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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 7/21/2026 has been entered.
Formal Matters
Claims 9 and 11 are cancelled. Claims 1-8, 10, and 12-22 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/21/2026 has been considered by the examiner. A signed copy is attached.
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.
Claims 1-5, 14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Steger et al., US 20200078109 (12 March 2020) (cited on Applicant’s IDS filed 21 July 2026).
Regarding independent claim 1, Steger teaches robotic surgical system (teleoperational surgical system 100; ¶47), comprising:
(a) a robotic arm that includes a distal end (FIGs 4, 29, manipulator 140; ¶101);
(b) a tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) operatively coupled with the distal end of the robotic arm (FIGs 4, 29, manipulator 140; ¶101); and
(c) a surgical instrument (FIG 4, mounted surgical instrument 128c; ¶58) comprising:
(i) a uterine manipulator (FIGs 4, 22, 29; tissue manipulator/probe 469; ¶¶2, 77, 101) configured to be inserted into a uterus of a patient (FIG 22; ¶¶2, 77), and
(ii) a tool drive adapter (FIG 4, force transmission assembly 164; ¶59).
The embodiment of FIG 4 of Steger does not teach wherein a tool drive adapter is configured to translate relative to the uterine manipulator from a non-engaged configuration where the tool drive adapter is spaced a distance from the uterine manipulator to an engaged configuration where the uterine manipulator and the tool drive adapter are engaged, wherein the tool drive adapter is operatively coupled with the tool driver in each of the non-engaged and engaged configurations.
However, the embodiment of FIG 29 teaches force transmission assembly 472 that Steger expressly teaches is “substantially similar to force transmission assembly 164” (¶101).
At FIG 29, Steger teaches joint 474 as a quick disconnect mechanism extending between instrument anchor 470 (¶101) which permits the linear translation of instrument 460 along axis A3 (¶100), and a tool drive adapter (FIG 29, force transmission assembly 472; ¶101) from a non-engaged configuration where the tool drive adapter is spaced a distance from the uterine manipulator (FIG 29, “joint 474 may also or alternatively allow for translation of the tissue probe along axis A34 from the joint”, ¶100) to an engaged configuration where the uterine manipulator and the tool drive adapter are engaged (FIG 29, “after instrument 460 is connected to joint 474, the force transmission assembly 472 is operable to control the translational movement of the tissue probe along axis A3”; ¶101), relative to the uterine manipulator (FIGs 22, 29, tissue manipulator/probe 469; ¶¶2, 77, 101), wherein the tool drive adapter is operatively coupled with the tool driver in each of the non-engaged and engaged configurations (FIG 29; ¶101).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the multiple embodiments of Steger given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Steger provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Steger teaches different and overlapping embodiments each solving known problems in the art. Steger does not teach the translational function of the components of FIG 4 within that embodiment. However, Steger expressly teaches translational motion in the embodiment of FIG 29 and expressly states that force transmission assembly 472 in FIG 29 is “substantially similar to force transmission assembly 164 in FIG 4 (¶101). These two force transmission assemblies are shown in FIGs 4 and 29 and taught at ¶¶100, 101 as being responsible for translational movement of the instrument along axis A3. One of ordinary skill in the art would be motivated to select among these “substantially similar” embodiments of Steger (¶101) when needing to recognize or adjust the degrees of freedom of the medical instruments. Steger teaches that the embodiment of FIG 29 differs from that in FIG 4 in that “FIG 29 is a schematic view of an assisting medical instrument 460 that may be mounted to the manipulator 140 of FIG 4 in a configuration that provides additional degrees of freedom of motion for the tissue probe” (¶100). One of ordinary skill in the art would have a reasonable expectation of success in selecting from the finite embodiments taught by Steger that are best suited for the particular end-use case, depending on the desired degrees of freedom.
Regarding claim 2, Steger teaches the robotic surgical system of claim 1, as set forth above, for the reasons set forth above.
Steger teaches wherein the uterine manipulator includes a coupling feature (FIG 29, joint 474; ¶101), wherein the tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) includes a coupling feature (FIG 29, instrument anchor 470, “where 470 may be an accessory clamp”; ¶100), configured to couple (¶100) with the coupling feature of the tool drive adapter (FIG 29, “joint 474 is between the instrument anchor 470 and the force transmission assembly 472”; ¶101).
Regarding claim 3, Steger teaches the robotic surgical system of claim 2, as set forth above, for the reasons set forth above.
