DETAILED ACTION
Claims 86-102, 104-106 and 191 are pending. Claims 1-85, 103 and 107-190 are cancelled and claim 191 is new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/12/2026 has been entered.
Response to Arguments
Applicant’s arguments, filed 5/12/26, have been fully considered but are not persuasive.
Applicant’s arguments regarding the rejections under 35 U.S.C. § 103 (pages 5-8) are moot in view of the newly cited reference, Stein, and because neither Navarro nor Robinson is currently cited.
For at least these reasons, the rejection of the claims is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 191 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
With regard to claim 191, this claim recites ‘to couple the at least one sensor to the spinal implant for implantation between vertebral bodies of a patient’ and it is not clear how ‘for implantation between vertebral bodies of a patient’ is intended to limit the claim or if this is merely a statement of intended use.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 86-88, 100 and 105 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stein et al. U.S. Patent Publication No. 20110319755 (hereinafter Stein).
Regarding claim 86, Stein discloses a method of sampling data from an implantable cartridge coupled to an interbody spacer implanted in a patient [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position], the method comprising:
obtaining one or more kinematic measurements associated with a patient's movements using at least one sensor of the implantable cartridge and generating sensor data [0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system], the implantable cartridge comprising:
a housing [0117, Fig. 7 — Compressible propagation structure 504 is coupled to a load bearing or contacting surface 508 and an encapsulating enclosure 510 (housing) of sensing module 200. A parameter to be measured is applied to either contacting surface 508, encapsulating enclosure 510, or both],
the at least one sensor [0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration)], and
an antenna [0086, Fig. 3 — an antenna 310 to permit wireless operation and telemetry functions; 0128, Figs. 3-7 — antenna 552],
wherein the at least one sensor and the antenna are positioned on or within the housing [0117, Fig. 7 — Compressible propagation structure 504 is coupled to a load bearing or contacting surface 508 and an encapsulating enclosure 510 (housing) of sensing module 200; 0127-0128, Fig. 7 — accelerometer 554 and antenna 552 are within housing 510],
wherein the housing is at least partially received within the interbody spacer to couple the at least one sensor to the interbody spacer [0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510)… The final insert device can be a passive component or sensored incorporating sensing module 200]; and
transmitting, via the antenna, the sensor data to and receiving the sensor data at a receiver at a remote location [0096-0100, Figs. 1-2 and 6 — communications system 400 comprises medical device communications components 410 of the sensing insert device 100 (see FIG. 1) and receiving system communications components 450 of the receiving system 110 (see FIG. 1)… sensing insert device 100 acquires sensor data by way of the data input to the ASIC 420…data packetizer 422 assembles the sensor data into packets… telemetry transmitter 416 then transmits the CRC encoded data packet through the matching network 414 by way of the antenna 412… receiving system communications components 450 receive transmission sent by medical device communications components 410].
Regarding claim 87, Stein further discloses obtaining one or more kinematic measurements occurs during movement of the patient [0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system].
Regarding claim 88, Stein further discloses obtaining detecting one or more kinematic measurements occurs wherein the interbody spacer is under load [0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration); 0117, Fig. 7 — Compressible propagation structure 504 is coupled to a load bearing or contacting surface 508 and an encapsulating enclosure 510 (housing) of sensing module 200. A parameter to be measured is applied to either contacting surface 508, encapsulating enclosure 510, or both].
Regarding claim 100, Stein further discloses the one or more kinematic measurements are used to determine one or more parameters of patient movement [0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071 — The accelerometer 122 can operate singly, as an integrated unit with the load sensing platform 121, and/or as an integrated unit with the sensing assemblies 123. Integrating one or more accelerometers 122 within the sensing assemblages 123 to determine position, attitude, movement, or acceleration of sensing assemblages 123 enables augmentation of presentation of data to accurately identify, but not limited to, orientation or spatial distribution of load, force, pressure, displacement, density, or viscosity, or localized temperature by controlling the load and position sensing assemblages to measure the parameter or parameters of interest relative to specific orientation, alignment, direction, or position as well as movement, rotation, or acceleration along any axis or combination of axes. Measurement of the parameter or parameters of interest may also be made relative to the earth's surface and thus enable computation and presentation of spatial distributions of the measured parameter or parameters relative to this frame of reference].
