DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 September 2025 has been entered.
The Examiner acknowledges the amendments to claims 1, 3, and 5, and the cancellation of claims 26-29. Claims 1-11 and 30-33 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character(s): “51” is used to refer to the step to “Move joint to baseline position” in Fig. 5 [Applicant’s Specification p. 13:26-28] and markings in Figs. 6B, 7A, and 7C [p. 13:17-21]; “52” is used to refer to the step to “Calibrate sensors” in Fig. 5 [p. 14:4-5] and one or more templates in Figs. 6A and 6D [p. 12:5-7]; “55” is used to refer to the step to “Recalibrate sensors” in Fig. 5 [p. 14:20-22] and a mobile device in Fig. 6E [p. 12:17].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “100” in Figs. 6C and 6D.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tam (US-20160220175-A1, previously presented) in view of Kord (US-20190282126-A1).
Regarding claim 1, Tam teaches
A method of calibrating a first sensor and a second sensor each mounted to a joint to be measured of a patient, the method comprising the steps of:
(a) in a baseline position of the joint to be measured in which the first sensor and the second sensor are in a first configuration relative to each other [In some embodiments, calibration may be achieved by having the patient perform a set of tasks, such as sitting with the knees bent at 90 degrees, followed by standing with the knees in full extension. If the knees were not able to reach full extension or 90 degrees, this would have to be accounted for using other activities or a goniometer for calibration verification (Tam ¶0049)], determining a first offset between a measured joint angle and an angle between the first sensor and the second sensor in the first configuration, for calibrating at least one of the first sensor and the second sensor [A software algorithm on the processor 50, located on the personal computer, mobile device, cloud or the like, will process the data obtained from the sensors placed proximal and distal to each joint in question. The program can be calibrated using a manual or digital goniometer for reference. After calibration, the sensors 42, 43 may be configured to provide continuous or intermittent measurements of joint range of motion to the software platform. Alternatively, the sensors 42, 43 may be calibrated by having the software guide the patient through several pre-set exercises. For example, the patient may be asked to walk up stairs then down and then sit in a chair and straighten the knee as much as possible then bend as much as possible. By doing these activities after indicating to the software that they are doing them, the software algorithm may calibrate the sensors 42, 43 (Tam ¶0047), wherein the reference goniometer measurement is considered to read on the measured joint angle, and wherein the measured joint range of motion is considered to read on an angle between the first sensor and the second sensor in the first configuration; the Examiner further notes that based on the plain definition of “calibrate”/“calibration” is considered to mean to standardize (something, such as a measuring instrument) by determining the deviation from a standard so as to ascertain the proper correction factors (https://www.merriam-webster.com/dictionary/calibrate)], the angle between the first sensor and the second sensor in the first configuration corresponds to a difference between at least one of a pitch angle and a roll angle of the first sensor and at least one of a pitch angle and a roll angle of the second sensor [the joint motion data may reflect an angle of flexion of the knee joint and an angle of extension of the knee joint (Tam ¶0010); Sensors 26, 28 may be any suitable motion sensor, such as but not limited to accelerometers, gyroscopes, magnometers, capacitive sensors, resistive sensors, optical sensors or any combination thereof (Tam ¶0036), wherein and angle of flexion/extension of the knee joint regarding range of motion of the knee joint as depicted in Tam Figures 12 and 17-18 is considered to read on an difference between a roll angle of the first sensor and the second sensor (see Annotated Figure 1)];
(b) after at least one of the first sensor and the second sensor has been removed and reapplied [Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044)], placing the joint into the baseline position such that the first sensor and the second sensor are in a second configuration relative to each other [In some embodiments, calibration may be achieved by having the patient perform a set of tasks, such as sitting with the knees bent at 90 degrees, followed by standing with the knees in full extension. If the knees were not able to reach full extension or 90 degrees, this would have to be accounted for using other activities or a goniometer for calibration verification (Tam ¶0049), wherein it is understood that the sensor being replaced throughout the course of care would include repeating/continuing the same joint angle measurements and measuring the angle between the first sensor and the second sensor]; and
