DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 18th, 2026 has been entered.
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.
Claims 15 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Axelson (U.S. Publication 2019/0117233) in view of Hodorek (U.S. Publication 2007/0066917) and in view of Amanatullah (U.S. Publication 2020/0405398) and in view of Arramon (U.S. Publication 2020/0093613).
Regarding claims 15 and 18-20:
Axelson discloses a method comprising:
(claim 15) determining a characteristic of a resected bone (see paragraphs 6, 15, 52, 53, and 60-61; before and after making a preliminary cut in a bone the shape of the bone required to engage a trial implant component is determined)
(claim 15) receiving a virtual model of the bone and developing a pre-surgical plan (see paragraphs 7, 14, 52, 62, and claim 2)
(claim 15) virtually plan a placement of the trial component on the resected bone based on the determined characteristic of the resected bone (see paragraphs 7, 14, 52, and 62; the bone model is provided with preliminary resection profile, i.e. planned positioning of the trial component based on the cut shape of the bone)
(claim 15) positioning the trial component on the resected bone based on the determined characteristic of the resected bone and on the pre-surgical plan
(claim 15) determining the shape of the resected bone based on engagement between the trial component and the resected bone and based on the determined characteristics of the resected bone (see paragraphs 6, 8, 12, and 60-65; the shape of the final resections on the distal femur are based on the engagement between the trial shims and the resected bone during kinematic analysis)
Axelson fails to disclose the method comprising the steps performing a step of a virtual surgery on a virtual model of the bone based on the pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based on the determined characteristic of the resected bone and based on the virtual surgery, determining the shape of the resected bone based on the virtual surgery, comparing the shape of the determined resected bone to the virtual model to validate the resected bone, updating the placement location based on the determined shape of the resected bone and the virtual surgery, placing the trial component on the resected bone based on the updated placement location, attaching a trial component to an end effector of a robotic surgical device, and operating the surgical device to move the end effector to position the trial component to engage the resected bone.
Regarding the method comprising performing a step of a virtual surgery on a virtual model on the bone based on a pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based on the virtual surgery, updating the placement location based on the determined shape of the resected bone and the virtual surgery, and placing the trial component on the resected bone based on the updated placement location. Hodorek teaches a method comprising the steps of performing a step of virtual surgery on a virtual model of a bone based on a pre-surgical plan (paragraph 37), determining a shaped of the resected bone based on the virtual surgery, updating the surgery plan and placement location based on the determined shape of the resected bone and the virtual surgery (see paragraphs 38-42; the surgeon determines if different trial components are needed based on the virtual surgery trialing), and placing the trial component on the resected bone based on the updated placement plan and placement location in order to position a component on a resected bone without requiring trial-and-error selection of components. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson further comprising the steps of performing a step of a virtual surgery on a virtual model on the bone based on a pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based on the virtual surgery, updating the placement location based on the determined shape of the resected bone and the virtual surgery, and placing the trial component on the resected bone based on the updated placement location in view of Hodorek in order to position a component on a resected bone without requiring trial-and-error selection of components.
Regarding the method further comprising the step of comparing the shape of the determined resected bone to the virtual model to validate the resected bone, Amanatullah teaches a method virtual surgery further comprising the step of comparing the shape of a determined resected bone to a virtual model to validate the resected bone (see paragraph 143) in order to validate the shape of the resected bone relative to the virtual model. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson as modified by Hodorek further comprising the step of comparing the shape of the determined resected bone to the virtual model to validate the resected bone in view of Amanatullah in order to validate the shape of the resected bone relative to the virtual model.
Regarding the method further comprising the steps of attaching a trial component to the end effector of a robot and positioning the trial component with the end effector of the robot, Arramon teaches a method comprising the steps of attaching a trial component to the end effector of a robot (see paragraph 51) and positioning the trial component with the end effector of the robot (see paragraph 22) in order to save time and increase precision while positioning a trial. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson as modified by Hodorek as further modified by Amanatullah further comprising the steps of attaching a trial component to the end effector of a robot and positioning the trial component with the end effector of the robot in view of Arramon in order to save time and increase precision while positioning a trial.
Regarding claim 20, the method of Axelson as modified by Hodorek as further modified by Amanatuallah as further modified by Arramon discloses a method wherein the end effector positions the trial component on the resected bone based on either the original placement plan or on an updated placement plan with an updated placement location.
