DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/2025 has been entered.
Claims 1-20 have been canceled.
Claims 21-40 are presented for examination.
Response to Arguments
Applicant’s arguments, see Remarks pg. 6, filed 02/12/2026, with respect to the rejection(s) of claim(s) 21, 27, and 32 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US Publication No. 2009/0254326 A1 issued to Isaacs.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 21-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Aubin et al (C. E. Aubin, H. Labelle, C. Cheverfils, G. Desroches, J. Clin, A. Boivin, “Preoperative Planning Simulator for Spinal Deformity Surgeries” pgs. 2143-2152, 2008) in view of US Publication No. 2009/0254326 A1 issued to Isaacs et al.
1-20. (Canceled)
21. Aubin et al discloses a method for implanting a spinal rod, the method comprising:
measuring one or more preoperative spinal parameters using a lateral radiographic image of a patient's spine (See: pg. 2144 right side column, the measured spine curvature of the 3 spine segments; pg. 2145 right side column, the interface comprises of a main window that displays and allows the manipulation of the complete patient-specific 3-dimensional spin model, which is obtained from the multiplanar radiographic 3-dimensional reconstruction, auxiliary window display the currently selected vertebra and the preoperative radiographs, additional tools that allow annotating and measuring different clinical indices are also provided);
determining a sagittal correction to the patient's spine based on the preoperative spinal parameters (See: pg. 2146 left side column, at any step of simulation, different clinical indices of the current spine geometry can be computed and displayed using a graphical interface, such as Cobb angles, sagittal plane curve angles, balance, vertebral rotation, orientation of the plane of maximum deformity etc; pg. 2151 left side column, the estimation of rod shape also has a direct influence on the Cobb angle in the sagittal plane after rod rotation; this explain the larger difference noted between postoperative and simulation results for kyphosis and lordosis of the instrumented segment; Table 1 preoperative angles);
generating a curve based on the sagittal correction to the patient's spine (See: pg. 2146 right side column, the simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane));
displaying a rod graphic representing a rod having the curve (See: pg. 2144 right side column, the implants (hooks, fixed screws, two parts of the multaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties);
generating bend instructions to approximate the curve (See: pg. 2144 right side column, finally the stiffness values were regionally fine-tuned using side bending radiographs of the patient and the results of an optimization algorithm that minimized the discrepancy between the simulated bending and the measured spine curvature of the 3 spine segments (proximal thoracic, main thoracic, and thoracolumbar/ lumbar scoliotic curves));
bending a spinal rod based on the bend instructions (See: Task 1 usually corresponds to the attachment of the first rod, generally (but not mandatory) in the concave side of the scoliotic spine. Displacement constraints in translation and rotation are created between the segment of the rod and the targeted implants to simulate the attachment. Cylindrical joints are thus introduced to connect the implant to the rod (pg. 2145 left side column); Finally the stiffness values were regionally fine-tuned using side bending radiographs of the patient and the results of an optimization algorithm22 that minimized the discrepancy between the simulated bending and the measured spine curvature of the 3 spine segments (proximal thoracic, main thoracic, and thoracolumbar/ lumbar scoliotic curves) (pg. 2144, right side column); The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified (pg. 2145 right side column); At any step of simulation, different clinical indices of the current spine geometry can be computed and displayed using a graphical interface, such as Cobb angles, sagittal plane curve angles, balance, vertebral rotation, orientation of the plane of maximum deformity, etc (pg. 2146 left side column)); and
implanting the spinal rod in the patient (See: The implants (hooks, fixed screws, two parts of the multiaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties (pg. 2144, right side column); The preceding implant and implant-vertebra link models were formulated in a generic form, and when the surgeon uses the Spine Surgery Simulator GUI, the specific behavior is attributed depending on the particular context (instrumented level, type of implant) (cf. next subsection) (pg. 2144 right side column); Once the implants are all defined by the surgeon, there are 5 main classes of maneuvers that were developed to simulate a given correction. The 5 maneuvers are discussed below, not necessarily in their chronological order of use by the surgeons (pg. 2144 right side column); The fourth possible task is compression or distraction maneuvers that allow bringing closer or moving away two implants along the rod axis. This is done by gradually applying a force on the two identified implants until a specified distance is achieved (pg. 2145 left side column);The main task bar (Figure 1, on the left) corresponds to the different surgical steps (as presented in the preceding subsection) such as positioning of the implants, rod contouring, attachment of the implants on the rod, rod rotation, etc. Each main task has its own task sub- menu for the specification of various actions and parameters necessary for completion of each surgical maneuver. In the “insert implant” task, when right-clicking on a veratebra, a dialog window offers a choice of various implants from a catalog (Figure 1, on the lower right corner) and another provides adjustment possibilities. The selected implant is initially positioned automatically on the specified vertebra using standard locations and orientations, which can then be fine-tuned using the adjustment tools. As an example, a pedicle screw can be inserted in the predetermined standard straightforward or in the anatomic trajectory,24 and it can subsequently be translated and/or rotated for a better biomechanical anchorage (pg. 2145 right side column); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.); Figs. 3 and 4, initial geometry after the installation of the implants).
