Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Applicant’s Arguments
Applicant’s arguments filed 04/08/2026 have been fully considered, but they are not deemed to be persuasive based on the new reference of BECKER et al (EP 3581121). Specifically, Becker teaches the amended feature “wherein the ordering corresponds to a sequential traversal of the periphery at the intersection” (Becker, [0082] - the resection volume (RV) is defined by the volumetric intersection of the anatomical model (AM) and the implant model (IM). The software program 80, with assistance from the geometric engine 72, is configured to compute geometric interactions between the anatomical model (AM) and the implant model (IM) for defining the resection volume (RV). The resection volume (RV) can be shaped to the implant model (IM), while taking into account any designed interferences/clearances for fit; [0118] - The software program 80, with the assistance of the geometric engine 72, is configured to define a reference guide (G), as shown in FIGS. 4-6. The reference guide (G) is a feature derived from the geometry of the resection volume (RV). As will be understood below, the reference guide (G) is used to define positioning of various segments of the milling path 100. The reference guide (G) may be a freeform CAD modeled geometry; [0137] - The intersection points (p) are spaced apart from one another along the reference spline (RS) by a distance (d1), as shown best in FIG. 4. The distance (d1) between any number of intersection points (p) may be constant or equidistant, or evenly distributed. Alternatively or additionally, as shown in FIG. 4, the distance (d1) between any number of successive intersection points (p) may be variable or non-equidistant; [0161] - To reiterate, each section path (SP) is defined with respect to a corresponding section (S). More specifically, the geometric engine 72 computes the intersection of the section (S) with the resection volume (RV). This intersection is the resection face (RF), which is the slice of the resection volume (RV) intended for milling. The resection face (RF) can be a planar or non-planar geometrical object. The resection face (RF) is a bounded subset of the section (S). Examples of the resection faces (RF) are shown in FIGS. 6A and 7-11; [0174] - Each section path (SP) has a starting point (SP-START) and an ending point (SP-END), as shown in FIGS. 7, 9 and 12, for example. The starting point (SP-START) and ending point (SP-END) are located on the section (S) and can be chosen based on default positions or positions for optimizing the tool path. In one example, as shown in FIG. 9, the starting point (SP-START) and ending point (SP-END) are each bounded within the resection face (RF). Alternatively, as shown in FIG. 7, the starting point (SP-START) and/or ending point (SP-END) can be outside of the resection face (RF). Milling for the section path (SP) begins at the starting point (SP-START) and finishes at the ending point (SP-END). The starting point (SP-START) and the ending point (SP-END) can sometimes be the same point, as in FIGS. 9 and 12. As will be described below, techniques are provided for transitioning between section paths (SP), or more specifically, from the ending point (SP-END) of one section path (SP) to the starting point (SP-START) of another section path (SP). With the single-pass milling techniques provided herein, milling continues along the entire path of each section path (SP), i.e., from the starting point (SP-START) to the ending point (SP-END); [0267] - The tool 20 initially begins moving along the lead-in segment (LIS) until the tool 20 tangentially reaches the starting point of the first section path (SP-F). The tool 20 follows transition segments (T) connecting successive section paths (SP). The tool 20 is elevated during certain transition segments (T) by following the offset transition segments (OTS)). Accordingly, the claimed invention as represented in the claims does not represent a patentable distinction over the art of record.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-33 are rejected under 35 U.S.C. 103 as being unpatentable over LANG (US 20210192759) in view of SUGITA et al (Tool path generator for bone machining in minimally invasive orthopedic) and MORIKAWA et al (5-Axis control tool path generation using curved surface interpolation -
https://www.jstage.jst.go.jp/article/jsmec/49/4/49_4_1209_pdf/-charen), and further in view of BECKER et al (EP 3581121).
