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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-6 and 15-20 in the reply filed on November 20, 2025 is acknowledged.
Allowable Subject Matter
Claims 2, 6, 16, and 20 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:
The prior art fails to teach or disclose wherein the method further comprises creating, based on the patient tracking array, a surface topography, determining a set of points associated with a set of touchpoints, navigating the set of points within a navigational space, determining, based on the navigation, a registration accuracy, and determining and outputting an indication to re-register or proceed based on the registration accuracy.
The prior art fails to teach or disclose wherein the method further comprises determining a dynamic re-registration and reconfiguration (DRR) simulation, the DDR simulation corresponding to a theoretical fluoroscopic image based on the instantaneous pose of a C-arm of the device and the patient relative to one another at any point in time after an initial registration, and outputting to a user interface (UI) the DDR simulation.
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, 5, 15, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2022/0160428 to Murray et al.
As to Claim 1, Murray discloses a method [0012] that comprises identifying, by a device, a medical image of a patient (described in [0065]), analyzing, by the device, medical image, the analysis comprising auto-segmentation of the medical image [0066-0067], determining, by the device, based on the analysis, an optimal location for surface-based registration (of 210, [0148-0149]), performing, by the device, registration of a patient tracking array (1410, [0154-0156]), determining, by the device, an accuracy of pedicle screw placement [0096, 0110], creating, by the device, a vertebral body specific registration [0110, 0150-0152], and outputting, by the device, tracking information based at least on the created vertebral body specific registration and/or patient tracking array [0152], the output caused to be displayed within a user interface (UI) [0067, 0073].
As to Claim 4, Murray discloses a method further comprising determining, based at least in part on the patient tracking array (612), whether a camera (200) has moved during a timespan [0135], determining that the patient tracking array has a gross deformation [0163], and outputting, via the UI, a notification indicating a need to re-register the patient tracking array [0140, 0166].
As to Claim 5, Murray discloses a method further comprising determining, based at least in part on the patient tracking array, whether a camera positioned captures both dynamic reference base (DRB) and planned screw trajectories (1100, [0116, 0134, 0188-0189], and outputting, via the UI, information related to the determination of the camera positioning [0192], wherein when both the DRB and planned screw trajectories are captured, a proceed message is provided, wherein when both are not captured, a repositioning message is provided [0166-0167].
As to Claim 15, Murray discloses a non-transitory computer-readable storage medium (2012) tangibly encoded with computer-executable instructions [0209], that when executed by a device, perform a method [0012] that comprises identifying, by a device, a medical image of a patient (described in [0065]), analyzing, by the device, medical image, the analysis comprising auto-segmentation of the medical image [0066-0067], determining, by the device, based on the analysis, an optimal location for surface-based registration (of 210, [0148-0149]), performing, by the device, registration of a patient tracking array (1410, [0154-0156]), determining, by the device, an accuracy of pedicle screw placement [0096, 0110], creating, by the device, a vertebral body specific registration [0110, 0150-0152], and outputting, by the device, tracking information based at least on the created vertebral body specific registration and/or patient tracking array [0152], the output caused to be displayed within a user interface (UI) [0067, 0073].
As to Claim 18, Murray discloses a non-transitory computer-readable storage medium including a method further comprising determining, based at least in part on the patient tracking array (612), whether a camera (200) has moved during a timespan [0135], determining that the patient tracking array has a gross deformation [0163], and outputting, via the UI, a notification indicating a need to re-register the patient tracking array [0140, 0166].
As to Claim 19, Murray discloses a non-transitory computer-readable storage medium including a method further comprising determining, based at least in part on the patient tracking array, whether a camera positioned captures both dynamic reference base (DRB) and planned screw trajectories (1100, [0116, 0134, 0188-0189], and outputting, via the UI, information related to the determination of the camera positioning [0192], wherein when both the DRB and planned screw trajectories are captured, a proceed message is provided, wherein when both are not captured, a repositioning message is provided [0166-0167].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2022/0160428 to Murray et al. in view of U.S. Patent Pub. No. 2022/0257320 to Junio et al.
As to Claims 3 and 17, Murray discloses the claimed invention except for wherein further comprising determining, based on the auto-segmentation of the medical image, information related to a planned pedicle screw implantation, determining skive probability based on an applied skive model, determining, based on the skive probability, an optimal pilot hole, and outputting, for displaying within the UI, information related to the optimal pilot hole.
Junio discloses a method (200, Fig. 2A, [0071]) and computer readable medium [0051] including determining, based on an auto-segmentation of the medical image, information related to a planned pedicle screw implantation [0068], determining skive probability based on an applied skive model [0066, 0098] determining, based on the skive probability, an optimal pilot hole, and outputting, for displaying within the UI, information related to the optimal pilot hole [0054, 0090] in order to assist in avoiding inaccurate placement of the pedicle screw [0054].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical method of Murray with the skive probability modification of Junio in order to assist in avoiding inaccurate placement of the pedicle screw.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775