DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07 May 2026 has been entered.
Status of Claims
Claim(s) 1, 8, 17 and 19 is/are currently amended. Claim(s) 3, 10 and 15 has/have been canceled. New claim(s) 21-23 has/have been added. Claim(s) 1-2, 4-9, 11-14 and 16-23 is/are pending.
Claim Objections
Applicant is advised that should either of claims 12 and 19 be found allowable, the other of said claims will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 1-2, 4-9, 11-14 and 16-23 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 8, claim 21 and claims dependent thereon, the limitation "detecting that an acceleration in a direction opposite to gravity exists prior to a preset time, and determining that no acceleration in the direction opposite to gravity exists prior to the preset time; starting, in response to the determining that the user has changed from a first state to a second state, and after the determining that no acceleration in the direction opposite to gravity exists prior to the preset time" of claim 1 and the comparable limitations of claims 8 and 21 are indefinite. Firstly, it is unclear how the limitations "detecting that an acceleration in a direction opposite to gravity exists prior to a preset time, and determining that no acceleration in the direction opposite to gravity exists prior to the preset time" can both be met as they appear to recite mutually exclusive conditions. Additionally, "prior to a preset time" is further unclear. It is unclear how, if at all the present time relates to the determination that the user has changed from a first state to a second state (or the timing of said determination), specifically, if the limitation is meant to confer some order to the steps.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-2, 4-9, 11-14 and 16-23 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 8, claim 21 and claims dependent thereon, Applicant discloses, "In addition, to ensure normal execution of the device, a time may be preset in a process of detecting an acceleration in the direction opposite to gravity, to avoid long-time detection of the acceleration in the direction opposite to gravity. In an embodiment, the preset time may be a time point. For example, the acceleration in the direction opposite to gravity is detected at a moment when it is detected that the user has changed from a first state to a second state. If no acceleration in the direction opposite to gravity is detected at the moment, blood pressure measurement may be continued. The preset time may alternatively be a time period. For example, the acceleration in the direction opposite to gravity is continuously detected within a time period after it is detected that the user has change from the first state to the second state. If no acceleration in the direction opposite to gravity is detected within the time period, detection of an acceleration in the direction opposite to gravity is no longer performed, and blood pressure measurement is performed" (¶ [0065]). Accordingly, Applicant discloses at a preset time corresponding to the time of the determination that the user changed from the first state to the second state, or for a present interval of time following said determination, the device may detect whether an acceleration in a direction opposite to gravity exists, and if it is determined that an acceleration in a direction opposite to gravity does not exist at or within said preset time, a blood pressure measurement can be made. There is no indication the detecting/determining is performed "prior to a preset time." Additionally, the only "preset time" for detection of the acceleration in a direction opposite to gravity is dependent on (i.e., made relative to) the determination that used change from the first to second state, or the timing of said determination, as discussed in the above-cited paragraph of the specification as filed. However, there is no limit as to what basis the "preset time" of the pending claims is set. Accordingly, the limitation "detecting that an acceleration in a direction opposite to gravity exists prior to a preset time, and determining that no acceleration in the direction opposite to gravity exists prior to the preset time; starting, in response to the determining that the user has changed from a first state to a second state, and after the determining that no acceleration in the direction opposite to gravity exists prior to the preset time" of claim 1 and the comparable limitations of claims 8 and 21 lack sufficient support in the application as filed, and are therefore directed to and/or encompass new matter.
The examiner notes amendments to the claim commensurate in scope with the above-noted disclosure and the originally-filed claims would overcome this rejection, e.g., with respect to claim 1, "[…] detecting a sleep status of a user using at least one of a signal of a motion sensor or a photoplethysmography (PPG) signal until determining that the user has changed from a first state to a second state, wherein the first state is an asleep state and the second state is an awake state; in response to determining that the user has changed from a first state to a second state, detecting if an acceleration in a direction opposite to gravity exists within a preset time of the determination that the user has changed from the first state to the second state; starting, in response to determining that no acceleration in the direction opposite to gravity exists with the preset time and without user input, a blood pressure measurement of the user by starting an inflation process to inflate an airbag to a preset pressure value at a preset rate; […]."
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-7, 21 and 23 is/are rejected under 35 U.S.C. 103 as obvious over US 2018/0279953 A1 (previously cited, Wang) in view of US 2011/0295130 A1 (previously cited, Tokko), US 2021/0085189 A1 (previously cited, Sato) and US 2019/0167118 A1 (previously cited, Vilenskii); or over Wang in view of Tokko, Sato, Vilenskii, and US 2019/0380624 A1 (previously cited, Ota).
Regarding claims 1, 4, 6, 21 and 23, Wang discloses/suggests a non-transitory computer-readable storage medium having instructions stored therein, which when executed by a processor, cause the processor to perform a blood pressure measurement method (e.g., ¶ [0007]), the blood pressure measurement method comprising:
detecting whether prerequisite conditions for performing a blood pressure measurement have been satisfied (¶ [0024]) using at least one of a signal of a motion sensor or a photoplethysmography (PPG) signal (¶ [0029]); and, in response to the detecting, automatically (i.e., without user input) starting measuring a blood pressure of the user and starting an inflation process to inflate an airbag to a preset pressure value (¶ [0024]; ¶ [0029]; ¶ [0041]; ¶ [0050]).
Wang neither expressly discloses the airbag is inflated at a preset rate, nor discloses the method further comprises obtaining a first duration of the inflation process; determining a correction value based on a mapping relationship between the first duration and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user; and after the measuring ends, obtaining a measurement value of the blood pressure of the user, and correcting the measurement value based on the correction value, to obtain a final blood pressure value of the user.
