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 January 28th, 2026 have been fully considered but they are not persuasive. Applicant argues that the prior art does not teach the newly amended features of the tensioner obtaining a tension measurement based on the provided tension to the medial and lateral collateral ligaments as well as the computing system using the measurement to determine a recommended implant design and size. The Examiner respectfully disagrees with this assertion. Chi discloses in [0167] that the tensioner (4240) performs joint gap balancing and that it can be desirable to have different ligaments tensions in the medial and lateral compartments. The tension(s) being applied by the medial and lateral ligaments and can be customized to the user’s individual needs. The measurements can be collected intraoperatively to determine the implant brand, size and position see [0170]. As a result, Applicant’s arguments and remarks are not found persuasive to overcome the prior art and rejections of record.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 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).
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 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 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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chi (US 2021/0137613).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chi (US 2021/0137613) in further view of Otto et al. (US 2021/0059656).
Regarding claim 9, Chi 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619