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 Species A in the reply filed on 15 July 2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 July 2026.
Priority
The priority date is 01 February 2024.
Claim Objections
Claims 1-12 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 12: “the respective flexion and extension motion;”
Claim 4 / line 2: “during flexion and extension motion”
Claim 4 / lines 3-4: “the respective flexion and extension motion”
Claim 10 / line 3: “the resected patella [[or]] and the patellar trial.”
Claim 11 / line 3: “the resected patella [[or]] and the patellar trial.”
Claim 12 / line 1: “the step of positioning [[a]] the first marker”
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.
Claims 1-5 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 11,510,737 to Perez et al. (hereinafter, “Perez”).
As to claim 1, Perez discloses a method for patellofemoral joint balancing comprising:
positioning a first marker on an unresected patella (col. 2 / line 61 – col. 3 / line 10; col. 5 / lines 9-20);
tracking the first marker during flexion and extension motion of a knee to track translation and rotation of the unresected patella during the flexion and extension motion (col. 2 / line 61 – col. 3 / line 10; col. 5 / lines 48-52; col. 7 / lines 22-39; col. 8 / lines 19-30);
generating a first patellofemoral joint profile (path representing the patellar range of motion) from the translation and rotation of the unresected patella (col. 3 / lines 21-28);
resecting the patella based on the first patellofemoral joint profile (col. 6 / lines 14-20);
selecting and placing a patellar trial on the resected patella based on the first patellofemoral joint profile (col. 7 / lines 44-45);
tracking the first marker on the patellar trial or the resected patella during flexion and extension motion of the knee to track translation and rotation of the resected patella and the patellar trial during the flexion and extension motion (col. 2 / lines 29-37; col. 3 / lines 11-20; col. 6 / lines 21-34; col. 8 / lines 19-30);
generating a second patellofemoral joint profile (second path representing the patellar range of motion) from the translation and rotation of the resected patella and the patellar trial (col. 6 / lines 21-34), and
selecting a patellar implant based on comparing the first and second patellofemoral joint profiles (col. 6 / line 21 – col. 7 / line 64).
As to claim 2, Perez discloses the method of claim 1, further including a step of selecting and placing a second patellar trial if a difference between the first and second patellofemoral joint profiles exceeds a predetermined threshold (col. 6 / line 21 – col. 7 / line 21; col. 7 / lines 52-59).
As to claim 3, Perez discloses the method of claim 1, wherein the step of selecting the patellar implant includes selecting a patellar implant that is similar to the patellar trial if a difference between the first and second patellofemoral joint profiles is within a predetermined threshold (col. 6 / line 21 – col. 7 / line 64).
As to claim 4, Perez discloses the method of claim 1, further including a step of tracking a marker on the patellar implant or the resected patella during flexion and extension of the knee to track translation and rotation of the resected patella and the patellar implant during the flexion and extension motion and generating a third patellofemoral joint profile from the translation and rotation of the resected patella and the patellar implant (col. 7 / lines 40-64; if the first trial and its second patellofemoral joint profile are determined, in comparison to the first patellofemoral joint profile, to be outside a predetermined threshold, a different trial is attached to the resected patella and the marker attached to the resected patella is tracked during flexion and extension of the knee to track translation and rotation of the resected patella and the different trial, thus generating a third patellofemoral joint profile or path that is compared to the first patellofemoral joint profile or path for suitability; if this different trial is determined as suitable, then a corresponding implant is chosen, and therefore the tracked translation and rotation of the resected patella and the different trial would correspond to the translation and rotation of the resected patella and the corresponding implant, and the third patellofemoral joint profile from the translation and rotation of the resected patella and the different trial would correspond to the third patellofemoral joint profile from the translation and rotation of the resected patella and the corresponding implant).
As to claim 5, Perez discloses the method of claim 4, further including a step of comparing the first and third patellofemoral joint profiles (col. 7 / lines 54-59).
