DETAILED ACTION
This office action is responsive to the amendment filed March 30, 2026. By that amendment, claims 1 and 22 were amended; and claim 21 was canceled. Claims 1-18 and 22 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30, 2026, has been entered.
Response to Arguments
The outstanding objection to claim 21 is overcome in view of the amendments of March 30, 2026.
The outstanding rejection of claims 1-4, 6 and 7 under 35 USC 102(a)(1) in view of Amiot (US 8,449,551) and teaching reference to Jansen (WO 2004/030556), is overcome in view of the amendments of March 30, 2026. A new rejection is necessitated, as below.
The outstanding rejection of claims 5, 10, and 11 under 35 USC 103 in view of Amiot and Weinstein et al. (US 2020/0078100); and the rejection of claims 15-18 under 35 USC 103 in view of Amiot, Jansen and Williamson et al. (US 2024/0216083 A1) are overcome. However, new rejections are necessitated by the amendment.
Applicant's arguments, in combination with amendments, filed March 30, 2026, related to the rejection of claims 8, 12-14, 21, and 22, under 35 USC 103 in view of Amiot, teaching reference Jansen, and Zheng (US 2009/0054910) have been fully considered. The argument is considered persuasive, in part, in that it requires examiner to re-consider his rationale for combination, as will be noted in the rejection, below, but the combination of references is still considered sufficient to reject the claims.
The arguments at pp. 5-6 discuss the rejection of prior claim 21, now incorporated into claim 1. The arguments state that Zheng operates under a different technological paradigm due to additional use of fluoroscopic imaging. The argument states “Zheng does not track the implant via an optical non-radiographic tracking device and it does not calculate landmark locations using a virtual model in combination with optical non-radiographic tracking data.” The argument states that Zheng derives tool trajectory information from radiographic image analysis. “One cannot properly combine Zheng’s radiographic approach with Amiot’s optical tracking system to arrive at the claimed tool trajectory output without fundamentally altering the manner in which Zheng operates.”
While examiner generally agrees that Zheng is using the radiographic portion of the method to determine trajectories of the holes, Examiner is not persuaded that the combination is insufficient to continue to be relied upon to indicate obviousness of the claims.
Examiner wishes to comment, initially, that Amiot is the base reference in the rejection of record. In amended claim 1, Amiot is relied upon to teach every claimed element except the “outputting a tool trajectory” limitation in the final clause of the claim. Zheng is relied upon only to indicate obviousness of outputting tool trajectories on Amiot’s surgical tracking system. The specific elements of Amiot and Zheng now being relied upon are identified in the modified rejection, below. It is noted that Applicant has not argued that Amiot is missing any features in the remarks, and is nearly silent as to the Amiot reference.
While the rejection being made is different, examiner wishes to expand on his new rationale, and address relevant arguments since the same references are still in question.
Without arguing the ‘different technological paradigm’ statement, Examiner considers Zheng and Amiot to be similar in concept in many ways: both references aim to identify particular locations on femoral implants which are concealed from view when implanted; and both references aim to do so using visual tracking of a marker on the implant, at least in part (27/46 in Zheng, 12/13 in Amiot).
It is examiner’s position that it is not a far leap to move from identifying and outputting points on a femoral implant to a user through an interface in real time during a surgical procedure; to identifying points on the femoral implant, which points are actually entrances and exits to holes through the implant. Examiner further takes the position that in an implant with holes therethrough, the entrance/exit of the holes are ‘points of interest’ which it would have been obvious to identify when using a registration pointer to identify points on the implant.
In the rejection below, Examiner now proposes modifying the teachings of Amiot in view of Zheng to use the Amiot guidance system during implantation of an intramedullary nail configured as taught by Zheng. Examiner proposes use of Amiot’s registration pointer and system to identify entrance and exit locations to the holes as additional points to points P1-P4 in the Amiot reference; which points will be additional landmarks to those obtained in the Amiot method. Having those identified entrance/exit locations of the holes displayed to the user through the interface, Amiot will thereby present data representative of trajectories through the holes. This takes a suggestion by Zheng and applies it to the Amiot reference to provide additional information to a surgeon, namely, location of the holes during placement of the implant.
The rejection of record is maintained, as modified, below.
Examiner has reconsidered the teachings of the references and the requirements of the claims, and now indicates claim 9 as including allowable subject matter if rewritten to be an independent claim.
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(s) 1-4, 6-8, 12-14, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amiot et al. (US 8,449,551 B2) and Zheng et al. (US 2009/0054910 A1). Some dependent claims further rely upon a teaching reference to Jansen et al. (WO 2004/030556 A2), incorporated into the Amiot disclosure.
Regarding claims 1, 12 and 13, Amiot teaches a system for tracking a surgical implant relative to a bone in computer-assisted surgery, comprising:
a processing unit of controller 31 (col. 7, line 49); and
a non-transitory computer-readable memory (database 38, col. 7, line 49 – col. 8, line 2) communicatively coupled to the processing unit of 31 and comprising computer-readable program instructions executable by the processing unit for:
obtaining a virtual model of the surgical implant (database 38 and registration points P1-P4), the virtual model including at least one landmark of the surgical implant (registered points P1-P4 using a registration pointer at step 56-60; see 32 and 35), the at least one landmark being configured to be inside the bone and/or soft tissue as at step 62 (e.g. implanted) whereby the at least one landmark is concealed from view (when the implant is inside the bone, the landmarks are concealed from view);
tracking the surgical implant, via an optical non-radiographic tracking device only 32/10 (discussed at col. 7, lines 30-40), as the surgical implant is inserted into the bone and/or the soft tissue when the at least one landmark is concealed from view at step 62;
calculating a location of the at least one landmark P1-P4 relative to the bone using the virtual model of the surgical implant and tracking data, from the optical non-radiographic tracking device only, of the tracking of the surgical implant (col. 7, lines 40-47); and
outputting the location of the at least one landmark P1-P4 relative to the bone through operator interface 34 (col. 7, line 47) when the at least one landmark P1-P4 is inside the bone and/or soft tissue.