Aubin et al does not specify but Isaacs et al discloses digitized screw location user input correction (See: Abstract, determining the shape of a surgical linking device that is to be attached to a bony body structure such as the spinal column based on digitized locations of a plurality of attachment means engaged to the bony structure, ….implemented by a computer system through a GUI to generate an initial bend curve to mate with the plurality of attachment means. The initial bend curve may be simplified based on user input to the GUI to reduce the number of bends necessary to produce a well-fitting linking device and may be altered to help obtain the goals of the surgery; [0015] receiving this digital format and using the relative spatial location to determine one or more shape locations in the surgical linking device, each shape location having one or more of a shape angle and shape rotation at each one or more shape locations such that shaping of the surgical linking device will enable the surgical linking device to attach to the bony body structure using the attachment means; [0020] c) transferring the digitized information to a computer which determines information of one or more of: [0021] i) one or more of the location, angle and rotation of shapes in a selected surgical linking device that could be made in order for the linking device to be attached to the bony structure using the attachment means; [0022] ii) one or more adjustments to the position of or addition to the attachment means that could be made so that a selected preformed, partially preformed or a minimally shaped surgical linking device can be attached to the bony structure with the attachment means; [0023] iii) one or more mathematical adjustments to the digitally rendered position of the attachment means so that the final shaped surgical linking device, once attached to the bony structure, will correct or alter the shape of the bony structure(s); [0062] FIG. 2 depicts three vertebrae each with a surgical rod attachment screw; [0072] FIGS. 12a-h show a comparison between the IdealScrewPositions in the XY (coronal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0073] FIGS. 13a-f show a comparison between the IdealScrewPositions in the XZ (sagittal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0087] A "linking device attachment means" refers to a means attached to a body structure designed to received the surgical linking device and hold it in place. Surgical clamps and screws are common examples of these devices. In the case of a surgical rod, a variety of surgical screws, bolts, and hooks are available to screw into the bone and or to hold the rods in place).
It would have been obvious before the effective filing date to combine surgical linking device as taught by Isaacs et al to preoperative planning simulator of Aubin et al would be to determine which linking device that should be chosen, with or without the need to further manipulate the screw locations or add additional offsetting devices (Isaacs et al, par [0098]).
22. Aubin et al discloses the method of claim 21, further comprising: determining preoperative spinal parameter measurements of the patient's spine, wherein the change adjusts one or more of the patient's spinal parameter adjustments to a target spinal parameter (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified; and wherein displaying the rod graphic includes: overlaying the rod graphic over locations of a plurality of implanted screws (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified).
23. Aubin et al discloses the method of claim 21, wherein the measuring of the one or more preoperative spinal parameters includes: receiving user input identifying at least two locations at the lateral radiographic image of the spine of the patient; and calculating the one or more preoperative spinal parameters of the spine of the patient based on the at least two locations (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way).
24. Aubin et al discloses the method of claim 21, wherein displaying the rod graphic representing the rod solution includes: overlaying the rod graphic over locations of a plurality of implanted screws (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified).
25. Aubin et al discloses the method of claim 21, further comprising: implanting the spinal rod in the patient, wherein the implanting includes adjusting the spine toward the spinal rod (See: pg. 2147 right side column, the pre- and postoperative radiographs of the 2 patients, whereas Figures 3b–e and 4b–e show intermediate steps of the simulated instrumentation procedures. Figures 3b and 4b display the spine after implants installation. Attachment of the first rod is shown on Figures 3c and 4c, followed by the rod rotation maneuver (Figures 3d and 4d); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.)).
26. Aubin et al discloses the method of claim 21, wherein the sagittal correction is a lordotic correction, a kyphotic correction, an osteotomy, an anterior column reconstruction, or an angular change within a sagittal plane (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a non-uniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way; pg. 2146 right side column, The simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane)).
