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 Statements
The information disclosure statements filed February 4, 2026 and November 8, 2023 have been entered and the references cited therein have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims 1-4, 6-10 and 12-16) in the reply filed on January 5, 2026 is acknowledged. Accordingly, claims 17-21 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-10 and 12-16 is/are rejected under 35 U.S.C. 103 as being obvious over Donovan et al. (PCT Publication No. WO 2021/050767 – hereinafter “Donovan I”) in view of Donovan et al. (U.S. Patent Application Publication No. 2023/0255676 – hereinafter “Donovan II”) and further in view of Vadalà et al., “Robotic Spine Surgery and Augmented Reality Systems: A State of the Art,” Neurospine, 2020; 17(1); 88-100 (hereinafter “Vadalà et al.”).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claims 1-4, 6-10, 12-14 and 16, Donovan I teaches systems and methods for modulating and treating an intraosseous (basivertebral) nerve within a bone (vertebral body) for the treatment or prevention of chronic back pain where the vertebral body may be located in any level of the vertebral column (see para. 0065). Various methods of access may be used to access a vertebral body (see para. 0070) and access tools may include an introducer assembly including an outer cannula and a sharpened stylet, an inner cannula configured to be introduced through the outer cannula and/or one or more additional stylets, curettes or drills to facilitate access to an interosseous location within a vertebral body (see paras. 0073, 0076-0078 and Fig. 3). Figures 3AA-3II detail method steps for using the access tools to facilitate access to a location within a vertebral body 500 (see para. 0106). A treatment device 501 (such as a flexible bipolar radiofrequency probe) may be inserted through the curve cannula 212 (inner cannula) and advanced out of the open distal tip of the curved cannula 212 to the target treatment location where it is activated to ablate the basivertebral nerve (see paras. 0100 and 0113 and Fig. 3HH). Donovan I teaches a robotic system 700 that may be a robotic control, surgical and/or navigation system capable of performing a variety of medical and/or diagnostic procedures and/or providing guidance and enhanced imaging to a clinician (see Fig. 7 and para. 0158). The robotic system 700 may include a control console 702 from which a clinician can control movement of one or more robotic arms 703 and the control console 702 may also include a computer-based control system that stores and is configured to execute (using one or more processors) program instructions stored on a non-transitory computer-readable storage medium (see para. 0159). The robotic arm 703 may be configured to move with six or more degrees of freedom and to support or carry the access tools, treatment device and/or diagnostic devices (see para. 0160). The robotic arms 703 may be coupled to a support system and controlled by one or more instrument drive systems that are in turn controlled by the control console 702 where the instrument drive systems include electro-mechanical components and mechanisms configured to actuate and move the robotic arms 703 (see para. 0160). The robotic system 700 may include one or more imaging devices 704 that are supported or carried by one or more of the robotic arms 703 where the imaging devices 704 may be calibrated to patient anatomy or using reference pins or trackers positioned at one or more locations of the patient’s body by a registration or localization system that may involve identification of natural landmarks of one or more vertebrae (see para. 0161). The imaging system may be configured to communicate with software that is configured to generate a real-time 3D may that may be registered with the robotic arms 703 or instruments (bone access tool) carried by the robotic arms 703 and the software may include surgery planning software configured to plan, based on pre-operative images (obtained via CT, MRI, fluoroscopy or other imaging modalities) a desired trajectory for access to target treatment locations within a vertebral body (see para. 0162). A computing device of the control console 702 is configured to direct movement of the robotic arms 703 based on instructions executed by the computing device either via inputs such as joystick controls (from the clinician) pr via automated programs and artificial intelligence algorithms stored in memory (see para. 0162). The robotic system 700 can independently modify the trajectory in response to imaging or other registration modalities (see para. 0163). Donovan I is silent as to the use of an augmented reality device that includes a see-through optical head mounted display. However, Donovan II teaches a similar device for access to the inner cancellous bone region 207 that may be performed using an automated system (robotic guidance system) which may incorporate augmented reality technology to facilitate more precise insertion and positioning of the access tools (see para. 0056). Vadalà et al. also teach that the use of augmented reality (AR) technology has been used in spinal surgery in the last decade (since 2010 as the article was published in 2020) to automatically track instrument position in order to provide the surgeon with real-time feedback of the instrument location (see page 92). This imaging included the virtual trajectory of the instrument being superimposed to live images (see page 93). Vadalà et al. specifically cite the use of Google Glass that includes eyeglasses that can project any image such as navigation or neuromonitoring directly in front of the surgeon’s eyes (see para. 93). Vadalà et al. also cite HoloLens, that, after acquiring a CT scan, generated a 3D reconstruction and loads it onto a headset where the reconstruction is projected as a hologram in the surgeon’s visual field (see page 93). Vadalà et al. also cite the use of xvision, which is an AR headset that is equipped with near-eye displays showing 3D navigation data including patient’s anatomy and instrument position directly onto the surgeon’s retina (see page 93). Donovan I thus demonstrates that the use of AR technology in conjunction with robotic guidance systems in order to facilitate more precise insertion and positioning of the access tools was well known in the art. Vadalà et al. further demonstrate that there are several AR headset devices with see-through displays (in front of the surgeon’s eyes) that are part of a headset that are utilized in spinal surgery also in conjunction with a robotic system (see pages 88-92 that discussed various robotic systems). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Donovan I with an AR device (as disclosed by both Donovan II and Vadalà et al.) that is a see-through headset (as disclosed by Vadalà et al.) systems in order to facilitate more precise insertion and positioning of the access tools. With further respect to claim 7, see para. 0008 of Donovan I. In regard to claim 15, see para. 0121 of Donovan I.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794