent the diastolic cuff reading by Yd(t) and the diastolic photodetector reading to be Xd(t). Then Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd where as and ad are respectively the systolic and diastolic scaling multiplication coefficients of a first order least squares polynomial line fit through the multiple calibration measurements, and the bs, and bd are respectively the systolic and diastolic offset coefficients of the straight line fit equations” Khair, Col. 16, line 46 – Col. 17, line 29), comprising:
calibrating a signal acquisition device (SAD) (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51; “The microcontroller executes operating system and image processing and calibration routines which are stored in machine-readable form in a memory 114. The memory 114 also stores acquired image data and hold down pressure data from both the calibration phase and the data acquisition phase, and also is used in the HDP and sensor translation and rotation compensation procedures. The microcontroller also issues commands to a photo-emitter control module 116 that controls the illumination of the light source 30 (FIG. 2). The microcontroller presents blood pressure and other physiologic data to the user via a user interface 120, such as a LCD display. Alternatively, the acquired blood pressure data could be transmitted to the base unit using a wireless transceiver module 122 and a low power, miniature RF antenna 124” Khair, Col. 15, lines 32-62; (“The coefficients c, and d represent the scaling and offset factors respectively. For the calibration mapping into mmHg, Y(t) are affected by measured variation in HDP as follows: Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)… the translation or rotation of the sensor relative to the patient is compensated by re-mapping the calibration coefficients” Khair, Col. 19, line 39 – Col. 20, line 55; “Assume the systolic cuff reading was represented by Ys(t) and systolic photodetector readings were represented by Xs(t) where t is measurement number taken at a discrete instance in time t=0,1,2,3, . . . , N. N is max number of measurements taken during calibration. Similarly we represent the diastolic cuff reading by Yd(t) and the diastolic photodetector reading to be Xd(t). Then Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd where as and ad are respectively the systolic and diastolic scaling multiplication coefficients of a first order least squares polynomial line fit through the multiple calibration measurements, and the bs, and bd are respectively the systolic and diastolic offset coefficients of the straight line fit equations” Khair, Col. 16, line 46 – Col. 17, line 29), the SAD comprising:
a blood flow occlusion device having an open surface available to be pressed against a body part of the subject or to have a body part of the subject pressed against it (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51);
a pressure sensor (“hold down pressure sensor 36” Khair, Col. 10, lines 35-53) adapted to provide an electrical signal indicative of the pressure applied to or by the open surface (“translate a hold down pressure to an analog voltage level” Khair, Col. 10, lines 35-53); and
an optical blood flow detecting device (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “The two-dimensional array of photo-sensitive elements is incorporated into an optical blood pressure sensor adapted to be placed on the surface of a patient and obtain optical information as to movement of the patient's skin in response to blood flow” Khair, Col. 5, lines 25-45) configured to detect the flow of blood in the body part of the subject when pressure is applied to or by the open surface (“An optical sensor generates blood pressure data by obtaining two dimensional images of the surface of the patient's body, such as in the vicinity of the radial artery in the wrist area. Blood flow in the patient causes light to be reflected off a flexible reflective surface applied against the patient with a hold down pressure, and the scattering of light is sensed with a two-dimensional array of photo-detectors” Khair, Abstract; “During use, the reflective surface 14 is layered against the skin over the radial artery area in the wrist area with a certain hold down pressure (HDP). Due to the blood pulsations in the radial artery 34 and corresponding skin deflections due to such pulsations, the reflective surface will assume a deflected shape, as shown in FIG. 3, adapting to the local anatomy due to the hold down pressure applied by the sensor's wrist strap 32, as shown in FIG. 1. Scattered reflected light is collected on a ceiling grid of photo-sensitive elements arranged in a two-dimensional array 17, such as an array of 32×32 miniature photo-detectors 18. The light is reflected with a certain pattern that is adapted to the local radial area anatomical surface. Variations in the local surface anatomy due to pulsation are immediately detected as variations in the scattering pattern of the reflected light beams. These variations are detected as fluctuations in the measured power received at the photo-detectors, which provide a direct correlation to the variations of actual blood pressure in the artery in accordance with the calibration relationship of equation (1)” Khair, Col. 9, lines 32-51);