Tokko discloses/suggests a blood pressure measurement method, the method comprising:
starting measuring a blood pressure of the user and starting an inflation process to inflate an airbag to a preset pressure at a preset rate (ST4-ST5, e.g., ¶ [0202] when measurement switch 41C is operated by the person to be measured, pump drive circuit 36 controls rotation of pump 33 to start supplying fluid to air bladder 21 so that cuff pressure rises until a predetermined pressure is reached; ¶ [0113] pump 33 is driven with a constant discharging flow rate per unit time to pressurize the cuff pressure; ¶¶ [0129]-[0136] pump 33 is driven with a constant discharge flow rate to a pressure P2 and/or a pressure P3; etc.);
obtaining a first duration of the inflation process (¶ [0203] in the pressurization process from the start to the end of the pressurization, the wrapping strength of the cuff 20 is detected by the wrapping strength detecting portion 134 while it is determined that the cuff pressure does not indicate the predetermined pressure; ¶ [0112] an elapse of time from pressure P1 to pressure P2 and/or an elapse of time from pressure P2 to pressure P3; ¶ [0137] V2-V1 and/or V3-V2; ¶ [0214] detecting fluid amount ΔQ corresponding to the change in cuff pressure of ΔPc, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.)) by recording a first start moment of inflation to the airbag, and detecting a pressure value of the airbag during the inflation (¶ [0129] starting pressure that is the cuff pressure detected at the start of pressurization is stored as pressure P1 and the pressurization start time is stored as time V1 and/or ¶¶ [0132]-[0133] detecting and storing pressure P2 and the time thereof as time V2, wherein V2 is the time the pressurization starts at a substantially constant pressurization speed based only on the volume of the fluid of the cuff 20; ¶ [0216] detecting the period in which the cuff pressure changes from Pc1 to Pc2; etc.); recording a first end moment when the pressure value reaches the preset pressure value (¶ [0132] detecting and storing pressure P2 and the time thereof as time V2 and/or ¶ [0134]-[0135] detecting and storing pressure P3 and the time thereof as time V3; ¶ [0216] detecting the period in which the cuff pressure changes from Pc1 to Pc2; etc.); and determining the first duration based on a difference between the first end moment and the first start moment (¶ [0137] V2-V1 and/or V3-V2; ¶ [0216] period in which the cuff pressure changes from Pc1 to Pc2; etc.);
determining a correction value based on the first duration or based on a first slope determined based on the preset pressure value and the first duration and a mapping relationship between the first function/slope and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user (e.g., ¶ [0138] ΔP12/ΔV12 and/or ΔP23/ΔV23; ¶ [0110], ¶¶ [0138]-[0141], etc., wrapping strength is assessed based on the above-noted duration(s) or a comparison of slopes derived therefrom; ¶¶ [0157]-[0159]; ¶¶ [0250]-[0259] correction amount determined based on wrapping strength);
after the measuring ends, obtaining a measurement value of the blood pressure of the user (¶ [0205] blood pressure is calculated in the depressurization process; ¶¶ [0250]-[0259] temporary maximum and minimum blood pressures), and correcting the measurement value based on the correction value, to obtain a final blood pressure value of the user (¶¶ [0250]-[0259] correcting the temporary blood pressure values based on the correction amount (ratio or offset) determined according to the wrapping strength).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang to comprise inflating the airbag to the preset pressure value at a preset rate; obtaining a first duration of the inflation process by recording a first start moment of inflation to the airbag, detecting a pressure value of the airbag during the inflation, recording a first end moment when the pressure value reaches the preset pressure value, and determining the first duration based on a difference between the first end moment and the first start moment; determining a correction value based on a mapping relationship between the first duration and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user; and after the measuring ends, obtaining a measurement value of the blood pressure of the user, and correcting the measurement value based on the correction value by determining a first slope based on the preset pressure value and the first duration, and determining the correction value based on the first slope to obtain a final blood pressure value of the user as taught/suggested by Tokko in order to maintain blood pressure measurement accuracy regardless of the wrapping strength of the blood pressure cuff at the measurement site (Tokko, ¶ [0157]).
Wang as modified does not disclose detecting whether prerequisite conditions for performing a blood pressure measurement have been satisfied includes detecting a change of a user from a first, asleep state to a second, awake state using at the motion sensor signal and/or PPG signal. However, Wang does disclose measuring blood pressure in the morning is recommended by some medical professionals (e.g., ¶ [0086]) and discloses monitoring for prerequisites within a short time frame in response to a triggering event may conserve power and/or memory (e.g., ¶ [0081]).
Sato discloses a measurement value obtained from a measurement performed after waking up is useful for accurately determining the physical condition and the like of the subject (¶ [0005]), and it is preferable to perform a blood pressure measurement within one hour after waking up (¶ [0058]), disclosing/suggesting a method comprising detecting a change of user from a first, asleep state to a second, awake state using a signal of a motion sensor (¶ [0175], ¶ [0182] acquisition unit 21 can acquire a sleep state from the control unit 11 and obtain the sleep information, such as a wake-up time (i.e., change from a sleep state to an non-sleep, or awake, state), based on the sleep state using an acceleration sensor 17 or other additional sensors). Accordingly, Sato discloses and/or suggests a time within an hour of detecting a change from a first/asleep state to a second/awake state of a user, which may be detected based on a motion sensor signal as noted above, is a desirable prerequisite condition for acquiring a, e.g., morning, blood pressure measurement.
