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 .
Status of claims
2. The following claims have been rejected or allowed for the following reasons:
Claim(s) 1-20 is rejected under 35 USC § 103
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 63/443,445, filed on 2/5/23.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 10-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over as applied to Abedinnasab (US 20180368928 A1), in further view of Herregodts (US 20220202511 A1).
Regarding claim 1 Abedinnasab teaches A system, comprising: a surgical robot comprising an end-effector and a plurality of actuators for moving the end- effector in response to: (Abedinnasab [0103] reads “In one preferred embodiment, methods of performing a long bone surgery are describe using a surgical robot that provides 6-degrees-of-freedom to empower the surgical team.”);
and a feedback mechanism communicating to a user of the system, a first position and orientation (POSE) (Abedinnasab [0097] reads “An optional display interface 1530 may permit information from the bus 1500 to be displayed on a display device 1535 in visual, graphic or alphanumeric format.”);
of the first portion of the bone with respect to a second POSE of the second portion of the bone when the first portion of the bone is separate from the second portion of the bone, (Abedinnasab [0103] reads “In one preferred embodiment, methods of performing a long bone surgery are describe using a surgical robot that provides 6-degrees-of-freedom to empower the surgical team. In some embodiments, the method employs the robot that includes a fixed frame defining a first plane, wherein the fixed frame includes an open space formed in a center region thereof; a moving frame defining a second plane, wherein the moving frame includes an open space in a center region thereof; three leg structures connecting the fixed frame and the moving frame, and configured to move the moving frame relative to the fixed frame; and a stabilizer configured to hold an anatomical structure in the open space formed in the center region of each of the moving frame and the fixed frame.”);
Abedinnasab does not teach a first control signal to align the end-effector with a first virtual plane having a first predefined location relative to a first portion of a bone for performing a first operation on the first portion of the bone; and a second control signal to align the end-effector with a second virtual plane having a second predefined location relative to a second portion of the bone for performing a second operation on the second portion of the bone; wherein the movement of the first bone portion to realign with the second bone portion occurs independent of contact with the robot.
Herregodts in analogous art, teaches a first control signal to align the end-effector with a first virtual plane having a first predefined location relative to a first portion of a bone for performing a first operation on the first portion of the bone; and a second control signal to align the end-effector with a second virtual plane having a second predefined location relative to a second portion of the bone for performing a second operation on the second portion of the bone; (Herregodts [0042] reads “The further robotic arm may be configured to lock a cutting tool for cutting within a predetermined plane, the predetermined plane obtained from calculations and positioning data provided by the processing unit.” One with ordinary skill in the art would appreciate that doing a process twice is substantially the same as doing the process for a first time.);
wherein the movement of the first bone portion to realign with the second bone portion occurs independent of contact with the robot. (Herregodts [0039] reads “The system further may be adapted to stabilize the limb for positioning an implant and/or cutting the bone. It is an advantage of embodiments of the present invention that the robotic arm may assist in positioning of a prosthesis, and also in cutting the bone, by fixing accurately and in a stable way the bone. For example, bone cutting may be performed by a surgeon or by the robotic system itself.” And [0069] reads “The present invention provides devices and controllers, and in general a robotic system for assisting and/or for performing bone surgery. Embodiments of the present invention will be explained with reference to total knee arthroplasty (TKA). However, the present invention can be applied to other types of bone surgery, such as partial knee replacement, osteotomy, fracture reduction and the like. Further, the present invention can be also applied to other limbs, such as an arm or elbow.”);
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention to have modified the teachings of Abedinnasab with that of Herregodts to include a method that would allow the surgeon to operate and modify the injured section independently from the robotic system. This would allow for the surgical system to be less invasive to the patient and improve their outcomes. (Herregodts [0004] reads “During surgery, bone cutting is usually performed manually. This operation depends on the human factor and the skill of the surgeon, it is a tiresome practice, and it may result in damage to nearby tissue or uneven cutting. Uneven cutting translates in suboptimal fitting of implants, longer recovery and possible complications such as wear, pain, etc. In order to relieve these problems, automatization of the cutting can be provided. However, this requires the machine (e.g. a robotic arm) to have accurate information regarding position and surface of the bone, as well as input regarding the cutting path. At least part of this information can usually be provided by scanning (such as CT scan) the bone. However, the reference position of the bone during the surgery itself is required.”);
Regarding claim 2 Abedinnasab/Herregodts teaches The system of claim 1 wherein the first control signals and the second control signals correspond, at least in part, to movement of at least one of the first portion of the bone, the second portion of the bone, (Abedinnasab [0007] reads “In some embodiments, a surgical robot may include a fixed frame and a moving frame. Each of the fixed frame and moving frame defines a respective plane, and includes an open space in a center region. … The robot may also include three leg structures connecting the fixed frame and the moving frame, and configured to move the moving frame relative to the fixed frame. The robot may also include a stabilizer configured to hold an anatomical structure in the open space formed in the center region of each of the moving frame and the fixed frame.
