DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Preliminary Amendment, filed 19 December 2023, the status of the claims is as follows:
Claims 1, 3-9, and 11-15 are currently amended; and
Claims 2 and 10 are previously presented.
Claim Objections
3. Claims 1 and 3-13 are objected to because of the following informalities:
these claims improperly include paratheses containing item numbers and labels of elements in the claims (which does not appear to be intended to further limit the claims), and should be amended to delete these paratheses containing item numbers and labels.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-8 are directed to a “device”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claims 9-13 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Claim 14 is directed to a “computer program product”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claim 15 is directed to a “computer readable data carrier”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 1-8, recite the following mental process:
…
(iii) apply the following two steps to the filtered acceleration data in any order:
(A) summing the filtered acceleration data of the first orthogonal axis and the second orthogonal axis discretely for each point in time, and
(B) smoothing the filtered acceleration data by calculating a moving average using a moving average window of a pre-defined width,
(iv) identify local extrema (LE) of the smoothed and summed acceleration data based on the first derivative of the acceleration data,
(v) identify significant extrema (SE) eligible for step counting based on at least one pre-defined condition from the local extrema (LE), and
(vi) determine a step count based on the significant extrema (SE) within the predefined first time interval.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing mathematical operations on the data, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “an accelerometer unit (40) and”, “wherein the patient's body has two orthogonal axes (YP, ZP), wherein the first orthogonal axis (YP) is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis (ZP) is given by the dorsoventral or similar axis of the patient's body, wherein the accelerometer unit is configured to determine at least 2-dimensional acceleration data (YD-data, ZD-data) over time along the first orthogonal axis (YP) and the second orthogonal axis (ZP), and”, “(i) receive a group of the acceleration data (YD-data, ZD-data) determined by the accelerometer unit within a predefined first time interval (TI1)”, and “(ii) apply a bandpass filter to the acceleration data with a frequency range between 0.001 and 100 Hz” in claim 1, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Furthermore, “a processor which are electrically interconnected” and “wherein the processor is configured to:” in claim 1 are merely parts of a computer to be used as a tool to perform the mental process.
Claim(s) 9-15, recite the following mental process:
…
(iii) applies the following two steps to the filtered acceleration data in any order:
(A) summing the filtered acceleration data of the first orthogonal axis and the second orthogonal axis discretely for each point in time, and
(B) smoothing the filtered acceleration data by calculating a moving average using a moving average window of a pre-defined width,
(iv) identifies local extrema (LE) of the smoothed and summed acceleration data based on the first derivative of the acceleration data,
(v) identifies significant extrema (SE) eligible for step counting based on at least one pre-defined condition from the local extrema (LE), and
(vi) determines a step count based on the significant extrema (SE) within the predefined first time interval.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “an accelerometer unit (40) and”, “wherein the patient's body has two orthogonal axes (YP, ZP), wherein the first orthogonal axis (YP) is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis (ZP) is given by the dorsoventral or similar axis of the patient's body, wherein the accelerometer unit is configured to determine at least 2-dimensional acceleration data (YD-data, ZD-data) over time along the first orthogonal axis (YP) and the second orthogonal axis (ZP), and”, “(i) receives a group of the acceleration data (YD-data, ZD-data) determined by the accelerometer unit within a predefined first time interval (TI1)”, and “(ii) applies a bandpass filter to the acceleration data with a frequency range between 0.001 and 100 Hz” in claim 9, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Furthermore, “a processor which are electrically interconnected” and “wherein the processor:” in claim 9, “A computer program product comprising instructions which, when executed by a processor, cause the processor to perform the steps of the method” in claim 14, and “A computer readable data carrier storing a computer program product” in claim 15, are merely parts of a computer to be used as a tool to perform