DETAILED ACTION
This Office Action is in response to the communication dated 29 January 2026 concerning Application No. 18/536,661 filed on 12 December 2023.
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 .
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 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.
Status of Claims
Claims 1, 3-16, 18, 19, 21-23, 25-27, 29-31, 33-35, and 37-41 are pending and currently under consideration for patentability; claims 1, 3, and 16 have been amended; claims 2, 17, 20, 24, 28, 32, and 36 have been cancelled; claims 40 and 41 have been added as new claims.
Response to Arguments
Applicant’s arguments dated 29 January 2026 have been fully considered, but they are not persuasive or 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.
Applicant has amended the independent claims to recite using a photoelectric pulse wave sensor or a pulse wave electrode unit for pulse wave measurement, as well as to recite a first blood pressure measurement unit similar to that appearing in previously presented claim 2. The Examiner has addressed the amended limitations in the updated text of the rejection below. Specifically regarding the Bartels reference, Applicant argues that “Bartels does not disclose, or otherwise describe or suggest, a wearable device including integral measuring units, electrodes, vibration sensors, etc., that is configured to be worn for long periods of time” (Arguments, p. 13). As a preliminary matter, the Examiner respectfully submits that the claims do not recite that the wearable device “is configured to be worn for long periods of time,” nor do the claims impart any limitations on the length of time for which the device is to be worn. Regarding those claims which recite that the components are wearable and/or integral (previously presented claims 11, 12, and 37-39, which recite that an electrode and a vibration sensor are integrally formed, and new claims 40 and 41 which recite an integrated device in the preamble), the Examiner respectfully submits that MPEP 2144.04(V)(B) obviates integrating the prior art elements into a one-piece construction. The Examiner has provided a more detailed analysis of the underlying limitations in the updated text of the rejection below.
Claim Objections
Claim 41 is objected to because of the following informalities.
Claim 41 contains minor typographical and/or grammatical errors.
Claim 41, line 1: Applicant is advised to change “a wearable…” to “the wearable…”
Claim 41, line 3: Applicant is advised to change “a body” to “body”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-7, 10-12, 16, 18, 21, 23, 25, 27, 33, 35, 37, 39, 40, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels et al. (US 2003/0220577 A1).
Regarding claims 1, 16, and 40 Bartels describes a biological information measurement device ([0044]) adapted to be attached on an upper arm of a human body and used thereon (figure 6), the biological information measurement device comprising
a belt portion adapted to be wound around the upper arm (figure 6, cuff portion 120 wound around arm)
an electrocardiographic measurement unit including a plurality of electrodes for detecting an electrocardiographic signal of the human body ([0058])
a pulse wave measurement unit including a pulse wave sensor or pulse wave electrode unit for detecting a pulse wave of the human body ([0046], use of a phonocardiogram, [0053], [0060])
a heartbeat vibration measurement unit including a vibration sensor for detecting vibration caused by beating of a heart of the human body ([0018] - [0019])
an analysis processing unit configured to calculate a pre-ejection time and a pulse transit time of the heart based on time series data of the electrocardiographic signal, time series data of the pulse wave, and time series data of the vibration caused by the beating of the heart ([0053], [0065])
a first blood pressure measurement unit ([0057]) configured to calculate a blood pressure value of the human body based on the pulse transit time calculated by the analysis processing unit ([0068], [0070])
Regarding claim 40 in particular, Bartels describes wherein the device is a wearable continuous monitoring device (figure 6).
Regarding claims 1, 16, and 40, although Bartels provides an embodiment in which the vibration sensor is located separately from the cuff (figure 6, for example), the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate all of the sensors onto the arm band, thereby forming an integrated device as recited in claim 40, as doing so would be a matter of integrating the components of the device into a one-piece construction, for the predictable result of a cleaner overall design with fewer wires or connections between the sensors (please see MPEP 2144.04). Such a modification also advantageously provides for a better form factor and increased portability of the device.
Regarding claim 3, Bartels describes a pressing cuff, a fluid supply configured to supply a fluid to the pressing cuff, a pressure sensor configured to detect pressure in the pressing cuff, and a second blood pressure measurement unit configured to calculate a blood pressure value of the human body based on an output signal of the pressure sensor ([0057], all components being inherent in “the blood pressure waveform is collected from the blood pressure cuff 120 using known art” and further descriptions of the inflation of the cuff).
Regarding claims 5 and 18, although Bartels does not explicitly disclose wherein the pulse wave sensor is disposed to be located on a side closer to a periphery of the human body than the plurality of electrodes, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to arrange the pulse wave sensor wherever appropriate, for example “on a side closer to a periphery of the human body than the plurality of electrodes” as recited, as doing so would be a matter of rearranging the known elements of a device without modifying the operation of the device (please see MPEP 2144.04). One advantageous result of rearranging the sensors would be to ensure that accurate data is collected for the pre-ejection period and pulse transit time calculations performed by the analysis processing unit.