Regarding claim 105, Stein further discloses obtaining the one or more kinematic measurements comprises obtaining from an inertial measurement unit having a plurality of accelerometers and/or a plurality of gyroscopes [0071 — The accelerometer 122 can operate singly, as an integrated unit with the load sensing platform 121, and/or as an integrated unit with the sensing assemblies 123. Integrating one or more accelerometers 122 within the sensing assemblages 123 to determine position, attitude, movement, or acceleration of sensing assemblages 123 enables augmentation of presentation of data to accurately identify, but not limited to, orientation or spatial distribution of load, force, pressure, displacement, density, or viscosity, or localized temperature by controlling the load and position sensing assemblages to measure the parameter or parameters of interest relative to specific orientation, alignment, direction, or position as well as movement, rotation, or acceleration along any axis or combination of axes. Measurement of the parameter or parameters of interest may also be made relative to the earth's surface and thus enable computation and presentation of spatial distributions of the measured parameter or parameters relative to this frame of reference].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 89-90 and 92-93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Sahasrabudhe et al. U.S. Patent Publication No. 20110172927 (hereinafter Sahasrabudhe).
Regarding claim 89, Stein teaches all the limitations of the base claims as outlined above.
But Stein fails to clearly specify calibrating the implantable cartridge when the patient is at a known position.
However, Sahasrabudhe teaches calibrating the implantable cartridge when the patient is at a known position [0035 — a manual approach for calibrating the posture state definitions may be used to calibrate the defined posture vectors. In this latter embodiment, the processor may initialize one or more of the defined vectors to values obtained from the sensor while a patient carrying the medical device assumes the corresponding defined posture state.; 0150-0195, Figs. 6-8 — FIG. 8A is a conceptual diagram of IMD (implantable medical device) 12 implanted within patient 14… posture state definitions are not created "on the fly" as the patient goes about daily life, but may require some type of calibration procedure to be performed…. FIGS. 8B and 8C are screen shots illustrating positioning of an avatar during the posture state calibration process. Such screen shots may be provided by a user interface of clinician or patient programmer, for instance. A user may navigate to the screen by selecting an Orientation tab 151 in preparation to perform posture state orientation. The user may then manipulate a position of avatar 153 to match a desired posture state, which may be any position the patient occupies, and need not be limited to an Upright or Lying posture state. For instance, in FIG. 8B, the patient is assumed to be lying in a reclining position as when lying on an inclining bed or sitting in a reclining chair. In FIG. 8C, the patient is in a position that represents being seated in a wheel chair.].
Stein and Sahasrabudhe are analogous art. Stein and Sahasrabudhe relate to treating patients, particularly involving motion sensing.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Sahasrabudhe.
One of ordinary skill in the art would have been motivated to do this modification to ensure position sensor data are accurately interpreted by calibrating the sensor and doing so in a manner that is more convenient for the patient or even transparent to the patient, as suggested by Sahasrabudhe [0004, 0178-0179].
Regarding claim 90, the combination of Stein and Sahasrabudhe teaches all the limitations of the base claims as outlined above.
Further, Sahasrabudhe teaches the known position is when the patient is laying down [0148 — the patient may be asked to assume any number of posture states contained within a predetermined set of posture states (e.g., standing upright, lying on a right side, lying on a left side, lying on his back; 0191-0192, Figs. 6-8 — FIGS. 8B and 8C are screen shots illustrating positioning of an avatar during the posture state calibration process. Such screen shots may be provided by a user interface of clinician or patient programmer, for instance. A user may navigate to the screen by selecting an Orientation tab 151 in preparation to perform posture state orientation. The user may then manipulate a position of avatar 153 to match a desired posture state, which may be any position the patient occupies, and need not be limited to an Upright or Lying posture state. For instance, in FIG. 8B, the patient is assumed to be lying in a reclining position as when lying on an inclining bed or sitting in a reclining chair… slider bar 155 is used to select the Z-axis rotation of the torso of the avatar, which may be selected to match the known angle at which the patient's torso is reclining; 0208 — the patient makes a therapy adjustment while occupying any of the lying down postures].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Sahasrabudhe.
