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 Amendment
This office action is responsive to the amendment filed on December 23, 2025. As directed by the amendment: claim(s) 1 and 3 have been amended, claim(s) 2, 10-22, 24-29, 31-32, 35-36, 38, 40-46, and 50-152 have been cancelled, and claim(s) 153-154 have been added. Thus, claims 1, 3-9, 23, 30, 33-34, 37, 39, 47-49, and 153-154 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-9, 23, 30, 33-34, 37, 39, 47-49, and 153-154 have been considered but the arguments do not apply to the combination of the references being used in the new grounds of rejection set forth above. The applicant asserts that the prior art rejections do not teach or suggest the features as now amended into the amended claims; therefore, the examiner has applied a new combination of prior art to reject the claims and address the arguments necessitated by such amendment.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-9, 23, 33-34, 37, 39, and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Shay (US 2017/0119318 A1) in view of Pryor (US 2013/0267813 A1) and Ravid (US 2016/0345845 A1)
Regarding claim 1, Shay discloses a medical monitoring system for remote monitoring of radiofrequency (RF)- based and light-based physiological information of a patient (e.g. abstract; Fig 1:100), comprising: a patch (e.g. [0042]-[0043]; [0113]; [0121] the system can be a wearable patch); a monitoring device removably mounted on the patch (e.g. [0042]-[0043]; [0113]; [0121] the RF system can be embedded i.e. permanent or integrated i.e. removable into the patch), wherein the monitoring device comprises and RF transmitter and an RF receiver and associated circuitry (e.g. [0042]-[0043]; [0113]; [0121]), an RF transmitter oriented along an axis directed towards an aortic region of the patient (e.g. [0046] Fig 7:115) comprising at least one of an aorta or one or more branching arteries proximate to the aorta (e.g. [0087]; [0107]-[0108]); an RF receiver and associated RF circuitry configured to receive RF waves reflected from the aortic region of the patient (e.g. [0046] Fig 7:117’/117”), wherein the RF circuitry is configured to provide RF sensor signals, based on the received RF waves (e.g. [0087]; [0107]-[0108]); wherein the patch or the monitoring device further comprises at least one light source and a light sensor and associated light sensor circuitry (e.g. Fig 1:165 [0093]; the system can include an optical sensor such as an LED light sensor for photoplethysmography which will generate light at minimum at one predetermined frequency), wherein the at least one light source is mounted on the patch and oriented to generate light of one or more predetermined frequencies (e.g. [0093]; the system can include an optical sensor such as an LED light sensor for photoplethysmography which will generate light at minimum at one predetermined frequency), towards one or more arteries below skin (e.g. Fig 1:165 [0035]-[0036]; [0107]-[0108]); wherein the light sensor and associated light sensor circuitry are mounted on the patch so as to receive light reflected from the one or more arteries below the skin (e.g. Fig 1:165 [0035]-[0036]; [0107]-[0108]), wherein the light sensor circuitry is being configured to provide light sensor signals, based on the received light (e.g. [0093]; the system can include an optical sensor such as an LED light sensor for photoplethysmography which will generate light based arterial waveform of the patient); a memory implemented in a non-transitory media (e.g. [0204]); and a processor in communication with the memory (e.g. [0034]-[0036]; [0131]; [0171] [0204]; Fig 1:150); the processor configured to: identify an RF-based aortic region waveform of the patient using the RF sensor signals received from the RF receiver and associated RF circuitry (e.g. [0038] details the transmitted signals are generated by the signal generator that can be a waveform or wave signal and [0040] details the sensor device proximal an artery of the user and targets regions of the chest and aorta, and [0087] details that the pulse signal generator can generate a waveform pulse signal); identify a light-based arterial waveform of the patient using the light sensor signals received from the light sensor and associated light sensor circuitry (e.g. [0035]-[0036]; [0107]-[0108] and [0038] details the transmitted signals are generated by the signal generator that can be a waveform or wave signal and [0040] details the sensor device proximal an artery of the user and targets regions of the chest and aorta, and [0087] details that the pulse signal generator can generate a