Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
2. Claims 1-20 are presented for the examination.
§ 101 2. 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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to Claims 1, 2 , 3, 4, 15, 16 have been rejected under 35 USC 101 for abstract idea without significantly more. Under Step 2A, Prong 1, the “ selecting at least a first point and a second point on the virtual bone model ”, “plate design data is determined”, “ the plate design data is determined”, “ recite a mental process since “ selecting” is function that can be reasonably performed in the human mind with the aid of pen and paper through observation, evaluation, judgment, opinion.
Under Prong 2, the additional element “ creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment; and generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters, wherein the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate. ” are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component, or merely a generic computer or generic computer components to perform the judicial exception, Accordingly, the additional elements do not integrate the recited judicial exception into a practical application, and the claim is therefore directed to the judicial exception. See MPEP 2106.05(f).
Under Step 2B, the additional elements “ creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment; and generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters, wherein the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate ” - this is mere instructions to apply the mental process under mpep 2106.05(f) amounts to merely generally linking the use of the judicial exception to a particular technological environment or field or use, and is merely applying the judicial exception, therefore, does not amount to significantly more, hence, cannot provide an inventive concept.
Claims 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to Claim 17 has been rejected under 35 USC 101 for abstract idea without significantly more. Under Step 2A, Prong 1, the “ determining relationships between a pointer positioned relative to the bone model”, “ determining, from the relationships between the pointer and the bone model,” recite a mental process since “ determining” is function that can be reasonably performed in the human mind with the aid of pen and paper through observation, evaluation, judgment, opinion.
Under Prong 2, the additional element “ visualizing, based on shape data of a bone, a bone model on a display device, deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data comprises, the plate design data is indicative of the positions of the points; determining a curve based on a sequence of two or more of said points, the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment; and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters ” are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component, or merely a generic computer or generic computer components to perform the judicial exception, Accordingly, the additional elements do not integrate the recited judicial exception into a practical application, and the claim is therefore directed to the judicial exception. See MPEP 2106.05(f).
Under Step 2B, the additional elements “ visualizing, based on shape data of a bone, a bone model on a display device, deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data comprises, the plate design data is indicative of the positions of the points; determining a curve based on a sequence of two or more of said points, the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment; and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters ” - this is mere instructions to apply the mental process under mpep 2106.05(f) amounts to merely generally linking the use of the judicial exception to a particular technological environment or field or use, and is merely applying the judicial exception, therefore, does not amount to significantly more, hence, cannot provide an inventive concept.
5 . The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application. See MPEP 2106.05(d). Thus, the claim is not patent eligible.
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.
6. Claim 15 is rejected as non-statutory because they are not patent eligible subject matter.
7. Claim 15 defines computer-readable recording media in the preamble. The specification does not exclude this media to be a carrier wave or signal transmission. Therefore, claim 16 is nonstatutory.
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 through 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 negative by the manner in which the invention was made.
8. Claim 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz (US 8246680 B2) in view of von Jako (US 20080154120 Al) in view of King (US 20120197303 Al) and further in view of Park( US 20130190767 A1).
As to claim 1, Betz teaches visualizing a virtual bone model on a display device , the virtual bone model being based on patient-specific shape data of a bone (The workstation can include a display configured to display the 3-D model of the implant (which may be, for example, a spinal implant), col 3, In 57-65/ In some embodiments, a display can display a virtual image of an implant shape that can be placed in the target space and altered in different shapes and dimensions to allow a clinician to virtually visualize the implant's affect post-surgery, col 4, In 37-45/Typically, the custom or patient-specific implant will have a 3-D shape. Volumetric image data that can be analyzed to obtain shapes and dimensions for the implant can be generated from known imaging modalities, such as, for example, MRI (Magnetic Resonance Imaging) and CT (Computed Tomography). Known two-dimensional (2-D) and three-dimensional (3-D) visualization products provide medical images that can render images from stored electronic data files. The data input used to create the image renderings can be a stack of image slices from a desired imaging modality, for example, a CT and/or MRI modality. The visualization can convert the image data into an image volume to create renderings that can be displayed on a workstation display, col 9, In 55-67 to col 10, In 1-10);
deriving plate design data representative of a plate-specific design property (In some embodiments, the simulating can include accepting user input to allow a clinician to modify a lateral wedge angle and/or thickness or other selected features for therapeutic effect (block 223). In some embodiments, geometry and features of the implant may be changed or adjusted according to the needs of the patient and/or according to the needs of the physician in order to customize the treatment and/or improve the ease of implantation of the device. For example, the implant device could be changed to match a specific approach, be usable with various additional means of fixation and also relocate the attachment points, if applicable, col 12, in 62- 67 to col 13, in 1-10) ;
and generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters (then generating a 3-D model of the total disc replacement spinal implant based on data from the 3-D model of the target disc space (block 203). Optionally, the method can include electronically accepting user input to adjust features of the 3-D model of total replacement disc implant to define an adjusted shape different from the 3- D model of the disc space that is used for the fabricating step, the user input can be by freehand (manual) drawing using a finger contact on the screen, a stencil, light beam, or other input tool. Alternatively, or additionally, the user input can include selectable tools, such as electronically assisted line or curve shape-assisted boundary drawing features, including, for example, spline format tools. Manipulation tools that allow the user to move a drawn line or inserted point, adjust the shape or size, zoom, rotate or otherwise manipulate the shape and/or features or boundary lines can be provided as a tool box or menu selection. An "undo", erase or backtrack tool can be provided to allow ease of editing the initial or altered shape, col 12, in 7- 31/A method for generating custom implants, comprising: programmatically analyzing a patient's image data to electronically obtain shapes and dimensions of relevant anatomical features of a target region of the patient; displaying an electronic model of a spinal implant based on the programmatically analyzing step; accepting user input to electronically modify the model with a change in at least one of shape, size and material formulation of moldable material for the molded spinal implant; and displaying a modified electronic model based on the user input with a corresponding change in anatomical structure in an anatomical model of the patient's spine to thereby allow a user to view potential therapeutic outcomes or effect on a patient using different models of the spinal implant; then fabricating a patient-specific replacement, non-articulating molded spinal implant for the patient using the analyzed patient image data, wherein the molded spinal implant has a molded custom 3-D bone interface surface that has contours that match excisable natural bone at a contact surface of adjacent local bone of the patient, claim 1).
Betz does not teach selecting at least a first point and a second point on the virtual bone model, the first point being representative of a center position of a first section of the bone plate and the second point being representative of a center position of a second section of the bone plate; and creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment. However, von Jako teaches selecting at least a first point and a second point on the virtual bone model, the first point being representative of a center position of a first section of the bone plate and the second point being representative of a center position of a second section of the bone plate; and creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment (The navigation module 260 registers the location of the device to acquired patient data, and generates image data suitable to visualize the patient image data and a representation of the device. In the embodiment illustrated in FIG. 2, the image data is transmitted to a display controller 230 over local interface 215. The display controller 230 is used to output the image data to two displays 214 and 218, para[0061], In 5-10/ As illustrated in FIG. 4, a user interface, such as a display, shows a real-time (or substantially real-time due to an inherent system delay) position and orientation of a model or representation of the implant (e.g., a pedicle screw) on 2D fluoroscopic images, for example. The position and orientation of the implant model may also be displayed on a registered 3D dataset such as a CT scan. The implant model may appear as a line rendering, a few simply shaded geometric primitives (e.g., a parametric model containing two cylinders representing the screw head and body), or a realistic 3D model from a computer-aided design (CAD) file, for example. Regardless of the visualization using to depict the implant[bone plate], the implant model includes representations of key features of the implant[bone plate] that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para[0068] to para[0069] /As shown, for example, in FIG. 4, a plurality of screws 410-413 are placed in a plurality of vertebrae in a patient's spine 420. Positional (and orientation) measurements of the implanted screws and orientation data may be measured for implants[bone plate] in real-time or substantially in real-time as the screws are placed by the user. An implant center point, such as a center of an implant screw head, is identified and used for measurement purposes, for example. As described above, a straight or curved rod may be placed by a user between screw heads (e.g., between center points of the screw heads). The position of the screw may be known due to navigation/tracking measurement, as described above, and/or through image processing without navigation, for example. Position and orientation of the implant may be measured and/or represented in 2D space, 3D space and/or a combination of 2D and 3D space, for example. In certain embodiments, position and distance measurement data may be presented to a user in an absence and/or aside from an image display, para[0076] to para[0077] / FIG. 4, a user interface, such as a display, shows a real-time (or substantially real-time due to an inherent system delay) position and orientation of a model or representation of the implant (e.g., a pedicle screw) on 2D fluoroscopic images, for example. The position and orientation of the implant model[bone plate] may also be displayed on a registered 3D dataset such as a CT scan. The implant model[bone plate] may appear as a line rendering, a few simply shaded geometric primitives (e.g., a parametric model[bone plate] containing two cylinders representing the screw head and body), or a realistic 3D model from a computer-aided design (CAD) file, for example the implant model[bone plate] includes representations of key features of the implant[bone plate] that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para [0068]/ the implant model includes representations of key features of the implant that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para[0069]/ once two or more screws are placed, measurements can be made between the features. A simple calculation of rod length may be determined using the cumulative distance between a series of screws (e.g., for three screws 1, 2, 3 the cumulative distance would be |pt2-ptl+|pt3-pt2]), para [0071]/ In certain embodiments, position and orientation data may be measured for implants in real-time or substantially in real-time as the screws are placed by the user. An implant center point, such as a center of an implant screw head, is identified and used for measurement purposes, for example., para[0076] / As described above, a straight or curved rod may be placed by a user between screw heads (e.g., between center points of the screw heads). The position of the screw may be known due to navigation/tracking measurement, as described above, and/or through image processing without may be taken automatically by a tracking system and/or in conjunction with a user initiation (e.g., by user trigger based on a button click, pressure on the tool, keyboard selection, mouse selection, etc.), para[0074]/ In certain embodiments, position navigation, for example. Position and orientation of the implant may be measured and/or represented in 2D space, 3D space and/or a combination of 2D and 3D space, for example. In certain embodiments, position and distance measurement data may be presented to a user in an absence and/or aside from an image display, para[0076] to para[0077]/ Based on implant position and orientation information and distance measurements between implants, a user may determine an appropriate rod length and/or curvature for placement between implant positions. In certain embodiments, a user may be provided with suggested types, lengths and/or curvatures of rod , para|(0078]/ For example, a calculation of rod length may be determined using a cumulative distance between a series of screws (e.g., for three screws 1,2,3 the cumulative distance would be [pt2-ptl[+|pt3-pt2)). Additionally, three or more screws have rod slot points that can be fit to a curve. Calculation of curvature may be used to select and/or suggest an appropriately shaped rod. An orientation of the rod slot in two or more screws may also be used for determination of curvature, for example. Additionally, pedicle screw and/or another implant placement may be stored to aid in subsequent implant placement. For example, a placement location of a pedicle screw may be stored or otherwise maintained while placing additional screws at adjacent levels. Knowing prior placement at adjacent levels may help subsequent screws to be driven to like depths and angles, para[0084] to para[0085]/ the first and second center point are located on the same implant mode[bone plate] of implant as described above).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz with von Jako to incorporate the feature of selecting a first point and a second point on the bone model, the first point being representative of a center position of a first plate section and the second point being representative of a center position of a second plate section, the second point being spaced from the first point: and creating a curve based on the first point and the second point, the curve interconnecting the first point and the second point and being representative of a length of the at least one plate segment of the bone plate design because this provides an increased precision in locating medical instruments within a patient may provide for a less invasive medical procedure by facilitating improved control over smaller instruments having less impact on the patient and provides Improved control and precision with smaller, more refined instruments may also reduce risks associated with more invasive procedures such as open surgery.
