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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/7/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 10, 11, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US Pub 2023/0074130) in view of Harrison et al. (US Patent 8,915,915) and in view of Mannanal et al. (US Pub 2017/0354439).
With respect to claim 1, Sun discloses a bone fixation device (see figures 1 and 7a and b below) for attaching to a bone externally to a body, the bone fixation device comprising: a set of two or more rings (fig 1, 2 and 4), each ring in the set of rings being coupled with distinct portions of the bone via corresponding bone connectors (paragraph 57, pin or wires); a strut (fig 1, 3) spanning between two of the rings in the set of rings; an adjustment element (fig 7, 11 and paragraph 44) for adjusting a length of the strut; and a modular driving element (fig 7a and b, 1 and 7) for selectively coupling to the adjustment element and controlling adjustment of the length of the strut, wherein the modular driving element is directly coupled to one of the two or more rings via a fastener (fig 7, 24 and paragraph 47, connected through a bolt) during the adjustment of the length of the strut (fig 7a and paragraph 47). With respect to claim 2, Sun discloses wherein the adjustment element is fixed to the strut (paragraph 44, lead screw) and the modular driving element is couplable and decouplable from the adjustment element (fig 7). With respect to claim 3, Sun discloses further comprising a plurality of additional struts spanning between the two rings, and wherein each of the plurality of additional struts comprises a distinct adjustment element for adjusting a length of the corresponding strut (fig 1 shows 6 struts each with a distinct adjustment element). With respect to claim 4, Sun discloses further comprising a plurality of additional modular driving elements (fig 1, each strut has a distinct driving element) for selectively coupling to each of the distinct adjustment elements to control adjustment of the length of each corresponding strut, and wherein: a) each of the modular driving elements is individually programmable to control an amount of the adjustment of the length of the corresponding strut (fig 1, 1, robots) ,b) at least one of the modular driving elements is configured to adjust the length of the corresponding strut without the presence of all of the modular driving elements (paragraph 47, adjusted separately to realize 6 degrees of freedom) ,c) each of the modular driving elements has a separate power source (each device is shown separate), or d) at least two of the modular driving elements share a common power source. With respect to claim 6, Sun discloses wherein the adjustment element includes a linear actuator (paragraph 44, lead screw causes linear translation of each strut). With respect to claim 10, Sun discloses wherein the adjustment element is embedded in the strut (fig 1 and paragraph 44). With respect to claim 11, Sun discloses wherein the bone fixation device provides negligible distortion of imaging of the bone under both X-ray imaging and MRI (paragraph 58, carbon fibers). With respect to claim 14, Sun discloses further comprising a manual adjustment tool (fig 7b) for mating with the adjustment element to adjust the length of the strut while the modular driving element is decoupled from the adjustment element (switch between robotic and manual modes, paragraphs 27-28). With respect to claim 15, Sun discloses wherein the bone connectors include at least one of bone screws or wires (paragraph 57).
With respect to claim 1, Sun discloses the claimed invention with a hexagonal tool interface (paragraph 54) to allow the for adjustment element and the modular drive element to interface (paragraph 54) to enable adjusting the length of the strut (paragraph 54) and does not disclose wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another and Sun does not disclose wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element.
Harrison discloses wherein the adjustment element (fig 1, 140) and the modular driving element (fig 1, 120) each comprise at least one magnet (fig 1, 126 and 130) configured to interface with one another (col. 3, ll. 45-50) to enable adjusting the length of the strut (col. 3, ll. 55-63).
Mannanal discloses wherein the modular driving element (fig 4B, 200) includes at least one gear (fig 4B, 220) with teeth for directly interfacing with teeth (fig 2A, 120) on the adjustment element (fig 2A, 110) to allow for more control over torque and greater accuracy compared to a screw driver interface (paragraph 38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a hexagonal tool interface of Sun with the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another in view of Harrison because a hexagonal tool interface and the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of enabling adjusting the length of the strut and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sun to include wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element in view of Mannanal in order to allow for more control over torque and greater accuracy compared to a screw driver interface.
