DETAILED ACTION
This Office Action is in response to the communication dated 31 December 2025 concerning Application No. 18/487,729 filed on 16 October 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 1-16 are pending and currently under consideration for patentability; claims 1, 7, 9, and 14-16 have been amended.
Response to Arguments
Applicant’s arguments dated 31 December 2025 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 a continuously operating electrocardiographic measurement unit, arguing that the Deno reference does not disclose or suggest such a feature. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Information Disclosure Statement
The Information Disclosure Statement submitted on 31 December 2025 has been acknowledged and considered by the Examiner.
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, 2, 4, 6-8, 10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Deno et al. (WO 2020/039830 A1) in view of Acquista (US 2013/0204100 A1).
The Examiner notes that Deno shares a common assignee with the instant application and qualifies as prior art based on its publication date of 27 February 2020 being more than one year prior to the effective filing date of the instant application, which is 28 May 2021. The Examiner had also provided, with the previous Office Action, a copy of the Deno reference in its original Japanese as well as an English translation, with the citations made herein referring to the English translation.
Regarding claims 1 and 7, Deno describes a biological information measurement device and a method for controlling a biological information measurement device (p. 7: “blood pressure measurement device 1 is an example of a measurement device that can measure a user's blood pressure and electrocardiogram”) comprising
a blood pressure measurement unit including a blood pressure measurement control unit configured to control a cuff configured to compress a target measurement site of a subject (p. 7: “pressing cuff”), a pump configured to supply a gas into the cuff (p. 7: “a pump that supplies a fluid to the press cuff”), an exhaust valve configured to adjust exhaust of the gas from the cuff (p. 7: “an exhaust valve provided in the press cuff”), and a pressure detection unit configured to detect a cuff pressure that is a pressure in the cuff (p. 7: “the pressure acquisition unit 2 acquires pressure information from, for example, a pressure sensor provided on the pressing cuff”), the blood pressure measurement unit being configured to measure a blood pressure of the subject (p. 7: “blood pressure calculation unit 4 calculates the blood pressure of the user based on the pressure information”)
an electrocardiographic measurement unit (p.7: “electrocardiogram measuring unit”) configured to measure an electrocardiographic waveform by processing an electrical signal obtained through a plurality of electrodes that can come into contact with a skin of the subject (p. 12: “in a state where each of the first electrode 30 and the second electrode 31 is in contact with the skin of the user”)
wherein the blood pressure measurement control unit
executes pressurization control of supplying the gas from the pump to the cuff to increase the cuff pressure from the start of blood pressure measurement (p. 7: “the pressing cuff control unit 3 expands the pressing cuff and pressurizes the pressing cuff, for example, by supplying a fluid from the pump to the pressing cuff”)
executes pressure reduction control of opening the exhaust valve to rapidly reduce the cuff pressure (p. 7: “the press cuff control unit 3 controls the state of the press cuff by controlling…an exhaust valve provided in the press cuff…the press cuff control unit 3 contracts the press cuff and reduces the pressure of the press cuff by, for example, discharging the fluid from the press cuff”)
holds the cuff pressure constant (p. 5: “pressurized state holding process”) before executing the pressure reduction control when it is determined whether the electrocardiographic measurement unit has ended measurement of the electrocardiographic waveform (p. 5: “the electrocardiogram detection information acquisition unit acquires the detection information from the pressurization process to the decompression process”) and it is determined that the electrocardiographic measurement unit continues to measure the electrocardiographic waveform at the end of the pressurization control (p. 5: “the electrocardiogram is measured in the pressurized state holding process provided between the pressurizing process of the press cuff and the depressurizing process”)
Regarding claims 1 and 7, although Deno describes an electrocardiographic measurement unit, Deno does not explicitly disclose wherein the electrocardiographic measurement unit continuously measures the electrocardiographic waveform for a predetermined electrocardiographic measurement period from start of blood pressure measurement. However, Acquista also describes a biological information measurement device ([0014]), including an electrocardiographic measurement unit that continuously measures the electrocardiographic waveform for a predetermined electrocardiographic measurement period from start of blood pressure measurement ([0053] - [0054]). As Acquista 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 continuously measure the electrocardiographic data as described by Acquista when using the device described by Deno, as doing so advantageously allows the resulting device to obtain a more complete data set before determining which data to include or exclude for further analysis.
