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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/04/2025 has been entered.
Response to Amendment
The amendment filed on 11/04/2025 has been entered:
Claim 1 – 20 remain pending in the application;
Claim 1, 5, 7, 10, 11 and 14 are amended.
Applicant’s amendments to claim overcome each and every claim interpretation under 35 U.S.C. 112(f) as set forth in the Final Office Action mailed on 09/16/2025. The corresponding 112(f) claim interpretation are withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 – 10 and 13 – 20 under 35 U.S.C. 102/103 have been fully considered but they are moot in view of new grounds of rejection.
Regarding the rejection of independent claim 1, applicant amended claim to include limitation “the plurality of images depicting a navigation probe contacting each divot of a plurality of divots on a medical instrument”, and submitted on p.6 – 8 that “although Henderson discloses a bone tracking array 20 with "at least one feature 24," Henderson does not discuss an embodiment where the tracking system 26 takes images that depict digitizer 10 contacting multiple features 24, where such images are then used to determine the pose of the alleged medical instrument (bone tracking array 20), as claimed”; “At no point, however, does Henderson disclose or suggest capturing multiple images depicting the digitizer 10 contacting multiple features 24, and then determining a pose of the bone tracking array 20 based on those images.” Applicant’s arguments have been fully considered but they are moot in view of new grounds of rejection.
Since applicant’s amendment changed the scope of claim, new reference, Foley et al. (US RE45,509 E; published on 05/05/2015) (hereinafter “Foley”), is introduced in new grounds of rejection to teach the amended claim in combination with other cited reference. See detail in later 103 rejections.
Thus, applicant’s arguments regarding the rejection of independent claim 1 have been fully considered, but they are moot in view of new grounds of rejection.
Regarding the rejection of independent claim 7 and 14, applicant amended claims to include similar features as amended in claim 1, and applicant’s arguments submitted on p.8 rely on similar supposed deficiencies with the rejection of claim 1. Applicant’s arguments are moot in view of new grounds of rejection for the same reasons detailed above.
Regarding the rejection of dependent claim 5, applicant’s arguments submitted on p.8 rely on amended limitations which changed the scope of claim. New reference Foley is introduced in new grounds of rejection and applicant’s arguments are moot in view of new grounds of rejection. See detail in later 103 rejection.
Regarding the rejection of all other corresponding dependent claims, applicant’s remarks submitted on p.8 rely on supposed deficiencies with the rejection of parent claim 1, 7 and 14. Applicant’s arguments are moot in view of new grounds of rejection for the same reasons detailed above.
Overall, applicant’s remarks submitted on p.6 – 9 have been fully considered, but they are not persuasive.
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.
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.
Claim 1, 7, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (US 2023/0137702 A1; filed on 04/08/2021) (hereinafter "Henderson") in view of Foley et al. (US RE45,509 E; published on 05/05/2015) (hereinafter “Foley”).
Regarding claim 1, Henderson teaches a method ("With reference now to FIGS. 4-6, a particular inventive embodiment of a method 200 …" [0046]), comprising:
receiving a plurality of images ("The tracking system 26 may be an optical tracking system having two or more cameras (28 a, 28 b) to track the tracking arrays (16, 20) in three-dimensional space." [0042]; "… and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera), the plurality of images depicting a navigation probe contacting ("… assembles the digitizer tip 14 with the feature 24 on the bone tracking array 20 (Block 204), and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera) a plurality of divots on a medical instrument ("... and at least one feature 24 formed on the rigid body 21. The feature 24 may be for example, a divot ... or other feature capable of receiving or restraining the digitizer tip 14." [0046]);
receiving information about the medical instrument ("… and the stored calibration definition of the feature 24 position are transmitted to the tracking system 26 [Block 202]." [0047]); and
determining, based on the plurality of images and the information, a pose of the medical instrument ("The method 200 also includes recording the POSE of the digitizer tracking array 16 and the bone tracking array 20′ when the digitizer tip 14 and feature 24 are assembled together … The tracking system 26 likewise calculates the position of the feature 24 in space by applying the transmitted calibration definition of the feature position with the recorded POSE of the digitizer tracking array 20′." [0051]).
Although Henderson teaches the plurality of divots for receiving digitizer, Henderson fails to explicitly teach the plurality of images depicting a navigation probe contacting each divot of a plurality of divots on a medical instrument.
