DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-3 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam (US 20230355991- previously cited) and further in view of Redtel (US 20220031176) and Banet et al. (US 20070276632), hereinafter Banet.
Regarding claim 1, Burnam teaches a wearable blood pressure measurement device (see fig. 1 and ¶ [0026], smart watch with sensor for blood pressure (BP) and watch position on arm), comprising:
a first set of one or more sensors (fig. 1, BP sensor 12);
a second set of one or more sensors (fig. 1, accelerometer 13); and
a processor configured to, obtain, from the first set of one or more sensors, a first set of one or more sensor outputs indicative of a blood pressure of a wearer of the wearable blood pressure measurement device (¶ [0038], BP sensor 12 outputs measurement); and
obtain, contemporaneously with obtaining the first set of one or more sensor outputs and from the second set of one or more sensors, a second set of one or more sensor outputs indicative of a set of one or more conditions under which the first set one or more sensor outputs is obtained (¶ [0039], “blood pressure is measured in a variety of positions, e.g. elevated, heart level and depressed height position of the arm and the measured value is stored in each arm position” (emphasis added)).
Burnam fails to teach determine, from the second set of one or more sensor outputs, each of: a position of the blood pressure measurement device on an arm portion of the wearer; and a length of the arm portion of the wearer.
Redtel teaches a method for continuously measuring blood pressure (¶[0016]). The blood pressure measurement is based on determining the position of the blood pressure measurement device and ensuring that it is in a correct position and the arm length (¶[0243-244,0264-74]).
Therefore, it would have been obvious to one of ordinary skill in that at the time the invention was effectively filed to have modified the device of Burnam, such that a position of the blood pressure measurement device on an arm portion of the wearer and a length of the arm portion of the wearer, as taught by Redtel, to aid in determining the correct position of the measurement device for reliable measurement and continuously monitoring the blood pressure.
Burnam-Redtel fail to teach that the length of the arm is measured with a sensor.
Banet teaches a calculating blood pressure based on determining arm length, which is derived by the bilateral pulse transit time (¶[0034,0041], “Use of BPTT to determine .DELTA.PTT means arm length can be estimated without having to enter it through a software user interface”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel, such that the length of the arm is measured with a sensor, as taught by Banet, to avoid having the user enter the arm length and streamlining the blood pressure measurement process.
Regarding claim 2, Burnam teaches wherein the processor is configured to, determine the blood pressure of the wearer using the first set of one or more sensor outputs; and adjust the blood pressure of the wearer using the second set of one or more sensor outputs (¶ [0072], “Monitor blood pressure, correct for time of day and arm position”).
Regarding claim 3, Burnam teaches wherein the processor is configured to, determine the blood pressure of the wearer using the first set of one or more sensor outputs; and determine a confidence level for the blood pressure of the wearer using the second set of one or more sensor outputs (¶ [0073-74] and fig. 6, after correcting the BP measurement, it is compared with known corrected BP data. The comparison establishes a confidence level to determine whether the measurement is accurate with confidence).
Regarding claim 17, Burnam teaches a method of determining a blood pressure, comprising: obtaining, from a first set of one or more sensors in a first electronic device, a first set of one or more sensor outputs indicative of a blood pressure (¶ [0028], “the smart watch or smartphone may be linked via blue tooth to a blood pressure sensor embodied in a finger ring” indicating that the finger ring BP device is the first sensor and the watch is a second sensor);
obtaining, contemporaneously with obtaining the first set of one or more sensor outputs and from a second set of one or more sensors, a second set of one or more sensor outputs indicative of a set of one or more conditions under which the first set one or more sensor outputs is obtained, at least one sensor in the second set of one or more sensors in a second electronic device (¶ [0039,0072], the watch monitors position of the arm to then correct the BP );
determining the blood pressure of a user using the first set of one or more sensor outputs (¶ [0072], BP is determined);
and adjusting the blood pressure of the user using the second set of one or more sensor outputs (¶ [0072], the BP measurements are corrected based on at least time of day and arm position).
Regarding claim 18, Burnam teaches wherein adjusting the blood pressure of the user using the second set of one or more sensor outputs comprises:
determining a position of a body part of the user (¶ [0039], “The smart watch 10 is also subject to secondary calibration based on a dynamic measurement of position of arm”); and
adjusting the blood pressure of the user in response to the position of the body part of the user (¶ [0072], “Monitor blood pressure, correct for time of day and arm position”).
