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
The amendment filed 03/30/2026 has been entered. Claims 5-7 have been canceled. Claims 1-4 and 8-9 remain pending in the application. Applicant’s amendments to the claims have overcome each and every claim objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 12/29/2025. Applicant states corrected drawings (figures) have been provided; however, it appears no new drawings have been filed and thus the drawings remain objected to.
Response to Arguments
Applicant’s arguments with respect to the pending claims 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the process as described in the specification. The specifications (¶ [0025-0026] & [0037-0038]) describe figures 4 and 5 as flowcharts for a process. However, the flowcharts shown in figures 4 and 5 are blank. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box). MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
“…send the bloor pressure data back…” should be corrected to:
“…send the blood pressure data back…”
Claim 8 is objected to because of the following informalities:
“…displaying the blorr pressure reading” should be corrected to:
“…displaying the blood pressure reading”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Xu ‘269 (US20220133269) in view of Xu ‘204 (US20230355204) and Orbach (US20080214903).
Regarding claim 1, Xu ‘269 teaches a blood pressure monitoring system, the blood pressure monitoring system comprising a wearable patch (102; 502) and a mobile computing device (112, 200; smartphone) (Figs. 2B & 10-11, Abstract, [0006], [0037-0038], [0043], [0048], [0053], wherein a smartphone comprises a mobile computing device, [0061], [0065-0066]),
the wearable patch (102; 502) including:
an array of ultrasound transducers (102) (Figs. 1 & 3, [0038-0039], [0049-0051], [0072-0073]);
a high-speed analogue to digital converter (143) in electrical communication with the array of ultrasound transducers (102) (Figs. 2B-2C, [0044], [0048]); and
a microprocessor (106; 149) which includes a wireless radio (151) for transmitting ultrasound data to the mobile computing device (112, 200) and is in electronic communication with the high speed analogue to digital converter (143) (Figs. 2A & 2C, [0040], [0043], [0048], [0052-0053]),
the mobile computing device (112, 200; smartphone) including: a memory; a processor; a wireless radio; and a screen (154) (Fig. 5, [0038], [0043], [0048], [0053], wherein a memory, processor, wireless radio, and screen are inherent components of a smartphone; an ordinarily skilled artisan would understand a smartphone would have the listed components),
wherein the mobile computing device is configured to display the blood pressure data ([0008], “the external computing environment may be configured to generate and display an indication of the monitored organ function…the displayed indication of the monitored physiologic parameter may be based on the measured shift…The displayed indication may be based on a step of machine learning, the machine learning associating the shift with the monitored physiologic parameter… The monitored physiologic parameter may be central blood pressure”, [0011], [0038], [0043]).
However, Xu ‘269 fails to explicitly teach wherein the wearable patch further includes: a flexible housing which includes a contact surface; an adhesive on at least part of the contact surface; and wherein the array of ultrasound transducers are embedded in the flexible housing and facing the contact surface.
In an analogous blood pressure monitoring system comprising a wearable patch field of endeavor, Xu ‘204 teaches such a feature. Xu ‘204 teaches a wearable ultrasonic-system-on-patch (USoP) which can continuously monitor physiological signals including blood pressure (Title, Abstract, [0004], [0094]). Xu ‘204 teaches the USoP is housed in an elastomeric package (Figs. 7 & 22-23, [0099], [0119], [0218-0219], wherein the elastomeric package comprises a flexible housing). Xu ‘204 teaches the USoP includes a stretchable ultrasonic probe which consists of a piezoelectric transducer array (Figs. 1a-1d, [0197], wherein the USoP including the piezoelectric transducer array comprises an array of ultrasound transducers embedded in the flexible housing/elastomeric packaging). Xu ‘204 further teaches wherein the packaged USoP is applied to skin with commercially available adhesives and wherein the transducers contact the skin via a probe-skin interface comprising a silicone elastomer (Figs. 1A-1B, [0118], [0218], wherein the USoP applied to skin with adhesives comprises the housing including a contact surface and adhesive thereon, and wherein the transducers contacting the skin via the silicone elastomer comprises the transducers facing the contact surface; see also figures 1A-1B). Xu ‘204 therefore teaches a wearable patch including a flexible housing (elastomeric packaging) including a contact surface, an adhesive on the contact surface, and an array of ultrasound transducers embedded in the flexible housing and facing the contact surface.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to house the device in an elastomeric packaging and to use adhesives on a surface of the packaging as taught by Xu ‘204 (Figs. 1A-1B, 7, & 22-23, [0099], [0118-0119], [0218-0219]). The elastomeric encapsulation may help mitigate strain concentrations and protect internal circuitry from irreversible deformations as recognized by Xu ‘204 ([0099]). Moreover, the adhesive may predictably be used to maintain robust adhesion of the device to the subject’s skin as further recognized by Xu ‘204 ([0204], [0218]), allowing for reliable interfacing of the ultrasound transducers with the skin to obtain physiological signals.