27. Aubin et al discloses a method comprising: providing an input representative of a change to a spine of a patient to a user interface showing a lateral radiographic image of the spine of the patient (See: pg. 2144 right side column, the measured spine curvature of the 3 spine segments; pg. 2145 right side column, the interface comprises of a main window that displays and allows the manipulation of the complete patient-specific 3-dimensional spin model, which is obtained from the multiplanar radiographic 3-dimensional reconstruction, auxiliary window display the currently selected vertebra and the preoperative radiographs, additional tools that allow annotating and measuring different clinical indices are also provided);
calculating, at a system associated with the user interface to calculate a rod solution incorporating the change to the spine (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way);
displaying, at the system, a rod graphic representing the rod solution (See: pg. 2144 right side column, the implants (hooks, fixed screws, two parts of the multaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties);
bending a spinal rod according to the rod solution (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way); and
implanting the spinal rod in the patient (See: The implants (hooks, fixed screws, two parts of the multiaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties (pg. 2144, right side column); The preceding implant and implant-vertebra link models were formulated in a generic form, and when the surgeon uses the Spine Surgery Simulator GUI, the specific behavior is attributed depending on the particular context (instrumented level, type of implant) (cf. next subsection) (pg. 2144 right side column); Once the implants are all defined by the surgeon, there are 5 main classes of maneuvers that were developed to simulate a given correction. The 5 maneuvers are discussed below, not necessarily in their chronological order of use by the surgeons (pg. 2144 right side column); The fourth possible task is compression or distraction maneuvers that allow bringing closer or moving away two implants along the rod axis. This is done by gradually applying a force on the two identified implants until a specified distance is achieved (pg. 2145 left side column); The main task bar (Figure 1, on the left) corresponds to the different surgical steps (as presented in the preceding subsection) such as positioning of the implants, rod contouring, attachment of the implants on the rod, rod rotation, etc. Each main task has its own task sub- menu for the specification of various actions and parameters necessary for completion of each surgical maneuver. In the “insert implant” task, when right-clicking on a vertebra, a dialog window offers a choice of various implants from a catalog (Figure 1, on the lower right corner) and another provides adjustment possibilities. The selected implant is initially positioned automatically on the specified vertebra using standard locations and orientations, which can then be fine-tuned using the adjustment tools. As an example, a pedicle screw can be inserted in the predetermined standard straightforward or in the anatomic trajectory,24 and it can subsequently be translated and/or rotated for a better biomechanical anchorage (pg. 2145 right side column); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.)).
Aubin et al does not specify but Isaacs et al discloses digitized screw location user input correction (See: Abstract, determining the shape of a surgical linking device that is to be attached to a bony body structure such as the spinal column based on digitized locations of a plurality of attachment means engaged to the bony structure, ….implemented by a computer system through a GUI to generate an initial bend curve to mate with the plurality of attachment means. The initial bend curve may be simplified based on user input to the GUI to reduce the number of bends necessary to produce a well-fitting linking device and may be altered to help obtain the goals of the surgery; [0015] receiving this digital format and using the relative spatial location to determine one or more shape locations in the surgical linking device, each shape location having one or more of a shape angle and shape rotation at each one or more shape locations such that shaping of the surgical linking device will enable the surgical linking device to attach to the bony body structure using the attachment means; [0020] c) transferring the digitized information to a computer which determines information of one or more of: [0021] i) one or more of the location, angle and rotation of shapes in a selected surgical linking device that could be made in order for the linking device to be attached to the bony structure using the attachment means; [0022] ii) one or more adjustments to the position of or addition to the attachment means that could be made so that a selected preformed, partially preformed or a minimally shaped surgical linking device can be attached to the bony structure with the attachment means; [0023] iii) one or more mathematical adjustments to the digitally rendered position of the attachment means so that the final shaped surgical linking device, once attached to the bony structure, will correct or alter the shape of the bony structure(s); [0062] FIG. 2 depicts three vertebrae each with a surgical rod attachment screw; [0072] FIGS. 12a-h show a comparison between the IdealScrewPositions in the XY (coronal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0073] FIGS. 13a-f show a comparison between the IdealScrewPositions in the XZ (sagittal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0087] A "linking device attachment means" refers to a means attached to a body structure designed to received the surgical linking device and hold it in place. Surgical clamps and screws are common examples of these devices. In the case of a surgical rod, a variety of surgical screws, bolts, and hooks are available to screw into the bone and or to hold the rods in place).
