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 .
Response to Amendment
The Amendment filed on 12/05/2025 has been entered. Claims 1-10 are pending in the application. In response to Applicant's amendments, Examiner withdraws the previous objections to the Drawings, the Specification, and the claims; and maintains the previous objections to the Abstract.
Response to Arguments
Applicant’s arguments filed 12/05/2025 with respect to claims 1-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
See additional comments in the Priority section below.
Priority
Examiner acknowledges the domestic priority claim to provisional application 63295405 filed 12/30/2021. However, Examiner notes that the limitations “receiving user input, and causing the robotic manipulator to manipulate the surgical instrument in accordance with the user input” recited in claim 4 and similarly in claim 9 are not supported by the provisional application, and therefore claims 4 and 9 are not entitled to the priority filing date.
Although control of a surgical instrument carried by a robotic manipulator according to user input is well-known in the art, user input is not described explicitly or implicitly in provisional application 63295405, and thus, is not supported.
Additionally, claims 1-10 are also not entitled to the priority filing date in view of the written description (“new matter”) rejections under 35 U.S.C. 112(a) below.
Specification
The abstract of the disclosure is objected to because “an position” should read “a position” and “sensed changed” should read “sensed change”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-3 and 5-10 are objected to because of the following informalities:
In claim 1, “in response to signals” should read “in response to the signals” in both the repositioning and releasing steps as signals from the position sensor are previously recited in the receiving step.
In claims 2, 3, 7, and 8, “the sensor” should read “the position sensor” for consistency with claims 1 and 6.
In claim 5, “in response to signals” should read “in response to the signals” as signals from the position sensor are previously recited in claim 1.
In claim 6, “introducing the surgical instrument through an incision” should read “introducing the surgical instrument through the incision” as an incision is previously recited in the positioning a trocar step.
In claim 6, “in response to signals” should read “in response to the signals” as signals from the position sensor are previously recited in the receiving step.
In claim 9, “receiving input” should read “receiving user input” for consistency.
In claim 10, “in response to signals” should read “in response to the signals” as signals from the position sensor are previously recited in claim 6.
In claim 10, the releasing step recites “indicating movement of the support”. It is unclear if this movement is the same movement of the support recited in claim 6. For the purpose of examination, it has been interpreted that the movement recited in claim 10 may be the same or different movement than the movement recited in claim 6.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitations “grasping tissue within the patient using the surgical instrument” and “automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support” do not have support in the disclosure of application 18092191 as originally filed on 12/30/2022 nor in the disclosure of the provisional application 63295405 incorporated by reference. The closest support found in the original specification of the instant application 18092191 is quoted below:
“Still other functions may be triggered when it is detected that bed motion is occurring. For example, the processor may generate signals that cause the robotic system to release the jaws/graspers of surgical tools disposed within the patient, and/or move the manipulator arms so as to retract tools to a safe position (a position where the instrument is retracted into the trocar, for instance).” [p. 5, lines 7-11]
This quotation does not provide sufficient support for the particular limitations “grasping tissue within the patient using the surgical instrument” and “automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.” Specifically, the Specification does not state that a surgical instrument grasps tissue or releases tissue from a surgical instrument’s grasp. Accordingly, claim 1 is rejected under 35 U.S.C. 112(a).
Claims 2-5 are rejected for depending upon the rejected claim 1.
Regarding claim 5, the limitation “wherein: introducing the surgical instrument through an incision in the patient includes passing a tip of the surgical instrument through a trocar positioned in the incision and into a body cavity of the patient; and the method includes causing the robotic manipulator to withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support” does not have support in the disclosure of application 18092191 as originally filed on 12/30/2022 nor in the disclosure of the provisional application 63295405 incorporated by reference. The closest support found in the original specification of the instant application 18092191 is quoted below:
“During a surgical procedure, the shaft 102a of the surgical instrument is positioned through an incision into a body cavity, so that the operative end 102b of the surgical instrument can be used for therapeutic and/or diagnostic purposes within the body cavity.” [p. 3, lines 15-18]
“Still other functions may be triggered when it is detected that bed motion is occurring. For example, the processor may generate signals that cause the robotic system to release the jaws/graspers of surgical tools disposed within the patient, and/or move the manipulator arms so as to retract tools to a safe position (a position where the instrument is retracted into the trocar, for instance).” [p. 5, lines 7-11]
These quotations do not provide sufficient support for the particular limitation “wherein: introducing the surgical instrument through an incision in the patient includes passing a tip of the surgical instrument through a trocar positioned in the incision and into a body cavity of the patient; and the method includes causing the robotic manipulator to withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support”. Specifically, the Specification does not state that the recited trocar is positioned in an incision in a patient, that the tip of the surgical instrument is passed through the trocar, nor withdrawing/causing withdrawal of the tip of the surgical instrument into the trocar. Accordingly, claim 5 is rejected under 35 U.S.C. 112(a).
