DETAILED ACTION
Claims 86-102 and 104-106 are pending. Claims 1-85, 103 and 107-190 are cancelled.
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 .
Response to Arguments
Applicant’s arguments, filed 2/17/26, have been fully considered but are not persuasive, except where noted below.
Applicant’s arguments regarding the rejection under 35 U.S.C. § 112 (pages 5-6) are persuasive and the claims are no longer rejected under that statute.
Applicant’s arguments regarding the rejection under 35 U.S.C. § 101 (pages 6-8) are moot because the claims are no longer rejected under that statute.
Applicant’s arguments regarding the rejections under 35 U.S.C. § 102 and 103 (pages 8-10) are moot because the claims are no longer rejected under 35 U.S.C. § 102 and in view of the newly cited reference, Robinson, in the current rejection under 35 U.S.C. § 103.
For at least these reasons, the rejection of the claims is maintained.
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) 86-88, 100 and 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Navarro et al. U.S. Patent Publication No. 20050273170 (hereinafter Navarro) in view of Robinson et al. U.S. Patent Publication No. 20210161406 (hereinafter Robinson).
Regarding claim 86, Navarro teaches a method of sampling data from an implantable cartridge coupled to an interbody spacer implanted in a patient, the method [0010 — A prosthetic implant located within a joint of a patient's body includes at least one transducer for generating a real time event signal responsive to an event within the prosthetic joint. The real time event signals from the transducer are input to a processor. The processor generates movement data parameters from the real time event signals and also generates a time stamp indicating the point in time the real time event signals were generated by the transducers; 0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer)… The electronics portion consists of a plurality of transducers 202, one of which is illustrated in FIG. 2… A number of transducers 202 provide inputs to a processing unit 502. The transducers 202 comprise piezoelectric devices that generate a voltage in response to mechanical forces being applied to the transducers caused by movements between the upper plate 106 and lower plate 108. These transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across… processing unit 502 processes the received transducer data and may either output the data in real time or store parameters representative of the data within a memory 504 associated with the processing unit 502; 0073-0075, Figs. 10-11 — a flow diagram describing the manner/method in which the transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode] 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 [0035 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across; 0073-0075, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004], the implantable cartridge comprising a housing, the at least one sensor, wherein the at least one sensor is positioned on or within the housing [0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer)… artificial disc 100 consists of an upper plate 106 and a lower plate 108 including an elastomeric layer 110 disposed between the upper and lower plates (housing within which sensor 202 is enclosed)… The electronics portion consists of a plurality of transducers 202, one of which is illustrated in FIG. 2… A number of transducers 202 provide inputs to a processing unit 502. The transducers 202 comprise piezoelectric devices that generate a voltage in response to mechanical forces being applied to the transducers caused by movements between the upper plate 106 and lower plate 108. These transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across… processing unit 502 processes the received transducer data and may either output the data in real time or store parameters representative of the data within a memory 504 associated with the processing unit 502]; and
transmitting, via the antenna, sensor data to and receiving the sensor data at a receiver at a remote location [0035-0038, Figs. 5-8 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors… Communications link 508 and antenna 510 are provided to generate a wireless communications link between the electronics package 310 of the artificial disc and an external processing functionality (remote location)… a real time mode, outputs of the transducers 202 are processed and output in real time from the processing unit 502 using the communications link 508 over antenna 510; 0055, Figs. 5-7 — transceiver circuitry 628 and antenna 634 utilized for uploading data from the artificial disc 100 to an external processing source 825; 0087-0088, Figs. 6-8, 10, 16-17 — The artificial disc 1602 interfaces with a monitor alarm 1604. The monitor alarm 1604 would be strapped to a patient's back in close proximity to the artificial disc 1602 on the exterior of the patient's body such that the artificial disc 1602 and alarm monitor 1604 could inductively communicate via a link 1603 in the manner described with respect to the FIG. 8 via an inductive coupling interface… CPU 614 is awakened from its sleep mode, as described previously with respect to FIG. 10, when it receives transducer input at step 1702… . The alarm signal and any data received from the transducers indicating the condition raising the alarm is transmitted to the alarm monitor at step 1710. The alarm monitor 1604 transmits the alarm signal and any associated data to the portable alarm/display at step 1712 — elements 1602, etc. are labelled as 1502, etc. in Fig. 16].
But Navarro fails to clearly specify the implantable cartridge comprising an antenna, wherein the antenna is positioned on or within housing.
However, Robinson teaches the implantable cartridge comprising an antenna, wherein the antenna is positioned on or within housing [0097-0098, Fig. 2 — the antenna 114, the transceiver 116, the reservoir 117, the power storage device 118, and the charging device 120 may be disposed within the housing 170… positional sensor 110 also may be disposed within the housing 170.].
Navarro and Robinson 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 modify the above method, as taught by Navarro, by incorporating the above limitations, as taught by Robinson.
One of ordinary skill in the art would have been motivated to do this modification to protect internal components from environmental hazards, e.g. fluids that may short circuit/affect electronic components such as sensors or antennas, and to provide structural integrity to the cartridge components.
Regarding claim 87, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches obtaining one or more kinematic measurements occurs during movement of the patient [0073-0078, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004… the output of a transducers 202a-202c responsive to movements of the intervertebral disc 100 caused by movement of the patient.].
Regarding claim 88, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches obtaining detecting one or more kinematic measurements occurs wherein the interbody spacer is under load [0087 — CPU 614 of the artificial disc 1602 would be programmed to generate and transmit alarm signals to the alarm monitor in response to forces measured by the transducers within the artificial disc 1602 exceeding predetermined limits. These predetermined limits would be established as indicating excessive load applied to the patient's spine or prosthesis ].