Vilenskii discloses detecting a sleep status of a user using a signal of a motion sensor, determining that the user has changed from a first, asleep state to a second, awake state; and starting measuring a blood pressure of the user in response to the change from the first state to the second state (¶ [0141] device 1000 may include a sensor for detecting a user's motion, determine using the sensor whether the user wakes up, and start a blood pressure measurement after an elapse of the time set by the user from the determined wake-up time of the user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang with detecting whether prerequisite conditions for performing a blood pressure measurement have been satisfied including detecting a change of the user from a first/asleep state to a second/awake state using a motion sensor signal, such that a blood pressure measurement is automatically started in response thereto, as taught and/or suggested by Sato and Vilenskii in order to enable monitoring of the user without unduly inhibiting his/her quality of life, to opportunistically identify good times for performing useful blood pressure measurements, such as within a preset time of waking (Wang, ¶ [0028]; Sato, ¶ [0005], ¶ [0058]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang with detecting the sleep status of the user only until it is determined that the user has changed from a first state to a second state in order to in order to conserve power and/or memory of the battery-powered device implementing the method (e.g., ¶ [0081]).
Wang as modified further discloses/suggests blood pressure measurements are ideally started/made when the user is stationary and/or not moving his/her arms (e.g., ¶ [0114]), wherein motion of the user, and/or an arm(s) thereof, is determined based on detecting acceleration (e.g., ¶ [0043]; Fig. 1B). Alternatively/Additionally, one of ordinary skill in the art would readily appreciate the particular state change claimed typically occurs while a user is in a lying down posture (supine, prone, etc.), e.g., in bed, and Wang discloses the wearable device having the motion sensor may be worn on the wrist (e.g., ¶ [0039]). Ota discloses/suggests a wearable device comprising a motion sensor configured to detect an acceleration in a direction opposite to gravity (¶ [0037] 3-axis acceleration sensor) and a processor configured to determine that no acceleration in the direction opposite to gravity exists (Fig. 8, S61, posture determination to determine whether posture is correct; ¶ [0039] correct posture means that a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small); and start measuring the blood pressure of the user when it is determined that no acceleration in the direction opposite to gravity exists (Fig. 8, S4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang to comprise detecting whether an acceleration in a direction opposite to gravity exists within a preset time, and starting the blood pressure measurement after determining that no acceleration in the direction opposite to gravity exists prior to the preset time as taught/suggested by Wang (e.g., user is stationary and not moving his/her arms) and/or Ota (e.g., user is in a correct posture wherein a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small, i.e., not raised or lowered with respect to his/her heart) in order to further facilitate limiting starting a blood pressure measurement to instance(s) when the user is in an ideal or correct posture for accurate measurements at the desired time (e.g., a preset time after waking) (Wang, ¶ [0023], ¶ [0114]; Ota, ¶ [0004], ¶ [0081], etc.).
Regarding claim 5, Wang as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose comparing the first duration with each of a first duration threshold and a second duration threshold; sending a first signal when the first duration is less than or equal to the first duration threshold; and sending a second signal when the first duration is greater than the second duration threshold.
Tokko discloses comparing the first duration with each of a first duration threshold and a second duration threshold (e.g., Fig. 23, comparing ΔQ, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.), to thresholds α and β); sending a first signal when the first duration is less than or equal to the first duration threshold (Fig. 23, ST110, detecting a "tight" wrapping when ΔQ ≤ α; ¶ [0123] detected wrapping strength, tight, is displayed on the displayed on the display unit 40 through the display control unit 160); and sending a second signal when the first duration is greater than the second duration threshold (Fig. 23, ST109, detecting a "loose" wrapping when ΔQ > β; ¶ [0123] detected wrapping strength, loose, is displayed on the displayed on the display unit 40 through the display control unit 160).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang with comparing the first duration with each of a first duration threshold and a second duration threshold; sending a first signal when the first duration is less than or equal to the first duration threshold; and sending a second signal when the first duration is greater than the second duration threshold as taught/suggested by Tokko in order to guide/urge the user to wrap the cuff at an appropriate strength, reduce insecurity of the user on the wrapping strength, etc. (Tokko, ¶ [0159]).
Regarding claim 7, Wang as modified discloses/suggests the limitations of claim 6, as discussed above. Tokko further discloses the first slope (e.g., ΔP12/ΔV12) is compared with at least one slope threshold (e.g., ΔP23/ΔV23). While Tokko does not expressly disclose the above-noted first slope is compared to each of a first slope threshold and a second slope threshold, Tokko discloses alternative embodiments for assessing wrapping strength, including detecting a duration (period) in which the cuff pressure changes from Pc1 to Pc2 (ΔPc) (¶ [0216] detecting fluid amount ΔQ corresponding to the change in cuff pressure of ΔPc, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.)), comparing said duration to each of a first duration threshold and a second duration threshold; and sending signals based on said comparison (see discussion of claim 5 above). Furthermore, one of ordinary skill in the art would readily appreciate, given ΔPc is based on predefined pressure values Pc1 and Pc2, a shorter measured duration (ΔQ) would correspond to a larger slope (ΔPc/ΔQ), a longer duration to a smaller slope, etc.
In view of the above, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Wang with determining a first slope based on the preset pressure value (ΔPc) and the first duration (ΔQ, or corresponding time period/duration thereof); comparing the first slope with each of a first slope threshold and a second slope threshold; sending a first signal when the first slope is greater than or equal to the first slope threshold; and sending a second signal when the first slope is less than the second slope threshold (i.e., comparing ΔPc/ΔQ to corresponding thresholds α and β, rather than ΔQ to determine the wrapping state) because Applicant has not disclosed that sending the first and second signals based on a determined slope, rather the determined duration, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses the first and second signals may be sent based on duration (see, e.g., claim 5, ¶¶ [0014]-[0015]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the wrapping state determination and output disclosed/suggested by Wang as modified because either arrangement enables presenting wrapping strength state to a user to urge rewrapping if needed (Tokko, ¶ [0159]).