waveform pulse signal); determine a first fiducial point on the RF-based aortic region waveform, the first fiducial point corresponding to an aortic region pressure event experienced at the aortic region of the patient; determine a second fiducial point on the light-based arterial waveform, the second fiducial point corresponding to an arterial pressure event experienced at the one or more arteries near the skin surface of the patient and above the sternum of the patient, wherein the arterial pressure event experienced at the one or more arteries near the skin surface of the patient and above the sternum of the patient corresponds to a same cardiac cycle as the aortic region pressure event experienced at the aortic region of the patient; determine a time difference parameter between the first fiducial point corresponding to the aortic region pressure event experienced at the aortic region of the patient and the second fiducial point corresponding to the arterial pressure event experienced at the one or more arteries near the skin surface of the patient and above the sternum of the patient; and determine, using the time difference parameter and a distance along an arterial tree between the aortic region and the one or more arteries below the skin, a pulse wave velocity of the patient (e.g. Shay does disclose that ability to determine the pulse wave velocity from the data captured from the data captured by the system (e.g. [0031]; [0179]; [0193]). Shay discloses in [0179] that the PWV or pulse wave velocity can be calculated by determining a change in pulse return time based from a first and second datasets and it can utilize two RF sensor devices or include a reflected pulse signal data set such as a PPG data to generate both the PWV and Pulse transit time which is defined in [0031] and [0180]-[0182] in which the data can be performed based on particular points such as max and minimum values, or max and min of first and second derivative points which would align with aortic region pressure event and arterial pressure events in the pulse cycle).
Shay is silent regarding wherein the patch is an adhesive patch, wherein the RF transmitter and RF receiver is removably mounted on the path and the data collected is near the skin surface of the patient and above the sternum of the patient, at least one light source is configured to be placed on the first location of the patient such that the generated light is directed towards one or more arteries near a skin surface of the patient.
However, Pryor discloses a medical sensor wherein the patch is an adhesive patch (e.g. [0035]-[0036]), and wherein the RF transmitter removably mounted on the patch (e.g. [0074]; [0217]; [0280]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Shay to incorporate the teachings of Pryor wherein the patch is an adhesive patch and wherein the RF transmitter removably mounted on the patch for the purpose of being able to remove the transmitter from the host without removing the adhesive patch from the user and salvaging the transmitter (e.g. Pryor [0217]; [0280]).
This combination of Shay in view of Pryor does not detail an RF receiver being removably mounted on the patch; however, Pryor teaches the concept of being able to remove portions of the sensor device. Therefore, it would have been obvious to one of ordinary skill in the art to also require the RRF receiver to also be removably mounted.
However, Ravid discloses a system and method for determining blood pressure utilizing a skin patch (e.g. [0028]) placed on the sternum of the patient and the data collected is near the skin surface of the patient and above the sternum of the patient (e.g. [0024]; [0028]; [0030]) integrated with a radio-frequency and photo-plethysmograph (PPG) sensor (e.g. Fig 5 abstract [0011]-[0013]; [0021]) wherein the at least one light source is configured to be placed on the first location of the patient such that the generated light is directed towards one or more arteries below skin on a thorax of the patient (e.g. [0028] Fig 4:401 and 402).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Shay to utilize the arrangement detailed in Ravid with utilizing a skin patch placed on the sternum of the patient and the data collected is near the skin surface of the patient and above the sternum of the patient wherein the at least one light source is configured to be placed on the first location of the patient such that the generated light is directed towards one or more arteries below skin on a thorax of the patient for the purpose of utilizing a known arrangement for measuring the pulse wave velocity of a user utilizing a patch.