Regarding claim 6, the limitations “positioning a trocar in an incision in a patient; introducing the surgical instrument through an incision in the patient by passing the tip of the surgical instrument through the trocar and into a body cavity;” and “causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support” do not have support in the disclosure of application 18092191 as originally filed on 12/30/2022 nor in the disclosure of the provisional application 63295405 incorporated by reference. The closest support found in the original specification of the instant application 18092191 is quoted below:
“During a surgical procedure, the shaft 102a of the surgical instrument is positioned through an incision into a body cavity, so that the operative end 102b of the surgical instrument can be used for therapeutic and/or diagnostic purposes within the body cavity.” [p. 3, lines 15-18]
“Still other functions may be triggered when it is detected that bed motion is occurring. For example, the processor may generate signals that cause the robotic system to release the jaws/graspers of surgical tools disposed within the patient, and/or move the manipulator arms so as to retract tools to a safe position (a position where the instrument is retracted into the trocar, for instance).” [p. 5, lines 7-11]
These quotations do not provide sufficient support for the particular limitations the limitations “positioning a trocar in an incision in a patient; introducing the surgical instrument through an incision in the patient by passing the tip of the surgical instrument through the trocar and into a body cavity;” and “causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support.” Specifically, the Specification does not state that the recited trocar is positioned in an incision in a patient, that the tip of the surgical instrument is passed through the trocar, nor withdrawing/causing withdrawal of the tip of the surgical instrument into the trocar. Accordingly, claim 6 is rejected under 35 U.S.C. 112(a).
Claims 7-10 are rejected for depending upon the rejected claim 6.
Regarding claim 10, the limitation “grasping tissue within the patient using the surgical instrument; and releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support” does not have support in the disclosure of application 18092191 as originally filed on 12/30/2022 nor in the disclosure of the provisional application 63295405 incorporated by reference. The closest support found in the original specification of the instant application 18092191 is quoted below:
“Still other functions may be triggered when it is detected that bed motion is occurring. For example, the processor may generate signals that cause the robotic system to release the jaws/graspers of surgical tools disposed within the patient, and/or move the manipulator arms so as to retract tools to a safe position (a position where the instrument is retracted into the trocar, for instance).” [p. 5, lines 7-11]
This quotation does not provide sufficient support for the particular limitations “grasping tissue within the patient using the surgical instrument” and “automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.” Specifically, the Specification does not state that a surgical instrument grasps tissue or releases tissue from a surgical instrument’s grasp. Accordingly, claim 10 is rejected under 35 U.S.C. 112(a).
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 3 and 8 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.
Claim 3 recites the limitation "wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum". There is insufficient antecedent basis for this limitation in the claim. A manipulating step is not previously recited in claim 3 nor amended claim 1, rendering this limitation indefinite. For the purpose of examination, the manipulating step is assumed to be one of the repositioning and releasing steps in claim 1.
Similarly, claim 8 recites the limitation "wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum". There is insufficient antecedent basis for this limitation in the claim. A manipulating step is not recited in claim 8 nor claim 6, rendering this limitation indefinite. For the purpose of examination, the manipulating step is assumed to be the causing withdrawal step in claim 6.
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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kopp (WO 2017053123 A1) in view of Thornberry (US 20130261633 A1) and Gonenc et al. (“Safe tissue manipulation in retinal microsurgery via motorized instruments with force sensing,” 2017; hereafter Gonenc).
