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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-Grant Publication US 2024/0382265 A1.
Response to Amendment
The amendment filed on 102/23/2026 has been entered:
Claim 1, 3 – 10,12 – 19 and 20 remain pending in the application;
Claim 1, 9, 16 and 21 are amended;
Claim 2 and 20 are cancelled.
Applicant’s amendments to claim overcome each and every 112 (a) claim rejection as set forth in the Non-Final Office Action mailed on 07/20/2026. The corresponding 112 claim rejections are withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 – 10 and 12 - 21 under 35 U.S.C. 103 have been fully considered but they are not persuasive and are moot in view of new grounds of rejection.
Regarding the rejection of independent claim 1, 9 and 16, applicant amend claim 1 to include limitation “navigating, using the robotic controller, one or more surgical instruments based at least partially on the second localizer pose information; and removing, after the one or more surgical instruments are navigated, the second localizer from the patient anatomy”, and amended claim 9 and 16 with similar features. Applicant submitted on p.7 – 8 that “amended claim 1 further emphasizes features of navigating surgical instruments and removing the second localizer from patient anatomy. The amendments are supported by at least original claim 20, Fig. 1D, and paragraphs 54, 74, and 100 of the application as filed.”
Applicant’s arguments have been fully considered but they are moot in view of new grounds of rejection for the following reasons.
First, the amended feature of navigating surgical instruments based on the second localizer pose information is taught by Snyder, which is detailed in the rejection of cancelled claim 2 (see [0053], [0056]).
Second, the amended limitations “removing, after the one or more surgical instruments are navigated, the second localizer from the patient anatomy” are NEW MATTER introduced in the amendment without written description support. The Fig.1D as recited by applicant only illustrates that the instrument with second localizer is disposed to the target anatomy. There is no illustration about the removal procedure.
The disclosure in [0054] of the specification of present application recites: “In some embodiments, the use of the second, smaller localizer may provide a technical solution to issues such as: concerns related to accidental movement of the patient tracker during surgery (e.g., due to bumps, vibrations, etc.), patient concerns about pain associated with the localizer (e.g., percutaneous pinning), and issues associated with limited referencing due to the small size of cervical anatomy.”
The disclosure in [0074] of the specification of present application recites: “The presence of both the first localizer 144 and the second localizer 148 may enable the navigation system of the system 100 to use both optical navigation and electromagnetic navigation by co-registering the first localizer 144 and the second localizer 148. The first localizer 144 may be tracked in an optical coordinate system, while the second localizer 148 may be tracked in an electromagnetic coordinate system. By determining the location of the first localizer 144 and the second localizer 148 relative to one another through co-registration, the navigation system can then determine the location of optically tracked and navigated components (e.g., surgical instruments) in the electromagnetic coordinate system as well as the location of electromagnetically tracked and navigated components (e.g., patient anatomy) in the optical coordinate system. As a result, the navigation system can navigate surgical instruments and other components relative to patient anatomy in the optical coordinate system, the electromagnetic coordinate system, a shared coordinate system, or the like.”
The disclosure in [0100] of the specification of present application recites: “The method 300 also comprises outputting the second localizer pose information to at least one of a display device and a robotic controller (step 324). In some embodiments, the display device may be or comprise the user interface 210 and the robotic controller may be or comprise the navigation system 218. Based on the second localizer pose information, the navigation system 218 may navigate one or more surgical tools relative to the second localizer 148. In some embodiments, the second localizer 148 may represent the location of patient anatomy, such as when the second localizer 148 is disposed on the patient anatomy.”
The above paragraphs as recited by applicant are all above navigation. There is no disclosure about the removal of the second localizer. Further, there is no disclosure regarding the removal of the second localizer through whole specification.
Therefore, there is no written description support for the amended limitations. The amendment introduced NEW MATTER and are rejected under 35 U.S.C. 112 (a).
Third, Snyder does indicate the removal of second localizer in the navigation procedure. Snyder teaches the tracking device 66 (interpreted as the second localizer) is disposed on the instrument 68, and the instrument 68 is displayed in real-time during surgical procedure. As shown in the Figs. 11A, 11B, 12A and 12B, the instrument 68 is displayed when the navigated procedure is performed, and the instrument 68 is not displayed when the procedure is done, which indicates the removal of instrument 68 from the surgical site together with the tracking device 66. See detail in later 103 rejections.
Thus, applicant’s arguments regarding the rejection of independent claim 1, 9 and 16 have been fully considered but they are not persuasive and are moot in view of new grounds of 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, 9 and 16. Applicant’s arguments are not persuasive and are moot for the same reasons detailed above.
Overall, applicant’s remarks submitted on p.7 – 8 have been fully considered, but they are not persuasive and are moot in view of new grounds of rejection. The amendments result in new grounds of rejection. THIS ACTION IS MADE FINAL.
Claim Objections
Claim 9 and 16 are objected to because of the following informalities:
Claim 9 line 16, limitation “wherein the robotic controller navigates” should read “wherein the robotic controller is configured to navigate”.
Claim 16 line 17, limitation “wherein the robotic controller navigates” should read “wherein the robotic controller is configured to navigate”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, 3 – 10, 12 – 19 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding limitation “removing, after the one or more surgical instruments are navigated, the second localizer from the patient anatomy” in claim 1, limitation “wherein the second localizer is removed from the anatomical element after the robotic controller navigates the one or more surgical instruments” in claim 9, and limitation “wherein the second localizer is removed from the patient anatomy after the robotic controller navigates the one or more surgical instruments” in claim 16, the above limitations are NEW MATTER introduced in the amendment without written description support.
The disclosure in [0054] of the specification of present application recites: “In some embodiments, the use of the second, smaller localizer may provide a technical solution to issues such as: concerns related to accidental movement of the patient tracker during surgery (e.g., due to bumps, vibrations, etc.), patient concerns about pain associated with the localizer (e.g., percutaneous pinning), and issues associated with limited referencing due to the small size of cervical anatomy.”
The disclosure in [0074] of the specification of present application recites: “The presence of both the first localizer 144 and the second localizer 148 may enable the navigation system of the system 100 to use both optical navigation and electromagnetic navigation by co-registering the first localizer 144 and the second localizer 148. The first localizer 144 may be tracked in an optical coordinate system, while the second localizer 148 may be tracked in an electromagnetic coordinate system. By determining the location of the first localizer 144 and the second localizer 148 relative to one another through co-registration, the navigation system can then determine the location of optically tracked and navigated components (e.g., surgical instruments) in the electromagnetic coordinate system as well as the location of electromagnetically tracked and navigated components (e.g., patient anatomy) in the optical coordinate system. As a result, the navigation system can navigate surgical instruments and other components relative to patient anatomy in the optical coordinate system, the electromagnetic coordinate system, a shared coordinate system, or the like.”
The disclosure in [0100] of the specification of present application recites: “The method 300 also comprises outputting the second localizer pose information to at least one of a display device and a robotic controller (step 324). In some embodiments, the display device may be or comprise the user interface 210 and the robotic controller may be or comprise the navigation system 218. Based on the second localizer pose information, the navigation system 218 may navigate one or more surgical tools relative to the second localizer 148. In some embodiments, the second localizer 148 may represent the location of patient anatomy, such as when the second localizer 148 is disposed on the patient anatomy.”
The above paragraphs as recited by applicant are all above navigation. There is no disclosure about the removal of the second localizer. Further, there is no disclosure regarding the removal of the second localizer through whole specification.
In addition, The Fig.1D as recited by applicant only illustrates that the instrument with second localizer is disposed to the target anatomy. There is no illustration about the removal procedure.
Thus, there is no written description support for the amended limitations. The amendment introduced NEW MATTER.
Therefore, claim 1, 9, 16 and all corresponding dependent claims are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
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, 3 – 10, 12 – 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 2020/0237444 A1; published on 07/30/2020) (hereinafter "Snyder").
Regarding claim 1, Snyder, in one embodiment of Fig.3, teaches a method ("Discussed herein, according various embodiments, are processes and systems for allowing registration between various coordinate systems." [0036]), comprising:
providing a first localizer ("… tracking devices may include a subject tracking device 58 …" [0038]) relative to a patient anatomy ("… the patient tracker 58 may be fixed relative to the subject 30, such as to a portion of the pelvis, including the iliac crest, or other appropriate portions." [0067]);
providing a second localizer ("… and/or a tool tracking device 66." [0038]) in proximity to the fist localizer (see Fig.3), where in the second localizer is sized to be disposed on the patient anatomy (“The tool 68 may also include an implant, such as a spinal implant or orthopedic implant.” [0038]; see Fig.3, the tracking device 66 is part of the tool 68, and tool 68 is implanted into vertebra);
co-registering the first localizer and the second localizer ("The subject tracker 58 may also be used for registration and/or calibration of instruments including the instrument 68 with selected fiducial or registration portion 150. The registration portion 150 may include a divot or indent that the instrument 68 may contact to allow the navigation system 20 to determine a distal end or terminal end of the instrument 68 relative to the tracking device 66." [0064]);
determining, based on tracking a pose of the first localizer, first localizer pose information ("The patient 80 can also be tracked as the patient moves with a patient tracking device (also referred to as a dynamic reference frame (DRF)) or tracker 58." [0042]; "Thus, when updating the image 108 the known position of the tracking device may be used to assist in determining an appropriate position (e.g. three-dimensional position and appropriate number of degrees of freedom of orientation) in the image." [0130]);
determining, based on a combination of the first localizer pose information and the co-registering of the first localizer with the second localizer, second localizer pose information ("As discussed further herein, registration of the image space to the patient space or subject space allows for navigation of the instrument 68 with the image data. When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84." [0042]; "After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]); and
outputting the second localizer pose information to a display device ("After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]);
navigating, using the robotic controller (“The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer.” [0051]), one or more surgical instruments based at least partially on the second localizer pose information ("Various portions of the navigation system 20, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66." [0053]; "The translation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108." [0056]); and
removing, after the one or more surgical instruments are navigated, the second localizer from the patient anatomy (the removal is indicated in the procedure as illustrated in Figs. 11A, 11B, 12A and 12B, the instrument 68 is displayed when the navigated procedure is performed, and the instrument 68 is not displayed when the procedure is done, which indicates the removal of instrument 68 from the surgical site together with the tracking device 66).
In another embodiment of Fig.8, Snyder further teaches the second localizer comprises an implant portion (“… as illustrated in FIG. 8, implants may be positioned relative to the subject 30. As discussed above, the implant is the instrument 68.” [0104]), and the electromagnetic device is positioned closer to the first end than to the second end (“The pedicle screw 410 may include tracking members, such as … a second or shank tracking member 424 … the tracking members 422, 424 may be EM tracking members.” [0105]; see Fig.8, the lower end of the screw is the first end, which is introduced into anatomy) and sized to be positioned within the patient anatomy (see Fig.8, the size of 424 is within the screw, which is implanted into anatomy).
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 instrument with EM tracking device as taught in one embodiment with the implantable screw as the instrument and corresponding EM tracking devices as taught in another embodiment. Doing so would make it possible to “track the position or relative position of different portions of the respective members” (see Snyder; [0107]).
Regarding claim 3, Snyder teaches all claim limitations, as applied in claim 1, and further teaches wherein the co-registering the first localizer and the second localizer comprises:
providing a tracking tool that includes an optical tracker and an electromagnetic tracker in a predetermined pose relative to the optical tracker ("Further, the subject tracker 58 may include an electromagnetic tracking member or portion 58 e. The EM tracker 58 e may be fixed relative to the optical tracker 58 o such that the position (including three-dimensional location and/or one or more degree of freedom orientation) is fixed. " [0063]).
Regarding claim 4, Snyder teaches all claim limitations, as applied in claim 3, and further teaches wherein the optical tracker comprises a plurality of navigation markers ("… the patient tracker 58 may include one or more optical trackable members or portions, such as a reflective member 580." [0063]), and wherein the method further comprises:
determining a pose of the second localizer relative to the electromagnetic tracker ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]).
Regarding claim 5, Snyder teaches all claim limitations, as applied in claim 3, and further teaches wherein the tracking tool is provided on a patient ("… the patient tracker 58 may be fixed relative to the subject 30, such as to a portion of the pelvis, including the iliac crest, or other appropriate portions." [0067]).
Regarding claim 6, Snyder teaches all claim limitations, as applied in claim 1, and further teaches wherein the co-registering the first localizer and the second localizer comprises:
providing an electromagnetic field emitter proximate the patient anatomy, wherein the first localizer is positioned on the electromagnetic field emitter (“… therefore, the individual member trackers 160 may only include a single type of tracking device. In various embodiments, the EM tracking devices may include one or more members of conductive material formed into coils that may sense and/or emit and electromagnetic field.” [0077]; here each individual tracker is equivalent to the first localizer); and
determining a pose of one or more navigation markers relative to the electromagnetic field emitter ("… as noted above, the members or elements in the navigation field may be tracked with individual trackers connected thereto. Further the portions or members moved relative to the subject 30 may also be tracked with a plurality of tracking devices. " [0092]).
Regarding claim 7, Snyder teaches all claim limitations, as applied in claim 6, and further teaches wherein the one or more navigation markers are tracked optically ("The selected camera 340, 344 may be used to identify the type of reflected light and identify the specific tracking members 360, 364." [0098]).
Regarding claim 8, Snyder teaches all claim limitations, as applied in claim 1, and further teaches providing an optical camera that comprises an electromagnetic field emitter and that tracks the pose of the first localizer ("… the navigation system 20 may include various elements or portions, such as an optical localizer 88 …" [0037]; "The optical localizer 88 may include a plurality of cameras …" [0095]; "For example, the patient tracker 58 may include one or more optical trackable members or portions, such as a reflective member 580." [0063]); and
determining a pose of the second localizer relative to the electromagnetic field emitter ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]).
Regarding claim 9 Snyder, in one embodiment of Fig.3, teaches a system ("Discussed herein, according various embodiments, are processes and systems for allowing registration between various coordinate systems." [0036]), comprising:
a first localizer ("… tracking devices may include a subject tracking device 58 …" [0038]);
a second localizer positionable proximate the first localizer ("… and/or a tool tracking device 66." [0038]; see Fig.3), wherein the second localizer is sized to be disposed on an anatomical element (“The tool 68 may also include an implant, such as a spinal implant or orthopedic implant.” [0038]; see Fig.3, the tracking device 66 is part of the tool 68, and tool 68 is implanted into vertebra);
a processor ("The controller 96, in various embodiments, may include a processor 97 …" [0045]); and
a memory storing data thereon that, when processed by the processor, cause the processor ("… and/or various memory portions." [0045]; "If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit." [0153]) to:
co-register the first localizer and the second localizer ("The subject tracker 58 may also be used for registration and/or calibration of instruments including the instrument 68 with selected fiducial or registration portion 150. The registration portion 150 may include a divot or indent that the instrument 68 may contact to allow the navigation system 20 to determine a distal end or terminal end of the instrument 68 relative to the tracking device 66." [0064]);
determine, based on tracking a pose of the first localizer, first localizer pose information ("The patient 80 can also be tracked as the patient moves with a patient tracking device (also referred to as a dynamic reference frame (DRF)) or tracker 58." [0042]; "Thus, when updating the image 108 the known position of the tracking device may be used to assist in determining an appropriate position (e.g. three-dimensional position and appropriate number of degrees of freedom of orientation) in the image." [0130]);
determine, based on a combination of the first localizer pose information and the co-registering of the first localizer with the second localizer, second localizer pose information ("As discussed further herein, registration of the image space to the patient space or subject space allows for navigation of the instrument 68 with the image data. When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84." [0042]; "After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]); and
output the second localizer pose information to a display device ("After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]);
wherein the robotic controller (“The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer.” [0051]) navigates, based at least partially on the second localizer pose information, one or more surgical instruments ("Various portions of the navigation system 20, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66." [0053]; "The translation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108." [0056]), and
wherein the second localizer is removed from the anatomical element after the robotic controller navigates the one or more surgical instruments (the removal is indicated in the procedure as illustrated in Figs. 11A, 11B, 12A and 12B, the instrument 68 is displayed when the navigated procedure is performed, and the instrument 68 is not displayed when the procedure is done, which indicates the removal of instrument 68 from the surgical site together with the tracking device 66).
In another embodiment of Fig.8, Snyder further teaches the second localizer comprises an implant portion (“… as illustrated in FIG. 8, implants may be positioned relative to the subject 30. As discussed above, the implant is the instrument 68.” [0104]), and the electromagnetic device is positioned closer to the first end than to the second end (“The pedicle screw 410 may include tracking members, such as … a second or shank tracking member 424 … the tracking members 422, 424 may be EM tracking members.” [0105]; see Fig.8, the lower end of the screw is the first end, which is introduced into anatomy) and sized to be positioned within a portion of the patient to physically contact an anatomical element (see Fig.8, the size of 424 is within the screw, which is implanted into anatomy).
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 instrument with EM tracking device as taught in one embodiment with the implantable screw as the instrument and corresponding EM tracking devices as taught in another embodiment. Doing so would make it possible to “track the position or relative position of different portions of the respective members” (see Snyder; [0107]).