However, the modified combination noted above fails to teach wherein the blood pressure monitoring system further comprises a remote computing device, and wherein the mobile computing device is configured to send the ultrasound data to the remote computing device, the remote computing device including: a memory; a processor; a wireless radio; and a screen, wherein the memory is configured for machine learning and to instruct the processor to convert the ultrasound data into blood pressure data and to send the blood pressure data back to the mobile computing device for display on the screen.
In an analogous monitoring system field of endeavor, Orbach teaches such a feature. Orbach teaches a physiological monitoring system (10) including a sensor (110), a mobile monitor (120), and a remote server (140) (Fig. 1, [0143-0145]). Orbach teaches wherein the mobile monitor (120) is a mobile phone ([0145]). Orbach teaches wherein data obtained by the sensor (110) may be sent from the mobile monitor (120) to the remote server (140) for in-depth analysis of the data via a communication link (128) comprising a cellular RF link (e.g. wireless radio) (Fig. 1, [0145]). Orbach teaches wherein the remote server includes a viewing station (e.g. a screen) having a second processor and wherein the remote server includes a mass storage ([0017], [0146], [0291]). Orbach therefore teaches a remote computing device including: a memory; a processor; a wireless radio; and a screen. Orbach teaches wherein the remote server and viewing station analyzes the signals sent from the mobile phone and transmits back results of the analysis to the mobile phone (Claim 2, [0017-0022], [0087]). Orbach teaches wherein the remote server may provide additional processing of the sensor’s data and provide feedback and recommendations to the user, e.g. through the mobile phone ([0195], [0259]). Moreover, Orbach teaches wherein the analysis of data may include a recommendation and the recommendation may be displayed on a screen of the mobile phone ([0092]). Orbach therefore teaches wherein the processing of sensor data may be offloaded from a mobile phone to a remote server (i.e. remote computing device) and that the remote server may send back results of the processing/analysis to the mobile phone for display.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to transmit the sensor data from the mobile phone to a remote server for analysis/processing and to send the results of the analysis back to the mobile phone for display as taught by Orbach (Fig. 1, [0017-0022], [0092], [0143-0145], [0195], [0259]). Xu ‘269 teaches wherein the machine learning algorithm (114) configured to convert ultrasound data to blood pressure data may be situated either in the mobile phone or a remote server ([0043], [0061]). Thus, Xu ‘269 modified by the teachings of Orbach to send the sensor data to a remote server for analysis would predictably result in the mobile phone of Xu ‘269 transmitting the ultrasound data to the remote computing device/server for conversion of the ultrasound data to blood pressure data to send back to the mobile phone for display. By offloading the processing to a remote server or remote computing device, the specifications, i.e. hardware (computing power), required of the mobile phone may be made lower. Xu ‘269 teaching that the machine learning algorithm may be situated in either the mobile phone or a remote server ([0043]) shows a person of ordinary skill in the art that the processing of the ultrasound data into blood pressure data (via the algorithm) may be performed either on the mobile phone device or on a remote server.
Regarding claim 2, Xu ‘269 in view of Xu ‘204 and Orbach teaches the invention as claimed above in claim 1.
However, Xu ‘269 fails to teach wherein the flexible housing comprises silicon.
In an analogous blood pressure monitoring system comprising a wearable patch field of endeavor, Xu ‘204 teaches such a feature. Xu ‘204 teaches a wearable ultrasonic-system-on-patch (USoP) which can continuously monitor physiological signals including blood pressure (Title, Abstract, [0004], [0094]). Xu ‘204 teaches the USoP is housed in an elastomeric package (Figs. 22-23, [0099], [0119], [0218-0219], wherein the elastomeric package comprises a flexible housing). Xu ‘204 teaches the elastomeric package comprises a silicone elastomer ([0119], “The entire structure was encapsulated by silicone elastomer”, [0218]). Because silicone is made of silicon, Xu ‘204 therefore teaches wherein the flexible housing comprises silicon.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to have the elastomeric package or housing comprise a silicone elastomer which encapsulates the entire structure as taught by Xu ‘204 ([0119]). Silicone may be thin and conformal. A thin and conformal housing may predictably conform to a user’s body surface (skin) and allow for a reliable ultrasound transducer-to-skin interface for acquiring physiological signals.
Regarding claim 8, Xu ‘269 in view of Xu ‘204 and Orbach teaches the blood pressure monitoring system of claim 1.