Regarding claim 1, Kopp discloses
A surgical method, comprising: positioning a patient on a support (Support: surgical table “ST”. See “process 400 includes a first step 402, where patient ‘P’ is prepared on surgical table ‘ST’” [0044]. See also Fig. 2, [0010], and [0031].);
placing a position sensor on the support (See “Next, in step 404, motion sensor 300 is attached to the surgical table ‘ST’ at the first attachment portion 302 and attached to patient ‘P’ at the second attachment portion 304” [0045]. See also Fig. 2 and [0031].);
positioning a surgical instrument on a robotic manipulator (See “In step 412, based on the initial location of patient ‘P,’ the ‘RCM’ for each electromechanical surgical instrument 200 of robotic arms 2, 3 are set, using control device 4” [0046]. See also Fig. 1, [0026], and [0028].);
introducing the surgical instrument through an incision in the patient (See “control device 4 may be configured to assign a tissue access point or a remote center of motion (hereinafter ‘RCM’) through which electromechanical surgical instrument 200 must pass when operating on a patient ‘P’ lying on a surgical table ‘ST.’ The ‘RCM’ is a point in space corresponding to a center of an incision ‘I’ in patient ‘P’” [0027]. See also Fig. 1, [0026], [0042], and [0046].);
receiving signals from the position sensor (See “sensor 312 [in motion sensor 300] may also be configured to communicate the location of patient "P," based on the data received from encoder 310 and gyroscope 314, to the robotic surgical system 1” [0041]. To “automatically update the ‘RCM’” or “automatically stop the surgical procedure and alert medical” personnel based on the location of patient “P” as described in [0043], the communicated signals from the position sensor must be received. See also [0023] and steps 416-426 in Fig. 4.); and
repositioning the robotic manipulator in response to signals from the position sensor indicating a change in the position… (See “a feedback assembly configured to determine the location of the patient on the surgical table and automatically adjust the location [reposition] of the point of entry on the patient, i.e. remote center of motion, for a given operation” [0023]. See “the location of patient "P" may be used to automatically update the ‘RCM’ for robotic arms 2, 3 and electrosurgical instrument 200,” [0042]. Updating/resetting the RCM (step 422 in Fig. 4) involves repositioning of the robot manipulator, whereas stopping the procedure because the patient ‘P’ has moved beyond “the movement trajectory constraints of “robotic arms 2, 3 and electrosurgical instrument 200” does not [0043]. See also Fig. 4, [0041], [0043], [0047]-[0048], and claim 12.).
However, Kopp does not explicitly teach “grasping tissue within the patient using the surgical instrument;” “signals from the position sensor indicating a change in the position of the support; and automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.”
Thornberry, in the same field of endeavor (computer-assisted surgery), teaches
positioning a patient on a support (See “The patient is positioned on surgical table 15” [0064].);
placing a position sensor on the support (See “table IMU 10 is secured to the table and calibrated” [0066].);
receiving signals from the position sensor… indicating a change in the position of the support (See “the surgical table is moved in a known manner--then, by monitoring [receiving] the data from pelvic IMU 20 and table IMU 10, the position of the pelvis can be determined relative to the position of the table” by comparing the table movement data to the pelvis movement data [0066]. See also [0061], [0073], and [0075].).
In combination, Kopp/Thornberry teaches “repositioning the robotic manipulator in response to signals from the position sensor indicating a change in the position of the support.”
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp to include monitoring a position of the surgical table as taught by Thornberry. One of ordinary skill in the art would have been motivated to make this modification “so that the position of [a patient] can be determined vis-a-vis [a] surgical table” that can move (Thornberry, [0066]).
However, Kopp/Thornberry does not explicitly teach “grasping tissue within the patient using the surgical instrument;” and “automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.”
Gonenc, in the same field of endeavor (computer-assisted surgery), teaches
grasping tissue within the patient using the surgical instrument (See “To firmly hold the tissue in membrane peeling, our microforceps tools work based on a grasping mechanism actuated by a motor inside the tool body” [p. 2, col. 1]. The membrane tissue is within an eye (within the patient) [p. 1, col. 1]. See also Fig. 1 and its caption.);
automatically releasing the tissue from a grasp of the surgical instrument in response to signals… (See “we programmed our micro-forceps to automatically open and release the grasped tissue if the detected tissue manipulation forces reach 7.5 mN” as detected by sensors in the tool shaft (surgical instrument) [p. 2, section II. Force-Based Automatic Tissue Release]. See also the rest of page 2.).
