DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Pending
1-22
35 U.S.C. 101
1-21
35 U.S.C. 103
1-22
Priority
Applicant’s indication of Domestic Benefit information based on provisional application 63/547,902 filed 11/09/2023 is acknowledged. This date has been established as the earliest effective filing date of the instant application claims through comparison of the provisional and non-provisional disclosures.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on 01/07/2025 and 02/06/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1 and 21 is/are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s):
1.
A computer-implemented method for generating a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone that defines a socket for a joint, the computer-implemented method comprising:
obtaining a model of the bone including the socket;
intersecting an allowed volume with the model of the socket for defining a resection volume intended to be removed from the bone;
generating a plurality of sections;
for at least one section:
identifying a sub-volume of the resection volume corresponding to the section;
generating one or more milling path segments designed to enable the tool to remove the sub-volume of the resection volume;
identifying, for the sub-volume of the resection volume, a region to be avoided by the tool;
generating one or more transition path segments designed to avoid the region; and
generating the milling path by combining the one or more milling path segments and the one or more transition path segments.
21.
A non-transitory computer readable medium comprising instructions executable by one or more processors, wherein the instructions implement a software program for generating a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone that defines a socket for a joint, the software program being configured to:
obtain a model of the bone including the socket;
intersect an allowed volume with the model of the socket to define a resection volume intended to be removed from the bone;
generate a plurality of sections;
for at least one section:
identify a sub-volume of the resection volume corresponding to the section;
generate one or more milling path segments designed to enable the tool to remove the sub-volume of the resection volume;
identify, for the sub-volume of the resection volume, a region to be avoided by the tool;
generate one or more transition path segments designed to avoid the region; and
generate the milling path by combining the one or more milling path segments and the one or more transition path segments.
These limitations, as drafted, are simple processes that, under their broadest reasonable interpretation, cover performance of the mind, but for the recitation of the italicized limitations above. That is, other than reciting the italicized limitations, nothing in the claim elements preclude the steps from being performed in the mind. For example, a human can, in their mind, perform the bolded limitations recited above.
This judicial exception is not integrated into a practical application. The claim recites the additional elements italicized above. The italicized elements is/are recited at a high level of generality and merely link(s) the use of the abstract idea to a particular technological environment (see MPEP 2106.05(h)). Accordingly, even in combination, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional italicized elements is/are no more than mere generic linking of the abstract idea to a technological environment, which cannot provide an inventive concept. Thus, the limitations do not provide an inventive concept, and the claim contains ineligible subject matter.
Claim(s) 2-5 and 7-20 recite(s) limitations that are no more that the abstract idea recited in claim(s) 1. The claims recite generating volumes, defining boundaries, defining transition path segments, identifying sub-volumes interrupted by a gap, determining dimensions of gaps and thresholds, generating transition path segments, defining the allowed volume, inner allowed volume, and safeguard volume, defining sectors, identifying sub-volumes based on sectors, defining milling path segments, generating connecting transition path segments, defining connecting transition path segments, defining geometries of the allowed volumes, and defining the type of bones can reasonably be performed in the human mind. Thus, the claim(s) contain(s) ineligible subject matter.
Claim(s) 6 recite(s) limitations that are no more that the abstract idea recited in claim(s) 1. The claims recite defining volume boundaries can reasonably be performed in the human mind. The claims recite the additional elements of the tool includes a spherical cutting burr having a burr radius are recited at a high level of generality to generically link the use of the abstract idea in a particular technological environment. Thus, the claim(s) contain(s) ineligible subject matter.
Claim(s) 22 recite(s) limitations that incorporate the abstract idea into a practical application. Thus, the claim(s) contain(s) eligible subject matter.
Examiner Note - Prior Art
Examiner has cited particular paragraphs/columns and line numbers or figures in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. See MPEP 2141.02 [R-01.2024] VI. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) . See also MPEP §2123. Applicant is reminded that the Examiner is entitled to give the broadest reasonable interpretation to the language of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. (US 20190380788 A1, “Becker”) and further in view of Mistry (US 2020/0261232 A1, “Mistry”).
