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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 13, 2026 has been entered.
Response to Amendment
Claims 1 and 9 have been amended. Claims 3-8 and 11-18 have not been modified. Claims 2 and 10 have been cancelled. Claims 1, 3-9, and 11-18 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments filed on December 15, 2025 have been considered but are not fully persuasive. Response has been provided below.
Applicant argues 35 U.S.C. §103 Rejections, pg. 12 of Remarks:
Applicant argues that Finley in view of Roh fail to teach the amended claim limitations.
Regarding a desired outcome model that is a predictive three-dimensional model of the treatment area after final completion of the medical operation, although Finley does mention an expected result model ([0160], “Operation 908 includes determining whether the topographical scan matches an expected result. In an example, the expected result is an expected model of the patient's anatomy generated using pre-operative or intra-operative medical imaging.”), new art is applied to more explicitly address the amended claim limitation.
Regarding Finley’s teaching of a generation of a three-dimensional model, Applicant argues that the model is used for registration and not for laser control. Examiner respectfully disagrees, as the registration is used to inform navigational and power control of the laser.
[0035] of Finley recites: “If movement of the spine is detected, then the topographical segmental registration process can be performed to update the navigation and coordinate system.”
[0038] further recites: “Topographical and spectral analysis of laser reflection and refraction can be used to determine the relative depth to plan, tissue type, and relative energy to be applied to complete the plan while reducing the risk of damaging tissues beyond the planned area.”
[0052] further recites: “The computer can integrate with a navigation and robotics system to gain an additional level of localization and precision of control over the tip of the laser instrument... The computer can receive a plan for the specific affected area on a 3D scan or a merged scan (e.g., the merger of two different 3D scan types, such as MRI or CT) to gain better localization of the high risk tissue through segmentation. A laser instrument is inserted proximate the area and before each set of laser pulses, the computer identifies the tissue to be removed, its relative thickness and then alters the laser's power setting to increase the likelihood of removing only the selected tissue type… Laser navigation can be beneficial when 3D orientation or specific locations are important and cannot be directly visualized.” Examiner notes that one of ordinary skill in the art would know that topographical scans determine qualities of the surface of the treatment area.
As noted in [0160] of Finley (“Operation 908 includes determining whether the topographical scan matches an expected result. In an example, the expected result is an expected model of the patient's anatomy generated using pre-operative or intra-operative medical imaging. To determine whether there is a match, the laser-based topographical analysis is compared to the expected result. If the amount or quality of difference is sufficiently high (e.g., passes a threshold), then it can be determined that there is not a match.”), the topographical scan (a measure of the surface of the treatment area) is compared to an anatomical model. Thus, Finley does determining surface differences between models.
Regarding regenerating a three-dimensional model of the treatment area, Applicant argues that Roh fails to teach this claim limitation. Examiner notes that Roh alone is not applied to teach this claim limitation. Rather, the iteration of steps in a laser-based surgical procedure as taught by Roh is combined with the specific surgical steps as taught by Finley teaches the claim limitations together. Regarding the specific limitation argued by Applicant, the previously provided explanation on pgs. 3-4 of the prior Office Action is restated below:
It would be obvious to one of ordinary skill in the art that combining an updated imaging scan via the iterative process as taught by Roh ([0082], “The computer system can continuously receive surgical procedure data in block 310. For example, the base module 130 may be configured to receive the surgical procedure data from the operation module 138. The operation module 138 can receive the data from the imaging devices 112 and/or the sensors 110 during the surgical procedure.” [0085], “ Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.”) with the generation of a model as taught by Finley ([0099], “Operation 306 includes conducting 306 a laser-based topographical analysis of the vertebra 10 using the laser instrument 200... The resulting topographical analysis can be, for example, 3D representation of the structures interrogated by the interrogation pulses 30, such as the vertebra 10 and surrounding tissue.”) would result in an regenerated three-dimensional model of the treatment area.
Examiner further notes that regenerating the model is a duplication of parts (MPEP 2144.04(VI)B; “the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”), as a new and unexpected result would not be produced by simply regenerating the model and performing the same steps in an iterative manner.
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.
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 1, 3-4, 6-9, 11-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Finley (US 20220183755) in view of Roh (US 20230225813) further in view of Roh2023 (US 20230270562).