the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “an accelerometer unit (40) and”, “wherein the patient's body has two orthogonal axes (YP, ZP), wherein the first orthogonal axis (YP) is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis (ZP) is given by the dorsoventral or similar axis of the patient's body, wherein the accelerometer unit is configured to determine at least 2-dimensional acceleration data (YD-data, ZD-data) over time along the first orthogonal axis (YP) and the second orthogonal axis (ZP), and”, “(i) receive a group of the acceleration data (YD-data, ZD-data) determined by the accelerometer unit within a predefined first time interval (TI1)”, and “(ii) apply a bandpass filter to the acceleration data with a frequency range between 0.001 and 100 Hz” in claim 1. Also, the additional limitations that are not directed to the mental processes are “an accelerometer unit (40) and”, “wherein the patient's body has two orthogonal axes (YP, ZP), wherein the first orthogonal axis (YP) is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis (ZP) is given by the dorsoventral or similar axis of the patient's body, wherein the accelerometer unit is configured to determine at least 2-dimensional acceleration data (YD-data, ZD-data) over time along the first orthogonal axis (YP) and the second orthogonal axis (ZP), and”, “(i) receives a group of the acceleration data (YD-data, ZD-data) determined by the accelerometer unit within a predefined first time interval (TI1)”, and “(ii) applies a bandpass filter to the acceleration data with a frequency range between 0.001 and 100 Hz” in claim 9. Such limitations are conventional and routine in the art (see Kazuhiro et al., JP H1142220 A, in para. [0011], [0013]-[0015], and fig. 1, which is discussed below in the rejection under 35 U.S.C. 102), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitations “a processor which are electrically interconnected” and “wherein the processor is configured to:” in claim 1 are merely parts of a computer to be used as a tool to perform the mental process. Also, the additional limitations “a processor which are electrically interconnected” and “wherein the processor:” in claim 9, “A computer program product comprising instructions which, when executed by a processor, cause the processor to perform the steps of the method” in claim 14, and “A computer readable data carrier storing a computer program product” in claim 15, are merely parts of a computer to be used as a tool to perform the mental process.
The additional limitations of dependent claims 2-8 and 10-12 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 102
6. 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.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-3, 5-10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kazuhiro et al., JP H1142220 A (“Kazuhiro”).
As to Claim 1, Kazuhiro teaches the following:
A medical device for a patient's body (see “The present invention relates to a body motion detection method and an apparatus for use in detecting a body vibration used as an index for controlling the amount.” in para. [0001]) comprising
an accelerometer unit (“acceleration sensing unit”) 1 (see “The body motion detection device according to the present embodiment uses an acceleration sensing unit (1) having a plurality of acceleration sensors and acceleration information output from the acceleration sensing unit (1).” in para. [0013]; and see fig. 1) and
a processor (“CPU”) 81 which are electrically interconnected (see “Reference numeral 81 denotes a CPU for controlling the operation of the entire pacemaker.” in para. [0032], and see fig. 8),
wherein the patient's body has two orthogonal axes, wherein the first orthogonal axis is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis is given by the dorsoventral or similar axis of the patient's body (see “According to the present invention, a two-axis or three-axis acceleration orthogonal to each other is used to increase the forward and backward direction of a human body parallel to a horizontal plane or about 10 degrees upward from the forward and backward direction of a human body parallel to a horizontal plane. Calculate the strength of the acceleration in the traveling direction (XACT), which is the direction, and the strength of the vertical acceleration (ZACT) substantially parallel to the direction of gravity, calculate the acceleration intensity ratio from XACT and ZACT, and calculate the XACT and ZACT or the acceleration intensity ratio.” in para. [0011]),
wherein the accelerometer unit 1 is configured to determine at least 2-dimensional acceleration data over time along the first orthogonal axis and the second orthogonal axis (see “An acceleration sensing unit (1) including an acceleration sensor measures three-axis acceleration, and inputs a value including a DC component to a coordinate conversion unit (49). The acceleration sensor is fixed inside the pacemaker, and the sensor X-axis at this time is set so as to be oriented perpendicular to the plane of the pacemaker case, that is, in the longitudinal direction of the body when implanted.” in para. [0014]), and