Regarding claims 2 and 8, Deno describes wherein, when it is determined that the electrocardiographic measurement unit continues to measure the electrocardiographic waveform at the end of the pressurization control, the blood pressure measurement control unit, before executing the pressure reduction control, controls the pump so that the cuff pressure remains constant (p. 7: “the electrocardiogram measuring unit 5 holds the pressure in the pressing cuff at a constant value in the pressing state holding process”). Therefore, Deno does not disclose wherein the cuff pressure increases more gradually than an increase rate of the cuff pressure at the end of the pressurization control or decreases more gradually than a decrease rate of the cuff pressure during the pressure reduction control. However, as the goal of Deno’s device is to maintain sufficient pressure in the cuff so that there is sufficient contact between the electrocardiogram electrodes and the user’s skin (p. 4: “if any of the pair of electrodes does not properly contact the measurement site of the user, a useful electrocardiogram measurement result may not be obtained”; p. 5: “in the pressurized state holding process, the electrocardiographic measurement electrode is securely brought into contact with the user's wear site and sufficiently adheres to the user's wear site by the expansion of the press cuff”), 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 ensure that any pressure increase or pressure decrease is performed gradually, so that there is minimal effect on the contact of the electrodes with the user’s skin and minimal interference with the electrogram measurement step.
Regarding claims 4 and 10, Acquista describes wherein, when the system detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]). As Acquista 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 data termination step similar to that described by Acquista when using the device described by Deno, as doing so advantageously allows the resulting device to, upon detection of an error condition, disregard erroneous electrocardiogram data. Although neither Deno nor Acquista explicitly disclose wherein the blood pressure measurement control unit continues execution of the pressurization control, 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 maintain the pressurization control and potentially continue obtaining blood pressure information from the user, as there may not be an error in the blood pressure measurement component of the device.
Regarding claim 6, Deno describes a display unit configured to display information (p. 5: “display an electrocardiographic waveform”) and a display control unit configured to control the display unit (p. 10: “control unit 21”). Acquista describes wherein the display control unit displays the fact that there is the abnormality in the measurement of the electrocardiographic waveform on the display unit after the end of the blood pressure measurement ([0083]).
Regarding claim 12, Acquista describes wherein, when the system detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]). Although neither Deno nor Acquista explicitly disclose wherein the blood pressure measurement control unit continues execution of the pressurization control, 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 maintain the pressurization control and potentially continue obtaining blood pressure information from the user, as there may not be an error in the blood pressure measurement component of the device.
Regarding claim 15, Acquista describes wherein, when the system detects an abnormality, measurement of the electrocardiographic waveform is stopped ([0058]). Although neither Deno nor Acquista explicitly disclose wherein the pressurization is continued, 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 maintain the pressurization and potentially continue obtaining blood pressure information from the user, as there may not be an error in the blood pressure measurement component of the device.
Claims 3, 5, 9, 11, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Deno in view of Acquista, further in view of Kinoshita et al. (US 2012/0232412 A1).
Regarding claims 3 and 9, Deno in view of Acquista suggests the biological information measurement device according to claim 1 and the method according to claim 7. Deno does not explicitly disclose wherein, when the blood pressure measurement control unit detects an abnormality, the blood pressure measurement control unit stops the pressurization control and executes the pressure reduction control, and the electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform. However, Kinoshita also describes a biological information measurement device ([0068]) including wherein, when a blood pressure measurement control unit detects an abnormality, the blood pressure measurement control unit stops pressurization control and executes pressure reduction control ([0077]). Similarly, Acquista also describes a biological information measurement device ([0014]) including wherein, when the system detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]). As Kinoshita and Acquista are both directed towards biological information measurement devices and are 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 cuff pressure reduction step and a data termination step similar to those described by Kinoshita and Acquista when using the device described by Deno, as doing so advantageously allows the resulting device to, upon detection of an error condition, disregard erroneous electrocardiogram data and safely depressurize the cuff prior to potentially injuring the user.
Regarding claim 5, Deno describes a display unit configured to display information (p. 5: “display an electrocardiographic waveform”) and a display control unit configured to control the display unit (p. 10: “control unit 21”). Kinoshita describes wherein the display control unit displays the fact that there is the abnormality in the measurement of the blood pressure on the display unit ([0068]).
Regarding claim 11, Deno in view of Acquista suggests the biological information measurement device according to claim 2. Kinoshita describes wherein, when a blood pressure measurement control unit detects an abnormality, the blood pressure measurement control unit stops pressurization control and executes pressure reduction control ([0077]). Acquista describes wherein, when the system detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]).
Regarding claims 13 and 16, Acquista describes wherein, when the electrocardiographic measurement unit detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]). Although Deno, Knoshita, and Acquista do not explicitly disclose wherein the blood pressure measurement control unit continues execution of the pressurization control, 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 maintain the pressurization control and potentially continue obtaining blood pressure information from the user, as there may not be an error in the blood pressure measurement component of the device.
Regarding claim 14, Deno in view of Acquista suggests the method according to claim 8. Kinoshita describes wherein, when a blood pressure measurement control unit detects an abnormality, the blood pressure measurement control unit stops pressurization control and executes pressure reduction control ([0077]). Acquista describes wherein, when the system detects an abnormality, an electrocardiographic measurement unit ends the measurement of the electrocardiographic waveform ([0058]).
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