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
1-20
Double Patenting
1-20
Potentially Allowable Subject Matter
1-20
Priority
Applicant’s indication of Domestic Benefit/National Stage information is acknowledged. This application is a CON of 17/513,368 filed 10/28/2021 which claims benefit of 63/107,781 filed 10/30/2020 and claims benefit of 63/125,481 filed 12/15/2020 and claims benefit of 63/131,654 filed 12/29/2020 and claims benefit of 63/189,508 filed 05/17/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on 12/16/2024, 02/20/2025, 03/13/2025, and 12/11/2025 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,214,501 B2.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,214,501 B2.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of U.S. Patent No. 12,214,501 B2.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 7 of U.S. Patent No. 12,214,501 B2.
Claims 5, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 15 of U.S. Patent No. 12,214,501 B2.
Claims 6, 7, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. 12,214,501 B2.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,214,501 B2.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10 of U.S. Patent No. 12,214,501 B2.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, and 10 of U.S. Patent No. 12,214,501 B2.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, and 10 of U.S. Patent No. 12,214,501 B2.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, and 15 of U.S. Patent No. 12,214,501 B2.
Claims 15, 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 15 of U.S. Patent No. 12,214,501 B2.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 13 of U.S. Patent No. 12,214,501 B2.
Claims 17, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,214,501 B2 in view of Lang et al. (US 11,553,969 B1, “Lang”). Lang, Col. 13, lines 7-15 recites “align the physical surgical guide or a physical saw drill, pin, burr, mill, reamer, broach, or impactor with the virtual surgical guide to guide a drilling, pinning, burring, milling, reaming, broach or impacting of the joint.” Claim 10 and Lang are analogous art to the claimed invention since they are from the similar field of surgical robots and controls. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify claim 10 of US 12,214,501 B2 with the aspects of Lang to create, with a reasonable expectation for success, a robotically-assisted surgical system wherein the surgical tool is a cutting guide, drill guide, jig, saw, drill, or burr. The motivation for modification would have been to increase accuracy and effectiveness of the robotic system by providing well-known surgical implements and guides as options for use by the robotic surgical system.
Table 1 (below) is provided for clarification of the above rejection statements. Table 1 gives a better visual understanding of the claim trees for the pending claims (vertical) and the issued claims (horizontal), and for visualizing which pending claims are not patentably distinct from which issued claims in combination and/or in combination with the prior art (Lang) recited above.
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Table 1. Chart of double patenting rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The following table shows the pending claims and the issued claims, and the bolded text demonstrates those limitations that are not patentably distinct from the issued claims, and those limitations that are not patentably distinct from the issued claims in combination with Lang, the cited prior art.
Claims from 18/981,916 (current application):
Claims from US 12,214,501 B2 (issued patent):
1. A method of operation of a robotically-assisted surgical system, comprising: capturing a first pose of a surgical tool during the operation of the robotically-assisted surgical system; intraoperatively defining a target orientation for the surgical tool using the first pose of the surgical tool; and controlling a robotic device to automatically move the surgical tool to the target orientation.
1. A method of operation of a robotically-assisted surgical system, comprising: defining a virtual geometry associated with a planned resection; determining a first pose of a surgical tool in response to an interruption of performance of the planned resection; intraoperatively defining a target orientation for the surgical tool on using the first pose such that the target orientation corresponds to an angle of the surgical tool in the virtual geometry at the interruption; controlling a robotic device to automatically move the surgical tool to both the virtual geometry and the target orientation.
2. The method of Claim 1, wherein intraoperatively defining the target orientation for the surgical tool using the first pose comprises: determining whether the first pose is in a first category or a second category; and defining the target orientation as a first orientation if the first pose is in the first category and defining the target orientation as a second orientation if the first pose is in the second category.
5. The method of claim 1, wherein defining the target orientation for the surgical tool based on the first pose, comprises: determining whether the first pose is in a first category or a second category; defining the target orientation as a first orientation if the first pose is in the first category and defining the target orientation as a second orientation if the first pose is in the second category.