As to claim 8, Perez discloses the method of claim 1, wherein the step of tracking the first marker includes tracking anterior-posterior translation, medial-lateral translation, and super-inferior translation of the unresected patella (as components of six degrees of freedom; col. 8 / lines 19-30).
As to claim 9, Perez discloses the method of claim 8, wherein the step of tracking the first marker includes tracking medial rotation, lateral rotation, superior rotation, inferior rotation and axial rotation of the unresected patella (as components of six degrees of freedom; col. 8 / lines 19-30).
As to claim 10, Perez discloses the method of claim 1, wherein the step of tracking the marker on the patellar trial or the resected patella includes tracking anterior-posterior translation, medial-lateral translation, and super-inferior translation of the resected patella or the patellar trial (as components of six degrees of freedom; col. 8 / lines 19-30).
As to claim 11, Perez discloses the method of claim 10, wherein the step of tracking the marker on the patellar trial or the resected patella includes tracking medial rotation, lateral rotation, superior rotation, inferior rotation and axial rotation of the resected patella or the patellar trial (as components of six degrees of freedom; col. 8 / lines 19-30).
Perez is silent as to a second marker on the patellar trial or the resected patella.
Perez does disclose tracking a marker on the patellar trial or the resected patella (col. 6 / lines 21-34). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a second marker on the patellar trial or the resected patella since the mere duplication of the essential working parts of a device involves only routine skill in the art, and so that there is no concern that the first marker is damaged during patella resection or during replacement of the first marker on the patellar trial or the resected patella. If the first marker is simply removed before resecting the patella, with the second marker then provided on the patellar trial or the resected patella, the location of the first marker on the unresected patella need not account for the location of the resection, therefore simplifying its placement. The tracking system/camera as disclosed in Perez would register the second tracker in the same field of registration for accurate comparison of the different joint profiles. The step of tracking the marker on the patellar trial or the resected patella would thus comprise tracking the second marker in the claimed translations and rotations of the six degrees of freedom.
Assuming arguendo, Perez is silent as to further including a step of tracking a third marker on the patellar implant or the resected patella during flexion and extension of the knee to track translation and rotation of the resected patella and the patellar implant during the flexion and extension motion and generating a third patellofemoral joint profile from the translation and rotation of the resected patella and the patellar implant (claim 4); further including a step of comparing the first and third patellofemoral joint profiles (claim 5).
Perez does disclose testing the implant to ensure proper kinematics of the implant (col. 7 / lines 62-64).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to subject the implanted implant to the same tracking in flexion and extension as the unresected patella and the trial/resected patella, to achieve the kinematic testing of the implant as required by Perez, and to ensure that the selected implant is suitable before completion of the surgery. As disclosed by Perez, the resected patella is tracked during flexion and extension of the knee to track translation and rotation of the resected patella and the component attached to it (the trial, or in this modification, the implant) during the flexion and extension motion and generating a patellofemoral joint profile from the translation and rotation of the resected patella and the component attached to it. In this modification, the patellofemoral joint profile would be the third patellofemoral joint profile of the translation and rotation of the resected patella and the patellar implant. This involves the mere duplication of a step of the process, which is within the ordinary skill in the art. The third patellofemoral joint profile would be compared to the first patellofemoral joint profile to confirm suitability of the implant and to make sure that the resected patella/implant have kinematics within the predetermined threshold to prevent patient pain or discomfort with the implant in place.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a third marker on the patellar implant or the resected patella for their tracking since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing a third marker reduces the time required to remove and replace the second marker, and would simplify placement of the second marker since it need not account for a location unaffected by removal of the trial and placement of the implant. The tracking system/camera as disclosed in Perez would register the third tracker in the same field of registration for accurate comparison of the different joint profiles.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of U.S. Patent Application Publication No. US 2021/0315640 to Dees, Jr. et al. (hereinafter, “Dees”).
Perez is silent as to further including a step of selecting and placing a second patellar implant if a difference between the first and third patellofemoral joint profiles exceeds a predetermined threshold.
