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 03 August 2026, the status of the claims is as follows:
Claims 1 and 9 are currently amended; and
Claims 2-8 and 10-15 are previously presented.
Response to Arguments
3. Applicant’s arguments, see Remarks, p. 7, filed 03 August 2026, with respect to the objections of claims 1 and 3-13 are objected to because of minor informalities, have been fully considered, and are persuasive. The objections of claims 1 and 3-13 have been withdrawn.
4. Applicant’s arguments, see Remarks, pp. 8-12, filed 03 August 2026, with respect to the rejection of claims 1-15 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more, have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn.
5. Applicant’s arguments, see Remarks, p. 12, filed 03 August 2026, with respect to the rejection of claims 1-3, 5-10, and 12-15 under 35 U.S.C. 102(a)(1) as being anticipated by Kazuhiro et al., JP H1142220 A (“Kazuhiro”), have been fully considered, and are persuasive in view of the Amendment, filed 03 August 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claims 1-3, 5-10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over 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 axis of the patient's body and the second orthogonal axis is given by the dorsoventral 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, the band pass filter comprising a high pass cut off (“high-frequency cutoff frequency was set to 10 Hz”) … and a low pass cut off (“low frequency cutoff frequency”) in the range of 3 Hz to 6 Hz (“5 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]).
Kazuhiro does not teach the following:
the band pass filter comprising a high pass cut off in the range of 0.001 Hz to 0.5 Hz ...
However, Martin teaches the following:
a band pass filter comprising a high pass cut off in the range of 0.001 Hz to 0.5 Hz (see “By way of example without limitation, as a result of a detection of a substantial orientation change, some embodiments may use a filter (e.g. high pass, or band pass) of any type (e.g. Butterworth, Chebyshev, or any other) or apply any type of pre-processing to try to eliminate the frequency components below 0.5 Hz (or any other threshold) from said motion sensor signal before being processed to determine the fundamental frequency.” in col. 9, ll. 29-36).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Kazuhiro’s band pass filter’s high pass cut off to be in the range of “below 0.5 Hz”, as taught by Martin, in order eliminate frequency components below 0.5 Hz from the motion signal to determine the fundamental frequency of the subject’s gait, and thus, providing a more accurate signal for further processing (see Martin, col. 9, ll. 1-67). Furthermore, Martin is analogous art to Kazuhiro since both teachings provide frequency analysis of a subject’s gait (see Martin, col. 1, ll. 53-55; and Kazuhiro, para. [0006]).
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 of the patient's body and the second orthogonal axis is given by the dorsoventral 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, the band pass filter comprising a high pass cut off (“high-frequency cutoff frequency was set to 10 Hz”) … and a low pass cut off (“low frequency cutoff frequency”) in the range of 3 Hz to 6 Hz (“5 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]).
Kazuhiro does not teach the following:
the band pass filter comprising a high pass cut off in the range of 0.001 Hz to 0.5 Hz ...
However, Martin teaches the following:
a band pass filter comprising a high pass cut off in the range of 0.001 Hz to 0.5 Hz (see “By way of example without limitation, as a result of a detection of a substantial orientation change, some embodiments may use a filter (e.g. high pass, or band pass) of any type (e.g. Butterworth, Chebyshev, or any other) or apply any type of pre-processing to try to eliminate the frequency components below 0.5 Hz (or any other threshold) from said motion sensor signal before being processed to determine the fundamental frequency.” in col. 9, ll. 29-36).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Kazuhiro’s band pass filter’s high pass cut off to be in the range of “below 0.5 Hz”, as taught by Martin, in order eliminate frequency components below 0.5 Hz from the motion signal to determine the fundamental frequency of the subject’s gait, and thus, providing a more accurate signal for further processing (see Martin, col. 9, ll. 1-67). Furthermore, Martin is analogous art to Kazuhiro since both teachings provide frequency analysis of a subject’s gait (see Martin, col. 1, ll. 53-55; and Kazuhiro, para. [0006]).
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. 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
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 10/03/2026
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