Steger teaches wherein the tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) includes proximal and distal ends (FIGs 4, 29), wherein the coupling feature (FIG 29, instrument anchor 470; ¶100) of the tool driver (148) is positioned at the distal end (FIG 29) of the tool driver (148).
Regarding claim 4, Steger teaches the robotic surgical system of claim 2, as set forth above, for the reasons set forth above.
Steger teaches wherein the tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) includes a decoupling feature configured to eject the coupling feature of the uterine manipulator from the coupling feature of the tool driver (FIG 29, instrument anchor 470, “where 470 may be an accessory clamp”; ¶100).
Regarding claim 5, Steger teaches the robotic surgical system of claim 1, as set forth above, for the reasons set forth above.
Steger teaches the tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) comprising:
(i) a stage (FIG 4, mounting carriage 149; ¶¶58-59), and
(ii) a carriage configured to move relative to the stage (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59, wherein the carriage is configured to move the tool drive adapter from the non-engaged configuration to the engaged configuration (FIG 4, insertion and withdrawal motion 162, ¶¶58-59).
Regarding claim 14, Steger teaches the robotic surgical system of claim 1, as set forth above, for the reasons set forth above.
Steger teaches wherein the uterine manipulator (FIGs 4, 22, 29; tissue manipulator/probe 469; ¶¶2, 77, 101) is completely separate from the tool drive adapter (FIG 4, force transmission assembly 164; ¶59) in the non-engaged configuration (FIG 29, ¶¶100, 101).
Regarding independent claim 16, Steger teaches a robotic surgical system (teleoperational surgical system 100; ¶47), comprising:
(a) a robotic arm (FIGs 4, 29, manipulator 140; ¶101);
(b) a tool driver operatively coupled with the robotic arm (FIGs 4, 29, instrument spar 148; ¶¶58, 101), the tool driver comprising:
(i) a stage (FIG 4, mounting carriage 149; ¶¶58-59), and
(ii) a carriage configured to move relative to the stage (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59); and
(c) a surgical instrument (FIG 4, mounted surgical instrument 128c; ¶58)
comprising:
(i) a first component (uterine manipulator, ¶¶2, 77) configured to be inserted into a uterus of a patient (¶¶2, 77), and
(ii) a second component (FIG 4, force transmission assembly 164; ¶59).
Embodiment of FIG 4 of Steger does not teach wherein a tool drive adapter is configured to translate relative to the uterine manipulator from a non-engaged configuration where the tool drive adapter is spaced a distance from the uterine manipulator to an engaged configuration where the uterine manipulator and the tool drive adapter are engaged, wherein the tool drive adapter is operatively coupled with the tool driver in each of the non-engaged and engaged configurations.
Related Embodiment FIG 29 teaches force transmission assembly 472 (interpreted as a tool drive adapter), which Steger expressly teaches is “substantially similar to force transmission assembly 164” (¶101).
In FIG 29, Steger teaches (i) a first component (FIGs 4, 22, 29; tissue manipulator/probe 469; ¶¶2, 77, 101) configured to be inserted into a patient (“instrument 460 and tissue manipulator/probe 469 may be positioned and arranged within the patient body cavity”; ¶101), and
(ii) a second component (FIG 29, force transmission assembly 472; ¶101) configured to translate relative to the first component (FIG 29, “after instrument 460 is connected to joint 474, the force transmission assembly 472 is operable to control the translational movement of the tissue probe 469 along axis A3”; ¶101) using the carriage (b) coupling (¶100) the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) with a tool driver (FIG 29, instrument spar 148; ¶100)
from a non-engaged configuration where the first component is spaced a distance from the second component (FIG 29, “joint 474 may also or alternatively allow for translation of the tissue probe 469 along axis A34 from the joint”, ¶100) to an engaged configuration where the first and second components are engaged (FIG 29, “after instrument 460 is connected to joint 474, the force transmission assembly 472 is operable to control the translational movement of the tissue probe along axis A3”; ¶101), wherein the first and second components are operatively coupled in each of the non-engaged and engaged configurations (FIG 29; ¶101).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the multiple embodiments of Steger given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Steger provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Steger teaches different and overlapping embodiments each solving known problems in the art. Steger does not teach the translational function of a tool drive adapter within the embodiment of FIG 4. However, Steger expressly teaches translational motion in the embodiment of FIG 29 and expressly states that force transmission assembly 472 in FIG 29 is “substantially similar to force transmission assembly 164 in FIG 4 (¶101). These two force transmission assemblies are shown in FIGs 4 and 29 and taught at ¶¶100, 101 as being responsible for translational movement of the instrument along axis A3. One of ordinary skill in the art would be motivated to select among these “substantially similar” embodiments of Steger (¶101) when needing to interact with the respective degrees of freedom of the medical instruments. Steger teaches that the embodiment of FIG 29 differs from that in FIG 4 in that “FIG 29 is a schematic view of an assisting medical instrument 460 that may be mounted to the manipulator 140 of FIG 4 in a configuration that provides additional degrees of freedom of motion for the tissue probe” (¶100). One of ordinary skill in the art would have a reasonable expectation of success in selecting from the finite embodiments taught by Steger that are best suited for the particular end-use case, depending on the desired degrees of freedom.
