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 .
Election/Restrictions
Claims 16, 17, 20-27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 March 2026.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 3: “a” (between “generate” and “bone”) should be changed to --the--, or claim 12 should be amended in a manner similar to that of claim 14.
Appropriate correction is required.
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.
Claim(s) 1-2, 5-12, 14 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forstein, U.S. PG-Pub 2020/0030036 in view of Hladio et al., U.S. PG-Pub 2019/0336220 (previously cited in PTO-892 dated 04/22/2026).
Regarding claim 1, Forstein discloses a computer-assisted surgical system comprising: a bone preparation tool (30); and at least one computing device (104) in communication with the bone preparation tool (Fig. 5), the at least one computing device comprising: processing circuitry; and a memory coupled to the processing circuitry (paragraph [0042]), the memory comprising instruction that, when executed by the processing circuitry, cause the processing circuitry to receive operating information of the bone preparation tool (spindle speed, force, friction and temperature) with a portion of the patient bone (paragraph [0031]), and determine bone characteristic information (bone quality data and density) of the portion of the patient bone based on the operating information (paragraph [0034]); and generate a bone preparation plane via updating an existing bone preparation plane (intra-operative changes) based on the bone characteristic information (paragraphs [0042] and [0045]); wherein the bone characteristic information comprises bone hardness (paragraph [0038]).
Forstein does not disclose generating the bone preparation plane comprising updating an implant type, an implant size, an implant position, and/or an implant orientation.
Hladio et al. discloses a computer assisted surgical system that updates a generated preparation plan for implant trajectory (i.e. orientation) and position for optimized placement of the implant (paragraph [0035]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the generated bone preparation plan of Forstein to update implant position and orientation in view of Hladio et al. to permit optimized placement of the implant within a patient.
Regarding claims 2 and 5, Forstein discloses wherein the bone preparation tool (30) comprises a cutting tool (32) (Fig. 5 and paragraph [0040]); and wherein the operating information comprises resistance (via force sensing) and rotation speed (spindle speed) (paragraph [0031]).
Regarding claims 6-8, Forstein discloses the memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to: access an interference-fit (press-fit due to undersized cavity) for a cementless implant component for the portion of the patient bone, and determine at least one implant component property of the cementless implant based on the bone characteristic information and the interference-fit value; the at least one implant component property comprising a size of the cementless implant (implant being larger than the cavity); and the at least one implant component property comprising a shape of the implant (paragraphs [0005], [0027], [0033]).
Regarding claims 9-11, Forstein discloses the memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to: access an interference-fit value for a cementless implant component for the portion of the patient bone, and generate an offset value based on the bone characteristic information, the offset value comprising an adjustment of the interference-fit value (via cavity size adjustment) (paragraph [0033]); wherein the bone characteristic information comprises a hardness value for each of a plurality of different regions of the portion of the patient bone; and the memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to generate an interference-fit value map to visually represent interference-fit values and corresponding offsets for the plurality of different regions of the portion of the patient bone (paragraphs [0033] and [0042]).
Regarding claims 12 and 14, Forstein discloses the memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to generate the bone preparation plane for a cementless implant component base, at least in part, on the bone characteristic information (paragraph [0005]), and wherein generating the bone preparation plan comprises updating the existing bone preparation plan with a modified interference-fit value (via cavity adjustments) (paragraph [0033]).
Regarding claim 61, Forstein as modified in view of Hladio et al. satisfies the claim due to claim 61 further defining the “implant type” of claim 1, wherein the “implant type” is used as an alternative choice or four options, due to the use of “or”, i.e. claim 1 recites “generating the bone preparation plan comprises updating an implant type, an implant size, an implant position, and/or an implant orientation.”
Response to Arguments
Applicant’s arguments, see Remarks, filed 15 June 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) and 102(a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made to Forstein, U.S. PG-Pub 2020/0030036 in view of Hladio et al., U.S. PG-Pub 2019/0336220.
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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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