and the surgical robot to maintain alignment of the end-effector with the first virtual plane and second virtual plane, respectively. (Abedinnasab [0014] reads “attaching a proximal fragment of a fractured bone to a fixed frame of a robot; attaching a distal fragment of the fractured bone to a moving frame of the robot; by a processing device, moving the moving frame of the robot to a desired position; by the processing device, rotating the moving frame to allow parallel alignment to a shaft of the proximal fragment; by the processing device, translating the moving frame in a plane transverse to an axis of the proximal fragment to enable the axis of the distal fragment to align with an axis of the proximal fragment; and by the processing device, moving the moving frame to a target pose for a fracture end of the distal fragment to align with an opposing fracture end of the proximal fragment. In some embodiments, the moving frame may move in 6 degree of freedom in relation to the fixed frame.”);
Regarding claim 3 Abedinnasab/Herregodts teaches The system of claim 2 wherein alignment of the end-effector with at least one of the first virtual plane or the second virtual plane is coincidence therewith. (Herregodts [0095] reads “FIG. 5 shows a coordinate system and an exemplary positioning system including a robot arm 410 for holding a proximal bone, including a plurality of interconnected arms 411. The direction of the arm indicates the direction X. The positioning system may include levers 412 for rotation in the relative X-Y plane (rotation Z), hinges 413 for rotation in the relative X-Z plane (rotation Y), and axles 414, for allowing rotation on the Y-Z plane (rotation X). The arm may include redundant degrees of motion. A similar configuration can be used to position the distal bone.”);
Regarding claim 4 Abedinnasab/Herregodts teaches The system of claim 1 wherein the feedback mechanism comprises a graphical user interface (GUI). (Abedinnasab [0097] reads “An optional display interface 1530 may permit information from the bus 1500 to be displayed on a display device 1535 in visual, graphic or alphanumeric format.”);
Regarding claim 5 Abedinnasab/Herregodts teaches The system of claim 4 wherein the GUI displays a bone model of the bone and a location of the bone model corresponding to a first location of the first portion of the bone with respect to a second location of the second portion of the bone. (Abedinnasab [0015] reads “The method may also include using an image-capturing device to capture in real-time one or more images during the procedure, where the one or more captured images include the fracture end of the distal fragment and the opposing fracture end of the proximal fragment, or a pelvis.”);
Regarding claim 6 Abedinnasab/Herregodts teaches The system of claim 1 further comprising a first tracking array configured to be affixed to the first bone portion and a second tracking configured to be affixed to the second portion of the bone. (Abedinnasab figure 1 depicts the robotic structure that is configured to hold two sections of the bone apart from each other.);
PNG
media_image1.png
621
501
media_image1.png
Greyscale
Abedinnasab Figure 1
Regarding claim 7 Abedinnasab/Herregodts teaches The system of claim 6 wherein bone data is registered to a first coordinate system of the first tracking array and a second coordinate system of the second tracking array. (Abedinnasab [0079] reads “Cartesian coordinates A(O, x, y, z) and B(P, u, v, w) represented by {A} and {B} are attached to the base and moving platforms, respectively. In FIG. 13, si represents the unit vector along the axes of i-th rotary actuator and di is the vector along AiBi with the length of di.”);
Regarding claim 10 Abedinnasab/Herregodts teaches The system of claim 1 wherein the feedback mechanism displays the location of the first tracking array with respect to the location of the second tracking array. (Abedinnasab [0015] reads “The method may also include using an image-capturing device to capture in real-time one or more images during the procedure, where the one or more captured images include the fracture end of the distal fragment and the opposing fracture end of the proximal fragment, or a pelvis”);
Regarding claim 11, Abedinnasab/Herregodts teaches the system of claim 1 wherein the bone comprises a defect between the first portion of the bone and the second portion of the bone. (Abedinnasab [0006] reads “At least one aspect of the present invention is directed to methods of performing a guided orthopedic surgery by attaching proximal fragments of a fractured bone to a fixed frame of a robot; attaching a distal fragment of the fractured bone to a moving frame of the robot;” and figure 1 shows a break in a patient’s bone.);
PNG
media_image2.png
621
501
media_image2.png
Greyscale
Abedinnasab Figure 1