(c) determining a second offset between the measured joint angle and an angle between the first sensor and the second sensor in the second configuration [A software algorithm on the processor 50, located on the personal computer, mobile device, cloud or the like, will process the data obtained from the sensors placed proximal and distal to each joint in question. The program can be calibrated using a manual or digital goniometer for reference. After calibration, the sensors 42, 43 may be configured to provide continuous or intermittent measurements of joint range of motion to the software platform (Tam ¶0047), wherein the reference goniometer measurement is considered to read on the measured joint angle, and wherein the measured joint range of motion is considered to read on an angle between the first sensor and the second sensor in the first configuration], for recalibrating at least one of the first sensor and the second sensor, wherein the angle between the first sensor and the second sensor in the second configuration corresponds to the difference between at least one of the pitch angle and the roll angle of the first sensor and at least one of the pitch angle and the roll angle of the second sensor [Tam ¶¶0010, 0036, wherein and angle of flexion/extension of the knee joint is considered to read on an difference between a pitch/roll angle of the first sensor and the second sensor (see Annotated Fig. 1)],
wherein the roll angle is defined by a rotation about a longitudinal axis along an entire length of the at least one of the first sensor and the second sensor that points away from the joint of the patient parallel to the ground and the pitch angle is defined by a rotation about a transverse axis of the at least one of the first sensor and the second sensor that is to the right of the patient [see Annotated Figure 1];
wherein the method further comprises prior to (b), calibrating the at least one of the first sensor and the second sensor based on the first offset [Tam ¶¶0047, 0049],
wherein calibrating the at least one of the first sensor and the second sensor includes applying the first offset to align the difference between the angle between the first sensor and the second sensor in the first configuration to the measured joint angle [Tam ¶¶0047, 0049, see above interpretation of Tam in light of the plain definition of “calibrate” / “calibration”]; and
wherein the method further comprises after (c), recalibrating at least one of the first sensor and the second sensor [Tam ¶¶0044, 0047, 0049],
wherein recalibrating the at least one of the first sensor and the second sensor includes applying the second offset to align the difference between the angle between the first sensor and the second sensor in the second configuration to the measured joint angle [Tam ¶¶0047, 0049, see above interpretation of Tam in light of the plain definition of “calibrate” / “calibration”].
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Annotated Figure 1. The sensors as depicted in Figure 12 of Tam may be considered to define a longitudinal axis along the length of the at least one of the first sensor and the second sensor that points away from the joint of the patient parallel to the ground and a transverse axis of the at least one of the first sensor and the second sensor that is to the right of the patient, wherein measuring range of motion of the knee joint [as depicted above and in Tam Figures 17-18] may be considered to read on a pitch angle defined by a rotation about a transverse axis. While Tam does not explicitly disclose measuring a roll angle defined by a rotation about the longitudinal axis, the roll angle may still be defined as such.
However, while Tam discloses maintaining consistent measurements between application of the sensors [Tam ¶0044] and the use of a goniometer to provide the measured joint angle as a reference for calibration of the first sensor and the second sensor [Tam ¶0047], Tam fails to explicitly disclose that in step (c) in each of the first configuration and the second configuration, a same joint angle for the baseline position is reported; and wherein the recalibration after step (c), in each of the first configuration and the second configuration, the same joint angle for the baseline position is reported.
