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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 7th, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-10have been considered but moot in light of the new ground of rejection necessitated by the amendment filed May 7th, 2026.
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.
Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chi (US 2021/0137613).
Regarding claim 1, Chi discloses a system for knee replacement surgery, comprising a sensor (4205, figure 42A) configured to measure a distance of a gap in a knee joint during a knee replacement procedure (¶163); a tensioner (4240) configured to provide tension to the medial and lateral collateral ligaments based on the distance measurement obtained from the sensor (¶164-166) and a tension measurement based on the provided tension to the medial and lateral collateral ligaments (¶167); a computing system (4407, figure 44) displaying real-time data (¶170) from the sensor on a display (4408) in communication with the computing system (¶170); and a robotic surgical device (4401) configured to shape a distal end of a femur based on the gap information and on a patient-specific knee instrument mated to the femur to provide an initial position and orientation of a knee implant (¶170); wherein the computing system determines a recommended implant design and an implant size based on dynamic knee measurements received from the sensor and the tensioner tension measurement during the knee replacement procedure (¶170-171). Chi fails to expressly each or disclose their system comprises a load cell embedded in a patella implant; the load cell measuring a load or gap for balancing of the patella implant in the knee joint. The load cell measurements are used during the knee replacement procedure.
Hershberger et al. disclose a system for knee replacement surgery (figures 1-32) the system having a load cell (240) embedded in a patella implant (85, figures 1-2, 23, 27); the load cell measuring a load or gap for balancing the patella implant in the knee joint (column 10, line 55 – column 11, line 4). A computing system (“computer” column 10, line 61) to determine proper alignment or deviation from alignment of the implant components (column 10, line 55 – column 11, line 12) as this data is used to assist with aligning the new joint line of the knee implant to the same position as the original joint line of the natural knee joint (column 11, lines 1-4). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of fling to have constructed the system for knee replacement surgery of Chi to include a load cell embedded in a patella implant; the load cell measuring a load or gap for balancing of the patella implant in the knee joint as taught by Hershberger et al. as this data is used to assist with aligning the new joint line of the knee implant to the same position as the original joint line of the natural knee joint (column 11, lines 1-4).
Regarding claim 2, Chi discloses the sensor comprises at least one of a force sensor, an ultrasonic sensor, a pressure sensor, or an optical sensor (“force sensor” ¶166, ¶168).
Regarding claim 3, Chi discloses the tensioner comprises a manual spreader (4220, figure 22B it is manual as the user has to manually activate the system, it is not autonomous). Regarding claim 4, Chi discloses the tensioner device comprises a spring- loaded spreader (4107, figure 41, ¶162-163).
Regarding claim 5, Chi discloses the tensioner comprises a motorized linear actuator (¶4220, ¶167).
Regarding claim 6, Chi discloses the sensor measures an extension gap (¶160-161, figure 39) and a flexion gap (¶162, figure 41) of the knee joint during the knee replacement procedure, wherein the extension gap is measured at a zero degrees orientation of the knee joint (¶160-161) and the flexion gap is measured at a 90 degree orientation of the knee joint (¶162). Regarding claim 7, Chi discloses the claimed invention, including measurement of the gaps through a range of motion (¶63, ¶75, ¶160, ¶162, ¶166-168) but fails to expressly teach or disclose the range of motion of the knee joint is from 0 degrees to more than 120 degrees of rotation and rather only teaches a range of 0 to 90 degrees (¶75, ¶160, ¶162, ¶166-168).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to the have the measured range of motion of the knee joint is from 0 degrees to more than 120 degrees of rotation and rather than the range of 0 to 90 degrees as taught by Chi, since it has been held that where the general conditions of a claim are disclosed in the prior art (dynamically measuring the knee joint through knee movement), discovering the optimum or workable ranges involves only routine skill in the art. Regarding claim 8, Chi discloses a communication interface (4405, figure 44) between the sensor and the computing system, wherein the communication interface is a wired or a wireless communication interface (¶170).
Regarding claim 10, Chi discloses the computer system displays a preoperative planning data simultaneously with a real-time measurement from the sensor (¶147, ¶170).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chi (US 2021/0137613) in view of Hershberger et al. (US 5,470,351) in further view of Otto et al. (US 2021/0059656).
Regarding claim 9, Chi in view of Hershberger et al. discloses the claimed invention except for the wireless communication interface is a Bluetooth connection, an RFID connection, or a Wi-Fi connection.
Otto et al. teaches the use of Wi-Fi or Bluetooth (¶67) as a form of wireless communication for the purpose of sending and receiving data from sensors to a computing system (¶67). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the communication interface of Chi to be Wi-Fi or Bluetooth wireless communication as taught by Otto et al. as it is a known form of wireless communication for the purpose of sending and receiving data from sensors to a computing system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited references on the PTO-892 which are listed but not relied upon are pertinent prior art directly specifically to the aspect of a load cell embedded into a patellar implant for the purpose of measuring meaningful data for the tracking and positioning of knee implants within a patient. Johanson et al. (US 2009/0005708) and Kovacevic et al. (US 5,425,775) teach similar structures with slightly different approaches to measuring tibial-patellar and femoral-patellar forces/values.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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