DETAILED ACTION
This action is in response to applicant’s amendment received on January 14th, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the placement plan" in line 13. There is insufficient antecedent basis for this limitation in the claim.
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 18-20 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).
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 plan 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 plan, 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 place 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 plan. 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 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 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 place 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 plan 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.
Response to Arguments
Applicant's arguments filed January 14th, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the amendments and new limitations to the independent claim, which are discussed above in the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
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 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