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 . This action is in response to the Applicant Arguments/Remarks Made in an Amendment received on March 16, 2026. Claims 1-23 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-14, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Viscardi et al. EP 3479792 A1, hereinafter “Viscardi” in view of Kostrzewski WO 2017/037127.
Claim 1, Viscardi discloses a surgical system (10, Figure 1) capable of performing a surgical procedure on a patient [paragraph 0012], the surgical system comprising: a cutting tool (22) that is hand-guided (i.e. in free mode the too can be moved by a user [paragraph 00344]; a robotic manipulator (57) capable of supporting and moving a cutting guide that is configured to guide the cutting tool to cut a tissue of the patient [paragraph 0005]; a control system (54) coupled to the robotic manipulator and capable of controlling a location of the cutting guide relative to the tissue [paragraph 0057]; a navigation system (26) coupled to the control system (indirectly via tracking devices) and including a localizer (34) and a tracker (48) coupled to one or both of the cutting tool and/or the cutting guide, wherein the navigation system is capable of registering “mapped” a virtual cutting plane to the tissue [paragraphs 0029-0031 and 0035], wherein the virtual cutting plane defines a virtual cutting limit [paragraphs 0031 and 0034]; detect the tracker with the localizer to track a pose of the cutting tool and/or the cutting guide relative to the virtual cutting plane [paragraph 0035]; and in response to cooperation of the cutting tool with the cutting guide to cut the tissue[paragraph 0035], the control system is capable of actively controlling the cutting tool and/or the cutting guide to prevent the cutting tool from cutting tissue beyond the virtual cutting limit [paragraph 0035].
Viscardi fails to disclose a cutting guide including a guide portion configured to receive and guide the cutting tool.
Kostrzewski discloses a cutting guide (404, Figure 4A) including a guide portion configured to receive and guide the cutting tool (452, Figure 4B) (Page 18, lines 21-26).
Therefore, it would have been obvious to one person having ordinary skill in the art at the time the invention was made to modify the surgical system of Viscardi with a cutting guide including a guide portion configured to receive and guide the cutting tool as taught by Kostrzewski in order to advance the cutting tool in a controlled manner.
Claim 2, the modified Viscardi’s surgical system discloses wherein the virtual cutting limit is geometrically customized for the patient: based on a virtual model associated with the tissue of the patient; and to avoid sensitive anatomical structures of the patient [paragraphs 0035 and 0049 describe mapping a virtual boundary based on the patient’s anatomy for highly accurate and repeatable cutting, which would avoid remaining sensitive and unattended anatomy].
Claim 3, the modified Viscardi’s surgical system discloses wherein the virtual cutting limit is a cutting depth limit beyond which the cutting tool should not pass [paragraph 0035 describes the tool should not move beyond the virtual boundary, i.e. a cutting depth].
Claim 4, the modified Viscardi’s surgical system discloses wherein the control system actively controls the cutting tool to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit by being capable of modifying “reposition” or stopping operation of the cutting tool [paragraphs 0037, 0041 and 0050 describe the cutting tool being controlled and moved based on a predetermined plan].
Claim 5, the modified Viscardi’s surgical system discloses wherein the control system actively controls the cutting guide to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit by being capable of controlling the robotic manipulator to autonomously move the cutting guide [paragraphs 0037-0038 describe the links 58 move according to the desired location to move the cutting tool].
Claim 6, the modified Viscardi’s surgical system discloses wherein: the robotic manipulator enables manual movement of the cutting guide by a user (i.e. in free mode or haptic mode [paragraph 0034]; and in response to the manual movement of the cutting guide, the control system is capable of autonomously changing the pose of the cutting guide to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit (i.e., in a semi-autonomous mode [paragraphs 0034, 0038, and 0057].
Claim 7, the modified Viscardi’s surgical system discloses wherein to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit, the control system is capable of controlling the robotic manipulator to autonomously adjust the pose of the cutting guide in one or more degrees of freedom relative to the virtual cutting plane while constraining the cutting guide to the virtual cutting plane [paragraphs 0037-0038 and 0057-0066].
Claim 8, the modified Viscardi’s surgical system discloses wherein to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit, the control system is configured to autonomously pull the cutting guide away from the tissue along one translational degree of freedom while constraining the cutting guide to the virtual cutting plane [paragraphs 0037-0038 and 0057-0066].
Claim 9, the modified Viscardi’s surgical system discloses wherein to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit, the control system is configured to autonomously rotate the cutting guide in one rotational degree of freedom while constraining the cutting guide to the virtual cutting plane [paragraphs 0037-0038 and 0057-0066].
Claim 10, the modified Viscardi’s surgical system discloses wherein the control system actively controls the cutting tool and/or the cutting guide to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit by being configured to generate vibratory feedback (i.e. haptic feedback to the cutting tool [paragraph 0035]).
