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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-7 and 14-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lang et al (11,553,969).
Regarding claim 5, Lang et al disclose a method comprising:
displaying a planned resection plane aligned with an object in a coordinate system on an augmented reality headset (at least one head mounted display (HMD) and a virtual bone cut plane – col.14, ll.28-30);
detecting, by the augmented reality headset, a guide marker attached to a resection guide (surgical instruments can be, for example, cut blocks, pin guides – col.22, ll.62-63; video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8);
determining an actual resection plan based on a position of the guide marker (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8);
displaying the actual resection plane on the augmented reality headset (video capture system integrated into the HMD – col.89, ll.61-65); and
placing the resection guide in accordance with guidance provided based on the actual resection plane and the planned resection plane (as the optical marker enters the surgeon’s field of view, an image and/or video capture system can detect the optical marker and display the next virtual surgical step, e.g. an outline of a virtual proximal tibial cut block corresponding to the physical proximal tibial cut block, so that the surgeon can align or superimpose the physical surgical cut block or instrument onto the outline of the virtual surgical cut block or instrument – col.86, l.63-col.87, l.4; the distal femoral cut block 35 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Regarding claim 6, Lang et al disclose further comprising:
attaching one or more markers to the object at one or more points (tracking markers can be used to determine the pose of the bony structure to which they are rigidly attached) – col.270, ll.41-42), wherein each marker of the one or more markers comprises fiducials (tracking markers can be comprised of one or more fiducials – col.270, l.43);
identifying a pattern of the fiducials attached to each marker by the augmented reality headset to provide an identification of each point of the object (tracking of the markers can be continuous or at regular or irregular intervals, and the computer display can be updated – col.270, ll.60-63); and
creating a coordinate system based in part on one or more identifications of the one or more points of the object by the augmented reality headset (a pose of the first vertebra in a coordinate system from the first marker and the second marker – col.1, ll.53-58).
Regarding claim 7, Lang et al disclose further comprising: identifying fiducials attached to the guide marker in the coordinate system by the augmented reality headset (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8); and
determining the actual resection plane based on a pattern of the fiducials (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Regarding claim 14, Lang et al disclose a system comprising:
a resection guide configured to be attached to an object (surgical instruments can be, for example, cut blocks, pin guides – col.22, ll.62-63; fig.14c);
an augmented reality headset (head mounted display, for example for augmented reality applications – col.7, ll.30-33) configured to:
determine a location of the resection guide in a coordinate system (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8);
determine an actual reception plane based on the location of the resection guide (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8; fig.14c);
display a planned resection plane and the actual resection plane in the coordinate system (video capture system integrated into the HMD – col.89, ll.61-65; fig.14c); and
guide placement of the resection guide based on the planned and actual resection planes (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Regarding claim 15, Lang et al disclose further comprising:
a guide marker configured to be attached to the resection guide, the guide marker comprising a plurality of fiducials configured to define a fiducial plane (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8);
wherein the augmented reality headset is configured to determine the actual resection plane based on the fiducial plane in the coordinate system (video capture system can track the optical marker and the surgical instrument with respect to its location, position, orientation, alignment and/or direction of movement – col.90, ll.6-8).
Regarding claim 16, Lang et al disclose further comprising:
one or more markers configured to be attached to the object at one or more points (tracking markers can be used to determine the pose of the bony structure to which they are rigidly attached), each marker of the one or more markers comprising fiducials (tracking markers can be comprised of one or more fiducials – col.270, l.43);
wherein the augmented reality headset is configured to:
identify a pattern of the fiducials attached to each marker by the augmented reality headset to provide an identification of each point of the object (tracking of the markers can be continuous or at regular or irregular intervals, and the computer display can be updated – col.270, ll.60-63); and
create a coordinate system based in part on one or more identifications of the one or more points of the object by the augmented reality headset (a pose of the first vertebra in a coordinate system from the first marker and the second marker – col.1, ll.53-58).
Regarding claim 17, Lang et al disclose wherein the augmented reality headset is further configured to:
display the planned resection plane aligned with the object in the coordinate system (fig.14c); and
prompt to adjust a location and orientation of the resection guide to reduce a difference between the actual resection plane to the planned resection plane (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Regarding claim 18, Lang et al disclose wherein the augmented reality headset is further configured to prompt to adjust the location and orientation of the resection guide to reduce a distance, angle, or combination thereof between the planned resection plane and the actual resection plane (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
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(s) 8-13 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lang et al (11,553,969) in view of Leitner et al (2004/0143178).
Regarding claim 8, Lang et al disclose further comprising: guiding the resection along the actual resection plane (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Lang et al fail to explicitly disclose prompting to attach the guide marker to the resection guide; prompting to place the resection guide on the object; prompting to remove the guide marker from the resection guide.
However, Leitner et al teach in the same medical field of endeavor, prompting to attach a guide marker to a resection guide (removable marker attached to the cutting jig); prompting to place the resection guide on an object (localization device is used to guide a surgeon in the placement of a cutting jig); prompting to remove the guide marker from the resection guide (after the cutting jig is secured, the removable marker is removed from the cutting jib) ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the attached guide marker to the resection guide of Lang et al with prompting to attach the guide marker, prompting to place the resection guide and prompting to remove the guide marker of Leitner et al as it would provide placement of marker for visualization of the device and placement of the device as well as removing the removably marker for later attachment to tools used in subsequent steps (Leitner [0003]).
Regarding claim 9, Lang et al disclose further comprising:
detecting a difference of the actual resection plane to the planned resection plane (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8); and
prompting to remove the guide marker from the resection guide if the detected difference is less than a predetermined difference (Examiner’s position is this limitation is a contingent limitation which does not provide any further patentable weight. The broadest reasonable interpretation of a method claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent area not met. See MPEP 2111.04. Examiner notes Leitner et al discloses securing the cutting jib and removing the marker only after the cutting jig is secured (difference is less than a predetermined distance, i.e., properly placed).).