Regarding claim 1, Finley teaches method for autonomous medical laser operation, comprising:
a) performing a three-dimensional imaging scan of a treatment area prior to commencement of the medical operation ([0043], “In an example, there is a method for open spine surgery with a laser. The method uses a laser to register the spine from a laser scan, create pilot holes from a plan using a laser, then use a laser to dynamically track the segmental movement of the spine during navigated instrumentation insertion into the pilot hole. The lasers used for these different operations can be the same or different lasers. A pre-operative scan of the patient is performed and a preoperative plan for screws is constructed.” [0084], “The navigation system 190 can be a system of one or more components configured to provide a user the ability to leverage intraoperative imaging in real-time to provide spatial awareness between anatomical structures and instrumentation, such as in relation to pre-operative 3D scans of the patient.”);
b) generating a scanned three-dimensional model of the treatment area based on the imaging scan ([0099], “Operation 306 includes conducting 306 a laser-based topographical analysis of the vertebra 10 using the laser instrument 200... The resulting topographical analysis can be, for example, 3D representation of the structures interrogated by the interrogation pulses 30, such as the vertebra 10 and surrounding tissue.” [0160], “ the expected result is an expected model of the patient's anatomy generated using pre-operative or intra-operative medical imaging.”);
c) comparing the scanned three-dimensional model to a desired outcome model of the treatment area ([0160], “Operation 908 includes determining whether the topographical scan matches an expected result. In an example, the expected result is an expected model of the patient's anatomy generated using pre-operative or intra-operative medical imaging.” [0057], “the monitoring system can provide an alert if there is a significant deviation from the plan. In some examples, between each level of bone removal, the laser fiber (or another fiber) is used to perform a topographical scan of the pilot hole area for use in confirming that the area matches a segmentation from a scan.” [0048], “By placing the same angled instrument in the disc space the surgeon can create a plan on where the surgeon would like to have the laser hit for disc removal and track the progress through topographical, reflection/refraction, and optical coherence tomography to ensure that the target areas have been removed while reducing the risk of affecting adjacent tissues (e.g., as nerves or vessels) or damaging the endplates.” [0084], “in relation to pre-operative 3D scans of the patient.”);
d) determining at least one surface difference between the scanned model of the treatment area and the desired outcome model, and generating laser operation instructions based on the surface difference such that the treatment area more closely resembles the desired outcome model after performing step (e) ([0057], “the laser fiber (or another fiber) is used to perform a topographical scan of the pilot hole area for use in confirming that the area matches a segmentation from a scan. If there is not a match, then the system can perform a cross correlation to determine what offset transformation matrices need to be adjusted to align with the appropriate topographical section on the vertebral body.” [0035] , “If movement of the spine is detected, then the topographical segmental registration process can be performed to update the navigation and coordinate system.” [0038], “Topographical and spectral analysis of laser reflection and refraction can be used to determine the relative depth to plan, tissue type, and relative energy to be applied to complete the plan while reducing the risk of damaging tissues beyond the planned area.” [0052], “The computer can integrate with a navigation and robotics system to gain an additional level of localization and precision of control over the tip of the laser instrument... The computer can receive a plan for the specific affected area on a 3D scan or a merged scan (e.g., the merger of two different 3D scan types, such as MRI or CT) to gain better localization of the high risk tissue through segmentation. A laser instrument is inserted proximate the area and before each set of laser pulses, the computer identifies the tissue to be removed, its relative thickness and then alters the laser's power setting to increase the likelihood of removing only the selected tissue type… Laser navigation can be beneficial when 3D orientation or specific locations are important and cannot be directly visualized.”);
e) operating a laser on the treatment area according to the laser operation instructions ([0064], “The laser generator adjusts its power according to tissue type and depth. The laser is activated to remove residual soft tissues layers on top of the bone. The laser detects the tissue type change (e.g., from soft tissue to bone) and adjusts a power profile to cut cortical outer layer of bone.”);
wherein operating the laser on the treatment area comprises automatically directing a beam of the laser and modifying operating parameters of the laser based on the laser operation instructions and based on a position of the laser with respect to the treatment area ([0064], “The laser generator adjusts its power according to tissue type and depth. The laser is activated to remove residual soft tissues layers on top of the bone. The laser detects the tissue type change (e.g., from soft tissue to bone) and adjusts a power profile to cut cortical outer layer of bone.” [0098], “Operation 304 includes disposing a distal end 204 of a laser instrument 200 proximate the vertebra 10. In some examples, the laser instrument 200 is manually or automatically moved into position such that the distal end 204 of the laser instrument 200 is proximate the vertebra 10.”).
