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 . This office action is in response to the set of claims received on March 21, 2025. Claims 1-12 are currently pending.
Claim Objections
Claim 6 is objected to because of the following informalities: In line 7, the recitation “served as a boundary” should read “serving as a boundary.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In line 4, the recitation “wherein the creating the cutting path comprises, upon the cutting not performed for all the…”appears to be grammatically defective. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, line 4 recites “a surgical target bone” this recitation follows “a surgical target bone” previously recited in line 3. It is unclear whether the second recitation found in line 4 refers to the same or different bone. For examination purposes, the second recitation will be interpretated as referring to the same bone as the first recitation.
In claim 12, line 5 recites “a surgical target bone” this recitation follows “a surgical target bone” previously recited in line 4. It is unclear whether the second recitation found in line 4 refers to the same or different bone. For examination purposes, the second recitation will be interpretated as referring to the same bone as the first recitation.
Claim 4 recites the limitation "the number" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the position again" in line 8. It is indefinite because the recitation “entering the position again” does not clearly identify which previously recited position is entered. It is unclear whether “the position” refers to the cutting starting position or another position associated with the cutting path.
Claim 8 recites the limitation "the safety region" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "one or more cutting start positions" in line 2 and “the plurality of cutting start positions” in line 6. It is indefinite because the plurality is not necessarily established based on the preceding “one or more” recitation.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 2, 4, 6, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. (US Publication 2019/0380788), hereinafter “Becker” in view of Bowling et al. (US Publication 2014/0222207), hereafter “Bowling”.
Regarding claim 1, Becker discloses a method of planning a cutting path of a surgical robot [paragraphs 0012-0015], which are performed by a surgical robot cutting path planning apparatus [paragraph 0015], the method comprising: determining a position and posture of an implant to be installed in a surgical target bone based on a 3D model of a surgical target bone (i.e., Becker discloses an anatomical model AM, a three dimensional virtual model of anatomical volume A for a femur and tibia and implant model IM, software program (80), geometric engine (72), a clinical application (74) and intraoperative placement of virtual implant IM relative to the anatomical model) [paragraphs 0065-0070]; determining a cutting surface of the surgical target bone required to be cut for installation of the implant (i.e., Becker discloses a patient specific resection volume RV, defined by the volumetric intersection of anatomical model AM and implant model IM; footprint FP defining the contact surface of the resected anatomy with the implant; and resection face RF) [paragraphs 0076-0080]; determining a cutting start position where the surgical robot starts cutting for the cutting surface and an entrance direction of the surgical robot in the cutting start position (i.e., Becker discloses a milling path (100), lead-in segment LIS, starting point of first section path SP-F, and tool access volume TAV, which guides tool (20) into resection volume RV; virtual boundary (70) guides the tool toward the resection volume) [paragraph 0076-0080]; setting a maximum region in which the cutting path by the surgical robot is definable based on the cutting start position and the entrance direction (i.e., Becker discloses allowed volume AV, a “keep-in” volume for milling-path generation; tool-access volume TAV integrated with resection volume RV and defining the permissible approach of tool (20); virtual boundary (70) limits movement of tool (20) during entry; section paths SP are constrained relative to resection volume RV and allowed area AA) [paragraphs 0082-96].
Becker fails to disclose generating a modified 3D model in which a virtual cut state of the cutting surface is reflected; and creating the cutting path of the surgical robot starting from the cutting start position within a range of the maximum region based on the modified 3D model.
Bowling teaches a tool-path generator (234) receiving a solid body model of material to be removed and defining 3-D tool path (248), including path segments (256, 262, and 266). Bowling further teaches removed material logger (275), which identifies portions of tissue to which energy applicator (184) has been applied, and tool-path generator (234) updates the solid body model by subtracting the corresponding tissue path segments from the original model. The tool path generator (234) thereafter revises tool path (248) based on the updated model, so the tool avoids voids resulting from the modeled removal [paragraphs 0130-0137].