wherein the processor 81 is configured to:
(i) receive a group of the acceleration data determined by the accelerometer unit within a predefined first time interval (see “An acceleration sensing unit (1) including an acceleration sensor measures three-axis acceleration, and inputs a value including a DC component to a coordinate conversion unit (49).” in para. [0014]),
(ii) apply a bandpass filter (“band-pass filters (4, 5, 6)”) to the acceleration data with a frequency range between 0.001 and 100 Hz (see “Therefore, the high-frequency cutoff frequency was set to 10 Hz so as not to remove the high-frequency component of the body motion due to the movement. The low frequency cutoff frequency is to eliminate gravitational acceleration and Considering not removing body movements of walking that is as slow as about 0 / min. 5 Hz. The accelerations in the X, Y, and Z axes passing through the band-pass filters (4, 5, 6) are assumed to be A .sub.x , A .sub.y , and A .sub.z.” in para. [0014]-[0015]),
(iii) apply the following two steps to the filtered acceleration data in any order:
(A) summing the filtered acceleration data of the first orthogonal axis and the second orthogonal axis discretely for each point in time (see “As shown in the figure, the angle correction coefficient K .sub.x1 (7), K .sub.y1 (8), K .sub.z1 (9), K .sub.x2 (10), K .sub.y2 (11), K .sub.z2 (12) are multiplied by multipliers (13, 14, 15, 16, 17, 18) to calculate the respective traveling direction components and vertical components of the three-axis acceleration, and are added. This is performed by adding the components of three axes in (19, 20).” in para. [0017]), and
(B) smoothing the filtered acceleration data by calculating a moving average using a moving average window of a pre-defined width (see “Then, an average value (or an integrated value or an added value) of the processing output for a predetermined time is calculated, and the calculated value is set as the acceleration intensity. In the present embodiment, the traveling direction acceleration and the vertical direction acceleration are squared by the multipliers (21, 22), and the low-pass filters (23, 24) Calculate the average value for the past 4 seconds. Furthermore, clipping is performed by the clipper (25, 26) to prevent overflow when processing a large acceleration during traveling or the like, and calculate the traveling direction acceleration intensity (XACT) and the vertical direction acceleration intensity (ZACT).” in para. [0019]),
(iv) identify local extrema (“traveling direction components and vertical components of the three-axis acceleration”) of the smoothed and summed acceleration data based on the first derivative (see “equations (1) and (2)”) of the acceleration data (see “The calculation of the traveling direction acceleration and the vertical direction acceleration in the coordinate conversion unit (49) is performed by the following equations (1) and (2). As shown in the figure, the angle correction coefficient K .sub.x1 (7), K .sub.y1 (8), K .sub.z1 (9), K .sub.x2 (10), K .sub.y2 (11), K .sub.z2 (12) are multiplied by multipliers (13, 14, 15, 16, 17, 18) to calculate the respective traveling direction components and vertical components of the three-axis acceleration, and are added. This is performed by adding the components of three axes in (19, 20). The traveling direction .sub.acceleration: A xX = K x1 × A x + K y1 × A y + K z1 × A z (1 type) vertical .sub.acceleration: A zZ = K x2 × A x + K y2 × A y + K .sub.z2 × A .sub.z (Equation 2) The calculation of the angle correction coefficients K .sub.x1 to K .sub.z2 is performed by the angle correction coefficient calculator (48). First, the elevation angle and the deviation angle of the pacemaker necessary for calculating K .sub.x1 to K .sub.z2 are determined by X, Y,…” in para. [0017]),
(v) identify significant extrema (“the elevation angle and the deviation angle of the pacemaker”) eligible for step counting based on at least one pre-defined condition (“However, it is also possible to calculate the acceleration in the traveling direction and the acceleration in the vertical direction in consideration of the deviation in the angle between the Xo axis and the Xs axis on the Xo-Yo plane.”) from the local extrema (“traveling direction components and vertical components of the three-axis acceleration”) (see “By measuring the DC component of the acceleration signal before performing each of the Y- and Z-axis filtering, the following equations (3) and (4) are obtained., (Equation 5). Here, in order to explain the elevation angle and the deviation angle of the pacemaker, the axis is defined as shown in FIG. (Xo is the longitudinal direction of the human body parallel to the horizontal plane. Axis, the horizontal direction of the human body parallel