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 .
Status of Claims
Claims 75-120 were previously pending and subject to a non-final Office Action having a notification date of May 15, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on August 14, 2026 (the “Amendment”), amending claims 75, 89, 94, 95, 106, 114, 117, and 119.
The present Final Office Action addresses pending claims 75-120 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
On page 19 of the Amendment in relation to independent claim 119, Applicant asserts that the cited references do not disclose or suggest “wherein the historical pre-operative data and the historical post-operative data comprise biomechanical parameters derived from virtual biomechanical models of the individuals.” However, independent claim 119 does not recite this limitation. Furthermore, the combination of Besier, Zucker, and Roh disclose all the limitations of claim 119 as set forth in the rejection below.
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 (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 119 and 120 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0249168 to Besier et al. ("Besier") in view of U.S. Patent App. Pub. No. 2022/0142709 to Zucker ("Zucker") and U.S. Patent App. Pub. No. 2019/0146458 to Roh et al. ("Roh"):
Regarding claim 119, Besier discloses a method comprising:
receiving, at a computer system, imaging data of a subject under evaluation for surgery (step 641 in Figure 6, items 756, 757 in Figure 7, and [0120]-[0122] illustrates/discloses receiving images of a patient under evaluation for surgery at a server (computing system));
generating, via at least one processor of the computer system using the imaging data, a virtual three-dimensional (3D) biomechanical model of the subject (steps 642, 643 in Figure 6, items 753, 762, 763 in Figure 7, and [0120], [0123]-[0150] illustrate/disclose generating a 3D model of the patient anatomy using an image processing application running on the server which necessarily includes a processor);
executing a virtual surgical procedure, via the at least one processor, of a surgical procedure on the subject using the virtual 3D biomechanical model (step 644 in Figure 6, the item after item 763 in Figure 7, and [0120], [0151]-[0162] illustrate/disclose simulating a fit between an implant and the patient anatomy in the 3D model (executing a "virtual surgical procedure"), resulting in predicted post-operative biomechanical parameters ([0164] discloses determining geometric/functional measurements (predicted post-operative biomechanical parameters) between the implant and bones),
wherein the surgical procedure comprises at least one of:
implanting a physical 3D hardware implant into the subject ([0009]-[0011] discloses implant surgical procedures (physical 3D hardware implant));
cutting a bone of the subject ([0165] discloses bone resection); or
a spinal decompression of the subject, and
wherein execution of the virtual surgical procedure of the surgical procedure on the subject further comprises:
sequentially performing the virtual surgical procedure corresponding to the surgical procedure (step 647 in Figure 6, the arrow going back to "implant fit simulation" in Figure 7, and [0120] illustrate/discuss performing the simulation for a plurality of different implants (sequentially performing the virtual surgical procedure)), with at least one step in individual steps of the virtual surgical procedure performed using a plurality of … surgical approaches, the individual steps occurring at a plurality of potential locations within the virtual 3D biomechanical model of the subject ([0155] discloses how different regions/landmarks can be used as objectives or constraints in the fitting simulation (virtual surgical procedure) depending on the bone and type/brand/size/variant of the implant; accordingly, different implants can be implanted at different regions/landmarks (different locations) resulting in a plurality of surgical approaches at potential locations in the 3D model), resulting in a plurality of virtual surgical procedure results ([0177] discloses simulation results (virtual surgical procedure results)); and
performing, for each virtual surgical procedure result in the plurality of virtual surgical procedure results, a dynamic analysis, resulting in the predicted post-operative biomechanical parameters ([0164] discusses determining for each simulation/virtual surgical procedure the geometric/functional measurements between the implant and bones e.g., range of joint motion which would require a "dynamic analysis"; furthermore, Figures 2, 4, 6, 7, [0120] illustrate/discuss predicting post-operative motion assessments/analyses for each simulation with a different implant (for each virtual surgical procedure result));
…; and
scoring, via the at least one processor using the predicted post-operative biomechanical parameters, potential surgical outcomes of the surgical procedure on the subject ([0164] discloses calculating, based on the geometric/functional measurements between an implant and bones (predicted post-operative biomechanical parameters) during a simulation, a score indicative of the quality of fit such as range of motion, etc. (potential surgical outcome) while [0107]-[0115] discloses how various potential implants can be scored and ranked to facilitate a surgeon's to selection of an appropriate implant) for each of the plurality of potential locations, resulting in a plurality of surgical location prediction scores ([0155] discloses how different regions/landmarks (locations) can be used as objectives or constraints in the fitting simulation (virtual surgical procedure) depending on the bone and type/brand/size/variant of the implant while step 647 in Figure 6, the arrow going back to "implant fit simulation" in Figure 7, and [0120] illustrate/discuss performing the simulation for a plurality of different implants (sequentially performing the virtual surgical procedure); therefore, a plurality of "surgical location prediction scores" for each of the potential locations are determined),
wherein the predicted post-operative biomechanical parameters comprise biomechanical parameters derived from the virtual 3D biomechanical model of the subject ([0164] discloses geometric/functional measurements between the implant and the bones after the simulation such as change in leg length before/after implant fit, range of joint motion, etc., where the implant simulation and thus the determined geometric/functional measurements are generated based on the 3D/virtual biomechanical model of the subject per the item after item 763 in Figure 7 and [0120], [0151]-[0162]).
