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 .
Response to Amendment
This Office action is responsive to Applicant’s AMENDMENT AND RESPONSE, filed December 15, 2025. Claims 12-19 are pending.
Response to Arguments
In view of Applicant’s amendment to the abstract (AMENDMENT, page 2), the objection to the abstract as set forth in the prior Office action dated October 22, 2025, pages 2-3, is withdrawn.
In view of Applicant’s cancellation of claims 1-11 and 20-22, the claim interpretation under 35 U.S.C. 112(f) (pre-AIA sixth paragraph), as well as the rejections of claims 1-11 and 20-22 under 35 U.S.C. 112(a) and 112(b) (pre-AIA first and second paragraphs, respectively), as set forth in the prior Office action, pages 3-10, are withdrawn.
The indicated allowability of claims 12-19 as set forth in the prior Office action, pages 10-11, is withdrawn in view of newly discovered prior art. Because the claim rejections below were not necessitated by Applicant’s amendment, the rejections are non-final.
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.
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 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication US 2021/0322148 A1 (hereinafter “Mitra”) in view of U.S. Patent Application Publication US 2007/0123902 A1 (hereinafter “Berberich”).
Regarding claim 12, Mitra discloses a positioning method for posteromedial structure, posterolateral structure and medial patellofemoral ligament reconstruction (present disclosure relates to methods and systems of planning and preparing a joint for a ligament reconstruction surgery and performing aspects of such a surgery paragraph [0002])), comprising:
- S1: establishing any one or more of a femoral coordinate system, a tibial coordinate system and a patellar coordinate system (tracking system 620 can be calibrated to provide a localized 3-D coordinate system within which a transplant host 601 and one or more surgical tools can be spatially tracked (paragraph [0182]));
- S2: selecting femoral feature points, tibial feature points, fibular feature points or patellar feature points by means of a probe under an arthroscope (a plurality of landmarks on a patient’s anatomy may be located using a point probe and a tracking system; mechanical axis of the tibia may be defined by capturing a location of the malleoli, which defines the ankle center, and the center of the knee on the tibia using a point probe; mechanical axis of the patient’s femur may be defined by rotating the patient’s hip joint to identify the hip center and using the point probe to record the center of the knee on the femur (paragraph [0185]));
- S3: determining a femoral point, a tibial point, a fibular point or a patellar point during reconstruction according to a preset reconstruction algorithm on the basis of the femoral feature points, the tibial feature points, the fibular feature points or the patellar feature points (as the point probe is in contact with the bony surface, the surgical navigation system detects a tracking array associated with the point probe and determines the location of the tip in reference to the tracking array (paragraph [0188]); locations of other areas of the femur may also be determined, such as a portion of the lateral metaphyseal bone in an area at which the ACL graft will exit; further location information pertaining to the tibia may be identified, such as the native ligament footprint, the planned entry point or exit point of the tunnel in the tibia, and/or the posterior metaphysis where the graft will be inserted (paragraph [0189]).
Mitra does not expressly disclose further determining a specific channel position of a posteromedial structure, posterolateral structure or medial patellofemoral ligament reconstruction channel by means of the femoral point, the tibial point, the fibular point or the patellar point.
Berberich discloses a device for a correctly targeted formation of a drill bore centrally in a femoral attachment site of a posterior cruciate ligament of a knee joint. Berberich states that the position and course of a femoral drill channel determines whether a reconstructed posterior cruciate ligament is anchored on the femur in the same way anatomically as in the natural posterior cruciate ligament and whether it protrudes from the femur in the same way anatomically as in the natural posterior cruciate ligament; and that the formation of a drill hole is correctly targeted if the drill channel formed is located with such precision that the replacement cruciate ligament protrudes from the femur in anatomically the same way as the natural posterior cruciate ligament (paragraph [0016]). Berberich recognized that in all cruciate ligament reconstructions, the placement of the drill channels is a critical step in the operation (paragraph [0015]). Therefore, it would have been obvious for one of ordinary skill in the art, at the time of Applicant’s invention, to have modified the teaching of Mitra by determining specific channel positions of a posteromedial structure, posterolateral structure or medial patellofemoral ligament reconstruction channel by means of the femoral point, the tibial point, the fibular point or the patellar point, such as taught by Berberich.
Regarding claim 14, Mitra discloses wherein the preset reconstruction algorithm comprises one or more of algorithms as follows: a posteromedial structure reconstruction algorithm; a posterolateral structure reconstruction algorithm; a medial patellofemoral ligament reconstruction algorithm (Fig. 8 depicts an illustrative flow diagram of an exemplary method of performing a surgical procedure (paragraph [0183]), particularly ACL reconstruction (paragraph [0185])). In view of Berberich (see rejection of claim 12 above), the algorithms may be modified to include location of a specific channel position, because the placement of drill channels is a crucial step in the operation (Berberich: paragraph [0015]).