One of ordinary skill in the art would have been motivated to do this modification to ensure position sensor data are accurately interpreted by calibrating the sensor and doing so in a manner that is more convenient for the patient or even transparent to the patient, as suggested by Sahasrabudhe [0004, 0178-0179] by using a known laying down position with the predictable result of a method involving calibrating an interbody spacer/implant using a laying down position.
Regarding claim 92, the combination of Stein and Sahasrabudhe teaches all the limitations of the base claims as outlined above.
Further, Sahasrabudhe teaches the known position is when the patient's back is at a predetermined angle while the patient is in a sitting position [0191-0192, Figs. 6-8 — FIGS. 8B and 8C are screen shots illustrating positioning of an avatar during the posture state calibration process. Such screen shots may be provided by a user interface of clinician or patient programmer, for instance. A user may navigate to the screen by selecting an Orientation tab 151 in preparation to perform posture state orientation. The user may then manipulate a position of avatar 153 to match a desired posture state, which may be any position the patient occupies, and need not be limited to an Upright or Lying posture state. For instance, in FIG. 8B, the patient is assumed to be lying in a reclining position as when lying on an inclining bed or sitting in a reclining chair… slider bar 155 is used to select the Z-axis rotation of the torso of the avatar, which may be selected to match the known angle at which the patient's torso is reclining].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Sahasrabudhe.
One of ordinary skill in the art would have been motivated to do this modification to ensure position sensor data are accurately interpreted by calibrating the sensor and doing so in a manner that is more convenient for the patient or even transparent to the patient, as suggested by Sahasrabudhe [0004, 0178-0179] by using a known sitting position with the predictable result of a method involving calibrating an interbody spacer/implant using a sitting position.
Regarding claim 93, the combination of Stein and Sahasrabudhe teaches all the limitations of the base claims as outlined above.
Further, Sahasrabudhe teaches the predetermined angle is 30 degrees, 45 degrees, or 90 degrees [0191-0192, Figs. 6-8 — FIGS. 8B and 8C are screen shots illustrating positioning of an avatar during the posture state calibration process. Such screen shots may be provided by a user interface of clinician or patient programmer, for instance. A user may navigate to the screen by selecting an Orientation tab 151 in preparation to perform posture state orientation. The user may then manipulate a position of avatar 153 to match a desired posture state, which may be any position the patient occupies, and need not be limited to an Upright or Lying posture state. For instance, in FIG. 8B, the patient is assumed to be lying in a reclining position as when lying on an inclining bed or sitting in a reclining chair… slider bar 155 is used to select the Z-axis rotation of the torso of the avatar, which may be selected to match the known angle at which the patient's torso is reclining — angles 0-180 degrees include 30/45/90 degrees].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Sahasrabudhe.
One of ordinary skill in the art would have been motivated to do this modification to ensure position sensor data are accurately interpreted by calibrating the sensor and doing so in a manner that is more convenient for the patient or even transparent to the patient, as suggested by Sahasrabudhe [0004, 0178-0179] by using a known sitting position at specific angles with the predictable result of a method involving calibrating an interbody spacer/implant using a sitting position at specific angles.
Claim(s) 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Stein and Sahasrabudhe in view of Ness U.S. Patent Publication No. 20190008418 (hereinafter Ness).
Regarding claim 91, the combination of Stein and Sahasrabudhe teaches all the limitations of the base claims as outlined above.
Further, Sahasrabudhe fails to clearly specify that the known position is when the patient is standing [0150-0195, Figs. 6-8 — Screen 104A further includes posture selection items 108A-108E (collectively "posture selection items 108"), which correspond to the posture states of "Standing," "Lying (Back)," "Lying (Front)," "Lying (Left)," and "Lying (Right) (0153)].
One of ordinary skill in the art would have been motivated to do this modification to ensure position sensor data are accurately interpreted by calibrating the sensor and doing so in a manner that is more convenient for the patient or even transparent to the patient, as suggested by Sahasrabudhe [0004, 0178-0179] by using a known standing position with the predictable result of a method involving calibrating an interbody spacer/implant using a standing position.
