Office Action 3: Notice of Allowance (2025-04-09)

CLAIMS:
Amendments to the Claims:

The following listing of claims will replace all prior versions, and listings, of claims in the application:

1\. (Currently Amended) A sphygmomanometer provided with an air system for blood pressure measurement and capable of performing air leakage testing on the air system, the air system comprising at least a cuff configured to surround a to-be-measured part, a pump connected to the cuff via a first fluid pipe, and a valve connected to the cuff via a second fluid pipe,
the sphygmomanometer comprising:
a processor;
a memory; and
a display, wherein the processor is configured to act as:
a main control unit to perform main control to make a first transition from a power-off state to a standby state in response to a power-on operation, to perform blood pressure measurement by driving the pump to feed an air to the cuff through the first fluid pipe to pressurize the cuff or driving the valve to exhaust the air from the cuff through the second fluid pipe to depressurize the cuff in response to a measurement start operation in the standby state, to make a second transition to the standby state after the blood pressure measurement, and to make a third transition to the power-off state in response to a power-off operation in the standby state;
an air leakage testing unit to perform, duringafter the blood pressure measurement te and before the second transition, air leakage testing on the air system to obtain an air leakage testing result of the air leakage testing, and to cause the memory to store the air leakage testing result; and

a notification control unit to perform notification control to control display contents on the display based on the air leakage testing result stored in the memory, wherein the air leakage testing result includes at least three air leakage levels of a first air leakage level as an acceptable level indicating that an air leakage amount of the air system is smaller than a predetermined first reference value, a third air leakage level as a failure level indicating that the air leakage amount of the air system is larger than a second reference value set greater than the first reference value, and a second air leakage level indicating that the air leakage amount of the air system corresponds to a value between the first reference value and the second reference value,
the processor acting as the notification control unit is configured:
when the air leakage testing result is the second air leakage level,
to display, during the first transition, on the display, the air leakage testing result in a first display mode displaying a message to notify a replacement of the cuff or displaying a first icon corresponding to the air leakage testing result with blinking,
to display, in the standby state, on the display, that the blood pressure measurement is enabled without displaying the air leakage testing result or with displaying the air leakage testing result in a second display mode ,
to not display the air leakage testing result during the blood pressure measurement and the second transition, and
to display, on the display, the air leakage testing result in a first display mode during the third transition, wherein when the displaying of the air leakage testing result in the first display mode is displaying the message, the displaying of the air leakage testing result in the second display

mode is displaying a second icon corresponding to the air leakage testing result, and when the displaying of the air leakage testing result in the first display mode is displaying the first icon with blinking, the displaying of the air leakage testing result in the second display mode is displaying the first icon with being kept lit.

2\. (Currently Amended) The sphygmomanometer according to claim 1, wherein when the air leakage testing result is the second air leakage level, the processor actingas the notification control unit is configured, during the first or third transition, to stop the displaying of the air leakage testing result in the first display mode, when a display stop operation is performed or a predetermined period elapses after having started isplaying the air leakage testing result in the first display mode.

3\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the processor acting as the notification control unit is configured:
to not display the air leakage testing result, during the first,
second and third transitions, when the air leakage testing result is the first air leakage level, and to display,on the display, an indication that the blood pressure measurement is disabled, during the first, second and third transitions, when the air leakage testing result is the third air leakage level.

4\. (Previously Presented) The sphygmomanometer according to claim 1, wherein the processor acting as the air leakage testing unit causes, each time the air leakage testing is performed on the air system, the memory to store the air leakage testing result of the air leakage testing.

5\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the cuff comprises a cuff unit having a cylindrical shape,
the cuff unit includes an outer peripheral member having a cylindrical shape, a winding air bag annularly disposed along an inner circumferential surface of the outer peripheral member, a curler formed of a flexible plate material curved and disposed along an inner circumferential surface of the winding air bag, the curler being reduced in diameter when the winding air bag is pressurized to expand radially inward, and a measurement air bag disposed along an inner circumferential surface of the SVG {EMBED HERE} 0.1330.427 and configured to be pressurized for the blood pressure measurement to compress an upper arm as the to-be-measured part, and
the processor acting as the air leakage testing unit obtains the air leakage testing result based on a pressure difference between a pressure in the winding air bag and a pressure in the measurement air bag at a time when a blood pressure calculation is completed in a depressurization process for the blood pressure measurement.

6\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the displaying of the air leakage testing result in the first display mode is displaying the message, and
the displaying ofithe air leakage testing result in the second display mode is displaying the second icon.

7\. (Currently Amended) The sphygmomanometer according to claim 1, wherein the displaying of the air leakage testing result in the first display mode is isplaying the first icon with blinking, and
the displaying ofithe air leakage testing result in the second display mode is isplaying the first icon with being kept lit.