Regarding claim 19, Burnam-Redtel-Banet teach wherein adjusting the blood pressure of the user using the second set of one or more sensor outputs comprises:
adjusting the blood pressure of the user in response to the position of the first electronic device on the body part of the user (¶ [0072] of Burnam, “Monitor blood pressure, correct for time of day and arm position,” since the arm position is the position of the device, the BP is corrected based on the position of the device; (¶[0243-244,0264-74] of Redtel).
Claims 4, 6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam in view of Redtel and Banet, as applied to claim 1, in view of Hyde et al. (US 20170164876), hereinafter Hyde.
Regarding claim 4, Burnam teaches where the second set of one or more sensors includes a timer associated with at least one of the second sensors (¶ [0072], “Monitor blood pressure, correct for time of day and arm position based on prior data at step”.
Burnam-Redtel-Banet fail to teach wherein the second set of sensors includes an acoustic transducer; obtaining the second set of one or more sensor outputs includes obtaining a time of emission of an ultrasonic pulse emitted by the at least one acoustic transducer and at least one time of receipt of at least one echo of the ultrasonic pulse; and the processor is configured to, cause the at least one acoustic transducer to emit the ultrasonic pulse and listen for the at least one echo of the ultrasonic pulse; and determine, using the time of emission of the ultrasonic pulse and the at least one time of receipt of the at least one echo, a position of the blood pressure measurement device on the wearer of the wearable blood pressure measurement device.
Hyde teaches a physiological and motion monitoring device 100 comprising an electronics layer 107, formed of electronics assembly 113 that includes interaction devices 780 (¶ [0082-84] and abstract, interaction devices include blood pressure sensor, etc.). Additionally, device 100 comprises a range sensor (ultrasound, e.g. acoustic, or electromagnetic, e.g., optical) that is configured to generate pulse waves to determine the “orientation, motion, rotation, and/or position of the attachment surface [body part] and/or epidermal electronics device [100]” based on the time-of-arrival of the pulse waves (¶ [0066,0113,0119,0125, 0132], “monitor one or more physiological conditions of a subject and one or more movements or positions of a body portion of the subject”). It is noted, the time-of-arrival is the time it takes for an emitted pulse, e.g., ultrasound, electromagnetic, to travel from the transducer, reflect off the object, and return to the receiver, in a time dependent manner, as known to one of ordinary skill in the art. The data generated along with other calculations aid in “a better estimate of unknown variables than one based on one measurement or data point. Additionally, signal noise and inaccuracies may be reduced.” (¶ [0111]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel-Banet, such the second set of sensors includes an acoustic transducer; obtaining the second set of one or more sensor outputs includes obtaining a time of emission of an ultrasonic pulse emitted by the at least one acoustic transducer and at least one time of receipt of at least one echo of the ultrasonic pulse; and the processor is configured to, cause the at least one acoustic transducer to emit the ultrasonic pulse and listen for the at least one echo of the ultrasonic pulse; and determine, using the time of emission of the ultrasonic pulse and the at least one time of receipt of the at least one echo, a position of the blood pressure measurement device on the wearer of the wearable blood pressure measurement device, as taught by Hyde, as it would merely be combining prior art elements (medical monitoring devices) according to known methods (comprising acoustic sensors to determine position of device in relation to the user) to yield predictable results. In addition, the modification can aid in reducing signal noise and inaccuracies. Moreover, Burnam understands the importance to “ establish a mean, standard deviation (SD), other statistical measures of variability of blood pressure as a function of arm position” to aid in determining BP (¶ [0039] of Burnam).
Regarding claim 6, Burnam teaches where the second set of one or more sensors includes a timer associated with at least one of the second sensors (¶ [0072], “Monitor blood pressure, correct for time of day and arm position based on prior data at step” (emphasis added)).
Burnam-Redtel-Banet fail to teach wherein the second set of sensors includes an active optical sensor; obtaining the second set of one or more sensor outputs includes obtaining a time of emission of an optical pulse emitted by the at least one active optical sensor and at least one time of receipt of at least one reflection of the optical pulse; and the processor is configured to, cause the at least one active optical sensor to emit the optical pulse and monitor for the at least one reflection of the optical pulse; and determine, using the time of emission of the optical pulse and the at least one time of receipt of the at least one reflection, a position of the blood pressure measurement device on the wearer of the wearable blood pressure measurement device.
