DETAILED ACTION
This action is pursuant to claims filed on 11/22/2023. Claims 1-11 are pending. A first action on the merits of claims 1-11 is as follows.
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 .
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 3-7 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.
Regarding claim 3, the claim recites the limitation “a normal state” in line 3. It is unclear if this limitation is meant to refer to the normal state from claim 1, line 9, or a different normal state. If it is meant to refer to the normal state from claim 1, it needs to refer back to it. If it is meant to refer to a different normal state, it needs to be distinguished from the normal state from claim 1. For purposes of examination, it is being interpreted as referring to the normal state from claim 1. Claim 5 is also rejected due to its dependence on claim 3.
Regarding claim 4, the claim recites the limitation “an abnormal state” in line 3. It is unclear if this limitation is meant to refer to the abnormal state from claim 1, line 11, or a different abnormal state. If it is meant to refer to the abnormal state from claim 1, it needs to refer back to it. If it is meant to refer to a different abnormal state, it needs to be distinguished from the abnormal state from claim 1. For purposes of examination, it is being interpreted as referring to the abnormal state from claim 1. Claim 6 is also rejected due to its dependence on claim 4.
Regarding claim 7, the claim recites the limitation “receive data” in line 3. It is unclear if this limitation is meant to refer to the data from claim 1, line 4, or different data. If it is meant to refer to the data from claim 1, it needs to refer back to it. If it is meant to refer to different data, it needs to be distinguished from the data from claim 1. For purposes of examination, it is being interpreted as referring to the data from claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ha (US 20100049059) in view of Nakamura (US 20180153423) and Adachi (WO 2017119367). Citations to WO 2017119367 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Ha teaches a wrist-wearable blood pressure measurement device (Abstract: “Disclosed are blood pressure measuring apparatus and method”) comprising:
a blood pressure measurement sensor placed to be adjacent to an artery of the subject ([0037]: “The living body signal measuring unit receives a living body signal of the person to be examined and measures a pulse wave and an electrocardiogram, and includes an electrocardiogram measuring unit 30 and a pulse wave measuring unit 40”; [0039]: “The converting unit 50 converts the electrocardiogram signal and the PPG signal, which are measured by the living body signal measuring unit, from an analog signal to a digital signal. The central processing unit 60 measures a pulse transit time (PTT), on the basis of the electrocardiogram signal and the PPG signal that are converted by the converting unit 50 from the analog signals to the digital signals. The central processing unit 60 uses the measured pulse transit time and the body information of the person to be examined, such as age, sex, height, and weight, which is input from the user interface unit 10, to calculate a pulse wave velocity (PWV), thereby measuring blood pressure of the person to be examined”. The electrocardiogram measuring unit and pulse wave measuring unit together are the blood pressure measurement sensor.).
However, Ha does not teach a strap configured to wrap a wrist of a subject.
Nakamura discloses a biological information reading device. Specifically, Nakamura teaches a strap configured to wrap a wrist of a subject ([0037]: “The affixing unit 13 has a band, as a conventional one, which opens at one side to be put on the wrist for fixing the affixing unit 13 put on the wrist to fixedly press the triaxial pressure sensor 11 to the skin of the wrist”). Ha and Nakamura are analogous arts as they are both related to devices used to measure blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the strap from Nakamura into the device from Ha as Ha is silent on how the device is attached to the wrist of the user, and Nakamura discloses a suitable strap in an analogous device.
The Ha/Nakamura combination teaches a blood pressure measurement module configured to receive data measured by the blood pressure measurement sensor (Ha, [0037]: “The living body signal measuring unit receives a living body signal of the person to be examined and measures a pulse wave and an electrocardiogram, and includes an electrocardiogram measuring unit 30 and a pulse wave measuring unit 40”. The living body signal measuring unit is the blood pressure measurement module.); and
an angle sensor configured to detect a rotation state of the wrist of the subject (Na, [0035]: “the inclination measuring unit 20 uses the three-axis gravity acceleration sensor to measure an elevation angle that is an angle between a direction where an arm of the person to be examined extends and the surface of the earth, and a rotation angle that indicates a degree to which a wrist rotates on the basis of the direction where the arm extends”. The three axis gravity acceleration sensor is the angle sensor.),
wherein the angle sensor measures an angle at which a surface of the wrist rotates around a vertical reference axis perpendicular to a ground (Ha, [0062]: “the central processing unit 60 sets a reference rotation angle .beta. for the rotation angle .theta.2. When the rotation angle .theta.2 measured by the inclination measuring unit 20 corresponds to the reference rotation angle .beta., the central processing unit 60 determines that the blood pressure measuring posture using the rotation angle .theta.2 is the reference measuring posture.”; [0064]: “the reference rotation angle .beta. is preferably based on an angle that is vertical to the surface of the earth”. The reference angle vertical to the surface of the earth is a vertical axis perpendicular to a ground, therefore is the angle is measured compared to the vertical reference axis.).
