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 .
Terminal Disclaimer
The terminal disclaimer filed on 12/30/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12004814 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1-6, 8-10, 12-15, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20100191088) in view of Linderman (US 20140208578).
With respect to claims 1, 4-6, 8-10, 12-15, 17, 18 and 20, Anderson teaches a system (see abstract below) comprising: one or more computer readable storage devices (see para. 62, 68, 72, 106) configured to store a plurality of computer executable instructions (see para. 82, 102 and 103); and one or more hardware computer processors in communication with the one or more computer readable storage devices and configured to execute the plurality of computer executable instructions (see para. 82, 102, 103) in order to cause the system to: receive position and/or orientation information of two or more vertebrae of a patient during a spinal surgery; compare the received position and/or orientation of the two or more vertebrae (see para. 189, 193) with a predetermined surgical plan comprising desired position and orientation data of the two or more vertebrae (see fig. 14 and note steps 134, 136, 138); and generate guidance instructions for performing the spinal surgery (interpreted as occurring either during or after the procedure to optimize a future surgery-see para. 96 (last 6 lines), 111, 120) based on the comparison of the determined position and/or orientation of the two or more vertebrae with the predetermined surgical plan for the patient (see fig. 14 and note steps 134, 136, 138); wherein the instructions further cause the system to continuously generate guidance instructions for performing the spinal surgery until a spine of the patient is adjusted to a predetermined acceptable level (either during or after the procedure for future procedures see Anderson fig. 21, 24, 29 and note steps 428 and 508- as the procedure is adjusted, guidance instructions generated to provide the desired surgical results); wherein the instructions further cause the system to receive tracking data comprising position and/or orientation data of the two or more vertebrae in substantially real time during the spinal surgery (see para. 189, 193); wherein the instructions further cause the system to display the position of the two or more vertebrae on a display based on the tracking data (see para. 102, 103, note the computer system); wherein the instructions further cause the system to compare at least a portion of the received tracking data to the predetermined surgical plan (see para. 172, 174, 187 and 197); wherein the instructions that cause the system to generate the guidance instructions comprise instructions that cause the system to recommend an implant dimension (see fig. 13-15 below); wherein the predetermined surgical plan is based on a predictive model (see fig. 15).
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Although spinal rods are part of a treatment plan of Anderson (see fig. 10 above and also para. 216) and the use of the system for revision surgery, contemplated (see para. 207, 217), Anderson does not specifically teach wherein the desired position and orientation data of the two or more vertebrae is based on: one or more medical images of the patient, a desired clinical outcome for the patient, and data related to previous spinal surgeries of one or more other patients having the desired clinical outcome; wherein the instructions further cause the system to determine a desired curvature of a spine of the patient based on predicted post-operative parameters, the predicted post-operative parameters based on the data related to previous spinal surgeries of the one or more other patients; wherein the one or more medical images of the patient comprise a pre-operative sagittal x-ray image of a spine of the patient; wherein the desired position and orientation data of the two or more vertebrae is further based at least in part on one or more preferences of a surgeon performing the spinal surgery for the patient; wherein the desired position and orientation data of the two or more vertebrae is further based on modifying the accessed medical images to simulate an outcome of the spinal surgery for the patient; wherein modifying the accessed medical images comprises simulating, on the one or more medical images, implantation of a spinal rod to a vertebral segment of interest; and wherein the instructions further cause the system to generate a report comprising an overlay comprising at least two images of a spine of the patient, the at least two images obtained pre-operation, intra-operation, and/or post-operation.