Hyde teaches a physiological and motion monitoring device 100 comprising an electronics layer 107, formed of electronics assembly 113 that includes interaction devices 780 (¶ [0082-84] and abstract, interaction devices include blood pressure sensor, etc.). Additionally, device 100 comprises a range sensor (ultrasound, e.g. acoustic, or electromagnetic, e.g., optical) that is configured to generate pulse waves to determine the “orientation, motion, rotation, and/or position of the attachment surface [body part] and/or epidermal electronics device [100]” based on the time-of-arrival of the pulse waves (¶ [0066,0113,0119,0125, 0132], “monitor one or more physiological conditions of a subject and one or more movements or positions of a body portion of the subject”). It is noted, the time-of-arrival is the time it takes for an emitted pulse, e.g., ultrasound, electromagnetic, to travel from the transducer, reflect off the object, and return to the receiver, in a time dependent manner, as known to one of ordinary skill in the art. The data generated along with other calculations aid in “a better estimate of unknown variables than one based on one measurement or data point. Additionally, signal noise and inaccuracies may be reduced.” (¶ [0111]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel-Banet, such that the second set of sensors includes an active optical sensor; obtaining the second set of one or more sensor outputs includes obtaining a time of emission of an optical pulse emitted by the at least one active optical sensor and at least one time of receipt of at least one reflection of the optical pulse; and the processor is configured to, cause the at least one active optical sensor to emit the optical pulse and monitor for the at least one reflection of the optical pulse; and determine, using the time of emission of the optical pulse and the at least one time of receipt of the at least one reflection, a position of the blood pressure measurement device on the wearer of the wearable blood pressure measurement device, as taught by Hyde, as it would merely be combining prior art elements (medical monitoring devices) according to known methods (comprising acoustic sensors to determine position of device in relation to the user) to yield predictable results. In addition, the modification can aid in reducing signal noise and inaccuracies. Moreover, Burnam understands the importance to “ establish a mean, standard deviation (SD), other statistical measures of variability of blood pressure as a function of arm position” to aid in determining BP (¶ [0039] of Burnam).
Regarding claim 8, Burnam teaches a wireless communication interface (¶ [0028], the smart watch or smartphone may be linked via blue tooth to a blood pressure sensor embodied in a finger ring).
Burnam-Redtel-Banet fail to teach wherein the processor is configured to transmit, to a remote device, at least one of the first set of one or more sensor outputs or the blood pressure; and the second set of one or more sensor outputs.
Hyde teaches transmitting the information gathered from the sensors (first set, BP, second set out outputs) to a remote device (¶ [0148]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam, such that the processor is configured to transmit, to a remote device, at least one of the first set of one or more sensor outputs or the blood pressure; and the second set of one or more sensor outputs, as taught by Hyde, as it would merely be combining prior art elements (monitoring devices) according to known methods (that transmit sensor data and calculated information) to yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Burnam in view of Redtel, Banet, and Hyde, as applied to claim 4, further in view of Sato et al. (US 9474485- previously cited), hereinafter Sato.
Regarding claim 5, Burnam-Redtel-Banet-Hyde fail to teach a blood pressure cuff; wherein, each acoustic transducer in the at least one acoustic transducer has a known position with respect to the blood pressure cuff.
Sato teaches a blood pressure measurement device that includes a cuff and a distance sensor (ultrasound transducer, e.g., sound waves, or electromagnetic transmitter, e.g., light waves) to detect the distance and position of the device in relation to the user (column 4, lines 40-58, and abstract). One skilled in the art understands that components, e.g., sensor embedded, in a housing would require knowing the position of each component in relation to each other for the purpose of manufacturing, this is well known in the medical diagnostics field, but also, in the general design and development of electronic devices. The position of the BP measurement device is the position of the cuff on the arm since the purpose of the device is to correctly measure the BP in relation to the position of the heart/wrist of the patient and are part of the same housing (column 8, lines 24-31, and figs. 1 and 3).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel-Banet-Hyde, such that device comprises a blood pressure cuff and each acoustic transducer in the at least one acoustic transducer has a known position with respect to the blood pressure cuff, as taught by Sato, to aid in improving the blood pressure measurement accuracy (column 1, lines 37-41). Additionally, the modification is using known techniques (cuff and positional information of the components in relation to the user) to improve similar products (BP measurement devices) in the same way.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Burnam in view of Redtel and Banet, as applied to claim 1, in view of Hyde and Sato.
