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
Applicant’s election without traverse of the election/restriction in the reply filed on February 26, 2026 is acknowledged.
Applicant has elected Group II: Claims 13-19, drawn to a method of planning an implant placement in a patient.
Claims 1-12 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 26, 2026.
Claims 1-20 are presently pending in this application.
Drawings Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the method of planning an implant placement in a patient described in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method of planning an implant placement in a patient without significantly more. The claim(s) recite(s) “retrieving data at a plurality of positions of a tibia of the patient relative to a femur of the patient, the plurality of positions collectively representative of at least part of a range of motion of a knee of the patient, wherein the data at each of the plurality of positions includes: a medial contact location defined by a maximum convergence of a low point on a medial condyle of the femur and a first medial tibial articular surface of the tibia; and a lateral contact location defined by a maximum convergence of a low point on a lateral condyle of the femur and a first lateral tibial articular surface of the tibia; analyzing the data collected from the plurality of positions to determine a range of medial contact locations based on the at least part of the range of motion and a range of lateral contact locations based on the at least part of the range of motion; virtually selecting a virtual tibial implant with a second medial tibial articular surface and a second lateral tibial articular surface; and determining a planned implant position for the virtual tibial implant and a planned implant orientation for the virtual tibial implant by positioning and orienting the virtual tibial implant such that the range of medial contact locations are overlaid within the second medial tibial articular surface and the range of lateral contact locations are overlaid within the second lateral tibial articular surface”. This judicial exception is not integrated into a practical application because the claim(s) do not result in an implant/prosthesis as there is no transformation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because mere instructions to apply an exception using a generic computer cannot provide an inventive concept. The claim is not patent eligible.
Claims 14-16 are rejected on being dependent to a rejected base claim.
Examiner’s Note
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitson (US 2005/0054917) in view of Cole et al. (US 11,298,246), herein referred to as Cole.
Regarding claim 13, Kitson discloses a method of planning an implant placement in a patient (Abstract) comprising retrieving data (figure 1), analyzing the data collected (figure 1), virtually selecting a virtual tibial implant (e.g. template via geometrical constructs, S4) with a second medial tibial articular surface (figures 5(a) and 6(a)) and a second lateral tibial articular surface (figures 5(a) and 6(a)), and determining a planned implant position (figure 1, S5) for the virtual tibial implant (e.g. template via geometrical constructs) and a planned implant orientation (¶95) for the virtual tibial implant (e.g. template via geometrical constructs) by positioning and orienting the virtual tibial implant such that a medial contact location is overlaid within the second medial tibial articular surface (figures 5(a) and 6(a)) and a lateral contact location is overlaid within the second lateral tibial articular surface (figures 5(a) and 6(a)).
Yet, Kitson lacks a detailed description on retrieving data at a plurality of positions of a tibia of the patient relative to a femur of the patient, the plurality of positions collectively representative of at least part of a range of motion of a knee of the patient, wherein the data at each of the plurality of positions includes: a medial contact location defined by a maximum convergence of a low point on a medial condyle of the femur and a first medial tibial articular surface of the tibia, and a lateral contact location defined by a maximum convergence of a low point on a lateral condyle of the femur and a first lateral tibial articular surface of the tibia, analyzing the data collected from the plurality of positions to determine a range of medial contact locations based on the at least part of the range of motion and a range of lateral contact locations based on the at least part of the range of motion.