8\. (Currently Amended) The sphygmomanometer according to claim 1, wherein

the processor acting as the main control unit is further configured to perform to make, in response to a maintenance mode transition operation, a fourth transition from the power- off state to a maintenance mode where the measurement start operation is disabled and a maintenance of the sphygmomanometer is to be performed, and to make, in response to a setting mode transitionoperation, a fifth transition from the standby state to a setting mode where the measurement start operation is disabled and a setting for the sphygmomanometer is to be performed,
the processor acting as the notification control nit is configured:
to not display the air leakage testing result, during the fourth and fifth transitions, when the air leakage testing result is the first air leakage level,
to display, on the display, the air leakage testing result in the first display mode, during the fourth and fifth transitions, when the air leakage testing result is the second air leakage level, and
to display, on the display, the indication that the blood pressure measurement is disabled, during the fourth and fifth transitions, when the air leakage testing result is the third air leakage level.

OFFICE ACTION:
EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Mr. Luke Hibbeler on 26 March 2025.
The application has been amended as follows:
Claims 6 and 7 have been cancelled.
Claim 8:
“the indication” in line 15 should read as “an indication”
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: The prior art of record fails to disclose, teach, or fairly suggest a sphygmomanometer provided with an air system for blood pressure measurement and capable of performing air leakage testing on the air system as claimed. The prior art that comes closest to teaching the limitations is Mori et al. ‘950, which teaches the claimed structure, the main control unit and the steps performed by the main control unit, and the notification control unit, the steps performed by the notification control unit, and the air leakage testing unit. However, it was found that Mori et al. ‘950 does not teach the air leakage testing unit to perform the claimed steps after the blood pressure measurement and before the second transition. An updated search and consideration was performed. Although the Examiner has found art that teaches performing an air leakage test in sphygmomanometers (such as Sawanoi et al. ‘221 (US Pub No. 2011/0282221), there was no art that was found to teach performing the air leakage test after the blood pressure measurement and before the second transition. It would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
It is noted that the Examiner and Mr. Hibbeler have discussed potential amendments for claim 1, in particular, lines 32-51. However, upon further consideration, Mr. Hibbeler and the Examiner have agreed that the language lines 32-51 do not need to be amended as lines 32-51 state what the processor acting as the notification control unit displays.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Claims 1-8 are pending in this application. By this Amendment, claims 1-3 and 5-8
are amended. Support for the amendments to the claims may be found throughout the original application, for example, in 1[ [0013], [0024], [0038], [0049], [0068], [0071], [0073]-[0074], and [0076] and Figs. 4, 14, 16, 17A, and 17C. No new matter is added.
Entry of the amendments is proper under 37 CFR § 1.1 16 because the amendments: (a) place the application in condition for allowance, for the reasons discussed herein; (b) do not raise any new issue requiring further search and/or consideration, as the amendments amplify issues previously discussed throughout prosecution; (c) satisfy a requirement of form asserted in the previous Office Action; (d) do not present any additional claims without canceling a corresponding number of finally rejected claims; and (e) place the application in better form for appeal, should an appeal be necessary. The amendments are necessary and were not earlier presented because they are made in response to arguments raised in the final rejection. Entry of the amendments is thus respectfully requested.
In view of the foregoing amendments and following remarks, reconsideration and allowance are respectfully requested.
I.    Interview
The courtesies extended to Applicant's representative by Examiner Tu during the telephone interview held January 15 are appreciated. The reasons presented during the interview as warranting favorable action are incorporated into the remarks below, which constitute Applicant's record of the interview. II.   Claim Objections
The Office Action objects to claims 6 and 7 for informalities. Claims 6 and 7 are
amended according to the Examiner's helpful suggestions. Accordingly, reconsideration and withdrawal of the objection are respectfully requested.
III.  Rejection Under 35 U.S.C. §101
The Office Action rejects claim 5 under 35 U.S.C. § 101 for allegedly being directed to non-statutory subject matter.
By this Amendment, claim 5 is amended to obviate the rejection, as discussed and agreed upon during the interview. Accordingly, reconsideration and withdrawal of the rejection are requested. IV.   Rejection Under 35 U.S.C. §112(a)
The Office Action rejects claim 1 as failing to comply with the written description requirement under 35 U.S.C. §112(a).
By this Amendment, claim 1 is amended to obviate the rejection, as discussed and agreed upon during the interview. Accordingly, reconsideration and withdrawal of the rejection are requested. V.    Rejection Under 35 U.S.C. §112(b)
The Office Action rejects claims 1-3 and 8 as being indefinite under 35 U.S.C.
§ 112(b). By this Amendment, claims 1-3 and 8 amended to obviate the rejection, as discussed and agreed upon during the interview. Accordingly, reconsideration and withdrawal of the rejection are requested. VI.   Conclusion


