DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8-17, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2018/0185113 A1 to Gregerson et al., in view of U.S. PG Pub. No. 2018/020002 A1 to Kostrzewski et al., and further in view of U.S. PG Pub. No. 2010/0063511 A1 to Plassky et al.
Regarding claim 1, Gregerson discloses a system for tracking movement of a marker, the system comprising: a plurality of markers, each marker configured to be coupled to a corresponding element, wherein only one marker is configured to be coupled to a corresponding one anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: track the plurality of markers; detect a movement of at least one marker; and determine a pose of the at least one marker based on the movement (see Figs. 1, 10, and 11 and para 112-136, noting in particular para 127).
Gregerson also discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to track the plurality of markers to calculate measurements that quantify movement of at least one anatomical element; and compare the measurements that quantify movement of the at least one anatomical element to measurements of a determined outcome of the surgical procedure, and when the measurements that quantify the amount of movement of the at least one anatomical element match the measurements of the determined outcome of the surgical procedure a notification is generated (see Figs. 1, 10, and 11 and para 112-136).
However, Kostrzewski discloses a similar robot aided surgical system, a robotic arm with a sensor is used to determine the pose of a marker when the robotic arm contacts the marker and validate the pose of each marker of the plurality of markers when the pose matches the predetermined pose, wherein the predetermined pose comprises a determined outcome of the surgical procedure, and wherein the pose of each marker is obtained from the at least one sensor when the robotic arm contacts each marker (see para 11, 19, 20, 107, 132-148).
It would have been obvious and predictable to have substituted one method of determining marker positions for another because doing so would predictably determine the markers pose. Moreover, providing a redundant method of determining a marker pose would provide enhanced registration, re-registration, and tracking of the marker relative to the robotic arm.
Plassky discloses a similar marker device, wherein the anatomical element is a vertebra and the one marker is releasably secured to a screw head of a screw embedded in the vertebra (see Figs. 1, 4, and 6 and abstract).
It would have been obvious and predictable to have substituted the screw connector of Plassky into the device of Gregerson because doing so would predictably attach the markers of Gregerson to bone.
Regarding claim 2, Gregerson discloses a system, wherein the marker comprises at least one of an optical marker, an electromagnetic tracker, a radio-frequency identification tracker, a magnetic marker, a light emitting diode, or an infrared light emitting diode (see para 35-38).
Regarding claim 3, Gregerson discloses a system, wherein the marker is integrated with a surgical implant, the surgical implant attached to the anatomical element (see Figs. 1, 10, and 11 and para 112-136, noting in particular para 114).
Regarding claim 4, Gregerson discloses a system, wherein the surgical implant is a rod (see Figs. 1, 10, and 11 and para 112-136, noting in particular para 114).
Regarding claim 8, Gregerson discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive a first image of the anatomical element, the first image obtained preoperatively; obtain a second image from an imaging device, the second image depicting the marker and the anatomical element; and detecting movement of the at least one anatomical element based on comparing a pose of the at least one marker in the first image and a pose of the at least one marker in the second image (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 10, Gregerson discloses a system, wherein detecting movement of the at least one anatomical element comprises comparing the first pose of the marker and the second pose of the marker (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 11, Gregerson discloses a system, further comprising a navigation system configured to track the pose of the marker, wherein a pose for each marker of the plurality of markers is obtained from the navigation system (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 12, Gregerson discloses a system, for tracking movement of an anatomical element comprising: one marker configured to be coupled to the anatomical element; a navigation system configured to track a pose of the one marker; a processor; and a memory storing data for processing by the processor, the data, when processed, causing the processor to: receive at least a first pose and a second pose of the one marker from the navigation system, the second pose received after the first pose; validate a pose of the anatomical element when the second pose of the at least one marker matches a predetermined pose, wherein the predetermined pose comprises a determined outcome of a surgical procedure (see Figs. 1, 10, and 11 and para 112-136).