Betz and von Jako do not teach the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate. However, King teaches the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate( FIGS. 1 and 2 are elevational perspective computer-assisted drawings ("CADs") of an embodiment of the compression plate shown with three of four drill guide inserts installed and 1 hovering above the plate, para[0011]/ latitudinal channel 12 appears at points between the bone plate holes 32, para[0037], In 19-34/ The compression plate assembly 10 has holes 32[number of fixation openings] along its length and through the plate 30 to accommodate bone screws 90 or anchors that are used to attach the plate to the surface of the bone under repair. "Holes" as they are used here means a substantially circular opening in the plate that perforates the entire thickness of the plate. The holes 32[number of fixation openings] are configured to accept bone screws 90 or anchor, para[0038], In 1-12/ Fig. 1/ Fig. 14).
It would have been obvious to one of the ordinary skill in the art before the effective filling date of claimed invention was made to modify the teaching of Betz and von Jako with King to incorporate the feature of the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate because this enables compression in multiple dimensions. Examples of such composite plates are shown in Any number of multi-armed plate designs can be envisioned, limited only by the desired repair application.
Betz, von Jako and King do not teach the virtual bone model being based on patient specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model. However, Park teaches the virtual bone model being based on patient-specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model( Using the surface matching or registration technique illustrated in FIG. 2, the shapes of a model of the bone surface 21, generated from a pre-operative image, are matched to surface data points identified during the first incision or during surgery, para[0010], ln 1-6/ During pre-operative planning, a bone surface image can be formed and preserved, not including the bone cement and implant device surfaces. Based on this (preserved) image data, another patient-specific jig is fabricated with its own (corrected) cutting slot, using the techniques discussed for primary or original TKA. Because all bone surfaces are already shaped due to the earlier primary TKA procedure, use of a surface-to-surface mapping would be appropriate here, para[0066], ln 10-20/ During pre-operative planning, a bone surface image can be formed and preserved, not including the bone cement and implant device surfaces. Based on this (preserved) image data, another patient-specific jig is fabricated with its own (corrected) cutting slot, using the techniques discussed for primary or original TKA. Because all bone surfaces are already shaped due to the earlier primary TKA procedure, use of a surface-to-surface mapping would be appropriate here, para[0005], ln 9-14/ The 2D and 3D models of the knee from Stage I are viewable on the pre-operative planning system PC display as well as a library LINK of the femoral and tibial knee implant components. The library includes 3D models of various size implants and other ancillary parts. The names of the implant manufacturers and manufacturer's surgical criteria and optimum alignment conditions for implant installation will also be available. As an example, using the system to determine the FMA, the surgeon may execute the following sequence: (1) select the center of the femoral head with an icon; (2) select the center of the hip (other end of the femur) with another icon; and (3) connect the two icons with a straight line. This defines an FMA, one of the primary axes, as illustrated in FIGS. 5, 6 and 7. If the surgeon has a preferred way of determining the FMA, the surgeon has the flexibility to use any desired graphical method. For ascertaining the FAA and the TMA, also shown in FIG. 7, similar techniques are implemented. Similar to commercially available graphic software, the pre-operative planning system includes capabilities for enlargement, shrinking, panning, zooming, rotating, etc. As shown in FIG. 7, a plane 72, perpendicular to FMA, para[0052]).
It would have been obvious to one of the ordinary skill in the art before the effective filling date of claimed invention was made to modify the teaching of Betz, von Jako and King with Park to incorporate the feature of the virtual bone model being based on patient-specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model because allows alignment of a three-dimensional (3-D) reconstruction of the patient bone.
9. Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz (US 8246680 B2) in view of von Jako (US 20080154120 Al) in view of King (US 20120197303 Al) in view of Park( US 20130190767 A1) and further in view of n view Stoklund(US 8043378 B2).
As to claim 2, Betz, Jako ,King and Park do not teach selecting a third point on the virtual bone model, the third point being representative of a center position of a third section of the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point. However, Stoklund teaches selecting a third point on the virtual bone model, the third point being representative of a center position of a third section the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point ( Typical spinal implant systems are implanted through a posterior approach to the spinal column and utilize as the support and stabilizing element connected to a series of two or more bone fasteners that have been inserted into two or more vertebrae, col 1, In 20-30).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of claimed invention was made to modify the teaching of Betz, Jako, King and Park with Stoklund to incorporate the feature of selecting a third point on the virtual bone model, the third point being representative of a center position of a third section of the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point because this allows the connections between these components are then secured, thereby fixing a supporting construct to multiple levels in the spinal column.
10. Claims 3, 4 are rejected under pre-AIJA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of von Jako( US 20080154120 Al) in view of King (US 20120197303 Al) in view of Park( US 20130190767 A1) and further in view of Chabanas(US 20130094732 Al) .
As to claim 3, Betz, von Jako, King and Park do not teach. However, Chabanas teaches he plate design data is determined in a coordinate system associated with the virtual bone model (FIG. 8, using the approximate head center HO and radius RO, an estimation of the neck axis represented by an axis AX0 can be computed. A predefined number of N hemi-lines Li, for an index i varying from 1 to N (N being an integer greater than 1), and emerging from the point HO are drawn in 3 dimensions. Since bone orientation is usually known approximately with respect to the 3D image coordinate system (Xct, Yect, Zct), a rough initial estimation of the neck axis is known, it can be for instance a first estimation axis AX00 that passes through HO and that makes an angle Q with the Yct axis and that is in the plane defined by HO, Xct and Yct. The angle Q can be 30.degree. for example. The hemi-lines Li constitute a bundle of lines starting from HO and extending within a cone around the first estimation axis AX00, the cone having a very large aperture angle of 80.degree. for example, para [0126], in 6- 10/As shown in FIG. 12, the collection of points Ai and A'i obtained by this method constitutes a 3D curve on the neck surface, roughly orthogonal to the initial neck axis. It is named the 3D neck minimal curve. A least-squares fitting to a plane is applied to the 3D neck minimal curve, resulting in the average plane PAX, para [0135], In 1-1.0).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, vo Jako , King and Park with Chabanas to incorporate the feature of the one or more points are determined in a coordinate system associated with at least one of the virtual model and the shape data because this minimizes the energy function by minimizing the distance between contiguous points.
As to claim 4, Chabanas teaches the first and second points lie on a surface defined by the virtual bone model (In another preferred embodiment for step S5, as shown in FIGS. 14A and 14B, for each radial plane Pi passing through the initial neck axis AXO0, the two bone surface points Ai and A'i which define the shortest segment of the neck portion are detected. Ai and A'i lie on an opposite side of the surface with respect to each other. A neck axis Axis is then determined as orthogonal to the AiA'l segment, and passing by the middle of that segment Ci (see FIG. 14A, para [0139], In 1-5) for the same reason as to claim 4 above.
11. Claims 5,9,10 are rejected under pre-AIJA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of von Jako( US 20080154120 Al) in view of King (US 20120197303 Al) in view of Park( US 20130190767 A1) and further in view of STEINES DANIEL(WO 2010099231 A2).
As to claim 5, STEINES teaches manipulating at least one of the first point or the second point, the manipulation comprising at least one of a deletion, insertion or a shifting of the first point or the second point; and adapting the plate design data in accordance with the manipulation. However, STEINES teaches manipulating at least one of the first point or the second point, the manipulation comprising at least one of a deletion, insertion or a shifting of the first point or the second point; and adapting the plate design data in accordance with the manipulation(The user can move the pegs by dragging them. The pegs are moved along the center lines keeping constant distance between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights. [000121] The pegs 700, 705 can be pre-viewed with dynamic view changing by clicking button Preview and made with filleting their intersection with the implant inner surface by clicking Accept, para[000120]).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, vo Jako , King and Park with STEINES to incorporate the feature of manipulating at least one of the first point or the second point, the manipulation comprising at least one of a deletion, insertion or a shifting of the first point or the second point; and adapting the plate design data in accordance with the manipulation because. his reduces the impetus to outsource such production to countries with less technically skilled but cheaper labor that may result in reduced quality in the design process.
As to claim 9, STEINES teaches generic plate parameters comprises at least one of: - a number of fixation openings of the bone plate; - a geometric property of the fixation openings of the bone plate; - a number of the segments of the bone plate; - a geometric property of the at least one segment of the bone plate; - at least one of a local and a total thickness of the bone plate; - at least one of a local and a total width of the bone plate; at least one of a local and a total length of the bone plate( For example, the maximum implant thickness or allowable positions of implant anchors may depend on the type of implant. The minimum implant thickness can depend on the patient's bone quality, para[00016], In 3-15) for the same reason as to claim 6 above .
As to claim 10, STEINES teaches providing a software-based parameter editing function configured to permit editing of the one or more geometric plate parameters ( switch to modification phase, the user clicks a "Modify" button in the toolbar. When a user moves the mouse over some contour element, the element is highlighted by displaying in bold lines. The user can drag the element along the direction, associated with each element, by pressing left button, moving the mouse and releasing it in a new position. The whole contour will be rebuilt accordingly, para[00096], In 5-20) for the same reason as to claim 6 above.
12. Claims 11, 12, 14, 15, 16 are rejected under pre-AIJA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of von Jako( US 20080154120 Al) in view of King (US 20120197303 Al) in view of Park( US 20130190767 A1) and further in view of Van Vorhis(US 20090209884 A1).
As to claim 11, Betz, Von do, King and Park not teach. However, Van teaches wherein the virtual bone model comprises at least one bone portion that is missing or to be removed and wherein the bone plate is adapted to extend at least partially over a bone gap previously filled by the at least one bone portion that is missing or to be removed and wherein, the method further comprises: generating reconstruction data for the at least one bone portion that is missing or to be removed, and the data set that geometrically defines the bone plate design is further generated from the reconstruction data( one point is mapped on a surface of the first implant model at a plurality of poses within the range of motion of the joint, inclusive, and at least one of the mapped points is aligned with the second implant model. A user can be enabled to change a pose of at least one of the first implant model and the second implant model to preserve a distance between the first implant model and the second implant model through at least a portion of the range of motion of the joint. A pose of at least one of the first implant model and the second implant model can be adjusted to achieve a desired relationship between the first implant model and the second implant model through at least a portion of the corrected range of motion of the joint, para[0015], In 2- 30).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, vo Jako, King and Park with Van to incorporate the feature of generating reconstruction data for the at least one bone portion that is missing or to be removed, and the data set that geometrically defines the bone plate design is further generated from the reconstruction data because this achieves a desired limb alignment concurrent with appropriate ligament tension throughout the range of motion of the joint.