Claim(s) 2 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Tokko, Sato and Vilenskii (or Wang in view of Tokko, Sato, Vilenskii, and Ota) as applied to claim(s) 1 and 21 above, and further in view of US 2017/0209053 A1 (previously cited, Pantelopoulos).
Regarding claims 2 and 22, Wang as modified discloses/suggests the limitations of claims 1 and 21, as discussed above, but does not disclose, the method comprises obtaining a current pulse wave signal amplitude of the user prior to starting measuring the blood pressure of the user and starting the inflation process; comparing the current pulse wave signal amplitude of the user with a target pulse wave signal amplitude; and determining that the current pulse wave signal amplitude of the user is not less than the target pulse wave signal amplitude. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Wang with the above-noted steps because Applicant has not disclosed that determining that the current pulse wave signal amplitude of the user is not less than the target pulse wave signal amplitude commensurate in scope with the present claims provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant discloses, "In an embodiment, a basic requirement for wrist blood pressure measurement is that peripheral arteries (including brachial artery, radial artery, and ulnar artery) of a measured arm should not be compressed and keep a blood flow unobstructed. However, when the user is in a lying position, the arm tends to be squeezed by the body (for example, lateral lying), causing compression on the upper arm artery and obstruction of blood flow, and affecting blood pressure measurement. In this case, the pulse wave signal amplitude may be detected by using the PPG signal of the signal receiver 170 to determine whether the upper arm blood pressure is compressed. The signal receiver 170 may usually be integrated on a side of the wearable device close to the skin of the user to transmit and receive light intensity signals (a light source may be in a plurality of forms, such as red light, green light, and infrared light), to obtain a pulse wave signal of the wrist. Therefore, after the signal receiver 170 detects the pulse wave signal, the processor 110 may calculate an amplitude of the pulse wave signal, and then compare the current pulse wave signal amplitude of the user with a target pulse wave signal amplitude, or compare the current pulse wave signal amplitude of the user with a pulse wave signal amplitude threshold which is preset and prestored in the memory 120. The pulse wave vibration amplitude usually reflects an intensity of heart beating. Typically, in a case that peripheral arteries of the upper arm (including brachial artery, radial artery, ulnar artery, and the like) are not compressed, a pulse wave vibration amplitude of a human body does not change greatly, but once the arteries are compressed, blood flow is obstructed, and the pulse wave vibration amplitude decreases. Therefore, if it is found that the pulse wave signal amplitude is less than the target pulse wave signal amplitude, it indicates that the pulse wave signal amplitude decreases, and it may be determined that the measured arm is compressed. At this time, it is not suitable to perform blood pressure measurement. If the pulse wave signal amplitude is not less than the target pulse wave signal amplitude, it may be considered that a current posture of the user is normal, and blood pressure measurement may be performed" (¶ [0064]). The above noted disclosure is specific to, inter alia, the PPG sensor being co-located with a wearable blood pressure measuring device, only performing the blood pressure measurement in response the amplitude meeting the condition, etc. None of these specifics are required by the claim. The claim encompasses obtaining a current pulse wave signal amplitude from any location on the body, including locations other than the site from which blood pressure is taken; there is no indication that the pulse wave signal amplitude is a condition for starting the measurement; etc. At best, all that is required by the method is that the current pulse wave signal amplitude is compared to the target pulse wave signal amplitude at some time period to a blood pressure measurement. Accordingly, as no and/or insufficient evidence has been provided to the contrary, and because the determination is not used by the method for any purpose, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the method disclosed and/or suggested by Wang as modified.
Alternatively/Additionally, Wang discloses the prerequisite condition(s) obtained by wearable sensors may include the user not moving his/her arms (¶ [0023], ¶ [0114]), having his/her arm supported during measurement (¶ [0030]), etc., thereby identifying good times for performing blood pressure measurements, providing higher quality data (¶ [0028]).
Pantelopoulos discloses/suggests a signal receiver of a wearable device is configured to obtain a current pulse wave signal amplitude of the user (throughout document, PPG amplitude). Pantelopoulos discloses/suggests a low, or a decrease in, PPG amplitude by more than a threshold value may be due to motion and/or position of the wearable device (¶ [0130], ¶ [0270], etc.).
Since Pantelopoulos indicates/suggests lower PPG amplitude may be due to motion (e.g., ¶ [0130]), and higher PPG amplitude is associated with higher quality (e.g., ¶ [0270]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang with obtaining a current pulse wave signal amplitude of the user prior to starting measuring the blood pressure of the user by starting the inflation process; comparing the current pulse wave signal amplitude of the user with a target pulse wave signal amplitude (e.g., threshold); and determining that the current pulse wave signal amplitude of the user is not less than the target pulse wave signal amplitude (e.g., not indicative of motion, is of sufficient quality, etc.) as taught and/or suggested by Wang and Pantelopoulos in order to facilitate limiting starting a blood pressure measurement to instance(s) when the user meets the prerequisites for such a measurement (e.g., still/not moving, device is properly positioned, etc.).
Claim(s) 8-9, 11-14 and 16-20 is/are rejected under 35 U.S.C. 103 as obvious over Wang in view of Tokko, Sato, Vilenskii and Pantelopoulos; or over Wang in view of Tokko, Sato, Vilenskii, Pantelopoulos and Ota.