Although Finley mentions an expected result model ([0160], “Operation 908 includes determining whether the topographical scan matches an expected result. In an example, the expected result is an expected model of the patient's anatomy generated using pre-operative or intra-operative medical imaging.”), Finley does not explicitly teach the desired outcome model being a predictive three-dimensional model of the treatment area after final completion of the medical operation; f) performing an updated three-dimensional imaging scan of the treatment area; g) generating an updated scanned three-dimensional model of the treatment area based on the updated imaging scan; h) comparing the updated scanned three-dimensional model to the desired outcome model; and i) if the updated scanned three-dimensional model does not sufficiently resemble the desired outcome (il) determining at least one surface difference between the updated scanned model and the desired outcome model,(i2) generating updated laser operation instructions based on the surface difference between the updated scanned model and such that the treatment area more closely resembles the desired outcome model after performing a subsequent step (e), and(i3) repeating steps (e)-(i) until the updated scanned model sufficiently resembles the desired outcome model; wherein the desired outcome model is generated based on the imaging scan and on prior data pertaining to the treatment area.
However, the combination of Finley in view of Roh does teach
f) performing an updated three-dimensional imaging scan of the treatment area (Roh, [0082], “The computer system can continuously receive surgical procedure data in block 310. For example, the base module 130 may be configured to receive the surgical procedure data from the operation module 138. The operation module 138 can receive the data from the imaging devices 112 and/or the sensors 110 during the surgical procedure.” [0085], “Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.” Finley, [0100], “the laser-based topographical analysis is or is used to generate a model of the patient's anatomy, which is registered with one or more pre-operative or intraoperative scans (e.g., a preoperative 3D scan) of the patient's anatomy.”);
g) generating an updated scanned three-dimensional model of the treatment area based on the updated imaging scan (Finley, [0099], “Operation 306 includes conducting 306 a laser-based topographical analysis of the vertebra 10 using the laser instrument 200... The resulting topographical analysis can be, for example, 3D representation of the structures interrogated by the interrogation pulses 30, such as the vertebra 10 and surrounding tissue.” Roh, [0082], “The computer system can continuously receive surgical procedure data in block 310. For example, the base module 130 may be configured to receive the surgical procedure data from the operation module 138. The operation module 138 can receive the data from the imaging devices 112 and/or the sensors 110 during the surgical procedure.”). It would be obvious to one of ordinary skill in the art that combining the updated imaging scan of the treatment area via the iterative process, as taught by Roh, with the generation of a model, as taught by Finely, would result in an updated scanned model.
h) comparing the updated scanned three-dimensional model to the desired outcome model (Finley, [0057], “the monitoring system can provide an alert if there is a significant deviation from the plan. In some examples, between each level of bone removal, the laser fiber (or another fiber) is used to perform a topographical scan of the pilot hole area for use in confirming that the area matches a segmentation from a scan.” [0048], “By placing the same angled instrument in the disc space the surgeon can create a plan on where the surgeon would like to have the laser hit for disc removal and track the progress through topographical, reflection/refraction, and optical coherence tomography to ensure that the target areas have been removed while reducing the risk of affecting adjacent tissues (e.g., as nerves or vessels) or damaging the endplates.” Roh, [0085], “Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.”). Examiner interprets comparing and tracking progress using topographical models to encompass the above claim limitation. Thus, it would be obvious to one of ordinary skill in the art that combining the comparison, as taught by Finley, with the iteration of Roh would result in a comparison between an updated model with the desired outcome model.
And i) if the updated scanned three-dimensional model does not sufficiently resemble the desired outcome, (il) determining at least one surface difference between the updated scanned model and the desired outcome model, (i2) generating updated laser operation instructions based on the surface difference between the updated scanned model and such that the treatment area more closely resembles the desired outcome model after performing a subsequent step (e) (Finley, [0057], “the laser fiber (or another fiber) is used to perform a topographical scan of the pilot hole area for use in confirming that the area matches a segmentation from a scan. If there is not a match, then the system can perform a cross correlation to determine what offset transformation matrices need to be adjusted to align with the appropriate topographical section on the vertebral body.” [0035] , “If movement of the spine is detected, then the topographical segmental registration process can be performed to update the navigation and coordinate system.” [0038], “Topographical and spectral analysis of laser reflection and refraction can be used to determine the relative depth to plan, tissue type, and relative energy to be applied to complete the plan while reducing the risk of damaging tissues beyond the planned area.” [0052], “The computer can integrate with a navigation and robotics system to gain an additional level of localization and precision of control over the tip of the laser instrument... The computer can receive a plan for the specific affected area on a 3D scan or a merged scan (e.g., the merger of two different 3D scan types, such as MRI or CT) to gain better localization of the high risk tissue through segmentation. A laser instrument is inserted proximate the area and before each set of laser pulses, the computer identifies the tissue to be removed, its relative thickness and then alters the laser's power setting to increase the likelihood of removing only the selected tissue type… Laser navigation can be beneficial when 3D orientation or specific locations are important and cannot be directly visualized.” Roh, [0085], “Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.”)Roh, [0085], “Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.”). Examiner notes that steps i, i1, and i2 are the same as step d, above.