As to claim 12, Van teaches the virtual bone model comprises at least one bone portion that is missing or to be removed and wherein the bone plate is adapted to extend at least partially over a bone gap previously filled by the at least one bone portion that is missing or to be removed and wherein, the method further comprises: generating the data set that geometrically defines the bone plate such that a first plate portion extending over the bone gap is offset into the bone gap and relative to a second plate portion adjacent to the bone gap( This may be accomplished in any known manner, such as, for example, the implant planning process described in the above-referenced U.S. Patent. In some embodiments, the representations 10, 11 are graphic models of the femur F and the tibia T generated from segmented CT data as is well known. To directly compare the relationship between two implant models at any desired flexion angle .theta. let T.sub.ifd be the transform from the femoral implant model 20 to the femoral CT data and T.sub.itd be the transform from the tibial implant model 30 to the tibial CT data. Then the femoral implant model 20 can be positioned relative to the tibial implant model 30 at any desired flexion angle .theta. by using the relationship T.sub.ifd T.sub.fd.sup.-1 T.sub.tf.sup.-1 T.sub.td T.sub.itd.sup.-1, para[0067], In 20- 50) for the same reason as to claim 12 above.
As to claim 14, Van teaches the bone plate is configured to be fixed to at least one of a cranial, facial or mandibular bone, or to a bone of an extremity ( As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.), para[0119], In 1-5) for the same reason as to claim 12.
As to claim 15, it is rejected for the same reason as to claim 1 above.
As to claim 16, it is rejected for the same reason as to claim 1 above. In additional, Van teaches the pointer being positional relative to the virtual bone model by a user interaction( In other examples, a user is enabled to change a pose of the first implant model, a pose of the second implant model, or both. Enabling can include enabling the user to change the pose of the first implant model, the pose of the second implant model, or both to preserve a distance between the first implant model and the second implant model through at least a portion of the range of motion of the joint, para[0014], In 1-12) for the same reason as to claim 12 above.
13. Claims 6, 7, 8, 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of von Jako( US 20080154120 Al) in view of King (US 20120197303 Al) in view of Park( US 20130190767 A1) and further in view of Takahashi (US 20100145231).
As to claim 6, Betz, Von , King and Park do not teach the first point is representative of a center position of a first fixation opening and the second point is representative of a center position of a second fixation opening. However, Takahashi teaches at least one plate segment interconnecting the at least one pair of fixation openings, determining, from the relationships between a pointer and the bone model, points being representative of center positions of the fixation openings of the at least one pair of fixation openings, wherein the plate design data is Indicative of the positions of the points(As the method for detecting the contours of a thigh femoral head and pelvis acetabulum [fixation openings].for example, a method for detecting the contours [fixation openings] from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi automatically in the contour detection unit 14, para[0129]/ Using the input unit 28, the user clicks and inputs a plurality of points[points] on the contours of the thigh femoral head and pelvis acetabulum in the image of the hip joint displayed on the display unit 32 shown in FIG. 3. Thereupon, the contour detection unit 14 recognizes a plurality of points which are clicked, and sets the line connecting the plurality of clicked points[interconnect] by, for example, spline interpolation as a contour line. Thereby, the contours of the thigh femoral head and pelvis acetabulum are detected( para[0130]/ Next, in step S12 of FIG. 4, the femoral head center point [center point]is calculated. As shown in FIG. 6B above, the ellipse "Ep" for approximating the edge "Ed" of the femoral head is detected, and therefore, the femoral head center point C is calculated as the center [center point](the same if it is called the center of gravity) of the approximation ellipse "Ep", para[0151]/ Since the edge points Ed1 of the pelvis acetabulum are detected above, the contour of the pelvis acetabulum[fixation openings] is obtained by approximating these edge points Ed1 by the ellipse Ep1l. The calculation method of the approximation ellipse Ep can be performed similarly to the one used when the thigh femoral head is approximated by the ellipse Ep above, para[0179] to par[0180]/ Meanwhile, the range which deviates from the circumference of the approximation ellipse Epl, and in which the edge points Ed1 are continuously present in the vicinity of the circumference is determined as the portion which cannot be approximated by the approximation ellipse Ep1. Thus, as shown by the arrows in FIG. 11, from both ends of the range which deviates from the circumference of the approximation ellipse Epl, and in which the edge points Ed1 are continuously present in the vicinity of the circumference, the edge points Ed1[ center point] which are continuously present are connected to one another toward the center [center point] of the range, para[0183], In 1-20/ Next, as shown in FIG. 10C, straight lines are radially drawn between the outer end P1 of the hip cup and the inner end P2 of the hip cup upward from the femoral head center C, and by searching the points at which the density of each pixel changes from high to low along the straight lines, the edge point Ed1[ center points] of the pelvis acetabulum[ second fixation opening] is detected, para[0176], Fig. 10c/ FIG. 15 is an explanatory view of the calculation method | of the space width. As shown in FIG. 15, the intersection points of a straight line L1[ interconnect] passing through the thigh femoral head center[center point] , and the contour of the pelvis acetabulum( the contour in the range from the angles .theta.l to .theta.2 with the thigh femoral head set as the center with the straight line LO of FIG. 15 as the reference) and the thigh femoral head contour (at the side opposed to the pelvis acetabulum) are respectively obtained, and the distance between these intersection points[center points] is calculated as a space width .delta.. The straight line L1 is considered as a plurality of straight lines extending radially from the thigh femoral head center by changing an inclination .alpha. of the straight line L1 with respect to the straight line LO within the aforementioned measurement range, and by calculating the space width .delta. with respect to each of the straight lines L1, serial data of the space width .delta. in the measurement range can be acquired. Hereinafter, the straight line LO is a straight line which is parallel with a straight line La connecting the tear drop lower end points M and N shown in FIG. 3, and passes through the thigh femoral head center. Further, as the thigh femoral head center, the result calculated in the contour detecting step (step S2 of FIG. 2) is used, para[0153], Fig. 15/ For positioning of the acetabular end points, only one of them may be positioned. If there are any points which can be positioned other [center points]than the start points and the end point of the space width graph, they may be used. The axis of abscissas in the space width graph can be matched in the actual size. For example, in the case of the relative position from the acetabular end point along the acetabular contour, the axis of abscissas can be matched in [mm], para[0309] ).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz,Von , King and Park with Takahashi to incorporate the feature of the first point is representative of a center position of a first fixation opening and the second point is representative of a center position of a second fixation opening because this measures space width of joint and a program which can correlate advance extent of space narrowing and an evaluation value of a joint space.
As to claim 7, Takahashi teaches visualizing a virtual plate model based on the plate design data, including the center position of the first and second fixation openings, and the one or more generic plate parameters on the virtual bone model( selecting the contours of a thigh femoral head and a pelvis acetabulum, for example, a method for detecting the contours from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi-automatically in the contour detection unit 14, para[0129] , In 1-30 / para[0151]) for the same reason as to claim 7 above.
As to claim 8, Takahashi teaches the data set that geometrically defines the bone plate is derived or generated at least in part based upon the shape data of the bone and, wherein the shape data is provided in scaled form and the data set that geometrically defines the bone plate is derived to inherit the scaling of the shape data( As the method for detecting the contours of a thigh femoral head and pelvis acetabulum[fixation openings], for example, a method for detecting the contours[fixation openings] from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi Automatically in the contour detection unit 14, para[0129]/ using the input unit 28, the user clicks and inputs a plurality of points[points] on the contours of the thigh femoral head and pelvis acetabulum in the image of the hip joint displayed on the display unit 32 shown in FIG. 3. Thereupon, the contour detection unit 14 recognizes a plurality of points which are clicked, and sets the line connecting the plurality of clicked points[interconnect] by, for example, spline interpolation as a contour line. Thereby, the contours of the thigh femoral head and pelvis acetabulum are detected( para[0130]) for the same reason as to claim 7 above.
As to claim 13, Takahashi teaches the shape data is patient-specific and is obtained by medical imaging( comparing images acquired over time, arranging a plurality of images, composing a plurality of images to form one image with high resolution, or displaying images by superimposing them on each other so that the shape of a subject is easily understood, para[0007], In 9-12) for the same reason as to claim 7 above.
14. Claims 17, 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) and further in view of Ek( US 20030060887 A1).
As to claim 17, Bryan teaches computer-implemented method of generating a data set that geometrically defines a bone plate design for a bone plate with at least one plate segment( in the surgical setting to machine or modify patient tissue to permit use of internal screws for fixation of fractures, to implant artificial joints, to fix intramedullary implants, for arthroplasty purposes, and to facilitate various other surgical procedures, para[0003], ln 1-8/ certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention…… certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention, para[0031],
visualizing, based on shape data of a bone, a bone model on a display device( he manufacturing instructions could be used in combination with a printer, monitor, or any other suitable device to display anticipated properties (e.g., size, shape, color, or any other user-perceptible property) of the outer shell 102 of the synthetic bone model 100 to a user in a visual, numerical, tactile, or any other format. For example, the user may be presented with a three-dimensional (perspective) view on a monitor of the anticipated final appearance of the outer shell 102, para[0019].