Kord discloses systems and methods to allow for repeatable calibration of several IMUs using offset angles between IMUs and known correct angles, wherein Kord discloses steps for repeatably positioning a user’s joints on which several IMUs are attached in a baseline position prior to calibration of the IMUs, wherein [A calibration frame in accord with the disclosed embodiments holds a motion capture subject's hand in a controlled and accurately repeatable orientation, thereby enabling an accurate determination of offset angles between the measurement axes of the IMUs used for motion capture and the corresponding positions of limb segments and joints in a biomechanical skeleton used for computer modelling of the motion capture subject's movements (Kord ¶0022); The stable character of the identified part of the hand led to the development of a calibration fixture for determining an offset in a spatial angle between the body surface to which the IMU is attached and a horizontal reference plane used for defining an initial position of a biomechanical skeleton. After an IMU is calibrated on a fixture in accord with the disclosed embodiments, IMU motion capture data may be corrected by the determined spatial offset angle(s) and the angle of a surface of the calibration fixture to accurately position the corresponding biomechanical skeleton segment with respect to a selected reference plane (Kord ¶0023); The position of the optional fingertip bar 120 may be adjustable to control a depth to which a subject's fingers are inserted between the partitions, thereby improving repeatability of calibration measurements (Kord ¶0028)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Tam to employ that in step (c) in each of the first configuration and the second configuration, a same joint angle for the baseline position is reported; and wherein the recalibration after step (c), in each of the first configuration and the second configuration, the same joint angle for the baseline position is reported, so as to allow for measurements after separate calibrations to be standardized with respect to the same baseline position and allow for consistent measurements of the joint angle across applications of the sensors.
Regarding claim 2, Tam in view of Kord teaches
The method according to claim 1, wherein the first sensor and the second sensor communicate such that the angle between the first sensor and the second sensor is determined by one of the first sensor or the second sensor [Tam ¶¶0010, 0047].
Regarding claim 3, Tam in view of Kord teaches
The method according to claim 1, further comprising, prior to (a), the step of measuring the joint angle by using a goniometer to define the measured joint angle [Tam ¶0047].
Regarding claim 4, Tam in view of Kord teaches
The method according to claim 1, wherein recalibrating the at least one of the first sensor and the second sensor is carried out as part of a sensor activation process [Tam ¶0047, wherein using the sensors for data collection after calibration is considered to read on the claimed limitation].
Regarding claim 5, Tam in view of Kord teaches
The method according to claim 3, wherein measuring the joint angle includes measuring the joint angle between respective portions of the joint [Tam ¶0047].
Regarding claim 6, Tam in view of Kord teaches
The method according to claim 5, wherein the measured joint angle is a pitch angle and/or a roll angle [Tam ¶0047, wherein and angle of flexion/extension of the knee joint is considered to read on a pitch angle of the joint based on pitch as well-understood in the art (based on the flexion/extension of the shank of the user relative to the thigh of the user as depicted in at least Tam Figs. 12, 17-18)].
Regarding claim 7, Tam in view of Kord teaches
The method according to claim 1, further comprising the step of moving the joint to the baseline position which is a joint full extension position [In some embodiments, calibration may be achieved by having the patient perform a set of tasks, such as sitting with the knees bent at 90 degrees, followed by standing with the knees in full extension (Tam ¶0049); wherein based on the § 103 modification in view of Kord, the calibration as taught by Tam teaching a joint full extension position applies to each of the first configuration and the second configuration].
Regarding claim 8, Tam in view of Kord teaches
The method according to claim 1, wherein reapplication of the at least one of the first sensor and the second sensor is carried out at substantially a same position [Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044)].
Regarding claim 9, Tam in view of Kord teaches
The method according to claim 1, further comprising the step of identifying an axis of movement of the joint [wherein measuring an angle of motion (Tam ¶0010, ¶0047) is considered to define an axis of movement of the joint].
Regarding claim 10, Tam in view of Kord teaches
The method according to claim 1, further comprising the step of applying the first sensor and the second sensor, one on each side of the joint [the sensor devices 42, 43 may take the form of a strip, or elements woven into fabric or fabric-like material. In various alternative embodiments, the sensor devices 42, 43 may be worn on or inside clothes, may be strapped onto the patient (Tam ¶0042); a first sensor 42 above the knee (over the femur) and a second sensor 43 below the knee (over the tibia) may be used to communicate relative position between the sensors 42, 43 (Tam ¶0040)].