Regarding claims 6, 21, and 23, Bartels describes a housing in which at least the vibration sensor is housed (figure 6, housing of pcg sensor 130; alternatively, housing of cuff 120). Although Bartels does not explicitly disclose wherein the vibration sensor is housed at a location that is near an inner wall surface of the housing and is located farthest from the skin surface of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to position the various sensors wherever necessary in order to obtain the physiological signals optimally, as doing so would be a matter of rearranging the positions of the sensor components without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the appropriate sensor can obtain its respective physiological signal.
Regarding claims 7, 25, and 27, although Bartels does not explicitly disclose wherein the vibration sensor includes a plurality of vibration sensors, and the plurality of vibration sensors are disposed at intervals from a side close to a periphery of the human body to a side close to a center of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the number and positions of the sensors as necessary, as doing so would be a matter of duplicating and rearranging the known elements without producing a new and unexpected result and without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the proper number of sensors are used for each physiological measurement and that the sensors are positioned optimally to sense their respective physiological signals.
Regarding claims 10, 33, and 35, although Bartels does not explicitly disclose wherein the vibration sensor is disposed to be located near an end portion on a side close to a center of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the position of the sensors as necessary, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the sensors are positioned optimally to sense their respective physiological signals.
Regarding claims 11, 37, and 39, Bartels describes wherein the contact surface of the electrode contacts the human body (figure 6). Although Bartels does not explicitly disclose wherein at least one of the plurality of electrodes and the vibration sensor are integrally formed, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to integrate the electrodes and vibration sensor, for example to form a more compact overall device, as doing so would be a matter of obvious engineering choice (please see MPEP 2144.04). Similarly, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the vibration sensor so that it is disposed on a side opposed to a contact surface of the electrode integrally formed with the vibration sensor, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the sensors are positioned optimally to sense their respective physiological signals.
Regarding claim 12, Bartels describes wherein the vibration sensor is a microphone ([0046]) and the electrode integrally formed with the vibration sensor is provided with a sound pickup structure ([0065]).
Regarding claim 41, Bartels describes wherein the belt portion is securable about a limb of the wearer’s body (figure 6).
Claims 4, 19, 22, 26, 34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Shirasaki (US 2003/0181816 A1)
Regarding claim 4, Bartels describes the biological information measurement device according to claim 3 but does not explicitly disclose wherein the first blood pressure measurement unit performs, based on the blood pressure value measured by the second blood pressure measurement unit, calibration of a calculation formula for calculating a blood pressure value based on the pulse transit time. However, Shirasaki also describes a biological information measurement device ([0002]), including a first blood pressure measurement unit which performs, based on a blood pressure value measured by a second blood pressure measurement unit, calibration of a calculation formula for calculating a blood pressure value based on the pulse transit time ([0020], [0027] - [0028]). As Shirasaki is also directed towards a biological information measurement device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a calibration step similar to that described by Shirasaki when using the device described by Bartels, as doing so advantageously allows the resulting device to increase the precision of the blood pressure measurement, as described by Shirasaki ([0027]).
Regarding claim 19, although Bartels and Shirasaki do not explicitly disclose wherein the pulse wave sensor is disposed to be located on a side closer to a periphery of the human body than the plurality of electrodes, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to arrange the pulse wave sensor wherever appropriate, for example “on a side closer to a periphery of the human body than the plurality of electrodes” as recited, as doing so would be a matter of rearranging the known elements of a device without modifying the operation of the device (please see MPEP 2144.04). One advantageous result of rearranging the sensors would be to ensure that accurate data is collected for the pre-ejection period and pulse transit time calculations performed by the analysis processing unit.
Regarding claim 22, Bartels describes a housing in which at least the vibration sensor is housed (figure 6, housing of pcg sensor 130; alternatively, housing of cuff 120). Although Bartels and Shirasaki do not explicitly disclose wherein the vibration sensor is housed at a location that is near an inner wall surface of the housing and is located farthest from the skin surface of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to position the various sensors wherever necessary in order to obtain the physiological signals optimally, as doing so would be a matter of rearranging the positions of the sensor components without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the appropriate sensor can obtain its respective physiological signal.
Regarding claim 26, although Bartels and Shirasaki do not explicitly disclose wherein the vibration sensor includes a plurality of vibration sensors, and the plurality of vibration sensors are disposed at intervals from a side close to a periphery of the human body to a side close to a center of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the number and positions of the sensors as necessary, as doing so would be a matter of duplicating and rearranging the known elements without producing a new and unexpected result and without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the proper number of sensors are used for each physiological measurement and that the sensors are positioned optimally to sense their respective physiological signals.