With respect to claim 16, Sun discloses a method of adjusting a bone fixation device attached to a bone external to a body, the bone fixation device having: a set of at least two rings (fig 1, 2 and 4) coupled with distinct portions of the bone via corresponding bone connectors (paragraph 57); at least one strut(fig 1, 3) spanning between two of the rings in the set of rings; and an adjustment element (Fig 7, 11) for adjusting a length of the strut, the method comprising: coupling a modular driving element (Fig 7a) or a manual adjustment tool (fig 7b) to the adjustment element; and actuating adjustment of the length of the strut with the modular driving element or the manual adjustment tool (paragraph 47 for modular and paragraph 49 for manual) wherein the modular driving element is directly coupled to one of the at least two rings via a fastener (See fig 7a below) during the adjustment of the length of the strut (fig 1 and paragraph 47). With respect to claim 17, Sun discloses wherein the modular driving element comprises a self-powered actuator (paragraph 47), the method further comprising: decoupling the coupled modular driving element or manual adjustment tool from the adjustment element; coupling the other one of the modular driving element or the manual adjustment tool to the adjustment element (paragraph 15 discloses switching between modes); and actuating adjustment of the length of the strut (paragraph 44).
With respect to claim 16, Sun discloses the claimed invention with a hexagonal tool interface (paragraph 54) to allow for the adjustment element and the modular drive element to interface (paragraph 54) to enable adjusting the length of the strut (paragraph 54) and does not disclose wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another and does not disclose wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another and Sun does not disclose wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element.
Harrison discloses wherein the adjustment element (fig 1, 140) and the modular driving element (fig 1, 120) each comprise at least one magnet (fig 1, 126 and 130) configured to interface with one another (col. 3, ll. 45-50) to enable adjusting the length of the strut (col. 3, ll. 55-63).
Mannanal discloses wherein the modular driving element (fig 4B, 200) includes at least one gear (fig 4B, 220) with teeth for directly interfacing with teeth (fig 2A, 120) on the adjustment element (fig 2A, 110) to allow for more control over torque and greater accuracy compared to a screw driver interface (paragraph 38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a hexagonal tool interface of Sun with the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another in view of Harrison because a hexagonal tool interface and the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of enabling adjusting the length of the strut and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sun to include wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element in view of Mannanal in order to allow for more control over torque and greater accuracy compared to a screw driver interface.
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Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. in view of Harrison et al. and in view of Mannanal et al as applied to claim 1 above, and further in view of Singh et al. (US Pub 2014/0058389).
With respect to claim 5, Sun in view of Harrison and in view of Mannanal discloses the claimed invention except for the set of rings comprising at least three rings.
Singh discloses a set of rings (fig 1, 200) comprising at least three rings (fig 1 shows three rings) to allow for correcting the alignment between bone fragments (paragraph 73).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sun in view of Harrison and in view of Mannanal to include the set of rings comprising at least three rings in view of Singh in order to allow for correcting the alignment between bone fragments.
Claim(s) 7, 9, 12, 13 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. in view of Harrison et al. and in view of Mannanal et al as applied to claim 1 and 16 above, and further in view of Cohen et al. (US Pub 2021/0038147).
With respect to claim 7, Sun in view of Harrison and in view of Mannanal discloses instructions are sent and performed (paragraph 15, robotic control) but does not specifically disclose wherein the modular driving element is wirelessly coupled with a controller for controlling adjustment of the length of the strut or is wirelessly coupled with the controller for controlling adjustment of the length of the strut, and wherein: a) the controller comprises a remote control device dedicated to controlling adjustment of the length of the strut or a smart device configured to operate a control platform for adjusting the length of the strut, or b) the controller is configured to run as a control platform at a remote location relative to the bone fixation device.
Cohen discloses wherein a modular driving element (fig 9E, 916) is wirelessly coupled (paragraph 100) with a controller (abstract) for controlling adjustment of the length of the strut or is wirelessly coupled with the controller for controlling adjustment of the length of the strut, and wherein: a) the controller comprises a remote control device dedicated to controlling adjustment of the length of the strut or a smart device configured to operate a control platform for adjusting the length of the strut (paragraph 96), or b) the controller is configured to run as a control platform at a remote location relative to the bone fixation device (paragraph 76) to allow a physician delivers a modified treatment protocol to the interface module in response to the compliance report (paragraph 128).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sun in view of Harrison and in view of Mannanal to have wherein the modular driving element is wirelessly coupled with a controller for controlling adjustment of the length of the strut or is wirelessly coupled with the controller for controlling adjustment of the length of the strut, and wherein: a) the controller comprises a remote control device dedicated to controlling adjustment of the length of the strut or a smart device configured to operate a control platform for adjusting the length of the strut, or b) the controller is configured to run as a control platform at a remote location relative to the bone fixation device in view of Cohen in order to allow a physician delivers a modified treatment protocol to the interface module in response to the compliance report.