Regarding claim 11, Tam in view of Kord teaches
The method according to claim 10, further comprising the step of, prior to applying the first sensor and the second sensor, marking locations for mounting at least one of the first sensor and the second sensor on each side of the joint [Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044), wherein the application of the first sensor and the second sensor may be considered to be replacement sensors, such that the markings (Tam ¶0044) may be considered to be placed prior to applying the first sensor and the second sensor].
Claim(s) 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tam in view of Kord, as applied to claim 1 above, in further view of Whitmore (US-20110166446-A1, previously presented).
Regarding claim 30, Tam in view of Kord teaches
The method according to claim 1, wherein the first sensor is configured to mount to a first mounting system, the second sensor configured to mount to a second mounting system [In an alternative embodiment, the positioning device may be a non-digital device. For example, the positioning device may look and function like a traditional knee brace. The patient (or healthcare profession) places the brace-like positioning device over the patient's joint, and the user may either attach tracking components using the placement device as a positional reference point, or the positioning device may have the tracking components pre-attached. In these embodiments, the patient simply removes the positioning device, and the tracking components remain in the desired location on the patient's body, for example with adhesive backing. Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044), wherein the adhesive backing as disclosed by Tam is only partially considered to read on the first mounting system], the method further comprising prior to (a) [wherein based on Tam ¶0044, the application of the first sensor and the second sensor may be considered to be replacement sensors, such that the steps of mounting may be considered to be prior to (a)]:
applying the first mounting system to a first side of the joint and the second mounting system to a second side of the joint [Tam ¶0042, ¶0044];
marking a first location of the first mounting system and a second location of the second mounting system [Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044)]; and
attaching the first sensor to the first mounting system and the second sensor to the second mounting system so that the first sensor and the second sensor are in the first configuration relative to each other [each sensor device 42, 43 may include a sensor electronics housing 44 (or “sensor pod”) and a base 46 (or “adhesive docking patch”). In some embodiments, most or all of the sensor electronics are disposed within the housing 44, and the base 46 is worn on the patient's skin, attached via an adhesive backing (Tam ¶0039); Magnets in the housing 44 and the base 46 may provide a strong yet detachable connection between the two. Alternatively, the electronics housing 44 may snap into the base 46 through a press fit, may be screwed in by mating threads on the housing 44 and the base 46, or may be attached to one another by any other suitable means (Tam ¶0040); Tam ¶0044)].
However, while Tam discloses wherein the first sensor is configured to mount to a first mounting system defining at least one first cutout portion, the second sensor configured to mount to a second mounting system, Tam in view of Kord fails to explicitly disclose the first mounting system defining at least one first cutout portion, as well as failing to explicitly disclose wherein the second mounting system defines at least one second cutout portion.