It would have been obvious before the effective filing date to combine surgical linking device as taught by Isaacs et al to preoperative planning simulator of Aubin et al would be to determine which linking device that should be chosen, with or without the need to further manipulate the screw locations or add additional offsetting devices (Isaacs et al, par [0098]).
28. Aubin et al discloses the method of claim 27, wherein the change is a lordotic correction, a kyphotic correction, an osteotomy, an anterior column reconstruction, or an angular change within a sagittal plane (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a non-uniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way; pg. 2146 right side column, The simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane)).
29. Aubin et al discloses the method of claim 27, further comprising: determining preoperative spinal parameter measurements of the patient's spine, wherein the change adjusts one or more of the patient's spinal parameter adjustments to a target spinal parameter (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way).
30. Aubin et al discloses the method of claim 27, further comprising: implanting the spinal rod in the patient, wherein the implanting includes the spine toward the spinal rod (See: pg. 2147 right side column, the pre- and postoperative radiographs of the 2 patients, whereas Figures 3b–e and 4b–e show intermediate steps of the simulated instrumentation procedures. Figures 3b and 4b display the spine after implants installation. Attachment of the first rod is shown on Figures 3c and 4c, followed by the rod rotation maneuver (Figures 3d and 4d); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.)).
31. Aubin et al discloses the method of claim 27, further comprising: detecting actuation of a user interface element of the user interface, wherein the calculating a rod solution incorporating the change to the spine is responsive to detecting the actuation (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a non-uniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way; pg. 2146 right side column, The simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane).
32. Aubin et al discloses a method for implanting a spinal rod, the method comprising:
displaying, on a user interface showing a lateral radiographic image of a spine of a patient (See: pg. 2144 right side column, the measured spine curvature of the 3 spine segments; pg. 2145 right side column, the interface comprises of a main window that displays and allows the manipulation of the complete patient-specific 3-dimensional spin model, which is obtained from the multiplanar radiographic 3-dimensional reconstruction, auxiliary window display the currently selected vertebra and the preoperative radiographs, additional tools that allow annotating and measuring different clinical indices are also provided; Figs. 3 and 4 and corresponding texts);
inputting, at the user interface, a change to the spine over the user interface (See: ; Step 2: development of a graphical user interface (GUI) that allows the surgeon to specify surgical parameters for the simulations (pg. 2144 left side column); The interface comprises of a main window that displays and allows the manipulation of the complete patient-specific 3-dimensional spine model, which is obtained from the multiplanar radiographic 3-dimensional reconstruction (pg. 2145 right side column); , the interface lets the surgeon select the implants on which the torque will be applied along with the target angle value (pg. 2145 right side column); The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes(pg. 2145 right side column); At any step of simulation, different clinical indices of the current spine geometry can be computed and displayed using a graphical interface, such as Cobb angles, sagittal plane curve angles, balance, vertebral rotation, orientation of the plane of maximum deformity, etc.(pg. 2146 left side column));
depicting the change on the displayed lateral radiographic image (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way; Figs. 3 and 4 and corresponding texts);
calculating a rod solution based on the lateral radiographic image and the change to the spine (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way);
displaying, on the user interface, a rod graphic representing the rod solution (See: pg. 2144 right side column, the implants (hooks, fixed screws, two parts of the multaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties; Figs 3 and 4 and corresponding texts);
bending a spinal rod according to the rod solution (See: Task 1 usually corresponds to the attachment of the first rod, generally (but not mandatory) in the concave side of the scoliotic spine. Displacement constraints in translation and rotation are created between the segment of the rod and the targeted implants to simulate the attachment. Cylindrical joints are thus introduced to connect the implant to the rod (pg. 2145 left side column); Finally the stiffness values were regionally fine-tuned using side bending radiographs of the patient and the results of an optimization algorithm22 that minimized the discrepancy between the simulated bending and the measured spine curvature of the 3 spine segments (proximal thoracic, main thoracic, and thoracolumbar/ lumbar scoliotic curves) (pg. 2144, right side column); The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified (pg. 2145 right side column); At any step of simulation, different clinical indices of the current spine geometry can be computed and displayed using a graphical interface, such as Cobb angles, sagittal plane curve angles, balance, vertebral rotation, orientation of the plane of maximum deformity, etc (pg. 2146 left side column)); and