However, Cole teaches retrieving data at a plurality of positions (e.g. range of motion, col. 13, ll. 19-30) of a tibia (element “T”) of the patient relative to a femur (element “F”) of the patient, the plurality of positions collectively representative of at least part of a range of motion of a knee of the patient (col. 13, ll. 19-30), wherein the data at each of the plurality of positions includes a medial contact location (figures 59-61) defined by a maximum convergence of a low point on a medial condyle of the femur (element “F”) and a first medial tibial articular surface of the tibia (element “T”), and a lateral contact location (figures 59-61) defined by a maximum convergence of a low point on a lateral condyle of the femur (element “F”) and a first lateral tibial articular surface of the tibia (element “T”), analyzing the data collected from the plurality of positions (e.g. range of motion, col. 13, ll. 19-30) to determine a range of medial contact locations based on the at least part of the range of motion (col. 13, ll. 19-30) and a range of lateral contact locations based on the at least part of the range of motion (col. 13, ll. 19-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Kitson’s method with retrieving data at a plurality of positions of a tibia of the patient relative to a femur of the patient, the plurality of positions collectively representative of at least part of a range of motion of a knee of the patient, wherein the data at each of the plurality of positions includes: a medial contact location defined by a maximum convergence of a low point on a medial condyle of the femur and a first medial tibial articular surface of the tibia, and a lateral contact location defined by a maximum convergence of a low point on a lateral condyle of the femur and a first lateral tibial articular surface of the tibia, analyzing the data collected from the plurality of positions to determine a range of medial contact locations based on the at least part of the range of motion and a range of lateral contact locations based on the at least part of the range of motion as taught by Cole, since such a modification would provide the user with multiple data points for evaluating a human knee joint (Abstract).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitson and Cole as applied to claim 13 above, and further in view of Heggendorn et al. (US 9,662,217), herein referred to as Heggendorn.
Regarding claim 14, the modified Kitson’s method discloses all the features/elements as claimed but lacks a detailed description on wherein the range of lateral contact locations collectively defines a first lengthwise sequence in a transverse plane and the range of medial contact locations collectively defines a second lengthwise sequence in a transverse plane, the first and second lengthwise sequences together defining a pivot point on one of the range of lateral contact locations, the range of medial contact locations and an intercondylar eminence, the implant position being determined in part by the virtual tibial implant being positioned so that an anatomical feature on the virtual tibial implant that corresponds to an anatomical feature at the pivot point is aligned with the anatomical feature at the pivot point.
However, Heggendorn teaches wherein a range of lateral contact locations collectively defines a first lengthwise sequence in a transverse plane (figure 2C) and the range of medial contact locations collectively defines a second lengthwise sequence in a transverse plane (figure 2C), the first and second lengthwise sequences together defining a pivot point (Abstract) on one of the range of lateral contact locations (figure 2C), the range of medial contact locations (figure 2C) and an intercondylar eminence (152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Kitson’s method with wherein the range of lateral contact locations collectively defines a first lengthwise sequence in a transverse plane and the range of medial contact locations collectively defines a second lengthwise sequence in a transverse plane, the first and second lengthwise sequences together defining a pivot point on one of the range of lateral contact locations, the range of medial contact locations and an intercondylar eminence as taught by Heggendorn, since such a modification would obtain information regarding the range of motion of the knee joint.
Thus, the modified Kitson’s method has the implant position being determined in part by the virtual tibial implant (e.g. template via geometrical constructs of Kitson) being positioned so that an anatomical feature on the virtual tibial implant that corresponds to an anatomical feature at the pivot point (figure 2C of Heggendorn) is aligned with the anatomical feature at the pivot point (figure 2C of Heggendorn).
Regarding claim 15, the modified Kitson’s method has wherein determining the planned implant position of the virtual tibial implant involves centering a medial sulcus point of a medial articular surface (figure 2C of Heggendorn) of the virtual tibial implant (e.g. template via geometrical constructs of Kitson) on the pivot point (figure 2C of Heggendorn), the pivot point being on the range of medial contact locations (figure 2C of Heggendorn).
Regarding claim 16, the modified Kitson’s method has wherein determining the planned implant orientation of the virtual tibial implant involves rotating the virtual tibial implant about the pivot point (figure 2C of Heggendorn) such that the range of lateral contact locations are overlaid within the second lateral tibial articular surface ((figures 5(a) and 6(a) of Kitson) and the range of medial contact locations are overlaid within the second medial tibial articular surface (figures 5(a) and 6(a) of Kitson).
Regarding claim 17, Kitson discloses a method of implanting a total knee prosthesis (Abstract) comprising the method of planning according to claim 13 (see claim 13 above), resecting the tibia (element “T”) to define a resected tibial surface (¶138, ¶139) and placing a tibial implant corresponding to the virtual tibial implant (e.g. template via geometrical constructs) on the resected tibial surface (¶138, ¶139) according to the planned implant position and the planned implant orientation (¶138, ¶139 and figure 1).
Allowable Subject Matter
Claims 18 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SI MING KU whose telephone number is (571)270-5450. The examiner can normally be reached Monday-Friday, 9:30am-6pm.
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/SI MING KU/Primary Examiner, Art Unit 3775
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