Regarding claim 1: Becker teaches: A computer-implemented method for generating a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone [. . .], the computer-implemented method comprising: ([0012] One example of computer-implemented method for generating milling path for tool of surgical system is provided. milling path is designed to remove resection volume associated with anatomical volume)
obtaining a model of the bone [. . .]; ([0104] resection volume is generated from intersection between two 3D CAD solid bodies. One of these solid bodies is anatomical model)
intersecting an allowed volume with the model [. . .] for defining a resection volume intended to be removed from the bone; ([0077] software program defines, in succession, plurality of sections along reference guide. Each section intersects reference guide at different intersection point. Each section is at specified orientation relative to reference guide at intersection point. each section intersects resection volume. software program generates section path bounded within each section. Each section path is designed to remove portion of resection volume. plurality of transition segments connect section paths of successive sections along reference guide. These features of Milling path will be described in detail below. [0122] allowed volume is region where milling is potentially allowed. allowed volume is subset of (often less than, but at maximum being equal in volume to) region where tool is allowed to move)
generating a plurality of sections; ([0077] software program defines, in succession, plurality of sections along reference guide. each section intersects resection volume. [0164] software program intersects resection volume into discrete cut sections (e.g., planar or non-planar surfaces))
for at least one section: ([0077] plurality of sections along reference guide. each section intersects resection volume. [0164] software program intersects resection volume into discrete cut sections (e.g., planar or non-planar surfaces))
identifying a sub-volume of the resection volume corresponding to the section; ([0077] milling path is designed to remove resection volume associated with anatomical volume. software program defines reference guide, such as reference spline, with respect to resection volume. software program defines, in succession, plurality of sections along reference guide. Each section intersects reference guide at different intersection point. Each section is at specified orientation relative to reference guide at intersection point. each section intersects resection volume. software program generates section path bounded within each section. Each section path is designed to remove portion of resection volume. plurality of transition segments connect section paths of successive sections along reference guide)
generating one or more milling path segments designed to enable the tool to remove the sub-volume of the resection volume; ([0067] milling path generator is another software program or module run by controller. milling path generator generates milling path for tool to traverse, such as for removing sections of anatomy to receive implant. [0077] milling path is designed to remove resection volume associated with anatomical volume. software program defines reference guide, such as reference spline, with respect to resection volume. software program defines, in succession, plurality of sections along reference guide. Each section intersects reference guide at different intersection point. Each section is at specified orientation relative to reference guide at intersection point. Furthermore, each section intersects resection volume. software program generates section path bounded within each section. Each section path is designed to remove portion of resection volume. plurality of transition segments connect section paths of successive sections along reference guide)
identifying, for the sub-volume of the resection volume, a region to be avoided by the tool; ([0116] protected volume is region of anatomical volume that should be protected from milling. milling by tool is prohibited in protected volume. entry into protected volume by tool is prohibited even if tool is not milling. [0121] allowed volume at least partially intersects anatomical volume. protected volume may be defined by any volumetric region not included within allowed volume)
generating one or more transition path segments designed to avoid the region; and ([0117] protected volume, when defined, may be stored by controller. Once anatomical registration is performed with navigation system, anatomical model and corresponding protected volume become linked to anatomical volume. This enables manipulator controller to control tool relative to tracked anatomical volume for avoiding milling in protected volume. [0118] To implement protected volume, software program may utilize boundary generator to define one or more virtual boundaries for delineating surfaces between resection volume and protected volume. protected volume can be defined offline as part of CAD model for each implant size)
generating the milling path by combining the one or more milling path segments and the one or more transition path segments ([0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path).
However, Becker does not explicitly teach: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket.
Mistry teaches: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket ([0043] particularly those where a close fit is desirable or required between an implant and a curved bone surface, such as other ball and socket joints. [0046] Data obtained from the CT scan or MRI is preferably converted to a working computer aided design (“CAD”) model or virtual model of the patient's joint. After the CAD or virtual model of the patient's joint is created, the topography or outer surface of the bones in the joint may be visualized on a computer screen or any like visual medium. Preferably, the virtual model of the patient's joint is a 3D model that may be rotated and manipulated in 3D such that an operator visualizing the model on a computer screen may be able to see certain tissue structures and structures of bones individually or of all the bones in a joint at once, such as the pelvis and proximal femur in THA.