Perez does disclose testing the implant to ensure proper kinematics of the implant (col. 7 / lines 62-64) which implies the possibility that the selected implant may have improper kinematics.
Dees teaches updating a surgical plan to include altering a selection of a surgical implant based on predicted post-surgery movement information (par. [0010]-[0011]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Perez a step of selecting and placing a second patellar implant if a difference between the first and third patellofemoral joint profiles exceeds a predetermined threshold, since Perez discloses testing the selected implant to ensure proper kinematics of the implant, which implies the possibility that the selected implant may have improper kinematics, in which case a second patellar implant of different size should be selected and placed for better suitability or closeness to the first patellofemoral joint profile, similarly to how Perez discloses when testing of a trial falls outside a predetermined threshold, a thinner or thicker trial can be selected and placed and then kinematically tested to compare to the first patellofemoral joint profile, with suitability determined when that comparison falls within a predetermined threshold. As taught by Dees, a surgical plan, including selection of a surgical implant, should be updated based on predicted post-surgery movement information, i.e. based on how the previously selected implant performs in kinematic testing, which predicts post-surgery suitability and comfort and proper gait for the patient. If the testing of the selected implant in Perez does not ensure proper kinematics, it would only be obvious to select and place a second more suitable implant, therefore updating the surgical plan as taught by Dees.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of U.S. Patent Application Publication No. US 2008/0108912 to Node-Langlois.
As to claim 7, Perez discloses placing a tracker on a femur as a reference to track patellar position during flexion-extension (col. 5 / lines 20-52) and contemplates placing a tracker on a tibia (col. 5 / lines 38-41), where the tracker on the femur/tibia is used to track the patella and thus tracks a position of the first and second markers which are on the patella; but is silent as to placing a first tracker on a femur and a second tracker on a tibia, the first and second trackers including detectors to detect a position of the first and second markers.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a tracker on each of the femur and the tibia (a first tracker on the femur and a second tracker on the tibia) so that both could be used to track the patella during flexion-extension, and thus track a position of the first and second markers which are on the patella, with more accuracy and relative to both bones on either side of the patella. This would account for discrepancies with respect to movement of one of the femur or tibia, and would provide a backup tracker in the event communication with one tracker is lost. The mere duplication of the essential working parts of a device (a tracker on an adjacent bone) involves only routine skill in the art.
Node-Langlois teaches trackers on a femur and a tibia comprise microsensors that provide tracking data to a sensor, the microsensors and sensor being EM field generators or receivers (par. [0026], [0027], [0031]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the trackers on the femur and tibia as microsensors that provide tracking data to a sensor, the microsensors and sensor being EM field generators or receivers (microsensors and sensor can be either generator or receiver, par. [0026]), as taught by Node-Langlois, since Perez contemplates that different types of trackers can be used (col. 5 / lines 17-20) and it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. The first and second trackers on the femur and the tibia, which are used to track the patella during flexion-extension, and thus track a position of the first and second markers which are on the unresected/resected patella, are now EM field generators or receivers (Node-Langlois allows for either) which detect magnetic field measurements to calculate position and orientation information of the microsensors and thus the bones. Therefore, the first and second trackers are detectors and, as part of the whole system, are used to detect a position of the patella/the first and second markers.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of U.S. Patent Application Publication No. US 2021/0379373 to Hincapie et al. (hereinafter, “Hincapie”).
Perez discloses wherein the step of positioning a first marker includes placing the first marker in contact with the unresected patella (col. 2 / lines 2-3 and 22-28; col. 5 / lines 10-11), but is silent as to wherein the step of positioning a first marker includes placing at least one magnet in contact with the unresected patella.
Hincapie teaches that an item to be tracked can include a magnet that can be detected from outside the body (par. [0023]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the first marker as a magnet, as taught by Hincapie, that can be detected from outside the body to track the patella. As required by Perez, the first marker, comprising the magnet, is placed in contact with the unresected patella to track translation and rotation of the unresected patella during the flexion-extension motion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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