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the method of Becker, with incorporating a 3-D solid body model to reflect material represented as removed and subsequent path generation based on that updated model into Becker’s patient-specific path planning system.
Regarding claim 2, the modified Becker’s method further comprising setting a safety region to protect tissue around the surgical target bone, wherein the cutting path is created not to perform cutting in the safety region (i.e. the safety region is protected volume PV and virtual boundary 70. Becker discloses PV protects anatomical tissue and that the manipulator controller 60 controls tool relative to tracked anatomical volume A so as to avoid milling in PV) [paragraph 0102 and 0115].
Regarding claim 4, the modified Becker’s method wherein the cutting path is individually created for each of the cutting surfaces based on the number of cutting surfaces required to be cut for the installation of the implant (i.e. Becker discloses different resection faces may have different contours, edges, valleys, hills and dimensions and therefore software program (80) generates customized section paths SP tailored to the respective faces) [paragraph 0209].
Regarding claim 6, the modified Becker’s method wherein the creating the cutting path of the surgical robot comprises: identifying an outer boundary of the cutting surface in the modified 3D model (i.e., Becker discloses the resection face RF, footprint FP, perimeter edges 110, and anatomical model AM); setting a cutting margin region excluded from the cutting by applying a predetermined offset from the outer boundary (i.e. Becker discloses offset boundary/offset relationship associated with the resection geometry and tool geometry); determining a cutting path creation region to create the cutting path based on the maximum region and the cutting margin region (i.e. Becker discloses intersection of AV and anatomical model AM defining RV, intersection of section S with AV defining allowed AA, PV/virtual boundary (70) excluding prohibited regions); and creating the cutting path with the cutting path creation region served as a boundary (i.e., Becker discloses a path generator 68 generates section paths SP within resection faces and permissible AV and AA regions) [paragraphs 0115-0126].
Regarding claim 10, the modified Becker’s method wherein the cutting path is determined considering types of cutting tool of the surgical robot and cutting characteristics of the cutting tool (i.e., Becker disclose generating milling path 100 according to characteristics and parameters of tool (20) and burr (25), including tool orientation, feed rate, burr rotation speed, surface finish and accuracy, milling type, and other cutting performance parameters. Becker discloses that the path geometry can depend upon tool geometry and clearance requirements) [paragraphs 0147-0151].
Regarding claim 11, the modified Becker’s method wherein the determining the position and posture of the implant comprises determining the position and posture of the implant based on a user input made through a user interface unit (i.e., Becker discloses placement of virtual implant IM relative to anatomical model AM, with software program 80/clinical application 74 and GUI 96 permitting the user to establish or adjust implant placement. The resulting RV and milling path 100 are recomputed according to that implant placement) [paragraphs 0066-0076].
Regarding claim 12, Becker discloses a surgical robot cutting path planning apparatus for planning a cutting path of a surgical robot [paragraphs 0012-0015], the apparatus comprising a processor (30), the processor being configured to: determine a position and posture of an implant to be installed in a surgical target bone based on a 3D model of a surgical target bone (i.e., Becker discloses an anatomical model AM, a three dimensional virtual model of anatomical volume A for a femur and tibia and implant model IM, software program (80), geometric engine (72), a clinical application (74) and intraoperative placement of virtual implant IM relative to the anatomical model) [paragraphs 0065-0070]; determine a cutting surface of the surgical target bone required to be cut for installation of the implant(i.e., Becker discloses a patient specific resection volume RV, defined by the volumetric intersection of anatomical model AM and implant model IM; footprint FP defining the contact surface of the resected anatomy with the implant; and resection face RF) [paragraphs 0076-0080]; determine a cutting start position where the surgical robot starts cutting for the cutting surface, and an entrance direction of the surgical robot in the cutting start position (i.e., Becker discloses a milling path (100), lead-in segment LIS, starting point of first section path SP-F, and tool access volume TAV, which guides tool (20) into resection volume RV; virtual boundary (70) guides the tool toward the resection volume) [paragraph 0076-0080]; set a maximum region in which the cutting path by the surgical robot is definable based on the cutting start position and the entrance direction (i.e., Becker discloses allowed volume AV, a “keep-in” volume for milling-path generation; tool-access volume TAV integrated with resection volume RV and defining the permissible approach of tool (20); virtual boundary (70) limits movement of tool (20) during entry; section paths SP are constrained relative to resection volume RV and allowed area AA) [paragraphs 0082-96]
Becker fails to disclose generating a modified 3D model in which a virtual cut state of the cutting surface is reflected; and creates the cutting path of the surgical robot starting from the cutting start position within a range of the maximum region based on the modified 3D model.