Regarding claim 34, although Bartels and Shirasaki do not explicitly disclose wherein the vibration sensor is disposed to be located near an end portion on a side close to a center of the human body, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the position of the sensors as necessary, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the sensors are positioned optimally to sense their respective physiological signals.
Regarding claim 38, Bartels describes wherein the contact surface of the electrode contacts the human body (figure 6). Although Bartels and Shirasaki do not explicitly disclose wherein at least one of the plurality of electrodes and the vibration sensor are integrally formed, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to integrate the electrodes and vibration sensor, for example to form a more compact overall device, as doing so would be a matter of obvious engineering choice (please see MPEP 2144.04). Similarly, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the vibration sensor so that it is disposed on a side opposed to a contact surface of the electrode integrally formed with the vibration sensor, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04). One advantageous result of such an arrangement would be to ensure that the sensors are positioned optimally to sense their respective physiological signals.
Claims 8, 9, 28, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Zhang et al. (US 2021/0204902 A1).
Regarding claim 8, Bartels suggests the biological information measurement device according to claim 7 but does not explicitly disclose wherein the vibration sensor is a sensor mounted on a substrate and the plurality of vibration sensors are mounted on different substrates separated from each other. However, Zhang also describes a biological information measurement device ([0004]), including wherein a vibration sensor is a sensor mounted on a substrate ([0077]) and a plurality of vibration sensors are mounted on different substrates separated from each other ([0078], [0081]). As Zhang is also directed towards a biological information measurement device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate the sensors on substrates in a manner similar to that described by Zhang when using the device described by Bartels, as doing so advantageously allows the resulting sensors to the arrange as necessary for optimal physiological signal detection.
Regarding claim 9, Bartels suggests the biological information measurement device according to claim 1, and Zhang describes wherein the vibration sensor includes a plurality of vibration sensors ([0077] - [0078]). Although neither Bartels nor Zhang explicitly disclose wherein the plurality of vibration sensors include at least one set of vibration sensors disposed at positions opposed to each other in a circumferential direction of the upper arm, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to arrange the sensors as necessary for optimally sensing physiological signals, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04).
Regarding claims 29 and 31, Bartels suggests the biological information measurement device according to claims 3 and 5, and Zhang describes wherein the vibration sensor includes a plurality of vibration sensors ([0077] - [0078]). Although neither Bartels nor Zhang explicitly disclose wherein the plurality of vibration sensors include at least one set of vibration sensors disposed at positions opposed to each other in a circumferential direction of the upper arm, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to arrange the sensors as necessary for optimally sensing physiological signals, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Wang et al. (US 2021/0204824 A1).
Regarding claim 13, Bartels suggests the biological information measurement device according to claim 12, but Bartels does not explicitly disclose wherein the sound pickup structure is a hollow portion disposed to extend through the electrode in a thickness direction. However, Wang also describes a biological information measurement device ([0005]), including the sound pickup structure in the form of a hollow portion disposed to extend through an electrode in a thickness direction ([0098] - [0099], [0102], figure 20). As Wang is also directed towards a biological information measurement devices and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a sound pickup structure similar to that described by Wang when using the device described by Bartels, as doing so advantageously allows the resulting device to optimally pickup the physiological sounds.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Bartels in view of Shirasaki and Zhang.
Regarding claim 30, Bartels in view of Shirasaki suggests the biological information measurement device according to claim 4. Bartels and Shirasaki do not explicitly disclose wherein the vibration sensor includes a plurality of vibration sensors and the plurality of vibration sensors include at least one set of vibration sensors disposed at positions opposed to each other in a circumferential direction of the upper arm, in a state where the biological information measurement device is attached on the upper arm. However, Zhang also describes a biological information measurement device ([0004]), including wherein the vibration sensor includes a plurality of vibration sensors ([0077] - [0078]). As Zhang is also directed towards a biological information measurement device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a plurality of vibration sensors, similar to that described by Zhang, when using the device described by Bartels and Shirasaki, as doing so advantageously allows the resulting device to have an adequate number of sensors to ensure proper signal acquisition. Although Bartels, Shirasaki, and Zhang do not explicitly disclose wherein the plurality of vibration sensors include at least one set of vibration sensors disposed at positions opposed to each other in a circumferential direction of the upper arm, in a state where the biological information measurement device is attached on the upper arm, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to arrange the sensors as necessary for optimally sensing physiological signals, as doing so would be a matter of rearranging the known elements of the device without modifying the overall operation of the device (please see MPEP 2144.04).
Allowable Subject Matter
Claims 14 and 15 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.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 14, Bartels, Wang, and the other prior art of record does not disclose or suggest a biological information measuring device similar to that recited in claim 13, including wherein the hollow portion is filled with a resin having a hardness comparable with a hardness of human skin to be flush with the contact surface.
Claim 15 depends on claim 14 and contains at least the same allowable subject matter as claim 14.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792