And (i3) repeating steps (e)-(i) until the updated scanned model sufficiently resembles the desired outcome model (Roh, [0085], “Once the laser settings are adjusted, the computer system can return to block 308, in which the surgical procedure is performed with the adjusted laser settings. Blocks 308-310 can be continuously performed until the computer system determines that the surgical procedure is complete in block 312.”).
Finley in view of Roh are considered analogous to the claimed invention because they are in the field of surgical robotics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Finley with Roh for the advantage of utilizing a system wherein “adjustments can be automatically made to the laser during the surgical procedure to ensure that the procedure is accurately and safely performed and completed” (Roh; [0083]).
Finley in view of Roh does not teach the desired outcome model being a predictive three-dimensional model of the treatment area after final completion of the medical operation.
However, Roh2023 does teach the desired outcome model being a predictive three-dimensional model of the treatment area after final completion of the medical operation ([0145], “This allows virtual models to accurately represent pre-operative conditions of complex anatomical structures, such as joints, movement of surgical robots, operation of tools, etc. Pre-operative virtual models can represent predicted outcomes for joints, such as improved functionality, stability, or the like. The virtual models can be used to perform simulations to generate simulation data. In some embodiments, virtual models can incorporate or be based on 3D renderings of medical images.” [0218], “Simulations for the virtual robotic surgical procedure can be performed using virtual models that can include two- or three-dimensional models to evaluate, for example, one or more steps of a surgical procedure (or entire procedure), predicted events, outcomes, etc. The simulations can be used to identify and assess biomechanics, access paths, stresses, strains, deformation characteristics (e.g., load deformation characteristics, load distributions, etc.), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The virtual model can include a model of the patient's anatomy, implant(s), end effectors, instruments, access tools, or the like.”). Therefore, it would obvious to one of ordinary skill in the art that combining the predictive 3D outcome anatomical model of Roh2023 with the iteration of steps in a laser-based surgical procedure as taught by Roh and the specific surgical steps as taught by Finley would result in performance of the claimed steps using a predictive 3D model of the treatment area after final completion of the medical operation.
Finley in view of Roh further in view of Roh2023 are considered analogous to the claimed invention because they are in the field of surgical robotics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Finley in view of Roh with Roh2023 for the advantage “using the modified virtual model to assess predicted outcomes” (Roh2023; [0131]).
Regarding claim 3, Finley in view of Roh further in view of Roh2023 teaches the method of claim 1. Finley does not explicitly teach wherein steps (e)-(i) are continuously repeated in real time.
However, Finley in view of Roh does teach wherein steps (e)-(i) are continuously repeated in real time (Roh, [0004], “ The computing system can determine real-time dynamic adjustments that can be made to the laser settings based on the monitoring of the surgical area using the imaging devices and/or sensors.” [0111], “The surgical procedure can continue to be performed. The computer system can determine whether the surgical procedure is complete in block 614. This determination can be made based on analysis of the image data that is continuously received of the surgical area (block 604). So long as the surgical procedure is not complete, the computer system can repeat blocks 604-612.”).
Finley in view of Roh are considered analogous to the claimed invention because they are in the field of surgical robotics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Finley with Roh for the advantage of allowing the system to “stop and reassess” after “ablat[ing] tissues from the treatment area” (Roh; [0108]).
Regarding claim 4, Finley in view of Roh further in view of Roh2023 teaches the method of claim 1. Finley does not teach wherein the prior data pertaining to the treatment area includes one or more of training data sets and historical data of prior procedures relevant to the treatment area.
However, Roh does teach wherein the prior data pertaining to the treatment area includes one or more of training data sets and historical data of prior procedures relevant to the treatment area ([0013], “The machine learning model could have been trained to generate a comparison of monitored surgical procedure data to historic surgical procedure data using a training data set.” [0055], “The imaging devices 112 can continuously capture image data of the particular surgical area during the surgical procedure. Therefore, the imaging devices 112 can be trained on the particular surgical area.”).
