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 .
Election/Restrictions
Applicant’s election of invention III in the reply filed on 06/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 7, 9, 12-14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Young et al. (US 2023/0233259 A1, Jul. 27, 2023) (hereinafter “Young”).
Regarding claim 7: Young discloses a computer-implemented method comprising: receiving, by a processor, at least one of an image and a statistical shape model of a patient anatomy ([0072], [0076], [0130], [0135]; the augmented reality display includes an image of the surgical field which is "received" by the processor); acquiring, using a tracking system in communication with the processor, a tracking marker location of a tracking marker ([0062] - headset 102 with vision system 112, marker 110, [0085], [0099] - where headset 308 corresponds to headset 102 and 202; [0132]); acquiring, using the tracking system, a plurality of point probe locations of a trackable point probe, wherein for each of the plurality of point probe locations the trackable point probe is positioned relative to the patient anatomy ([0068]-[0070], [0083], [0085], [0099] - where headset 308 corresponds to headset 102 and 202; [0133]); registering, by the processor, a first position and orientation of the patient anatomy relative to the tracking marker based on the tracking marker location and the plurality of point probe locations ([0086], [0100]-[0101], [0103] - where the locations of specific anatomical landmarks such as Whiteside's line indicate patient position and identification of particular planes such as the sagittal plane and body axes such as the A/P axis are indications of patient orientation, [0118]-[0121]); acquiring, using the tracking system, landmark locations of at least three landmarks on a rigid, low-profile body configured to affix to the patient anatomy (fig. 5, [0113] - resection guide 502 with fiducials 504-510, fig. 13a, [0152] - "substantially flat and thin" with resection marker having four fiducials); registering, by the processor, a position and orientation of the rigid, low-profile body relative to the tracking marker location based on the tracking marker location and the landmark locations ([0157] - landmark coordinates based on resection marker, which has four fiducials); generating, by the processor, a transformation matrix between the position and orientation of the rigid, low-profile body and the first position and orientation of the patient anatomy ([0158], [0118]-[0119] - transforms via matrix multiplication); acquiring, using the tracking system, updated landmark locations of the at least three landmarks, absent the tracking marker ([0158]-[0160] - relative positions, including anatomical landmarks, are retained while resection marker and associated fiducials are removed, [0161]-[0163]); and determining, by the processor, a second position and orientation of the patient anatomy based on the updated landmark locations and the transformation matrix ([0068] - the anatomy model, which would include position and orientation is updated intra-operatively, [0101], [0123], [0157] and [0160] - the updated view includes position and orientation of the anatomy).
Regarding claim 9: Young discloses the computer-implemented method of claim 7, wherein the at least three landmarks are arranged on a surface of the rigid, low-profile body in an at least partially asymmetrical configuration, such that an orientation of the rigid, low-profile body is unambiguous based on a location of the at least three landmarks (figs. 13a, 13d - the marker comprising the fiducials is arranged on a surface of the rigid, low-profile body and are at least partially asymmetrical, see e.g. 1302a in fig. 13a).
Regarding claim 12: Young discloses the computer-implemented method of claim 7, wherein the tracking marker is affixed to the patient anatomy via a “femoral head remover” ([0065] - “one or more fixtures such as a screw, clamp, adhesive, or other fastener adapted to attach the marker 110 to the patient 104 (e.g., to a bone or other components of the patient 104); where anything capable of being used to lift/remove a portion of resected femoral head is considered a “femoral head remover” in the absence of any further limitation, i.e. a portion of resected femoral head could be removed from the surgical site using a clamp).
Regarding claim 13: Young discloses the computer-implemented method of claim 7, wherein the tracking system is an optical tracking system, the method further comprising acquiring, using the tracking system, the position and orientation of the rigid, low-profile body based on an optical detection of the landmark locations ([0062] - cameras for tracking are optical, [0064]-[0065] - fiducials are optical targets).