However, the Ha/Nakamura combination is silent on the side of the wrist that the sensor is on.
Nakamura teaches the sensor on the inner side surface of the wrist ([0036]: “The affixing unit 13 has a curved resin structure to bring the triaxial pressure sensor 11 into contact with the skin of the wrist of the human body, and has a flat inner surface portion to which the triaxial pressure sensor 11 is attached, and the triaxial pressure sensor can be fixed to the wrist”; Fig. 3A shows the sensor on the inner surface of the wrist.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the location of the sensor from Nakamura into the Ha/Nakamura combination as the combination is silent on the location of the sensor and Nakamura discloses a suitable location in an analogous device.
The Ha/Nakamura combination teaches the blood pressure measurement module determines that the angle is in a normal state when the angle measured by the angle sensor is within an allowable angle value (Ha, [0062]: “the central processing unit 60 sets a reference rotation angle .beta. for the rotation angle .theta.2. When the rotation angle .theta.2 measured by the inclination measuring unit 20 corresponds to the reference rotation angle .beta., the central processing unit 60 determines that the blood pressure measuring posture using the rotation angle .theta.2 is the reference measuring posture”).
However, the Ha/Nakamura combination does not teach the angle being within an allowable angle range. Adachi discloses an instrument to measure blood pressure. Specifically, Adachi teaches the angle being within an allowable angle range (Page 41: “the "second tolerance range" is set as the range that is more preferable for initiating the blood pressure measurement period. For the tilt angle θ of the left wrist at 90 degrees, a second allowable angle range is set from the lower limit θ<sub>Ｌ２</sub> to the upper limit θ<sub>Ｕ２</sub>.”). Ha, Nakamura, and Adachi are analogous arts as they are all related to devices used to measure blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the allowable angle range from Adachi into the Han/Nakamura combination as it allows for a larger angle range to be used for measurement, which can allow for more measurements to be taken and for less adjustment to be required from the user.
The Ha/Nakamura/Adachi combination teaches wherein the device determines the angle is in an abnormal state when the angle measured by the angle sensor is not within the allowable angle range, and determines at least one of whether to continue measurement, whether to provide guidance, and whether a measurement value is valid (Ha, [0036]: “The central processing unit 60 can calculate a blood pressure measuring posture of the person to be examined, on the basis of the data that is measured by the inclination measuring unit 20. At this time, the central processing unit 60 determines whether the calculated blood pressure measuring posture of the person to be examined is maintained at a reference measuring posture. When it is determined that the person to be examined does not maintain the reference measuring posture, the central processing unit 60 outputs a voice or a message that urges the person to be examined to take the reference measuring posture, thereby guiding a correct blood pressure measuring posture … the central processing unit 60 activates the operation of the living body signal measuring unit, when the calculated blood pressure measuring posture of the person to be examined is maintained at the reference measuring posture.”; [0063]: “when the rotation angle .theta.2 measured by the inclination measuring unit 20 does not correspond to the reference rotation angle .beta., the central processing unit 60 generates a message of `please rotate your wrist inward by 10.degree. and allows the generated message to be output through the display unit 70”. The central processing unit determines whether the user is in the correct reference position, and either takes the measurement of blood pressure if the position is correct, or if the user is not in the correct reference position, guides the user to the correct position, which is the guidance provided.).
Regarding claim 3, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 1, wherein when the blood pressure measurement module determines that the angle of the wrist of the subject is in a normal state, notification information is output to inform the subject that the angle is in the normal state (Ha, [0015]: “The central processing unit outputs a driving signal to the living body signal measuring unit, when it is determined that the person to be examined maintains the reference measuring posture on the basis of the elevation angle and the rotation angle that are measured by the inclination measuring unit”. The driving signal is notification that is output when the user is in the normal state.).
Regarding claim 4, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 1, wherein when the blood pressure measurement module determines that the angle of the wrist of the subject is in an abnormal state, guidance is provided to the subject to adjust the inner side surface of the wrist to be parallel to the vertical reference axis or the inner side surface of the wrist to be perpendicular to the vertical reference axis to face sky (Ha, [0064]: “the reference rotation angle .beta. is preferably based on an angle that is vertical to the surface of the earth”; [0063]: “when the rotation angle .theta.2 measured by the inclination measuring unit 20 does not correspond to the reference rotation angle .beta., the central processing unit 60 generates a message of `please rotate your wrist inward by 10.degree. and allows the generated message to be output through the display unit 70”. The central processing unit generates a message to guide the user to angle their wrist to the rotation angle, which is parallel to the vertical reference axis.).