Regarding claim 21:
Axelson discloses a method comprising:
(claim 21) with a system determining a characteristic of a resected bone (see paragraphs 6, 15, 52, 53, and 60-61; before and after making a preliminary cut in a bone the shape of the bone required to engage a trial implant component is determined; the system is used to take images of the bone and create a virtual model of the bone determining the shape, i.e. a characteristic of the bone)
(claim 21) the system receiving a virtual model of the bone (see paragraphs 7, 14, 52, 62, and claim 2)
(claim 21) the system performing a step of virtual surgery on a virtual model of the bone based on a pre-surgical plan (see paragraphs 7, 14, 52, and 62; the bone model is provided with preliminary resection profile, i.e. planned positioning of the trial component based on the cut shape of the bone)
(claim 21) positioning the trial component on the resected bone based on the determined characteristic of the resected bone and on the pre-surgical plan
(claim 21) determining the shape of the resected bone based on engagement between the trial component and the resected bone and based on the determined characteristics of the resected bone (see paragraphs 6, 8, 12, and 60-65; the shape of the final resections on the distal femur are based on the engagement between the trial shims and the resected bone during kinematic analysis)
Axelson fails to disclose the method comprising the steps attaching a trial component to an end effector of a robotic surgical device operated by a system, the performing a step of a virtual surgery on a virtual model of the bone based on the pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based on the determined characteristic of the resected bone and based on the virtual surgery, determining the shape of the resected bone based on the virtual surgery, comparing the shape of the determined resected bone to the virtual model to validate the resected bone, placing the trial component on the resected bone based on the resected bone and the virtual surgery, attaching a trial component to an end effector of a robotic surgical device, and operating the surgical device to move the end effector to position the trial component to engage the resected bone.
Regarding the method comprising performing a step of a virtual surgery on a virtual model on the bone based on a pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based and on the virtual surgery, and placing the trial component on the resected bone. Hodorek teaches a method comprising using a system to perform the steps of performing a step of virtual surgery on a virtual model of a bone based on a pre-surgical plan (paragraph 37), and determining a shaped of the resected bone based on the virtual surgery (see paragraphs 38-42; the surgeon determines if different trial components are needed based on the virtual surgery trialing), and placing the trial component on the resected bone based on the surgical plan and placement location in order to position a component on a resected bone without requiring trial-and-error selection of components. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson further comprising using a system to perform the steps of performing a step of a virtual surgery on a virtual model on the bone based on a pre-surgical plan, virtually planning a placement location of the trial component on the resected bone based on the virtual surgery, and placing the trial component on the resected bone based on the surgical plan and placement location in view of Hodorek in order to position a component on a resected bone without requiring trial-and-error selection of components.
Regarding the method further comprising the step of using a system to compare the shape of the determined resected bone to the virtual model to validate the resected bone, Amanatullah teaches a method virtual surgery further comprising the step of using a system to compare the shape of a determined resected bone to a virtual model to validate the resected bone (see paragraph 143) in order to validate the shape of the resected bone relative to the virtual model. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson as modified by Hodorek further comprising the step of comparing the shape of the determined resected bone to the virtual model to validate the resected bone in view of Amanatullah in order to validate the shape of the resected bone relative to the virtual model.
Regarding the method further comprising the steps of attaching a trial component to the end effector of a robot and positioning the trial component with the end effector of the robot, Arramon teaches a method comprising the steps of attaching a trial component to the end effector of a robot (see paragraph 51) and using a system to position the trial component with the end effector of the robot (see paragraph 22) in order to save time and increase precision while positioning a trial. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Axelson as modified by Hodorek as further modified by Amanatullah further comprising the steps of attaching a trial component to the end effector of a robot and using a system to position the trial component with the end effector of the robot in view of Arramon in order to save time and increase precision while positioning a trial.
Response to Arguments
Applicant's arguments filed June 18th, 2026 have been fully considered but they are not persuasive. The applicant’s argument that the Arramon reference is related to using a robot to place an implant in a spinal joint and does not teach placing the implant in engagement with a resected bone. However, the Hodorek reference does teach this limitation. Hodorek teaches using a tool to engage an implant with a resected surface of a bone and Arramon further teaches using a robot connected to the tool to insert the implant. Therefore, the combination of references disclose the limitation as presented. The applicant’s argument that the Amanatullah reference does not disclose comparing the shape of the determined resected bone to the virtual model to validate the resected bone is not persuasive. Paragraph 143 of the Amanatullah reference explicitly states “…the computer can extract a 3D contour of the exposed femoral condyle in the surgical field following resection by the surgeon and compare this 3D contour of the actual resected femoral condyle to the target resected contour of the femoral condyle defined in the virtual patient model to determine whether any portion of the target resected contour of the femoral condyle extends beyond (i.e., falls outside of) the actual resected surface of the femoral condyle…”. Therefore, the reference clearly teaches the limitation of comparing the shape of the determined resected bone to the virtual mode to validate the resected bone. The applicant’s argument that the examiner’s rejection is base on conclusory statements is not persuasive. As discussed in the applicant’s arguments, the examiner has provided recitations from the references to support the examiner’s rejection. Therefore, the examiner’s rejection is not base on conclusory statements.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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