Regarding claim 12, Abedinnasab/Herregodts teaches the system of claim 1 wherein the first operation is a first bone cut through the first portion of the bone and the second operation is a second bone cut through the second portion of the bone (Herregodts [0142] reads “The cutting system and its software may be adapted to perform any or all the processes in one or more bones of a limb, for example it may perform cutting on a first and/or second bone of a joint, e.g. on a femur and/or on a tibia.”);
Regarding claim 13 Abedinnasab teaches A system, comprising: a surgical robot comprising an end-effector and a plurality of actuators for moving the end- effector in response to: (Abedinnasab [0103] reads “In one preferred embodiment, methods of performing a long bone surgery are describe using a surgical robot that provides 6-degrees-of-freedom to empower the surgical team.”);
Abedinnasab does not teach a first control signal to align the end-effector with a first virtual plane having a first predefined location relative to a first bone fragment and a second bone fragment for performing a first operation on the first bone fragment and the second bone fragment; and a second control signal to align the end-effector with a second virtual plane having a second predefined location relative to the first bone fragment and the second bone fragment for performing a second operation on the first bone fragment and the second bone fragment, wherein first bone fragment is detached from with the second bone portion and independent of contact with the surgical robot.
Herregodts in analogous art, teaches a first control signal to align the end-effector with a first virtual plane having a first predefined location relative to a first bone fragment and a second bone fragment for performing a first operation on the first bone fragment and the second bone fragment; and a second control signal to align the end-effector with a second virtual plane having a second predefined location relative to the first bone fragment and the second bone fragment for performing a second operation on the first bone fragment and the second bone fragment, (Herregodts [0042] reads “The further robotic arm may be configured to lock a cutting tool for cutting within a predetermined plane, the predetermined plane obtained from calculations and positioning data provided by the processing unit.” One with ordinary skill in the art would appreciate that doing a process twice is substantially the same as doing the process for a first time.);
wherein first bone fragment is detached from with the second bone portion and independent of contact with the surgical robot. (Herregodts [0039] reads “The system further may be adapted to stabilize the limb for positioning an implant and/or cutting the bone. It is an advantage of embodiments of the present invention that the robotic arm may assist in positioning of a prosthesis, and also in cutting the bone, by fixing accurately and in a stable way the bone. For example, bone cutting may be performed by a surgeon or by the robotic system itself.” And [0069] reads “The present invention provides devices and controllers, and in general a robotic system for assisting and/or for performing bone surgery. Embodiments of the present invention will be explained with reference to total knee arthroplasty (TKA). However, the present invention can be applied to other types of bone surgery, such as partial knee replacement, osteotomy, fracture reduction and the like. Further, the present invention can be also applied to other limbs, such as an arm or elbow.”);
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention to have modified the teachings of Abedinnasab with that of Herregodts to include a method that would allow the surgeon to operate and modify the injured section independently from the robotic system. This would allow for the surgical system to be less invasive to the patient and improve their outcomes. (Herregodts [0004] reads “During surgery, bone cutting is usually performed manually. This operation depends on the human factor and the skill of the surgeon, it is a tiresome practice, and it may result in damage to nearby tissue or uneven cutting. Uneven cutting translates in suboptimal fitting of implants, longer recovery and possible complications such as wear, pain, etc. In order to relieve these problems, automatization of the cutting can be provided. However, this requires the machine (e.g. a robotic arm) to have accurate information regarding position and surface of the bone, as well as input regarding the cutting path. At least part of this information can usually be provided by scanning (such as CT scan) the bone. However, the reference position of the bone during the surgery itself is required.”);