CITED REFERENCE SUMMARIES: Ref US20110282221: Claims:
A management device that performs management of an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor, the management device comprising: a connecting unit that connects to the electronic sphygmomanometer; a test unit that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer with the connecting unit; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and a first output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit. 2. The management device according to claim 1, wherein the test unit comprises: a first test unit that performs an operation that tests for air leakage inside the electronic sphygmomanometer; and a second test unit that performs an operation that tests for accuracy of the output value of the sensor while being connected to the electronic sphygmomanometer with the connecting unit, and wherein the calibration unit calibrates the output value of the sensor in the electronic sphygmomanometer according to the test result of the second test unit. 3. The management device according to claim 2, wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the first test unit comprises an air leakage determination unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and determines presence or absence of air leakage inside the electronic sphygmomanometer based on a temporal change of the predetermined pressure, and wherein the first output unit notifies on a screen when determined that air leakage is present inside the electronic sphygmomanometer by the air leakage determination unit. 4. The management device according to claim 2, wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the second test unit comprises: a measurement control unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and outputs a control signal that measures an inner pressure of the closed space with the sensor with respect to the electronic sphygmomanometer; an acquiring unit that acquires the inner pressure measured with the sensor from the electronic sphygmomanometer; and a pressure determination unit that determines whether or not a difference between the predetermined pressure and the inner pressure is within a tolerable range, and wherein the calibration unit comprises a calibration control unit that outputs a control signal that changes a relationship between the sensor signal from the sensor and the output value of the sensor with respect to the electronic sphygmomanometer when determined that the difference is outside the tolerable range by the pressure determination unit. 5. The management device according to claim 4, wherein when determined that the difference is outside the range even after the calibration is carried out a predetermined number of times by the calibration unit, the first output unit displays on a screen that the sensor has a defect. 6. The management device according to claim 1, wherein the electronic sphygmomanometer comprises a mode that carries out a measurement and a mode that carries out a test for operation modes, and wherein a second output unit that outputs a control signal that shifts the operation mode to the mode that carries out the test with respect to the electronic sphygmomanometer when detected as being connected to the electronic sphygmomanometer with the connecting unit is further arranged. 7. The management device according to claim 1, further comprising a first storage unit that stores information related to when the calibration is carried out by the calibration unit. 8. The management device according to claim 1, further comprising: a communication unit that communicates with another device, wherein the first output unit transmits the test result of the test unit or presence or absence of calibration in the calibration unit to the other device with the communication unit along with information that specifies the electronic sphygmomanometer. 9. The management device according to claim 1, further comprising a second storage unit that stores the test result of the test unit along with information that specifies the electronic sphygmomanometer. 10. A management system comprising: an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer, wherein the management device comprises: a test unit that carries out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and an output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit, and wherein the electronic sphygmomanometer comprises: a drive unit that operates the electronic sphygmomanometer according to a control signal output in the test unit; a measurement unit that transmits a signal corresponding to the output value of the sensor to the management device with the operation; and a changing unit that changes a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit. 11. The management system according to claim 10, wherein the electronic sphygmomanometer further comprises: a first storage unit that stores the blood pressure value along with information that specifies time of measurement; a second storage unit that stores information indicating that the calibration has been carried out along with information that specifies time of calibration according to a control signal output in the output unit; and a processing unit that performs a process of adding information indicating a measurement result of before the calibration is carried out with respect to the blood pressure value from when a calibration immediately before the calibration is carried out until the time of calibration of the information stored in the first storage unit according to the control signal output in the output unit. 12. A management method of an electronic sphygmomanometer in a management system comprising: an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer, wherein the method comprises the steps of: having the management device detect connecting with the electronic sphygmomanometer, and carry out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; the electronic sphygmomanometer operating according to a control signal output from the management device in a step of carrying out the operation that tests the equipment performance; the electronic sphygmomanometer transmitting a signal corresponding to the output value of the sensor to the management device with the operation; the management device determining the equipment performance of the electronic sphygmomanometer based on at least one of the signal transmitted from the electronic sphygmomanometer and the output value detected in the connected state; the management device calibrating the equipment performance of the electronic sphygmomanometer according to the determination; the electronic sphygmomanometer changing a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output from the management device in the step of calibrating the equipment performance; and the management device outputting the test result or presence or absence of calibration of the output value of the sensor.
A management device that performs management of an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor, the management device comprising: a connecting unit that connects to the electronic sphygmomanometer; a test unit that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer with the connecting unit; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and a first output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit.