As per claim 1, Lang teaches the claimed "computer-implemented method" comprising: "obtaining a three-dimensional (3D) model of a patient anatomy, the 3D model comprising a collection of points defining a periphery of the 3D model, the periphery of the 3D model representing a periphery of the patient anatomy" (Lang, [0025] - the first anatomic structure and/or the second anatomic structure comprises at least one of an anatomic landmark, an anatomic plane, an articular surface, a cartilage surface, a subchondral bone surface, a cortical bone surface, a cut bone surface, a reamed bone surface, a milled bone surface, an impacted bone surface, a tissue resection, a surface, one or more surface points, an anterior-posterior dimension of at least a portion of the physical joint, a medio-lateral dimension of at least a portion of the physical joint, a superior-inferior dimension of at least a portion of the physical joint, a joint space in extension, a joint space in flexion, a flexion gap, an extension gap, an anatomic axis, a biomechanical axis, a mechanical axis or a combination thereof; [0311] - A 3D reconstruction of image data or other data of the patient can be generated preoperatively, intraoperatively and/or postoperatively. A virtual 3D representation can include an entire anatomic area or select tissues or select tissues of an anatomic area); "based on clipping the 3D model, the clipping forming at least one clipped surface of the 3D model that intersects the periphery of the 3D model, obtaining a set of points, of the collection of points, that are on or adjacent one or more intersections of the at least one clipped surface and the periphery of the 3D model, the set of points forming a path along the periphery of the 3D model and corresponding to points on the patient anatomy" (Lang, [0108] - the virtual bone cut plane is configured to guide a bone cut in a predetermined varus or valgus orientation or in a predetermined tibial slope or in a predetermined femoral flexion of an implant component or in a predetermined leg length; [0353] - Using the touch area or other virtual interface, the surgeon can then move the arbitrary virtual plane into a desired position, orientation and/or alignment. The moving of the arbitrary virtual plane can include translation and rotation or combinations thereof in any desired direction using any desired angle or vector. The surgeon can move the arbitrary virtual plane to intersect with select anatomic landmarks or to intersect with select anatomic or biomechanical axes; [0723] - The following is an exemplary description of a portion of a hip replacement procedure shown in the illustrative example in FIG. 7A-H, where the surgeon elects to make a correction to the proximal femoral cut prior to proceeding with the subsequent steps of the procedure; [0725] - FIG. 7B shows a cross-section or top view of the intended virtual femoral neck cut (broken outline) 97, for example as developed in the virtual surgical plan. The perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur, for example simulated using data from a pre-operative imaging study of the patient, e.g. CT or MRI, is relatively round in this example with slightly greater diameter in medial-lateral direction). It is noted that Lang does not explicitly teach "determining an ordering of the set of points, the ordering specifying a sequence of the points, of the set of points, from a first point of the set of points to a last point of the set of points in a continuous path along the periphery of the 3D model, such that each next point in the sequence from a current point in the sequence is a next-encountered point traveling along the continuous path from the first point to the last point; and performing processing based on the determining." However, Morikawa and Sugita teaches the claimed "determining an ordered sequence of points" in the cutting plane to define a tool path (Morikawa, Figures 2 and 3 - cutting point curve Ci; 3. Tool path generation - Figures 4-7; Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software). Furthermore, Becker teaches the amended feature “wherein the ordering corresponds to a sequential traversal of the periphery at the intersection” (Becker, [0082] - the resection volume (RV) is defined by the volumetric intersection of the anatomical model (AM) and the implant model (IM). The software program 80, with assistance from the geometric engine 72, is configured to compute geometric interactions between the anatomical model (AM) and the implant model (IM) for defining the resection volume (RV). The resection volume (RV) can be shaped to the implant model (IM), while taking into account any designed interferences/clearances for fit; [0118] - The software program 80, with the assistance of the geometric engine 72, is configured to define a reference guide (G), as shown in FIGS. 4-6. The reference guide (G) is a feature derived from the geometry of the resection volume (RV). As will be understood below, the reference guide (G) is used to define positioning of various segments of the milling path 100. The reference guide (G) may be a freeform CAD modeled geometry; [0137] - The intersection points (p) are spaced apart from one another along the reference spline (RS) by a distance (d1), as shown best in FIG. 4. The distance (d1) between any number of intersection points (p) may be constant or equidistant, or evenly distributed. Alternatively or additionally, as shown in FIG. 4, the distance (d1) between any number of successive intersection points (p) may be variable or non-equidistant; [0161] - To reiterate, each section path (SP) is defined with respect to a corresponding section (S). More specifically, the geometric engine 72 computes the intersection of the section (S) with the resection volume (RV). This intersection is the resection face (RF), which is the slice of the resection volume (RV) intended for milling. The resection face (RF) can be a planar or non-planar geometrical object. The resection face (RF) is a bounded subset of the section (S). Examples of the resection faces (RF) are shown in FIGS. 6A and 7-11; [0174] - Each section path (SP) has a starting point (SP-START) and an ending point (SP-END), as shown in FIGS. 7, 9 and 12, for example. The starting point (SP-START) and ending point (SP-END) are located on the section (S) and can be chosen based on default positions or positions for optimizing the tool path. In one example, as shown in FIG. 9, the starting point (SP-START) and ending point (SP-END) are each bounded within the resection face (RF). Alternatively, as shown in FIG. 7, the starting point (SP-START) and/or ending point (SP-END) can be outside of the resection face (RF). Milling for the section path (SP) begins at the starting point (SP-START) and finishes at the ending point (SP-END). The starting point (SP-START) and the ending point (SP-END) can sometimes be the same point, as in FIGS. 9 and 12. As will be described below, techniques are provided for transitioning between section paths (SP), or more specifically, from the ending point (SP-END) of one section path (SP) to the starting point (SP-START) of another section path (SP). With the single-pass milling techniques provided herein, milling continues along the entire path of each section path (SP), i.e., from the starting point (SP-START) to the ending point (SP-END); [0267] - The tool 20 initially begins moving along the lead-in segment (LIS) until the tool 20 tangentially reaches the starting point of the first section path (SP-F). The tool 20 follows transition segments (T) connecting successive section paths (SP). The tool 20 is elevated during certain transition segments (T) by following the offset transition segments (OTS)). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by using an ordered sequence of point to define a tool path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 2 adds into claim 1 "wherein the obtained set of points comprises the points, of the set of points, with no ordering specified in terms of the sequence from the first point to the last point in the continuous path" which Lang teaches in his "perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur" (e.g., figures 8B and 8D) in which the points along the continuous boundary of the cross- section have no ordering specified in terms of the sequence from the first point to the last point in the continuous path; or points on Sugita's cross-section boundary not belong to the zig-zag cutting path (Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software) (Lang, [0723] - The following is an exemplary description of a portion of a hip replacement procedure shown in the illustrative example in FIG. 7A-H, where the surgeon elects to make a correction to the proximal femoral cut prior to proceeding with the subsequent steps of the procedure; [0725] - FIG. 7B shows a cross-section or top view of the intended virtual femoral neck cut (broken outline) 97, for example as developed in the virtual surgical plan. The perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur, for example simulated using data from a pre-operative imaging study of the patient, e.g. CT or MRI, is relatively round in this example with slightly greater diameter in medial-lateral direction). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by obtaining points with no order specified in terms of the sequence from the first point to the last point in the continuous path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 3 adds into claim 1 "wherein the obtained set of points is obtained without a specified ordering of the points" which Lang teaches in his "perimeter and/or cross- section and/or surface area and/or shape of the virtually cut femur" (e.g., figures 8B and 8D) in which the points along the continuous boundary of the cross-section have no ordering specified in terms of the sequence from the first point to the last point in the continuous path; or points on Sugita's cross-section boundary not belong to the zig-zag cutting path (Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software) (Lang, [0725] - FIG. 7B shows a cross-section or top view of the intended virtual femoral neck cut (broken outline) 97, for example as developed in the virtual surgical plan. The perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur, for example simulated using data from a pre-operative imaging study of the patient, e.g. CT or MRI, is relatively round in this example with slightly greater diameter in medial-lateral direction; [0727] - FIG. 7D shows the top view or cross-section of the physical femoral neck cut (solid outline) 99. The perimeter and/or cross-section and/or surface area and/or shape of the physical femoral neck cut is different than the perimeter and/or cross-section and/or surface area and/or shape of the virtually planned cut femur). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by obtaining points with no order specified in terms of the sequence from the first point to the last point in the continuous path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 4 adds into claim 1 "wherein the obtained set of points is obtained with an order that indicates two points of the set, having one or more other points of the set between the two points along the periphery of the 3D model by being sequentially-prior, in the order, to the one or more other points" (Morikawa, Figures 2 and 3 - cutting point curve Ci; 3. Tool path generation - Figures 4-7; Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by using an ordered sequence of point to define a tool path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 5 adds into claim 1 "wherein the ordering of the set of points identifies a contiguous path on the periphery of the patient anatomy identifying step-wise traversal around the patient anatomy in a direction" (Morikawa, Figures 2 and 3 - cutting point curve Ci; 3. Tool path generation - Figures 4-7; Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by using an ordered sequence of point to define a tool path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 6 adds into claim 1 "receiving from a user a definition of one or more clips to clip the 3D model" (Lang, [0108] - the virtual bone cut plane is configured to guide a bone cut in a predetermined varus or valgus orientation or in a predetermined tibial slope or in a predetermined femoral flexion of an implant component or in a predetermined leg length; [353] - Using the touch area or other virtual interface, the surgeon can then move the arbitrary virtual plane into a desired position, orientation and/or alignment. The moving of the arbitrary virtual plane can include translation and rotation or combinations thereof in any desired direction using any desired angle or vector. The surgeon can move the arbitrary virtual plane to intersect with select anatomic landmarks or to intersect with select anatomic or biomechanical axes; [0723] - The following is an exemplary description of a portion of a hip replacement procedure shown in the illustrative example in FIG. 7A-H, where the surgeon elects to make a correction to the proximal femoral cut prior to proceeding with the subsequent steps of the procedure; [0725] - FIG. 7B shows a cross-section or top view of the intended virtual femoral neck cut (broken outline) 97, for example as developed in the virtual surgical plan. The perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur, for example simulated using data from a pre-operative imaging study of the patient, e.g. CT or MRI, is relatively round in this example with slightly greater diameter in medial-lateral direction).