Xu ‘269 further teaches a method of monitoring a user’s blood pressure ([0008], “The monitored physiologic parameter may be central blood pressure”, Claims 12 & 13), the method comprising:
a user selecting the blood pressure monitoring system of claim 1 (wherein Xu ‘269 in view of Xu ‘204 teach the system of claim 1 above comprises a user selecting said system; figures 10-11 of Xu ‘269 show a user using and thus selecting said system);
the user providing the wearable patch with a power source ([0006], “Such systems and methods allow for human bio-interface motion monitoring via a stretchable ultrasonic patch”, [0045], “A rechargeable miniaturized battery may provide the power for the entire system”);
the user releasably attaching the wearable patch to a skin surface on the user’s arm (Fig. 2A & 11, [0066], [0071], wherein figure 11 showing the patch mounted on the hand/fingers comprises attaching said patch to a skin surface of the user’s arm, the hands/fingers are part of a user’s arm anatomically);
the array of ultrasound transducer (102) emitting ultrasound waves under control of the microprocessor (MCU, 149) ([0018], [0038-0039], [0048], [0066-0068]);
the array of ultrasound transducer (102) receiving reflected ultrasound waves (Claims 12 & 16, [0039], [0042], [0044], [0048], [0052], [0072-0073]);
the high-speed analogue to digital converter digitizing the reflected ultrasound waves to provide a data set ([0043], “All the signals are amplified through the AFE 104, digitalized by ADCs in the MCU”, [0048], [0052], “…and store all the data into the built-in memory of MCU”);
the wireless radio (151) sending the data set to the mobile computing device (112, 200; smartphone) ([0043], “All the signals are amplified through the AFE 104, digitalized by ADCs in the MCU within digital circuit 106, and wirelessly transmitted to a smartphone or other analysis system 200”, [0048], “Once the signal is received and digitalized, the Wi-Fi module 151 may transmit the signals wirelessly to terminal devices (e.g., PC or smartphone) 112”, [0052], “…After that, this data may be transmitted wirelessly to the terminal device”); and
the mobile computing device (112, 200) analyzing the data set to provide a blood pressure reading ([0008], [0010-0011], [0043], “The algorithm may be situated on the smartphone”, [0061], “The blood pressure, blood flow, and cardiac pressure signals can be extracted from ultrasound images”, [0066], “the device allows the monitoring of the CBP waveform by emitting ultrasound pulses into the deep vessel”, wherein monitoring of central blood pressure from ultrasound images comprises providing a blood pressure reading by analyzing the ultrasound data set).
However, Xu ‘269 fails to teach the mobile computing device sending the ultrasound data to the remote computing device; the remote computing device analyzing the data set to provide the blood pressure reading; the remote computing device sending the blood pressure reading to the mobile computing device; and the mobile computing device displaying the blood pressure reading.
In an analogous monitoring system field of endeavor, Orbach teaches such a feature. Orbach teaches a physiological monitoring system (10) including a sensor (110), a mobile monitor (120), and a remote server (140) (Fig. 1, [0143-0145]). Orbach teaches wherein the mobile monitor (120) is a mobile phone ([0145]). Orbach teaches wherein data obtained by the sensor (110) may be sent from the mobile monitor (120) to the remote server (140) for in-depth analysis of the data via a communication link (128) comprising a cellular RF link (e.g. wireless radio) (Fig. 1, [0145]). Orbach teaches wherein the remote server includes a viewing station (e.g. a screen) having a second processor and wherein the remote server includes a mass storage ([0017], [0146], [0291]). Orbach teaches wherein the remote server and viewing station analyzes the signals sent from the mobile phone and transmits back results of the analysis to the mobile phone (Claim 2, [0017-0022], [0087]). Orbach teaches wherein the remote server may provide additional processing of the sensor’s data and provide feedback and recommendations to the user, e.g. through the mobile phone ([0195], [0259]). Moreover, Orbach teaches wherein the analysis of data may include a recommendation and the recommendation may be displayed on a screen of the mobile phone ([0092]). Orbach therefore teaches wherein the processing of sensor data may be offloaded from a mobile phone to a remote server (i.e. remote computing device) and that the remote server may send back results of the processing/analysis to the mobile phone for display.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to transmit the sensor data from the mobile phone to a remote server for analysis/processing and to send the results of the analysis back to the mobile phone for display as taught by Orbach (Fig. 1, [0017-0022], [0092], [0143-0145], [0195], [0259]). Xu ‘269 teaches wherein the machine learning algorithm (114) configured to convert ultrasound data to blood pressure data may be situated either in the mobile phone or a remote server ([0043], [0061]). Thus, Xu ‘269 modified by the teachings of Orbach to send the sensor data to a remote server for analysis would predictably result in the mobile phone of Xu ‘269 transmitting the ultrasound data to the remote computing device/server for conversion of the ultrasound data to blood pressure data to send back to the mobile phone for display. By offloading the processing to a remote server or remote computing device, the specifications, i.e. hardware (computing power), required of the mobile phone may be made lower. Xu ‘269 teaching that the machine learning algorithm may be situated in either the mobile phone or a remote server ([0043]) shows a person of ordinary skill in the art that the processing of the ultrasound data into blood pressure data (via the algorithm) may be performed either on the mobile phone device or on a remote server.