receiving electrical signals from the pressure sensor and the optical blood flow detecting device (“The scattering patterns acquired by the array 17… could be sent to a remote processing unit such as the base unit of FIG. 1 and there processed into useful blood pressure data… The n×m photodetector analog signals and the HDP sensor signals are multiplexed in multiplexer 104, filtered by an anti-aliasing low pass filter 106, amplified by amp 108, and sampled and converted into digital signals in an analog to digital converter 110” Khair, Col. 15, lines 15-31)
providing a measurement of the subject’s DBP and SBP, wherein the subject’s DBP and SBP values are estimated by: calculating an initial DBP value and an initial SBP value without taking account of the effect of respiration (“Y(t)” Col. 16, line 46-Col. 17, line 29, Col. 19, line 39-Col. 20, line 55) by (1) generating candidate optical signals (“X(t)” Col. 16, line 46-Col. 17, line 29 or “X(t)+ΔZ(t)” Col. 19, line 39-Col. 20, line 55; “measurements of the patient’s blood pressure are made with a second blood pressure device, such as an air cuff” and “systolic cuff reading was represented by Ys(t)… diastolic cuff reading by Yd(t)” Col. 16, line 46-Col. 17, line 29) using a model (“Ys(t)=asXs(t)+bs and Yd(t)=adXd(t)+bd” Col. 16, line 46-Col. 17, line 29 or “Ys(t)=as (Xs(t)+ΔZ(t))+bs, where ΔZ(t)=c (HDP(t)current−HDPcalibration)” Col. 19, line 39-Col. 20, line 55).
However, Khair does not appear to disclose providing a measurement of the subject’s DBP and SBP that uses the electrical signals to account for an effect of respiration on the measurement.
However, in the same field of endeavor of blood pressure measurement, Elliott teaches providing a measurement of the subject’s DBP and SBP (measure systolic and diastolic blood pressure, Table, P.5-6, [0085], [0101], [0117], [0120], [0122]) that uses the electrical signals to determine an effect of respiration on the measurement (blood photosensor receives detected light transmitted through or scattered by the body part to generate an electrical signal, [0060]-[0061]; pressure sensor produces electrical signals, [0044], [0055], [0074], [0100], [0124]; the state of the respiration cycle and the effect on blood pressure and pulse is measured from one or more of the interval between pulses of the signals, magnitude/amplitude, and mean values from the blood photosensor, Table, P.5-6; the state of the respiration cycle is measured from one or more of the pulse rate, amplitude of the systolic pulse, and the mean blood pressure measured by the blood photosensor and/or pressure sensor, [0131]-[0136]; perturbations of the respiratory cycle is measured using the blood photosensor measuring blood flow, Table, P.5-6, [0140]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Elliott’s known technique of determining the state and/or perturbation of the respiration cycle using the interval between pulses of the signals, magnitude/amplitude, and mean values from the electrical signals of blood flow and pressure to Khair’s known process of measuring DBP and SBP blood pressure using electrical signals of blood flow and pressure to achieve the predictable result that using electrical signals of blood flow and pressure to determine the respiration cycle allows for increased reliability in the determination of the respiratory cycle through the combination of multiple measurements. See, e.g., Elliott, [0136].
However, while Khair in further view of Elliott teaches providing a measurement of the subject’s DBP and SBP that uses the electrical signals of blood flow and pressure to determine an effect of respiration on the measurement, Khair in further view of Elliott does not appear to teach providing a measurement of the subject’s DBP and SBP that accounts for an effect of respiration on the measurement, wherein the subject’s DBP and SBP values are estimated by:
estimating an initial DBP value and an initial SBP value without taking account of the effect of respiration; and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value.