Linderman, drawn to systems and methods for revision surgeries, teaches wherein the desired position and orientation data of the two or more vertebrae is based on: one or more medical images of the patient (see step 40 of fig. 1a, para. 153-155, 157,158, 166), and data (e.g., images) related to previous spinal surgeries of one or more other patients (see steps 10 and 20 of fig. 1a, table 1 and also para. 26, 150, 166); wherein the instructions further cause the system to determine a desired curvature of a spine of the patient based on predicted post-operative parameters (see fig. 13-15 above), the predicted post-operative parameters based on the data related to previous spinal surgeries of the one or more other patients (see steps 10 and 20 of fig. 1a, table 1 and also para. 26, 150, 166); wherein the one or more medical images of the patient
comprise a pre-operative sagittal x-ray image of a spine of the patient (see para. 172, 176-177); wherein the desired position and orientation data of the two or more vertebrae is further based at least in part on one or more preferences (e.g., evaluation by visualization) of a surgeon performing the spinal surgery for the patient (see steps 10, 20, 30 and 40 of fig. 1a and also para. 26); wherein the desired position and orientation data of the two or more vertebrae is further based on modifying the accessed medical images to simulate an outcome of the spinal surgery for the patient (e.g., as shown in the image in step 10 of fig. 1a, table 1 and also para. 150); wherein modifying the accessed medical images comprises simulating, on the one or more medical images, implantation of a spinal rod to a vertebral segment of interest (e.g., see fig. 1b), wherein the desired position and orientation data of the two or more vertebrae is based on at least two of the one or more medical images of the patient after the at least two of the one or more medical images have been calibrated and scaled based on at least one common feature (see fig. 1b, step 30, 40); wherein the instructions further cause the system to generate a report comprising an overlay comprising at least two images of a spine of the patient, the at least two images obtained pre-operation, intra-operation, and/or post-operation (see fig. 1b) in order to improve upon previous methodology used in revision surgery by collecting and assessing multiple sources of patient, implant and general population anatomical data, evaluating the data and then using this information to better plan, customize and implant a revision implant within a patient (see para. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Anderson wherein the desired position and orientation data of the two or more vertebrae is based on: one or more medical images of the patient, and data (e.g., images) related to previous spinal surgeries of one or more other patients; wherein the instructions further cause the system to determine a desired curvature of a spine of the patient based on predicted post-operative parameters, the predicted post-operative parameters based on the data related to previous spinal surgeries of the one or more other patients; wherein the one or more medical images of the patient comprise a pre-operative sagittal x-ray image of a spine of the patient; wherein the desired position and orientation data of the two or more vertebrae is further based at least in part on one or more preferences of a surgeon performing the spinal surgery for the patient; wherein the desired position and orientation data of the two or more vertebrae is further based on modifying the accessed medical images to simulate an outcome of the spinal surgery for the patient; wherein modifying the accessed medical images comprises simulating, on the one or more medical images, implantation of a spinal rod to a vertebral segment of interest; wherein the desired position and orientation data of the two or more vertebrae is based on at least two of the one or more medical images of the patient after the at least two of the one or more medical images have been calibrated and scaled based on at least one common feature; wherein the instructions further cause the system to generate a report comprising an overlay comprising at least two images of a spine of the patient, the at least two images obtained pre-operation, intra-operation, and/or post-operation, in view of Linderman, in order to improve upon previous methodology used in revision surgery by collecting and assessing multiple sources of patient, implant and general population anatomical data, evaluating the data and then using this information to better plan, customize and implant a revision implant within a patient.
Nawana, also drawn to systems and methods for surgeries, teaches a desired clinical outcome for the patient (see para. 115, 315, 320 and para. 319- note “desired functional outcome”), and data related to previous spinal surgeries of one or more other patients having the desired clinical outcome (see para. 315, 319-320) in order to help the patient reach interim or final recovery targets (e.g., clinical outcomes) (see para. 319).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Anderson, as modified by Linderman, to include a desired clinical outcome for the patient, and data related to previous spinal surgeries of one or more other patients having the desired clinical outcome, in view of Nawana, in order to help the patient reach interim or final recovery targets.
As for claim 2, Anderson, as modified by Linderman and Nawana, further teaches the system of claim 1, further comprising sensors (see abstract) attached to the two or more vertebrae of the patient, wherein the instructions that cause the system to receive the position and/or orientation information of the two or more vertebrae comprise instructions that cause the system to receive the position and/or orientation information from the sensors attached to the two or more vertebrae (see para. 172, 174, 187 and 197).
As for claim 3, Anderson, as modified by Linderman and Nawana, further teaches the system of claim 2, wherein the sensors are configured to be attached to the two or more vertebrae in a configuration such that two of three axes of position data to be collected by the sensors are on a plane assumed to be substantially parallel with a determinate angle to a sagittal plane of the patient (see para. 172, 174).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20100191088), Linderman (US 20140208578) and Nawana (US 20140081659), as applied to claim 1 above, in view of Steines (WO2013020026A1).
As for claim 7, Anderson, as modified by Linderman and Nawana, does not appear to teach wherein data related to previous spinal surgeries of the one or more other patients comprises data related to similar cases based on patient age, severity of deformation, or bone strength or density.
Steines, also drawn to systems for patient-specific surgical procedures and implants (see abstract), teaches wherein data related to previous spinal surgeries of the one or more other patients (see para. 55) comprises data related to similar cases based on patient age, severity of deformation, or bone strength or density (see para. 55) in order to generate the best implant/procedure for the patient using known design criteria to account for any underlying known issues that should be assessed properly during this process (see para. 55-56).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify Anderson, as modified by Linderman and Nawana, wherein data related to previous spinal surgeries of the one or more other patients comprises data related to similar cases based on patient age, severity of deformation, or bone strength or density, in view of Steines, in order to generate the best implant/procedure for the patient using known design criteria to account for any underlying known issues that should be assessed properly during this process.
Allowable Subject Matter
Claims 11, 16, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10, 12-15, 17, 18 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Double Patenting rejection is withdrawn in view of the Terminal Disclaimer entered on 12/30/2025 and the amendment entered on 12/30/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: AU-2012289973-A1.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773