Becker and Mistry are analogous art to the claimed invention since they are from the similar field of surgical robots and modelling. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Becker with the aspects of Mistry to create, with a reasonable expectation for success, a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone that defines a socket for a joint, and model of the bone including the socket. The motivation for modification would have been to improve the effectiveness of procedures to seat implants in the joint including improved accuracy and stability of implant placement (Mistry, [0005]). This motivation for modification is similarly applied to claims that depend from claim 1.
Regarding claim 2: Becker-Mistry further teach: The computer-implemented method of claim 1, further comprising generating a safeguard volume within the allowed volume, wherein the safeguard volume defines a boundary for the tool, (Becker: [0122] allowed volume is region where milling is potentially allowed. allowed volume is subset of (often less than, but at maximum being equal in volume to) region where tool is allowed to move. allowed volume is potentially more restrictive than region where tool is allowed to move. less restrictive region where tool is able to move is important to allow user to move tool in and out of resection volume during procedure, for example, to get tool out of way in order to clean up soft tissue, apply suction, inspect anatomy, etc. [0123] In some instances, allowed volume may be understood as “keep in” volume, in terms of milling path generation. virtual boundaries are often “keep out” boundaries. Any combination of keep-in and/or keep-out virtual boundaries may be mixed along with keep-in allowed volume since allowed volume part is used for semi-autonomous or autonomous milling path generation)
wherein the allowed volume defines a boundary for the tool, wherein the boundary of the safeguard volume is spaced apart from the boundary of the allowed volume, and (Becker: [0090] As will be described in detail below, geometric engine is further configured to compute intersections between anatomical model and other objects, such as implant models, allowed volumes, etc. [0091] Another feature of geometric engine is ability to perform 3D offset operations. Offset operations define surface that is spaced apart from another surface by predefined distance. One output of offset operation is definition of offset boundary, which is described below. geometric engine can also support offset operations for given planar or non-planar contours. [0139] Accordingly, software program, with assistance of geometric engine and boundary generator, is configured to generate offset boundary, as shown in FIGS. 5 and 7-11. In one example, offset boundary is to account for geometric characteristics of tool. Alternatively, offset boundary may be to facilitate modifying resection volume for patient specific parameters. Hence, offset boundary may correspond to patient specific parameter)
wherein the one or more transition path segments are defined by a geometry of the safeguard volume (Becker: [0065] in FIG. 2, controller includes boundary generator. boundary generator is software program or module that generates planar or non-planar virtual boundary for constraining movement and/or operation of tool. Such virtual boundaries may also be referred to as virtual meshes, virtual constraints, or like. virtual boundaries may be defined with respect to anatomical model, such as 3-D bone model. [0066] virtual boundaries can be either implant-specific or patient-specific. [0069] geometric engine is another software program or module run by controller. geometric engine may be sub-set of milling path generator or may be program or module separate from milling path generator. geometric engine is configured to assist in milling path generation as well as providing on-the-fly flexibility for accommodating intra-operative changes to surgical plan, e.g., implant placement. [0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path).
Regarding claim 3: Becker-Mistry further teach: The computer-implemented method of claim 1, further comprising identifying that the sub-volume of the resection volume is interrupted by a gap defining an absence of the resection volume, wherein the region to be avoided by the tool includes the gap (Becker: [0116] protected volume (gap) is region of anatomical volume that should be protected from milling. milling by tool is prohibited in protected volume (gap). [0117] protected volume (gap), when defined, may be stored by controller. Once anatomical registration is performed with navigation system, anatomical model and corresponding protected volume (gap) become linked to anatomical volume. This enables manipulator controller to control tool relative to tracked anatomical volume for avoiding milling in protected volume (gap). [0118] To implement protected volume, software program may utilize boundary generator to define one or more virtual boundaries for delineating surfaces between resection volume and protected volume. [0196] section path is designed to remove resection face. remaining area of section that does not include resection face is prohibited region (gap). [0291] If milling will not occur during transition (gap), it is important that elevation of transition segment is such that tool does not interact with resection volume during transition between adjacent sections. [0141] offset boundary is defined relative to resection volume. defined within or beyond resection volume. Where there is allowed volume, offset boundary may be defined within allowed volume. offset boundary may extend beyond resection volume in direction extending away from bone/tissue being milled, in order to protect soft tissue or to avoid other objects).
