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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 21 January 2026. As directed by the amendment: claims 1, 3, and 10-16 have been amended, claims 18, 20, 22, and 24 stand withdrawn, and claims 9, 19, 21, and 23 are cancelled. Claims 1-8, 10-18, 20, 22, and 24 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the claim objections listed in the previous action, which are repeated below in relevant part, in addition to further claim objections as necessitated by the claim amendments.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) and (d) listed in the previous action, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments filed 21 January 2026 have been fully considered but they are not persuasive. As to the rejections under 35 U.S.C. 102(a)(1) as anticipated by WO 2018/132804 to Lang, Applicant contends that Lang does not disclose determining a deviation, determining a clinical consequence associated with the deviation as the surgeon moves the instrument relative to the bone or joint, and providing an indication of the clinical consequence as the surgeon moves the instrument relative to the bone or joint. Examiner respectfully submits that, as articulated in the rejections below, Lang does disclose these steps. Lang discloses determining a deviation based on the pose of the instrument against the surgical plan (page 513 / line 19 – page 514 / line 30) (see page 508 / line 20 – page 529 / line 13). Lang discloses determining a clinical consequence associated with the deviation as the surgeon moves the instrument relative to the bone or joint. Lang discloses that when the deviation is less than a defined value, it is determined that the instrument is in or has returned to the intended pose from the surgical plan, and therefore the clinical consequence associated with the pose of the instrument being in the intended pose from the surgical plan is that the instrument will perform the action of the surgical plan, e.g. reaming at a particular location and to a particular depth (page 511 / line 3 – page 512 / line 2; page 514 / lines 2-23). This occurs in real-time as the surgeon moves the instrument relative to the bone or joint because the determining utilizes live data, particularly as the surgeon moves the instrument from a deviated pose and returns to the intended pose (page 512 / line 3 – page 514 / line 23). Lang discloses providing an indication of the clinical consequence as the surgeon moves the instrument relative to the bone or joint. Lang discloses when the surgeon has moved the instrument to return to the intended pose, an indication such as color change or light changes on the display is provided to the surgeon to indicate that the instrument is in the intended pose (page 514 / lines 19-23), and thus indicating that the clinical consequence of the surgical plan will be achieved with that pose; as above, the live data tracks the surgeon’s movement of the instrument, to the intended pose from the surgical plan and also while performing the action, e.g. reaming, of the surgical plan.
Claim Objections
Claims 1-8 and 10-17 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 14: “or the joint;”
Claim 1 / line 17: “or the joint.”
Claim 8 / lines 2-3: “a broach configured for medullary canal preparation.”
Claim 13 / line 1: “The system of claim 12,”
Claim 17 / line 2: “and the determining the pose”
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.
(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.
Claims 1-7 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by WO 2018/132804 to Lang (as cited in the IDS filed 06 September 2022).
As to claim 1, Lang discloses a system for assisting a surgeon in implanting a joint replacement implant component during a surgery of replacing a joint (see page 508 / line 20 – page 529 / line 13), the system comprising: an instrument for medullary canal preparation (page 513 / lines 9-16); a camera to capture image data of the instrument (page 513 / lines 16-18); a computer system to: store a surgical plan (page 42 / lines 23-26; page 360 / line 25 – page 361 / line 5); determine a pose of the instrument relative to a bone or the joint based on the image data from the camera (page 73 / lines 16-29; page 513 / lines 16-18; page 518 / lines 3-26); assess the pose of the instrument against the surgical plan (page 513 / lines 16-23); determine, based on the pose of the instrument against the surgical plan, a deviation between the pose and the surgical plan (page 513 / line 19 – page 514 / line 30) (see page 508 / line 20 – page 529 / line 13); determine, based on the deviation between the pose and the surgical plan, a clinical consequence associated with the pose as the surgeon moves the instrument relative to the bone or joint (when the deviation is less than a defined value, it is determined that the instrument is in or has returned to the intended pose from the surgical plan, and therefore the clinical consequence associated with the pose of the instrument being in the intended pose from the surgical plan is that the instrument will perform the action of the surgical plan, e.g. reaming at a particular location and to a particular depth, page 511 / line 3 – page 512 / line 2; page 514 / lines 2-23; the determining occurs as the surgeon moves the instrument relative to the bone or joint because the determining utilizes live data, page 512 / line 3 – page 514 / line 23, particularly as the surgeon moves the instrument from a deviated pose and returns to the intended pose); and provide an indication to the surgeon of the clinical consequence associated with the pose as the surgeon moves the instrument relative to the bone or joint (when the surgeon has moved the instrument to return to the intended pose, an indication such as color change or light changes on the display is provided to the surgeon to indicate that the instrument is in the intended pose, page 514 / lines 19-23, and thus indicating that the clinical consequence of the surgical plan will be achieved with that pose; as above, the live data tracks the surgeon’s movement of the instrument, to the intended pose from the surgical plan and also while performing the action, e.g. reaming, of the surgical plan).
As to claim 2, Lang discloses the system of claim 1, wherein the surgical plan comprises a two-dimensional plan (page 392 / lines 10-30), FIG. 15.