But the combination of Stein and Sahasrabudhe fails to clearly specify that the known position is when the patient is standing against a wall.
However, Ness teaches that the known position is when the patient is standing against a wall [0077, Fig. 9 — the patient stands adjacent to the wall with her back against the wall].
Stein, Sahasrabudhe and Ness are analogous art. They relate to healthcare for patients.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to simply substitute known standing against a wall position of Ness for the known position of Stein and Sahasrabudhe for the predictable result of a method involving calibrating an interbody spacer/implant using a standing against a wall position.
Claim(s) 94, 97, 99, 101-102, 104 and 191 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Hunter et al. U.S. Patent Publication No. 20170196508 (hereinafter Hunter).
Regarding claim 94, Stein teaches all the limitations of the base claims as outlined above.
Further, Stein teaches one or more kinematic measurements and the interbody spacer [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position; 0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system].
But Stein fails to clearly specify that one or more kinematic measurements are used to determine fusion of the interbody spacer.
However, Hunter teaches that one or more kinematic measurements are used to determine fusion of the interbody spacer [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion] .
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
Regarding claim 97, Stein teaches all the limitations of the base claims as outlined above.
Further, Stein teaches one or more kinematic measurements and the interbody spacer [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position; 0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system].
But Stein fails to clearly specify that one or more kinematic measurements are used to determine migration of the interbody spacer.
However, Hunter teaches that one or more kinematic measurements are used to determine migration of the interbody spacer [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion].
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
Regarding claim 99, the combination of Stein and Hunter teaches all the limitations of the base claims as outlined above.
Further, Stein teaches one or more kinematic measurements and the interbody spacer [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position; 0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system].
Further, Hunter teaches that determining migration comprises detecting changes in the one or more kinematic measurements [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
Regarding claim 101, Stein teaches all the limitations of the base claims as outlined above.
But Stein fails to clearly specify a determined parameter of patient movement is at least one of step count, cadence, walking speed, angle of motion, and gait
However, Hunter teaches a determined parameter of patient movement is at least one of step count, cadence, walking speed, angle of motion, and gait [0128 — clinically important data to be collected such as, but not restricted to: extent of patient ambulation (time, distance, steps, speed, cadence), patient activity levels (frequency of activity, duration, intensity), exercise tolerance (work, calories, power, training effect), range of motion (discussed later) and spinal device/implant performance under various “real world” conditions].
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to simply substitute known cadence parameter of Hunter for the known movement parameter of Stein for the predictable result of a method involving determining patient cadence.
Regarding claim 102, Stein teaches all the limitations of the base claims as outlined above.
But Stein fails to clearly specify determining patient recovery progress by monitoring changes in the one or more kinematic measurements.
However, Hunter teaches determining patient recovery progress by monitoring changes in the one or more kinematic measurements [0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion in order to assess both short-term and long-term product performance, as well as assessment of healing and patient recovery].
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
Regarding claim 104, the combination of Stein and Hunter teaches all the limitations of the base claims as outlined above.
Further, Stein teaches the implantable cartridge further comprises a battery [0089, Fig. 3 — energy storage 330 can utilize power management technologies such as replaceable batteries].