Claim 7 adds into claim 1 "obtaining a definition of one or more clips to clip the 3D model and determining the set of points by clipping the 3D model with the defined one or more clips" (Lang, [0725] - FIG. 7B shows a cross-section or top view of the intended virtual femoral neck cut (broken outline) 97, for example as developed in the virtual surgical plan. The perimeter and/or cross-section and/or surface area and/or shape of the virtually cut femur, for example simulated using data from a pre-operative imaging study of the patient, e.g. CT or MRI, is relatively round in this example with slightly greater diameter in medial-lateral direction; [0727] - FIG. 7D shows the top view or cross-section of the physical femoral neck cut (solid outline) 99. The perimeter and/or cross-section and/or surface area and/or shape of the physical femoral neck cut is different than the perimeter and/or cross-section and/or surface area and/or shape of the virtually planned cut femur).
Claim 8 adds into claim 7 "wherein the clipping is defined by one or more clips defined by a user" (Lang, [0108] - the virtual bone cut plane is configured to guide a bone cut in a predetermined varus or valgus orientation or in a predetermined tibial slope or in a predetermined femoral flexion of an implant component or in a predetermined leg length; [0353] - Using the touch area or other virtual interface, the surgeon can then move the arbitrary virtual plane into a desired position, orientation and/or alignment. The moving of the arbitrary virtual plane can include translation and rotation or combinations thereof in any desired direction using any desired angle or vector. The surgeon can move the arbitrary virtual plane to intersect with select anatomic landmarks or to intersect with select anatomic or biomechanical axes).
Claim 9 adds into claim 1 "wherein the set of points comprises at least 5 points" which is obvious in the graphical representation of the perimeter, top view or cross- section of the physical femoral neck cuts 111 and 113 (Lang, figure 8B and 8D) in which the number of points is used to define the continuous perimeter curve of the cutting surface.
Claim 10 adds into claim 1 "wherein the performing processing comprises outputting the ordering of the set of points as, or to facilitate generation of, a cut path along the periphery of the patient anatomy" (Morikawa, Figures 2 and 3 - cutting point curve Ci; 3. Tool path generation - Figures 4-7; Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by using an ordered sequence of point to define a tool path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claim 11 adds into claim 1 "using the ordering of the set of points to define a virtual boundary for surgical cutting execution" (Morikawa, Figures 2 and 3 - cutting point curve Ci; 3. Tool path generation - Figures 4-7; Sugita, IV. TOOL PATH GENERATION IN MINIMALLY INVASIVE SURGERY - D. Generation of Tool Path - The type of generated path is a zig-zag, and the cutting parameters, such as up/down cutting, are set in the software). Thus, it would have been obvious, in view of Morikawa, Sugita and Becker, to configure Lang's method as claimed by using an ordered sequence of point to define a tool path. The motivation is to generate a minimally invasive surgical procedure, avoiding interference with soft tissues.
Claims 12-22 and 23-33 claim a system and a computer program product based on the method of claims 1-11; therefore, they are rejected under a similar rationale.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHU K NGUYEN whose telephone number is (571)272-7645. The examiner can normally be reached M-F 8-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel F. Hajnik can be reached at (571) 272-7642. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHU K NGUYEN/ Primary Examiner, Art Unit 2616
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