Given Kopp/Thornberry teaches “repositioning the robotic manipulator in response to signals from the position sensor indicating a change in the position of the support” and Gonenc teaches “automatically releasing the tissue from a grasp of the surgical instrument in response to signals” from sensors, it would have been obvious to respond to signals from the position sensor indicating movement of the support by automatically releasing tissue from the grasp of a surgical instrument. Thus, the combination of Kopp/Thornberry and Gonenc teaches “automatically releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.”
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry to grasp and release the grasp of tissue in response to sensor data as taught by Gonenc. One of ordinary skill in the art would have been motivated to make this modification because “opening the forceps and releasing the grasped membrane can be an effective and simple aid to prevent direct transfer of excessive forces and hence damage to the retina” (tissue) (Gonenc, p. 2, col. 1).
Regarding claim 2, Kopp/Thornberry/Gonenc discloses the limitations of claim 1 as addressed above, and Thornberry additionally discloses
wherein the sensor is an inertial measurement unit (See “table IMU 10 is secured to the table and calibrated” [0066].).
Regarding claim 4, Kopp/Thornberry/Gonenc discloses the limitations of claim 1 as addressed above, and Kopp additionally discloses
further including receiving user input, and causing the robotic manipulator to manipulate the surgical instrument in accordance with the user input (Telemanipulation requires receiving user input. See “Control device 4 (e.g., a computer) is set up to activate the drives… in such a way that robotic arms 2, 3… and thus electromechanical surgical instrument 200… execute a desired movement according to a movement defined by means of manual input devices 7, 8” [0026]. See also [0025] and [0028].).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kopp in view of Thornberry and Gonenc, and further in view of Ruiz and Correcher (US 9855662 B2; hereafter “Ruiz”).
Regarding claim 3, Kopp/Thornberry/Gonenc discloses the limitations of claim 1 as addressed above, and Kopp additionally discloses
wherein the method further includes: in response to the signals from the sensor, re-calculating the defined fulcrum (See “a feedback assembly configured to determine the location of the patient on the surgical table and automatically adjust [re-calculate] the location of the point of entry on the patient, i.e. remote center of motion [defined fulcrum], for a given operation” [0023]. See “the location of patient "P" may be used to automatically update the ‘RCM’ for robotic arms 2, 3 and electrosurgical instrument 200,” [0042]. The location of patient ‘P’ is supplied by the motion sensor 300 [0041]. See also Fig. 4, [0047]-[0048], and claim 12.).
However, Kopp/Thornberry/Gonenc does not explicitly teach “wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum.”
Ruiz, in the same field of endeavor (robotic surgery), teaches
wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum (After insertion of the instrument into a trocar 22, “the instrument 14 is pivoted with respect to its tip 20 until a sufficient contact force (about 3 N) is reached” [col. 14, lines 19-30]. Since the tip is on the same axis as the straight instrument shaft 18 (as shown in Fig. 1 and Fig. 2) through the initial fulcrum position (at the trocar 22), pivoting with respect to the tip of the instrument is also pivoting relative to a defined fulcrum. See also: after finding the true fulcrum location, “all moves (pivot and penetration) [of the surgical instrument 14] can be given with respect to the fulcrum 23” [col 14, lines 38-43].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry/Gonenc to add the initial fulcrum/RCM position determination method of Ruiz. One of ordinary skill in the art would have been motivated to make this modification for the benefit of avoiding “wear on the incision, which can lead to the release of the trocar… thereby unnecessarily increasing the intervention time” (Ruiz, col. 11, lines 18-38).
Claims 6, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kopp in view of Thornberry and Ye et al. (US 20230310099 A1, with earliest priority date of 03/31/2021; hereafter “Ye”).