Finley in view of Roh are considered analogous to the claimed invention because they are in the field of surgical robotics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Finley with Roh for the advantage of “assess[ing] the surgical procedure and compare the surgical procedure with surgical procedures that had been previously conducted” (Roh; [0122]).
Regarding claim 6, Finley in view of Roh further in view of Roh2023 teaches the method of claim 1. Finley further teaches wherein the imaging scan comprises three-dimensional volumetric data ([0053], “The computer can receive a plan for the specific affected area on a 3D scan or a merged scan (e.g., the merger of two different 3D scan types, such as MRI or CT) to gain better localization of the high risk tissue through segmentation.” [0048], “Laser energy can be tuned to hit specific frequencies that will be able to cut disc but not bone or vice versa. By placing the same angled instrument in the disc space the surgeon can create a plan on where the surgeon would like to have the laser hit for disc removal and track the progress through topographical, reflection/refraction, and optical coherence tomography to ensure that the target areas have been removed while reducing the risk of affecting adjacent tissues (e.g., as nerves or vessels) or damaging the endplates. This volume can then be relayed back to the user to create additional plans or to validate that the current plan is progressing as desired.”). Examiner notes [0022] of Applicant specification defines volumetric as “representing an area or volume to be surgically or non-surgically treated by laser”. Thus, Examiner interprets a 3D scan displaying volume that has been removed to encompass three-dimensional volumetric data.
Regarding claim 7, Finley in view of Roh further in view of Roh2023 teaches the method of claims 1 and 6. Finley further teaches wherein the imaging scan further comprises two-dimensional data ([0057], “perform 2D intraoperative imaging to help the surgeon visualize on 2D imaging regarding how far and where the laser has cut by visualizing the location of the wire.”).
Regarding claim 8, Finley in view of Roh further in view of Roh2023 teaches the method of claim 1. Finley further teaches wherein operating the laser further comprises:
determining a situation of a source of the laser with respect to the treatment area ([0084], “ The navigation system 190 can be a system of one or more components configured to provide a user the ability to leverage intraoperative imaging in real-time to provide spatial awareness between anatomical structures and instrumentation, such as in relation to pre-operative 3D scans of the patient. An example navigation system 190 includes one or more optical tracking components configured to detect (e.g., using visible light or infrared light) in real-time location of objects in relationship to each other as the objects move through space. Using the optical tracking system, the navigation system 190 can obtain usable to determine the location of one or more tracking arrays, which can be used to provide dynamic 3D position information corresponding to the anatomical features, the surgical instruments, and the surgical implants being tracked.” [0062], “A fiber optic based navigation system can be used to permit the surgeon to ascertain where the tip of the laser instrument is in case the actual position is too far deviated from the planned position.”); and
controlling operation of the laser at one or more locations of the treatment area according to the laser operation instructions while accounting for the situation of the source of the laser ([0098], “In some examples, the laser instrument 200 is manually or automatically moved into position such that the distal end 204 of the laser instrument 200 is proximate the vertebra 10.”);
wherein the situation of the source of the laser includes one or more of a position of the source of the laser, an orientation of the source of the laser, and a movement of the source of the laser ([0062], “A fiber optic based navigation system can be used to permit the surgeon to ascertain where the tip of the laser instrument is in case the actual position is too far deviated from the planned position.” [0120], “The angle can be manually (e.g., by the surgeon) or automatically controlled. In further examples, the angling is achieved by changing a position of the laser instrument.”); and
wherein controlling operation of the laser includes one or more of activating the laser, deactivating the laser, directing the laser, and varying an intensity of the laser ([0062], “one or more parameters of the cutting can be changed (e.g., laser intensity or cutting plan location).”).
Regarding claim 9, this claim is rejected for the same reasons as claim 1, as described above. Finley further teaches a system for autonomous medical laser operation, comprising:
a laser module including a surgical laser and a guidance system ([0039], “ A guide can be attached to the laser end effector (e.g., not in line with the laser) to place the navigated instrument, implant, or access into the prepared hole.” [0063], “a mirror or another laser directing device is placed at the tip of the device to provide an off axis laser beam that is used in a rotational method in addition to stepping into the anatomy that it is cutting.”);
a scanning module including one or more of a 3D imaging device and a 2D imaging device ([0053], “The computer can receive a plan for the specific affected area on a 3D scan or a merged scan (e.g., the merger of two different 3D scan types, such as MRI or CT) to gain better localization of the high risk tissue through segmentation.” [0057], “perform 2D intraoperative imaging to help the surgeon visualize on 2D imaging regarding how far and where the laser has cut by visualizing the location of the wire.”); and
a controller ([0078], “The computer 120 can be a computing environment, such as the one described in more detail in FIG. 10. In the illustrated example, the computer 120 includes one or more processors 122 and memory 124, which can correspond to the processors and memory described in relation to FIG. 10. In an example, the memory 124 stores one or more programs or instructions that, when executed by the one or more processors 122 cause the one or more processors 122 to perform one or more operations as described herein.”).