Whitmore discloses systems wherein sensors are applied to a subject’s skin [see at least abstract of Whitmore], wherein Whitmore discloses a mounting system comprising a patch comprising holes [an attachment member, e.g., a disk, for use with a marker device in an image-guided procedure on a patient. The marker device includes an EM sensor and a frame assembly. The frame assembly includes a base portion having plural projections. The disk has an adhesive undersurface and an opening for receipt of a respective one of the plural projections of the marker device. Each disk is arranged to be releasably coupled to the frame assembly of the marker device by locating a respective one of the projections in the opening of the disk and then adhesively secured to the skin of the patient, whereupon the marker device is releasably secured to the patient (Whitmore ¶0014); The frame assembly 24 in addition to having a "tripod" set of legs 38A, 38B and 38C that support it and the adhesive attachments provided by the adhesive disks 22A-22C, has three, asymmetrically spaced openings or apertures 40A, 40B and 40C in a common plane in the base portion 32. As best seen in FIGS. 1 and 2 the apertures 40A, 40B and 40C are located adjacent a respective one of the legs 38A, 38B and 38C. Each of the apertures is at a different distance from the others. The apertures allow the operator to mark or "tattoo" indicia on the skin of the patient using the singular orientation of the device's frame. In particular, the marker device 20 can be placed on the patient's skin at the time of an imaging exam and within the field being imaged. The skin can be marked using these three apertures as a guide at that time. Then at a later time an identical marker device 20 can be replaced in the exact same position and orientation by using the skin marks as a guide to placement (Whitmore ¶0036, Figures 1-2)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Tam in view of Kord to employ marking holes, so as to ensure identical placement of the first sensor and the second sensor during subsequent placements of the first sensor and the second sensor [Whitmore ¶0036], and would further amount to mere simple substitution of one known element [mounting system of Tam] for another [patch comprising holes of Whitmore] to obtain predictable results [ensure proper placement] [MPEP § 2143(I)(B)]. Furthermore, under the present modification of Tam in view of Kord and Whitmore, the modification is considered to teach the limitation wherein the marking includes marking a first location of the at least one first cutout portion and a second location of the at least one second cutout portion [Tam ¶0044, Whitmore ¶0036].
Regarding claim 31, Tam in view of Kord and Whitmore teaches
The method of claim 30, further comprising prior to (b), reapplying the first sensor and the second sensor [Tam ¶0044, see Examiner’s interpretations of claims 1 and 30 above].
Regarding claim 32, Tam in view of Kord and Whitmore teaches
The method of claim 31, wherein reapplying the first sensor and the second sensor includes aligning the at least one first cutout portion of the first mounting system with the first location and aligning the at least one second cutout portion of the second mounting system with the second location [see § 103 modification of claim 30 above, wherein the modification of Tam in view of Kord and Whitmore is considered to read on the claimed limitation (see Tam ¶0044; Whitmore ¶0036)].
Regarding claim 33, Tam in view of Kord and Whitmore teaches
The method of claim 32, wherein reapplying the first sensor and the second sensor includes reattaching at least one of the first sensor to the first mounting system and the second sensor to the second mounting system [see § 103 modification of claim 30 above, wherein the modification of Tam in view of Kord and Whitmore is considered to read on the claimed limitation (see Tam ¶¶0039-0040, ¶0044; Whitmore ¶0036)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 29 September 2025, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for failing to depict claimed subject matter have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-8, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claim 1 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously applied claim rejections under § 112(b) have been fully considered and are persuasive. The § 112(b) rejections of claims 1, 3, 5, 8, 10-11, 28, and those dependent therefrom have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-14, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tam (US-20160220175-A1, previously presented) in view of Kord (US-20190282126-A1) with respect to claim 1.
The Applicant asserts that there is no disclosure, teaching, or suggestion in Tam regarding the limitations “the first sensor and the second sensor are in a first configuration relative to each other”, “determining a first offset between a measured joint angle and an angle between the first sensor and the second sensor in the first configuration, for calibrating at least one of the first sensor and the second sensor”, “determining a second offset between the measured joint angle and an angle between the first sensor and the second sensor in the second configuration for recalibrating at least one of the first sensor and the second sensor”, “such that, in each of the first configuration and the second configuration, a same joint angle for the baseline position is reported” [emphasis applied by Applicant], as the Applicant argues that ¶¶0047-0049 of Tam discloses calibrating a program using a goniometer and not calibrating sensors, and further argues that ¶0047 does not describe or disclose how the software may calibrate the sensors 42, 43. Applicant’s argument has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Tam is further modified by Kord to teach the argued subject matter regarding the same joint angle for the baseline position being reported in each of the first configuration and the second configuration, as Kord discloses steps to allow for repeated calibrations in which a same baseline position is reported at the start of each calibration [A calibration frame in accord with the disclosed embodiments holds a motion capture subject's hand in a controlled and accurately repeatable orientation, thereby enabling an accurate determination of offset angles between the measurement axes of the IMUs used for motion capture and the corresponding positions of limb segments and joints in a biomechanical skeleton used for computer modelling of the motion capture subject's movements (Kord ¶0022); The stable character of the identified part of the hand led to the development of a calibration fixture for determining an offset in a spatial angle between the body surface to which the IMU is attached and a horizontal reference plane used for defining an initial position of a biomechanical skeleton. After an IMU is calibrated on a fixture in accord with the disclosed embodiments, IMU motion capture data may be corrected by the determined spatial offset angle(s) and the angle of a surface of the calibration fixture to accurately position the corresponding biomechanical skeleton segment with respect to a selected reference plane (Kord ¶0023); The position of the optional fingertip bar 120 may be adjustable to control a depth to which a subject's fingers are inserted between the partitions, thereby improving repeatability of calibration measurements (Kord ¶0028), emphasis applied by Examiner].
