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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and claims depending therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 – 3, 6 – 13, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1).
Claim 1, Chi discloses an on-bone robotic system [abstract, Figs. 1 – 45] comprising:
a bone anchor device configured to be received in a cavity of a bone [Fixture 3909 defines a plate mounted to femur of Fig.39 is described in Fig.27, wherein pegs 2702 are intended to secure the plate 2701 of the fixture to the femur];
a robotic tool unit [3901 or 2901] releasably connected directly to the bone anchor device with a releasable connection for the robotic tool unit releasable from the bone anchor device [the locking mechanism 2703 defines a releasable connection for receiving bar 2704 of the robotic tool unit therethough, Fig.27 and ¶148, or alternatively, ¶150, wherein the robot is detachable from structure 2902 and 2903], the robotic tool unit including at least one actuator for displacing a surgical implement of the robotic tool unit relative to the bone when the robotic tool unit is connected to the bone anchor device when the bone anchor device is implanted [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6, for displacing surgical implement, i.e. 3906, Fig. 39 or the implement connected to 2903, Fig.29A, wherein the implement is a cutting / resection guide / jig, ¶94, ¶167 and claims 14 – 15. Note: the implement is not positive recitation of the claimed system];
wherein the on-bone robotic system includes at least one joint [by at least one of 2902, 2903, 2904, 2905 and 2906] enabling at least one degree of freedom of movement of the surgical implement relative to the bone anchor device [¶150]; and
wherein the on-bone robotic system includes a processor for operating the at least one actuator as a function of the tracking of the bone by the sensor [¶13, ¶76 - ¶77 and ¶145, processing device and non-transitory computer-readable medium encoded with instructions].
Chi discloses the preceding limitations except for disclosing wherein the bone anchor device including at least one sensor for tracking an orientation of the bone, the at least one sensor configured to be inside the bone, whereby the bone anchor device is an implanted electronic device.
Trabish teaches an analogous system [abstract, Figs. 1 – 9] comprising a bone anchor device [262 or 264, or 274 or 276] configured to be received in a cavity of the bone [Figs. 8 – 9], the bone anchor device including at least one sensor for tracking an orientation of the bone [¶113 - ¶116], the at least one sensor being inside the bone, whereby the bone anchor device is an implanted electronic device [¶113 - ¶116 and Figs. 8 – 9, wherein the IMU is within each screw].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi and Trabish, and substitute the bone anchor device with built-in IMU of Trabish for the pegs of Chi, or alternatively, construct the pegs of Chi including built-in IMU in view of Trabish . One would have been motivated to do to allow the user tracking movement and position of the bone anchor device relative to a subject, i.e. bone [Trabish, ¶113].
The combination of Chi and Trabish discloses the limitations of claim 1, as above, and further, Trabish discloses:
Claim 2, wherein the bone anchor device has a receptacle configured to be received in the bone, the receptacle accommodating the at least one sensor [¶113, wherein the IMU is housed within each of screws 262 and 264, in a similar manner to measurement system 130].
Claim 3, wherein a leading end of the bone anchor is flared [Figs. 8 – 9, wherein a distal end, defining a leading end of the anchor, is flared].
Claim 6, wherein the at least one sensor includes an inertial sensor [¶113].
Claim 7, wherein the bone anchor device includes a battery [¶119].
Claim 8, wherein the bone anchor device is configured to be used as an implant to track movement of the bone post-operatively [¶113 - ¶116].
The combination of Chi and Trabish discloses the limitations of claim 1, as above, and further, Chi discloses:
Claim 9, wherein the at least one actuator includes at least one motor [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6].
Claim 10, wherein the at least one motor includes two motors [plurality of activators having servo motors, claim 6 and ¶13], the robotic tool unit displacing the surgical implement in at least two rotational degrees of freedom [about at least two of joints 2902, 2903 and 2904, ¶150].
Claim 11, wherein the at least one actuator includes at least one linear actuator [at least one of 2905 and 2906, ¶150].
Claim 12, wherein the surgical implement has a cut slot [Figs. 29].
Claim 13, wherein the robotic tool unit includes at least one sensor for tracking an orientation of the surgical implement [¶75 - ¶78, inertial sensors provided with the bone mounted robotic system].
Claim 15, including a communication device connected to the processor and configured for wireless communication [¶145 - ¶148, wireless transceiver].