With respect to claim 9, Sun in view of Harrison and in view of Mannanal discloses wherein the modular driving element comprises: a driving actuator (paragraph 47, D-shaped shaft) for interfacing with a driven mechanism (paragraph 47, D-shaped hole) on the adjustment element and a motor coupled to the drive actuator (paragraph 47) but does not disclose a control unit for controlling actuation of the driving actuator; a communication system coupled with the control unit, the communication system configured to receive instructions to actuate the driving actuator; and at least one of: a) a motor coupled with the control unit and the driving actuator, or b) a power source coupled with the control unit and the driving actuator, wherein an output of the power source is prescribed according to an amount of potential adjustment of the length of the strut.
Cohen discloses a control unit (abstract, control circuitry) for controlling actuation of the driving actuator; a communication system (paragraph 100) coupled with the control unit, the communication system configured to receive instructions to actuate the driving actuator; and at least one of: a) a motor (fig 9, 918) coupled with the control unit and the driving actuator, or b) a power source coupled with the control unit and the driving actuator (paragraph 142), wherein an output of the power source is prescribed according to an amount of potential adjustment of the length of the strut (fig 4D) to allow a physician delivers a modified treatment protocol to the interface module in response to the compliance report (paragraph 128).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sun in view of Harrison and in view of Mannanal to have a control unit for controlling actuation of the driving actuator; a communication system coupled with the control unit, the communication system configured to receive instructions to actuate the driving actuator; and at least one of: a) a motor coupled with the control unit and the driving actuator, or b) a power source coupled with the control unit and the driving actuator, wherein an output of the power source is prescribed according to an amount of potential adjustment of the length of the strut in view of Cohen to allow a physician delivers a modified treatment protocol to the interface module in response to the compliance report.
With respect to claims 12 and 13, Sun in view of Harrison and in view of Mannanal discloses the claimed invention except for further comprising: a feedback system in communication with the modular driving element, wherein the modular driving element provides feedback on a force response to the adjustment of the length of the strut wherein the feedback system comprises a sensor, and either: a) the feedback system provides instructions to a controller for the modular driving element to modify a force applied during the adjustment of the length of the strut based on the feedback on the force response, or b) the feedback system comprises a model correlating force response and force applied during adjustment of the length of the strut, wherein the model is based at least in part on historical data from a set of struts in distinct bone fixation devices.
Cohen discloses further comprising: a feedback system in communication with the modular driving element (paragraph 145), wherein the modular driving element provides feedback on a force response (paragraph 240) to the adjustment of the length of the strut wherein the feedback system comprises a sensor (fig 4C, 408), and either: a) the feedback system provides instructions to a controller for the modular driving element to modify a force applied during the adjustment of the length of the strut based on the feedback on the force response, or b) the feedback system comprises a model correlating force response and force applied during adjustment of the length of the strut, wherein the model is based at least in part on historical data from a set of struts in distinct bone fixation devices (paragraph 241 and fig 1B) to allow for emergency control of the actuation (paragraph 242).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sun in view of Harrison and in view of Mannanal to have further comprising: a feedback system in communication with the modular driving element, wherein the modular driving element provides feedback on a force response to the adjustment of the length of the strut wherein the feedback system comprises a sensor, and either: a) the feedback system provides instructions to a controller for the modular driving element to modify a force applied during the adjustment of the length of the strut based on the feedback on the force response, or b) the feedback system comprises a model correlating force response and force applied during adjustment of the length of the strut, wherein the model is based at least in part on historical data from a set of struts in distinct bone fixation devices in view of Cohen in order to allow for emergency control of the actuation.
With respect to claim 18, Sun in view of Harrison and in view of Mannanal discloses the claimed invention except for the method of receiving feedback about a force applied in actuating the adjustment of the length of the strut; and adjusting the force applied in actuating adjustment of the length of the strut in response to the feedback indicating that the force applied in actuating adjustment of the length of the strut deviates from a threshold.
