DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 30 April 2026. The Examiner acknowledges the amendments to claims 1 and 5, as well as the cancelation of claim 3. Claims 1-2, 4-11, and 30-33 are pending.
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 .
Specification
The amendment filed 18 April 2022 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [This application is the National Stage of International application no. PCT/IB2020/059720 filed October 15, 2020, which claims the benefit of priority from United Kingdom patent application no. 1915135.6, filed October 18, 2019, which are incorporated by reference herein in their entirety (Applicant’s Specification p. 1)]. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 should read “wherein step (c) is performed without remeasuring the measured joint angle with the goniometer” [lines 46-47].
Appropriate correction is required.
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) 1-2 and 4-11 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, previously presented), Heijkants (US-20100286950-A1), and Yamamoto (US-20060112754-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), 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 [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), 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 a respective 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”];
wherein calibrating further comprises establishing, for each of the first sensor and the second sensor, a respective baseline orientation reference corresponding to the baseline position, and storing the respective baseline orientation reference [Tam ¶0044, wherein providing a marking for sensor placement for subsequent attachments of the sensors is considered to read on the broadest reasonable interpretation of the claimed limitation as a form of “storing” a baseline orientation reference of the baseline position of the first sensor and the second sensor];
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”];
wherein the measured joint angle is measured during step (a) using a goniometer and stored [Tam ¶0047].
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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) the determination of the second offset is a difference between the measured joint angle determined in step (a) and the angle between the first sensor and the second sensor in the second configuration, and 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; and wherein step (c) is performed without measuring the measured joint angle with the goniometer.
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 during each instance of calibration and recalibration the same joint angle for the baseline position is reported, as Kord defines an initial measured joint angle that is used as a reference for each calibration and recalibration [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), wherein the calibration frame being configured to hold the subject’s hand in a “controlled and accurately repeatable orientation” is considered to define an initial and singular reference measurement for performing subsequent calibrations and recalibrations, such that in subsequent calibrations and recalibrations there is no additional measuring of the initial reference measurement, as the hand is considered to be placed in a known orientation].
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) the determination of the second offset is a difference between the measured joint angle determined in step (a) and the angle between the first sensor and the second sensor in the second configuration, and 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; and wherein step (c) is performed without measuring the measured joint angle with the goniometer, 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.
However, while Tam generally discloses calibrating as understood in the art, Tam in view of Kord fails to explicitly disclose wherein, after applying the first offset, a reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the first offset; and wherein, after applying the second offset, the reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the second offset.
Heijkants discloses systems for calibrating a first sensor and a second sensor each mounted to a joint to be measured of a patient, wherein Heijkants discloses steps of 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, 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; wherein, after applying the first offset, a reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the first offset [After the knee brace 5 has been installed the processing module 9 is activated to measure, under static condition, i.e. during rest of the upper leg 1 and lower leg 2, the inclination angle .alpha.static1 of the first member 1 (the upper leg) using the first acceleration sensor 3, as well as the inclination angle .alpha.static2 of the second member 2 (the under leg) using the second acceleration sensor 4, and to calculate the angle .alpha.static=.alpha.static1-.alpha.static2. The processing module 9, moreover, is activated to measure the (same) angle between the first and second member by means of the angle measuring device 6-8, i.e. the optical fiber goniometer, and to compute, from the ratio of the input power (of the signal to the light source 7) and the power output (of the signal from the light detector 8), the angle between the upper leg 1 and the lower leg 2, resulting in a calculation result .alpha.static'. Next the processing module 9 calculates and stores an angle error correction factor c from c=.alpha.static-.alpha.static' or c=.alpha.static/.alpha.static', which correction factor c must be applied to future angle measurements performed by the angle measuring device (fiber goniometer) 6-8… The measuring results, i.e. the measured angle values, may be registered in (or via) the processing module 9 or be sent directly to a remote control device, however, after being corrected by the error correction factor c, which was calculated during the last static (rest) period (Heijkants ¶¶0031-0034), wherein applying the angle error correction factor (numerical value as defined in ¶0033) to subsequently measured numerical values is considered to read on an algebraic sum of the angle between the first sensor and the second sensor and the determined offset].
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 wherein, after applying the first offset, a reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the first offset; and wherein, after applying the second offset, the reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the second offset, so as to report corrected joint angles based on each of the first and second offset.
However, while each of Tam, Kord, and Heijkants are directed towards performing steps of calibrating sensors, Tam in view of Kord and Heijkants fails to explicitly disclose a step of (d) preventing recording or storing a subsequent data set after the at least one sensor has been removed and reapplied until the second offset has been determined and applied.