However, in the same field of endeavor, Foley teaches the plurality of images depicting a navigation probe contacting each divot of a plurality of divots on a medical instrument (“The fiducial array 170 also has, for example, divots 29 (shown in FIG. 2) shaped to interface with an instrument such as a surgical pointer 130 which can touch that divot 29 to register the location of the divot 29 and, thus, the location of the fiducial array 170 and likewise the spinal element in the surgical navigation system. Multiple divots can be registered to further increase accuracy of the registration system.” Col.7, Ln.57 – Col.8, Ln.10; each divot is registered by a single touch; in Foley, registration is carried out via camera and image is inherent result of camera acquisition, see Col.9, Ln.5 – 30).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the multiple divots features as taught by Henderson with the multiple divots registration as taught by Foley. Doing so would make it possible "to further increase accuracy of the registration system " (see Foley; Col.7, Ln.57 – Col.8, Ln.10).
Regarding claim 7, Henderson teaches a system ("A medical system for performing the computerized method for checking and verifying the calibration of a digitizer during a computer-assisted medical procedure is provided." [0017]), comprising:
a processor ("The computer also includes a processor …" [0017]); and
a memory storing data thereon that, when processed by the processor ("… non-transient storage memory, and other hardware, software, data and utilities to execute the method." [0017]), cause the processor to:
receive a plurality of images ("The tracking system 26 may be an optical tracking system having two or more cameras (28 a, 28 b) to track the tracking arrays (16, 20) in three-dimensional space." [0042]; "… and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera) depicting a navigation probe contacting ("… assembles the digitizer tip 14 with the feature 24 on the bone tracking array 20 (Block 204), and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera) a plurality of divots on a surgical device ("... and at least one feature 24 formed on the rigid body 21. The feature 24 may be for example, a divot ... or other feature capable of receiving or restraining the digitizer tip 14." [0046]);
receive information about the surgical device ("… and the stored calibration definition of the feature 24 position are transmitted to the tracking system 26 [Block 202]." [0047]); and
determine, based on the plurality of images and the information about the surgical device, a pose of the surgical device ("The method 200 also includes recording the POSE of the digitizer tracking array 16 and the bone tracking array 20′ when the digitizer tip 14 and feature 24 are assembled together … The tracking system 26 likewise calculates the position of the feature 24 in space by applying the transmitted calibration definition of the feature position with the recorded POSE of the digitizer tracking array 20′." [0051]).
Although Henderson teaches the plurality of divots for receiving digitizer, Henderson fails to explicitly teach the plurality of images depicting a navigation probe contacting each divot of a plurality of divots on a surgical device.
However, in the same field of endeavor, Foley teaches to receive a plurality of images depicting a navigation probe contacting each divot of a plurality of divots on a surgical device (“The fiducial array 170 also has, for example, divots 29 (shown in FIG. 2) shaped to interface with an instrument such as a surgical pointer 130 which can touch that divot 29 to register the location of the divot 29 and, thus, the location of the fiducial array 170 and likewise the spinal element in the surgical navigation system. Multiple divots can be registered to further increase accuracy of the registration system.” Col.7, Ln.57 – Col.8, Ln.10; each divot is registered by a single touch; in Foley, registration is carried out via camera and image is inherent result of camera acquisition, see Col.9, Ln.5 – 30).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the multiple divots features as taught by Henderson with the multiple divots registration as taught by Foley. Doing so would make it possible "to further increase accuracy of the registration system " (see Foley; Col.7, Ln.57 – Col.8, Ln.10).
Regarding claim 13, Henderson in view of Foley teaches all claim limitations, as applied in claim 7, and Henderson further teaches wherein each divot of the plurality of divots includes a first geometric shape, and wherein the first geometric shape is a circle (see Fig.5, feature 24 is a circle).
Regarding claim 14, Henderson teaches an apparatus ("A medical system for performing the computerized method for checking and verifying the calibration of a digitizer during a computer-assisted medical procedure is provided." [0017]), comprising:
an imaging device ("The tracking system 26 may be an optical tracking system having two or more cameras (28 a, 28 b) to track …" [0043]);
a bone mount device configured to attach to an anatomical element ("The bone tracking array 20 is a tracking array that is fixable to a bone B. The bone tracking array 20 may be a rigid body 21 …" [0043]) and including a plurality of divots ("... and at least one feature 24 formed on the rigid body 21. The feature 24 may be for example, a divot ... or other feature capable of receiving or restraining the digitizer tip 14." [0046]);
a processor ("The computer also includes a processor …" [0017]); and
a memory storing data thereon that, when processed by the processor ("… non-transient storage memory, and other hardware, software, data and utilities to execute the method." [0017]), cause the processor to:
receive a plurality of images from the imaging device ("The tracking system 26 may be an optical tracking system having two or more cameras (28 a, 28 b) to track the tracking arrays (16, 20) in three-dimensional space." [0042]; "… and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera) depicting a plurality of navigation markers disposed on a navigation probe that contacts ("… assembles the digitizer tip 14 with the feature 24 on the bone tracking array 20 (Block 204), and the tracking system 26 records the position and orientation (POSE) of the digitizer tracking array 16 and the bone tracking array 20′ [Block 206]." [0047]; here the images are inherent output of camera) the plurality of divots ("... and at least one feature 24 formed on the rigid body 21. The feature 24 may be for example, a divot ... or other feature capable of receiving or restraining the digitizer tip 14." [0046]);
receive information about an orientation of the plurality of divots ("… and the stored calibration definition of the feature 24 position are transmitted to the tracking system 26 [Block 202]." [0047]); and
determine, based on the plurality of images and the information about the orientation of the plurality of divots, a pose of the bone mount device ("The method 200 also includes recording the POSE of the digitizer tracking array 16 and the bone tracking array 20′ when the digitizer tip 14 and feature 24 are assembled together … The tracking system 26 likewise calculates the position of the feature 24 in space by applying the transmitted calibration definition of the feature position with the recorded POSE of the digitizer tracking array 20′." [0051]).