Cohen discloses receiving feedback (fig 1B, 130) about a force (paragraph 240) applied in actuating the adjustment of the length of the strut (fig 1B, 124); and adjusting the force applied in actuating adjustment of the length of the strut in response to the feedback indicating that the force applied in actuating adjustment of the length of the strut deviates from a threshold (fig 1B, 136) to allow for emergency control of the actuation (paragraph 242).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sun in view of Harrison and in view of Mannanal to have the method of receiving feedback about a force applied in actuating the adjustment of the length of the strut; and adjusting the force applied in actuating adjustment of the length of the strut in response to the feedback indicating that the force applied in actuating adjustment of the length of the strut deviates from a threshold in view of Cohen in order to allow for emergency control of the actuation.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (US Pub 2023/0074130) in view of Harrison et al. (US Patent 8,915,915) in view of Mannanal et al. (US Pub 2017/0354439) and in view of Brinker (US Pub 2006/0276786).
With respect to claim 19, Sun discloses method of a bone connected with a bone fixation device external to a body (fig 1), the bone fixation device having: a set of at least two rings (fig 1, 2 and 4) coupled with distinct portions of the bone via corresponding bone connectors (paragraph 57); at least one strut (fig 1, 3) spanning between two of the rings in the set of rings; an adjustment element (fig 7, 11) for adjusting a length of the strut; and a modular driving element (fig 1, 1 and fig 7a) coupled to the adjustment element, wherein the modular driving element is directly coupled (fig 1 and paragraph 47) to one of the two or more rings vias a fastener (see fig 7a above) during the adjustment of the strut (paragraph 47), the method comprising: decoupling the modular driving element from the adjustment element (paragraph 15);
Sun discloses the claimed invention with a hexagonal tool interface (paragraph 54) to allow for the adjustment element and the modular drive element to interface (paragraph 54) to enable adjusting the length of the strut (paragraph 54) and does not disclose wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another and does not disclose wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another and Sun does not disclose wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element and Sun does not specifically disclose imaging the bone with at least one of MRI or X-ray imaging.
Harrison discloses wherein the adjustment element (fig 1, 140) and the modular driving element (fig 1, 120) each comprise at least one magnet (fig 1, 126 and 130) configured to interface with one another (col. 3, ll. 45-50) to enable adjusting the length of the strut (col. 3, ll. 55-63).
Mannanal discloses wherein the modular driving element (fig 4B, 200) includes at least one gear (fig 4B, 220) with teeth for directly interfacing with teeth (fig 2A, 120) on the adjustment element (fig 2A, 110) to allow for more control over torque and greater accuracy compared to a screw driver interface (paragraph 38).
Brinker discloses imaging the bone with at least one of MRI or X-ray imaging (paragraph 10) to verify the positioning of the bone fragments (paragraph 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a hexagonal tool interface of Sun with the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another in view of Harrison because a hexagonal tool interface and the wherein the adjustment element and the modular driving element each comprise at least one magnet configured to interface with one another are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of enabling adjusting the length of the strut and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sun to include wherein the modular driving element includes at least one gear with teeth for directly interfacing with teeth on the adjustment element in view of Mannanal in order to allow for more control over torque and greater accuracy compared to a screw driver interface and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sun to image the bone with at least one of MRI or X-ray imaging in view of Brinker in order to verify the positioning of the bone fragments. With respect to claim 20, Sun in view of Harrison in view of Mannanal and in view of Brinker discloses wherein when the modular driving element is decoupled from the adjustment element (paragraph 15, decoupling the modular drive), the bone fixation device provides negligible distortion of imaging of the bone under MRI and X-ray imaging (paragraph 58, carbon fiber), the method further comprising coupling the modular driving element to the adjustment element or coupling a manual adjustment tool to the adjustment element after imaging (Brinker discloses imaging to verify positioning, paragraph 10) the bone (paragraph 15, switching between modes after adjusting).
Response to Arguments
Applicant’s arguments, see remarks, filed 1/7/2026, with respect to the objection of claim 20 have been fully considered and are persuasive. The objection of claim 20 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-7 and 9-20 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.
Conclusion
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773