Amiot fails to teach the processing unit following instructions for outputting a tool trajectory for guiding a tool to the location of the at least one landmark relative to the bone.
Zheng teaches a system for identifying landmarks on an implant. The system includes an optical tracking element 27/46. The implant is a femoral intramedullary nail 1. The landmarks to be identified in Zheng are distal cross-pinning holes 3 and 4, such holes having entrances and exits. The system outputs on a user interface trajectories 8 capable of guiding a tool to locations of the landmarks.
It would have been obvious to one with ordinary skill in the art at the time of the invention to use the Amiot method to identify landmarks at holes 3 and 4 on the Zheng implant. One would have done so by replacing the Amiot femoral implant with the Zheng femoral nail; attaching the Amiot device 10 to the Zheng nail; and using the registration pointer of Amiot to identify entrance and exit locations of the holes 3 and 4 (in addition to identification of other reference points on the nail). Such would have permitted a user to monitor the location of the implant during a surgical procedure, as in Amiot, while providing the user with the additional information of the locations of additional landmarks on the nail via the user interface. It is examiner’s position that displaying an identifying an entrance location and an exit location of the holes 3 and 4 is sufficient to read on identifying and outputting a trajectory for guiding a tool to a location of the landmark (e.g. show the surgeon how to drive the tool through the hole).
Regarding claims 2-4, a correlation between the implant and bone is described as at Amiot col. 7, lines 30-35 and step 64. Reference is made to the Jansen teaching reference. The reference describes (abstract) that the proximity of the implant to the bone is determined by a CAS system. The system is taught moving the implant to a “desired implant position” (it is clear that to maintain the implant in the desired position, movement of the implant relative to the bone must be stopped). Display of the implant relative to the bone to the surgeon is seen at Jansen fig. 2 (line between 52 and Operator S). It is clear that landmarks P1-P4 may be at boundaries of the bone when positioned within the IM canal.
Regarding claim 6, Jansen teaches forming 3D bone models from preoperative CT images (p. 15, lines 16-24).
Regarding claim 7, the database 38 (Amiot) is taught storing “digital model[s] of implants”. It is clear that a “manufacturer file” would be one way to convey this information into the database.
Regarding claims 8 and 14, the limitations of claim 1 were suggested by the combination, above. Further, Zheng teaches use of a robot 42. [0028] The structure 42 in fig. 1 is considered to be a robotic arm. Guidance of 42 is ‘under control of the computer’ and as a function of position of the implant [0028].
It would have been obvious to include the robot 42 of Zheng into the Amiot system, controlled by the computer as taught by Amiot, and to perform the functions as taught by Zheng (e.g. drilling through an IM rod cross-pinning hole). One would have done so in order to reduce strain on the surgeon in that he will not have to manually manipulate a tool to perform the surgical step.
Regarding claim 22, the claim is considered to contain many of the same limitations as claim 1. Additionally, claim 22 now requires the implant be an intramedullary rod and the landmarks be holes through the IM rod, which is covered by the combination made in rejecting claim 1. For all the same reasons that claim 1 is rejected, claim 22 is also rejected.
Claim(s) 5, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amiot and Zheng and Weinstein et al. (US 2020/0078100 A1). Some claims further rely upon a teaching reference to Jansen, incorporated into the Amiot disclosure, as discussed above.
Regarding claims 5, 10 and 11, the combination suggests the limitations of claim 4, as above. The combination further teaches use of displays to interact with a user, but no specific nature of the display is provided. However, it is fairly clear from the Jansen teaching that the display is intended as a computer peripheral (“e.g. mouse, display unit, keyboard, sound emitter” p. 29, lines 16-17).
Weinstein teaches use of a head-mounted display (HMD) 200 which “can visualize the same objects” as other displays, as well as other objects not on the other displays [0077]. The HMD can be a “mixed reality” device [0078]. The HMD is considered to be a face shield in that it shields at least a portion of the user’s face when worn (the device can take other forms [0079]). The HMD is associated with at least one camera for tracking the implant. [0078]
It would have been obvious to one with ordinary skill in the art at the time of the invention to use the HMD of Weinstein in place of a computer peripheral version of the user interface as suggested by the combination. One would have done so in order to provide the user of the device with a means to improve sterility of the surgical field and protect the surgeon by masking the surgeon with the HMD during the procedure.
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amiot and Zheng and Williamson et al. (US 2024/0216083 A1). Some claims further rely upon a teaching reference to Jansen, incorporated into the Amiot disclosure, as discussed above.
Regarding claims 15-18, the combination suggests the limitations of claim 1, as above, but fails to teach the implant being an orthopedic plate with a locking hole.
Williamson teaches use of a robot 90 to drive a drill 92 through a screw hole 14 in a plate 10 in a bone, in the manner claimed. [0058]-[0069] The plate can be considered to be a pair of plates 16a/b as at fig. 1, which become interlocked to the bone when the screws are installed, therein.
It would have been obvious to one with ordinary skill in the art at the time of the invention to utilize the combination device with the robot 90 of Williamson to install a plate. One would have done so in order to provide for an operation in which the surgeon is permitted to make smaller incisions since he can install screws in areas which are not visible.
Allowable Subject Matter
Claim 9 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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