Regarding claim 4: Becker-Mistry further teach: The computer-implemented method of claim 3, further comprising determining whether a dimension of the gap is greater than a threshold value and generating the one or more transition path segments in response to determining that the dimension of the gap is greater than the threshold value (Becker: [0116]-[0118]. [0196] section path is designed to remove resection face. remaining area of section that does not include resection face is prohibited region (gap). [0141] offset boundary is defined relative to resection volume. defined within or beyond resection volume. Where there is allowed volume, offset boundary may be defined within allowed volume. offset boundary may extend beyond resection volume in direction extending away from bone/tissue being milled, in order to protect soft tissue or to avoid other objects. [0291] If milling will not occur during transition (gap), it is important that elevation of transition segment is such that tool does not interact with resection volume during transition between adjacent sections. [0293] In some instances, transition segment may be offset or “lifted” from the footprint. lifting the transition segment from footprint reduces amount of material milled while traversing transition segment and avoids overly aggressive material removal of anatomical volume. [0295] transition-offset defines how high to lift transition segment. computed based on maximum depth of resection volume along body of the transition segment, such that minimal or non-excessive material is removed during transition. transition-offset distance may be different or same on opposite sides of transition segment. [0296] offset transition segment has effect of creating lift for transition segment. [0299] offset transition segments are bounded within sections, and more specifically, to same section by which binds section path connected to offset transition segments. [0300] offset transition segments may be entirely or partly within any of the allowed volume, inner volume, and/or resection volume. offset transition segments may have configurations or shapes other than those described herein).
Regarding claim 5: Becker-Mistry further teach: The computer-implemented method of claim 2, further comprising generating an inner allowed volume within the allowed volume, the inner allowed volume defining a boundary for the tool, wherein the boundary of the inner allowed volume is spaced apart from the boundary of the allowed volume, and (FIGS. 5 and 7-11. [0142] intersection of offset boundary and allowed volume is inner volume, as shown in FIG. 5. intersection of section and offset boundary is inner area, as shown in FIGS. 7-11. inner area excludes area spaced between footprint and offset boundary. inner area may or may not intersect resection volume)
wherein the safeguard volume is defined within the inner allowed volume and (Becker: [0090] geometric engine is further configured to compute intersections between anatomical model and other objects, such as implant models, allowed volumes, etc. [0091] Another feature of geometric engine is ability to perform 3D offset operations. Offset operations define surface that is spaced apart from another surface by predefined distance. One output of offset operation is definition of offset boundary, which is described below. geometric engine can also support offset operations for given planar or non-planar contours. FIGS. 5 and 7-11)
the boundary of the safeguard volume is spaced apart from the inner allowed volume (Becker: [0065] FIG. 2, controller includes boundary generator. boundary generator is software program or module that generates planar or non-planar virtual boundary for constraining movement and/or operation of tool. Such virtual boundaries may also be referred to as virtual meshes, virtual constraints, or like. virtual boundaries may be defined with respect to anatomical model, such as 3-D bone model. [0110] resection volume can be defined using any predefined solid bodies, primitive volumes, or any mathematically described surface or volume not described herein. FIGS. 5 and 7-11).
Regarding claim 6: Becker-Mistry further teach: The computer-implemented method of claim 5, wherein the tool includes a spherical cutting burr having a burr radius, and wherein the boundary of the inner allowed volume is spaced apart from the boundary of the allowed volume by the burr radius (Becker: [0050] burr may be substantially spherical and comprise spherical center, radius and diameter. geometric feature may be considered in certain features relating to offsets from virtual constraints involved with how tool path is calculated. [0139] generate offset boundary, as shown in FIGS. 5 and 7-11. to account for geometric characteristics of tool. offset boundary may be to facilitate modifying resection volume for patient specific parameters. FIGS. 5 and 7-11).
Regarding claim 7: Becker-Mistry further teach: The computer-implemented method of claim 5, wherein the allowed volume extends along an axis (Becker: [0090] geometric engine is further configured to compute intersections between anatomical model and other objects, such as implant models, allowed volumes, etc. [0091] Another feature of geometric engine is ability to perform 3D offset operations. Offset operations define surface that is spaced apart from another surface by predefined distance. One output of offset operation is definition of offset boundary, which is described below. geometric engine can also support offset operations for given planar or non-planar contours. FIGS. 5 and 7-11).