Regarding claims 8, 11, 13 and 17, Wang discloses and/or suggests a wearable device, comprising:
a processor (processing apparatus 166);
a signal receiver, wherein the signal receiver is configured to: detect a PPG signal and send the PPG signal to the processor (heart rate sensor(s); ¶ [0029]; Fig. 1B; etc.);
an air pump control circuit (blood pressure controller 174; ¶ [0041]);
an air pump (¶ [0041] means for applying pneumatic pressure in the bladder of cuff 172);
an airbag (¶ [0041], ¶ [0046], etc., inflatable bladder);
a motion sensor (motion sensor(s); Fig. 1B; etc.); and
a pressure sensor (¶ [0046] pressure sensor),
wherein the pressure sensor is configured to detect a pressure value of the airbag in an inflation process of inflating the airbag by the air pump, and send the pressure value to the processor (¶ [0039]; ¶ [0041]; etc.); and
wherein the processor is configured to detect, based on at least the PPG signal, whether prerequisite conditions for performing a blood pressure measurement have been satisfied (¶ [0024]; ¶ [0029]; etc.); and, in response to detecting the prerequisite conditions have been satisfied, automatically (i.e., without user input) indicate the air pump control circuit to start the inflation process to drive the air pump to inflate the airbag to a preset pressure value, starting a blood pressure measurement of the user (¶ [0024]; ¶ [0029]; ¶ [0041]; ¶ [0050]).
Wang neither expressly discloses the airbag is inflated at a preset rate, nor discloses the processor is configured to obtain a first duration of the inflation process, determine a correction value based a mapping relationship between the first duration and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user, and after the measuring ends, obtain a measurement value of the blood pressure of the user, and correct the measurement value based on the correction value, to obtain a final blood pressure value of the user.
Tokko discloses a wearable (e.g., Figs. 1, 3-4, etc.) device comprising:
an output means (display unit 40);
a processor (CPU 100);
an air pump control circuit (pump drive circuit 36);
an air pump (pump 33);
and airbag (air bladder 21); and
a pressure sensor (pressure sensor 25 or 32), wherein the pressure sensor is configured to: detect a pressure value of the airbag in an inflation process of inflating the airbag by the air pump, and send the pressure value to the processor (e.g., ¶ [0202] the cuff pressure is detected by pressure detection unit 101 based on the output signal of the pressure sensor);
wherein the processor is configured to:
indicate the air pump control circuit to start the inflation process of measuring a blood pressure to drive the air pump to inflate the airbag to the preset pressure value at a preset rate (¶ [0202] when measurement switch 41C is operated by the person to be measured, pump drive circuit 36 controls rotation of pump 33 to start supplying fluid to air bladder 21 so that cuff pressure rises until a predetermined pressure is reached; ¶ [0113] pump 33 is driven with a constant discharging flow rate per unit time to pressurize the cuff pressure; ¶¶ [0129]-[0136] pump 33 is driven with a constant discharge flow rate to a pressure P2 and/or a pressure P3; etc.),
obtain a first duration of the inflation process (¶ [0203] in the pressurization process from the start to the end of the pressurization, the wrapping strength of the cuff 20 is detected by the wrapping strength detecting portion 134 while it is determined that the cuff pressure does not indicate the predetermined pressure; ¶ [0112] an elapse of time from pressure P1 to pressure P2 and/or an elapse of time from pressure P2 to pressure P3; ¶ [0137] V2-V1 and/or V3-V2; ¶ [0214] detecting fluid amount ΔQ corresponding to the change in cuff pressure of ΔPc, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.)) by recording a first start moment of inflation to the airbag, and detecting a pressure value of the airbag during the inflation (¶ [0129] starting pressure that is the cuff pressure detected at the start of pressurization is stored as pressure P1 and the pressurization start time is stored as time V1 and/or ¶¶ [0132]-[0133] detecting and storing pressure P2 and the time thereof as time V2, wherein V2 is the time the pressurization starts at a substantially constant pressurization speed based only on the volume of the fluid of the cuff 20; ¶ [0216] detecting the period in which the cuff pressure changes from Pc1 to Pc2; etc.); recording a first end moment when the pressure value reaches the preset pressure value (¶ [0132] detecting and storing pressure P2 and the time thereof as time V2 and/or ¶ [0134]-[0135] detecting and storing pressure P3 and the time thereof as time V3; ¶ [0216] detecting the period in which the cuff pressure changes from Pc1 to Pc2; etc.); and determining the first duration based on a difference between the first end moment and the first start moment (¶ [0137] V2-V1 and/or V3-V2; ¶ [0216] period in which the cuff pressure changes from Pc1 to Pc2; etc.);
determine a correction value based on the first duration or based on a first slope determined based on the preset pressure value and the first duration and a mapping relationship between the first duration and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user (e.g., ¶ [0138] ΔP12/ΔV12 and/or ΔP23/ΔV23; ¶ [0110], ¶¶ [0138]-[0141], etc., wrapping strength is assessed based on the above-noted duration(s) or a comparison of slopes derived therefrom; ¶¶ [0157]-[0159]; ¶¶ [0250]-[0259] correction amount determined based on wrapping strength);
compare the first duration with each of a first duration threshold and a second duration threshold (e.g., Fig. 23, comparing ΔQ, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.), to thresholds α and β)
when the first duration is less than or equal to the first duration threshold, indicate the output means to send a first signal (Fig. 23, ST110, detecting a "tight" wrapping when ΔQ ≤ α; ¶ [0123] detected wrapping strength, tight, is displayed on the displayed on the display unit 40 through the display control unit 160);
when the first duration is greater than the second duration threshold, indicate the output means to send a second signal (Fig. 23, ST109, detecting a "loose" wrapping when ΔQ > β; ¶ [0123] detected wrapping strength, loose, is displayed on the displayed on the display unit 40 through the display control unit 160); and
after the measuring ends, obtain a measurement value of the blood pressure of the user, and correct the measurement value based on the correction value, to obtain a final blood pressure value of the user (¶ [0205] blood pressure is calculated in the depressurization process; ¶¶ [0250]-[0259] temporary maximum and minimum blood pressures), and correcting the measurement value based on the correction value, to obtain a final blood pressure value of the user (¶¶ [0250]-[0259] correcting the temporary blood pressure values based on the correction amount (ratio or offset) determined according to the wrapping strength).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang with inflating the airbag to the preset pressure value at a preset rate, wherein the processor is configured for obtaining a first duration of the inflation process by recording a first start moment of inflation to the airbag, detecting a pressure value of the airbag during the inflation, recording a first end moment when the pressure value reaches the preset pressure value, and determining the first duration based on a difference between the first end moment and the first start moment; determining a correction value based on a mapping relationship between the first duration and a blood pressure offset, wherein the blood pressure offset corresponds to a deviation caused by a wearing tightness of a wearable device on the user; and after the measuring ends, obtaining a measurement value of the blood pressure of the user, and correcting the measurement value based on the correction value by determining a first slope based on the preset pressure value and the first duration, and determining the correction value based on the first slope to obtain a final blood pressure value of the user as taught/suggested by Tokko in order to maintain blood pressure measurement accuracy regardless of the wrapping strength of the blood pressure cuff at the measurement site (Tokko, ¶ [0157]).