Regarding claim 14 Abedinnasab/Herregodts teaches The system of claim 13 wherein the first operation comprises aligning a first pin coincident with the first virtual plane for inserting the first pin in the first bone fragment and aligning a second pin coincident with the first virtual plane for inserting the second pin in the second bone fragment in the second bone fragment, and wherein the second operation comprises aligning a third pin coincident with the second virtual plane for inserting the third pin in the first bone fragment and aligning a fourth pin coincident with the second virtual plane for inserting the fourth pin in the second bone fragment. (Herregodts [0074] reads “The fixation may be provided by at least one pin nailed or drilled into the bone, for example a femur, or otherwise attached thereto, or at least two pins 103 as shown in FIG. 1, allowing the femur to rotate around the hip joint 104. It is noted that the fixation element includes pins which are directly attached to the bone by perforating locally the skin, muscles and other tissue of the leg. The pins may be distributed longitudinally. In some embodiments, the pins are distributed along the shaft of the bone. In the specific embodiment of FIG. 1, a device 101 with two pins 103 is shown attached to the bone (femur 102) along its length. However, the present invention is not limited to this configuration, and the two pins may be attached in different sides of the bone, for example at different sides at similar distance from the join, for example in diametral opposite sides. The distribution of the pins can be easily used also in combination with sensors, or beacons 105 for indicating the position to sensors, as it will be explained below with reference to the positioning system.” It would be appreciated by one with ordinary skill in the art that multiple pins would normally be placed to support each bone fragment during a surgery.);
Regarding claim 15 Abedinnasab/Herregodts teaches The system of claim 13 wherein a first predefined location for the first virtual plane is defined with respect to a first bone fragment model and a second bone fragment model. (Herregodts [0042] reads “The further robotic arm may be configured to lock a cutting tool for cutting within a predetermined plane, the predetermined plane obtained from calculations and positioning data provided by the processing unit.” And [0034] reads “The robotic system may include a data input of 3D model data of the bone based on imaging, at least the robotic arm adapted to impose movement on the limb to position the bone in accordance with the 3D model data.”);
Regarding claim 16 Abedinnasab/Herregodts teaches The system of claim 15 further comprising a first coupler for coupling to the first pin and the second pin, and a second coupler for coupling to the third pin and the fourth pin. (Abedinnasab figures 1 and 2A depict of sets of two or more pins are mechanically paired together to support different bone fragments.);
PNG
media_image1.png
621
501
media_image1.png
Greyscale
PNG
media_image3.png
403
490
media_image3.png
Greyscale
Abedinnasab Figure 1 and Figure 2A
Regarding claim 17 Abedinnasab/Herregodts teaches The system of claim 16 wherein the first coupler and second coupler comprise a clamping mechanism. (Herregodts [0077] reads “The device in accordance with some embodiments of the first aspect of the present invention is movable to allow changing the position of the bone (its angle F with respect to the torso). For example, the fixation element (e.g. pins 103), and/or fixation device (e.g. clamp) 101, 201 may be anchored to an external frame or mechanism 203 for fixing the position of the bone (fixing its angle).”);
Regarding claim 19 Abedinnasab/Herregodts teaches The system of claim 13 further comprising a first tracking array configured to be affixed to the first bone fragment and a second tracking configured to be affixed to the second bone fragment. (Abedinnasab figure 1 depicts the robotic structure that is configured to hold two sections of the bone apart from each other.);
PNG
media_image1.png
621
501
media_image1.png
Greyscale
Abedinnasab Figure 1
Regarding claim 20 Abedinnasab/Herregodts teaches A method for repairing a defect in a bone comprising: operating the system of claim 1 to modify the bone to correct the defect. (Herregodts [0010] reads “It is a further object to provide an automated robotic arm and setup for providing accurate bone cutting with stable and controllable bone positioning and fixation. The present invention relates to a robotic system for assisting during bone surgery, the robotic system adapted to control the position of a limb including a distal bone, e.g. to control the position of a distal bone. The robotic system includes a robotic arm and a fixation device connectable to the robotic arm.”);
Claim(s) 8, 9, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over as applied to Abedinnasab/Herregodts, in further view of Zheng (US 20190125461 A1).
Regarding claim 8 Abedinnasab/Herregodts teaches The system of claim 7.
Abedinnasab/Herregodts does not teach wherein the feedback mechanism displays: (i) the bone data; and (ii) a location of the bone data corresponding to a location of the first portion of the bone with respect to a location of the second tracking array.