Regarding claim 10, Lang et al disclose prompting to adjust a location and orientation of the resection guide to reduce a distance, angle, or combination thereof between the planned resection plane and the actual resection plane (the distal femoral cut block 305 (solid line) can be moved and aligned to be substantially superimposed with or aligned with the virtual surgical guide – col.231, ll.5-8).
Regarding claims 11 and 12, Lang et al as modified by Leitner et al disclose the invention as claimed and discussed above. Lang et al further disclose an insertion member of the guide marker into a slot of the resection guide; and remove the insertion member from the slot (one or more optical markers can be included in, integrated into or attached to an insert for a cutting block or guide. The insert can be configured to fit into one or more slots or guides within the cutting block or guide for guiding a saw blade – col.87, ll.42-46).
Regarding claim 13, Lang et al as modified by Leitner et al disclose the invention as claimed and discussed above. Lang et al further discloses wherein guiding resections along the actual resection plane comprises guiding a resection device into a slot (one or more optical markers can be included in, integrated into or attached to an insert for a cutting block or guide. The insert can be configured to fit into one or more slots or guides within the cutting block or guide for guiding a saw blade – col.87, ll.42-46).
Regarding claim 19, Lang et al disclose the invention substantially as claimed, but fail to explicitly disclose prompting to place the resection guide on the object; prompting to attach the guide marker to the resection guide before adjusting; and prompting to remove the guide marker from the resection guide after adjusting.
However, Leitner et al teach in the same medical field of endeavor, prompting to place the resection guide on an object (localization device is used to guide a surgeon in the placement of a cutting jig); prompting to attach a guide marker to a resection guide before adjusting (removable marker attached to the cutting jig); and prompting to remove the guide marker from the resection guide after adjusting (after the cutting jig is secured, the removable marker is removed from the cutting jib) ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the attached guide marker to the resection guide and augmented reality headset of Lang et al with prompting to attach the guide marker, prompting to place the resection guide and prompting to remove the guide marker of Leitner et al as it would provide placement of marker for visualization of the device and placement of the device as well as removing the removably marker for later attachment to tools used in subsequent steps (Leitner [0003]).
Regarding claim 20, Lang et al as modified by Leitner et al disclose the invention as claimed and discussed above. Lang et al further discloses wherein the guide marker comprises an insertion member; and wherein the resection guide comprises a slot extending along the actual resection plane, the slot configured to receive either a resection device or the insertion member (one or more optical markers can be included in, integrated into or attached to an insert for a cutting block or guide. The insert can be configured to fit into one or more slots or guides within the cutting block or guide for guiding a saw blade – col.87, ll.42-46).
Response to Arguments
Applicant's arguments filed 20 October 2025 have been fully considered but they are not persuasive.
Regarding claim 5, Applicant states the prior art fails to explicitly disclose “determining an actual resection plane based on a position of the guide marker” and “placing the resection guide in accordance with guidance provided based on the actual resection plane and the planned resection plane”.
Specifically, Applicant states Lang does not disclose or suggest that the resection plane is determined based on the guide marker connected to the resection guide because Lang describes a video capture system that can determine the location, position, orientation, alignment and direction of movement of a variant of surgical instruments. Lang does not disclose or suggest “determining an actual resection plane based on a position of the guide marker”.
Lang further does not disclose or suggest “placing the resection guide in accordance with guidance provided based on the actual resection plane and the planned resection plane”. Lang describes an alignment of a physical guide to match a virtual guide and does not describe “placing the resection guide in accordance with guidance provided based on the actual resection plane and the planned resection plane” as recited in the combination of claim 5.
Examiner’s position is the actual resection plane is considered to be the plane in which the physical surgical instrument (i.e., block) is located. This information is determined since the location, position, alignment and/or orientation of the optical marker on the surgical instrument are known and the dimensions or geometry of the surgical instrument are known. The image and/or video capture system tracks the optical marker and the surgical instrument, therefore the actual resection plane is determined based on the position of the guide marker that is attached to the surgical instrument (i.e., resection guide).
Lang et al further disclose placing the resection guide in accordance with guidance provided based on the actual resection plane and the planned resection plane (as the optical marker enters the surgeon’s field of view, an image and/or video capture system can detect the optical marker and display the next virtual surgical step, e.g. an outline of a virtual proximal tibial cut block corresponding to the physical proximal tibial cut block, so that the surgeon can align or superimpose the physical surgical cut block or instrument onto the outline of the virtual surgical cut block or instrument – col.86, l.63-col.87, l.4). This is similarly disclosed in col.231, ll.5-8. The actual resection plane being the determined current plane of the surgical instrument and the planned resection plane being the virtual resection plane. The placement of the resection guide is in accordance with “guidance provided based on the actual resection plane and the planned resection plane” as the surgical instrument is moved from the determined physical surgical instrument (actual resection plane of the instrument) to the virtual surgical block or instrument (virtual resection plane).
The planes of both the physical cut block (actual resection plane) and the virtual cut block (planned resection plane) can be seen in corresponding figures 14b and 14c. Examiner notes the claim does not define the “guidance provided” nor does the claim define how the guidance is “based on” the actual resection plane and the planned resection plane.
Applicant states for at least analogous reasons described above with reference to claim 5, Applicant submits that Lang fails to disclose the features described.
Examiner’s position is Lang et al disclose the features described for at least the reasons set forth with respect to claim 5.
Conclusion
THIS ACTION IS MADE FINAL. 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 ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher 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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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797