Regarding claim 8: Becker-Mistry further teach: The computer-implemented method of claim 7, wherein the allowed volume, the inner allowed volume, and the safeguard volume are coaxial about the axis (Becker: [0090] geometric engine is further configured to compute intersections between anatomical model and other objects, such as implant models, allowed volumes, etc. [0091] Another feature of geometric engine is ability to perform 3D offset operations. Offset operations define surface that is spaced apart from another surface by predefined distance. One output of offset operation is definition of offset boundary, which is described below. geometric engine can also support offset operations for given planar or non-planar contours. FIGS. 5 and 7-11).
Regarding claim 9: Becker-Mistry further teach: The computer-implemented method of claim 7, wherein the allowed volume, the inner allowed volume, and the safeguard volume are each rotationally symmetric (Becker: [0090] geometric engine is further configured to compute intersections between anatomical model and other objects, such as implant models, allowed volumes, etc. [0091] Another feature of geometric engine is ability to perform 3D offset operations. Offset operations define surface that is spaced apart from another surface by predefined distance. One output of offset operation is definition of offset boundary, which is described below. geometric engine can also support offset operations for given planar or non-planar contours. FIGS. 5 and 7-11).
Regarding claim 10: Becker-Mistry further teach: The computer-implemented method of claim 7, wherein the section is further defined as a sector extending radially from the axis toward the boundary of the allowed volume (Becker: [0065] FIG. 2, controller includes boundary generator. [0077] software program defines, in succession, plurality of sections along reference guide. each section intersects resection volume. [0164] software program intersects resection volume into discrete cut sections (e.g., planar or non-planar surfaces). FIGS. 5 and 7-11).
Regarding claim 11: Becker-Mistry further teach: The computer-implemented method of claim 10, wherein the sector is defined as being normal to the boundary of the allowed volume (Becker: [0165] software program computes plurality of sections, as shown in FIGS. 3, 5, 6-11. sections are defined along reference spline. sections may be planar or non-planar. [0179] Each section is designed to intersect resection volume, or vice-versa. FIGS. 5 and 7-11).
Regarding claim 12: Becker-Mistry further teach: The computer-implemented method of claim 10, wherein the sector is further defined as a first sector, wherein a section adjacent to the section is further defined as a second sector, and (Becker: [0164] With reference spline defined with respect to resection volume, software program can execute next steps for planning and generating milling path. With assistance of geometric engine, software program intersects resection volume into discrete cut sections (e.g., planar or non-planar surfaces))
wherein identifying the sub-volume of the resection volume corresponding to the first sector comprises identifying the sub-volume of the resection volume between the first and second sectors (Becker: [0164] With reference spline defined with respect to resection volume, software program can execute next steps for planning and generating milling path. With assistance of geometric engine, software program intersects resection volume into discrete cut sections (e.g., planar or non-planar surfaces). [0179] Each section is designed to intersect resection volume, or vice-versa. sections are representative of resection volume because sections are defined with respect to underlying reference spline derived from of some geometry (e.g., such as center line) of resection volume. FIGS. 5-11).
Regarding claim 13: Becker-Mistry further teach: The computer-implemented method of claim 5, wherein the one or more milling path segments are generated based on an intersection of the inner allowed volume and the section (Becker: [0179] Each section is designed to intersect resection volume, or vice-versa. sections are representative of resection volume because sections are defined with respect to underlying reference spline derived from of some geometry (e.g., such as center line) of resection volume. FIGS. 5 and 7-11).
Regarding claim 14: Becker-Mistry further teach: The computer-implemented method of claim 5, wherein generating the one or more transition path segments includes generating one or more transition path segments to connect the one or more milling path segments for the at least one section, and wherein the one or more transition path segments extend along the section between the one or more milling path segments and the boundary of the safeguard volume (Becker: [0126] allowed volume further comprises tool access volume. tool access volume entry guides user into zone. tool access volume guides user into resection volume. FIGS. 5 and 7-11. [0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path).