to the horizontal plane is the Yo axis, the gravity direction is the Zo axis, and the X, Y, and Z axes of the acceleration sensor are Xs and Xs, respectively. Ys and Zs. First, what is the elevation angle of the pacemaker? The angle between the body surface below the clavicle, which is a common implant for pacemakers, and the direction of gravity, in other words, Xs The angle between the axis and the Xo axis. The shift angle of the pacemaker is the angle between the Ys axis and the Yo axis, and Z It is the angle between the s-axis and the Zo-axis. Use that angle, K .sub.x1 to K .sub.z2 are calculated at the time of regular medical checkup or at predetermined time intervals, (Equation 6), (Equation 7), (Equation 8), (Equation 9), (Equation 10), (11) Equation). At this time, the elevation angle φ of the pacemaker is a measured value or a value smaller by about 10 degrees than the measured value, so that the acceleration in the traveling direction is 10 degrees from the longitudinal direction of the human body parallel to the horizontal plane or the longitudinal direction of the human body parallel to the horizontal plane. The direction is forward and backward. Note that the influence of the angle between the Xo axis and the Xs axis (the angle between the Ys axis and the Yo axis) on the Xo-Yo plane is small unless a pacemaker is implanted under the armpit. I ignored it. However, it is also possible to calculate the acceleration in the traveling direction and the acceleration in the vertical direction in consideration of the deviation in the angle between the Xo axis and the Xs axis on the Xo-Yo plane. Elevation angle of pacemaker: φ = sin .sup.-1直流 DC component of sensor X-axis acceleration / gravity acceleration｝ (Formula 3) Deviation angle of pacemaker: θ = sin .sup.-1 ｛DC component of sensor Y-axis acceleration / (gravity acceleration Degree × cos φ)｝ (Equation 4) θ = cos .sup.-1直流 DC component of sensor Z-axis acceleration / (Gravity acceleration × cos φ)｝ (Equation 5) Angle correction coefficient: K .sub.x1 = K / 2 × cos φ ( Equation 6) K .sub.y1 = -K x sin φ x sin θ (Equation 7) K .sub.z1 = -K x sin φ x cos θ (Equation 8) K .sub.x2 = K / 4 x sin φ (Equation 9) .sub.Ky 2 = K / 2 × cos φ × sin θ (Equation 10) K .sub.z2 = K / 2 × cos φ × cos θ (Equation 11) Considering the difference in the input dynamic range of the X-axis and Y- and Z-axis of the acceleration sensing unit, The correction coefficients K .sub.x1 and K .sub.x2 are 1/ 2. When calculating the acceleration intensity between the traveling direction acceleration and the vertical direction acceleration, the angle correction coefficients K .sub.x2 , .sub.Ky .sub.2 , and K .sub.z2 are calculated in consideration of the property that the acceleration intensity is greater in the vertical direction than in the traveling direction even if the amplitude is the same. Was halved. Therefore, the angle correction coefficient K .sub.x2 is １/.” In para. [0017]-[0019]), and
(vi) determine a step count based on the significant extrema within the predefined first time interval (see “A step count measuring unit (3) for measuring the number of steps based on the traveling direction acceleration and the vertical acceleration output from the coordinate transforming unit (49), and an acceleration intensity calculating unit (2).” in para. [001]).
As to Claim 2, Kazuhiro teaches the following:
wherein the width of the moving average window is between 0.1 seconds and 0.6 seconds (see “Then, an average value (or an integrated value or an added value) of the processing output for a predetermined time is calculated, and the calculated value is set as the acceleration intensity. In the present embodiment, the traveling direction acceleration and the vertical direction acceleration are squared by the multipliers (21, 22), and the low-pass filters (23, 24) Calculate the average value for the past 4 seconds. Furthermore, clipping is performed by the clipper (25, 26) to prevent overflow when processing a large acceleration during traveling or the like, and calculate the traveling direction acceleration intensity (XACT) and the vertical direction acceleration intensity (ZACT).” in para. [0019]).
As to Claim 3, Kazuhiro teaches the following:
wherein the processor 81 is configured to determine a peak-to-peak amplitude of two consecutive local extrema or significant extrema, wherein one of the two consecutive local extrema is not regarded as a significant extremum eligible for step counting if the determined amplitude is less than or equal to a pre-defined first threshold (see “The input range is arbitrary, but in this embodiment, the X axis is ± 1.5G, Y and Z axes were ± 3G. According to the analysis of the data by the inventor, the ratio of the absolute value of the amplitude of the AC component between the acceleration in the traveling direction and the acceleration in the vertical direction is determined by the following: walking on level ground, climbing stairs,” in para. [0014]).