Although Henderson teaches the plurality of divots for receiving digitizer, Henderson fails to explicitly teach the plurality of images depicting a navigation probe contacting each divot of a plurality of divots.
However, in the same field of endeavor, Foley teaches to receive a plurality of images from the imaging device depicting a plurality of navigation markers disposed on a navigation probe (“… then touches an instrument with a tracking emitter such as a surgical pointer 130 with emitters 195 to the divots 29 …” Col.8, Ln.56 – Col.9, Ln.4; “The emitters 195 generate infrared signals to be picked up by camera digitizer array 110 …” Col.9, Ln.5 – 30) that contacts each divot of the plurality of divots (“The fiducial array 170 also has, for example, divots 29 (shown in FIG. 2) shaped to interface with an instrument such as a surgical pointer 130 which can touch that divot 29 to register the location of the divot 29 and, thus, the location of the fiducial array 170 and likewise the spinal element in the surgical navigation system. Multiple divots can be registered to further increase accuracy of the registration system.” Col.7, Ln.57 – Col.8, Ln.10; each divot is registered by a single touch; in Foley, registration is carried out via camera and image is inherent result of camera acquisition, see Col.9, Ln.5 – 30).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the multiple divots features as taught by Henderson with the multiple divots registration as taught by Foley. Doing so would make it possible "to further increase accuracy of the registration system " (see Foley; Col.7, Ln.57 – Col.8, Ln.10).
Claim 2 – 6, 8 – 10 and 15 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson in view of Foley, as applied in claim 1, 7 and 14 respectively, and further in view of Gullotti et al. (US 2020/0405395 A1; published on 12/31/2020) (hereinafter "Gullotti").
Regarding claim 2, Henderson in view of Foley teaches all claim limitations, as applied in claim 1, except the step of updating, based on the pose of the medical instrument, a surgical plan.
However, in the same field of endeavor, Gullotti teaches the step of updating, based on the pose of the medical instrument, a surgical plan ("… then the probe-based acquisitions of each bone-mounted fiducial provides updated information as to the new location and pose of individual vertebrae … this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 3, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 2, and Gullotti further teaches wherein updating the surgical plan further comprises:
registering the medical instrument to an anatomical element ("FIGS. 117I-117J illustrate the registration process of a bone-mounted fiducial 11701 that is implanted into the spine 11741 which is being rapidly registered via a 3D-tracked probe 11682. In some embodiments, after the 3D-tracked probe 11731 is fully engaged with the bone-mounted fiducial 11701, the trigger button 11733 can actuate the TMSM 11737 and signal to the computer the active registration of a unique bone-mounted fiducial." [1327]; see Fig.117A-J); and
determining, based on the registering, a new trajectory for a surgical implant ("… this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 4, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 3, and Gullotti further teaches wherein the surgical implant includes a pedicle screw ("… the flexibility assessment devices attach directly to instrumented pedicle screws within the spine via a pseudo-rod component that is compressed with a standard screw cap to convert a polyaxial screw into a monoaxial screw and enable rigid manipulation of the attached vertebrae." [1354]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 5, Henderson in view of Foley teaches all claim limitations, as applied in claim 1, and Henderson further teaches wherein the medical instrument comprises a bone mounting device ("The bone tracking array 20 is a tracking array that is fixable to a bone B." [0043]; see Fig.3).