3. The method of Claim 2, wherein: the first category corresponds to poses in which the surgical tool points at least partially in a medial-to-lateral direction with respect to a joint of a patient; and the second category corresponds to poses in which the surgical tool points at least partially in a lateral-to-medial direction with respect to the joint of the patient.
6. The method of claim 5, wherein: the first category corresponds to poses in which the surgical tool points at least partially in a medial-to-lateral direction with respect to a joint of a patient; and the second category corresponds to poses in which the surgical tool points at least partially in a lateral-to-medial direction with respect to the joint of the patient.
4. The method of Claim 2, wherein: defining the target orientation as the first orientation comprises dynamically defining the first orientation as a component of the first pose; and defining the target orientation as the second orientation comprises providing the second orientation using a static orientation.
7. The method of claim 5, wherein: the first orientation is dynamically defined to comprise an angle of the first pose; and the second orientation is static and predefined.
5. The method of Claim 2, wherein determining whether the first pose is in the first category or the second category comprises checking whether the surgical tool is further than a threshold distance from a landmark.
5. The method of claim 1, [. . .] determining whether the first pose is in a first category or a second category; [. . .].
15. [. . .] detecting a deviation of the tool from the virtual geometry; [. . .] first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and [. . .] second position having a second distance from the anatomical feature if the deviation is less than the threshold.
6. The method of Claim 1, intraoperatively defining the target orientation for the surgical tool using the first pose of the surgical tool is based on whether the first pose of the surgical tool is within a threshold distance of an anatomical landmark.
15. [. . .] defining a virtual geometry relative to an anatomical feature; [. . .] detecting a deviation of the tool from the virtual geometry; controlling the robotic device to automatically move the tool to a first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and controlling the robotic device to automatically move the tool to a second position having a second distance from the anatomical feature if the deviation is less than the threshold.
7. The method of Claim 6, wherein intraoperatively defining the target orientation for the surgical tool using the first pose of the surgical tool comprises assigning a first orientation as the target orientation when the first pose is within the threshold distance of the anatomical landmark and assigning a second orientation as the target orientation when the first pose is outside the threshold distance of the anatomical landmark.
15. [. . .] defining a virtual geometry relative to an anatomical feature; [. . .] detecting a deviation of the tool [. . .]; controlling the robotic device to automatically move the tool to a first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and controlling the robotic device to automatically move the tool to a second position having a second distance from the anatomical feature if the deviation is less than the threshold.
8. The method of Claim 6, wherein controlling the robotic device to automatically move the surgical tool to the target orientation further comprises controlling the robotic device to move the surgical tool away from the anatomical landmark.
15. [. . .]: [. . .]; [. . .]; [. . .]; controlling the robotic device to automatically move the tool to a first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and controlling the robotic device to automatically move the tool to a second position having a second distance from the anatomical feature if the deviation is less than the threshold.
9. The method of Claim 1, wherein controlling the robotic device to automatically move the surgical tool to the target orientation further comprises controlling the robotic device to automatically move the surgical tool to a position in a virtual haptic geometry.
1. A method of operation of a robotically-assisted surgical system, comprising: [. . .]; intraoperatively defining a target orientation for the surgical tool on using the first pose such that the target orientation corresponds to an angle of the surgical tool in the virtual geometry at the interruption; controlling a robotic device to automatically move the surgical tool to both the virtual geometry and the target orientation.
10. A robotically-assisted surgical system, comprising: a robotic device; a surgical tool coupled to the robotic device; and a control system programmed to: define a target orientation for the surgical tool using a tracked first pose of the surgical tool; and control the robotic device to automatically move the surgical tool to the target orientation.
10. A surgical system comprising: a robotic device; a surgical tool coupled to the robotic device; a controller configured to: [. . .]; determine a last angular orientation of the surgical tool in the plane before occurrence of the interruption; and control the robotic device to automatically realign the surgical tool to both the plane and the last angular orientation of the surgical tool.