Wang as modified does not disclose detecting whether prerequisite conditions for performing a blood pressure measurement have been satisfied includes detecting a change of a user from a first, asleep state to a second, awake state. However, Wang does disclose measuring blood pressure in the morning is recommended by some medical professionals (e.g., ¶ [0086]).
Similarly, Sato discloses a measurement value obtained from a measurement performed after waking up is useful for accurately determining the physical condition and the like of the subject (¶ [0005]), and it is preferable to perform a blood pressure measurement within one hour after waking up (¶ [0058]), disclosing/suggesting a method comprising detecting a change of user from a first, asleep state to a second, awake state using a signal of a motion sensor (¶ [0175], ¶ [0182] acquisition unit 21 can acquire a sleep state from the control unit 11 and obtain the sleep information, such as a wake-up time (i.e., change from a sleep state to an non-sleep, or awake, state), based on the sleep state using an acceleration sensor 17 or other additional sensors). Accordingly, Sato discloses and/or suggests a time within an hour of detecting a change from a first/asleep state to a second/awake state of a user, which may be detecting based on a motion sensor signal, is a desirable prerequisite condition for acquiring a, e.g., morning, blood pressure measurement.
Vilenskii discloses detecting a change of a user from a first/asleep state to a second/awake state using a signal of a motion sensor, and starting measuring a blood pressure of the user in response to the detecting (¶ [0141] device 1000 may include a sensor for detecting a user's motion, may determine using the sensor whether the user wakes up, and start a blood pressure measurement after an elapse of the time set by the user from the wake-up time of the user).
Pantelopoulos discloses a wearable device (¶ [0008]; Fig. 8A; etc.) comprising a processor (Fig. 8A) and sensors (Fig. 8A, biometric sensors, environmental sensors, etc.) including a signal receiver configured to detect a PPG signal and send the PPG signal to the processor (throughout document, PPG sensor) and a motion sensor configured to detect motion and/or acceleration (throughout document, accelerometer, inertial sensor, motion sensor, etc.), disclosing determining that a user has changed from a first/asleep state to a second/awake state (i.e., has awoken) based on signals from the PPG signal (e.g., heart rate determined therefrom, ¶ [0061]) and the motion sensor (¶ [0190]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang with detecting whether prerequisite conditions for performing a blood pressure measurement have been satisfied including detecting a change of the user from a first/asleep state to a second/awake state based on the PPG signal, such that a blood pressure measurement is automatically started in response thereto, as taught and/or suggested by Sato, Vilenskii and Pantelopoulos in order to enable monitoring of the user, without unduly inhibiting his/her quality of life, to opportunistically identify good times for performing useful blood pressure measurements, such as within a preset time of waking (Wang, ¶ [0028]; Sato, ¶ [0005], ¶ [0058]).
Wang as modified further discloses/suggests blood pressure measurements are ideally started/made when the user is stationary and/or not moving his/her arms (e.g., ¶ [0114]), wherein motion of the user, and/or an arm(s) thereof, is determined based on detecting acceleration (e.g., ¶ [0043]; Fig. 1B). Alternatively/Additionally, one of ordinary skill in the art would readily appreciate the particular state change claimed typically occurs while a user is in a lying down posture (supine, prone, etc.), e.g., in bed, and Wang discloses the wearable device having the motion sensor may be worn on the wrist (e.g., ¶ [0039]). Ota discloses/suggests a wearable device comprising a motion sensor configured to detect an acceleration in a direction opposite to gravity (¶ [0037] 3-axis acceleration sensor) and a processor configured to determine that no acceleration in the direction opposite to gravity exists (Fig. 8, S61, posture determination to determine whether posture is correct; ¶ [0039] correct posture means that a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small); and start measuring the blood pressure of the user when it is determined that no acceleration in the direction opposite to gravity exists (Fig. 8, S4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang with the motion sensor being configured to detect that an acceleration in a direction opposite to gravity exists prior to a preset time, and send a detection result to the processor, wherein the processor is configured determine that no acceleration in the direction opposite to gravity exists prior to the preset time; and starting the blood pressure measurement after determining that no acceleration in the direction opposite to gravity exists prior to the preset time as taught/suggested by Wang (e.g., user is stationary and not moving his/her arms) and/or Ota (e.g., user is in a correct posture wherein a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small, i.e., not raised or lowered with respect to his/her heart) in order to further facilitate limiting starting a blood pressure measurement to instance(s) when the user is in an ideal or correct posture for accurate measurements at the desired time (e.g., a preset time after waking) (Wang, ¶ [0023], ¶ [0114]; Ota, ¶ [0004], ¶ [0081], etc.).