implanting the spinal rod in the patient (See: The implants (hooks, fixed screws, two parts of the multiaxial screws) were modeled as rigid bodies. The graphical rendering was done using a detailed CAD representation. To obtain realistic and adequate behavior of their connection to the spine and rods, generalized constraints (equivalent to defining binary joints such as spherical or cylindrical joints) and/or flexible elements were introduced to restrain appropriate degrees of freedom (DOF) and/or to represent proper flexibility properties (pg. 2144, right side column); The preceding implant and implant-vertebra link models were formulated in a generic form, and when the surgeon uses the Spine Surgery Simulator GUI, the specific behavior is attributed depending on the particular context (instrumented level, type of implant) (cf. next subsection) (pg. 2144 right side column); Once the implants are all defined by the surgeon, there are 5 main classes of maneuvers that were developed to simulate a given correction. The 5 maneuvers are discussed below, not necessarily in their chronological order of use by the surgeons (pg. 2144 right side column); The fourth possible task is compression or distraction maneuvers that allow bringing closer or moving away two implants along the rod axis. This is done by gradually applying a force on the two identified implants until a specified distance is achieved (pg. 2145 left side column);The main task bar (Figure 1, on the left) corresponds to the different surgical steps (as presented in the preceding subsection) such as positioning of the implants, rod contouring, attachment of the implants on the rod, rod rotation, etc. Each main task has its own task sub- menu for the specification of various actions and parameters necessary for completion of each surgical maneuver. In the “insert implant” task, when right-clicking on a veratebra, a dialog window offers a choice of various implants from a catalog (Figure 1, on the lower right corner) and another provides adjustment possibilities. The selected implant is initially positioned automatically on the specified vertebra using standard locations and orientations, which can then be fine-tuned using the adjustment tools. As an example, a pedicle screw can be inserted in the predetermined standard straightforward or in the anatomic trajectory,24 and it can subsequently be translated and/or rotated for a better biomechanical anchorage (pg. 2145 right side column); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.); Figs. 3 and 4, initial geometry after the installation of the implants).
Aubin et al does not specify but Isaacs et al discloses digitized screw location user input correction (See: Abstract, determining the shape of a surgical linking device that is to be attached to a bony body structure such as the spinal column based on digitized locations of a plurality of attachment means engaged to the bony structure, ….implemented by a computer system through a GUI to generate an initial bend curve to mate with the plurality of attachment means. The initial bend curve may be simplified based on user input to the GUI to reduce the number of bends necessary to produce a well-fitting linking device and may be altered to help obtain the goals of the surgery; [0015] receiving this digital format and using the relative spatial location to determine one or more shape locations in the surgical linking device, each shape location having one or more of a shape angle and shape rotation at each one or more shape locations such that shaping of the surgical linking device will enable the surgical linking device to attach to the bony body structure using the attachment means; [0020] c) transferring the digitized information to a computer which determines information of one or more of: [0021] i) one or more of the location, angle and rotation of shapes in a selected surgical linking device that could be made in order for the linking device to be attached to the bony structure using the attachment means; [0022] ii) one or more adjustments to the position of or addition to the attachment means that could be made so that a selected preformed, partially preformed or a minimally shaped surgical linking device can be attached to the bony structure with the attachment means; [0023] iii) one or more mathematical adjustments to the digitally rendered position of the attachment means so that the final shaped surgical linking device, once attached to the bony structure, will correct or alter the shape of the bony structure(s); [0062] FIG. 2 depicts three vertebrae each with a surgical rod attachment screw; [0072] FIGS. 12a-h show a comparison between the IdealScrewPositions in the XY (coronal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0073] FIGS. 13a-f show a comparison between the IdealScrewPositions in the XZ (sagittal) plane for an exemplary implant and the calculated positions according to one example of the curve fitting approach of the present invention; [0087] A "linking device attachment means" refers to a means attached to a body structure designed to received the surgical linking device and hold it in place. Surgical clamps and screws are common examples of these devices. In the case of a surgical rod, a variety of surgical screws, bolts, and hooks are available to screw into the bone and or to hold the rods in place).
It would have been obvious before the effective filing date to combine surgical linking device as taught by Isaacs et al to preoperative planning simulator of Aubin et al would be to determine which linking device that should be chosen, with or without the need to further manipulate the screw locations or add additional offsetting devices (Isaacs et al, par [0098]).
33. Aubin et al discloses the method of claim 32, further comprising: receiving selections of at least two locations at the lateral radiographic image of the spine of the patient; and calculating one or more spinal parameters of the spine of the patient based on the at least two locations, wherein the change to the spine received over the user interface modifies the calculated one or more spinal parameters of the spine of the patient (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way).
