DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 12/04/2025 has been entered. Claims 1-8 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the blood pressure measurement automatically starts according to a schedule determined in advance” and additionally, “the schedule includes a first type of schedule… and a second type of schedule”. It is unclear how the blood pressure measurement may start according to a first and second schedule simultaneously.
Claims 2-8 are rejected due to dependency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 20080214941 A1) in view of Soni et al. (US 20190371467 A1), hereinafter Soni.
Regarding claim 1, Lin discloses a sphygmomanometer configured to perform blood pressure measurement by an oscillometric method (abstract: " blood pressure self-monitoring device", [0029]: “the blood pressure is determined in the oscillometric method”) by temporarily compressing a measurement site of a subject with a blood pressure measurement cuff ([0029]: “A cuff 16 is attached to the housing by means of a tube 17. The cuff is adapted to be placed around an upper arm of the user. The blood pressure measuring unit works in a manner known in the art, in particular by inflating the cuff and slowly decreasing the pressure in the cuff while measuring the pressure within cuff. "), the sphygmomanometer having a normal blood pressure measurement mode in which the blood pressure measurement is performed according to a blood pressure measurement instruction ([0014]: "In the regular mode, the device is operating in a manner comparable to a current state of the art blood pressure monitoring devices") and a nocturnal blood pressure measurement mode in which the blood pressure measurement automatically starts according to a schedule determined in advance ([0006]: "or to automatically switch the device on according to a predetermined measurement schedule”, [0019]: “When certain criteria of the measurement schedule are fulfilled, an alarm signal is generated or the device is automatically turned on. "), the sphygmomanometer comprising: a first operation switch for inputting the blood pressure measurement instruction in the normal blood pressure measurement mode ([0032]: " A start button 23 is used to start the measurement of the blood pressure values."), a second operation switch for inputting, in the nocturnal blood pressure measurement mode, a mode instruction to suspend the nocturnal blood pressure measurement mode and to recover to the nocturnal blood pressure measurement mode ([0032]: "An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device off would suspend the measurement and switching it on would recover the measurements), the second operation switch being arranged separately from the first operation switch ([0032], button 23 and button 22); and a processor ([0030]: "a calculating unit 13 which controls operation of the device"), wherein the schedule includes a first type of schedule to start the blood pressure measurement at predetermined clock times during a nighttime ([0006]: “predetermined measurement schedule”, [0012]: “The measurement schedule may generate an alarm daily, in particular in the morning and in the evening”), and a second type of schedule to start the blood pressure measurement at predetermined intervals during the nighttime from a designated clock time when the mode instruction is input using the second operation switch ([0020]: ” Operation of the device during times outside a time window around the alarm time may be blocked in the diagnostic mode” [0040]: “It is waited until the on/off key 22 shown in FIG. 3 is pressed or until the time is 7 am or 7 pm.... it is made sure that the user cannot make measurements at inappropriate time intervals, e.g. at times lying outside the 6 to 9 am/pm range. When the user presses the start button 23 (FIG. 3), the measurement procedure will start.”), the processor is configured to act as: a blood pressure measurement unit to automatically start blood pressure measurement during the night time according to the schedule and measure blood pressure when the blood pressure measurement cuff is in a pressurization process or a depressurization process, in the nocturnal blood pressure measurement mode ([0006]: "to automatically switch the device on according to a predetermined measurement schedule.", wherein the measurement schedule may be at nighttime), a suspension processing unit to perform, when the second operation switch is operated at a first time during standby waiting for a clock time set in the schedule in the nocturnal blood pressure measurement mode, a process for transitioning to a measurement suspension state in which blood pressure measurement does not start even when the clock time set in the schedule arrives, with keeping the schedule ([0032]: "An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device off would suspend the measurement regardless of if a prescheduled time arrives).
While Lin discloses and a recovery processing unit to perform, in the measurement suspension state, a process for recovering to the nocturnal blood pressure measurement mode ([0032]: " An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device on would resume the measurement schedule and wherein a second predetermined time may be immediate), and to allow, in the nocturnal blood pressure measurement mode, the blood pressure measurement to automatically start when a remaining clock time set in the schedule arrives ([0048]: "If the measurement day is not equal to 7, the device is set back into the waiting status. If the measurement day is equal to 7, blood pressure measurements in the morning and in the evening of seven days have been successfully made.", wherein the device is on standby until the schedule is complete and will continue to make measurements.), they fail to disclose recovering to the nocturnal blood pressure mode when a first predetermined time has elapsed a lapse of a predetermined time from a clock time when the second operation switch is operated at the first time, or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time. Lin further fails to disclose a power switch for turning the sphygmomanometer on and a second operation switch being arranged separately from the power switch.
Soni discloses a blood pressure measurement device ([0039]: ““biomarker” can mean a physiological variable measured to provide data relevant to a patient such as for example… a blood pressure measurement”) configured to automatically measure blood pressure ([0146]: “the processor 102 of the collection device 24 uses the one or more criteria to automatically start, evaluate, and end the structured collection procedure”) including a power switch for turning the sphygmomanometer on and a second operation switch being arranged separately from a power switch ([0081]: “each structured collection procedure 70… can be then be selectively executed by… user interface 146,” And [0072]: “the collection device 24 can be switched off by holding down one of the buttons 147, 149 for a pre-defined period of time”), and a recovery processing unit to perform, in the measurement suspension state ([0096]: “and can include a snooze functionality should the patient 12 need additional time to conduct the measurement”), a process for recovering to the nocturnal blood pressure measurement mode, when a first predetermined time has elapsed from a clock time when the second operation switch is operated at the first time ([0159]: " biomarker measurements to be ‘snoozed’ as mentioned above for a period, such as for example, 15 minutes and up to a number of times, for non-critical measurements”, [0194]: “can use the user interface 146 to enable a delay or to skip the data collection.”), or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sphygmomanometer disclosed by Lin with the process for recovering to the nocturnal blood pressure measurement mode when a first predetermined time has elapsed from a clock time when the second operation switch is operated at the first time, or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time as disclosed by Soni in order to provide the subject with additional time to conduct a measurement should they need it (Soni [0096]) and modify the second operation switch disclosed by Lin to being arranged separately from the power switch as disclosed by Soni in order to improve subject control of the device.