Regarding claim 7, Burnam teaches determining a position of a body part on which the wearable device is work with respect to hear of the wearer of the wearable blood pressure measurement device (¶ [0039], “[S]mart watch 10 is also subject to secondary calibration based on a dynamic measurement of position of arm,” “blood pressure is measured in a variety of positions, e.g. elevated, heart level and depressed height position of the arm,” “data sampling is repeatedly performed during a predetermined number of days (e.g. three) before therapy begins to create a database for the monitored patient,” “ measures of variability of blood pressure as a function of arm position.” That is, the dynamic position of the arm (body part) is determined with respect to the heart level (also considered the torso) of the user).
Burnam-Redtel-Banet fail to teach the second set of one or more sensors includes an inertial measurement unit (IMU);the second set of one or more sensor outputs includes a gravity angle and the processor is configured to, determine, using an output of the IMU, the gravity angle; and determine, using the gravity angle, at least one of: an orientation of the wearable blood pressure measurement device; a position or orientation of a body part on which the wearable blood pressure measurement device is worn; or a position or orientation of the wearable blood pressure measurement device with respect to a torso or heart of the wearer of the wearable blood pressure measurement device.
Hyde teaches an integrated circuit comprising accelerometers, gyroscopes, inclinometers (¶ [0069], “The sensors may also be part of or supported by integrated circuits,” which is interpreted to define an IMU). The sensor outputs are used to determine “ the direction of gravity,” “orientation of epidermal electronics device 100 relative to the direction of gravity,” and “to measure pitch, roll, and/or yaw”(¶ [0075]). That is the IMU sensor outputs are used to determine the gravity angle, such that the orientation of the BP device is determined.
Sato teaches that the position of the body part on which the BP measurement device is located is important, and must be within a certain range from the user’s heart (column 8, lines 24-49, “The height of your wrist is significantly off from the height of your heart. Please bring your wrist to a higher (lower) position” and “As such, the blood pressure measurement device according to one or more embodiments of the present invention can also improve precision in the blood pressure measurement”).
Burnam further teaches that the position of the BP device on the wrist is relevant and must be accounted for determining BPf (¶ [0039], “blood pressure is measured in a variety of positions, e.g. elevated, heart level and depressed height position of the arm and the measured value is stored in each arm position” (emphasis added); ¶ [0072], “Monitor blood pressure, correct for time of day and arm position”).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel-Banet-Hyde, such that the second set of one or more sensors includes an inertial measurement unit (IMU);the second set of one or more sensor outputs includes a gravity angle and the processor is configured to, determine, using an output of the IMU, the gravity angle; and determine, using the gravity angle, at least one of: an orientation of the wearable blood pressure measurement device; a position or orientation of a body part on which the wearable blood pressure measurement device is worn; or a position or orientation of the wearable blood pressure measurement device with respect to a torso or heart of the wearer of the wearable blood pressure measurement device, as taught by Hyde and Sato, to aid an improving precision in blood measurement. Additionally, the modification is merely using a known technique (using an IMU to calculate gravity angle to determine orientation and/or position of the body part and/or BP device) to improve similar devices (BP measurement devices) in the same way.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Burnam in view of Redtel and Banet, as applied to claim 1, in view of Lec (US 20130144176- previously cited).
Regarding claim 20, Burnam fails to teach wherein adjusting the blood pressure of the user using the second set of one or more sensor outputs comprises: determining a movement or activity of the user; and adjusting the blood pressure of the user in response to the movement or activity of the user.
Lec teaches a non-invasive blood pressure sensor system comprising a BP sensor, accelerometer, and gyroscope (¶ [0071] and abstract). The system is configured to correct the BP readings during movement of the users arm (¶ [0071]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burnam-Redtel-Banet, such that the BP adjustment is based on the determined movement or activity of the user, as taught by Lec, to aid in providing reliable information as to the BP of the user and prevent false alarms (¶ [0071] of Lec).
Response to Arguments
The following is in response to the Remarks entered on 05/04/2026.
Applicant’s request for reconsideration for the restriction requirement has been considered but not persuasive. The amendments does not eliminate distinctness of the inventions identified in the restriction requirement. Accordingly, the restriction requirement is maintained.
Applicant’s arguments with respect to amended independent claim have been considered but are moot because amendments require news ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park teaches a method of calculating the arm length of a user. US 20150375039
Sato teaches using the users arm length for calculating BP and adjusting the position of the device in relation to the position to the heart. US 20130237865
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 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, Robert (Tse) Chen can be reached at (571) 272-3672. 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.
/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights