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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12/03/2024 and 12/28/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goyette et al. (U.S. Pub. No. 20210177526) hereinafter Goyette.
Regarding claim 1, Goyette teaches:
A system for performing a medical procedure (abstract), the system comprising:
an instrument for delivery of an active implant within a subject anatomy ([0020]-[0025], trackable implant from surgical device 100 for delivery of the implant to a subject anatomy region of interest; [0026], trackable surgical tools and implants during a surgery. Trackable implant forms an active implant; [0029]; [0030]-[0038], surgical device 100 for implanting implant to patient’s spine; see also [0039]-[0053], for method steps of procedure); and
at least one processor ([0031], [0036], computing device 210; [0054], processing unit 512) configured to:
receive an anatomical model of the subject anatomy, wherein the anatomical model is based on data captured prior to delivery of the active implant ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], anatomical model is generated used in place of the images and provides position and orientation of surgical tools, implants, and spine anatomy; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant);
receive positional information for the active implant, wherein the positional information includes a pose of the active implant within the subject anatomy ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.”); and
establish the pose of the active implant as a reference within the anatomical model ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.”).
Regarding claim 2, Goyette teaches all of the limitations of claim 1. Goyette further teaches:
wherein the at least one processor is further configured to update the anatomical model based on the positional information for the active implant ([0029]-[0031], 3D anatomical models; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine, provided in real-time during a procedure forms an update to the displayed model based on positional information regarding the implant; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.” Relative position adjustment of the implant forms an updated of the anatomical model based on positional information of the active implant).
Regarding claim 3, Goyette teaches all of the limitations of claim 2. Goyette further teaches:
wherein the anatomical model is updated to reflect anatomical deformation of the subject anatomy ([0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space forms an updating of the anatomical model based upon any anatomical deformation or movement of the spine during the procedure; [0036]-[0037], updating of the patient’s spine imagery when a new surgical screw is planted; [0038], anatomical model; [0039]-[0040], 3D anatomical model of the spine, tracked throughout a procedure; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; [0047]-[0051]).
Regarding claim 4, Goyette teaches all of the limitations of claim 1. Goyette further teaches:
wherein the instrument includes a delivery instrument localization sensor, and the positional information describing the pose of the active implant is received from the delivery instrument localization sensor ([0021]-[0022], trackable member 120 on instrument 100 forms a delivery instrument localization sensor and provide relative pose and position measurements tracked in relation to associated implants; [0026], trackable member 120; [0030]-[0031]; [0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space including based upon trackable member 120; [0036]-[0040]; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; see also [0043]-[0051]).
Regarding claim 6, Goyette teaches all of the limitations of claim 4. Goyette further teaches:
wherein establishing the pose of the active implant as the reference within the anatomical model includes registering the instrument to the anatomical model based on data from the delivery instrument localization sensor ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.”).
Regarding claim 7, Goyette teaches all of the limitations of claim 4. Goyette further teaches:
wherein the positional information from the delivery instrument localization sensor is a delivery location of the instrument when the instrument delivers the active implant to the delivery location ([0021]-[0022], trackable member 120 on instrument 100 forms a delivery instrument localization sensor and provide relative pose and position measurements tracked in relation to associated implants; [0026], trackable member 120; [0030]-[0031]; [0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space including based upon trackable member 120; [0036]-[0040]; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; see also [0043]-[0051]).
Regarding claim 8, Goyette teaches all of the limitations of claim 1. Goyette further teaches:
wherein the instrument includes an imaging system, wherein the imaging system is configured to provide data used to update the anatomical model to reflect anatomical deformation of the subject anatomy ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure, including from imaging systems for anatomical imaging; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], anatomical model is generated used in place of the images and provides position and orientation of surgical tools, implants, and spine anatomy; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant).
Regarding claim 9, Goyette teaches all of the limitations of claim 1. Goyette further teaches:
wherein the positional information describing the describes a location of the active implant and is based at least in part on an input from a user ([0025], input devices for interacting with display and GUI devices; [0027]; [0028], position based upon user input provides for the tracked position based at least in part on an input from a user; [0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041], user manipulation of the device with navigation data provided to the GUI for tracking; [0042]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.”).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Goyette as applied to claim 4 above, and further in view of Allenby et al. (U.S. Pub. No. 20160192860) hereinafter Allenby.
Regarding claim 5, primary reference Goyette teaches all of the limitations of claim 4. Primary reference Goyette further fails to teach:
wherein the delivery instrument localization sensor includes a shape sensing fiber or at least one EM sensor, and wherein the delivery instrument localization sensor is configured to provide a position and an orientation of at least a distal section of the instrument
However, the analogous art of Allenby of a surgical instrument advancement and tracking system and method (abstract) teaches:
wherein the delivery instrument localization sensor includes a shape sensing fiber or at least one EM sensor, and wherein the delivery instrument localization sensor is configured to provide a position and an orientation of at least a distal section of the instrument ([0030], fiber optic sensing of instrument; [0034]-[0038], optical fiber shape sensing system for determining position and shape of distal end of the surgical instrument).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant position and orientation tracking and anatomical model display system of Goyette to incorporate the instrument sensor of a fiber as taught by Allenby because an optical fiber may be used to monitor the shape of at least a portion of the surgical instrument by processing light passing through the optical fiber to detect the shape of the instrument (Allenby, [0038]). This leads to more precise real-time shape, pose and position estimation, improving accuracy during interventional procedures.
Claims 10-16, 18-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Goyette as applied to claim 1 above, and further in view of Dayan et al. (U.S. Pub. No. 20180132947) hereinafter Dayan.
Regarding claim 10, primary reference Goyette teaches all of the limitations of claim 1. Primary reference Goyette further fails to teach:
further comprising the active implant, wherein the active implant includes an implant localization sensor
However, the analogous art of Dayan of an apparatus for providing an implantable device (abstract) teaches:
further comprising the active implant, wherein the active implant includes an implant localization sensor ([0024], implant includes the shape-sensing optical fiber which provides for implant localization during placement; [0280]-[0290], shape-sensing optical fiber 420 provides for implant localization within an active implant; [0291]-[0298]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant position and orientation tracking and anatomical model display system of Goyette to incorporate the shape sensing implant localization sensor as taught by Dayan because it provides for feedback regarding the shape of the implant during a surgical procedure, leading to facilitated advancement and navigation of the device to the target region of interest (Dayan, [0024]). This improves interventional accuracy leading to enhanced clinical outcomes.
Regarding claim 11, the combined references of Goyette and Dayan teach all of the limitations of claim 10. Primary reference Goyette, in view of Dayan, further teaches:
wherein the at least one processor is further configured to register the subject anatomy to the anatomical model based on data from the implant localization sensor of the active implant (Goyette: [0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], “The anatomical model of the spine 10, the intra-operative images of the spine 10, the position and orientation of the surgical device 100 and/or the position and orientation of the surgical tool(s) and/or implant(s) may be displayed on the display device 230 during the surgery.”; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant; [0051], “Accordingly, the tracking of the spine 10 and/or of the surgical tool(s) or implant(s) may occur in the 3D coordinate system X-Y-Z. The tracking information may be output for display on the display device 230. For example, the position and orientation of the spine 10 and/or the position and orientation of the surgical tool(s) or implant(s) relative to the spine 10 may be displayed.” Note that the implant localization sensor as taught by Dayan in the combined prior art invention, would be utilized in conjunction with the teachings of Goyette to provide the position data to the system).
Regarding claim 12, the combined references of Goyette and Dayan teach all of the limitations of claim 10. Primary reference Goyette further teaches:
wherein the anatomical model includes an anatomical target ([0029]-[0030]; [0031], 3D anatomical models from preoperative data forms anatomical model of the subject anatomy captured prior to delivery of the implant during a surgical procedure. The spine forms an anatomical target; [0032]-[0035]; [0036], 3D position and orientation determination of tool, implant and spine; [0038], anatomical model is generated used in place of the images and provides position and orientation of surgical tools, implants, and spine anatomy; [0039]-[0040], anatomical model; see also [0041]-[0053] for tracking of tools and implant).
Regarding claim 13, the combined references of Goyette and Dayan teach all of the limitations of claim 12. Primary reference Goyette further teaches:
wherein the at least one processor is further configured to determine an implant location for delivery of the active implant, wherein the implant location is based at least in part on a location of the anatomical target ([0031], desired trajectory and position for a spinal screw; [0039], desired position and trajectory of a spinal screw; [0047], trajectory planned based upon the navigation output and the tracking and surgical space model forms an implant location based upon the anatomical target of the spine; see also [0041]-[0053]).
Regarding claim 14, the combined references of Goyette and Dayan teach all of the limitations of claim 12. Primary reference Goyette further teaches:
wherein the at least one processor is further configured to determine a section of the subject anatomy for treatment based on the anatomical target ([0031] and [0039]-[0053], the computer assisted surgical process provides for a desired position and trajectory of a spinal screw at a location that is a section of the subject anatomy for treatment, based upon the anatomical target of the spine).
Regarding claim 15, the combined references of Goyette and Dayan teach all of the limitations of claim 14. Primary reference Goyette further teaches:
wherein the at least one processor is further configured to provide guidance for treatment of the section of the subject anatomy ([0031], desired trajectory and position for a spinal screw; [0039], desired position and trajectory of a spinal screw, wherein the screw is a form of treatment, forms a guidance for treatment of the section of the subject anatomy (spine); [0047], trajectory planned based upon the navigation output and the tracking and surgical space model forms an implant location based upon the anatomical target of the spine; see also [0041]-[0053]).
Regarding claim 16, the combined references of Goyette and Dayan teach all of the limitations of claim 15. Primary reference Goyette further teaches:
wherein the guidance includes graphical indicators on or within the anatomical model, wherein the graphical indicators represent the section of the subject anatomy for treatment ([0031], desired trajectory and position for a spinal screw; [0032]-[0037], spine is tracked and provided on the display device with position and orientation indicators of the instrument and implants, forming graphical indicators of the section for treatment; [0038]-[0039], desired position and trajectory of a spinal screw, wherein the screw is a form of treatment, forms a guidance for treatment of the section of the subject anatomy (spine) and display of the trajectory forms a graphical indicator of the section for treatment; [0047], trajectory planned based upon the navigation output and the tracking and surgical space model forms an implant location based upon the anatomical target of the spine; see also [0041]-[0053]).
Regarding claim 18, the combined references of Goyette and Dayan teach all of the limitations of claim 14. Primary reference Goyette further teaches:
further comprising a therapeutic device configured for treatment of the section, wherein the therapeutic device includes a therapeutic localization sensor ([0021]-[0022], trackable member 120 on instrument 100 forms a therapeutic localization sensor and provide relative pose and position measurements tracked in relation to associated implants of a therapeutic device of surgical instruments; [0026], trackable member 120; [0030]-[0031]; [0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space including based upon trackable member 120; [0036]-[0040]; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; see also [0043]-[0051]).
Regarding claim 19, the combined references of Goyette and Dayan teach all of the limitations of claim 18. Primary reference Goyette further teaches:
wherein the at least one processor is further configured to register the therapeutic device to the anatomical model ([0021]-[0022], trackable member 120 on instrument 100 forms a therapeutic localization sensor and provide relative pose and position measurements tracked in relation to associated implants of a therapeutic device of surgical instruments; [0026], trackable member 120; [0030]-[0031]; [0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space including based upon trackable member 120; [0036]-[0040]; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; see also [0043]-[0051]).
Regarding claim 21, the combined references of Goyette and Dayan teach all of the limitations of claim 18. Primary reference Goyette further teaches:
wherein providing guidance for treatment of the section includes providing a representation of the therapeutic device within the anatomic model ([0021]-[0022], trackable member 120 on instrument 100 forms a therapeutic localization sensor and provide relative pose and position measurements tracked in relation to associated implants of a therapeutic device of surgical instruments; [0026], trackable member 120; [0030]-[0031]; [0033], positions of devices displayed to user; [0035], tracking of the spine position and orientation throughout a surgical procedure within 3D space including based upon trackable member 120; [0036]-[0040], anatomical models are displayed including medical devices utilized for therapeutic treatment; [0041], “Once the surgical device 100 is attached to the vertebra 12 via the spinal screw 130, the position and orientation of the spine 10 may be tracked by the CAS system 200, with reference to the surgical device 100 remaining connected to the vertebra 12. The position and orientation of the spine 10 may be tracked using the tracking of the trackable member 120 and the geometrical relation between the trackable member 120, the surgical device 100 and spinal screw 130, or directly by tracking the surgical device 100 if tracking modality permits.”; see also [0043]-[0051]).
Regarding claim 22, the combined references of Goyette and Dayan teach all of the limitations of claim 12. Primary reference Goyette further teaches:
wherein the at least one processor is further configured to generate a planned path to the anatomical target in the anatomical model ([0039]; [0047], trajectory planned based upon the navigation output and the tracking and surgical space model; see also [0042]-[0053]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hladio et al. (U.S. Pub. No. 20150182292) teaches to computer assisted surgical systems that utilize position sensing and computer modeling to provide additional localization features for interventional procedures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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