The Applicant further asserts that the Examiner applies inherency [MPEP § 2112(IV)] and fails to provide any factual basis to support allegations of alleged inherent characteristics of Tam. The Applicant specifically notes that Tam never explicitly discloses, teaches or suggest that after a sensor is removed/reapplied, a second offset is determined so that a same angle is reported in both configurations, and merely makes assumptions that a recalibration “would” occur. However, the Examiner disagrees, as the Examiner notes that inherency [MPEP § 2112(IV)] is not applied anywhere in the rejection under § 102 as anticipated by Tam. The Examiner notes that Tam is merely interpreted based on the context as disclosed by Tam, as Tam is directed towards systems and methods for monitoring patient movement across a course of care, wherein a sensor system may be replaced during the course of care [Some embodiments of the system 40 may include a positioning device (not shown), to provide consistent and reliable positioning of tracking components, including the sensors 42, 43, on the patient's body… In these embodiments, the patient simply removes the positioning device, and the tracking components remain in the desired location on the patient's body, for example with adhesive backing. Once the correct position of the two sensor devices on either side of a joint has been determined, the positions may be marked manually with an indelible marker or temporary tattoo. Alternatively, there may be indelible ink built into the initial calibration affixation adhesive devices to mark the spot for the replacement of the sensors through the course of care (Tam ¶0044, emphasis applied by Examiner)], wherein the sensors undergo an initial calibration upon application [After calibration, the sensors 42, 43 may be configured to provide continuous or intermittent measurements of joint range of motion to the software platform (Tam ¶0047)]. As such, the Examiner does not allege any inherent characteristics of Tam and merely interprets Tam based on the disclosure of Tam.
The Applicant also asserts that the assertion by the Office Action that the claimed “angle between sensors corresponds to the difference of pitch/roll of each sensor” being considered to read on Tam’s generic “range of motion” data is improper, as Tam does not disclose the claimed computation (difference-of-IMU pitch/roll) nor the axis definition and the Applicant notes the Examiner admits that Tam does not explicitly disclose measuring a roll angle as claimed. As such, the Applicant notes that the use of Tam to teach the argued subject matter is based in improper possibilities and probabilities, and is not considered inherent due to such subject matter not being necessarily present in Tam. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that claim 1 specifically recites “the angle between the first sensor and the second sensor in the first configuration corresponds to a difference between at least one of a pitch angle and a roll angle of the first sensor and at least one of a pitch angle and a roll angle of the second sensor” and “the angle between the first sensor and the second sensor in the second configuration corresponds to the difference between at least one of the pitch angle and the roll angle of the first sensor and at least one of the pitch angle and the roll angle of the second sensor”, such that Tam is only required to teach one of a pitch angle or a roll angle. The Examiner notes that the depiction of the roll angle in Annotated Fig. 1 of Tam Fig. 12 is merely to depict that the geometric relationship as defined by the Applicant exists within the space measured by Tam. Furthermore, as claim 1 recites “wherein the roll angle is defined by a rotation about a longitudinal axis along an entire length of the at least one of the first sensor and the second sensor that points away from the joint of the patient parallel to the ground and the pitch angle is defined by a rotation about a transverse axis of the at least one of the first sensor and the second sensor that is to the right of the patient”, the Applicant defines geometric relationships between the sensors, patient, and ground, that are not structural requirements of the sensors. Based on the Applicant’s Fig. 2, and the Examiner’s Annotated Fig. 1, which annotates Fig. 12 of Tam, the range of motion defines a pitch angle between sensors 42, 43, as sensor 42/43 rotates about a transverse axis of sensor 43/42, as defined in claim 1.