Zheng in analogous art, teaches wherein the feedback mechanism displays: (i) the bone data; (Zheng [0011] reads “The surgical image acquisition equipment acquires two real-time images, an anteroposterior (AP) view and a lateral (LT) view, which are sent to the remote operation workstation with data line or wireless network, then the images are shown on the graphical user interface on the said workstation.”);
and (ii) a location of the bone data corresponding to a location of the first portion of the bone with respect to a location of the second tracking array. (Zheng [0061] reads “FIG. 4. The graphical user interface displays at least the following path planning related mark lines and contours: mark lines representing the midline of the proximal bone segment 3-3 and 3-4, mark lines representing the midline of the distal bone segment 3-5 and 3-6, mark lines representing the midline of the distal bone segment after the robot movement 3-7 and 3-8, contour lines of the distal bone segment 3-9 and 3-10, contour lines of the distal bone segment after the robot movement 3-11 and 3-12, and an indicator representing the rotation angle of the axis of the distal bone segment after the robot movement 3-13 (shown as a double arrow in FIG. 4). Preferably, the path planning related mark lines and contours are shown by overlaying them or incorporating them into the fluoroscopy images, as shown in 3-1 and 3-2.” It would be understood by one with ordinary skill in the art that the view of the path planning of robotic device would include imagery of the bone with respect to the surgical instruments.);
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention to have modify the teachings of Abedinnasab/Herregodts with that of Zheng to include a method that would allow the system to give more information back to the surgeon. This would allow the surgeon to preform better work which would lead to improved patient outcomes. (Zheng [0005] reads “There are three drawbacks of these navigation methods. Firstly, a time consuming preoperative calibration of the image acquisition equipment is needed, which may cause accuracy loss of the system due to calibration errors. Secondly, necessary trackers mounted on the surgical tools and the patient's body lead to extra injuries to the patient and additional surgery steps. Thirdly, the purchase of customized navigation systems, such as intraoperative CT and infrared optical navigation systems, means an increase of the surgery cost.”);
Regarding claim 9 Abedinnasab/Herregodts teaches The system of claim 7.
Abedinnasab/Herregodts does not teach wherein the feedback mechanism displays: (i) at least a portion of the bone data; (Zheng [0011] reads “The surgical image acquisition equipment acquires two real-time images, an anteroposterior (AP) view and a lateral (LT) view, which are sent to the remote operation workstation with data line or wireless network, then the images are shown on the graphical user interface on the said workstation.”);
(ii) a location of the bone data corresponding to a location of the first portion of the bone; (Zheng [0023] reads “Δx2, Δy2, Δθ3 are the horizontal displacement, the vertical displacement and the rotation angle of the contour line of the distal bone segment after the robot's movement with respect to the mark line, which represents the midline of the distal bone segment after the robot's movement, in the LT Fluoroscopy image generated by the doctor's operation through the graphical user interface.”);
(iii) a copy of the bone data; (Zheng [0011] reads “The surgical image acquisition equipment acquires two real-time images, an anteroposterior (AP) view and a lateral (LT) view, which are sent to the remote operation workstation with data line or wireless network, then the images are shown on the graphical user interface on the said workstation.” One with ordinary skill in the art would appreciate that the ability for a GUI to display a set of data would allow for that GUI to then display a second set of that data.);
and (iv) a location of the copy of the bone data corresponding to a location of the second portion of the bone. (Zheng [0023] reads “Δx2, Δy2, Δθ3 are the horizontal displacement, the vertical displacement and the rotation angle of the contour line of the distal bone segment after the robot's movement with respect to the mark line, which represents the midline of the distal bone segment after the robot's movement, in the LT Fluoroscopy image generated by the doctor's operation through the graphical user interface.”);
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention to have modify the teachings of Abedinnasab/Herregodts with that of Zheng to include a method that would allow the system to give more information back to the surgeon. This would allow the surgeon to perform better work which would lead to improved patient outcomes. (Zheng [0005] reads “There are three drawbacks of these navigation methods. Firstly, a time consuming preoperative calibration of the image acquisition equipment is needed, which may cause accuracy loss of the system due to calibration errors. Secondly, necessary trackers mounted on the surgical tools and the patient's body lead to extra injuries to the patient and additional surgery steps. Thirdly, the purchase of customized navigation systems, such as intraoperative CT and infrared optical navigation systems, means an increase of the surgery cost.”);
Regarding claim 18 Abedinnasab/Herregodts teaches The system of claim 13 communicating a predetermined distance for fixating the first bone fragment to the second bone fragment. (Abedinnasab[0079 reads “Cartesian coordinates A(O, x, y, z) and B(P, u, v, w) represented by {A} and {B} are attached to the base and moving platforms, respectively. In FIG. 13, si represents the unit vector along the axes of i-th rotary actuator and di is the vector along AiBi with the length of di. Assuming that each limb is connected to the fixed base by a universal joint, the orientation of i-th limb with respect to the fixed base can be described by two successive rotations, rotation θi around the axis si, followed by rotation ψi around ni, which is itself perpendicular to both di and si.”);
Abedinnasab/Herregodts does not teach further comprising a feedback mechanism.