Regarding claim 100, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches the one or more kinematic measurements are used to determine one or more parameters of patient movement [0010, 0073-0078, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004… the output of a transducers 202a-202c responsive to movements of the intervertebral disc 100 caused by movement of the patient... the parameters may consist of a variety of information including maximum and minimum values for each of the transducers… various parameters may be stored with associated time stamps 1204].
Regarding claim 105, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches 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 [0035, Fig. 5 — the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device].
Claim(s) 89-90 and 92-93 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Navarro and Robinson in view of Sahasrabudhe et al. U.S. Patent Publication No. 20110172927 (hereinafter Sahasrabudhe).
Regarding claim 89, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
But the combination of Navarro and Robinson 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.].
Navarro, Robinson and Sahasrabudhe are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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, Navarro, Robinson 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 the combination of Navarro and Robinson, 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, Navarro, Robinson 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 the combination of Navarro and Robinson, 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, Navarro, Robinson 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 the combination of Navarro and Robinson, 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 Navarro, Robinson and Sahasrabudhe in view of Ness U.S. Patent Publication No. 20190008418 (hereinafter Ness).
Regarding claim 91, the combination of Navarro, Robinson 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 Navarro, Robinson 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].
Navarro, Robinson, 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 Navarro, Robinson 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 and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Navarro and Robinson in view of Hunter et al. U.S. Patent Publication No. 20170196508 (hereinafter Hunter).
Regarding claim 94, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches one or more kinematic measurements and the interbody spacer [0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer); 0035 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across; 0073-0075, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004].
But the combination of Navarro and Robinson 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].
Navarro, Robinson and Hunter are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches one or more kinematic measurements and the interbody spacer [0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer); 0035 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across; 0073-0075, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004].
But the combination of Navarro and Robinson fails to clearly specify that one or more kinematic measurements are used to determine migration of the interbody spacer.
Further, 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].
Navarro, Robinson and Hunter are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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 Navarro, Robinson and Hunter teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches one or more kinematic measurements and the interbody spacer [0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer); 0035 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across; 0073-0075, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004].
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 the combination of Navarro and Robinson, 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, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
But the combination of Navarro and Robinson 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].
Navarro, Robinson and Hunter are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 Navarro and Robinson for the predictable result of a method involving determining patient cadence.
Regarding claim 102, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
But the combination of Navarro and Robinson 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].
Navarro, Robinson and Hunter are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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 Navarro, Robinson and Hunter teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches the implantable cartridge further comprises a battery [0037, Fig. 5 — processing unit 502, communications link 508, memory 504 and transducers 202 are powered by a local power supply 506 which may consist of, for example, a battery, which battery may be rechargeable.; 0042 — power supply 624, as described herein below, is provided by a battery. ].
Claim(s) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Navarro and Robinson in view of Hunter and further in view of Bray et al. U.S. Patent Publication No. 20170020683 (hereinafter Bray).
Regarding claim 95, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches one or more kinematic measurements and the interbody spacer [0030-0036, Figs. 1-3 and 5 — the artificial disc 100 rests in the space between the vertebrae 102 and 104 where the disc of an individual's spine normally resides (interbody spacer); 0035 — transducers 202 are able to measure compressive forces in the artificial disc 100. In addition to the piezoelectric transducers, the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device. The transducers 202 utilized by the artificial disc 100 may also include a temperature sensor for providing local temperature information related to the artificial disc 100. The transducers enable the measurement of static data, dynamic data and positional data with respect to movement within the artificial disc 100 and distributed there across; 0073-0075, Figs. 10-13 — transducers 202 may generate an input to awaken the central processing unit 502 from a sleep mode. Initially, at step 1000, the central processing unit 502 has powered down to a sleep mode in order to conserve energy within the artificial disc 100. Patient movement is detected at step 1002 and generates an input to the transducers 202 that is detected by the transducers at step 1004].
But the combination of Navarro and Robinson 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].
Navarro, Robinson and Hunter are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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 Navarro, Robinson 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].
Navarro, Robinson, 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 Navarro, Robinson 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 Navarro and Robinson in view of Hunter and further in view of Suo et al. U.S. Patent Publication No. 20250099025 (hereinafter Suo).
Regarding claim 96, the combination of Navarro, Robinson 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 Navarro, Robinson 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 Navarro, Robinson 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 Navarro, Robinson and Hunter in view of Palmatier et al. U.S. Patent Publication No. 20170209286 (hereinafter Palmatier).
Regarding claim 98, the combination of Navarro, Robinson 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 the combination of Navarro and Robinson, 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 Navarro, Robinson 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].
Navarro, Robinson, 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 Navarro, Robinson 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 the combination of Navarro and Robinson in view of Mahfouz U.S. Patent Publication No. 20170143494 (hereinafter Mahfouz).
Regarding claim 106, the combination of Navarro and Robinson teaches all the limitations of the base claims as outlined above.
Further, Navarro teaches obtaining the one or more kinematic measurements from an inertial measurement unit having a plurality of accelerometers and/or a plurality of gyroscopes [0035, Fig. 5 — the transducers 202 may include one or more accelerometer/inclinometer sensors for enabling acceleration and inclination measurements in the sagital and coronal planes. In one embodiment, the accelerometer/inclinometer sensor may comprise the VTI Technologies SCA610 series device].
But the combination of Navarro and Robinson 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].
Navarro, Robinson and Mahfouz are analogous art. Navarro and Robinson relate to treating patients, particularly involving sensing/treatment for spinal issues. And Navarro 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 the combination of Navarro and Robinson, 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].
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
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERNARD G. LINDSAY whose telephone number is (571)270-0665. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mohammad Ali can be reached on (571)272-4105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BERNARD G LINDSAY/
Primary Examiner, Art Unit 2119