The Applicant asserts that that regarding claimed step (a), Tam never discloses computing knee angle as difference of IMU pitch/roll outputs [the Applicant refers to the claimed specific inter-sensor angle definition], and notes that Tam only states it can process sensed data to provide ROM. The Applicant further notes that the Examiner improperly applies inherency when using Tam to teach a “roll angle” that is not explicitly disclosed in Tam. Regarding the argument that Tam never discloses computing the knee angle as a difference of IMU pitch/roll outputs, the Examiner notes that the Applicant defines the roll/pitch angles as being a rotation about an axis of the first sensor or the second sensor relative to the other of the first sensor or second sensor, wherein as Tam discloses a joint angle measured by the relative position of one sensor device to another sensor device using sensors that are known to comprise an inertial measurement unit as well-understood in the art [Sensors 26, 28 may be any suitable motion sensor, such as but not limited to accelerometers, gyroscopes, magnometers, capacitive sensors, resistive sensors, optical sensors or any combination thereof (Tam ¶0036)] and depicts the range of motion of the joint angle in Figs. 12 and 17-18 in a sagittal plane of the user, the measurement axes of sensors 42, 43 are considered to be at least equivalent to the claimed pitch angle [see Annotated Fig. 1, as sensors 42, 43 measure at least rotation in a transverse axis as defined by the Applicant]. The angle prior to calibration between the first sensor and the second sensor corresponds to a pitch angle difference of each of the first sensor and the second sensor in space, as the angle measured between sensors 42, 43 is considered to be defined by the difference in the measurement axis of the sensors in space, which as depicted in at least Tam Figs. 12, 17-18, and Annotated Fig. 1 is about a transverse axis. The Examiner directs attention to the response presented above regarding the roll angle of Tam.
The Applicant further asserts that Tam does not disclose (i) a second offset after reapplication; and (ii) the functional result that the baseline reports the same joint angle across two different sensor configurations. The Applicant notes that the Examiner improperly applied inherency by stating that it “would be reported”, which is not taught, disclosed, or suggested by Tam. However, the Examiner disagrees with the Applicant’s argument that Tam does not disclose (i) a second offset after reapplication, for similar reasons as discussed in the Examiner’s response above regarding the interpretation of Tam based on the context as disclosed by Tam. Applicant’s argument, with respect to the argument that Tam does not disclose (ii) the functional result that the baseline reports the same joint angle across two different sensor configurations, has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Tam is further modified by Kord to teach the argued subject matter regarding the same joint angle for the baseline position being reported in each of the first configuration and the second configuration, as Kord discloses steps to allow for repeated calibrations in which a same baseline position is reported at the start of each calibration [Kord ¶¶0022-0023, 0028].