Regarding claim 9, Xu ‘269 in view of Xu ‘204 and Orbach teaches the invention as claimed above in claim 8.
However, Xu ‘269 fails to teach the invention further comprising displaying the blood pressure reading in real time.
In an analogous blood pressure monitoring system comprising a wearable patch field of endeavor, Xu ‘204 teaches such a feature. Xu ‘204 teaches a wearable ultrasonic-system-on-patch (USoP) which can continuously monitor physiological signals including blood pressure (Title, Abstract, [0004], [0094]). Xu ‘204 teaches monitoring a physiological parameter in real-time and outputting data reflective of the monitored physiological parameter ([0025], [0041], [0194]). Xu ‘204 teaches a smartphone application displays a data stream from the USoP and physiological signals can be derived and displayed in real time ([0197]). Xu ‘204 teaches wherein the physiological signals include blood pressure (Claim 28, [0004], [0011], [0033]). Xu ‘204 therefore teaches wherein blood pressure may be displayed in real time on a screen of a mobile computing device (i.e. smartphone).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to display blood pressure readings in real time as taught by Xu ‘204 (Claim 28, [0197], [0004], [0011], [0033]). Displaying blood pressure in real-time allows for continuous monitoring of blood pressure which may, for example, provide insight to workout/exercise intensity which can guide formulation of personalized training plans as recognized by Xu ‘204 ([0190]).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Xu ‘269 (US20220133269) in view of Xu ‘204 (US20230355204) and Orbach (US20080214903) as applied to claim 2 above, and further in view of Kaib (US20170143977).
Regarding claim 3, Xu ‘269 in view of Xu ‘204 and Orbach teaches the invention as claimed above in claim 2.
However, Xu ‘269 fails to teach wherein the flexible housing comprises a three dimensionally printed plastic polymer.
In an analogous wearable blood pressure monitoring device field of endeavor, Kaib teaches such a feature. Kaib teaches a wearable cardiac device including sensors (306; 426) configured to measure blood pressure (Abstract, [0013], [0055], [0148], [0169]). Kaib teaches the sensors may include ultrasonic sensors ([0139]). Kaib teaches the device includes a flexible conformal housing (1600) ([0133-0134], [0136]). Kaib teaches the flexible conformal housing (1600) may be fabricated using a 3D printer system using plastic material ([0136], wherein plastic comprises a plastic polymer). Kaib also teaches wherein other methods and/or materials may be used ([0136]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to have the flexible housing comprise 3D printed plastic as taught by Kaib ([0136]). A 3D printed conformable housing made of plastic material may similarly be configured to be flexible and comfortable for patients to wear, including while a patient is asleep or performing physical activity as recognized by Kaib ([0133], [0136]). Moreover, 3D printing is known in the art and may have the advantages of speed of production and lower costs.
Regarding claim 4, Xu ‘269 in view of Xu ‘204, Orbach, and Kaib teaches the invention as claimed above in claim 3.
However, Xu ‘269 fails to explicitly teach wherein the high-speed analogue to digital converter is configured to operate at over one million samples per second.
In an analogous blood pressure monitoring system comprising a wearable patch field of endeavor, Xu ‘204 teaches such a feature. Xu ‘204 teaches a wearable ultrasonic-system-on-patch (USoP) which can continuously monitor physiological signals including blood pressure (Title, Abstract, [0004], [0094]). Xu ‘204 teaches circuitry of the wearable device includes a data acquisition (DAQ) module and teaches wherein analog echoes are relayed to the DAQ module ([0098]). Xu ‘204 teaches the DAQ module consists of a microcontroller unit (MCU) with a built-in analog-to-digital converter (Fig. 1C, [0098], [0197], [0202]). Xu ‘204 therefore teaches wherein the DAQ module comprises an analog-to-digital converter. Xu ‘204 further teaches wherein the DAQ has a sampling rate of 12 Msps (Megasamples per second) ([0100]). Xu ‘204 therefore teaches a high-speed analog-to-digital converter configured to operate at over one million samples per second (wherein 12 Msps comprises 12 million samples per second).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Xu ‘269 to have a sample rate of 12 Msps for the ADC as taught by Xu ‘204 ([0100], wherein 12 Msps is 12 million samples per second, [0197], [0202], wherein the DAQ comprises an ADC). By having such a high sampling rate, ultrasound signals emitted by ultrasound probes which have MHz-level bandwidth may be sufficiently sampled as recognized by Xu ‘204 ([0100]).
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 TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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