However, in the same field of endeavor of determining the blood pressure and being pertinent to the problem of removing respiratory artefacts in blood pressure measurements, Danehorn teaches providing a measurement of the subject’s DBP and SBP that accounts for an effect of respiration on the measurement (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]), wherein the subject’s DBP and SBP values are estimated by:
estimating an initial DBP value and an initial SBP value without taking account of the effect of respiration (measured diastolic and systolic blood pressure data values, [0016], [0022], [0028], Fig. 1); and
calculating a measured DBP value and a measured SBP value based on an estimate of the subject’s respiration cycle and, respectively, the initial DBP value and the initial SBP value (a model is derived for respiratory artifacts and the model is subtracted from the measured diastolic and systolic blood pressure data, Abstract, see also [0012]-[0019]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Danehorn’s known technique of accounting for an effect of respiration on a blood pressure measurement by removing respiratory artifacts from acquired blood pressure measurements using a model based on acquired measurements of the respiratory cycle to Khair in further view of Elliott’s known process of providing a measurement of the subject’s DBP and SBP that uses the electrical signals of blood flow and pressure to determine an effect of respiration on the measurement to achieve the predictable result that removing respiratory artifacts improves the accuracy by reducing the cyclic variation in the blood pressure measurements. See, Danehorn, [0004]-[0007].
Allowable Subject Matter
Claims 4, 13, 19, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Elliott et al. (WO 2014125431A1) discloses a personal monitor for measuring blood pressure with a processing device, a blood flow occlusion device pressed against a body part of the subject, a pressure sensor, an optical blood flow detecting device, providing an estimate of the rotation of the body part relative to the sensors using a ratio established by a linear relationship between the pressure and optical signals, minimizing the error between a model and measured values of diastolic and systolic blood pressure to get diastolic and systolic blood pressure values.
Susstrunk et al. (U.S. Pub. No. 2011/0166461) discloses a personal monitor for measuring blood pressure with a processing device, a blood flow occlusion device pressed against a body part of the subject, a pressure sensor, an optical blood flow detecting device, providing an estimate of the rotation of the body part relative to the sensors using a ratio established by a linear relationship between the pressure and optical signals, minimizing the error between a model and measured values of diastolic and systolic blood pressure to get diastolic and systolic blood pressure values.
Zhang et al. (U.S. Pub. No. 2016/0262695) discloses a personal monitor for measuring blood pressure with a processing device, a blood flow occlusion device pressed against a body part of the subject, a pressure sensor, an optical blood flow detecting device, and minimizing the error between a model and measured values of diastolic and systolic blood pressure to get diastolic and systolic blood pressure values.
Shimazu et al. (U.S. Pub. No. 2005/0256412) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Whinnett et al. (U.S. Pub. No. 2009/0069859) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Ukawa et al. (U.S. Pub. No. 2016/0213332) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Kawamoto et al. (U.S. Pub. No. 2015/0245775) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Brooks (U.S. Patent No. 4,785,820) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Murai et al. (U.S. Pub. No. 2016/0073905) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Kinoshita et al. (U.S. Pub. No. 2016/0081565) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Schrimpf et al. (U.S. Patent No. 5,752,919) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Wiesel et al. (U.S. Patent No. 7,020,514) discloses a portable blood pressure monitor that measures and compensates for the effect of the respiratory cycle on the systolic and diastolic blood pressure estimates.
Mezenok et al. (U.S. Pub. No. 2017/0319079) discloses a portable blood pressure monitor embodied as a mobile device with a camera containing the finger/hand within the field of view while taking contact measurements of the blood pressure.
Kasama et al. (U.S. Pub. No. 2010/0168590) discloses a portable blood pressure monitor embodied as a mobile device with a camera containing the finger/hand within the field of view while taking contact measurements of the blood pressure.
Kasama et al. (U.S. Pub. No. 2010/0249619) discloses a portable blood pressure monitor embodied as a mobile device with a camera containing the finger/hand within the field of view while taking contact measurements of the blood pressure.
Klinghult (U.S. Pub. No. 2013/0182144) discloses a portable blood pressure monitor embodied as a mobile device with a camera containing the finger/hand within the field of view while taking contact measurements of the blood pressure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Johnathan Maynard whose telephone number is (571)272-7977. The examiner can normally be reached 10 AM - 6 PM.
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.
/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798