Regarding claim 14: Young discloses a system comprising: a tracking system ([0062], fig. 2); a tracking marker configured to affix to a patient anatomy at a first affixation point (markers 110 with fiducials 118); a trackable point probe (pointer 108); a rigid, low-profile body configured to affix to the patient anatomy at a second affixation point, wherein the rigid, low-profile body comprises at least three landmarks (fig. 5, [0113] - resection guide 502 with fiducials 504-510, fig. 13a, [0152] - "substantially flat and thin" with resection marker having four fiducials); a processor in communication with the tracking system ([0072] - processor 210); and a non-transitory, processor-readable storage medium, wherein the non-transitory, processor-readable storage medium comprises one or more programming instructions ([0072] - memory 208) that, when executed, cause the processor to: receive at least one of an image and a statistical shape model of the patient anatomy ([0072], [0076], [0130], [0135]; the augmented reality display includes an image of the surgical field which is "received" by the processor); receive at least one of an image and a statistical shape model of the patient anatomy ([0072], [0076], [0130], [0135]; the augmented reality display includes an image of the surgical field which is "received" by the processor); acquire, using the tracking system, a tracking marker location of the tracking marker ([0062] - headset 102 with vision system 112, marker 110, [0085], [0099] - where headset 308 corresponds to headset 102 and 202; [0132]); acquire, using the tracking system, a plurality of point probe locations of the trackable point probe, wherein for each of the plurality of point probe locations the trackable point probe is positioned relative to the patient anatomy ([0068]-[0070], [0083], [0085], [0099] - where headset 308 corresponds to headset 102 and 202; [0133]); register a first position and orientation of the patient anatomy relative to the tracking marker based on the tracking marker location and the plurality of point probe locations ([0086], [0100]-[0101], [0103] - where the locations of specific anatomical landmarks such as Whiteside's line indicate patient position and identification of particular planes such as the sagittal plane and body axes such as the A/P axis are indications of patient orientation, [0118]-[0121]); acquire, using the tracking system, landmark locations of the at least three landmarks (fig. 5, [0113] - resection guide 502 with fiducials 504-510, fig. 13a, [0152] - "substantially flat and thin" with resection marker having four fiducials); register a position and orientation of the rigid, low-profile body relative to the tracking marker location based on the tracking marker location and the landmark locations ([0157] - landmark coordinates based on resection marker, which has four fiducials); generate a transformation matrix between the position and orientation of the rigid, low-profile body and the first position and orientation of the patient anatomy ([0158], [0118]-[0119] - transforms via matrix multiplication); acquire, using the tracking system, updated landmark locations of the at least three landmarks, absent the tracking marker ([0158]-[0160] - relative positions, including anatomical landmarks, are retained while resection marker and associated fiducials are removed, [0161]-[0163]); and determine a second position and orientation of the patient anatomy based on the updated landmark locations and the transformation matrix ([0068] - the anatomy model, which would include position and orientation is updated intra-operatively, [0101], [0123], [0157] and [0160] - the updated view includes position and orientation of the anatomy).
Regarding claim 16: Young discloses the system of claim 14, wherein the at least three landmarks are arranged on a surface of the rigid, low-profile body in an at least partially asymmetrical configuration, such that an orientation of the rigid, low-profile body is unambiguous based on a location of the at least three landmarks (figs. 13a, 13d - the marker comprising the fiducials is arranged on a surface of the rigid, low-profile body and are at least partially asymmetrical, see e.g. 1302a in fig. 13a).
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.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Solar et al. (US 2004/0167393 A1, Aug. 26, 2004) (hereinafter “Solar”).
Regarding claims 8 and 15: Young discloses the method of claim 7 and the system of claim 14, but does not disclose wherein each of the at least three landmarks comprises a divot configured to be reliably captured by the trackable point probe.
Solar, in the same field of endeavor, discloses fiducial markers usable with an optical tracking system comprising a divot configured to be reliably captured by a trackable point probe (“wand”) (fig. 1A, [0028], [0036], [0030]). Solar further discloses that the divot allows positioning of the point probe (“wand”) at the center of mass of the fiducial which aids in registration ([0030]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the fiducial markers of Young to include a divot as taught by Solar in order to improve the accuracy of registration by identifying the center of mass of the fiducials in view of the further teachings of Solar.
Claim(s) 10-11, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of McGinley et al. (US 2004/0153062 A1, Aug. 5, 2004) (hereinafter “McGinley”).
Regarding claims 10 and 17: Young discloses the method of claim 7 and the system of claim 14, including navigation of instruments by the AR display (which comprises a processor) ([0157]-[0159]) which also provides the location of a cut plane for a cut between a first affixation point of the tracking marker to the patient anatomy and a second affixation point of the rigid, low-profile body to the patient anatomy (fig. 14a, [0161]) but does not disclose a marking device configured to mark the patient anatomy for the cut.
McGinley, in the same field of endeavor, discloses the use of a computer-assisted navigation system to guide a cutting tool which is configured to mark the patient anatomy for a resection (fig. 2, [0031], fig. 3, [0035], where the cutting tool may be an electrocautery device - [0039]). It is noted that the claim does not require that actually marking the bone be part of the method, merely that the guided tool is configured to make a mark.
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to include navigating an electrocautery tool which may be used for any purpose including cauterizing the incision which may be necessary during the procedure. It is noted that the claim does not require that making the marking cut be part of the method, merely that the guided tool is configured to make a mark. In this case, the electrocautery tool is configured to mark the bone regardless of whether the mark is actually made.
Regarding claims 11 and 19: Young and McGinley disclose the method of claim 10 and the system of claim 17. Young further discloses that the cut is configured to remove a femoral head from the patient anatomy, and wherein the tracking marker is affixed to the femoral head (see location of planned resection planes 1604 and 1606 in figs. 16a-16b, and the location of the tracking marker 1004 in figs. 10b-j; it is noted that this portion of the femur may be referred to as the “femoral head” as evidenced by US 2019/0076198 - see element 202 in fig. 2 and [0016]).
Regarding claim 18: Young and McGinley disclose the system of claim 17, wherein the marking device is an electrosurgical device ([0039]).
Regarding claim 20: Young and McGinley disclose the system of claim 17. Young further discloses that the tracking device is affixed to the patient anatomy via a “femoral head remover” ([0065] - “one or more fixtures such as a screw, clamp, adhesive, or other fastener adapted to attach the marker 110 to the patient 104 (e.g., to a bone or other components of the patient 104); where anything capable of being used to lift/remove a portion of resected femoral head is considered a “femoral head remover” in the absence of any further limitation, i.e. a portion of resected femoral head could be removed from the surgical site using a clamp).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Williamson et al. (US 2024/0216083 A1, Jul. 4, 2024) - discloses a rigid, low-profile body having three or more divots configured to be reliably captured by the trackable point probe.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799
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