As to claim 3, Lang discloses the system of claim 1, wherein the surgical plan comprises a three-dimensional surgical plan, and wherein the computer system is configured to create the three-dimensional surgical plan from two or more two-dimensional medical images (page 392 / lines 10-30).
As to claim 4, Lang discloses the system of claim 3, wherein the medical images are X-ray images (page 392 / lines 10-30).
As to claim 5, Lang discloses the system of claim 1, wherein the surgical plan comprises a three-dimensional surgical plan (page 392 / lines 10-30).
As to claim 6, Lang discloses the system of claim 1, wherein the instrument is one of a broaching instrument and a rasping instrument (page 513 / lines 9-16).
As to claim 7, Lang discloses the system of claim 1, wherein the instrument comprises a broach handle with an impact surface to receive impact from a surgeon operated hammer (interpreted as language of intended use; any broach would have a handle, or something that can be grasped, and an impact surface, since any exposed surface is fully capable of receiving an impact from a hammer).
As to claim 14, Lang discloses the system of claim 1, wherein the computer system is configured to generate a graphical display of the joint and an indication of the pose of the instrument in relation to the joint (page 471 / line 24 – page 472 / line 3; page 473 / line 1 – page 477 / line 5).
As to claim 15, Lang discloses the system of claim 1, wherein the computer system is further configured to: receive an x-ray image; display the x-ray image; and overlay over the x-ray image an indication of the pose of the instrument (page 668 / line 15 – page 679 / line 11).
As to claim 16, Lang discloses the system of claim 1, wherein the determining the pose of the instrument comprises detecting objects in the image data and fitting an object model to the objects (page 467 / line 10 – page 470 / line 5).
As to claim 17, Lang discloses the system of claim 1, wherein a two-dimensional marker is affixed to the instrument and determining the pose of the instrument comprises determining the pose of the two-dimensional marker (page 100 / lines 14-24; page 101 / lines 20-27; page 102 / line 23 – page 103 / line 25; page 118 / line 22 – page 120 / line 8).
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 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of U.S. Reissued Patent No. RE46,954 to Pedicini.
Lang discloses wherein the instrument is an impactor (page 513 / line 14) that generates impact energy and that is fully capable of delivering the impact energy to a broach for medullary canal preparation but is silent as to the instrument is an automatic impactor that delivers a predefined amount of the impact energy to the broach.
Pedicini teaches that an impactor that delivers impact energy to a broach (col. 1 / lines 63-67; col. 2 / line 59 – col. 3 / line 8) is an automatic impactor that delivers a predefined amount of the impact energy to the broach because it provides controlled continuous impacting after the start switch is activated (col. 8 / lines 41-51) and has energy control for controlling the impact energy to a predefined amount based on the tool settings to avoid damage caused by uncontrolled impacts or impacts of excessive energy (col. 8 / line 65 – col. 9 / line 26).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Lang’s instrument as an automatic impactor that generates and delivers a predefined amount of energy to the broach for medullary canal preparation, since as taught by Pedicini, this allows for controlled continuous impacting which allows easy control of the creation or shaping of the surgical area by the surgeon while reducing expended effort, and allows for the control of impact energy to a predefined amount based on the tool settings to avoid damage caused by uncontrolled impacts or impacts of excessive energy.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of U.S. Patent Application Publication No. US 2018/0161101 to Barsoum et al. (hereinafter, “Barsoum”).
Lang fails to disclose the clinical consequence comprises a risk stratification or a simulated performance metric determined by simulating a three-dimensional model of the joint based on the pose of the instrument; wherein the simulating the three-dimensional model is based on an implant placement defined by the pose of the instrument.
Barsoum teaches a system which provides a clinical consequence comprising a risk stratification or a simulated performance metric determined by simulating a three-dimensional model of the joint based on an implant placement (par. [0027]-[0035]), where the simulations provide the surgeon with the positions and orientations of the implant that result in a safe zone for optimal anatomical functioning.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Lang’s system that the deviation between the pose and the surgical plan includes a clinical consequence, and wherein the clinical consequence comprises a risk stratification or a simulated performance metric determined by simulating a three-dimensional model of the joint, since Barsoum teaches that simulating a three-dimensional model of the joint based on an implant placement provides the positions and orientations of the implant that result in a safe zone for optimal anatomical functioning. As applied to Lang, the deviation between the pose and the surgical plan would include a clinical consequence, and based on the risk stratification or simulated performance metric as taught by Barsoum where simulations of various implant positions and orientations provide information about a safe zone, the surgeon can determine if the deviation falls within an acceptable range for optimal anatomical functioning (the safe zone) or if the deviation results in a clinical consequence with high risk that is unacceptable and for which the pose of the instrument should be adjusted back closer into line with the surgical plan. As applied to Lang, the implant placement which is simulated to determine the safe zone is dependent upon and defined by the pose of the instrument, which creates the hole in the bone into which the implant is placed in a certain position and orientation, and thus the simulating that is based on the implant placement is also based on the pose of the instrument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775