Gregerson also discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to calculate measurements that quantify movement of the anatomical element based on the first pose and the second pose of the at least one marker; and compare the measurements that quantify movement of the anatomical element to measurements of a determined outcome of a surgical procedure, and when the measurements that quantify the amount of movement of the anatomical element match the measurements of the determined outcome of the surgical procedure a notification is generated (see Figs. 1, 10, and 11 and para 112-136).
Further, Gregerson discloses a device, including a robotic arm having at least one sensor for sensing a pose of the robotic arm (see Figs. 1, 10, and 11 and para 112-136, noting that arm 101 has sensors and encoders for determining the arms position).
It is unclear if Gregerson discloses using the arm to touch a marker to determine the markers pose.
However, Kostrzewski discloses a similar robot aided surgical system, a robotic arm with a sensor is used to determine the pose of a marker when the robotic arm contacts the marker and validate the second pose of the at least one marker when the second pose matches a predetermined pose, wherein the predetermined pose comprises a determined outcome of a surgical procedure (see para 11, 19, 20, 107, 132-148). Examiner notes that in combination a skilled artisan would have found obvious and predictable to measure both poses by the Kostrzewski technique as doing so would predictably provide both poses.
It would have been obvious and predictable to have substituted one method of determining marker positions for another because doing so would predictably determine the markers pose. Moreover, providing a redundant method of determining a marker pose would provide enhanced registration, re-registration, and tracking of the marker relative to the robotic arm.
Plassky discloses a similar marker device, wherein the anatomical element is a vertebra and the one marker is releasably secured to a screw head of a screw embedded in the vertebra (see Figs. 1, 4, and 6 and abstract).
It would have been obvious and predictable to have substituted the screw connector of Plassky into the device of Gregerson because doing so would predictably attach the markers of Gregerson to bone.
Regarding claim 13, Gregerson discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: compare the second pose to a predetermined pose; and validate the second pose when the second pose matches the predetermined pose (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 14, Gregerson discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: compare the first pose and the second pose; detect a movement of the at least one marker based on the comparison of the first pose and the second pose, the movement detected when the second pose does not match the first pose; and generate a notification when the movement meets or exceeds at least one of a movement threshold or a position threshold (see Figs. 1, 10, and 11 and para 48 and 112-136).
Regarding claim 15, Gregerson discloses a system, wherein the anatomical element comprises a vertebra (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 16, Gregerson discloses a system, wherein the one marker comprises at least one of an optical marker, a magnetic marker, an electromagnetic tracker, a radio-frequency identification tracker, a light emitting diode, and an infrared light emitting diode (see para 35-38).
Regarding claim 17, Gregerson discloses a system, wherein the one marker is integrated with a surgical implant that is attached to the anatomical element (see Figs. 1, 10, and 11 and para 112-136).
Regarding claim 20, Gregerson discloses a system, for tracking movement of an anatomical element comprising: a single marker configured to be coupled to the anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causing the processor to: receive a first pose of the marker obtained during a surgical procedure; determine a second pose of the marker from the at least one sensor when the robotic arm contacts the at least one marker; and validate a pose of the anatomical element when the second pose of the at least one marker matches a predetermined pose, wherein the predetermined pose comprises a determined outcome of the surgical procedure (see Figs. 1, 10, and 11 and para 2, 32, 52, and 112-136).
Examiner notes that using pre-operative and post-operative data is merely an intended use and the device of Gregerson is capable of using pre-operative and post-operative data.
Gregerson also discloses a system, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to calculate measurements that quantify movement of the anatomical element based on the first pose and the second pose of the at least one marker; and compare the measurements that quantify movement of the anatomical element to measurements of a determined outcome of a surgical procedure, and when the measurements that quantify the amount of movement of the anatomical element match the measurements of the determined outcome of the surgical procedure a notification is generated (see Figs. 1, 10, and 11 and para 112-136).
Further, Gregerson discloses a device, including a robotic arm having at least one sensor for sensing a pose of the robotic arm (see Figs. 1, 10, and 11 and para 112-136, noting that arm 101 has sensors and encoders for determining the arms position).
It is unclear if Gregerson discloses using the arm to touch a marker to determine the markers pose.