As to Claim 5, Kazuhiro teaches the following:
wherein the processor 81 is configured to determine a time difference between two consecutive local or significant extrema, and wherein one of the two extrema is not regarded as a significant extremum eligible for step counting if the determined time difference is greater than or equal to a pre-defined second threshold (see “First, the acceleration signals in the traveling direction and the vertical direction and threshold values sthX and sthZ (29, 30) are compared with comparators (31, 32). And a signal is generated when the acceleration signal becomes larger than the threshold value. The pulse generator (33, 34) generates a non-trigger pulse of 300ms width in synchronization with the comparator signal. The non-trigger function does not generate a pulse even if the comparator signal comes again within 300 ms.” in para. [0021]).
As to Claim 6, Kazuhiro teaches the following:
wherein the processor 81 is configured to determine a time difference between a local maximum or significant maximum and a consecutive local minimum or significant minimum, and wherein one of the minimum and the maximum is not regarded as a significant minimum or significant maximum eligible for step counting, respectively, if the time difference is less than or equal to a pre-defined third threshold (see “First, the acceleration signals in the traveling direction and the vertical direction and threshold values sthX and sthZ (29, 30) are compared with comparators (31, 32). And a signal is generated when the acceleration signal becomes larger than the threshold value. The pulse generator (33, 34) generates a non-trigger pulse of 300ms width in synchronization with the comparator signal. The non-trigger function does not generate a pulse even if the comparator signal comes again within 300 ms.” in para. [0021]).
As to Claim 7, Kazuhiro teaches the following:
wherein the processor 81 is configured to determine the peak-to-peak amplitudes of each two consecutive of at least three consecutive extrema, wherein the processor 81 is configured to sum the determined peak-to-peak amplitudes, wherein at least one of the at least three consecutive extrema is not regarded as a significant extremum eligible for step counting if the sum is less than or equal to a pre-defined fourth threshold (see “The input range is arbitrary, but in this embodiment, the X axis is ± 1.5G, Y and Z axes were ± 3G. According to the analysis of the data by the inventor, the ratio of the absolute value of the amplitude of the AC component between the acceleration in the traveling direction and the acceleration in the vertical direction is determined by the following: walking on level ground, climbing stairs,” in para. [0014]).
As to Claim 8, Kazuhiro teaches the following:
wherein the processor 81 is configured to discard a counted step if it is not preceded by a pre-defined first number of steps or followed by a pre-defined second number of steps within a predefined second time interval (see “FIG. 7 shows an algorithm for selecting the number of steps according to the exercise mode in the step information selecting section (45)” in para. [0030], and see fig. 7).
As to Claim 9, Kazuhiro teaches the following:
A method for determining the number of steps made by a patient using a medical device for a patient's body (see “The present invention relates to a body motion detection method and an apparatus for use in detecting a body vibration used as an index for controlling the amount.” in para. [0001]) comprising
an accelerometer unit (“acceleration sensing unit”) 1 (see “The body motion detection device according to the present embodiment uses an acceleration sensing unit (1) having a plurality of acceleration sensors and acceleration information output from the acceleration sensing unit (1).” in para. [0013]; and see fig. 1) and
a processor (“CPU”) 81 which are electrically interconnected (see “Reference numeral 81 denotes a CPU for controlling the operation of the entire pacemaker.” in para. [0032], and see fig. 8),
wherein the patient's body has two orthogonal axes, wherein the first orthogonal axis is given by the craniocaudal or similar axis of the patient's body and the second orthogonal axis is given by the dorsoventral or similar axis of the patient's body (see “According to the present invention, a two-axis or three-axis acceleration orthogonal to each other is used to increase the forward and backward direction of a human body parallel to a horizontal plane or about 10 degrees upward from the forward and backward direction of a human body parallel to a horizontal plane. Calculate the strength of the acceleration in the traveling direction (XACT), which is the direction, and the strength of the vertical acceleration (ZACT) substantially parallel to the direction of gravity, calculate the acceleration intensity ratio from XACT and ZACT, and calculate the XACT and ZACT or the acceleration intensity ratio.” in para. [0011]),