Regarding claim 10, Snyder teaches all claim limitations, as applied in claim 9, and further teaches wherein the first localizer is positioned relative to the anatomical element and disposed on at least one of a surgical tool ("… the patient tracker 58 may be fixed relative to the subject 30, such as to a portion of the pelvis, including the iliac crest, or other appropriate portions." [0067]; "the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 ..." [0063]; DRF is a surgical tool).
Regarding claim 12, Snyder teaches all claim limitations, as applied in claim 9, and further teaches wherein the anatomical element comprises a vertebra ("A tracking member may be connected to a vertebrae or portion of a vertebrae of a patient." [0011]), and wherein the second localizer comprises a smaller footprint than the first localizer (see Fig.3; tracking device 66 is smaller than patient marker 58).
Regarding claim 13, Snyder teaches all claim limitations, as applied in claim 9, and further teaches wherein the first localizer and the second localizer are co-registered by:
identifying an optical tracker and an electromagnetic tracker disposed in a pose relative to the optical tracker ("Further, the subject tracker 58 may include an electromagnetic tracking member or portion 58 e. The EM tracker 58 e may be fixed relative to the optical tracker 58 o such that the position (including three-dimensional location and/or one or more degree of freedom orientation) is fixed ... Accordingly, the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94. " [0063]).
Regarding claim 14, Snyder teaches all claim limitations, as applied in claim 9, and further teaches wherein the first localizer and the second localizer are co-registered by:
determining a pose of one or more optically tracked navigation markers relative to an electromagnetic field emitter ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]).
Regarding claim 15, Snyder teaches all claim limitations, as applied in claim 9, and further teaches wherein the first localizer and the second localizer are co-registered by:
determining a pose of the second localizer relative to an electromagnetic field emitter ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]); and
determining a pose of the electromagnetic field emitter relative to an optical camera that is configured to optically track the pose of the first localizer ("Within the operating theater, the navigation system 20 may include various elements or portions, such as an optical localizer 88 and an electromagnetic (EM) localizer 94, which define or are used to generate navigation or tracking spaces in selected first and/or second coordinate systems, as discussed further herein. The respective localizers 88, 94 may also be registered, also referred to as correlated, relative to one another, as also discussed further herein, to allow for tracking one or more instruments in either or both of the coordinate systems and relating the tracked position to an additional coordinate system." [0037]; here the registration between 88 and 94 is a relative pose between two system).
Regarding claim 16, Snyder teaches a processor 9 "The controller 96, in various embodiments, may include a processor 97 …" [0045]); and
a memory storing data thereon that, when processed by the processor, cause the processor ("… and/or various memory portions." [0045]; "If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit." [0153]) to:
co-register a first localizer and a second localizer ("… tracking devices may include a subject tracking device 58 and/or a tool tracking device 66." [0038]; "The subject tracker 58 may also be used for registration and/or calibration of instruments including the instrument 68 with selected fiducial or registration portion 150. The registration portion 150 may include a divot or indent that the instrument 68 may contact to allow the navigation system 20 to determine a distal end or terminal end of the instrument 68 relative to the tracking device 66." [0064]), the first localizer positionable relative to a patient anatomy ("… the patient tracker 58 may be fixed relative to the subject 30, such as to a portion of the pelvis, including the iliac crest, or other appropriate portions." [0067]) and the second localizer positionable proximate the first localizer ("… and/or a tool tracking device 66." [0038]; see Fig.3), wherein the second localizer is sized to be disposed on the patient anatomy (“The tool 68 may also include an implant, such as a spinal implant or orthopedic implant.” [0038]; see Fig.3, the tracking device 66 is part of the tool 68, and tool 68 is implanted into vertebra);
determine, based on information from an optical camera that tracks a pose of the first localizer, first localizer pose information ("The patient 80 can also be tracked as the patient moves with a patient tracking device (also referred to as a dynamic reference frame (DRF)) or tracker 58." [0042]; "The tracking system is able to generate a signed based on the tracking (e.g. within a field of view of a camera, EM field, etc.) and the signal is used within the navigation system to determine the position of the tracked element." [0043]; "Thus, when updating the image 108 the known position of the tracking device may be used to assist in determining an appropriate position (e.g. three-dimensional position and appropriate number of degrees of freedom of orientation) in the image." [0130]);
determine, based on a combination of the first localizer pose information and the co-registering of the first localizer with the second localizer, second localizer pose information ("As discussed further herein, registration of the image space to the patient space or subject space allows for navigation of the instrument 68 with the image data. When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84." [0042]; "After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]); and
output the second localizer pose information to a display device ("After the registration of the image space to the patient space, the instrument 68 can be tracked relative to the image 108. As illustrated in FIG. 1, the icon 68 i representing a position (which may include a 6 degree of freedom position (including 3D location and orientation)) of the instrument 68 can be displayed relative to the image 108 on the display 84." [0062]);
wherein the robotic controller (“The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer.” [0051]) navigates, based at least partially on the second localizer pose information, one or more surgical instruments ("Various portions of the navigation system 20, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66." [0053]; "The translation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108." [0056]), and
wherein the second localizer is removed from the anatomical element after the robotic controller navigates the one or more surgical instruments (the removal is indicated in the procedure as illustrated in Figs. 11A, 11B, 12A and 12B, the instrument 68 is displayed when the navigated procedure is performed, and the instrument 68 is not displayed when the procedure is done, which indicates the removal of instrument 68 from the surgical site together with the tracking device 66).