Regarding claim 191, Stein teaches a method of sampling data from an implantable cartridge coupled to a spinal implant implanted in a patient [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position], the method comprising:
obtaining one or more kinematic measurements associated with a patient's movements using at least one sensor of the implantable cartridge and generating sensor data [0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system], the implantable cartridge comprising:
a housing [0117, Fig. 7 — Compressible propagation structure 504 is coupled to a load bearing or contacting surface 508 and an encapsulating enclosure 510 (housing) of sensing module 200. A parameter to be measured is applied to either contacting surface 508, encapsulating enclosure 510, or both],
the at least one sensor [0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration)], and
an antenna [0086, Fig. 3 — an antenna 310 to permit wireless operation and telemetry functions; 0128, Figs. 3-7 — antenna 552],
wherein the at least one sensor and the antenna are positioned on or within the housing [0117, Fig. 7 — Compressible propagation structure 504 is coupled to a load bearing or contacting surface 508 and an encapsulating enclosure 510 (housing) of sensing module 200; 0127-0128, Fig. 7 — accelerometer 554 and antenna 552 are within housing 510],
wherein the housing is at least partially received within the spinal implant to couple the at least one sensor to the spinal implant for implantation between bodies of a patient [0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510)… The final insert device can be a passive component or sensored incorporating sensing module 200; 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position]; and
transmitting, via the antenna, the sensor data to and receiving the sensor data at a receiver at a remote location [0096-0100, Figs. 1-2 and 6 — communications system 400 comprises medical device communications components 410 of the sensing insert device 100 (see FIG. 1) and receiving system communications components 450 of the receiving system 110 (see FIG. 1)… sensing insert device 100 acquires sensor data by way of the data input to the ASIC 420…data packetizer 422 assembles the sensor data into packets… telemetry transmitter 416 then transmits the CRC encoded data packet through the matching network 414 by way of the antenna 412… receiving system communications components 450 receive transmission sent by medical device communications components 410].
But Stein fails to clearly specify an implant for implantation between vertebral bodies.
However, Hunter teaches an implant for implantation between vertebral bodies of a patient [0063, Figs. 5-6 — Within various embodiments of the invention, sensors may be placed in some or all of the spinal implants and associated devices used for vertebroplasty and kyphoplasty. For example, as shown in FIG. 5, a variety of sensors can be placed on, or within the kyphoplasty balloon… Contact sensors (designated as an open rectangle) may also be distributed throughout the balloon in order to monitor contact between the balloon and the cancellous bone of the vertebral body — an implant between vertebral bodies is shown in the figures; 0088-0090, Fig. 14 — position sensors can be placed on and/or within an artificial disc (implant) between 2 vertebral bodies of a patient].
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery for spinal procedures, as suggested by Hunter [0083, 0088-0090], thus facilitating more informed decisions about ongoing treatment of the patient. In addition, it would be obvious to one having ordinary skill in the art to simply substitute the known intervertebral positioning of the implant, as taught by Hunter, for the generic positioning of the spinal implant, as taught by Stein, for the predictable result of a method of sampling data from an implant between vertebral bodies.
Claim(s) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Hunter and further in view of Bray et al. U.S. Patent Publication No. 20170020683 (hereinafter Bray).
Regarding claim 95, Stein teaches all the limitations of the base claims as outlined above.
Further, Stein teaches one or more kinematic measurements and the interbody spacer [0002, 0108 — The present invention pertains generally to a joint prosthesis, and particularly to methods and devices for assessing and determining proper alignment and placement of an implant component or components during joint reconstructive surgery and long-term implantation; 0052, Figs. 1-3 — a surgical procedure is performed to place a femoral prosthetic component 104 onto a prepared distal end of the femur 102. Similarly, a tibial prosthetic component 106 is placed to a prepared proximal end of the tibia 108. The tibial prosthetic component 106 can be a tray or plate affixed to a planarized proximal end of the tibia 108. The sensing insert device 100 is a third prosthetic component that is placed between the plate of the tibial prosthetic component 106 and the femoral prosthetic component 104 (interbody spacer); 0076, Figs. 1-3 and 5-7 — the sensing insert device 100 comprises an insert dock 202 (interbody spacer) and the sensing module 200 (sensing module with housing 510); 0050, 0133 — A knee joint is disclosed for illustrative purposes but sensing insert device 100 is applicable to other joints of the muscular-skeletal system. For example, the hip, spine, and shoulder have similar structures comprising two or more bones that move in relation to one another. In general, insert device 100 can be used between two or more bones allowing movement of the bones during measurement or maintaining the bones in a fixed position; 0048, 0059 — the medical device can intra-operatively assess a load on the prosthetic knee components (implant) and collect load data for real-time viewing of the load over various applied loads and angles of flexion (knee flexion/patient movement); 0055 — the sensing insert device 100 is in a final insert that is part of the final prosthesis implanted in the patient; 0071, 0085, Figs. 5-7 — Accelerometer 302 can also be used to sense orientation, vibration, impact and shock. The electronic circuitry 307 in conjunction with the accelerometer 302 and sensing assemblies 303 can measure parameters of interest (e.g., distributions of load, force, pressure, displacement, movement, rotation, torque and acceleration) relative to orientations of the sensing module with respect to a reference point. In such an arrangement, spatial distributions of the measured parameters relative to a chosen frame of reference can be computed and presented for real-time display; 0076 — The final insert device allows natural movement of the muscular-skeletal system and does not interfere with ligaments, tendons, tissue, muscles, and other components of the muscular-skeletal system].