Regarding claim 17, Steger teaches the robotic surgical system of claim 16, as set forth above, for the reasons set forth above.
Steger teaches wherein the first component includes a uterine manipulator (FIGs 22, 29, tissue manipulator 469; ¶¶2, 77, 101), configured to be inserted into a uterus of the patient (FIG 22; ¶¶2, 77), wherein the second component includes a tool drive adaptor (FIG 29, force transmission assembly 472; ¶101) configured to couple with the uterine manipulator (FIG 29, “after instrument 460 is connected to joint 474, the force transmission assembly 472 is operable to control the translational movement of the tissue probe 469 along axis A3”; ¶101).
Regarding independent claim 18, Steger teaches a method of operating a uterine manipulator assembly of a robotic surgical system (¶108), the method comprising:
(a) manually inserting a distal end of a uterine manipulator (FIGs 4, 22, 29; tissue probe 469; ¶¶2, 77, 101) of the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) into a patient (“instrument 460 and tissue probe 469 may be positioned and arranged within the patient body cavity”; ¶101);
(b) coupling (¶100) the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) with a tool driver (FIG 29, instrument spar 148; ¶100) of the robotic surgical system (¶100) after manually inserting the distal end of the uterine manipulator into the patient (“[a]fter this initial set-up activity is complete, the instrument spar 148 with force transmission assembly 472 is introduced to the instrument 460”; ¶101);
(c) moving (via rotation or translation; ¶101) a tool drive adapter (FIG 29, force transmission assembly 472; ¶101) of the uterine manipulator assembly (460) relative to the uterine manipulator (469) after coupling (¶100) the uterine manipulator (469) with the tool driver (148) of the robotic surgical system (¶101);
(d) coupling the uterine manipulator and the tool drive adapter of the uterine manipulator assembly together (¶101).
Steger does not teach the step (e) manipulating a uterus of the patient using the uterine manipulator assembly in the same embodiment of FIG 29.
However, Steger teaches the step (e) manipulating a uterus of the patient using the uterine manipulator assembly at ¶108 as part of the overall teachings of the “above described systems and methods”.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the multiple embodiments of Steger given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Steger provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. Steger teaches different and overlapping embodiments each solving known problems in the art. Steger does not teach the method of manipulating a uterus of the patient using the uterine manipulator assembly in the same embodiment where the components of the uterine manipulator assembly are assembled. However, Steger teaches the step of manipulating the uterus of the patient as part of the “above described systems and methods” at ¶108. One of ordinary skill in the art would be motivated to combine the steps of the method of assembly concluding with functionally performing the manipulation of the uterus of the patient as an obvious next-step following the assembly of the uterine manipulator assembly as taught in the embodiments of FIG 29 (¶¶100-101). One of ordinary skill in the art would have a reasonable expectation of success in selecting from the finite embodiments taught by Steger that are best suited for the particular end-use case, where the using the assembled instrument on a patient followed the assembly of the instrument components.
Regarding claim 19, Steger teaches the method of claim 18, as set forth above, for the reasons set forth above.
Steger teaches the method further comprising operatively coupling (¶101) the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) of the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) with a carriage (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59).
Regarding claim 20, Steger teaches the method of claim 18, as set forth above, for the reasons set forth above.
Steger teaches wherein moving (¶101) the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) relative to the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) further comprises translating (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59) the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) relative to the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) along a stage of the tool driver (FIG 4, mounting carriage 149; ¶¶58-59).
Regarding claim 21, Steger teaches the method of claim 18, as set forth above, for the reasons set forth above.