Regarding claims 11 and 12, these claims are rejected for the same reasons as claims 3 and 4, respectively.
Regarding claim 14, Finley in view of Roh further in view of Roh2023 teaches the system of claim 9. Finley further teaches the system further comprising a housing, wherein the laser module is disposed within the housing ([0079], “The robot 130 is a surgical robot. The robot 130 can include one or more arms 132. As illustrated, a first arm 132 has the laser instrument 200 as an end effector 136”). Examiner notes that the robot arm housing holding the laser instrument can be seen in Fig. 1, below.
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Regarding claim 15, Finley in view of Roh further in view of Roh2023 teaches the system of claims 9 and 14. Finley further teaches wherein the scanning module is disposed within the housing ([0084], “The navigation system 190 can be a system of one or more components configured to provide a user the ability to leverage intraoperative imaging in real-time to provide spatial awareness between anatomical structures and instrumentation, such as in relation to pre-operative 3D scans of the patient. An example navigation system 190 includes one or more optical tracking components configured to detect (e.g., using visible light or infrared light) in real-time location of objects in relationship to each other as the objects move through space.”). Examiner notes that the navigation system/scanning module is contained in a housing with the robot as seen in Fig. 1, below.
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Regarding claims 16-18, these claims are rejected for the same reasons as claim 8, as described above. Examiner notes that no distinction is made between the laser as claimed in claim 8 and the housing that contains the laser as claimed in claims 16-18 because the rejection for claim 14 demonstrates that the laser is in a housing.
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Finley (US 20220183755) in view of Roh (US 20230225813) further in view of McKinnon (US 20200275976).
Regarding claim 5, Finley in view of Roh further in view of Roh2023 teaches the method of claims 1 and 4. Finley does not teach wherein the desired outcome model is generated by machine learning or artificial intelligence procedures that are trained on the prior data.
However, McKinnon does teach wherein the desired outcome model is generated by machine learning or artificial intelligence procedures that are trained on the prior data ([0217], “Historical data sets from the online database are used as inputs to a machine learning model such as, for example, a recurrent neural network (RNN) or other form of artificial neural network... For the sections that follow, it is assumed that the machine learning model is trained to generate predictor equations. These predictor equations may be optimized to determine the optimal size, position, and orientation of the implants to achieve the best outcome or satisfaction level.” [0194], “In some embodiments, the relationship(s) between the factors and responses may be defined by a set of trained neural networks rather than a series of equations. Similar statistical and modeling tools to those described above may be used to define and train the neural networks and the factors used therein.” [0358], “This allows a surgical user to access the statistical database model to develop a surgical plan that can then be used by a CASS or displayed to the user.” [0177], “one or more surgical planning models may be incorporated into the CASS 100 and used in the development of the surgical plans provided to the surgeon 111. The term “surgical planning model” refers to software that simulates the biomechanics performance of anatomy under various scenarios to determine the optimal way to perform cutting and other surgical activities.”).
Finley in view of Roh further in view of Roh2023 and McKinnon are considered analogous to the claimed invention because they are in the field of surgical robotics. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Finley in view of Roh further in view of Roh2023 with McKinnon for the advantage of “predict[ing] one or more values based on the input data.” (McKinnon; [0217]).
Regarding claim 13, this claim is rejected for the same reasons as claim 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tucker; Scott, Comparison of Actual Surgical Outcomes and 3-Dimensional Surgical Simulations, Oct 2010, Journal of Oral and Maxillofacial Surgery, Vol. 68, Issue 10, pgs. 2412-2421, which teaches assessing differences in predicted post-surgery 3D models used to simulate a surgical procedure preoperatively and actual surgical results.
Qian; Nidan, Machine Learning Prediction of Visual Outcome after Surgical Decompression of Sellar Region Tumors, 25 Jan 2022, Journal of Personalized Medicine, 12(2):152, which teaches a machine learning-based model integrating clinical and ophthalmic features to predict visual outcomes after transsphenoidal resection of sellar region tumors.
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/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684