Zheng in analogous art, teaches further comprising a feedback mechanism (Zheng [0011] reads “1) The surgical image acquisition equipment acquires two real-time images, an anteroposterior (AP) view and a lateral (LT) view, which are sent to the remote operation workstation with data line or wireless network, then the images are shown on the graphical user interface on the said workstation.”);
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the claimed invention to have modify the teachings of Abedinnasab/Herregodts with that of Zheng to include a method that would allow the system to give more information back to the surgeon. This would allow the surgeon to perform better work which would lead to improved patient outcomes. (Zheng [0005] reads “There are three drawbacks of these navigation methods. Firstly, a time consuming preoperative calibration of the image acquisition equipment is needed, which may cause accuracy loss of the system due to calibration errors. Secondly, necessary trackers mounted on the surgical tools and the patient's body lead to extra injuries to the patient and additional surgery steps. Thirdly, the purchase of customized navigation systems, such as intraoperative CT and infrared optical navigation systems, means an increase of the surgery cost.”);
Other references not Cited
Throughout examination other references were found that could read onto the prior art. Though these references were not used in this examination they could be used in future examination and could read on the contents of the current disclosure. These references are, Jaramaz (US 11197679 B2); Henderson (US 20230157773 A1); Forstein (US 20230248374 A1).
Response to arguments
Applicant argues < Distinct from the teachings of the prior art combination, claim 1 now includes recitations that clarify that the feedback mechanism communicates with a user, such as a surgeon and that the movement of the first bone portion to realign with the second bone portion occurs independent of contact with the robot.> [page 8 First paragraph]. The examiner respectfully disagrees. This added amendment is fully taught by the prior art. Specifically Herregodts teaches that the realignment or any other known medical procedure may be performed by a surgeon independently from any control that the robotic system may be doing. (Herregodts [0039] reads “The system further may be adapted to stabilize the limb for positioning an implant and/or cutting the bone. It is an advantage of embodiments of the present invention that the robotic arm may assist in positioning of a prosthesis, and also in cutting the bone, by fixing accurately and in a stable way the bone. For example, bone cutting may be performed by a surgeon or by the robotic system itself.” And [0069] reads “The present invention provides devices and controllers, and in general a robotic system for assisting and/or for performing bone surgery. Embodiments of the present invention will be explained with reference to total knee arthroplasty (TKA). However, the present invention can be applied to other types of bone surgery, such as partial knee replacement, osteotomy, fracture reduction and the like. Further, the present invention can be also applied to other limbs, such as an arm or elbow.”); Therefore, the combination teaches the claimed invention.
Applicant argues <It is respectfully submitted that not only does the prior art combination lack these features, but further if Abedinnasab were so modified as to satisfy these claim recitations, then the system of Abedinnasab would no longer function as intended. The courts have indicated this is a strong indication of non-obviousness. > [Page 8 First paragraph]. The examiner respectfully disagrees. Abedinnasab is relied upon to teach that multiple bone sections may be controlled in planes that are parallel to each other. These teachings would be compatible with the teaching of Herregodts, which is relied upon to teach some aspects of the control as well as holing different bone segments in a manner that would allow the surgeon to independently operate on them. Therefore, each piece of prior art would still be able to perform is intended function while combined. Therefore, the combination teaches the claimed invention.
Applicant argues < It is of note that the claimed invention also affords additional advantages as to surgical speed as bone fragments do not need to exposed to the same extent or undergo the damaging and time-consuming fixturing per Abedinnasab. Furthermore, while the invention of claim 1 is scalable to smaller bones or complex, multi-fragmented bones, it is unclear how Abedinnasab would function in such situations. > [page 9 first paragraph]. The examiner respectfully disagrees. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the combination teaches the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN MARTIN O'MALLEY whose telephone number is (571)272-6228. The examiner can normally be reached Mon - Fri 9 am - 5 pm.
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, Ramon Mercado can be reached at (571) 270 - 5744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN MARTIN O'MALLEY/Examiner, Art Unit 3658
/Ramon A. Mercado/Supervisory Patent Examiner, Art Unit 3658
Prosecution Insights