Regarding claim 3, modified Shay discloses further comprising a second RF transmitter configured to generate a second set of RF waves, wherein the second RF transmitter is removably mounted on a second location of the patient such that the second set of RF waves are directed towards an artery of the patient at the second location (e.g. Shay [0031]-[0032]; [0046]; [0113] Pryor [0074]; [0217]; [0280] Ravid Fig 5 [0032]); and a second RF receiver and associated second RF circuitry removably mounted on the second location of the patient so as to receive a second set of RF waves reflected from the artery at the second location of the patient, the second RF circuitry being configured to provide a second set of RF signals, based on the received second set of RF waves (e.g. Shay [0031]-[0032]; [0046]; [0113] Pryor [0074]; [0217]; [0280] Ravid Fig 5 [0032]).
Regarding claim 4, modified Shay discloses wherein the processor is further configured to identify an RF-based waveform of the artery at the second location; determine a third fiducial point on the RF-based aortic region waveform, the third fiducial point corresponding to a second aortic region pressure event experienced at the aortic region of the patient; determine a fourth fiducial point on the RF-based waveform of the artery at the second location, the fourth fiducial point corresponding to a second-location arterial pressure event experienced at the artery at the second location of the patient; and determine a second time difference parameter between the third fiducial point and the fourth fiducial point (e.g. Shay [0031]-[0032]; [0046]; [0113]; [0179]-[0182]; [0193] the references detail utilizing the data to calculate multiple measurements over time over the same or multiple datasets from multiple types of sensors).
Regarding claim 5, modified Shay discloses wherein the processor is further configured to determine, using the second time difference parameter and a distance along the arterial tree between the aortic region and the artery at the second location, a second pulse wave velocity of the patient (e.g. Shay [0031]-[0032]; [0046]; [0113]; [0179]-[0182]; [0193]).
Regarding claim 6, modified Shay discloses wherein the processor is further configured to determine, using at least one of the second pulse wave velocity or the second time difference parameter, a blood pressure of the patient (e.g. Shay [0166]-[0168]).
Regarding claim 7, modified Shay discloses wherein the second location comprises a location above a radial artery of the patient, and wherein the RF-based waveform of the artery at the second location comprises an RF-based radial waveform of the patient (e.g. (e.g. Shay [0031]; [0040] Ravid [0021]).
Regarding claim 8, modified Shay is silent wherein the second location comprises a location above a subclavian artery of the patient, and wherein the RF-based waveform of the artery at the second location comprises an RF-based subclavian waveform of the patient.
However, Ravid discloses a system and method for determining blood pressure utilizing radio-frequency and photo-plethysmograph (PPG) sensor wherein it details that the sensor may be utilized at a variety of arteries (e.g. [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Shay to incorporate the teachings of Ravid wherein the second location comprises a location above a subclavian artery of the patient, and wherein the RF-based waveform of the artery at the second location comprises an RF-based subclavian waveform of the patient for the purpose of utilizing a variety of arteries.
Regarding claim 9, modified Shay discloses wherein the second location comprises a location above a brachial artery of the patient, and wherein the RF-based waveform of the artery at the second location comprises an RF-based brachial waveform of the patient (e.g. Shay [0031]; [0040]).
Regarding claim 23, modified Shay discloses wherein the processor is further configured to determine, using at least one of the pulse wave velocity or the time difference parameter, a blood pressure of the patient (e.g. Shay [0166]-[0168]).
Regarding claim 33, modified Shay discloses wherein the time difference parameter between the first fiducial point and the second fiducial point is one of a plurality of time difference parameters between fiducial points of the RF-based aortic region waveform and light-based arterial waveform over a summary time period (e.g. Shay [0133]; [0136]; [0150]; [0168]; [0170]; [0182]).
Regarding claim 34, modified Shay discloses wherein the processor is further configured to determine the plurality of time difference parameters by determining a plurality of first fiducial points on the RF-based aortic region waveform; determining a plurality of second fiducial points on the light-based arterial waveform; and determining a time difference parameter between each first fiducial point and corresponding second fiducial point (e.g. Shay [0031]-[0032]; [0046]; [0113]; [0179]-[0182]; [0193]).