wherein the accelerometer unit 1 determines at least 2-dimensional acceleration data over time along the first orthogonal axis and the second orthogonal axis (see “An acceleration sensing unit (1) including an acceleration sensor measures three-axis acceleration, and inputs a value including a DC component to a coordinate conversion unit (49). The acceleration sensor is fixed inside the pacemaker, and the sensor X-axis at this time is set so as to be oriented perpendicular to the plane of the pacemaker case, that is, in the longitudinal direction of the body when implanted.” in para. [0014]), and
wherein the processor 81:
(i) receives a group of the acceleration data determined by the accelerometer unit within a predefined first time interval (see “An acceleration sensing unit (1) including an acceleration sensor measures three-axis acceleration, and inputs a value including a DC component to a coordinate conversion unit (49).” in para. [0014]),
(ii) applies a bandpass filter (“band-pass filters (4, 5, 6)”) to the acceleration data with a frequency range between 0.001 and 100 Hz (see “Therefore, the high-frequency cutoff frequency was set to 10 Hz so as not to remove the high-frequency component of the body motion due to the movement. The low frequency cutoff frequency is to eliminate gravitational acceleration and Considering not removing body movements of walking that is as slow as about 0 / min. 5 Hz. The accelerations in the X, Y, and Z axes passing through the band-pass filters (4, 5, 6) are assumed to be A .sub.x , A .sub.y , and A .sub.z.” in para. [0014]-[0015]),
(iii) applies the following two steps to the filtered acceleration data in any order:
(A) summing the filtered acceleration data of the first orthogonal axis and the second orthogonal axis discretely for each point in time (see “As shown in the figure, the angle correction coefficient K .sub.x1 (7), K .sub.y1 (8), K .sub.z1 (9), K .sub.x2 (10), K .sub.y2 (11), K .sub.z2 (12) are multiplied by multipliers (13, 14, 15, 16, 17, 18) to calculate the respective traveling direction components and vertical components of the three-axis acceleration, and are added. This is performed by adding the components of three axes in (19, 20).” in para. [0017]), and
(B) smoothing the filtered acceleration data by calculating a moving average using a moving average window of a pre-defined width (see “Then, an average value (or an integrated value or an added value) of the processing output for a predetermined time is calculated, and the calculated value is set as the acceleration intensity. In the present embodiment, the traveling direction acceleration and the vertical direction acceleration are squared by the multipliers (21, 22), and the low-pass filters (23, 24) Calculate the average value for the past 4 seconds. Furthermore, clipping is performed by the clipper (25, 26) to prevent overflow when processing a large acceleration during traveling or the like, and calculate the traveling direction acceleration intensity (XACT) and the vertical direction acceleration intensity (ZACT).” in para. [0019]),
(iv) identifies local extrema (“traveling direction components and vertical components of the three-axis acceleration”) of the smoothed and summed acceleration data based on the first derivative (see “equations (1) and (2)”) of the acceleration data (see “The calculation of the traveling direction acceleration and the vertical direction acceleration in the coordinate conversion unit (49) is performed by the following equations (1) and (2). As shown in the figure, the angle correction coefficient K .sub.x1 (7), K .sub.y1 (8), K .sub.z1 (9), K .sub.x2 (10), K .sub.y2 (11), K .sub.z2 (12) are multiplied by multipliers (13, 14, 15, 16, 17, 18) to calculate the respective traveling direction components and vertical components of the three-axis acceleration, and are added. This is performed by adding the components of three axes in (19, 20). The traveling direction .sub.acceleration: A xX = K x1 × A x + K y1 × A y + K z1 × A z (1 type) vertical .sub.acceleration: A zZ = K x2 × A x + K y2 × A y + K .sub.z2 × A .sub.z (Equation 2) The calculation of the angle correction coefficients K .sub.x1 to K .sub.z2 is performed by the angle correction coefficient calculator (48). First, the elevation angle and the deviation angle of the pacemaker necessary for calculating K .sub.x1 to K .sub.z2 are determined by X, Y,…” in para. [0017]),