Regarding claim 5, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 3, wherein the wrist-wearable blood pressure measurement device outputs notification information indicating that the rotation state of the wrist is in the normal state or notification information indicating that the rotation state of the wrist is in the abnormal state through vibration notification, voice notification, a display screen output, or an air pressure of a cuff (Ha, [0060]: “the central processing unit 60 generates a message of `please raise your wrist above 10 cm` in consideration of the height difference between the heart and the blood pressure measuring apparatus that is 10 cm, and allows the generated message to be output through the display unit 70. Of course, the central processing unit 60 may generate voice data and output the generated voice data through a speaker”).
Regarding claim 6, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 4, wherein the wrist-wearable blood pressure measurement device outputs notification information indicating that the rotation state of the wrist is in the normal state or notification information indicating that the rotation state of the wrist is in the abnormal state through vibration notification, voice notification, a display screen output, or an air pressure of a cuff (Ha, [0060]: “the central processing unit 60 generates a message of `please raise your wrist above 10 cm` in consideration of the height difference between the heart and the blood pressure measuring apparatus that is 10 cm, and allows the generated message to be output through the display unit 70. Of course, the central processing unit 60 may generate voice data and output the generated voice data through a speaker”).
Regarding claim 7, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 1, further comprising: a communication unit configured to transmit and receive data to and from an external device (Ha, [0032]: “The communication unit 90 includes at least one of a wireless communication module, such as Bluetooth, ZigBee, and a wireless LAN, and a wired communication module, such as a serial interface and a USB, and exchanges data with an external apparatus using a wired/wireless communication method. At this time, the communication unit 90 transmits to the outside signals that are measured by the inclination measuring unit 20 and the living body signal measuring unit and the measured data, such as an electrocardiogram, a pulse wave, and blood pressure measured by the central processing unit 60.”).
Regarding independent claim 8, Ha teaches a method of controlling blood pressure measurement device (Abstract: “Disclosed are blood pressure measuring apparatus and method”), the method comprising:
measuring an angle at which a surface of a wrist of a subject rotates around a vertical reference axis perpendicular to a ground by using an angle sensor included in the blood pressure measurement device ([0062]: “the central processing unit 60 sets a reference rotation angle .beta. for the rotation angle .theta.2. When the rotation angle .theta.2 measured by the inclination measuring unit 20 corresponds to the reference rotation angle .beta., the central processing unit 60 determines that the blood pressure measuring posture using the rotation angle .theta.2 is the reference measuring posture.”; [0064]: “the reference rotation angle .beta. is preferably based on an angle that is vertical to the surface of the earth”. The reference angle vertical to the surface of the earth is a vertical axis perpendicular to a ground, therefore is the angle is measured compared to the vertical reference axis; [0035]: “the inclination measuring unit 20 uses the three-axis gravity acceleration sensor to measure an elevation angle that is an angle between a direction where an arm of the person to be examined extends and the surface of the earth, and a rotation angle that indicates a degree to which a wrist rotates on the basis of the direction where the arm extends”. The three axis gravity acceleration sensor is the angle sensor.).
However, the Ha/Nakamura combination is silent on the side of the wrist that the sensor is on.
Nakamura teaches the sensor on the inner side surface of the wrist ([0036]: “The affixing unit 13 has a curved resin structure to bring the triaxial pressure sensor 11 into contact with the skin of the wrist of the human body, and has a flat inner surface portion to which the triaxial pressure sensor 11 is attached, and the triaxial pressure sensor can be fixed to the wrist”; Fig. 3A shows the sensor on the inner surface of the wrist.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the location of the sensor from Nakamura into the Ha/Nakamura combination as the combination is silent on the location of the sensor and Nakamura discloses a suitable location in an analogous device.
The Ha/Nakamura combination teaches determining that the angle is in a normal state when the measured angle is within an allowable angle value, and determining that the angle is in an abnormal state when the measured angle is not within the allowable angle value; informing the subject that the angle is in the abnormal state when the angle is in the abnormal state; and measuring blood pressure of the subject by using a blood pressure measurement sensor when the angle is in the normal state (Ha, [0036]: “The central processing unit 60 can calculate a blood pressure measuring posture of the person to be examined, on the basis of the data that is measured by the inclination measuring unit 20. At this time, the central processing unit 60 determines whether the calculated blood pressure measuring posture of the person to be examined is maintained at a reference measuring posture. When it is determined that the person to be examined does not maintain the reference measuring posture, the central processing unit 60 outputs a voice or a message that urges the person to be examined to take the reference measuring posture, thereby guiding a correct blood pressure measuring posture … the central processing unit 60 activates the operation of the living body signal measuring unit, when the calculated blood pressure measuring posture of the person to be examined is maintained at the reference measuring posture.”; [0063]: “when the rotation angle .theta.2 measured by the inclination measuring unit 20 does not correspond to the reference rotation angle .beta., the central processing unit 60 generates a message of `please rotate your wrist inward by 10.degree. and allows the generated message to be output through the display unit 70”. The central processing unit determines whether the user is in the correct reference position, and either takes the measurement of blood pressure if the position is correct, or if the user is not in the correct reference position, guides the user to the correct position.).