In addition, Foley teaches wherein the navigation probe contacts each divot of the plurality of divots in a sequence (“The fiducial array 170 also has, for example, divots 29 (shown in FIG. 2) shaped to interface with an instrument such as a surgical pointer 130 which can touch that divot 29 to register the location of the divot 29 and, thus, the location of the fiducial array 170 and likewise the spinal element in the surgical navigation system. Multiple divots can be registered to further increase accuracy of the registration system.” Col.7, Ln.57 – Col.8, Ln.10; each divot is registered by a single touch, in order to perform multiple divots registration, the pointer touching must be in sequential manner since there is one pointer).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to utilize the multiple divots features as taught by Henderson with the multiple divots registration as taught by Foley. Doing so would make it possible "to further increase accuracy of the registration system " (see Foley; Col.7, Ln.57 – Col.8, Ln.10).
Henderson in view of Foley fails to explicitly teach wherein the information about the medical instrument comprises information about a pre-configured orientation of the plurality of divots.
However, in the same field of endeavor, Gullotti teaches wherein the medical instrument comprises a bone mounting device ("… the bone-mounted fiducial devices can be placed anywhere within or near the surgical site …" [1323]), and
wherein the information about the medical instrument comprises information about a pre-configured orientation of the plurality of divots ("... the fiducial device has screw threads 11703 that align with the mating interface and its screwdriver wall interface 11707." [1323]; "… given this complementary, asymmetric mating mechanism, a 3D-tracked probe can only mate with the bone-mounted fiducial 11701 in one unique trajectory and orientation." [1324]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 6, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 5, and Gullotti further teaches wherein determining the pose of the medical instrument further comprises:
determining a pose of a plurality of tracking markers on the navigation probe ("… the 3D-tracked probe comprises a probe shaft 11679 encased in a trigger sleeve handle 11698, and a 3D-tracked dynamic reference frame (DRF) 11686 that comprises a unique array of 3D-tracked markers 11684 …" [1322]; here the DRF is 3D-tracked, whcih means the pose of DRF (including markers) is determined in 3D space) when the navigation probe contacts each divot of the plurality of divots ("... the 3D-tracked probe 11731 is fully mated with the female bone-mounted fiducial 11701 and the trigger button 11733 actuated the TMSM 11737 into an active state, which signals to the computer to record the current 3D location and orientation of the bone-mounted fiducial 11701." [1325]); and
determining, based on the pre-configured orientation and the determined pose of the tracking markers, a position of the medical instrument ("… given this complementary, asymmetric mating mechanism, a 3D-tracked probe can only mate with the bone-mounted fiducial 11701 in one unique trajectory and orientation." [1324]; "... a 3D-tracked probe registers the unique 3D location and orientation of the bone-mounted fiducial device with a probe tip that can features a complementary mating interface." [1325]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 8, Henderson in view of Foley teaches all claim limitations, as applied in claim 7, except wherein the data further cause the processor to: update, based on the pose of the surgical device, a surgical plan.
However, in the same field of endeavor, Gullotti teaches wherein the data further cause the processor to: update, based on the pose of the surgical device, a surgical plan ("… then the probe-based acquisitions of each bone-mounted fiducial provides updated information as to the new location and pose of individual vertebrae … this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 9, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 8, and Gullotti further teaches wherein updating the surgical plan further comprises:
registering the surgical device to an anatomical element ("FIGS. 117I-117J illustrate the registration process of a bone-mounted fiducial 11701 that is implanted into the spine 11741 which is being rapidly registered via a 3D-tracked probe 11682. In some embodiments, after the 3D-tracked probe 11731 is fully engaged with the bone-mounted fiducial 11701, the trigger button 11733 can actuate the TMSM 11737 and signal to the computer the active registration of a unique bone-mounted fiducial." [1327]; see Fig.117A-J); and
updating, based on the registering, a trajectory of a surgical implant ("… this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 10, Henderson in view of Foley teaches all claim limitations, as applied in claim 7, except wherein the surgical device comprises: an upper body; a clamp connected to the upper body and configured to attach the surgical device to an anatomical element; and a screw that secures the clamp to the anatomical element.
However, in the same field of endeavor, Gullotti teaches wherein the surgical device comprises:
an upper body ("… the bone-clamping fiducial (initial position) 15002 a comprises … a device body …" [1487]);
a clamp connected to the upper body and configured to attach the surgical device to an anatomical element ("… with a bone-clamping mechanism 15006, which includes one or more set screws to rigidly attach the device to the vertebra 15008 a." [1487]); and
a screw that secures the clamp to the anatomical element ("… which includes one or more set screws to rigidly attach the device to the vertebra 15008 a." [1487]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 15, Henderson in view of Foley teaches all claim limitations, as applied in claim 14, except wherein the data further cause the processor to: update, based on the pose of the bone mount device, a surgical plan.