(v) identifies significant extrema (“the elevation angle and the deviation angle of the pacemaker”) eligible for step counting based on at least one pre-defined condition (“However, it is also possible to calculate the acceleration in the traveling direction and the acceleration in the vertical direction in consideration of the deviation in the angle between the Xo axis and the Xs axis on the Xo-Yo plane.”) from the local extrema (“traveling direction components and vertical components of the three-axis acceleration”) (see “By measuring the DC component of the acceleration signal before performing each of the Y- and Z-axis filtering, the following equations (3) and (4) are obtained., (Equation 5). Here, in order to explain the elevation angle and the deviation angle of the pacemaker, the axis is defined as shown in FIG. (Xo is the longitudinal direction of the human body parallel to the horizontal plane. Axis, the horizontal direction of the human body parallel to the horizontal plane is the Yo axis, the gravity direction is the Zo axis, and the X, Y, and Z axes of the acceleration sensor are Xs and Xs, respectively. Ys and Zs. First, what is the elevation angle of the pacemaker? The angle between the body surface below the clavicle, which is a common implant for pacemakers, and the direction of gravity, in other words, Xs The angle between the axis and the Xo axis. The shift angle of the pacemaker is the angle between the Ys axis and the Yo axis, and Z It is the angle between the s-axis and the Zo-axis. Use that angle, K .sub.x1 to K .sub.z2 are calculated at the time of regular medical checkup or at predetermined time intervals, (Equation 6), (Equation 7), (Equation 8), (Equation 9), (Equation 10), (11) Equation). At this time, the elevation angle φ of the pacemaker is a measured value or a value smaller by about 10 degrees than the measured value, so that the acceleration in the traveling direction is 10 degrees from the longitudinal direction of the human body parallel to the horizontal plane or the longitudinal direction of the human body parallel to the horizontal plane. The direction is forward and backward. Note that the influence of the angle between the Xo axis and the Xs axis (the angle between the Ys axis and the Yo axis) on the Xo-Yo plane is small unless a pacemaker is implanted under the armpit. I ignored it. However, it is also possible to calculate the acceleration in the traveling direction and the acceleration in the vertical direction in consideration of the deviation in the angle between the Xo axis and the Xs axis on the Xo-Yo plane. Elevation angle of pacemaker: φ = sin .sup.-1直流 DC component of sensor X-axis acceleration / gravity acceleration｝ (Formula 3) Deviation angle of pacemaker: θ = sin .sup.-1 ｛DC component of sensor Y-axis acceleration / (gravity acceleration Degree × cos φ)｝ (Equation 4) θ = cos .sup.-1直流 DC component of sensor Z-axis acceleration / (Gravity acceleration × cos φ)｝ (Equation 5) Angle correction coefficient: K .sub.x1 = K / 2 × cos φ ( Equation 6) K .sub.y1 = -K x sin φ x sin θ (Equation 7) K .sub.z1 = -K x sin φ x cos θ (Equation 8) K .sub.x2 = K / 4 x sin φ (Equation 9) .sub.Ky 2 = K / 2 × cos φ × sin θ (Equation 10) K .sub.z2 = K / 2 × cos φ × cos θ (Equation 11) Considering the difference in the input dynamic range of the X-axis and Y- and Z-axis of the acceleration sensing unit, The correction coefficients K .sub.x1 and K .sub.x2 are 1/ 2. When calculating the acceleration intensity between the traveling direction acceleration and the vertical direction acceleration, the angle correction coefficients K .sub.x2 , .sub.Ky .sub.2 , and K .sub.z2 are calculated in consideration of the property that the acceleration intensity is greater in the vertical direction than in the traveling direction even if the amplitude is the same. Was halved. Therefore, the angle correction coefficient K .sub.x2 is １/.” In para. [0017]-[0019]), and
(vi) determines a step count based on the significant extrema within the predefined first time interval (see “A step count measuring unit (3) for measuring the number of steps based on the traveling direction acceleration and the vertical acceleration output from the coordinate transforming unit (49), and an acceleration intensity calculating unit (2).” in para. [001]).
As to Claim 10, Kazuhiro teaches the following:
wherein the processor 81 determines a peak-to-peak amplitude (A) of two consecutive local extrema or significant extrema, wherein one of the two consecutive local extrema or significant extrema is not regarded as a significant extremum eligible for step counting if the determined amplitude is less than or equal to a pre-defined first threshold (see “The input range is arbitrary, but in this embodiment, the X axis is ± 1.5G, Y and Z axes were ± 3G. According to the analysis of the data by the inventor, the ratio of the absolute value of the amplitude of the AC component between the acceleration in the traveling direction and the acceleration in the vertical direction is determined by the following: walking on level ground, climbing stairs,” in para. [0014]).