Regarding claim 9, Wang as modified discloses/suggests the limitations of claim 8, and further discloses/suggests the processor is configured to notify the air pump control circuit to drive the air pump to inflate the airbag to the preset pressure value at the preset rate, as discussed above. Wang as modified does not disclose the signal receiver is further configured to obtain a current pulse wave signal amplitude of the user; and the processor is further configured to compare the current pulse wave signal amplitude of the user with a target pulse wave signal amplitude, and, when the current pulse wave signal amplitude of the user is not less than the target pulse wave signal amplitude, notify the air pump control circuit to drive the air pump to inflate the airbag to the preset pressure value at the preset rate.
However, Wang discloses use of the prerequisites, including the user not moving his/her arms (¶ [0023]) and/or having his/her arm supported during measurement (¶ [0030]) enables identifying good times for performing blood pressure measurements, providing higher quality data (¶ [0028]).
Pantelopoulos discloses/suggests signal receiver of the wearable device is configured to obtain a current pulse wave signal amplitude of the user (throughout document, PPG amplitude). Pantelopoulos discloses/suggests a low, or a decrease in, PPG amplitude by more than a threshold value may be due to motion and/or position of the wearable device (¶ [0130], ¶ [0270], etc.).
Since Pantelopoulos indicates/suggests lower PPG amplitude may be due to motion (e.g., ¶ [0130]), and higher PPG amplitude is associated with higher quality (e.g., ¶ [0270]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tokko with the signal receiver being further configured to obtain a current pulse wave signal amplitude of the user, and the processor being further configured to compare the current pulse wave signal amplitude of the user with a target pulse wave signal amplitude (e.g., threshold), and, when the current pulse wave signal amplitude of the user is not less than the target pulse wave signal amplitude (e.g., not indicative of motion, is of sufficient quality, etc.)., notify the air pump control circuit to drive the air pump to inflate the airbag to the preset pressure value at the preset rate as taught/suggested by Wang and Pantelopoulos in order to facilitate limiting starting a blood pressure measurement to instance(s) when the user meets the prerequisites for such a measurement (e.g., still/not moving, device is properly positioned, etc.).
Regarding claims 12 and 19-20, Wang as modified discloses/suggests the limitations of claims 8 and 11, as discussed above, but does not expressly disclose comparing the first duration with each of a first duration threshold and a second duration threshold; sending a first signal when the first duration is less than or equal to the first duration threshold; and sending a second signal when the first duration is greater than the second duration threshold.
Tokko discloses comparing the first duration with each of a first duration threshold and a second duration threshold (e.g., Fig. 23, comparing ΔQ, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.), to thresholds α and β); sending a first signal when the first duration is less than or equal to the first duration threshold (Fig. 23, ST110, detecting a "tight" wrapping when ΔQ ≤ α; ¶ [0123] detected wrapping strength, tight, is displayed on the displayed on the display unit 40 through the display control unit 160); and sending a second signal when the first duration is greater than the second duration threshold (Fig. 23, ST109, detecting a "loose" wrapping when ΔQ > β; ¶ [0123] detected wrapping strength, loose, is displayed on the displayed on the display unit 40 through the display control unit 160).
Pantelopoulos discloses a wearable device comprising an audio circuit is configured to give a voice broadcast (e.g., ¶ [0302] the biometric monitoring device may convey information to a user through audio feedback, for example, a speaker in the biometric monitoring device may convey information through the use of audio tones, voice, songs, or other sounds) and a vibrator configured to vibrate for prompt (e.g., ¶ [0301] the biometric monitoring device may convey information into a user through the physical motion of the device, for example, via a vibration-inducing motor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang with the processor being configured for comparing the first duration with each of a first duration threshold and a second duration threshold; sending a first signal when the first duration is less than or equal to the first duration threshold; and sending a second signal when the first duration is greater than the second duration threshold as taught/suggested by Tokko in order to guide/urge the user to wrap the cuff at an appropriate strength, reduce insecurity of the user on the wrapping strength, etc. (Tokko, ¶ [0159]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang to comprise an audio circuit configured to give a voice broadcast and a vibrator configured to vibrate for prompt, wherein the processor indicates the audio circuit and/or vibrator to send the first and/or second signal, as taught and/or suggested by Pantelopoulos in order to more reliably convey information (e.g., wrapping state) to a user who has just awoken and/or as a simple substitution of one suitable means of conveying information to the user for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 14, Wang as modified teaches/suggests the limitations of claim 13, as discussed above, but does not disclose the device comprises an audio circuit configured to give a voice broadcast and a vibrator configured to vibrate for prompt, wherein the processor indicates the audio circuit and/or vibrator to send the first and/or second signal.
Pantelopoulos discloses a wearable device comprising an audio circuit is configured to give a voice broadcast (e.g., ¶ [0302] the biometric monitoring device may convey information to a user through audio feedback, for example, a speaker in the biometric monitoring device may convey information through the use of audio tones, voice, songs, or other sounds) and a vibrator configured to vibrate for prompt (e.g., ¶ [0301] the biometric monitoring device may convey information into a user through the physical motion of the device, for example, via a vibration-inducing motor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wang to comprise an audio circuit configured to give a voice broadcast and a vibrator configured to vibrate for prompt, wherein the processor indicates the audio circuit and/or vibrator to send the first and/or second signal as taught and/or suggested by Pantelopoulos in order to more reliably convey information (e.g., determined wrapping state) to a user who has just awoken and/or as a simple substitution of one suitable means of conveying information to the user for another to yield no more than predictable results. See MPEP 2143(I)(B).