However, Kostrzewski discloses a similar robot aided surgical system, a robotic arm with a sensor is used to determine the pose of a marker when the robotic arm contacts the marker and validate the second pose of the at least one marker when the second pose matches a predetermined pose, wherein the predetermined pose comprises a determined outcome of the surgical procedure (see para 11, 19, 20, 107, 132-148). Examiner notes that in combination a skilled artisan would have found obvious and predictable to measure both poses by the Kostrzewski technique as doing so would predictably provide both poses.
It would have been obvious and predictable to have substituted one method of determining marker positions for another because doing so would predictably determine the markers pose. Moreover, providing a redundant method of determining a marker pose would provide enhanced registration, re-registration, and tracking of the marker relative to the robotic arm.
Plassky discloses a similar marker device, wherein the anatomical element is a vertebra and the one marker is releasably secured to a screw head of a screw embedded in the vertebra (see Figs. 1, 4, and 6 and abstract).
It would have been obvious and predictable to have substituted the screw connector of Plassky into the device of Gregerson because doing so would predictably attach the markers of Gregerson to bone.
Regarding claim 21, Gregerson discloses a system with a memory configured to compare the first pose and the second pose; and detect a movement of the at least one marker based on the comparison of the first pose and the second pose, the movement detected when the second pose does not match the first pose (see Figs. 1, 10, and 11 and para 2, 32, 52, and 112-136).
Further, Gregerson discloses a device, including a robotic arm having at least one sensor for sensing a pose of the robotic arm (see Figs. 1, 10, and 11 and para 112-136, noting that arm 101 has sensors and encoders for determining the arms position).
It is unclear if Gregerson discloses using the arm to touch a marker to determine the markers pose.
However, Kostrzewski discloses a similar robot aided surgical system, a robotic arm with a sensor is used to determine the pose of a marker when the robotic arm contacts the marker and validate the second pose of the at least one marker when the second pose matches a predetermined pose, wherein the predetermined pose comprises a determined outcome of the surgical procedure (see para 11, 19, 20, 107, 132-148). Examiner notes that in combination a skilled artisan would have found obvious and predictable to measure both poses by the Kostrzewski technique as doing so would predictably provide both poses.
Regarding claim 22, Gregerson discloses a system configured to generate a notification when the movement meets or exceeds at least one of a movement threshold or a position threshold (see Figs. 1, 10, and 11 and para 48 and 112-136).
Regarding claim 23, Gregerson discloses a system, wherein the marker comprises at least one of an optical marker, an electromagnetic tracker, a radio-frequency identification tracker, a magnetic marker, a light emitting diode, or an infrared light emitting diode (see para 35-38).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gregerson, Kostrzewski, and Plassky as applied to claim 18 above, and further in view of U.S. PG Pub. No. 2006/0100638 A1 to Sarin et al.
Regarding claim 19, Sarin discloses a similar maker, wherein the screw head comprises a threaded cavity configured to receive a threaded protrusion of the one marker (see Figs. 6 and 7 and para 30-36).
It would have been obvious and predictable to have substituted the screw connector of Sarin into the device of Gregerson because doing so would predictably attach the marker to the screw and would allow for a convenient method of attaching and detaching an optical marker as well adjusting said marker.
Response to Arguments
Although Applicant’s arguments filed June 17, 2025 are moot in view of the new grounds of rejection, Applicant’s remarks where still relevant are unpersuasive.
Applicant argues that Gregerson does not disclose the newly added features and that the claimed invention provides some benefits.
Examiner disagrees because Gregerson as above cited reads on the newly amended claims. Further, the benefit argued by Applicant is not embodied or claimed by the newly amended subject matter.
Applicant’s remarks regarding Kostrzewski are unpersuasive for the reasons noted in the proceeding Office Actions.
Lastly, Applicant contends that Plassky does not serve the intended purpose claimed.
Applicant’s remarks are unpersuasive because Applicant does not provide any support or rationale for Applicant’s contention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJEEV P SIRIPURAPU whose telephone number is (571)270-3085. The examiner can normally be reached 9-5 M-F.
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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798
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