However, in the same field of endeavor, Gullotti teaches wherein the data further cause the processor to: update, based on the pose of the bone mount device, a surgical plan ("… then the probe-based acquisitions of each bone-mounted fiducial provides updated information as to the new location and pose of individual vertebrae … this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 16, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 15, and Gullotti further teaches wherein updating the surgical plan further comprises:
registering the bone mount device to the anatomical element ("FIGS. 117I-117J illustrate the registration process of a bone-mounted fiducial 11701 that is implanted into the spine 11741 which is being rapidly registered via a 3D-tracked probe 11682. In some embodiments, after the 3D-tracked probe 11731 is fully engaged with the bone-mounted fiducial 11701, the trigger button 11733 can actuate the TMSM 11737 and signal to the computer the active registration of a unique bone-mounted fiducial." [1327]; see Fig.117A-J); and
updating, based on the registering, a trajectory for a surgical implant ("… this system rapidly registers the 3D spinal alignment parameters between vertebrae that contain implanted bone-mounted fiducials 11701." [1327]; here the spinal alignment parameter is the new trajectory of alignment implant).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 17, Henderson in view of Foley teaches all claim limitations, as applied in claim 14, except wherein the bone mount device further comprises: an upper body; a clamp connected to the upper body; and a moveable component that attaches the clamp to the anatomical element.
However, in the same field of endeavor, Gullotti teaches wherein the bone mount device further comprises:
an upper body ("… the bone-clamping fiducial (initial position) 15002 a comprises … a device body …" [1487]);
a clamp connected to the upper body ("… with a bone-clamping mechanism 15006, which includes one or more set screws to rigidly attach the device to the vertebra 15008 a." [1487]); and
a moveable component that attaches the clamp to the anatomical element ("… which includes one or more set screws to rigidly attach the device to the vertebra 15008 a." [1487]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 18, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 17, and Gullotti further teaches wherein the plurality of divots includes a first divot, a second divot, and a third divot (see Fig.117H; there are 6 fiducials and each has a mating interface), wherein the moveable component includes a fourth divot ("… the fiducial device has screw threads 11703 that align with the mating interface and its screwdriver wall interface 11707." [1323]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 19, Henderson in view of Foley and Gullotti teaches all claim limitations, as applied in claim 18, and Gullotti further teaches wherein the navigation probe is perpendicular to a surface of the bone mount device when contacting at least one of the first divot, the second divot, the third divot, or the fourth divot ("… given this complementary, asymmetric mating mechanism, a 3D-tracked probe can only mate with the bone-mounted fiducial 11701 in one unique trajectory and orientation." [1324]; "... a 3D-tracked probe registers the unique 3D location and orientation of the bone-mounted fiducial device with a probe tip that can features a complementary mating interface." [1325]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Regarding claim 20, Henderson in view of Foley teaches all claim limitations, as applied in claim 14, except wherein the bone mount device is attached to a spinous process of a vertebra, and wherein the apparatus further comprises: a connector coupled to the bone mount device at a first end and coupled to a robotic arm at a second end.
However, in the same field of endeavor, Gullotti teaches wherein the bone mount device is attached to a spinous process of a vertebra ("The vertebra 300 is shown with a bone-mounted fiducial 320 fastened to the bone." [0746]), and
wherein the apparatus further comprises: a connector coupled to the bone mount device at a first end and coupled to a robotic arm at a second end ("… the fixed base 4905 can be resting on a surface, or mounted to a rigid surface including a component of a robot according to some embodiments." [0905]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the tracked probe as taught by Henderson with the application of tracked probe on bone-mounted device as taught by Gullotti. Doing so would make it possible "for precise registration of their 3D locations and poses for purposes of calculating spinal alignment parameters, 3D visualization of anatomy, and updating the registration of image-guided navigation systems" (see Gullotti; [1323]).
Allowable Subject Matter
Claim 11 and 12 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 11, Henderson in view of Gullotti teaches all claim limitations, as applied in claim 10, except wherein the plurality of divots include a first divot, a second divot, and a third divot each disposed on the upper body, and a fourth divot disposed on the screw.
Although Gullotti teaches four detents 11601 on the upper body for probe tapping ([1317]; Fig.116A), there is no teaching of “fourth divot” or equivalent disposed on the tightening mechanism.
Thus, the cited prior art and other search results collectively neither teach nor fairly well suggest all limitations as recited in claim 11.
Claim 12 is dependent on claim 11 and therefore include all allowable features as identified above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Murphy et al. (US 10,335,236 B1; published on 07/02/2019) teach a multiple divots registration with pointer tip touching each divot.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797