Regarding claim 6, Kopp discloses
A surgical method, comprising: positioning a patient on a support (Support: surgical table “ST”. See “process 400 includes a first step 402, where patient ‘P’ is prepared on surgical table ‘ST’” [0044]. See also Fig. 2, [0010], and [0031].);
placing a position sensor on the support (See “Next, in step 404, motion sensor 300 is attached to the surgical table ‘ST’ at the first attachment portion 302 and attached to patient ‘P’ at the second attachment portion 304” [0045]. See also Fig. 2 and [0031].);
positioning a surgical instrument on a robotic manipulator… (See “In step 412, based on the initial location of patient ‘P,’ the ‘RCM’ for each electromechanical surgical instrument 200 of robotic arms 2, 3 are set, using control device 4” [0046]. See also Fig. 1, [0026], and [0028].);
introducing the surgical instrument through an incision in the patient… (See “control device 4 may be configured to assign a tissue access point or a remote center of motion (hereinafter ‘RCM’) through which electromechanical surgical instrument 200 must pass when operating on a patient ‘P’ lying on a surgical table ‘ST.’ The ‘RCM’ is a point in space corresponding to a center of an incision ‘I’ in patient ‘P’” [0027]. See also Fig. 1, [0026], [0042], and [0046].);
receiving signals from the position sensor (See “sensor 312 [in motion sensor 300] may also be configured to communicate the location of patient "P," based on the data received from encoder 310 and gyroscope 314, to the robotic surgical system 1” [0041]. To “automatically update the ‘RCM’” or “automatically stop the surgical procedure and alert medical” personnel based on the location of patient “P” as described in [0043], the communicated signals from the position sensor must be received. See also [0023] and steps 416-426 in Fig. 4.).
However, Kopp does not explicitly teach “the surgical instrument including a tip; positioning a trocar in an incision in a patient; introducing the surgical instrument through an incision in the patient by passing the tip of the surgical instrument through the trocar and into a body cavity;” and “causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support.”
Thornberry, in the same field of endeavor (computer-assisted surgery), teaches
positioning a patient on a support (See “The patient is positioned on surgical table 15” [0064].);
placing a position sensor on the support (See “table IMU 10 is secured to the table and calibrated” [0066].);
signals from the position sensor indicating movement of the support (See “the surgical table is moved in a known manner--then, by monitoring the data from pelvic IMU 20 and table IMU 10, the position of the pelvis can be determined relative to the position of the table” by comparing the table movement data to the pelvis movement data [0066]. See also [0061], [0073], and [0075].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp to include monitoring a position of the surgical table as taught by Thornberry. One of ordinary skill in the art would have been motivated to make this modification “so that the position of [a patient] can be determined vis-a-vis [a] surgical table” that can move (Thornberry, [0066]).
However, Kopp/Thornberry does not explicitly teach “the surgical instrument including a tip; positioning a trocar in an incision in a patient; introducing the surgical instrument through an incision in the patient by passing the tip of the surgical instrument through the trocar and into a body cavity;” and “causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support.”
Ye, in the same field of endeavor (surgical robotic systems), teaches
the surgical instrument including a tip (See “the tip of the surgical instrument” [0209]. See also [0314].);
positioning a trocar in an incision in a patient (See “Trocar position detection module 1420 may be executed by processor 1402 for determining the position and/or orientation of one or more trocar port inserted within the patient... the position of the trocar ports on the patient… may be controlled by the system to point to the optimal or determined position on the patient's body to insert the trocar” [0207]. See “a surgical instrument coupled to the distal end of robot arm 300 is inserted through a trocar port such that the tip of the instrument is inside of the patient”; therefore, the trocar is in an incision [0209]. See also [0186] and [0232].);
introducing the surgical instrument through an incision in the patient by passing the tip of the surgical instrument through the trocar and into a body cavity (See “a surgical instrument coupled to the distal end of robot arm 300 is inserted through a trocar port such that the tip of the instrument is inside of the patient” [0209].);
causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support (See “upon detection of movement of the patient bed, the system may automatically move the robot arm to retract the surgical instrument coupled thereto within the trocar… such that the distal end [tip] of the surgical instrument is positioned within the trocar” [0314]. See optical scanners 202 acting as position sensors in [0313]. See also [0209].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry to include withdrawing a surgical instrument into a trocar in response to detected operating table movement as taught by Ye. One of ordinary skill in the art would have been motivated to make this modification to place the surgical instrument “out of contact with anatomical structures within the patient’s body” during table movement (Ye, [0209]) and thereby prevent injury to the patient.
Regarding claim 7, Kopp/Thornberry/Ye discloses the limitations of claim 6 as addressed above, and Thornberry additionally discloses
wherein the sensor is an inertial measurement unit (See “table IMU 10 is secured to the table and calibrated” [0066].).
Regarding claim 9, Kopp/Thornberry/Ye discloses the limitations of claim 6 as addressed above, and Kopp additionally discloses
further including receiving [user] input, and causing the robotic manipulator to manipulate the surgical instrument in accordance with the user input (Telemanipulation requires receiving user input. See “Control device 4 (e.g., a computer) is set up to activate the drives… in such a way that robotic arms 2, 3… and thus electromechanical surgical instrument 200… execute a desired movement according to a movement defined by means of manual input devices 7, 8” [0026]. See also [0025] and [0028].).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kopp in view of Thornberry and Ye, and further in view of Ruiz.