Delp teaches determining relationships between a pointer positioned relative to the bone model on the display device and the bone model at points in time when user interaction signals are generated( During the registration process, data points are sampled by touching a pointer 870 attached to the CMM 670 to desired points on the patient's bone and signaling the computer 770 of the location of the CMM 670. In the current embodiment, the user signals the computer 770 by pressing a button 820 on the CMM 670, however, other signaling means may be used without departing from the instant invention, col 16, ln 20-30/ he user samples ten points; however, any number large enough to run an accurate optimization algorithm (such as that described by Besl and McKay and known as the Iterative Closest Point algorithm) can be used without departing from the present invention. As the points are sampled, a counter preferably is displayed on the computer indicating the number of points left to sample, col 17, ln 20-30/ After sampling, the procedure software relates the sampled points to points on the three-dimensional computer model of the body, to more accurately register the surgical plan data to the femur 10, col 17, ln 35-40);
deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data ( Suggested pose registration is used to define the approximate pose of the patient's bone. The procedure software contains predefined CMM poses relative to each bone. Turning now to FIG. 21, these poses are displayed, as reflected by block 910, and the surgeon is prompted to register the pose by aligning the CMM 670 with the pose displayed, as reflected by block 920, and signalling the computer 770 that the CMM 670 is in the displayed pose by pressing a signalling button 820 on the CMM 670, as reflected by block 930, col 16, ln 40-60/ The surgical procedure subsystem allows the surgeon to implement the preoperative plan by accurately guiding the placement of the jigs on the patient's bones. The procedure subsystem, as shown in FIG. 17, first consists of a registration means 750, for registering the three-dimensional computer model of the body to the patient's femur 10 and tibia 2 , col 14, ln 65-67/ Still another registration method that may be used with the instant invention is contour matching (also known as curve-matching) registration. In contour matching registration, the operator samples a number of points from characteristic curves on the patient's anatomy using the CMM. Characteristic curves are curves that define the major shape of a surface. For example, one set of curves that may be used for the femur are curves over the sides and top of one of the condyles; however, other curves can be used without departing from the instant invention. A set of curves that may be used for the tibia are curves over the front of the tibial plateau and over the tibial tuberosity; however, again, other curves can be used without departing from the instant invention. In a preferred embodiment, ten to twenty points are sampled per curve; however, any number sufficient to define the shape of the curve may be used without departing from the instant invention. Polynomials or other mathematical functions are next fit to these data points to make smooth curves, col 18, ln 20-40);
determining, from the relationships between the pointer and the bone model, points relative to the bone model( After sampling, the procedure software relates the sampled points to points on the three-dimensional computer model of the body, to more accurately register the surgical plan data to the femur 10, col 17, ln 35-40)
wherein the plate design data is indicative of the positions of the points( As reflected by block 280, the "snake" algorithm first forms a continuous boundary, called an active contour 290, which consists of a series of points 300 connected by straight lines 310. For the first slice of image data, the operator specifies the positions of these points on the image data using a pointer,, col 9, ln 55-61),
determining a curve based on a sequence of two or more of said points( which consists of a series of points 300 connected by straight lines 310, col 9, ln 57-60/ The ankle center 390 is determined by finding the midpoint of a line connecting points located approximately at the center of each of the medial and lateral malleoli ("malleoli points"), col 11, ln 39-42/ Polynomials or other mathematical functions are next fit to these data points to make smooth curves, col 18, ln 37-40/ identifying epicondyle points on each of a femoral lateral epicondyle and a femoral medial epicondyle, defining a line segment connecting the epicondyle points, col 26, ln 55-60).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan with Delp to incorporate the above feature because this determines optimal alignment of resections preoperatively, and uses computer modeling techniques to help the surgeon achieve that alignment.
EK teaches the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment( A 3-D transducer probe (e.g., a digitizer) is moved on or over the surface along a random path, and the sample points are digitized to generate a real-time topography or map on a computer screen of selected properties of the object,, para[0015], ln 6-11/ and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters, Datum curves 86 and 87, representing the medial-lateral ("ML") and anterior-posterior ("AP") curves, are constructed by connecting the end points of the line elements 81a and 81b, and 82a and 82b and the point of origin 80, which is common to both curves, para[0177], ln 1-6/ Fig. 14a/ if a greater depth of implant is needed as a result of the defect appearance the offset curves 88 and 89 (as shown in FIG. 14a) can be extended to increase the overall thickness of the implant 40, para[0183], ln 1-6),
generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters( the offset curves may be eliminated entirely so that the contoured surface is backed by a revolved geometry that is symmetrical to reference axis 20A. Turning to FIG. 19c, where the ML curve and AP curve (defined by the obtained measurements) are not axially symmetrical, the thickness of the implant 40 requires adjustment. At the same time, an unnecessarily thick implant requires a greater amount of bone to be removed at the target site. Therefore, the thickness of the implant may be determined by taking the largest obtained measurement and adding a minimal offset amount 208. (The implant is thinnest at the highest point on the ML curve.) This can be similarly accomplished by adjusting the angle A (FIG. 19a) of the bone-contacting surface 42 of the implant 40 and a corresponding angle of the preparation tool. This also allows for a correction of the implant geometry, to compensate for any non-perpendicular placement of the guide pin with respect to the articular surface, para[0183], ln 3-23).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan and Delp with EK to incorporate the above feature because this provides A single procedure technique involving establishing the normal axis, measuring, and selecting the appropriate size implant is therefore feasible and utilizing a single reference axis, multiple reference axes may be used for measuring, mapping, or cutting a single defect or an articular surface having multiple defects, as well as for fabricating a single implant, or multiple implants for a single articular surface.
As to claim 18, EK teaches visualizing, on the display device, the points relative to the bone model; visualizing, on the display device, a manipulation of the points, and adapting the plate design data in accordance with the manipulation, the manipulation comprising at least one of a deletion, insertion and shifting of a point, col 16, ln 62-67/ col 17, ln 25-34) for the same reason as to claim 17 above.
15. Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) and further in view of Ek( US 20030060887 A1) and further in view of Leloup( US 20050027304 A1).
As to claim 19, Leloup teaches visualizing the points comprises visualizing a graphical representation of at least one pair of fixation openings( a graphical view representing a cross section of the nail at the locking hole. The latter view is generated from a 3D model of the IN obtained before the operation on the basis of data for manufacturing the implant. The model is produced using a conic projection model with three projection parameters in order to simulate the projection of the points in space on 2D images. Projection cones are therefore not constructed. Thanks to this 3D model, the orientation and the position of the distal holes are known relative to the proximal end of the nail, Para[007], ln 6-20/ The authors define the "centre of the nail" as the middle of the segment joining the centres of the two distal locking holes. The translational movement is calculated so as to bring into coincidence, on each image, the projections of the centre of the nail of the 3D model with the corresponding points located on each image, para[0007], ln 27-32/ The sole constraint lies in the visibility of the distal holes in each of the two images. Adjustment of the position of the radioscopic unit is thereby simplified, which reduces the irradiation of the patient and of the surgical team. In addition, the surgeon has available a three-dimensional view, which makes it possible to display simultaneously several views of the nail and of the tool at whatever angle; an extrapolation of the path of the drill bit may be displayed on the screen, and the error in the initial position may be calculated and supplied to the surgeon before insertion of the screw, para[0089]).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan, Delp and EK with Leloup to incorporate the above feature because this provides the aid of the brightness amplifier in order for the axis of the drill to coincide with that of the locking hole.
16. Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) and further in view of Ek( US 20030060887 A1) and further in view of Leloup( US 20050027304 A1) and further in view of Steingart( US 20090248184 A1).
As to claim 20, Leloup teaches visualizing the curve on the display device( para[0077], ln 5-8) for the same reason as to claim 19 above.
Steingart teaches and adapting the visualized curve responsive to the manipulation of the points( Profiles are edited by manipulating a series of joined lines and curves on a two-dimensional plane. The haptic device is restricted in motion to x and y and gives the physical sensation of touching a flat plane. As with the guide curve edit points, haptic snaps assist in the selection and movement of the profile points, as well as the manipulation of handles to control the curve tangent direction at those points., para[0185]).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan, Delp, EK and Leloup with Steingart to incorporate the above feature because this features a computer-based design application configured to allow the intuitive construction of irregular, amorphous three-dimensional structures.
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 through 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 negative by the manner in which the invention was made.
28. Claims 1, 5, 9, 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz (US 8246680 B2) in view of STEINES(WO 2010099231 A2) and in view of King (US 20120197303 Al) and further in view of Borja( US 20100064216 A1).
As to claim 1 , Betz teaches visualizing a virtual bone model on a display device , the virtual bone model being based on shape data of a bone (The workstation can include a display configured to display the 3-D model of the implant (which may be, for example, a spinal implant), col 3, In 57-65/ In some embodiments, a display can display a virtual image of an implant shape that can be placed in the target space and altered in different shapes and dimensions to allow a clinician to virtually visualize the implant's affect post-surgery, col 4, In 37-45/Typically, the custom or patient-specific implant will have a 3-D shape. Volumetric image data that can be analyzed to obtain shapes and dimensions for the implant can be generated from known imaging modalities, such as, for example, MRI (Magnetic Resonance Imaging) and CT (Computed Tomography). Known two-dimensional (2-D) and three-dimensional (3-D) visualization products provide medical images that can render images from stored electronic data files. The data input used to create the image renderings can be a stack of image slices from a desired imaging modality, for example, a CT and/or MRI modality. The visualization can convert the image data into an image volume to create renderings that can be displayed on a workstation display, col 9, In 55-67 to col 10, In 1-10);
deriving plate design data representative of a plate-specific design property (In some embodiments, the simulating can include accepting user input to allow a clinician to modify a lateral wedge angle and/or thickness or other selected features for therapeutic effect (block 223). In some embodiments, geometry and features of the implant may be changed or adjusted according to the needs of the patient and/or according to the needs of the physician in order to customize the treatment and/or improve the ease of implantation of the device. For example, the implant t device could be changed to match a specific approach, be usable with various additional means of fixation and also relocate the attachment points, if applicable, col 12, in 62- 67 to col 13, in 1-10) ; and
generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters (then generating a 3-D model of the total disc replacement spinal implant based on data from the 3-D model of the target disc space (block 203). Optionally, the method can include electronically accepting user input to adjust features of the 3-D model of total replacement disc implant to define an adjusted shape different from the 3- D model of the disc space that is used for the fabricating step, the user input can be by freehand (manual) drawing using a finger contact on the screen, a stencil, light beam, or other input tool. Alternatively, or additionally, the user input can include selectable tools, such as electronically assisted line or curve shape-assisted boundary drawing features, including, for example, spline format tools. Manipulation tools that allow the user to move a drawn line or inserted point, adjust the shape or size, zoom, rotate or otherwise manipulate the shape and/or features or boundary lines can be provided as a tool box or menu selection. An "undo", erase or backtrack tool can be provided to allow ease of editing the initial or altered shape, col 12, in 7- 31/A method for generating custom implants, comprising: programmatically analyzing a patient's image data to electronically obtain shapes and dimensions of relevant anatomical features of a target region of the patient; displaying an electronic model of a spinal implant based on the programmatically analyzing step; accepting user input to electronically modify the model with a change in at least one of shape, size and material formulation of moldable material for the molded spinal implant; and displaying a modified electronic model based on the user input with a corresponding change in anatomical structure in an anatomical model of the patient's spine to thereby allow a user to view potential therapeutic outcomes or effect on a patient using different models of the spinal implant; then fabricating a patient-specific replacement, non-articulating molded spinal implant for the patient using the analyzed patient image data, wherein the molded spinal implant has a molded custom 3-D bone interface surface that has contours that match excisable natural bone at a contact surface of adjacent local bone of the patient, claim 1).