However, the Ha/Nakamura combination does not teach the angle being within an allowable angle range. Adachi teaches the angle being within an allowable angle range (Page 41: “the "second tolerance range" is set as the range that is more preferable for initiating the blood pressure measurement period. For the tilt angle θ of the left wrist at 90 degrees, a second allowable angle range is set from the lower limit θ<sub>Ｌ２</sub> to the upper limit θ<sub>Ｕ２</sub>.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the allowable angle range from Adachi into the Han/Nakamura combination as it allows for a larger angle range to be used for measurement, which can allow for more measurements to be taken and for less adjustment to be required from the user.
Regarding claim 10, the Han/Nakamura/Adachi combination teaches the method of claim 8, wherein the measuring of the blood pressure includes outputting notification information indicating that the angle is in the normal state (Ha, [0015]: “The central processing unit outputs a driving signal to the living body signal measuring unit, when it is determined that the person to be examined maintains the reference measuring posture on the basis of the elevation angle and the rotation angle that are measured by the inclination measuring unit”. The driving signal is notification that is output when the user is in the normal state.).
Regarding claim 11, the Han/Nakamura/Adachi combination teaches the method of claim 8, wherein in the informing the subject, notification information indicating that the rotation state of the wrist is in the normal state or notification information indicating that the rotation state of the wrist is in the abnormal state is output through vibration notification, voice notification, a display screen output, or an air pressure of a cuff (Ha, [0064]: “the reference rotation angle .beta. is preferably based on an angle that is vertical to the surface of the earth”; [0063]: “when the rotation angle .theta.2 measured by the inclination measuring unit 20 does not correspond to the reference rotation angle .beta., the central processing unit 60 generates a message of `please rotate your wrist inward by 10.degree. and allows the generated message to be output through the display unit 70”. The central processing unit generates a message to guide the user to angle their wrist to the rotation angle, which is parallel to the vertical reference axis.).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over the Ha/Nakamura/Adachi as applied to claims 1 and 8 above, and further in view of Wang (CN 108852323). Citations to CN 108852323 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 2, the Ha/Nakamura/Adachi combination teaches the wrist-wearable blood pressure measurement device of claim 1.
However, the Ha/Nakamura/Adachi combination does not teach wherein the allowable angle range is greater than or equal to 0 degrees and less than or equal to 90 degrees.
Wang discloses a wearable device to measure blood pressure. Specifically, Wang teaches wherein the allowable angle range is greater than or equal to 0 degrees and less than or equal to 90 degrees ([0103]: “The fact that the wristwatch remains within a preset range of activity angles for a preset duration includes: setting a horizontal plane based on the wearing angle of the wristwatch when viewed by the user; and based on the set horizontal plane, the angle of rotation of the wristwatch within a certain duration is +/- 30 degrees.” The range includes the angle of rotation being within 30 degrees, which includes an angle range between 0 and 90 degrees.). Ha, Nakamura, Adachi, and Wang are analogous arts as they are all related to devices used to measure blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the range from Wang into the Ha/Nakamura/Adachi combination as the combination is silent on the specific values of the range, and Wang discloses a suitable range in an analogous device.
Regarding claim 9, the Ha/Nakamura/Adachi combination teaches the method of claim 8.
However, the Ha/Nakamura/Adachi combination does not teach wherein the allowable angle range is greater than or equal to 0 degrees and less than or equal to 90 degrees.
Wang discloses a wearable device to measure blood pressure. Specifically, Wang teaches wherein the allowable angle range is greater than or equal to 0 degrees and less than or equal to 90 degrees ([0103]: “The fact that the wristwatch remains within a preset range of activity angles for a preset duration includes: setting a horizontal plane based on the wearing angle of the wristwatch when viewed by the user; and based on the set horizontal plane, the angle of rotation of the wristwatch within a certain duration is +/- 30 degrees.” The range includes the angle of rotation being within 30 degrees, which includes an angle range between 0 and 90 degrees.). Ha, Nakamura, Adachi, and Wang are analogous arts as they are all related to devices used to measure blood pressure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the range from Wang into the Ha/Nakamura/Adachi combination as the combination is silent on the specific values of the range, and Wang discloses a suitable range in an analogous device.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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