11. The robotically-assisted surgical system of Claim 10, wherein the control system is programed to define the target orientation by: determining whether the tracked first pose is in a first category or a second category; and defining the target orientation as a first orientation if the tracked first pose is in the first category and defining the target orientation as a second orientation if the tracked first pose is in the second category.
10. A surgical system comprising: a robotic device; a surgical tool coupled to the robotic device; a controller configured to: define a plane for performing a cut of a bone; [. . .]; determine a last angular orientation of the surgical tool in the plane before occurrence of the interruption; [. . .].
5. The method of claim 1, wherein defining the target orientation for the surgical tool based on the first pose, comprises: determining whether the first pose is in a first category or a second category; defining the target orientation as a first orientation if the first pose is in the first category and defining the target orientation as a second orientation if the first pose is in the second category.
12. The robotically-assisted surgical system of Claim 11, wherein: the first category corresponds to poses in which the surgical tool points at least partially in a medial-to-lateral direction with respect to a joint of a patient; and the second category corresponds to poses in which the surgical tool points at least partially in a lateral-to-medial direction with respect to the joint of the patient.
6. The method of claim 5, wherein: the first category corresponds to poses in which the surgical tool points at least partially in a medial-to-lateral direction with respect to a joint of a patient; and the second category corresponds to poses in which the surgical tool points at least partially in a lateral-to-medial direction with respect to the joint of the patient.
13. The robotically-assisted surgical system of Claim 11, wherein the control system is programmed to: define the target orientation as the first orientation by dynamically defining the first orientation as a component of the tracked first pose; and define the target orientation as the second orientation by providing the second orientation using a static orientation.
7. The method of claim 5, wherein: the first orientation is dynamically defined to comprise an angle of the first pose; and the second orientation is static and predefined.
14. The robotically-assisted surgical system of Claim 11, wherein the control system is programmed to determine whether the tracked first pose is in the first category or the second category by checking whether the tracked first pose of the surgical tool is further than a threshold distance from a landmark.
5. The method of claim 1, [. . .] determining whether the first pose is in a first category or a second category; [. . .].
15. [. . .] detecting a deviation of the tool from the virtual geometry; [. . .] first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and [. . .] second position having a second distance from the anatomical feature if the deviation is less than the threshold.
15. The robotically-assisted surgical system of Claim 10, wherein the control system is programmed to define the target orientation for the surgical tool based on whether the tracked first pose of the surgical tool is within a threshold distance of an anatomical landmark.
15. [. . .]; controlling the robotic device to automatically move the tool to a first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and controlling the robotic device to automatically move the tool to a second position having a second distance from the anatomical feature if the deviation is less than the threshold.
16. The robotically-assisted surgical system of Claim 15, wherein the control system is programmed to define the target orientation for the surgical tool by assigning a first orientation as the target orientation when the tracked first pose is within the threshold distance of the anatomical landmark and assigning a second orientation as the target orientation when the tracked first pose is outside the threshold distance of the anatomical landmark.
15. [. . .] defining a virtual geometry relative to an anatomical feature; [. . .] detecting a deviation of the tool [. . .]; controlling the robotic device to automatically move the tool to a first position having a first distance from the anatomical feature if the deviation exceeds a threshold; and controlling the robotic device to automatically move the tool to a second position having a second distance from the anatomical feature if the deviation is less than the threshold.
17. The robotically-assisted surgical system of Claim 10, wherein the surgical tool is a cutting guide, drill guide, or jig.
10. A surgical system comprising: a robotic device; a surgical tool coupled to the robotic device; [. . .].
Lang: Col. 13, lines 7-15: “align the physical surgical guide or a physical saw drill, pin, burr, mill, reamer, broach, or impactor with the virtual surgical guide to guide a drilling, pinning, burring, milling, reaming, broach or impacting of the joint.”