Betz does not teach selecting at least a first point and a second point on the virtual bone model, the first point being representative of a center position of a first section of the bone plate and the second point being representative of a center position of a second section of the bone plate; and creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment. However, Steines teaches selecting at least a first point and a second point on the virtual bone model, the first point being representative of a center position of a first section of the bone plate and the second point being representative of a center position of a second section of the bone plate; and creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment ( the system can add pegs or anchors or other attachment mechanisms. The system can place the features using anatomical landmarks. Constraints can be used to restrict the placement of the features. Examples of constraints for placement of pegs are the distance between pegs and from the pegs[points] to the edge of the implant[bone plate], the height of the pegs that results from their position on the implant, and forcing the pegs to be located on the center[center] line[curve], para[00025]/ Once the posterior bone cut surface 350is properly positioned, a posterior tray 360 is filled in on the virtual implant and trimmed to optimize the design of the implant. As shown in FIG. 11, fixation pegs 370 and 380 can then be added. Preferably, the pegs 370 and 380 are positioned in a flexed position relative to the mechanical axis and/or the primary direction of the forces on the knee applied by the femur, para[0069], In 8-30/referring to FIGS. 29 and 30, the system provides a function for positioning of pegs 700, 705 for attachment of the implant 710 [bone plate] to bone. The system allows a user to control the distances and the pegs heights, but these aspects could also be automated in other embodiments,[000119]/ Referring to FIGS. 29 and 30, the system provides a function for positioning of pegs 700, 705 for attachment of the implant 710 to bone. The system allows a user to control the distances and the pegs heights, but these aspects could also be automated in other embodiments. [000119] When started, the class displays the implant in the wireframe mode in the profile view and suggests default positions 720, 730 for the pegs, marked[select] on the screen as circles: [000120] The user can move the pegs by dragging[select] them. The pegs are moved along the center lines keeping constant distance between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights. [000121] The pegs 700, 705 can be pre-viewed with dynamic view changing by clicking button Preview and made with filleting their intersection with the implant inner surface by clicking Accept, para[000118]/ When started, the class displays the implant in the wireframe mode in the profile view and suggests default positions 720, 730 for the pegs, marked[select] on the screen as circles: [000120]/ The user can move the pegs by dragging them. The pegs are moved along the center lines[curve] keeping constant distance[length] between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights, [000121]/ of constraints for placement of pegs are the distance between pegs and from the pegs to the edge of the implant, the height of the pegs that results from their position on the implant, and forcing the pegs to be located on the center line, para[0025], ln 5-9/ while using a larger tolerance in the approximation make a smoother outer curve, but it may result in deviation from the vertical center line. To accommodate this phenomenon, a function is implemented that corrects the control points of the center line B- spline -- adjusting them into the vertical line starting at some point, para[000104], ln 8-12/ the line center is created since length of line center is forced by using the constraint distance between the legs as described above ).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz with Steines to incorporate the feature of selecting a first point and a second point on the bone model, the first point being representative of a center position of a first plate section and the second point being representative of a center position of a second plate section, the second point being spaced from the first point: and creating a curve based on the first point and the second point, the curve interconnecting the first point and the second point and being representative of a length of the at least one plate segment of the bone plate design because this allows the surgeon to resurface rather than replace the joint, providing for far more tissue preservation, a reduction in surgical trauma, and a simplified technique.
Betz and Steines do not teach the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate. However, King teaches the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate( FIGS. 1 and 2 are elevational perspective computer-assisted drawings ("CADs") of an embodiment of the compression plate shown with three of four drill guide inserts installed and 1 hovering above the plate, para[0011]/ latitudinal channel 12 appears at points between the bone plate holes 32, para[0037], In 19-34/ The compression plate assembly 10 has holes 32[ number of fixation openings] along its length and through the plate 30 to accommodate bone screws 90 or anchors that are used to attach the plate to the surface of the bone under repair. "Holes" as they are used here means a substantially circular opening in the plate that perforates the entire thickness of the plate. The holes 32[number of fixation opening]are configured to accept bone screws 90 or anchor, para[0038], In 1-12/ Fig. 1/ Fig. 14).
It would have been obvious to one of the ordinary skill in the art before the effective filling date of claimed invention was made to modify the teaching of Betz and STEINES with King to incorporate the feature of the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate because this enables compression in multiple dimensions. Examples of such composite plates are shown in Any number of multi-armed plate designs can be envisioned, limited only by the desired repair application.
Betz, STEINES and King do not teach the virtual bone model being based on patient specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model. However, Borja teaches the virtual bone model being based on patient-specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model( The target shapes 110, if for example in the form of slots, can be wide enough to allow a beam of laser light, such as for example a beam in the form of a plane or a cross-hair beam, to pass through the target shapes 110. FIG. 20 illustrates an embodiment of a target probe 18b with a target shape 110 in the form of a single slot, and a target probe 18a with two slots in the form of a cross, for example formed as two perpendicular lines or slots. With at least one cross-hair laser beam pointing towards the ankle, the knobs on the universal jig 16 can be adjusted until the laser beam illuminates a target shape 110 on the target portion 108 of target probe 18a. As described above, the target shape 110 can be a cross-shaped object, slot, cross mark, T-shaped, L-shaped, or some other shape containing perpendicular lines that meet or intersect. The user can adjust the position of the universal jig 16 until the crosshair beam of the laser beam lines up in both directions along or through the target shape 110, para[0186] to para[0208]/ For example, the display 24 can indicate zero degrees when the cutting block is aligned with the sagittal plane, and can read other values when the cutting block is swung one way or the other relative to the initial position. This can allow the user to change the varus/valgus angle until the varus/valgus angle of the cutting block is at its pre-operatively determined value, para[0307], ln 5-11/ With reference to FIG. 2a, a tibial preparation system 10 can comprise a surgical orientation device 12, or other measuring device, which can be used to measure and record the location of anatomical landmarks of use in a total knee procedure, such as the location of the mechanical axis of the leg. The mechanical axis of the leg, as defined herein, generally refers to an axial line extending from the center of rotation of a proximal head of a femur (e.g. the center of the femoral head) through the center of the knee, to a center, or mid-point, of the ankle (see, for example, FIG. 1). Generally, an ideal mechanical axis in a patient allows load to pass from the center of the hip, through the center of the knee, and to the center of the ankle. The tibial preparation system 10 also can include a coupling device 14, a universal jig 16, and target probes 18a, 18b., para[0092]).
It would have been obvious to one of the ordinary skill in the art before the effective filling date of claimed invention was made to modify the teaching of Betz, STEINES and King with Borja to incorporate the feature of the virtual bone model being based on patient-specific shape data of a bone, pre-operatively deriving plate design data using the virtual bone model because this provides systems and methods for knee joint replacement which utilize a surgical orientation device or devices.
As to claim 5, STEINES teaches manipulating at least one of the first point or the second point, the manipulation comprising at least one of a deletion, insertion or a shifting of the first point or the second point; and adapting the plate design data in accordance with the manipulation(The user can move the pegs by dragging them. The pegs are moved along the center lines keeping constant distance between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights. [000121] The pegs 700, 705 can be pre-viewed with dynamic view changing by clicking button Preview and made with filleting their intersection with the implant inner surface by clicking Accept, para[000120]) for the same reason as to claim 2 above.
As to claim 9, Steines teaches generic plate parameters comprises at least one of: - a number of fixation openings of the bone plate; - a geometric property of the fixation openings of the bone plate; - a number of the segments of the bone plate; - a geometric property of the at least one segment of the bone plate; - at least one of a local and a total thickness of the bone plate; - at least one of a local and a total width of the bone plate; at least one of a local and a total length of the bone plate( For example, the maximum implant thickness or allowable positions of implant anchors may depend on the type of implant. The minimum implant thickness can depend on the patient's bone quality, para[00016], In 3-15) for the same reason as to claim 2 above.
As to claim 10, STEINES teaches providing a software-based parameter editing function configured to permit editing of the one or more geometric plate parameters ( switch to modification phase, the user clicks a "Modify" button in the toolbar. When a user moves the mouse over some contour element, the element is highlighted by displaying in bold lines. The user can drag the element along the direction, associated with each element, by pressing left button, moving the mouse and releasing it in a new position. The whole contour will be rebuilt accordingly, para[00096], In 5-20) for the same reason as to claim 2 above.
29. Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz (US 8246680 B2) in view of STEINES(WO 2010099231 A2) in view of King (US 20120197303 Al) in view of in view of Borja( US 20100064216 A1) and further in view Stoklund(US 8043378 B2).
As to claim 2, Betz, Steines, King and Borja do not teach selecting a third point on the virtual bone model, the third point being representative of a center position of a third section of the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point. However, Stoklund teaches selecting a third point on the virtual bone model, the third point being representative of a center position of a third section of the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point ( Typical spinal implant systems are implanted through a posterior approach to the spinal column and utilize as the support and stabilizing element connected to a series of two or more bone fasteners that have been inserted into two or more vertebrae, col 1, In 20-30).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of claimed invention was made to modify the teaching of Betz, Steines , King and Borja with Stoklund to incorporate the feature of selecting a third point on the virtual bone model, the third point being representative of a center position of a third section of the bone plate; and extending the curve on the virtual bone model to at least interconnect the first point, the second point and the third point because this allows the connections between these components are then secured, thereby fixing a supporting construct to multiple levels in the spinal column.
30. Claims 3, 4, 14 are rejected under pre-AIJA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of STEINES(WO 2010099231 A2) in view of King (US 20120197303 Al) in view of Borja( US 20100064216 A1) and further in view of Chabanas(US 20130094732 Al).
As to claim 3, Betz, Steines, Borja and King do not teach. However , Chabanas teaches wherein the plate design data is determined in a coordinate system associated with the virtual bone model. (FIG. 8, using the approximate head center HO and radius RO, an estimation of the neck axis represented by an axis AX0 can be computed. A predefined number of N hemi-lines Li, for an index i varying from 1 to N (N being an integer greater than 1), and emerging from the point HO are drawn in 3 dimensions. Since bone orientation is usually known approximately with respect to the 3D image coordinate system (Xct, Yect, Zct), a rough initial estimation of the neck axis is known, it can be for instance a first estimation axis AX00 that passes through HO and that makes an angle Q with the Yct axis and that is in the plane defined by HO, Xct and Yct. The angle Q can be 30.degree. for example. The hemi-lines Li constitute a bundle of lines starting from HO and extending within a cone around the first estimation axis AX00, the cone having a very large aperture angle of 80.degree. for example, para [0126], in 6- 10/As shown in FIG. 12, the collection of points Ai and A'i obtained by this method constitutes a 3D curve on the neck surface, roughly orthogonal to the initial neck axis. Itis named the 3D neck minimal curve. A least-squares fitting to a plane is applied to the 3D neck minimal curve, resulting in the average plane PAX, para [0135], In 1-1.0).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, Steines, King and Borja with Chabanas to incorporate the feature of the one or more points are determined in a coordinate system associated with at least one of the virtual model and the shape data because this minimizes the energy function by minimizing the distance between contiguous points.
As to claim 4, Chabanas teaches he first and second points lie on a surface defined by the virtual bone model(In another preferred embodiment for step S5, as shown in FIGS. 14A and 14B, for each radial plane Pi passing through the initial neck axis AXO0, the two bone surface points Ai and A'i which define the shortest segment of the neck portion are detected. Ai and A'i lie on an opposite side of the surface with respect to each other. A neck axis Axis is then determined as orthogonal to the AiA'l segment, and passing by the middle of that segment Ci (see FIG. 14A), para [0139], In 1-5) for the same reason as to claim 4 above.