Bowling teaches a tool-path generator (234) receiving a solid body model of material to be removed and defining 3-D tool path (248), including path segments (256, 262, and 266). Bowling further teaches removed material logger (275), which identifies portions of tissue to which energy applicator (184) has been applied, and tool-path generator (234) updates the solid body model by subtracting the corresponding tissue path segments from the original model. The tool path generator (234) thereafter revises tool path (248) based on the updated model, so the tool avoids voids resulting from the modeled removal [paragraphs 0130-0137].
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the method of Becker, with incorporating a 3-D solid body model to reflect material represented as removed and subsequent path generation based on that updated model into Becker’s patient-specific path planning system.
Claims 3, 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. (US Publication 2019/0380788), hereinafter “Becker” in view of Bowling et al. (US Publication 2014/0222207), hereafter “Bowling”, and further in view of Junio et al. (US 2023/0020476), hereinafter “Junio”.
Regarding claim 3, the modified Becker’s method fails to disclose wherein one or more cutting start positions of the surgical robot are determined for the cutting surface based on skin incision information preset for the cutting of the surface and a location of the safety region, and the maximum region and the cutting path are individually determined corresponding to each cutting start position.
Junio teaches a robotic surgical path planning based on a mapped work volume and one or more no-fly zones, including accounting for an existing incision in path planning. Junio teaches detecting the boundary of the incision and using the incision when calculating the path of robotic arm (116) from outside the patient’s anatomy into the anatomy. The computing device (102), processor (1040, memory (106), user interface (110), imaging device (112), robot (114), robotic arm (116), and navigation system (110) implement the planning. The robot can be positioned at specific positions and orientations and later returned thereto [paragraphs 0077-0079].
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the method of determining tool access and start location of Becker with known incision and no fly zone information of Junio in order to determine a safe robotic approach into patient anatomy.
Regarding claim 5, the modified Becker’s method discloses further comprising setting a free cutting region that the surgical robot can perform cutting freely based on a location of tissue around the surgical target bone and preset skin incision information (i.e., Junio discloses determining a work volume accessible by the robot and no fly zones representing regions the robot is restricted from accessing and using soft tissue information and an incision boundary in determining the permissible robotic path) [paragraphs 0087-0092].
Regarding claim 8, the modified Becker’s method discloses wherein one or more cutting start positions of the surgical robot are determined for the cutting surface based on skin incision information preset for the cutting of the cutting surface and a location of the safety region, and a plurality of cutting path creation regions are determined corresponding to the plurality of cutting start positions, respectively (i.e., Junio teaches planning robotic paths based on the incision and void volume accessible work volume and no fly zones) [paragraphs 0087-0092].
Regarding claim 9, the modified Becker’s method discloses wherein the creating the cutting path of the surgical robot comprises determining a return position for the surgical robot to return to the cutting start position after the cutting (i.e., Junio teaches the robot 114 may position a tool at precise positions and orientations and return the tool to the same position and orientation at a later time and describes autonomous robotic movement to and from a cut) [paragraphs 0055-0056].
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. None of the prior art discloses the specific sequence of cutting some regions as recited in claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-270-5963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