But Stein fails to clearly specify that the one or more kinematic measurements are used to determine subsidence of the interbody spacer.
However, Hunter teaches that one or more kinematic measurements are used to determine movement of the interbody spacer [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion].
Stein and Hunter are analogous art. Stein and Hunter relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
But the combination of Stein and Hunter fails to clearly specify subsidence of the interbody spacer.
However, Bray teaches subsidence of the interbody spacer [0157 — interface members 530 may extend from a surface of the base member in a direction that is aligned with an elongate direction of two adjacent bone bodies, such as two vertebrae in a spine. The interface members are thus configured to provide progressive penetration into a bone body over a period of time. The subsidence profile, which is a relationship between an applied load and an amount of settling the implant device 510 experiences when secured to the bone bodies, is dependent on the configuration or shape of the interface members 530].
Stein, Hunter and Bray are analogous art. They relate to treating patients, particularly involving sensing/treatment for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to simply substitute known subsidence of Bray for the known movement of Stein and Hunter for the predictable result of a method involving subsidence of an interbody spacer/implant.
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Stein and Hunter and further in view of Suo et al. U.S. Patent Publication No. 20250099025 (hereinafter Suo).
Regarding claim 96, the combination of Stein and Hunter teaches all the limitations of the base claims as outlined above.
Further, Hunter teaches that one or more kinematic measurements are used to determine fusion of the interbody spacer [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion].
But the combination of Stein and Hunter fails to clearly specify that determining fusion comprises measuring an amount of force applied by vertebrae adjacent to the interbody spacer.
However, Suo teaches that determining fusion comprises measuring an amount of force applied by vertebrae adjacent to the interbody spacer [0012-0013 — the bone fusion data includes at least one of bone density, bone growth, a temperature change, an electrical property, a bone loading… the bone loading includes at least one of a force, stress, strain, or pressure; 0085 — the sensor 114 may measure loading (i.e., force, stress, strain, and/or pressure) on the implant body 108; 0091-0093, Figs. 1D, 1K, 1L — implant body 108 is secured to one or more vertebrae 130a, b, and c (adjacent vertebrae) via one or more fasteners 128 such as screws. For example the implant body 108 may provide a therapeutic effect of fusing the vertebrae 130a-c to treat degeneration of the discs 132a,b between the vertebrae 130a-c. The sensor 114 may measure any type of data described above to assess the fusion of the implant body 108 to the cervical spine 136 of the patient 102].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to simply substitute known force of Suo for the known movement of Stein and Hunter for the predictable result of a method involving force measurement of an interbody spacer/implant.
Claim(s) 98 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Stein and Hunter in view of Palmatier et al. U.S. Patent Publication No. 20170209286 (hereinafter Palmatier).
Regarding claim 98, the combination of Stein and Hunter teaches all the limitations of the base claims as outlined above.
Further, Hunter teaches that that determining migration comprises measuring movement of the interbody spacer from a point of implantation [0072, Fig. 8 — a cage (interbody spacer) is implanted between vertebrae; 0083 — position sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bony fusion as spinal cage movement should become progressively less as new bone growth successfully fuses the two segments together (and “locks” the cages within the bone mass); conversely, ongoing positional movement or increasing positional movement would be cause for concern that fusion is not progressing as expected. Positional sensors therefore allow for the continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.) and bony fusion].
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Hunter.
One of ordinary skill in the art would have been motivated to do this modification to assess healing and patient recovery, as suggested by Hunter [0083], thus facilitating more informed decisions about ongoing treatment of the patient.