31. Claims 11, 12, 15, 16 are rejected under pre-AIJA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of STEINES(WO 2010099231 A2) in view of King (US 206120197303 Al) in view of Borja( US 20100064216 A1) and further in view of Van Vorhis(US 20090209884 Al).
As to claim 11, Betz , Steines , King and Borja do not teach. However, Van teaches wherein the virtual bone model comprises at least one bone portion that is missing or to be removed and wherein the bone plate is adapted to extend at least partially over a bone gap previously filled by the at least one bone portion that is missing or to be removed and wherein, the method further comprises: generating reconstruction data for the at least one bone portion that is missing or to be removed, and the data set that geometrically defines the bone plate design is further generated from the reconstruction data( one point is mapped on a surface of the first implant model at a plurality of poses within the range of motion of the joint, inclusive, and at least one of the mapped points is aligned with the second implant model. A user can be enabled to change a pose of at least one of the first implant model and the second implant model to preserve a distance between the first implant model and the second implant model through at least a portion of the range of motion of the joint. A pose of at least one of the first implant model and the second implant model can be adjusted to achieve a desired relationship between the first implant model and the second implant model through at least a portion of the corrected range of motion of the joint, para[0015], In 2- 30).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, Steines, King and Borja with Van to incorporate the feature of generating reconstruction data for the at least one bone portion that is missing or to be removed, and the data set that geometrically defines the bone plate design is further generated from the reconstruction data because this achieves a desired limb alignment concurrent with appropriate ligament tension throughout the range of motion of the joint.
As to claim 12, Van teaches the virtual bone model comprises at least one bone portion that is missing or to be removed and wherein the bone plate is adapted to extend at least partially over a bone gap previously filled by the at least one bone portion that is missing or to be removed and wherein, the method further comprises: generating the data set that geometrically defines the bone plate such that a first plate portion extending over the bone gap is offset into the bone gap and relative to a second plate portion adjacent to the bone gap( This may be accomplished in any known manner, such as, for example, the implant planning process described in the above-referenced U.S. Patent. In some embodiments, the representations 10, 11 are graphic models of the femur F and the tibia T generated from segmented CT data as is well known. To directly compare the relationship between two implant models at any desired flexion angle .theta. let T.sub.ifd be the transform from the femoral implant model 20 to the femoral CT data and T.sub.itd be the transform from the tibial implant model 30 to the tibial CT data. Then the femoral implant model 20 can be positioned relative to the tibial implant model 30 at any desired flexion angle .theta. by using the relationship T.sub.ifd T.sub.fd.sup.-1 T.sub.tf.sup.-1 T.sub.td T.sub.itd.sup.-1, para[0067], In 20- 50) for the same reason as to claim 12 above. As to claim 15, Van teaches the bone plate is configured to be fixed to at least one of a cranial, facial or mandibular bone, or to a bone of an extremity ( As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.), para[0119], In 1-5) for the same reason as to claim 12 above.
As to claim 14, Van teaches the bone plate is configured to be fixed to at least one of a cranial, facial or mandibular bone, or to a bone of an extremity ( As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.), para[0119], In 1-5) for the same reason as to claim 12.As to claim 15, it is rejected for the same reason as to claim 2 above.
As to claim 16, it is rejected for the same reason as to claim 1 above. In additional, Van teaches the pointer being positional relative to the virtual bone model by a user interaction( In other examples, a user is enabled to change a pose of the first implant model, a pose of the second implant model, or both. Enabling can include enabling the user to change the pose of the first implant model, the pose of the second implant model, or both to preserve a distance between the first implant model and the second implant model through at least a portion of the range of motion of the joint, para[0014], In 1-12) for the same reason as to claim 12 above. 15.
32. Claims 6, 7, 8, 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Betz(US 8246680 B2) in view of STEINES(WO 2010099231 A2) in view of King (US 20120197303 Al) in view of Borja( US 20100064216 A1) and further in view of Takahashi (US 20100145231).
As to claim 6, Betz, Steines, King and Borja do not teach the first point is representative of a center position of a first fixation opening and the second point is representative of a center position of a second fixation opening. However, Takahashi teaches at least one plate segment interconnecting the at least one pair of fixation openings, determining, from the relationships between a pointer and the bone model, points being representative of center positions of the fixation openings of the at least one pair of fixation openings, wherein the plate design data is Indicative of the positions of the points(As the method for detecting the contours of a thigh femoral head and pelvis acetabulum [fixation openings].for example, a method for detecting the contours[fixation openings] from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi automatically in the contour detection unit 14, para[0129]/ Using the input unit 28, the user clicks and inputs a plurality of points[points] on the contours of the thigh femoral head and pelvis acetabulum in the image of the hip joint displayed on the display unit 32 shown in FIG. 3. Thereupon, the contour detection unit 14 recognizes a plurality of points which are clicked, and sets the line connecting the plurality of clicked points[interconnect] by, for example, spline interpolation as a contour line. Thereby, the contours of the thigh femoral head and pelvis acetabulum are detected( para[0130]/ Next, in step S12 of FIG. 4, the femoral head center point [center point]is calculated. As shown in FIG. 6B above, the ellipse "Ep" for approximating the edge "Ed" of the femoral head is detected, and therefore, the femoral head center point C is calculated as the center [center point](the same if it is called the center of gravity) of the approximation ellipse "Ep", para[0151]/ Since the edge points Ed1 of the pelvis acetabulum are detected above, the contour of the pelvis acetabulum[fixation openings] is obtained by approximating these edge points Ed1 by the ellipse Ep1. The calculation method of the approximation ellipse Ep can be performed similarly to the one used when the thigh femoral head is approximated by the ellipse Ep above, para[0179] to par[0180]/ Meanwhile, the range which deviates from the circumference of the approximation ellipse Epl, and in which the edge points Ed1 are continuously present in the vicinity of the circumference is determined as the portion which cannot be approximated by the approximation ellipse Ep1. Thus, as shown by the arrows in FIG. 11, from both ends of the range which deviates from the circumference of the approximation ellipse Epl, and in which the edge points Ed1 are continuously present in the vicinity of the circumference, the edge points Ed1[center point] which are continuously present are connected to one another toward the center[ center point] of the range, para[0183], In 1-20/ Next, as shown in FIG. 10C, straight lines are radially drawn between the outer end P1 of the hip cup and the inner end P2 of the hip cup upward from the femoral head center C, and by searching the points at which the density of each pixel changes from high to low along the straight lines, the edge point Ed1[ center points] of the pelvis acetabulum[ second fixation opening] is detected, para[0176], Fig. 10c/ FIG. 15 is an explanatory view of the calculation method | of the space width. As shown in FIG. 15, the intersection points of a straight line L1[ interconnect] passing through the thigh femoral head center[center point] , and the contour of the pelvis acetabulum( the contour in the range from the angles .theta.1 to .theta.2 with the thigh femoral head set as the center with the straight line LO of FIG. 15 as the reference) and the thigh femoral head contour (at the side opposed to the pelvis acetabulum) are respectively obtained, and the distance between these intersection points[center points] is calculated as a space width .delta.. The straight line L1 is considered as a plurality of straight lines extending radially from the thigh femoral head center by changing an inclination .alpha. of the straight line L1 with respect to the straight line LO within the aforementioned measurement range, and by calculating the space width .delta. with respect to each of the straight lines L1, serial data of the space width .delta. in the measurement range can be acquired. Hereinafter, the straight line LO is a straight line which is parallel with a straight line La connecting the tear drop lower end points M and N shown in FIG. 3, and passes through the thigh femoral head center. Further, as the thigh femoral head center, the result calculated in the contour detecting step (step S2 of FIG. 2) is used, para[0153], Fig. 15/ For positioning of the acetabular end points, only one of them may be positioned. If there are any points which can be positioned other [center points]than the start points and the end point of the space width graph, they may be used. The axis of abscissas in the space width graph can be matched in the actual size. For example, in the case of the relative position from the acetabular end point along the acetabular contour, the axis of abscissas can be matched in [mm], para[0309] ).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Betz, Steines, King and Borja with Takahashi to incorporate the feature of the first point is representative of a center position of a first fixation opening and the second point is representative of a center position of a second fixation opening because this measures space width of joint and a program which can correlate advance extent of space narrowing and an evaluation value of a joint space.
As to claim 7, Takahashi teaches visualizing a virtual plate model based on the plate design data, including the center position of the first and second fixation openings, and the one or more generic plate parameters on the virtual bone model( selecting the contours of a thigh femoral head and a pelvis acetabulum, for example, a method for detecting the contours from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi-automatically in the contour detection unit 14, para[0129] , In 1-30 / para[0151]) for the same reason as to claim 7 above.
As to claim 8, Takahashi teaches the data set that geometrically defines the bone plate is derived or generated at least in part based upon the shape data of the bone and, wherein the shape data is provided in scaled form and the data set that geometrically defines the bone plate is derived to inherit the scaling of the shape data( As the method for detecting the contours of a thigh femoral head and pelvis acetabulum[fixation openings], for example, a method for detecting the contours[fixation openings] from the information manually inputted by a user in the information input unit 28 is conceivable, but the contours may be detected automatically or semi Automatically in the contour detection unit 14, para[0129]/ using the input unit 28, the user clicks and inputs a plurality of points[points] on the contours of the thigh femoral head and pelvis acetabulum in the image of the hip joint displayed on the display unit 32 shown in FIG. 3. Thereupon, the contour detection unit 14 recognizes a plurality of points which are clicked, and sets the line connecting the plurality of clicked points[interconnect] by, for example, spline interpolation as a contour line. Thereby, the contours of the thigh femoral head and pelvis acetabulum are detected( para[0130]).
As to claim 13, Takahashi teaches the shape data is patient-specific and is obtained by medical imaging( comparing images acquired over time, arranging a plurality of images, composing a plurality of images to form one image with high resolution, or displaying images by superimposing them on each other so that the shape of a subject is easily understood, para[0007], In 9-12) for the same reason as to claim 7 above.
33. Claims 17, 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) and further in view of Ek( US 20030060887 A1).
As to claim 17, Bryan teaches computer-implemented method of generating a data set that geometrically defines a bone plate design for a bone plate with at least one plate segment( in the surgical setting to machine or modify patient tissue to permit use of internal screws for fixation of fractures, to implant artificial joints, to fix intramedullary implants, for arthroplasty purposes, and to facilitate various other surgical procedures, para[0003], ln 1-8/ certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention…… certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention, para[0031],
visualizing, based on shape data of a bone, a bone model on a display device( he manufacturing instructions could be used in combination with a printer, monitor, or any other suitable device to display anticipated properties (e.g., size, shape, color, or any other user-perceptible property) of the outer shell 102 of the synthetic bone model 100 to a user in a visual, numerical, tactile, or any other format. For example, the user may be presented with a three-dimensional (perspective) view on a monitor of the anticipated final appearance of the outer shell 102, para[0019].