Steger teaches wherein coupling (¶101) the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) and the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) of the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) together further comprises fluidly coupling (¶92) the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) and the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) of the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) together (¶101).
Regarding claim 22, Steger teaches the method of claim 18, as set forth above, for the reasons set forth above.
Steger teaches wherein manipulating the uterus of the patient (¶108) using the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) further comprises manipulating the uterus of the patient (¶108) using the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) while the uterine manipulator (FIG 29; “tissue probe 469 mounted to the distal end of instrument 460”; ¶100) and the tool drive adapter (FIG 29, force transmission assembly 472; ¶101) of the uterine manipulator assembly (FIGs 4, 22, 29; instrument 460; ¶¶2, 77, 101) are coupled together (¶101).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Steger et al., US 20200078109 (12 March 2020) (cited on Applicant’s IDS filed 21 July 2026) in view of Devengenzo et al., US 20070137371 (21 June 2007).
Regarding claim 6, Steger teaches the robotic surgical system of claim 5, as set forth above, for the reasons set forth above.
Steger does not teach wherein the stage includes at least one track, wherein the carriage is configured to translate along the at least one track between the non-engaged configuration and the engaged configuration.
However, Steger teaches FIG 4, “insertion and withdrawal motion” 162 (¶¶58-59) associated with “insertion and withdrawal actuator” 146 (¶¶58, 59) and FIG 29 comprising instrument 460 connected to joint 474 and force transition assembly 472 operable to control the rotational movement of tissue probe 469 about the axis A3 and to control the translation of the tissue probe along axis A3 (¶101).
Devengenzo teaches a telescoping insertion axis of a robotic surgical system comprising insertion axis 100 comprising linear rails 117, linear bearings (comprising slide units 116 and rails 117, ¶55), and dual rail pressure plates 118 for operably translating links 102, 104, and 106 (FIGs 5A, 7, 8A, 8B; ¶¶54-56) along translatable axis C “in telescoping fashion” (FIG 5A, ¶50).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Steger and Devengenzo, given that the prior art included each element claimed, although not necessarily in a single reference.
Steger and Devengenzo teach in the same field of endeavor of robotic surgical systems comprising telescoping manipulator arms.
Although, Steger discloses the claimed base robotic system comprising a robotic arm with a translational assembly, Steger does not disclose wherein the stage includes at least one track, wherein the carriage is configured to translate along the at least one track between the non-engaged configuration and the engaged configuration.
Devengenzo specifically addresses telescoping robotic manipulator arms comprising and insertion axis with links that are translatable on linear rails, linear bearings (comprising slide units 116 and rails 117, ¶55), and dual rail pressure plates 118 for operably translating links 102, 104, and 106 (FIGs 5A, 7, 8A, 8B; ¶¶54-56) along translatable axis C “in telescoping fashion” (FIG 5A, ¶50). Because Steger includes a longitudinal insertion axis assembly and a translation insertion axis A3, a person of ordinary skill in the art, seeking to better understand and apply the mechanisms of linear translation in Steger’s architecture would reasonably consult Devengenzo’s telescoping insertion axis translation solution. Devengenzo’s telescoping insertion axis translation solution can be incorporated alongside Steger’s tool driver (FIGs 4, 29, instrument spar 148; ¶¶58, 101) comprising a stage (FIG 4, mounting carriage 149; ¶¶58-59), and a carriage configured to move relative to the stage (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59), wherein the carriage is configured to move the tool drive adapter from the non-engaged configuration to the engaged configuration (FIG 4, insertion and withdrawal motion 162, ¶¶58-59) using known assembly methods without redesigning Steger’s manipulator arm 140 design. A person of ordinary skill in the art attempting to render Steger’s insertion and withdrawal actuator 146 (FIG 4) with insertion and withdrawal motion 162 (FIG 4) would look for established telescoping translation designs and components to avoid creating a novel robot interface. Devengenzo’s telescoping insertion axis 100 (axis C) and robotic links are modular and can be adapted to the manipulator arm 140, instrument spar 148, insertion and withdrawal actuator 146 having insertion and withdrawal motion 162 of Steger to enable robotic translation actuation.
Because the references address the same engineering problem (robotic insertion and withdrawal motion in robotic arm surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing linear rails and linear bearings compatible with the existing insertion spur, stage and carriage), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Steger et al., US 20200078109 (12 March 2020) (cited on Applicant’s IDS filed 21 July 2026) in view of Devengenzo et al., US 20070137371 (21 June 2007), and further in view of Prior et al., US 20210282814 (16 September 2021) (cited in Applicant’s IDS filed 21 July 2026).