As to Claim 12, Kazuhiro teaches the following:
wherein the processor 81 determines a time difference between two consecutive local or significant extrema, and wherein one of the two extrema is not regarded as a significant extremum eligible for step counting if the determined time difference is greater than or equal to a pre-defined second threshold (see “First, the acceleration signals in the traveling direction and the vertical direction and threshold values sthX and sthZ (29, 30) are compared with comparators (31, 32). And a signal is generated when the acceleration signal becomes larger than the threshold value. The pulse generator (33, 34) generates a non-trigger pulse of 300ms width in synchronization with the comparator signal. The non-trigger function does not generate a pulse even if the comparator signal comes again within 300 ms.” in para. [0021]).
As to Claim 13, Kazuhiro teaches the following:
wherein the processor 81 determines one or both of:
(A) a time difference between a local maximum or significant maximum and a consecutive local minimum or significant minimum, and wherein one of the minimum and the maximum is not regarded as a significant minimum or significant maximum eligible for step counting, respectively, if the time difference is less than or equal to a pre-defined third threshold (see “First, the acceleration signals in the traveling direction and the vertical direction and threshold values sthX and sthZ (29, 30) are compared with comparators (31, 32). And a signal is generated when the acceleration signal becomes larger than the threshold value. The pulse generator (33, 34) generates a non-trigger pulse of 300ms width in synchronization with the comparator signal. The non-trigger function does not generate a pulse even if the comparator signal comes again within 300 ms.” in para. [0021]), or
(B) the peak-to-peak amplitudes of each two consecutive of at least three consecutive extrema, wherein the processor 81 sums the determined peak-to-peak amplitudes, and wherein at least one of the at least three consecutive extrema is not regarded as a significant extremum eligible for step counting if the summed amplitude is less than a pre-defined fourth threshold (see “The input range is arbitrary, but in this embodiment, the X axis is ± 1.5G, Y and Z axes were ± 3G. According to the analysis of the data by the inventor, the ratio of the absolute value of the amplitude of the AC component between the acceleration in the traveling direction and the acceleration in the vertical direction is determined by the following: walking on level ground, climbing stairs,” in para. [0014]).
As to Claim 14, Kazuhiro teaches the following:
A computer program product (“ROM”) 82 comprising instructions which, when executed by a processor (“CPU”) 81, cause the processor 81 to perform the steps of the method according to claim 9 (see “FIG. 8 shows an example in which the body motion detection procedure is incorporated in software, but as described above, a part and the whole may be constituted by hardware. Many parts in FIG. 8 can be realized by integrated IC chips. Reference numeral 81 denotes a CPU for controlling the operation of the entire pacemaker. Reference numeral 82 denotes an ROM for storing the processing procedure of the CPU 81, and the processing procedure is a body motion detection program 82a.” in para. [0031]-[0032]).
As to Claim 15, Kazuhiro teaches the following:
A computer readable data carrier (“ROM”) 82 storing a computer program product (“body motion detection program”) 82a according to claim 14 (see “FIG. 8 shows an example in which the body motion detection procedure is incorporated in software, but as described above, a part and the whole may be constituted by hardware. Many parts in FIG. 8 can be realized by integrated IC chips. Reference numeral 81 denotes a CPU for controlling the operation of the entire pacemaker. Reference numeral 82 denotes an ROM for storing the processing procedure of the CPU 81, and the processing procedure is a body motion detection program 82a.” in para. [0031]-[0032]).
Allowable Subject Matter
9. Claims 4 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
10. Claims 4 and 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
11. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 4, neither Kazuhiro nor the prior art of record teaches the medical device of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the processor is configured to determine the polarity of two consecutive local extrema or significant extrema, and wherein one of the two extrema is not regarded as a significant extremum eligible for step counting if the acceleration data of the extrema have the same polarity.
As to Claim 11, neither Kazuhiro nor the prior art of record teaches the medical device of base claim 9, including the following, in combination with all other limitations of the base claim:
wherein the processor determines the polarity of two consecutive local extrema or significant extrema, and wherein one of the two extrema is not regarded as a significant extremum eligible for step counting if the acceleration data of the extrema have the same polarity.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 04/29/2026
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