Delp teaches determining relationships between a pointer positioned relative to the bone model on the display device and the bone model at points in time when user interaction signals are generated( During the registration process, data points are sampled by touching a pointer 870 attached to the CMM 670 to desired points on the patient's bone and signalling the computer 770 of the location of the CMM 670. In the current embodiment, the user signals the computer 770 by pressing a button 820 on the CMM 670, however, other signalling means may be used without departing from the instant invention, col 16, ln 20-30/ he user samples ten points; however, any number large enough to run an accurate optimization algorithm (such as that described by Besl and McKay and known as the Iterative Closest Point algorithm) can be used without departing from the present invention. As the points are sampled, a counter preferably is displayed on the computer indicating the number of points left to sample, col 17, ln 20-30/ After sampling, the procedure software relates the sampled points to points on the three-dimensional computer model of the body, to more accurately register the surgical plan data to the femur 10, col 17, ln 35-40);
deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data ( Suggested pose registration is used to define the approximate pose of the patient's bone. The procedure software contains predefined CMM poses relative to each bone. Turning now to FIG. 21, these poses are displayed, as reflected by block 910, and the surgeon is prompted to register the pose by aligning the CMM 670 with the pose displayed, as reflected by block 920, and signalling the computer 770 that the CMM 670 is in the displayed pose by pressing a signalling button 820 on the CMM 670, as reflected by block 930, col 16, ln 40-60/ The surgical procedure subsystem allows the surgeon to implement the preoperative plan by accurately guiding the placement of the jigs on the patient's bones. The procedure subsystem, as shown in FIG. 17, first consists of a registration means 750, for registering the three-dimensional computer model of the body to the patient's femur 10 and tibia 2 , col 14, ln 65-67/ Still another registration method that may be used with the instant invention is contour matching (also known as curve-matching) registration. In contour matching registration, the operator samples a number of points from characteristic curves on the patient's anatomy using the CMM. Characteristic curves are curves that define the major shape of a surface. For example, one set of curves that may be used for the femur are curves over the sides and top of one of the condyles; however, other curves can be used without departing from the instant invention. A set of curves that may be used for the tibia are curves over the front of the tibial plateau and over the tibial tuberosity; however, again, other curves can be used without departing from the instant invention. In a preferred embodiment, ten to twenty points are sampled per curve; however, any number sufficient to define the shape of the curve may be used without departing from the instant invention. Polynomials or other mathematical functions are next fit to these data points to make smooth curves, col 18, ln 20-40)
determining, from the relationships between the pointer and the bone model, points relative to the bone model( After sampling, the procedure software relates the sampled points to points on the three-dimensional computer model of the body, to more accurately register the surgical plan data to the femur 10, col 17, ln 35-40)
wherein the plate design data is indicative of the positions of the points( As reflected by block 280, the "snake" algorithm first forms a continuous boundary, called an active contour 290, which consists of a series of points 300 connected by straight lines 310. For the first slice of image data, the operator specifies the positions of these points on the image data using a pointer,, col 9, ln 55-61),
determining a curve based on a sequence of two or more of said points( which consists of a series of points 300 connected by straight lines 310, col 9, ln 57-60/ The ankle center 390 is determined by finding the midpoint of a line connecting points located approximately at the center of each of the medial and lateral malleoli ("malleoli points"), col 11, ln 39-42/ Polynomials or other mathematical functions are next fit to these data points to make smooth curves, col 18, ln 37-40/ identifying epicondyle points on each of a femoral lateral epicondyle and a femoral medial epicondyle, defining a line segment connecting the epicondyle points, col 26, ln 55-60).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan with Delp to incorporate the above feature because this determines optimal alignment of resections preoperatively, and uses computer modeling techniques to help the surgeon achieve that alignment.
EK teaches the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment( A 3-D transducer probe (e.g., a digitizer) is moved on or over the surface along a random path, and the sample points are digitized to generate a real-time topography or map on a computer screen of selected properties of the object,, para[0015], ln 6-11/ and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters, Datum curves 86 and 87, representing the medial-lateral ("ML") and anterior-posterior ("AP") curves, are constructed by connecting the end points of the line elements 81a and 81b, and 82a and 82b and the point of origin 80, which is common to both curves, para[0177], ln 1-6/ Fig. 14a/ if a greater depth of implant is needed as a result of the defect appearance the offset curves 88 and 89 (as shown in FIG. 14a) can be extended to increase the overall thickness of the implant 40, para[0183], ln 1-6),
generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters( the offset curves may be eliminated entirely so that the contoured surface is backed by a revolved geometry that is symmetrical to reference axis 20A. Turning to FIG. 19c, where the ML curve and AP curve (defined by the obtained measurements) are not axially symmetrical, the thickness of the implant 40 requires adjustment. At the same time, an unnecessarily thick implant requires a greater amount of bone to be removed at the target site. Therefore, the thickness of the implant may be determined by taking the largest obtained measurement and adding a minimal offset amount 208. (The implant is thinnest at the highest point on the ML curve.) This can be similarly accomplished by adjusting the angle A (FIG. 19a) of the bone-contacting surface 42 of the implant 40 and a corresponding angle of the preparation tool. This also allows for a correction of the implant geometry, to compensate for any non-perpendicular placement of the guide pin with respect to the articular surface, para[0183], ln 3-23).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan and Delp with EK to incorporate the above feature because this provides A single procedure technique involving establishing the normal axis, measuring , and selecting the appropriate size implant is therefore feasible and utilizing a single reference axis, multiple reference axes may be used for measuring, mapping, or cutting a single defect or an articular surface having multiple defects, as well as for fabricating a single implant, or multiple implants for a single articular surface.
As to claim 18, EK teaches visualizing, on the display device, the points relative to the bone model; visualizing, on the display device, a manipulation of the points, and adapting the plate design data in accordance with the manipulation, the manipulation comprising at least one of a deletion, insertion and shifting of a point, col 16, ln 62-67/ col 17, ln 25-34) for the same reason as to claim 17 above.
34. Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) in view of Ek( US 20030060887 A1) and further in view of Leloup( US 20050027304 A1).
As to claim 19, Leloup teaches visualizing the points comprises visualizing a graphical representation of at least one pair of fixation openings( a graphical view representing a cross section of the nail at the locking hole. The latter view is generated from a 3D model of the IN obtained before the operation on the basis of data for manufacturing the implant. The model is produced using a conic projection model with three projection parameters in order to simulate the projection of the points in space on 2D images. Projection cones are therefore not constructed. Thanks to this 3D model, the orientation and the position of the distal holes are known relative to the proximal end of the nail, para[007], ln 6-20/ The authors define the "centre of the nail" as the middle of the segment joining the centres of the two distal locking holes. The translational movement is calculated so as to bring into coincidence, on each image, the projections of the centre of the nail of the 3D model with the corresponding points located on each image, para[0007], ln 27-32/ The sole constraint lies in the visibility of the distal holes in each of the two images. Adjustment of the position of the radioscopic unit is thereby simplified, which reduces the irradiation of the patient and of the surgical team. In addition, the surgeon has available a three-dimensional view, which makes it possible to display simultaneously several views of the nail and of the tool at whatever angle; an extrapolation of the path of the drill bit may be displayed on the screen, and the error in the initial position may be calculated and supplied to the surgeon before insertion of the screw, para[0089]).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan, Delp and EK with Leloup to incorporate the above feature because this provides the aid of the brightness amplifier in order for the axis of the drill to coincide with that of the locking hole.
35. Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bryan(US 20130085590 A1) in view of Delp(US 5682886 A) in view of Ek( US 20030060887 A1) in view of Leloup( US 20050027304 A1) and further in view of Steingart( US 20090248184 A1).
As to claim 20, Leloup teaches visualizing the curve on the display device( para[0077], ln 5-8) for the same reason as to claim 19 above.
Steingart teaches adapting the visualized curve responsive to the manipulation of the points( Profiles are edited by manipulating a series of joined lines and curves on a two-dimensional plane. The haptic device is restricted in motion to x and y and gives the physical sensation of touching a flat plane. As with the guide curve edit points, haptic snaps assist in the selection and movement of the profile points, as well as the manipulation of handles to control the curve tangent direction at those points., para[0185]).
It would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the teaching of Bryan, Delp, EK and Leloup with Steingart to incorporate the above feature because this features a computer-based design application configured to allow the intuitive construction of irregular, amorphous three-dimensional structures.
Response to the argument:
29. Applicant amendment filed on 9/03/04 has been considered but they are not persuasive:
Applicant argued in substance that :
(1) “ Claims 1-4 and 15-20 were rejected under 35 U.S.C. § 101 as being directed to an abstract idea "without significantly more." Applicant respectfully disagrees with this rejection because the claims are directed to methods and devices for pre-operatively designing a bone plate for subsequent use in a surgical procedure.”.
(2) “ von Jako fails to teach or motivate the claimed details of the selected points being representative of the respective center positions of first and second bone plate sections, but again rather only discloses that these are virtually representative of implant screw head centers. Further, von Jako fails to teach or motivate the claimed details of a curve interconnecting the first and second points being created on the virtual bone model and being representative of a length of at least one bone plate segment, but rather discloses that a curve virtually interconnects the implant screw head centers of different implants,”.
(3) “ first and second points being selected on the virtual bone model, but rather discloses that the attachment features, such as the pegs, are added to the implant design, i.e., when the implant basic shape has already been virtually designed. Additionally, Steines fails to teach or motivate the claimed details of a curve being created on the virtual bone model in order to interconnect the first and second points, i.e., identification of the points necessarily precedes the curve creation but rather discloses that that the attachment features are added at a later point in time to an already virtually defined center line curve of the designed implant extension”
30. Examiner respectfully disagreed with Applicant's remarks:
As to the point(1), As to Claims 1, 2 , 3, 4, 15, 16 have been rejected under 35 USC 101 for abstract idea without significantly more. Under Step 2A, Prong 1, the “ selecting at least a first point and a second point on the virtual bone model ”, “plate design data is determined”, “ the plate design data is determined”, “ recite a mental process since “ selecting” is function that can be reasonably performed in the human mind with the aid of pen and paper through observation, evaluation, judgment, opinion.
Under Prong 2, the additional element “ creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment; and generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters, wherein the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate. ” are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component, or merely a generic computer or generic computer components to perform the judicial exception, Accordingly, the additional elements do not integrate the recited judicial exception into a practical application, and the claim is therefore directed to the judicial exception. See MPEP 2106.05(f).
Under Step 2B, the additional elements “ creating a curve on the virtual bone model, the curve at least interconnecting the first point and the second point and being representative of a length of the at least one plate segment; and generating a data set that geometrically defines the bone plate from at least the derived plate design data and one or more generic plate parameters, wherein the derived plate design data or the one or more generic plate parameters comprises a number of fixation openings of the bone plate ” - this is mere instructions to apply the mental process under mpep 2106.05(f) amounts to merely generally linking the use of the judicial exception to a particular technological environment or field or use, and is merely applying the judicial exception, therefore, does not amount to significantly more, hence, cannot provide an inventive concept.