Claim 11, the modified Viscardi’s surgical system discloses wherein the control system actively controls the cutting tool and/or the cutting guide to prevent the cutting tool from cutting the tissue beyond the virtual cutting limit in response to detection of a condition, wherein the condition comprises one or both of: the cutting tool being within a predetermined distance of the virtual cutting limit (i.e. a plane of the tool 22 is aligned with a desired pose of planar resection [paragraph 0041]); and incorrect positioning of the cutting tool and/or the cutting guide for a particular step of the surgical procedure [paragraph 0037].
Claim 12, the modified Viscardi’s surgical system discloses wherein the tracker (48, Figure 1) is coupled to the cutting tool and the cutting guide is trackerless (i.e., robot has the navigation marker “tracker” not the guide [page 4, lines 1-7] of Kostrzewski), and wherein the navigation system is capable of detecting the tracker with the localizer to track the pose of the cutting tool relative to the virtual cutting plane [paragraph 0021] of Viscardi.
Claim 13, the modified Viscardi’s surgical system discloses wherein the tracker (48, Figure 1) is coupled to the cutting guide and the cutting tool is trackerless (i.e., robot has the navigation marker “tracker” not the guide [page 4, lines 1-7] of Kostrzewski), and wherein the navigation system is configured to detect the tracker with the localizer to track the pose of the cutting guide relative to the virtual cutting plane [paragraph 0021].
Claim 14, the modified Viscardi’s surgical system discloses wherein the navigation system includes a display device (28 and 29) and the control system is capable of presenting, on the display device, an alert or notification related to the cutting tool approaching, reaching, and/or exceeding the virtual cutting limit [paragraph 0013].
Claim 22, Viscardi discloses a surgical system (10, Figure 1) capable of performing a surgical procedure on a patient [paragraph 0012], the surgical system comprising: a cutting tool (22) that is hand-guided (i.e. in free mode the tool can be moved by a user [paragraph 00344]; a robotic manipulator (57) capable of supporting and move a cutting guide that is capable of guiding the cutting tool to cut a tissue of the patient; a control system (54) coupled to the robotic manipulator and capable of controlling a location of the cutting guide relative to the tissue [paragraph 0057]; a navigation system (26) coupled to the control system and including a localizer (34), wherein the navigation system is configured to: registering “mapping” a virtual cutting plane to the tissue [paragraphs 0029-0031 and 0035], wherein the virtual cutting plane defines a virtual cutting limit [paragraphs 0031 and 0034]; and in response to cooperation of the cutting tool with the cutting guide to cut the tissue, detect, with the localizer, a distance between the cutting tool and the virtual cutting limit; wherein, in response to detection of the distance, the control system is capable of actively changing a pose of the cutting guide in one or more degrees of freedom while constraining the cutting guide to the virtual cutting plane to prevent the cutting tool from cutting tissue beyond the virtual cutting limit[paragraphs 0057-0066].
Viscardi fails to disclose a cutting guide including a guide portion configured to receive and guide the cutting tool.
Kostrzewski discloses a cutting guide (404, Figure 4A) including a guide portion configured to receive and guide the cutting tool (452, Figure 4B) (Page 18, lines 21-26).
Therefore, it would have been obvious to one person having ordinary skill in the art at the time the invention was made to modify the surgical system of Viscardi with a cutting guide including a guide portion configured to receive and guide the cutting tool as taught by Kostrzewski in order to advance the cutting tool in a controlled manner.
Claim 23, Viscardi discloses a surgical system (10, Figure 1) capable of performing a surgical procedure on a patient[paragraph 0012], the surgical system comprising: a cutting tool (22) that is hand-guided (i.e. in free mode the tool can be moved by a user [paragraph 00344]; a robotic manipulator (57) capable of supporting and moving a cutting guide that is configured to guide the cutting tool to cut a tissue of the patient; a control system (54) coupled to the robotic manipulator and configured to control a location of the cutting guide relative to the tissue; a navigation system (26) coupled to the control system and including a localizer, wherein the navigation system is configured to: register a virtual cutting plane to the tissue[paragraphs 0029-0031 and 0035], wherein the virtual cutting plane defines a virtual cutting limit [paragraphs 0031 and 0034]; and in response to cooperation of the cutting tool with the cutting guide to cut the tissue, detect, with the localizer, a distance between the cutting tool and the virtual cutting limit; wherein, in response to detection of the distance, the control system is capable of actively modify or stop operation of the cutting tool to prevent the cutting tool from cutting tissue beyond the virtual cutting limit [paragraphs 0037, 0041 and 0050 describe the cutting tool being controlled and moved based on a predetermined plan].
Viscardi fails to disclose a cutting guide including a guide portion configured to receive and guide the cutting tool.
Kostrzewski discloses a cutting guide (404, Figure 4A) including a guide portion configured to receive and guide the cutting tool (452, Figure 4B) (Page 18, lines 21-26).
Therefore, it would have been obvious to one person having ordinary skill in the art at the time the invention was made to modify the surgical system of Viscardi with a cutting guide including a guide portion configured to receive and guide the cutting tool as taught by Kostrzewski in order to advance the cutting tool in a controlled manner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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