Regarding claim 2, Lin discloses when the second operation switch is operated again before the first predetermined time elapses from the clock time when the second operation switch is operated at the first time, immediately perform the process for recovering to the nocturnal blood pressure measurement mode ([0012]: “may be designed in such a way that measurements can only be made in a certain time window, e.g. 3 hours around the alarm time.”, [0020]: “Operation of the device during times outside a time window around the alarm time may be blocked in the diagnostic mode”, wherein if the device is switched back on between measurement windows, the measurement will only resume after said predetermined window arrives again).
Regarding claim 3, Soni discloses the first predetermined time and the second predetermined time are each five minutes, respectively ([0160]: “for bedtime measurements, up to 15 minutes in anticipation is acceptable”).
Regarding claim 4, Lin discloses an indicator lamp indicating whether the sphygmomanometer is in the nocturnal blood pressure measurement mode or in the measurement suspension state (Fig 3 element 14).
Regarding claim 5, Lin discloses wherein the measurement site is a wrist (Fig 1 element 16, wherein the cuff may be placed on the arm in any location).
Regarding claim 6, Lin discloses a main body provided integrally with the blood pressure measurement cuff (Fig 1 element 10), wherein the main body is equipped with the first operation switch (Fig 3 element 23), the second operation switch (Fig 3 element 22), and the processor (Fig 2) .
Regarding claim 7, Lin discloses a blood pressure measurement method ([0001]: “a method for operating a blood pressure measuring device.”) for the sphygmomanometer according to claim 1, the blood pressure method comprising: automatically starting blood pressure measurement according to the schedule and measuring blood pressure when the blood pressure measurement cuff is in a pressurization process or a depressurization process, in the nocturnal blood pressure measurement mode ([0006]: "or to automatically switch the device on according to a predetermined measurement schedule… [0019]: 'When certain criteria of the measurement schedule are fulfilled, an alarm signal is generated or the device is automatically turned on.”); performing, when the second operation switch is operated at a first time during standby waiting for a clock time set in the schedule in the nocturnal blood pressure measurement mode, a process for transitioning to a measurement suspension state in which blood pressure measurement does not start even when the clock time set in the schedule arrives, with keeping the schedule ([0032]: "An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device off would suspend the measurement and switching it on would recover the measurements); and performing, in the measurement suspension state, a process for recovering to the nocturnal blood pressure measurement mode, under condition that the second operation switch is operated at a second time ([0032]: " An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device on would resume the measurement schedule) or after a lapse of a predetermined time from a clock time when the second operation switch is operated at the first time, and allowing, in the nocturnal blood pressure measurement mode, the blood pressure measurement to automatically start when a remaining clock time set in the schedule arrives ([0048]: "If the measurement day is not equal to 7, the device is set back into the waiting status. If the measurement day is equal to 7, blood pressure measurements in the morning and in the evening of seven days have been successfully made.", wherein the device is on standby until the schedule is complete and will continue to make measurements.).
Regarding claim 8, Lin discloses A computer-readable recording medium non-transitorily storing a program for causing a computer to execute the blood pressure measurement method according to claim 7 ([0007]: “measurement schedule is stored in a memory within the device. It is possible to have a predefined measurement schedule stored in a read only memory.”, [0008]).
While Lin discloses and a recovery processing unit to perform, in the measurement suspension state, a process for recovering to the nocturnal blood pressure measurement mode ([0032]: " An on/off button 22 is used to turn the device 10 on or off.", wherein switching the device on would resume the measurement schedule and wherein a second predetermined time may be immediate), and to allow, in the nocturnal blood pressure measurement mode, the blood pressure measurement to automatically start when a remaining clock time set in the schedule arrives ([0048]: "If the measurement day is not equal to 7, the device is set back into the waiting status. If the measurement day is equal to 7, blood pressure measurements in the morning and in the evening of seven days have been successfully made.", wherein the device is on standby until the schedule is complete and will continue to make measurements.), they fail to disclose recovering to the nocturnal blood pressure mode when w a first predetermined time has elapsed a lapse of a predetermined time from a clock time when the second operation switch is operated at the first time, or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time. Lin further fails to disclose the second operation switch being arranged separately from the power switch.
Soni discloses a blood pressure measurement device ([0039]: ““biomarker” can mean a physiological variable measured to provide data relevant to a patient such as for example… a blood pressure measurement”) including a process for recovering to the nocturnal blood pressure measurement mode, when a first predetermined time has elapsed from a clock time when the second operation switch is operated at the first time ([0159]: " biomarker measurements to be ‘snoozed’ as mentioned above for a period, such as for example, 15 minutes and up to a number of times, for non-critical measurements”), or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the sphygmomanometer disclosed by Lin with the process for recovering to the nocturnal blood pressure measurement mode when a first predetermined time has elapsed from a clock time when the second operation switch is operated at the first time, or when a second predetermined time has elapsed from a clock time when the second operation switch is operated at a second time after the first time as disclosed by Soni in order to provide the subject with additional time to conduct a measurement should they need it (Soni [0096]).
Response to Arguments
Applicant’s arguments, see pages 6-8 of Remarks, filed 12/04/2-25, with respect to the rejection(s) of claim(s) 1-8 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103.
Conclusion
THIS ACTION IS MADE FINAL. 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 KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791