34. Aubin et al discloses the method of claim 32, wherein displaying the rod graphic representing the rod solution includes: overlaying the rod graphic over locations of a plurality of implanted screws (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a nonuniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified).
35. Aubin et al discloses the method of claim 32, further comprising: determining preoperative spinal parameter measurements of the patient's spine, wherein the change adjusts one or more of the patient's spinal parameter measurements to a target spinal parameter (See: pg. 2144 right side column, the measured spine curvature of the 3 spine segments; pg. 2145 right side column, the interface comprises of a main window that displays and allows the manipulation of the complete patient-specific 3-dimensional spin model, which is obtained from the multiplanar radiographic 3-dimensional reconstruction, auxiliary window display the currently selected vertebra and the preoperative radiographs, additional tools that allow annotating and measuring different clinical indices are also provided; pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a non-uniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process).
36. Aubin et al discloses the method of claim 32, further comprising: implanting the spinal rod in the patient, wherein the implanting includes adjusting the spine toward the spinal rod (See: pg. 2147 right side column, the pre- and postoperative radiographs of the 2 patients, whereas Figures 3b–e and 4b–e show intermediate steps of the simulated instrumentation procedures. Figures 3b and 4b display the spine after implants installation. Attachment of the first rod is shown on Figures 3c and 4c, followed by the rod rotation maneuver (Figures 3d and 4d); pg. 2151 left side column, It gives a report of the details related to the instrumentation process (implant type and position at each level, three-dimensional coordinates of points along the rod shape, each maneuver and translation to be applied at each pair of implants to provide the required distraction/compression, etc.)).
37. Aubin et al discloses the method of claim 32, further comprising: detecting actuation of a user interface element of the user interface, wherein the calculating a rod solution incorporating the change to the spine is responsive to detecting the actuation (See: pg. 2145 right side column, The “rod-shaping” task enables the user to add and bend a rod in the frontal and lateral planes. It is done by dragging seven control points which define the rod profile using a non-uniform rational B-spline (NURBS) formulation. Once the shape of the rod is defined, the next task is the “rod attachment,” where the order of attachment of the screws or hooks on each rod can be specified. Attachment of implants on the rod can be done one at a time, or simultaneously in one step to speed up the process. The ‘bottom up’ and ‘top down’ sequences are already defined, but the user can specify any desired attachment order. Each time an action is defined, the model is solved and the resulting geometry and reaction forces can be seen on screen (Figure 2). The rotation of the rod is done with a specific window that lets the user specify the magnitude and direction of rotation. If desired, additional rods can be added, shaped, and attached in a similar way; pg. 2146 right side column, The simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane).
38. Aubin et al discloses the method of claim 32, wherein the change is an osteotomy (See: pg. 2144 left side column, The purpose of this work is to present the design of a novel spine surgery simulator (Spine Surgery Simulator or S3) developed specifically to address these needs, and to report its feasibility as a surgical planning tool; pg. 2144 right side column, For multiaxial screws, a spherical joint was defined between the head and the body of the screw. An additional 3 DOF spring allows specifying moment-angle behavior. Before the screw is locked, high stiffness is defined between the body of the screw and the bone (allowing slight possible local deformation), and a quasi-null rotational stiffness between the head and the body of the screw until the angle of the head reaches 27° from the screw axis. When this maximum rotation is reached, a quasi infinite stiffness value is introduced to simulate the locking of the screw at its limit of motion).
39. Aubin et al discloses the method of claim 32, wherein the change is an anterior column reconstruction (See: pg. 2145 right side column, a 3-dimensional reconstructed model of the patient’s spine is created from the acquired radiographs and is then uploaded into the system ready to be used to simulate preoperative surgical maneuvers).
40. Aubin et al discloses the method of claim 32, wherein the change is an angular change within a sagittal plane of the spine (See: pg. 2146 right side column, The simulation results were compared to the real postoperative results using various geometrical indices in the coronal and sagittal planes, such as the thoracic computerized Cobb angle (angle between the intersection of two lines perpendicular to the spinal curve at its inflection points as projected in the coronal plane), kyphosis and lordosis (angles calculated using the same method in the sagittal plane)).
Conclusion
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KIBROM K. GEBRESILASSIE
Primary Examiner
Art Unit 2189
/KIBROM K GEBRESILASSIE/Primary Examiner, Art Unit 2189 07/10/2026
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