But the combination of Stein and Hunter fails to clearly specify translation of the interbody spacer.
However, Palmatier teaches translation of the interbody spacer at a point of implantation [0022 — this configuration provides indicia and/or display of implant position corresponding to an amount of manipulation, movement, translation and/or rotation of the implant… manipulating, moving, translating and/or rotating the interbody spacer in a precise amount upon selected disposal of the interbody spacer in the intervertebral disc space; 0052, 0075-0077 — display of an amount of manipulation, movement, translation and/or rotation of spinal implant 150].
Stein, Hunter and Palmatier are analogous art. They relate to treating patients, particularly involving sensing/treatment for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to simply substitute known translation of Palmatier for the known movement of Stein and Hunter for the predictable result of a method involving translating an interbody spacer/implant.
Claim(s) 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of Mahfouz U.S. Patent Publication No. 20170143494 (hereinafter Mahfouz).
Regarding claim 106, Stein teaches all the limitations of the base claims as outlined above.
Further, Stein teaches obtaining the one or more kinematic measurements from an inertial measurement unit having a plurality of accelerometers and/or a plurality of gyroscopes [0071 — The accelerometer 122 can operate singly, as an integrated unit with the load sensing platform 121, and/or as an integrated unit with the sensing assemblies 123. Integrating one or more accelerometers 122 within the sensing assemblages 123 to determine position, attitude, movement, or acceleration of sensing assemblages 123 enables augmentation of presentation of data to accurately identify, but not limited to, orientation or spatial distribution of load, force, pressure, displacement, density, or viscosity, or localized temperature by controlling the load and position sensing assemblages to measure the parameter or parameters of interest relative to specific orientation, alignment, direction, or position as well as movement, rotation, or acceleration along any axis or combination of axes. Measurement of the parameter or parameters of interest may also be made relative to the earth's surface and thus enable computation and presentation of spatial distributions of the measured parameter or parameters relative to this frame of reference].
But Stein fails to clearly specify measuring data associated with a first measurement axis, wherein the data associated with the first measurement axis is obtained from a first accelerometer and a first gyroscope of the inertial measurement unit; measuring data associated with a second measurement axis, wherein the data associated with the second measurement axis is obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; and measuring data associated with a third measurement axis, wherein the data associated with the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit.
However, Mahfouz teaches measuring data associated with a first measurement axis, wherein the data associated with the first measurement axis is obtained from a first accelerometer and a first gyroscope of the inertial measurement unit; measuring data associated with a second measurement axis, wherein the data associated with the second measurement axis is obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; and measuring data associated with a third measurement axis, wherein the data associated with the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit [0011 — the inertial measurement unit includes at least three accelerometers and three magnetometers, each of the at least three accelerometers outputs data relative to three axes for a total of no less than nine accelerometer data streams; 0511 — each IMU 1002 (inertial measurement unit) includes three gyroscopes, three accelerometers, and three Hall-effect magnetometers (set of three, tri-axial gyroscopes, accelerometers, magnetometers) that may be integrated into a single circuit board or comprised of separate boards of one or more sensors (e.g. gyroscope, accelerometer, magnetometer) in order to output data concerning three directions perpendicular to one another (e.g., X, Y, Z directions). In this manner, each IMU 1002 is operative to generate 21 voltage or numerical outputs from the three gyroscopes, three accelerometers, and three Hall-effect magnetometers].
Stein and Mahfouz are analogous art. Stein and Mahfouz relate to treating patients, particularly involving motion sensing for spinal issues.
Therefore at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Stein, by incorporating the above limitations, as taught by Mahfouz.
One of ordinary skill in the art would have been motivated to do this modification to more comprehensively obtain translational and rotational angular data by performing measurements in 3 perpendicular directions, as suggested by Mahfouz [0511].
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gradel et al. U.S. Patent Publication No. 20130338455 discloses a device for monitoring a medical prosthesis and the human body including a sensor with a housing.
Note that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Conclusion
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/BERNARD G LINDSAY/
Primary Examiner, Art Unit 2119
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