Regarding claim 15: Becker-Mistry further teach: The computer-implemented method of claim 2, comprising generating a connecting transition path segment for connecting a milling path segment of a first section and a milling path segment of an adjacent second section, (Becker: [0126] allowed volume further comprises tool access volume. tool access volume entry guides user into zone. tool access volume guides user into resection volume. FIGS. 5 and 7-11. [0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path)
wherein the connecting transition path segment extends along the boundary of the safeguard volume between the first section and the adjacent second section (Becker: [0126] allowed volume further comprises tool access volume. tool access volume entry guides user into zone. tool access volume guides user into resection volume. FIGS. 5 and 7-11. [0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path. [0139] generate offset boundaries).
Regarding claim 16: Becker-Mistry further teach: The computer-implemented method of claim 15, wherein the plurality of connecting transition path segments form a spiral extending along the boundary of the safeguard volume (Becker: [0017] milling path is generated using section paths interconnected by transition segments. [0161] Path could be completed in multiple pieces. For complex shape, it may be desirable to divide resection volume into sub-volumes, create path for each sub-volume, and then re-combine paths to create full path. FIGS. 5 and 7-11).
Regarding claim 17: Becker-Mistry further teach: The computer-implemented method of claim 1, wherein a geometry of the allowed volume is based on a geometry of an implant to be inserted into the socket (Becker: [0082] FIG. 2, geometric engine to compute and/or execute geometric operations that are needed to produce milling path. [0084] Another input into geometric engine is implant model, as shown in FIG. 3. In FIG. 3, implant model is shown in planned position on anatomical model. implant model may be any surgical implants. Mistry: [0043] ball and socket joints. [0046] operator visualizing model on computer screen may be able to see certain tissue structures and structures of bones individually or of all the bones in a joint at once, such as the pelvis and proximal femur in THA).
Regarding claim 18: Becker-Mistry further teach: The computer-implemented method of claim 7, wherein the allowed volume includes a cylindrical portion including a first end and a second end along the axis, the first end and the second end defining a height of the cylindrical portion (Becker: [0122] allowed volume is region where milling is potentially allowed. allowed volume is subset of (often less than, but at maximum being equal in volume to) region where tool is allowed to move. allowed volume is potentially more restrictive than region where tool is allowed to move. FIGS. 5 and 7-11. See also [123]-[0126]).
Regarding claim 19: Becker-Mistry further teach: The computer-implemented method of claim 18, wherein the allowed volume includes a spherical dome portion having a center located on the axis, and wherein the spherical dome portion is integrated with the cylindrical portion and extends from the second end of the cylindrical portion (Becker: [0126] allowed volume further comprises tool access volume, as shown in FIG. 5. tool access volume may be any suitable geometry, such as access funnel, cone, bubble, hemi-sphere, prism, or like. see also [0122]-[0125]. FIGS. 5 and 7-1).
Regarding claim 20: Becker-Mistry further teach: The computer-implemented method of claim 1, wherein the bone is a pelvis or a scapula (Mistry: [0043] ball and socket joints. [0046] operator visualizing model on computer screen may be able to see certain tissue structures and structures of bones individually or of all the bones in a joint at once, such as the pelvis and proximal femur in THA).
Regarding claim 21: A non-transitory computer readable medium comprising instructions executable by one or more processors, wherein the instructions implement a software program for generating a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone [. . . ], the software program being configured to: ([0013] One example non-transitory computer readable medium is provided. non-transitory computer readable medium comprises instructions executable by one or more processors. When executed, instructions implement software program for generating milling path for tool of surgical system. milling path is designed to remove resection volume associated with anatomical volume. software program is configured to define reference guide with respect to resection volume and define, plurality of sections along reference guide)
obtain a model of the bone [. . . ]; ([0104]) intersect an allowed volume with the model [. . . ]to define a resection volume intended to be removed from the bone; ([0077], [0122]) generate a plurality of sections; ([0077], [0164]) for at least one section: ([0077]) identify a sub-volume of the resection volume corresponding to the section; ([0077]) generate one or more milling path segments designed to enable the tool to remove the sub-volume of the resection volume; ([0067], [0077]) identify, for the sub-volume of the resection volume, a region to be avoided by the tool; ([0116], [0121]) generate one or more transition path segments designed to avoid the region; and ([0117], [0118]) generate the milling path by combining the one or more milling path segments and the one or more transition path segments ([0017], [0161]).
However, Becker does not explicitly teach: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket.
