DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This communication is responsive to application filed on 11/16/2021.
Claims 1-20 have been canceled.
Claims 21-40 are presented for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22, 23, and 27-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the change" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the one or more spinal parameters" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the change" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-24, 26-29, 31-35, and 37-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
21. (New) A method comprising:
measuring one or more preoperative spinal parameters by referencing anatomy from a lateral radiographic image of a patient's spine [insignificant pre-solution, e.g. mere data-gathering];
determining a sagittal correction to the patient's spine by referencing the anatomy from the lateral radiographic image of the patient's spine [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion)];
generating a curve based on the sagittal correction to the patient's spine [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion)];
displaying a rod graphic representing a rod having the curve;
generating bend instructions to approximate the curve [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts];
forming a spinal rod based on the bend instructions [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts]; and
providing the spinal rod for implantation in the patient [insignificant post extra solution, e.g. mere data-gathering].
Step 1 (Does this claim fall within at least one statutory category?): Yes, the claim recites a series of steps and, therefore, is a process.
Step 2A, Prong 1: ((a) identify the specific limitation(s) in the claim that recites an abstract idea: and (b) determine whether the identified limitation(s) falls within at least one of the groups of abstract ideas enumerates in MPEP 2106.04(a)(2)):
Claim 21 recites “determining, generating, generating and forming” which fall into [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts].
Step 2A, Prong 2 (1. Identifying whether there are any additional elements recited in the claim beyond the judicial exception; and 2. Evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application): The claim is directed to the judicial exception.
Claim 21 recites “measuring, displaying, and providing”. These additional elements are insignificant pre-solution/post-solutions (i.e. data gathering and/or mere data output).
Step 2B: (Does the claim recite additional elements that amount to significantly more than the judicial exception? No): As explained above, the additional elements of “measuring, displaying, and providing” are insignificant pre/post-solutions (i.e. data gathering and/or mere data output). At most the additional elements are not found to including anything more than data gathering or mere data output. See MPEP 2106.04(d) referencing MPEP 2106.05(g), example (iv) - Obtaining information about transactions and/or (ii)-printing or downloading generated menus and/or (iii)- presenting offers to potential customers.
Dependent claim 22 recites “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 [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts]; and wherein displaying the rod graphic includes: overlaying the rod graphic over locations of a plurality of implanted screw [pre/post-solutions (i.e. data gathering and/or mere data output)].”
Dependent claim 23 recites “receiving user input identifying at least two locations at the lateral radiographic image of the spine of the patient [pre/post-solutions (i.e. data gathering and/or mere data output)]; and calculating the one or more spinal parameters of the spine of the patient based on the at least two locations [Mathematical Concepts]”.
Dependent claim 24 recites “overlaying the rod graphic over locations of a plurality of implanted screws [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts].”
Dependent claim 26 recites “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 [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts].”
As per Claim 27, independent claim 27 recites limitations analogous in scope to those of independent claim 21, and as such are similar rejected.
As per Claims 28 and 29, dependent claims 28 and 29 recite limitations analogous in scope to those of dependent claims 23 and 26, and as such are similar rejected.
Dependent claim 31 recites “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 [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion) and/or Mathematical Concepts].”
As per Claim 32, independent claim 8 recites limitations analogous in scope to those of independent claim 21, and as such are similar rejected.
Dependent claim 33 recites “receiving selections of at least two locations at the lateral radiographic image of the spine of the patient [“mental process i.e. concepts performed in the human mind or with pen and paper (including an observation, evaluation judgement, opinion)]; 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 [Mathematical Concepts].”
As per Claims 34, 35 and 37-40, dependent claims 34, 35, and 37-40 recite limitations analogous in scope to those of dependent claims 22, 24, and 26, and as such are similar rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by C. E. Aubin, H. Labelle, C. Cheverfils, G. Desroches, J. Clin, A. Boivin, “Preoperative Planning Simulator for Spinal Deformity Surgeries” (herein referred as Aubin et al), pgs. 2143-2152, 2008.
1-20. (Canceled)
21. Aubin et al discloses a method comprising:
measuring one or more preoperative spinal parameters by referencing anatomy from 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 by referencing the anatomy from the lateral radiographic image of the patient's spine (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);
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));
forming a spinal rod based on the bend instructions (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
providing the spinal rod for implantation in the patient (See: 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.)).
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 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 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);
causing 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);
causing the system to display 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
providing the spinal rod for implantation in the patient (See: 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.)).
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 comprising:
providing 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);
receiving a change to the spine over the user interface (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);
depicting the change (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);
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 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
providing the spinal rod for implantation in the patient (See: 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.)).
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 04/14/2025
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