In another embodiment of Fig.8, Snyder further teaches the second localizer comprises an implant portion (“… as illustrated in FIG. 8, implants may be positioned relative to the subject 30. As discussed above, the implant is the instrument 68.” [0104]), and the electromagnetic device is positioned closer to the first end than to the second end (“The pedicle screw 410 may include tracking members, such as … a second or shank tracking member 424 … the tracking members 422, 424 may be EM tracking members.” [0105]; see Fig.8, the lower end of the screw is the first end, which is introduced into anatomy) and sized to be implanted into a portion of a patient to couple with the patient anatomy (see Fig.8, the size of 424 is within the screw, which is implanted into anatomy).
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 instrument with EM tracking device as taught in one embodiment with the implantable screw as the instrument and corresponding EM tracking devices as taught in another embodiment. Doing so would make it possible to “track the position or relative position of different portions of the respective members” (see Snyder; [0107]).
Regarding claim 17, Snyder teaches all claim limitations, as applied in claim 16, and further teaches wherein the co-registering the first localizer and the second localizer comprises:
identifying a tracking tool ("the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 ..." [0063]; DRF is a surgical tool) that comprises one or more optical navigation markers and an electromagnetic tracker disposed in a pose relative to the one or more optical navigation markers ("Further, the subject tracker 58 may include an electromagnetic tracking member or portion 58 e. The EM tracker 58 e may be fixed relative to the optical tracker 58 o such that the position (including three-dimensional location and/or one or more degree of freedom orientation) is fixed ... Accordingly, the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94. " [0063]).
Regarding claim 18, Snyder teaches all claim limitations, as applied in claim 16, and further teaches wherein the co-registering the first localizer and the second localizer comprises:
determining a pose of one or more optical navigation markers relative to an electromagnetic field emitter ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]).
Regarding claim 19, Snyder teaches all claim limitations, as applied in claim 16, and further teaches wherein the co-registering the first localizer and the second localizer comprises:
determining a pose of the second localizer relative to an electromagnetic field emitter ("… the patient tracker 58 may be used as a registration or dynamic reference frame relative to the patient 30 using at least two tracking systems, such as the optical localizer 88 and the EM localizer 94." [0063]; "As discussed above, the tracking device 66 may also be tracked in more than one tracking system including the optical tracking device 66 o and the EM tracking device 66 e." [0064]; "... the instrument 68, as discussed above, may include one or both tracking devices 66 e and 66 o to be tracked relative to the subject 30 ..." [0075]); and
determining a pose of the electromagnetic field emitter relative to the optical camera ("Within the operating theater, the navigation system 20 may include various elements or portions, such as an optical localizer 88 and an electromagnetic (EM) localizer 94, which define or are used to generate navigation or tracking spaces in selected first and/or second coordinate systems, as discussed further herein. The respective localizers 88, 94 may also be registered, also referred to as correlated, relative to one another, as also discussed further herein, to allow for tracking one or more instruments in either or both of the coordinate systems and relating the tracked position to an additional coordinate system." [0037]; here the registration between 88 and 94 is a relative pose between two system).
Regarding claim 21, Snyder teaches all claim limitations, as applied in claim 1, and further teaches wherein the second localizer is disposed on the patient anatomy percutaneously via a laparoscopic incision or a stab incision (“The navigation system 20 and the various instruments may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure.” [0038]; the final arrangement of tracking devices as shown in Fig.3 or Fig.8 is inherent result of either minimally invasive or open procedure which requires either a laparoscopic incision for minimally invasive procedure or a stab incision for open procedure).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