Regarding claim 37, modified Shay discloses wherein the processor is further configured to determine, using the plurality of time difference parameters, a summary time difference parameter for the summary time parameter (e.g. Shay [0133]; [0136]; [0150]; [0168]; [0170]; [0182].
Regarding claim 39, modified Shay discloses wherein the processor is further configured to determine, using the plurality of time difference parameters and the distance along the arterial tree between the aortic region and the one or more arteries near the skin surface of the patient and above the sternum of the patient, a summary pulse wave velocity of the patient for the summary time period (e.g. Shay [0031]-[0032]; [0046]; [0113]; [0179]-[0182]; [0193] Ravid [0013]; [0024]; [0028]; [0030]; [0032]-[0034]).
Regarding claim 47, modified Shay discloses further comprising two or more ECG electrodes, wherein the processor is further configured to receive ECG signals from the two or more ECG electrodes (e.g. Shay [0093]; [0177]; [0179]).
Regarding claim 48, modified Shay discloses, wherein the monitoring device comprises the memory (e.g. Shay [0039]; [0044]; [0072]; [0076]; [0083]), and the processor (e.g. Shay [0039]; [0044]; [0072]; [0204] Fig 1:150).
Regarding claim 49, modified Shay discloses further comprising a remote server, wherein the remote server comprises the memory and the processor (e.g. Shay [0036]; [0039]; [0044]; [0072]).
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Shay in view of Pryor and Ravid as applied to claim 23 above, and further in view of McCombie (US 2008/0039731 A1)
Regarding claim 30, modified Shay is silent wherein the processor is configured to determine the blood pressure of the patient based on a predetermined function of a logarithm of a square of the pulse wave velocity.
However, McCombie teaches a wearable pulse wave velocity blood pressure sensor wherein the processor is configured to determine the blood pressure of the patient based on a predetermined function of a logarithm of a square of the pulse wave velocity (e.g. [0058]-[0064] equation 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Shay to incorporate the teachings of McCombie wherein the processor is configured to determine the blood pressure of the patient based on a predetermined function of a logarithm of a square of the pulse wave velocity for the purpose of utilizing a known relationship between pulse wave velocity and blood pressure (e.g. McCombie [0058]-[0064] equation 5).
Claim(s) 153 and 154 are rejected under 35 U.S.C. 103 as being unpatentable over Shay in view of Pryor and Ravid as applied to claim 1 above, and further in view of Toth (US 2015/0335288 A1)
Regarding claim 153, modified Shay is silent regarding wherein at least a portion of the adhesive patch is transparent, and wherein the at least one light source and the light sensor and associated light sensor circuitry are removably mounted on the patch over the transparent portion.
However, Toth discloses a modular physiologic monitoring system and kit wherein at least a portion of the adhesive patch is transparent (e.g. [0481] Fig 11b:1140), and wherein the at least one light source (e.g. [0481] Fig 11b:1165) and the light sensor (e.g. [0481] Fig 11b:1170) and associated light sensor circuitry are removably mounted on the patch over the transparent portion (e.g. [0481] Fig 11b:1150/1160).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Shay to incorporate the teachings of Toth wherein at least a portion of the adhesive patch is transparent, and wherein the at least one light source and the light sensor and associated light sensor circuitry are removably mounted on the patch over the transparent portion for the purpose of utilizing a known configuration for a modular system (e.g. Toth [0164]).
Regarding claim 154, newly modified Shay discloses wherein the monitoring device comprises the at least one light source and the light sensor and associated light sensor circuitry and is removably mounted on the patch such that the at least one light source and the light sensor and associated light sensor circuitry are over the transparent portion (e.g. Toth [0481] 11b:1150/1160).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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Jessandra Hough April 21, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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