The Applicant also asserts that Tam does not disclose any of the claimed axes [“roll angle is defined by a rotation about a longitudinal axis”, “the pitch angle is defined by a rotation about a transverse axis”], and that the Examiner merely treats the claimed axes as merely geometric, which the Applicant considers to be improper treatment of positively recited claim terms that have definition and meaning in the art and to one of ordinary skill in the art. The Applicant further notes that the claimed axes are relevant to how the inter-sensor angle is computed. Furthermore, the Applicant notes that the Examiner’s assertion that the axes may still be defined by the measurements of Tam is a possibility, but fails to be present in Tam and constitutes improper inherency assertion. However, the Examiner disagrees with the Applicant’s argument, as Tam discloses measuring a joint angle [the joint motion data may reflect an angle of flexion of the knee joint and an angle of extension of the knee joint (Tam ¶0010)], and only fails to provide a name to the joint angle that is the same name as the Applicant’s recitation of a roll/pitch angle. Based on the joint angle measured by Tam in Figs. 12 and 17-18, and further interpreted in Annotated Fig. 1, the joint angle measured by Tam is equivalent to the claimed pitch angle.
The Applicant asserts that the Examiner’s assertion that the angle of flexion/extension “is considered to read on” differences of pitch/roll, which the Applicant notes does not mean that the feature is disclosed, taught, or suggested, by Tam. The Applicant further notes that the ROM output of Tam may be computed in many ways that are not the claimed difference-of-IMU pitch/roll. However, the Examiner disagrees with the Applicant’s argument for reasons as discussed in the Examiner’s response above with respect to the argument that Tam never discloses computing knee angle as difference of IMU pitch/roll outputs.
The Applicant further asserts that that the Examiner’s assertion that the same baseline after re-application “is considered” to be reported is an improper inherency assertion, as the Applicant notes that there is no step in Tam that is a post-re-application offset matching the original baseline measure. Applicant’s argument has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Tam is further modified by Kord to teach the argued subject matter regarding the same joint angle for the baseline position being reported in each of the first configuration and the second configuration, as Kord discloses steps to allow for repeated calibrations in which a same baseline position is reported at the start of each calibration [Kord ¶¶0022-0023, 0028].
The Applicant also asserts that Tam does not inherently or explicitly disclose the further features of amended claim 1 of “wherein the method comprises prior to (b), calibrating the at least one of the first sensor and the second sensor based on the first offset, wherein calibrating the at least one of the first sensor and the second sensor includes applying the first offset to align the difference between the angle between the first sensor and the second sensor in the first configuration to the measured joint angle; and wherein the method further comprises after (c), recalibrating at least one of the first sensor and the second sensor such that, in each of the first configuration and the second configuration, the same joint angle for the baseline position is reported, wherein recalibrating the at least one of the first sensor and the second sensor includes applying the second offset to align the difference between the angle between the first sensor and the second sensor in the second configuration to the measured joint angle”. Regarding the amended limitations, Tam is considered to teach the steps of calibration prior to (b) and recalibrating after (c) [Tam ¶¶0047, 0049, see above interpretation of Tam in light of the plain definition of “calibrate” / “calibration”]. Applicant’s argument has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, with respect to the claim language regarding the same joint angle for the baseline position is reported in each of the first configuration and the second configuration. Tam is further modified by Kord to teach the argued subject matter regarding the same joint angle for the baseline position being reported in each of the first configuration and the second configuration, as Kord discloses steps to allow for repeated calibrations in which a same baseline position is reported at the start of each calibration [Kord ¶¶0022-0023, 0028].
The Examiner notes that the rejections based on prior art do not rely on inherency, but merely rely on what is taught in the art. While it is not expressly stated, the sensors of Tam operate under their well-known functionality, such that while Tam may not expressly disclose each and every function or operation performed in the disclosed calibration of the sensors, it doesn’t mean steps and functions similar to the instant claims isn’t what is happening based on the plain definition of “calibration”. The Applicant has merely alleged reliance on inherency, but has failed to show any flaw or provide any evidence that the Examiner’s interpretation of Tam is wrong, or how the prior art can’t perform or doesn’t perform the invention as claimed. The mere allegation that Tam may possibly perform the claimed method is not considered to be a sufficient argument that the disclosure Tam may not be interpreted to read on the claimed method.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791