Claim 21, Chi discloses an on-bone robotic system [abstract, Figs. 1 – 45] comprising:
a portion configured to penetrate a bone and be used as an implant and another portion connected directly to the implant and configured to project out of the bone [Fixture 3909 defines a plate mounted to femur of Fig.39 is described in Fig.27, wherein pegs 2702, defining at least a portion to penetrate bone, are intended to secure the plate 2701 to the femur, and another components i.e. 2901 or 3901, defining a portion out of the bone, intended to directly connect to the implant by 2704];
the portion configured to penetrate the bone being a bone anchor device configured to be received in a cavity of a bone and remain in the cavity of the bone post-surgery as an implanted electronic device [at least portion of pegs 2702, defining a bone anchor device, exhibits substantially identical structure to the claimed portion, and therefore inherently capable of performing the claimed function(s) if one desire to do so],
the other portion being a robotic tool unit [wherein at least a portion of 3901 or 2901 defines a robotic tool unit] releasably connected directly to the bone anchor device with a releasable connection for the robotic tool unit releasable from the bone anchor device [the locking mechanism 2703 defines a releasable connection for receiving bar 2704 of the robotic tool unit therethough, Fig.27 and ¶148, or alternatively, ¶150, wherein the robot is detachable from structure 2902 and 2903], the robotic tool unit including at least one actuator for displacing a surgical implement of the robotic tool unit relative to the bone intra-operatively when the robotic tool unit is connected to the bone anchor device when the bone anchor device is implanted [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6, for displacing surgical implement, i.e. 3906, Fig. 39 or the implement connected to 2903, Fig.29A, wherein the implement is a cutting / resection guide / jig, ¶94, ¶167 and claims 14 – 15. Note: the implement is not positive recitation of the claimed system];
wherein the on-bone robotic system includes at least one joint [by at least one of 2902, 2903, 2904, 2905 and 2906] enabling at least one degree of freedom of movement of the surgical implement relative to the bone anchor device [¶150];
wherein the on-bone robotic system includes the releasable connection directly between the bone anchor device and the robotic tool unit [27 – 29]; and
wherein the on-bone robotic system includes a processor for operating the at least one actuator as a function of the tracking of the bone by the sensor [¶13, ¶76 - ¶77 and ¶145, processing device and non-transitory computer-readable medium encoded with instructions].
Chi discloses the preceding limitations except for disclosing wherein the bone anchor device including at least one sensor for tracking an orientation of the bone, the at least one sensor configured to be inside the bone, whereby the bone anchor device is an implanted electronic device.
Trabish teaches an analogous system [abstract, Figs. 1 – 9] comprising a bone anchor device [262 or 264, or 274 or 276] configured to be received in a cavity of the bone and remain in the cavity post-surgery [Figs. 8 – 9], the bone anchor device including at least one sensor for tracking an orientation of the bone [¶113 - ¶116], the at least one sensor being inside the bone, whereby the bone anchor device is an implanted electronic device [¶113 - ¶116 and Figs. 8 – 9, wherein the IMU is within each screw].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi and Trabish, and substitute the bone anchor device with built-in IMU of Trabish for the pegs of Chi, or alternatively, construct the pegs of Chi including built-in IMU in view of Trabish . One would have been motivated to do to allow the user tracking movement and position of the bone anchor device relative to a subject, i.e. bone [Trabish, ¶113].
Claim(s) 4 – 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1), as above, and further, in view of Mehl et al. (US Pub. 2019/0388131 A1),Whipple (US Pub. 2006/0217717 A1), or Vitale et al. (US Pub. 2018/0153697 A1).
Claims 4 – 5, the combination of Chi and Trabish discloses the limitations of claim 2, as above.
The combination of Chi and Trabish does not disclose wherein an anti-rotation feature projects laterally from the receptacle; and wherein the anti-rotation feature includes at least one fin.
Mehl teaches an analogous system [abstract, Figs. 1 – 4] comprising a bone anchor device [50] having an anti- rotation feature projects laterally from the receptacle [fins 20 project laterally from a body portion 14 of the anchor device 50, defining receptacle 18]; and wherein the anti-rotation feature includes at least one fin [¶49].
Whipple teaches an analogous system [abstract, Figs. 1 – 30] comprising a bone anchor device [10] having an anti- rotation feature projects laterally from the receptacle [fins 21 project laterally from a body portion of the anchor device 10]; and wherein the anti-rotation feature includes at least one fin [¶15 - ¶17].
Vitale teaches an analogous system [abstract, Figs. 5 – 6] comprising a bone anchor device having an anti- rotation feature projects laterally from the receptacle [fins 224 project laterally from a body portion of the anchor device , ¶45]; and wherein the anti-rotation feature includes at least one fin [Fig.6].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi, Trabish and Mehl, Whipple or Vitale and construct the anchor device of the combination of Chi and Trabish having anti-rotation fins in view of Mehl, Whipple or Vitale. One would have been motivated to do so in order to provide the anchor device of the combination of Chi and Trabish with a configuration that resist rotation of the implant once fully seated into the bone [¶49, Mehl].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1), as above, and further, in view of Dees, Jr. (US Pub. 2022/0039869 A1).
Claim 14, the combination of Chi and Trabish discloses the limitations of claim 1, as above, except for explicitly disclosing wherein the robotic tool unit includes at least one camera oriented toward the bone and configured to capture images of the bone.
Dees teaches an analogous system comprising a robotic tool unit including at least one camera oriented toward the bone and configured to capture images of the bone [¶64, camera mounted on robotic arm].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi, Trabish and Dees, and construct the robotic tool unit of the combination of Chi and Trabish having camera in view of Dees. One would have been motivated to do so in order to provide the robotic tool unit of the combination of Chi and Trabish with a tacking system that allow tracking surgical objects and patient anatomy in the surgical theatre.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The reference to Herregodts et al. (US Pub. 2022/0202511 A1) discloses a related system [abstract, Figs. 1 – 7] and can be applied instead of the reference to Chi in an alternative rejection.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775