Mistry teaches: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket ([0043] particularly those where a close fit is desirable or required between an implant and a curved bone surface, such as other ball and socket joints. [0046] Data obtained from the CT scan or MRI is preferably converted to a working computer aided design (“CAD”) model or virtual model of the patient's joint. After the CAD or virtual model of the patient's joint is created, the topography or outer surface of the bones in the joint may be visualized on a computer screen or any like visual medium. Preferably, the virtual model of the patient's joint is a 3D model that may be rotated and manipulated in 3D such that an operator visualizing the model on a computer screen may be able to see certain tissue structures and structures of bones individually or of all the bones in a joint at once, such as the pelvis and proximal femur in THA.
Becker and Mistry are analogous art to the claimed invention since they are from the similar field of surgical robots and modelling. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Becker with the aspects of Mistry to create, with a reasonable expectation for success, a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone that defines a socket for a joint, and model of the bone including the socket. The motivation for modification would have been to improve the effectiveness of procedures to seat implants in the joint including improved accuracy and stability of implant placement (Mistry, [0005]).
Regarding claim 22: A surgical system comprising: ([0043] robotic surgical system) a manipulator comprising a robotic arm formed of a plurality of links and joints and supporting a tool; ([0045] system includes manipulator with base and plurality of links. FIG. 1: robot arm. [0049] surgical tool couples to manipulator) a control system configured to ([0052] system includes controller) generate a milling path designed to enable the tool to resect material from a bone [. . . ], wherein to generate the milling path, the control system is configured to: ([0012] One example of computer-implemented method for generating milling path for tool of surgical system is provided. milling path is designed to remove resection volume associated with anatomical volume)
obtain a model of the bone [. . . ]; ([0104]) intersect an allowed volume with the model [. . . ] to define a resection volume intended to be removed from the bone; ([0077], [0122]) generate a plurality of sections; and ([0077], [0164]) for at least one section: ([0077], [0164]) identify a sub-volume of the resection volume corresponding to the section; ([0077]) generate one or more milling path segments designed to enable the tool to remove the sub-volume of the resection volume; ([0067], [0077]) identify, for the sub-volume of the resection volume, a region to be avoided by the tool; and ([0116], [0121]) generate one or more transition path segments designed to avoid the region; and ([0117], [0118]) generate the milling path by combining the one or more milling path segments and the one or more transition path segments; ([0017], [0161])
wherein the control system is configured to control the manipulator to move the tool along the generated milling path ([0073] In the semi-autonomous mode, the input for the primary movement of the TCP for bone resection is based off the tool path. In the semi-autonomous mode, the manipulator is capable of moving the tool free of operator assistance. [0317] tool initially begins moving along lead-in segment until tool tangentially reaches starting point of first section path. follows transition segments connecting successive section paths. tool is elevated during certain transition segments by following offset transition segments. [0318] tool performs majority of milling through section paths and transitions. After completing last section path, tool follows lead-out segment. tool moves along lead-out segment thereby returning near first section path along trajectory following above reference spline. Near end of lead-out segment tool moves away from anatomical volume, thereby concluding milling).
However, Becker does not explicitly teach: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket.
Mistry teaches: that defines a socket for a joint, [model of the bone] including the socket; [model] of the socket ([0043] particularly those where a close fit is desirable or required between an implant and a curved bone surface, such as other ball and socket joints. [0046] Data obtained from the CT scan or MRI is preferably converted to a working computer aided design (“CAD”) model or virtual model of the patient's joint. After the CAD or virtual model of the patient's joint is created, the topography or outer surface of the bones in the joint may be visualized on a computer screen or any like visual medium. Preferably, the virtual model of the patient's joint is a 3D model that may be rotated and manipulated in 3D such that an operator visualizing the model on a computer screen may be able to see certain tissue structures and structures of bones individually or of all the bones in a joint at once, such as the pelvis and proximal femur in THA.
Becker and Mistry are analogous art to the claimed invention since they are from the similar field of surgical robots and modelling. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Becker with the aspects of Mistry to create, with a reasonable expectation for success, a milling path for a tool of a surgical system, the milling path designed to enable the tool to resect material from a bone that defines a socket for a joint, and model of the bone including the socket. The motivation for modification would have been to improve the effectiveness of procedures to seat implants in the joint including improved accuracy and stability of implant placement (Mistry, [0005]).
Conclusion
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/MADISON B EMMETT/Examiner, Art Unit 3658
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