Tokko (or Wang as modified thereby) further discloses the first slope (e.g., ΔP12/ΔV12) is compared with at least one slope threshold (e.g., ΔP23/ΔV23). While Tokko does not expressly disclose the above-noted first slope is compared to each of a first slope threshold a second slope threshold, Tokko discloses alternative embodiments for assessing wrapping strength, including detecting a duration (period) in which the cuff pressure changes from Pc1 to Pc2 (ΔPc) (¶ [0216] detecting fluid amount ΔQ corresponding to the change in cuff pressure of ΔPc, which may be substituted by an elapsed time from pressure Pc1 to pressure Pc2 (as described in ¶ [0040], ¶ [0169], etc.)), comparing said duration to each of a first duration threshold and a second duration threshold; and sending signals based on said comparison (see discussion of claim 5 above). Furthermore, one of ordinary skill in the art would readily appreciate, given ΔPc is based on predefined pressure values Pc1 and Pc2, a shorter measured duration (ΔQ) would correspond to a larger slope (ΔPc/ΔQ), a longer duration to a smaller slope, etc.
In view of the above, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Wang with determining a first slope based on the preset pressure value (ΔPc) and the first duration (ΔQ, or corresponding time period/duration thereof); comparing the first slope with each of a first slope threshold and a second slope threshold; sending a first signal when the first slope is greater than or equal to the first slope threshold; and sending a second signal when the first slope is less than the second slope threshold (i.e., comparing ΔPc/ΔQ to corresponding thresholds α and β, rather than ΔQ to determine the wrapping state) because Applicant has not disclosed that sending the first and second signals based on a determined slope, rather the determined duration, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses the first and second signals may be sent based on duration (see, e.g., claim 5, ¶¶ [0014]-[0015]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the wrapping state determination and output disclosed/suggested by Wang because either arrangement enables presenting wrapping strength state to a user to urge rewrapping if needed (Tokko, ¶ [0159]).
Regarding claims 16 and 18, Wang as modified discloses/suggests the limitations of claim 9, as discussed above. The additional limitations of claims 16 and 18 are further disclosed and/or suggested by Wang as modified, or would have been obvious in view of the applied references (see discussion of claim 8, discussion of comparable claim 12, etc.).
Response to Arguments
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant contends no reference, alone or combined, discloses using a motion sensor or PPG signal to continuously detect a user's sleep status until determining the asleep-to-awake transition, the prior art fails to teach or render obvious this limitation (Remarks, pgs. 11-12).
The examiner respectfully disagrees. Vilenskii, which Applicant does not appear to address with respect to this limitation, discloses/suggests detecting a sleep status of a user using at least one of a signal of a motion sensor or a PPG signal and determining that the user has changed from a first state to a second state. With respect to detecting the sleep status "until" the state change is determined, Wang provides sufficient motivation for said limitation/condition. Specifically, Wang discloses monitoring for prerequisites to blood pressure measurements within a short time frame in response to a triggering event may conserve power and/or memory (e.g., ¶ [0081]), such that detecting the sleep state only until the change from the first state to the second state is determined would be an obvious modification in order to conserve power and/or memory of a device (e.g., wearable device) carrying out the claimed method.
Applicant contends the prior art references do not disclose or suggest "this integrated sequence within a single cuff-based blood pressure measurement workflow" of amended claim 1 (Remarks, pgs. 13-14), asserting, "Even combining all five references leaves a central gap: no reference discloses or suggests a control architecture in which the sleep-to-wake detection, combined with confirmation that no acceleration opposite to gravity exists, together constitute the causal and sufficient conditions that, without user action, command starting the inflation process to inflate the airbag to a preset pressure value at a preset rate and measuring the blood pressure of the user" (Remarks, pgs. 14-15).
The examiner respectfully disagrees. As discussed above Wang discloses and/or suggests automatically (i.e., without user input) starting a blood pressure measurement when particular prerequisite conditions are met. Wang as modified discloses/suggests within a predetermined time after waking is a beneficial prerequisite condition for a blood pressure measurement. Wang further discloses/suggests said the user being still and/or not moving his/her arms is another beneficial prerequisite condition. Accordingly, Wang at least suggests determining that no acceleration in the direction opposite to gravity exists prior to a preset time as a prerequisite for starting a blood pressure measurement (e.g., no body or arm motion for some preset duration before a measurement can/will begin). Alternatively/Additionally, Wang discloses the wearable device having the motion sensor may be worn on the wrist (e.g., ¶ [0039]). Ota discloses/suggests a wearable device comprising a motion sensor configured to detect an acceleration in a direction opposite to gravity (¶ [0037] 3-axis acceleration sensor) and a processor configured to determine that no acceleration in the direction opposite to gravity exists (Fig. 8, S61, posture determination to determine whether posture is correct; ¶ [0039] correct posture means that a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small); and start measuring the blood pressure of the user when it is determined that no acceleration in the direction opposite to gravity exists (Fig. 8, S4). Since one of ordinary skill in the art would readily appreciate the particular state change claimed typically occurs while a user is in a lying down posture (supine, prone, etc.), e.g., in bed, it would be obvious to only initiate blood pressure measurements within a preset time of the transition to the awake state when no acceleration in the direction opposite to gravity exists prior to the preset time in order to ensure a blood pressure measurement is only initiated if/when the user is in a correct posture in which a height difference between the position of the blood pressure measuring apparatus and the position of the heart is small, i.e., not raised or lowered with respect to his/her heart, thereby permitting only accurate/reliable measurements are made.
Applicant further submits the cited prior art, particularly Tokko does not disclose determining a correction value based on the claimed "mapping relationship" (Remarks, pgs. 15-16).
The examiner respectfully disagrees. The pending claims require determining a correction value based on a mapping relationship between the first duration and a blood pressure offset. Tokko discloses a blood pressure offset is changed/determining according to wrapping strength, which is a function of the first duration. While Tokko may map multiple duration values associated with a wrapping strength level or bin to a particular blood pressure offset, the language of the claim does not clearly preclude such a mapping.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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