The management device according to claim 1, wherein the test unit comprises: a first test unit that performs an operation that tests for air leakage inside the electronic sphygmomanometer; and a second test unit that performs an operation that tests for accuracy of the output value of the sensor while being connected to the electronic sphygmomanometer with the connecting unit, and wherein the calibration unit calibrates the output value of the sensor in the electronic sphygmomanometer according to the test result of the second test unit.
The management device according to claim 2, wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the first test unit comprises an air leakage determination unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and determines presence or absence of air leakage inside the electronic sphygmomanometer based on a temporal change of the predetermined pressure, and wherein the first output unit notifies on a screen when determined that air leakage is present inside the electronic sphygmomanometer by the air leakage determination unit.
The management device according to claim 2, wherein the connecting unit comprises a communication unit that communicates with the electronic sphygmomanometer and a tube connecting unit that connects an air tube to configure a closed space with an interior of the electronic sphygmomanometer, wherein the second test unit comprises: a measurement control unit that applies a predetermined pressure with respect to the closed space while being connected to the interior of the electronic sphygmomanometer with the tube connecting unit, and outputs a control signal that measures an inner pressure of the closed space with the sensor with respect to the electronic sphygmomanometer; an acquiring unit that acquires the inner pressure measured with the sensor from the electronic sphygmomanometer; and a pressure determination unit that determines whether or not a difference between the predetermined pressure and the inner pressure is within a tolerable range, and wherein the calibration unit comprises a calibration control unit that outputs a control signal that changes a relationship between the sensor signal from the sensor and the output value of the sensor with respect to the electronic sphygmomanometer when determined that the difference is outside the tolerable range by the pressure determination unit.
The management device according to claim 4, wherein when determined that the difference is outside the range even after the calibration is carried out a predetermined number of times by the calibration unit, the first output unit displays on a screen that the sensor has a defect.
The management device according to claim 1, wherein the electronic sphygmomanometer comprises a mode that carries out a measurement and a mode that carries out a test for operation modes, and wherein a second output unit that outputs a control signal that shifts the operation mode to the mode that carries out the test with respect to the electronic sphygmomanometer when detected as being connected to the electronic sphygmomanometer with the connecting unit is further arranged.
The management device according to claim 1, further comprising a first storage unit that stores information related to when the calibration is carried out by the calibration unit.
The management device according to claim 1, further comprising: a communication unit that communicates with another device, wherein the first output unit transmits the test result of the test unit or presence or absence of calibration in the calibration unit to the other device with the communication unit along with information that specifies the electronic sphygmomanometer.
The management device according to claim 1, further comprising a second storage unit that stores the test result of the test unit along with information that specifies the electronic sphygmomanometer.
A management system comprising: an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer, wherein the management device comprises: a test unit that carries out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; a calibration unit that calibrates the equipment performance of the electronic sphygmomanometer according to a test result of the test unit; and an output unit that outputs the test result of the test unit or presence or absence of calibration in the calibration unit, and wherein the electronic sphygmomanometer comprises: a drive unit that operates the electronic sphygmomanometer according to a control signal output in the test unit; a measurement unit that transmits a signal corresponding to the output value of the sensor to the management device with the operation; and a changing unit that changes a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output in the calibration unit.
The management system according to claim 10, wherein the electronic sphygmomanometer further comprises: a first storage unit that stores the blood pressure value along with information that specifies time of measurement; a second storage unit that stores information indicating that the calibration has been carried out along with information that specifies time of calibration according to a control signal output in the output unit; and a processing unit that performs a process of adding information indicating a measurement result of before the calibration is carried out with respect to the blood pressure value from when a calibration immediately before the calibration is carried out until the time of calibration of the information stored in the first storage unit according to the control signal output in the output unit.
A management method of an electronic sphygmomanometer in a management system comprising: an electronic sphygmomanometer that detects an inner pressure change of an air bladder with a sensor and calculates a blood pressure value based on an output value of the sensor; and a management device, connected to the electronic sphygmomanometer, that manages the electronic sphygmomanometer, wherein the method comprises the steps of: having the management device detect connecting with the electronic sphygmomanometer, and carry out an operation that tests an equipment performance of the electronic sphygmomanometer while being connected to the electronic sphygmomanometer; the electronic sphygmomanometer operating according to a control signal output from the management device in a step of carrying out the operation that tests the equipment performance; the electronic sphygmomanometer transmitting a signal corresponding to the output value of the sensor to the management device with the operation; the management device determining the equipment performance of the electronic sphygmomanometer based on at least one of the signal transmitted from the electronic sphygmomanometer and the output value detected in the connected state; the management device calibrating the equipment performance of the electronic sphygmomanometer according to the determination; the electronic sphygmomanometer changing a relationship between the sensor signal from the sensor and the output value of the sensor according to a control signal output from the management device in the step of calibrating the equipment performance; and the management device outputting the test result or presence or absence of calibration of the output value of the sensor.