Regarding claim 7, Steger modified by Devengenzo teaches the robotic surgical system of claim 6, as set forth above, for the reasons set forth above.
Steger teaches wherein the carriage is configured to move relative to the stage along a first axis (FIG 4, insertion and withdrawal motion 162, ¶¶58-59).
Embodiment FIG 4 of Steger does not expressly teach wherein the tool drive adapter includes a handle including a coupling feature configured to be actuated along a second axis, wherein the second axis is perpendicular to the first axis.
However, embodiment 400 of Steger teaches handle 406 of instrument 400 as being removeable along an axis that is perpendicular to both the first and second axes (FIG 24, compare handle 406 attached to mounting portion 408 against instrument spar 148 with axes A1, C1, A2; ¶¶91, 97, 98).
Prior teaches robotically and manually operatable uterine manipulators (¶2). Prior teaches uterine manipulator 100 comprising a housing 36 configured to be coupled to an instrument drive unit of a robotic system, a shaft extending distally from the housing, an articulation assembly (tool drive adapter) disposed within the housing, and a handle 110 removably coupled to the housing (FIGs 1A-B; ¶¶19, 42; claims 8, 18).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Steger, Devengenzo, and Prior, given that the prior art included each element claimed, although not necessarily in a single reference.
Steger, Devengenzo, and Prior teach in the same field of endeavor, robotic surgical systems.
Although, Steger and Devengenzo disclose the claimed base robotic system comprising a robotic arm with a translational assembly and Steger teaches that the translational assembly comprising a carriage is configured to move relative to the stage along a first axis (FIG 4, insertion and withdrawal motion 162, ¶¶58-59) and Steger does not expressly disclose the tool drive adapter includes a handle including a coupling feature configured to be actuated along a second axis, wherein the second axis is perpendicular to the first axis.
Prior specifically addresses uterine manipulator 100 comprising housing 36 configured to be coupled to an instrument drive unit of a robotic system, wherein an articulation assembly (tool drive adapter) is disposed within the housing and wherein handle 110 is removably coupled to the housing (FIGs 1A-B; ¶¶19, 42; claims 8, 18).
Prior’s removable handle coupled to the housing comprising an articulation assembly can be incorporated alongside Steger’s tool driver adapter (FIG 29, force transmission assembly 472; ¶101) comprising a carriage configured to move relative to the stage (FIG 4, insertion and withdrawal actuator 146; ¶¶58, 59), using known assembly methods without redesigning Steger’s manipulator arm 140 design. A person of ordinary skill in the art attempting to render Steger’s tool driver adapter (FIG 29, force transmission assembly 472; ¶101) manually manipulatable would look for established manual manipulation designs and components to avoid creating a novel interface. Prior’s removable handle can be adapted to Steger’s force transmission assembly (tool driver adapter) without it interfering with the motion or translation of the force transmission assembly. Steger’s removable handle 406 of instrument 400, which does not have the same force transmission assembly as in the embodiment of FIG 29, is taught as being removeable along an axis that is perpendicular to both the first and second axes (FIG 24, compare handle 406 attached to mounting portion 408 against instrument spar 148 with axes A1, C1, A2; ¶¶91, 97, 98).
Because the references address the same engineering problem (manual and robotic insertion and withdrawal motion in robotic arm surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing a removable handle on the force transmission assembly (tool driver adapter) component, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 8, Steger modified by Devengenzo and Prior teaches the robotic surgical system of claim 7, as set forth above, for the reasons set forth above.
Prior teaches wherein the handle 110 is configured to be removed (FIGs 1A-B; ¶¶19, 42; claims 8, 18). Prior teaches that “handle 110 may extend perpendicularly relative to a longitudinal axis defined by the handle 110 or at an angle relative thereto, e.g. between about 45 degrees and 90 degrees” (¶¶23, 42). Prior teaches that “handle 110 is positioned so as to not interfere with the robotic interface controls assessable from housing 36” (¶42). Additionally, in Embodiment 400, Steger teaches that handle 406 as being removeable along an axis that is perpendicular to both the first and second axes (FIG 24, compare handle 406 attached to mounting portion 408 against instrument spar 148 with axes A1, C1, A2; ¶¶91, 97, 98).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Steger et al., US 20200078109 (12 March 2020) (cited on Applicant’s IDS filed 21 July 2026) in view of Prior et al., US 20210282814 (16 September 2021) (cited on Applicant’s IDS filed 21 July 2026).