Allowable Subject Matter
Claims 13 and 15-19 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 13, the cited prior art fails to disclose or suggest Applicant’s positioning method according to claim 12, where the step S1 of establishing any one or more of a femoral coordinate system, a tibial coordinate system and a patellar coordinate system specifically comprises:
S11: fixing an optical femoral marker at a femur, fixing an optical tibial marker at a tibia, or fixing an optical patellar marker at a patella, SO as to track a position of the femur, a position of the tibia or a position of the patella in real time by an optical tracker;
S12: obtaining a femoral position data set of the optical femoral marker under the optical tracker, and computing a hip midpoint by fitting the femoral position data set;
S13: obtaining a tibial position data set of the optical tibial marker under the optical tracker, fitting the tibial position data set to obtain a plane, taking a normal line of the plane as a flexion- extension axis of the tibia, and taking the flexion-extension axis as a femoral x-axis of the femoral coordinate system and a tibial x-axis of the tibial coordinate system;
S14: obtaining position information of a knee midpoint and an ankle midpoint, taking a connecting line between the knee midpoint and the hip midpoint as a femoral y-axis of the femoral coordinate system, establishing a femoral z-axis by means of a cross product of the femoral x-axis and the femoral y-axis, and taking the knee midpoint as an origin of the femoral coordinate system, such that the femoral coordinate system is established; taking a connecting line between the knee midpoint and the ankle midpoint as a tibial y-axis of the tibial coordinate system, establishing a tibial z-axis by means of a cross product of the tibial x-axis and the tibial y-axis, and taking the knee midpoint as an origin of the tibial coordinate system, such that the tibial coordinate system is established; and taking a connecting line between a superior patellar pole and an inferior patellar pole as a patellar x-axis of the patellar coordinate system, taking a connecting line between a patellar widest portion medial point and a patellar widest portion lateral point as a patellar y-axis of the patellar coordinate system, establishing a patellar z-axis by means of a cross product of the patellar x-axis and the patellar y-axis, and taking a point where the two connecting lines intersect as an origin of the patellar coordinate system, such that the patellar coordinate system is established.
Regarding claim 15, the cited prior art fails to disclose or suggest Applicant’s positioning method according to claim 14, wherein the posteromedial structure reconstruction algorithm specifically comprises:
- determining the femoral point for posteromedial structure reconstruction, which specifically comprises: using a method of moving a medial epicondyle top point on the femur by a first preset distance in a positive direction of a y-axis and a second preset distance in a negative direction of a z-axis of the femoral coordinate system as a double-tunnel femoral point selection method, using a method of moving the medial epicondyle top point on the femur by preset distances in a positive direction of a y-axis and in a negative direction of a z-axis of the femoral coordinate system as a single-tunnel femoral point selection method, or determining the femoral point comprising an adductor tubercle proximal side and a femoral medial central established proximal side;
- determining the tibial point for posteromedial structure reconstruction, which specifically comprises: moving a posteromedial tibial plateau inferior portion by a preset distance in a negative direction of a y-axis of the tibial coordinate system to point to a tibial anterolateral side, and moving a Gerdy tubercle distal portion and a posterior medial crest constriction point anterior side by preset distances in a negative direction of a z-axis of the tibial coordinate system to point to a tibial lateral surface or a medial crest superior portion and a constriction point.
Claim 16 depends from claim 15.
Regarding claim 17, the cited prior art fails to disclose or suggest Applicant’s positioning method according to claim 14, wherein the posterolateral structure reconstruction algorithm specifically comprises:
- determining the fibular point for posterolateral structure reconstruction, which specifically comprises: an anterolateral styloid process and a posteromedial edge;
- determining the tibial point for posterolateral structure reconstruction, which specifically comprises: moving a Gerdy tubercle inferior portion by a preset distance in a negative direction of a y-axis of the tibial coordinate system to point to a right posterior portion;
- determining the femoral point for posterolateral structure reconstruction, which specifically comprises: using a method of moving a distal posterior side of a lateral epicondyle top point on the femur by preset distances in a negative direction of a y-axis and in a negative direction of a Z- axis of the femoral coordinate system as a single-tunnel femoral point selection method; or using a method of moving the lateral epicondyle top point on the femur by a first preset distance towards a posterior side in a negative direction of a y-axis and a second preset distance towards a distal side in a negative direction of the z-axis of the femoral coordinate system as a double- tunnel femoral point selection method.
Claim 18 depends from claim 17.
Regarding claim 19, the cited prior art fails to disclose or suggest Applicant’s positioning method according to claim 14, wherein the medial patellofemoral ligament reconstruction algorithm specifically comprises:
- determining the femoral point for patellofemoral ligament reconstruction, which specifically is an incenter of a triangle delimited by means of a medial epicondyle top point, an adductor tubercle and a gastrocnemius tubercle as the femoral point;
- determining the patellar point for patellofemoral ligament reconstruction, which specifically comprises: moving a superior patellar pole inferior portion by a preset distance in a positive direction of a patellar x-axis to set a start point for patellofemoral ligament single-tunnel reconstruction, wherein the preset distance is one third of a distance between a superior patellar pole and an inferior patellar pole; and making, by passing through an origin of the patellar coordinate system, a perpendicular line of a plane parallel to the patellar x-axis and a patellar y- axis where a point at a patellar surface midline is located, and setting a point where the perpendicular line intersects the plane as an end point for patellofemoral ligament single tunnel reconstruction;
- determining the medial patellofemoral ligament reconstruction tunnel, which specifically comprises: determining a medial patellofemoral ligament single-tunnel reconstruction channel by means of the start point and the end point for patellofemoral ligament single-tunnel reconstruction; or translating the medial patellofemoral ligament single-tunnel reconstruction channel by preset distances in a positive direction and a negative direction of a patellar x-axis to determine a medial patellofemoral ligament double-tunnel reconstruction channel.
Conclusion
As set forth above, because the new claim rejections were not necessitated by Applicant’s amendment, the rejections are non-final.
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/THOMAS D LEE/Primary Examiner, Art Unit 2683