Claim 10 and Lang are analogous art to the claimed invention since they are from the similar field of surgical robots and controls. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify claim 10 of US 12,214,501 B2 with the aspects of Lang to create, with a reasonable expectation for success, a robotically-assisted surgical system wherein the surgical tool is a cutting guide, drill guide, jig, saw, drill, or burr. The motivation for modification would have been to increase accuracy and effectiveness of the robotic system by providing well-known surgical implements and guides as options for use by the robotic surgical system.
18. The robotically-assisted surgical system of Claim 10, wherein the surgical tool is a saw, drill, or burr.
10. A surgical system comprising: a robotic device; a surgical tool coupled to the robotic device; [. . .].
Lang: Col. 13, lines 7-15: “align the physical surgical guide or a physical saw drill, pin, burr, mill, reamer, broach, or impactor with the virtual surgical guide to guide a drilling, pinning, burring, milling, reaming, broach or impacting of the joint.”
Claim 10 and Lang are analogous art to the claimed invention since they are from the similar field of surgical robots and controls. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify claim 10 of US 12,214,501 B2 with the aspects of Lang to create, with a reasonable expectation for success, a robotically-assisted surgical system wherein the surgical tool is a cutting guide, drill guide, jig, saw, drill, or burr. The motivation for modification would have been to increase accuracy and effectiveness of the robotic system by providing well-known surgical implements and guides as options for use by the robotic surgical system.
19. The robotically-assisted surgical system of Claim 10, further comprising an optical tracking system configured to track a patient and provide data to the control system indicative of the tracked first pose relative to the patient.
1. [. . .]: defining a virtual geometry associated with a planned resection; [. . .]; intraoperatively defining a target orientation for the surgical tool on using the first pose such that the target orientation corresponds to an angle of the surgical tool in the virtual geometry at the interruption; [. . .].
13. The surgical system of claim 10, wherein the interruption comprises an occlusion of a tracking system.
20. One or more non-transitory computer-readable media storing program instructions that, when executed by one or more processors, cause the one or more processors to perform operations comprising: intraoperatively defining a target orientation for a surgical tool based on whether a tracked pose of the surgical tool is in a first category or a second category; and controlling a robotic device to automatically move the surgical tool to the target orientation.
15. Non-transitory computer-readable media storing program instructions that, when executed by one or more processors, cause the one or more processors to perform operations comprising: defining a virtual geometry relative to an anatomical feature; controlling a robotic device coupled to a tool to guide the tool with the virtual geometry; [. . .].
5. The method of claim 1, wherein defining the target orientation for the surgical tool based on the first pose, comprises: determining whether the first pose is in a first category or a second category; [. . .].
Potentially Allowable Subject Matter
Claims 1-20 are all rejected above for non-statutory double patenting. However, if they can be amended in a way to overcome those rejections without creating new rejections under an alternative statute, they may potentially contain allowable subject matter. The reasoning for this is that the prior art does not teach or suggest the combination of limitations currently presented in the independent claims. It is hereby asserted by the Examiner that, in light of the above and in further deliberation over all of the evidence at hand, that the current claims are NOT rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by prior art, and are NOT rejected under 35 U.S.C. 103 as being unpatentable over any combination of prior art. The current claims thus recite potential allowable subject matter, as the evidence at hand does not anticipate the current claims and does not render obvious any further modification of the references to a person of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jaramaz et al. US 20220160440 A1: A surgical robotic arm (520) for use with an external vision system (512) includes onboard control and at least four degrees of articulation. The robotic arm (520) can position various tools (534) in the surgical theatre responsive to positional feedback In from the vision system (512). Exemplary tools (534) include a handpiece (519) that includes a motorized bun or saw, a cutting guide (542) for a handheld saw, or a laser to actively define a resection area for a surgeon. The tool (534) or a reference point on the arm (520) relative to the tool (534) includes fiducial marks to register the position of the tool (534) with the vision system (512). Exemplary (534) are especially suited for knee and hip arthroplasty and can be moved under processor or manual control.
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/MADISON B EMMETT/Examiner, Art Unit 3658