Regarding claim 15, Steger teaches the robotic surgical system of claim 1, as set forth above, for the reasons set forth above.
Steger does not expressly teach the system further comprising a pressurized fluid source containing fluid, the uterine manipulator further comprising: (A) a shaft assembly including a lumen extending at least partially therethrough, and (B) an expandable balloon configured to be inflated by transferring fluid from the pressurized fluid source through the lumen and into the expandable balloon.
However, Steger teaches the system comprising instrument 400 (FIGs 24-26) comprising (A) a tissue probe with a shaft that provides passage for fluid flow (¶92) and a tissue probe that may be expanded by inflation with a fluid (¶96).
Prior teaches robotically and manually operatable uterine manipulators (¶2). Prior teaches uterine manipulator 10 (¶62) further comprising a pressurized fluid source containing fluid, the uterine manipulator further comprising:
(A) a shaft assembly including a lumen extending at least partially therethrough (¶49), and
(B) an expandable balloon configured to be inflated by transferring fluid from the pressurized fluid source through the lumen and into the expandable balloon (sleeve 84 “comprising a vaginal occlude balloon coupled to a source of fluid for selective expansion” ¶65).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Steger and Prior, given that the prior art included each element claimed, although not necessarily in a single reference.
Steger and Prior teach in the same field of endeavor, robotic surgical systems comprising uterine manipulators.
Although, Steger disclose the claimed base robotic system comprising a robotic arm with a translational assembly and Steger discloses the system comprising embodiment 400 comprising instrument 400 (FIGs 24-26) comprising a tissue probe with a shaft that provides passage for fluid flow and a tissue probe that may be expanded by inflation with a fluid, Steger does not expressly disclose the system further comprising a pressurized fluid source containing fluid, the uterine manipulator further comprising: (A) a shaft assembly including a lumen extending at least partially therethrough, and (B) an expandable balloon configured to be inflated by transferring fluid from the pressurized fluid source through the lumen and into the expandable balloon.
Prior specifically addresses robotically and manually operatable uterine manipulators (¶2). Prior teaches uterine manipulator 10 (¶62) further comprising a pressurized fluid source containing fluid, the uterine manipulator further comprising a shaft assembly including a lumen extending at least partially therethrough (¶49), and an expandable balloon configured to be inflated by transferring fluid from the pressurized fluid source through the lumen (¶62) and into the expandable balloon (sleeve 84 “comprising a vaginal occluder balloon coupled to a source of fluid for selective expansion” ¶65).
Prior’s pressurized fluid source, sleeve comprising a lumen, and distal vaginal occlude balloon coupled to a source of fluid for selective expansion can be incorporated alongside Steger’s robotic uterine manipulator assembly using known assembly methods without redesigning Steger’s manipulator arm 140 and transmission design. A person of ordinary skill in the art attempting to render Steger’s tool drive assembly compatible for a fluidics-based balloon expansion system would look for established fluidics-based balloon expansion designs for uterine manipulators to avoid creating a novel interface. Prior’s vaginal occluder balloon system can be adapted to Steger’s robotic force transmission assembly without it interfering with the motion or translation of Steger’s system.
Because the references address the same engineering problem (use of surgical tools with manual and robotic insertion and withdrawal mechanisms in robotic arm surgical system) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing a known fluidics-based balloon system surgical tool with a robotic manipulator arm system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Allowable Subject Matter
Claims 10, 12, and 13 are 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.
Regarding claim 10, the prior art does not teach or reasonably suggest the robotic surgical system of claim 5 wherein the tool drive adapter includes a handle where the tool driver includes a cartridge positioned between the carriage and the handle
Regarding claim 12, the prior art does not teach or reasonably suggest wherein the cartridge includes a coupling feature that is configured to be actuated along a second axis that extends parallel to and is offset from the first axis.
Regarding claim 13, the prior art does not teach or reasonably suggest wherein the cartridge is configured to be removed from the carriage with the handle remaining coupled with the cartridge in a first decoupling sequence, wherein the handle is configured to be removed from the cartridge while the cartridge is still attached to the carriage in a second decoupling sequence.
Conclusion
Claims 9 and 11 are cancelled. Claims 1-8 and 14-22 are rejected. Claims 10, 12, and 13 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHERIE M POLAND/Examiner, Art Unit 3771
Prosecution Insights