Claims 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to Claim 17 has been rejected under 35 USC 101 for abstract idea without significantly more. Under Step 2A, Prong 1, the “ determining relationships between a pointer positioned relative to the bone model”, “ determining, from the relationships between the pointer and the bone model,” recite a mental process since “ determining” is function that can be reasonably performed in the human mind with the aid of pen and paper through observation, evaluation, judgment, opinion.
Under Prong 2, the additional element “ visualizing, based on shape data of a bone, a bone model on a display device, deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data comprises, the plate design data is indicative of the positions of the points; determining a curve based on a sequence of two or more of said points, the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment; and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters ” are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component, or merely a generic computer or generic computer components to perform the judicial exception, Accordingly, the additional elements do not integrate the recited judicial exception into a practical application, and the claim is therefore directed to the judicial exception. See MPEP 2106.05(f).
Under Step 2B, the additional elements “ visualizing, based on shape data of a bone, a bone model on a display device, deriving, responsive to the user interaction signals that are indicative of user interactions relative to the bone model, plate design data, wherein deriving the plate design data comprises, the plate design data is indicative of the positions of the points; determining a curve based on a sequence of two or more of said points, the curve being representative of an extension of the bone plate or of the at least one plate segment of the bone plate, and wherein the plate design data comprise curve data indicative of the extension of the bone plate or of the at least one plate segment; and generating a data set that geometrically defines a bone plate design from at least the plate design data and one or more generic plate parameters ” - this is mere instructions to apply the mental process under mpep 2106.05(f) amounts to merely generally linking the use of the judicial exception to a particular technological environment or field or use, and is merely applying the judicial exception, therefore, does not amount to significantly more, hence, cannot provide an inventive concept.
As to the point (2), von Jako teaches The navigation module 260 registers the location of the device to acquired patient data, and generates image data suitable to visualize the patient image data and a representation of the device. In the embodiment illustrated in FIG. 2, the image data is transmitted to a display controller 230 over local interface 215. The display controller 230 is used to output the image data to two displays 214 and 218, para[0061], In 5-10/ As illustrated in FIG. 4, a user interface, such as a display, shows a real-time (or substantially real-time due to an inherent system delay) position and orientation of a model or representation of the implant (e.g., a pedicle screw) on 2D fluoroscopic images, for example. The position and orientation of the implant model may also be displayed on a registered 3D dataset such as a CT scan. The implant model may appear as a line rendering, a few simply shaded geometric primitives (e.g., a parametric model containing two cylinders representing the screw head and body), or a realistic 3D model from a computer-aided design (CAD) file, for example. Regardless of the visualization using to depict the implant[bone plate], the implant model includes representations of key features of the implant[bone plate] that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para[0068] to para[0069] /As shown, for example, in FIG. 4, a plurality of screws 410-413 are placed in a plurality of vertebrae in a patient's spine 420. Positional (and orientation) measurements of the implanted screws and orientation data may be measured for implants[bone plate] in real-time or substantially in real-time as the screws are placed by the user. An implant center point, such as a center of an implant screw head, is identified and used for measurement purposes, for example. As described above, a straight or curved rod may be placed by a user between screw heads (e.g., between center points of the screw heads). The position of the screw may be known due to navigation/tracking measurement, as described above, and/or through image processing without navigation, for example. Position and orientation of the implant may be measured and/or represented in 2D space, 3D space and/or a combination of 2D and 3D space, for example. In certain embodiments, position and distance measurement data may be presented to a user in an absence and/or aside from an image display, para[0076] to para[0077] / FIG. 4, a user interface, such as a display, shows a real-time (or substantially real-time due to an inherent system delay) position and orientation of a model or representation of the implant (e.g., a pedicle screw) on 2D fluoroscopic images, for example. The position and orientation of the implant model[bone plate] may also be displayed on a registered 3D dataset such as a CT scan. The implant model[bone plate] may appear as a line rendering, a few simply shaded geometric primitives (e.g., a parametric model[bone plate] containing two cylinders representing the screw head and body), or a realistic 3D model from a computer-aided design (CAD) file, for example the implant model[bone plate] includes representations of key features of the implant[bone plate] that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para [0068]/ the implant model includes representations of key features of the implant that may be used for subsequent measurements. For example, the screw model includes a point feature for a center of a rod slot in the screw head. Additionally, the model may include a vector feature describing the orientation of the rod slot, for example, para[0069]/ once two or more screws are placed, measurements can be made between the features. A simple calculation of rod length may be determined using the cumulative distance between a series of screws (e.g., for three screws 1, 2, 3 the cumulative distance would be |pt2-ptl+|pt3-pt2]), para [0071]/ In certain embodiments, position and orientation data may be measured for implants in real-time or substantially in real-time as the screws are placed by the user. An implant center point, such as a center of an implant screw head, is identified and used for measurement purposes, for example., para[0076] / As described above, a straight or curved rod may be placed by a user between screw heads (e.g., between center points of the screw heads). The position of the screw may be known due to navigation/tracking measurement, as described above, and/or through image processing without may be taken automatically by a tracking system and/or in conjunction with a user initiation (e.g., by user trigger based on a button click, pressure on the tool, keyboard selection, mouse selection, etc.), para[0074]/ In certain embodiments, position navigation, for example. Position and orientation of the implant may be measured and/or represented in 2D space, 3D space and/or a combination of 2D and 3D space, for example. In certain embodiments, position and distance measurement data may be presented to a user in an absence and/or aside from an image display, para[0076] to para[0077]/ Based on implant position and orientation information and distance measurements between implants, a user may determine an appropriate rod length and/or curvature for placement between implant positions. In certain embodiments, a user may be provided with suggested types, lengths and/or curvatures of rod , para|(0078]/ For example, a calculation of rod length may be determined using a cumulative distance between a series of screws (e.g., for three screws 1,2,3 the cumulative distance would be [pt2-ptl[+|pt3-pt2)). Additionally, three or more screws have rod slot points that can be fit to a curve. Calculation of curvature may be used to select and/or suggest an appropriately shaped rod. An orientation of the rod slot in two or more screws may also be used for determination of curvature, for example. Additionally, pedicle screw and/or another implant placement may be stored to aid in subsequent implant placement. For example, a placement location of a pedicle screw may be stored or otherwise maintained while placing additional screws at adjacent levels. Knowing prior placement at adjacent levels may help subsequent screws to be driven to like depths and angles, para[0084] to para[0085]/ the first and second center point are located on one implant mode[bone plate] of implant as described above).
As to the point( 3), Steines teaches the system can add pegs or anchors or other attachment mechanisms. The system can place the features using anatomical landmarks. Constraints can be used to restrict the placement of the features. Examples of constraints for placement of pegs are the distance between pegs and from the pegs[points] to the edge of the implant[bone plate], the height of the pegs that results from their position on the implant, and forcing the pegs to be located on the center[center] line[curve], para[00025]/ Once the posterior bone cut surface 350is properly positioned, a posterior tray 360 is filled in on the virtual implant and trimmed to optimize the design of the implant. As shown in FIG. 11, fixation pegs 370 and 380 can then be added. Preferably, the pegs 370 and 380 are positioned in a flexed position relative to the mechanical axis and/or the primary direction of the forces on the knee applied by the femur, para[0069], In 8-30/referring to FIGS. 29 and 30, the system provides a function for positioning of pegs 700, 705 for attachment of the implant 710 [bone plate] to bone. The system allows a user to control the distances and the pegs heights, but these aspects could also be automated in other embodiments,[000119]/ Referring to FIGS. 29 and 30, the system provides a function for positioning of pegs 700, 705 for attachment of the implant 710 to bone. The system allows a user to control the distances and the pegs heights, but these aspects could also be automated in other embodiments. [000119] When started, the class displays the implant in the wireframe mode in the profile view and suggests default positions 720, 730 for the pegs, marked[select] on the screen as circles: [000120] The user can move the pegs by dragging[select] them. The pegs are moved along the center lines keeping constant distance between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights. [000121] The pegs 700, 705 can be pre-viewed with dynamic view changing by clicking button Preview and made with filleting their intersection with the implant inner surface by clicking Accept, para[000118]/ When started, the class displays the implant in the wireframe mode in the profile view and suggests default positions 720, 730 for the pegs, marked[select] on the screen as circles: [000120]/ The user can move the pegs by dragging them. The pegs are moved along the center lines[curve] keeping constant distance[length] between them. The toolbar displays the distances between the cutting plane and the first peg (dl), between the two pegs (d2), and between the second peg and the apex point of the implant contour (d3). It also displays the pegs heights, [000121]/ of constraints for placement of pegs are the distance between pegs and from the pegs to the edge of the implant, the height of the pegs that results from their position on the implant, and forcing the pegs to be located on the center line, para[0025], ln 5-9/ while using a larger tolerance in the approximation make a smoother outer curve, but it may result in deviation from the vertical center line. To accommodate this phenomenon, a function is implemented that corrects the control points of the center line B- spline -- adjusting them into the vertical line starting at some point, para[000104], ln 8-12/the line center is created since length of line center is forced by using the constraint distance between the legs as described above ).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
US 20050049603 teaches A1US 20130190767 A1( The 2D and 3D models of the knee from Stage I are viewable on the pre-operative planning system PC display as well as a library LINK of the femoral and tibial knee implant components. The library includes 3D models of various size implants and other ancillary parts. The names of the implant manufacturers and manufacturer's surgical criteria and optimum alignment conditions for implant installation will also be available.
US 20100064216 A1 teaches FIG. 2a, a tibial preparation system 10 can comprise a surgical orientation device 12, or other measuring device, which can be used to measure and record the location of anatomical landmarks of use in a total knee procedure, such as the location of the mechanical axis of the leg. The mechanical axis of the leg, as defined herein, generally refers to an axial line extending from the center of rotation of a proximal head of a femur (e.g. the center of the femoral head) through the center of the knee, to a center, or mid-point, of the ankle (see, for example, FIG. 1).
US 20080319491 A1 teaches Furthermore, if the surgeon desires, he can rotate or manipulate model 301 so that he can visually appreciate the general shape and characteristics of the patient's femur, particularly as the acquired bony anatomical landmark points shown on the model remain accurate as it is manipulated by the surgeon. In addition to displaying the acquired femoral landmark points (i.e. points 307, 309, 311, 313 and 315),
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LECHI TRUONG whose telephone number is ( 571) 272-3767. The examiner can normally be reached on 10-8PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chow, Dennis can be reached on ( 571) 272-7767 . The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR of Public PAIP. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pairdirect.uspto.gov. Should you have questions on access to the Private PAIP system, contact the Electronic Business Center (EBC) at 866-217- 9197(toll-free).
/LECHI TRUONG/ Primary Examiner, Art Unit 2194
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