Yamamoto discloses systems and methods for monitoring movement, wherein Yamamoto discloses steps to prevent acceleration data from being recorded or stored after application of a sensor until a step of sensor correction [considered to be equivalent to a step of calibration] is performed [it becomes possible for the device to automatically detect if the wearer has put on/off the device, thereby prompting the wearer to perform a correction or automatically starting a correction, judging automatically whether a correction is needed or not (Yamamoto ¶0017); Here, "parameter correction" refers to clarify a relationship between (i) directions of the respective acceleration sensors included in the device and (ii) a reference direction of the wearer (e.g. front serves as the reference direction of the wearer). Thus, the above correction needs to be performed every time the attachment position of the device changes (Yamamoto ¶0046); First, when the attachment detection unit 61 detects that the device has been put on the wearer (S1301: Yes), the correction trigger unit 31 sends, to the acceleration sensing unit 11, the attachment position judgment unit 32, and the audio guidance unit 41, a signal indicating that a correction is to be started (Yamamoto ¶0094)].
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 and Heijkants to employ a step of (d) preventing recording or storing a subsequent data set after the at least one sensor has been removed and reapplied until the second offset has been determined and applied, so as to prevent erroneous data collection and ensure that only correct/calibrated measurements are performed.
Regarding claim 2, Tam in view of Kord, Heijkants, and Yamamoto 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 4, Tam in view of Kord, Heijkants, and Yamamoto 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; see also Yamamoto ¶¶0017, 0046, 0094].
Regarding claim 5, Tam in view of Kord, Heijkants, and Yamamoto teaches
The method according to claim 1, 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto 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, Heijkants, and Yamamoto, as applied to claim 1 above, in further view of Whitmore (US-20110166446-A1, previously presented).
Regarding claim 30, Tam in view of Kord, Heijkants, and Yamamoto 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 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, Heijkants, and Yamamoto 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, Heijkants, Yamamoto, 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, Heijkants, Yamamoto, 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, Heijkants, Yamamoto, 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 based on the disclosure of Whitmore is considered to read on the claimed limitation (see Tam ¶0044; Whitmore ¶0036)].
Regarding claim 33, Tam in view of Kord, Heijkants, Yamamoto, 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 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. 9, filed 30 April 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for the same reference character being used to refer to different elements and reference character(s) not mentioned in the description have been withdrawn.
The Examiner acknowledges the Applicant’s amendments to the Specification, however the Examiner notes that the Applicant’s Specification as filed does not specifically include paragraph numbers and instead uses page and line numbers, such that the Applicant’s amendments to the Specification [referred to by ¶¶0072, 0074-0075] are considered to refer to the paragraphs on p. 13:25-28 and p. 14:4-28 of the Applicant’s Specification as filed 18 April 2022.
Applicant’s arguments, see Applicant’s Remarks p. 9-11, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 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, previously presented), Heijkants (US-20100286950-A1), and Yamamoto (US-20060112754-A1).
The Applicant asserts that Tam fails to disclose the amended limitations of claim 1 [lines 31-32, 33-35, 42-44, 45-47, and 48-49], wherein the Applicant particular notes that while Tam discloses generally that sensed data from sensors placed around a joint may be processed to provide joint motion data and reported/communicated, Tam does not disclose generating a “reported joint angle” as claimed. The Applicant further asserts that Kord similar fails to disclose or suggest the same noted amended limitations of claim 1 to remedy Tam. However, the Examiner notes that the Applicant’s arguments with respect to claim(s) 1 have 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. While the Examiner disagrees with the Applicant’s arguments that Tam fails to teach the amended limitations “wherein calibrating further comprises establishing, for each of the first sensor and the second sensor, a respective baseline orientation reference corresponding to the baseline position, and storing the respective baseline orientation reference” [Tam ¶0044, wherein providing a marking for sensor placement for subsequent attachments of the sensors is considered to read on the broadest reasonable interpretation of the claimed limitation as a form of “storing” a baseline orientation reference of the baseline position of the first sensor and the second sensor]; wherein the method further comprises after (c), recalibrating at least one of the first sensor and the second sensor [Tam ¶¶0044, 0047, 0049]; “wherein the measured joint angle is measured during step (a) using a goniometer and stored” [Tam ¶0047]; Tam is presently further modified in view of Kord, Heijkants, and Yamamoto, wherein the Examiner notes that Kord is considered to disclose performing subsequent calibrations/recalibrations without remeasuring the measured joint angle [Kord ¶¶0022-0023, 0028, wherein the calibration frame being configured to hold the subject’s hand in a “controlled and accurately repeatable orientation” is considered to define an initial and singular reference measurement for performing subsequent calibrations and recalibrations, such that in subsequent calibrations and recalibrations there is no additional measuring of the initial reference measurement, as the hand is considered to be placed in a known orientation]; Heijkants discloses steps of 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, 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; wherein, after applying the first offset, a reported joint angle is generated as an algebraic sum of (i) the angle between the first sensor and the second sensor and (ii) the first offset [Heijkants ¶¶0031-0034, wherein applying the angle error correction factor (numerical value as defined in ¶0033) to subsequently measured numerical values is considered to read on an algebraic sum of the angle between the first sensor and the second sensor and the determined offset]; and Yamamoto discloses steps to prevent acceleration data from being recorded or stored after application of a sensor until a step of sensor correction [Yamamoto ¶¶0017, 0046, 0094]. As such, in combination, Tam in view of Kord, Heijkants, and Yamamoto are considered to render obvious amended claim 1.
Conclusion
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.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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