While [0155] discloses how different regions/landmarks can be used as objectives or constraints in the fitting simulation (virtual surgical procedure) depending on the bone and type/brand/size/variant of the implant such that different implants implanted at different regions/landmarks (different locations) result in a plurality of surgical approaches at potential locations in the 3D model, Besier might be silent regarding such surgical approaches being distinct surgical approaches.
Nevertheless, Zucker teaches ([0031]) that it was known in the healthcare informatics art for common spinal surgery (e.g., lumbar interbody fusion) approaches to include anterior (ALIF), oblique/anterior to psoas (OLIF/ATP), lateral/extreme lateral (LLIF/XLIF), posterior (PLIF), and transforaminal (TLIF) ("distinct surgical approaches") to account for the difficulty in accessing the spinal column due to the internal positioning of the spinal column and because no single approach is ideal for each application ([0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the plurality of surgical approaches of Besier to be distinct surgical approaches as taught by Zucker to account for the difficulty in accessing the spinal column due to the internal positioning of the spinal column and because no single approach is ideal for each application. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Furthermore, the Besier/Zucker combination might be silent regarding the dynamic analysis specifically including analyzing redistribution of forces and moments to adjacent spinal levels.
Nevertheless, Roh teaches ([0127]-[0133]) that it was known in the healthcare informatics art to provide surgical assistance to a spinal surgeon via building a virtual 3D model of a patient's spine based on images of the patient (the virtual model including e.g., virtual vertebrae per [0130]), virtually insert/implant implants into the spine in the virtual 3D model, and analyze mechanical interaction between a patient's vertebrae and loading of implants to generate output usable to implant configurations/trajectories/locations to optimize axial/shear loads (forces) and moments to manage stresses between adjacent vertebrae (adjacent spinal levels). Such axial/shear loads (forces) and moments to adjacent spinal levels would need to be calculated/analyzed for each implant configuration/location/etc. (redistribution of forces and moments to adjacent spinal levels) in order to optimize such axial/shear loads (forces) and moments to manage stresses between adjacent vertebrae. This arrangement advantageously provides assistance to a surgeon in screw/implant placement during a spinal procedure ([0007]) via providing patient-specific surgical information, surgical plans, technology recommendations (e.g., implant/instrument recommendations), etc. ([0032]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the dynamic analysis of the Besier/Zucker combination to include analyzing redistribution of forces and moments to adjacent spinal levels similar to as taught by Roh to advantageously provide assistance to a surgeon in screw/implant placement during a spinal procedure via providing patient-specific surgical information, surgical plans, technology recommendations, etc. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 120, the Besier/Zucker/Roh combination discloses the method of claim 119, further including wherein the plurality of distinct surgical approaches comprises at least an anterior approach, a posterior approach, or a lateral approach (Zucker discloses ([0031]) common spinal surgery (e.g., lumbar interbody fusion) approaches to include anterior (ALIF), oblique/anterior to psoas (OLIF/ATP), lateral/extreme lateral (LLIF/XLIF), posterior (PLIF), and transforaminal (TLIF) ("distinct surgical approaches") to account for the difficulty in accessing the spinal column due to the internal positioning of the spinal column and because no single approach is ideal for each application ([0004]); again, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the plurality of surgical approaches of Besier to be distinct surgical approaches as taught by Zucker to account for the difficulty in accessing the spinal column due to the internal positioning of the spinal column and because no single approach is ideal for each application. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Allowable Subject Matter
Claims 75-118 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Regarding independent claims 75, 89, 94, 95, 106, and 114, the combination of Aubin, Besier, Yoshinaka, and Roh do not alone or in any combination disclose or suggest the historical pre and post-operative data used to train the ML algorithm to include biomechanical parameters derived from virtual biomechanical models of the individuals that previously underwent the surgical procedure.
Conclusion
THIS ACTION IS MADE FINAL. 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 JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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