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 Arguments
Applicant's arguments filed 01/20/26 have been fully considered but they are not persuasive.
On pages 8-10 Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-6, 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon et al. (WO 2013013170 A1) hereinafter known as McKinnon in view of "Surgical Treatment of Isolated Patellofemoral Osteoarthritis". Roland Becker et al. Clin Orthop Relat Res (2008) 466:433-499, hereinafter known as Becker.
Regarding claim 1 McKinnon discloses a computer-implemented method of planning a replacement procedure (Abstract) for a patella of a knee of a patient ([0036] the method can include replacing a patella with any of the described implants), the method comprising:
receiving input comprising knee imaging data and generating a 3d model of at least a portion of the knee of the patient based on the input, the 3d model comprising a patella model ([0012]);
characterizing a morphology of the patella based on the model ([0043]),
selecting an implant parameter based on the model or morphology ([0044] implant size);
performing a biomechanical simulation based on the implant parameter ([0043]-[0044], [0039]);
optimizing a position and orientation of the implant based on the simulation ([0038]-[0039], [0041]); and
outputting patient-specific planning information related to the position and orientation as optimized ([0038]-[0039], [0041], [0044], [0047], [0050]) to an external computing device or computer-readable storage device ([0081], [0079], [0039]),
but is silent with regards to characterizing the morphology of the patella by classifying a shape of the patella based on the medial and lateral facets thereof.
However, regarding claim 1 Becker teaches a Wiberg classification of a patella can be assigned preoperatively (page 445, Column 1 paragraphs 3-4), which is understood to characterize the morphology of the patella based on the medial and lateral facet dimensions (see Applicant’s specification [0200]). McKinnon and Becker are involved in the same field of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of McKinnon to classify the patella as is taught by Becker since this is a known mechanism to determine the shape and morphology of a patella which can help a surgeon identify the ultimate shape and surgery techniques which will be successful in a replacement surgery.
Regarding claims 2 and 17 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses identifying an anatomical landmark on the model and characterizing the morphology is based on the landmark ([0043]), and
selecting the implant parameter is based on the landmark ([0044]).
Regarding claim 3 the McKinnon Becker Combination teaches the method of claim 2 substantially as is claimed,
wherein McKinnon further discloses the landmark comprises a perimeter point ([0067]).
Regarding claim 5 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the imaging data comprises MRI data ([0012]).
Regarding claim 6 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the model further comprises a femur or tibia model ([0044]).
Regarding claim 9 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses verifying the implant parameter ([0044] size) by generating a virtual resection plane on the 3d model based on the virtual resection plane ([0018], [0059]) and resecting the 3d model according to the virtual resection plane and the implant fit ([0011]),
wherein Becker further teaches characterizing the morphology of the patella includes assigning a Wiberg classification to the patella (page 445, Column 1 paragraphs 3-4).
Regarding claim 10 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the implant parameters comprise an implant size ([0044]).
Regarding claim 11 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the simulation comprises biomechanical information associated with one or more poses of the knee through a range of motion thereof ([0047]).
Regarding claim 12 the McKinnon Becker Combination teaches the method of claim 11 substantially as is claimed,
wherein McKinnon further discloses the biomechanical information comprises a ligament strain ([0047] ligament tension), and
the biomechanical information is associated with a medial or lateral collateral ligament ([0040]).
Regarding claims 13-15 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the patient-specific planning information comprises a pre-operative surgical plan ([0050]) comprising a 3d model of a patient-specific surgical instrument ([0050]) or an intra-operative surgical plan comprising a planned resection plane for the patella ([0018]).
Regarding claim 16 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses a system for performing the method including a processor ([0017]).
Claim 4, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon and Becker as is applied above, further in view of Mahfouz (WO 2010099359 A1).
Regarding claim 4 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the input comprises demographic information including ancestry data for the patient.
However, regarding claim 4 Mahfouz teaches a method which includes utilizing ancestry data for a patient ([0139]). McKinnon and Mahfouz are involved in the same filed of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination by utilizing ancestry data for the input as is taught by Mahfouz since it has been established that ancestry data significantly influences the anatomical characteristics of a patient’s knee, and taking it into account can create a better fit custom prosthesis.
Regarding claim 18 the McKinnon Becker Combination teaches the method of claim 16 substantially as is claimed,
wherein McKinnon further discloses the imaging data comprises MRI data ([0012]),
but is silent with regards to the input comprises demographic information including ancestry data for the patient.
However, regarding claim 18 Mahfouz teaches a method which includes utilizing ancestry data for a patient ([0139]). McKinnon and Mahfouz are involved in the same filed of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination by utilizing ancestry data for the input as is taught by Mahfouz since it has been established that ancestry data significantly influences the anatomical characteristics of a patient’s knee, and taking it into account can create a better fit custom prosthesis.
Claims 7, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon and Becker as is applied above, further in view of "Total knee arthoplasty using trochlear groove as guide for position of femoral component in severe knee osteoarthritis". Huang et al. BMC Surgery (2016) 16:33, hereinafter known as Huang.
Regarding claim 7 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to assessing a trochlear groove alignment of a femur model.
However, regarding claim 7 Huang teaches assessing a trochlear groove alignment (page 6 column 2, paragraph 1). McKinnon and Huang are involved in the same field of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination so the surgeon assesses the trochlear groove alignment on the femur model, as is taught by Huang, since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the trochlear groove is known to be a mechanism to guide a position for a femoral component during arthoplasty.
Regarding claim 19 the McKinnon Becker Combination teaches the method of claim 16 substantially as is claimed,
wherein McKinnon further discloses the model further comprises a femur or tibia model ([0044]),
but is silent with regards to assessing a trochlear groove alignment of a femur model.
However, regarding claim 19 Huang teaches assessing a trochlear groove alignment (page 6 column 2, paragraph 1). McKinnon and Huang are involved in the same field of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination so the surgeon assesses the trochlear groove alignment on the femur model, as is taught by Huang, since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the trochlear groove is known to be a mechanism to guide a position for a femoral component during arthoplasty.
Regarding claim 20 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
wherein McKinnon further discloses the model further comprises a femur or tibia model ([0044]),
identifying an anatomical landmark on the model and characterizing the morphology is based on the landmark ([0043]), and
selecting the implant parameter is based on the landmark ([0044]).
and the biomechanical information is associated with a medial or lateral collateral ligament ([0040]);
but is silent with regards to assessing a trochlear groove alignment of a femur model.
However, regarding claim 20 Huang teaches assessing a trochlear groove alignment (page 6 column 2, paragraph 1). McKinnon and Huang are involved in the same field of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination so the surgeon assesses the trochlear groove alignment on the femur model, as is taught by Huang, since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the trochlear groove is known to be a mechanism to guide a position for a femoral component during arthoplasty.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon and Becker as is applied above, further in view of Otto et al. (US 20100076563 A1) hereinafter known as Otto.
Regarding claim 8 the McKinnon Becker Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to determining a quadriceps angle (q-angle) based on the femur and tibia model.
However, regarding claim 8 Otto teaches determining a q-angle based on a model of a femur and tibia ([0105], Figures 14a-c). McKinnon and Otto are involved in the same field of endeavor, namely knee replacement. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the McKinnon Becker Combination to determine a q-angle as is taught by Otto in order to ensure the best implant position for performance of the final implant ([0081]).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/03/26