Regarding claim 8, Kopp/Thornberry/Ye discloses the limitations of claim 6 as addressed above, and Kopp additionally discloses
wherein the method further includes: in response to the signals from the sensor, re-calculating the defined fulcrum (See “a feedback assembly configured to determine the location of the patient on the surgical table and automatically adjust [re-calculate] the location of the point of entry on the patient, i.e. remote center of motion [defined fulcrum], for a given operation” [0023]. See “the location of patient "P" may be used to automatically update the ‘RCM’ for robotic arms 2, 3 and electrosurgical instrument 200,” [0042]. The location of patient ‘P’ is supplied by the motion sensor 300 [0041]. See also Fig. 4, [0047]-[0048], and claim 12.).
However, Kopp/Thornberry/Ye do not explicitly teach “wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum.”
Ruiz, in the same field of endeavor (robotic surgery), teaches
wherein the manipulating step includes pivoting the surgical instrument relative to a defined fulcrum (After insertion of the instrument into a trocar 22, “the instrument 14 is pivoted with respect to its tip 20 until a sufficient contact force (about 3 N) is reached” [col. 14, lines 19-30]. Since the tip is on the same axis as the straight instrument shaft 18 (as shown in Fig. 1 and Fig. 2) through the initial fulcrum position (at the trocar 22), pivoting with respect to the tip of the instrument is also pivoting relative to a defined fulcrum. See also: after finding the true fulcrum location, “all moves (pivot and penetration) [of the surgical instrument 14] can be given with respect to the fulcrum 23” [col 14, lines 38-43].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry/Ye to add the initial fulcrum/RCM position determination method of Ruiz. One of ordinary skill in the art would have been motivated to make this modification for the benefit of avoiding “wear on the incision, which can lead to the release of the trocar… thereby unnecessarily increasing the intervention time” (Ruiz, col. 11, lines 18-38).
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kopp in view of Thornberry, Gonenc, and Ye.
Regarding claim 5, Kopp/Thornberry/Gonenc discloses the limitations of claim 1 as addressed above. However, Kopp/Thornberry/Gonenc does not explicitly teach “wherein: introducing the surgical instrument through an incision in the patient includes passing a tip of the surgical instrument through a trocar positioned in the incision and into a body cavity of the patient; and the method includes causing the robotic manipulator to withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support.”
Ye, in the same field of endeavor (surgical robotic systems), teaches
wherein: introducing the surgical instrument through an incision in the patient by passing a tip of the surgical instrument through a trocar positioned in the incision and into a body cavity of the patient (See “a surgical instrument coupled to the distal end of robot arm 300 is inserted through a trocar port such that the tip of the instrument is inside of the patient”; therefore, the trocar is in an incision [0209]. See also [0186], [0207], and [0232].);
the method includes causing the robotic manipulator to withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support (See “upon detection of movement of the patient bed, the system may automatically move the robot arm to retract the surgical instrument coupled thereto within the trocar… such that the distal end [tip] of the surgical instrument is positioned within the trocar” [0314]. See optical scanners 202 acting as position sensors in [0313]. See also [0209].).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry/Gonenc to include withdrawing a surgical instrument into a trocar in response to detected operating table movement as taught by Ye. One of ordinary skill in the art would have been motivated to make this modification to place the surgical instrument “out of contact with anatomical structures within the patient’s body” during table movement (Ye, [0209]) and thereby prevent injury to the patient.
Regarding claim 10, Kopp/Thornberry/Ye discloses the limitations of claim 6 as addressed above, and Ye additionally discloses
grasping tissue within the patient using the surgical instrument (See “if a tissue retractor advanced through the trocar is engaged with (e.g., grasping) bodily tissue or another object inside the body, the force exerted on the end of the instrument from the bodily tissue or other object may cause a change in the force applied to the trocar” [0211]. See also [0277].).
However, Kopp/Thornberry/Ye does not explicitly teach “releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.”
Gonenc, in the same field of endeavor (computer-assisted surgery), teaches
grasping tissue within the patient using the surgical instrument (See “To firmly hold the tissue in membrane peeling, our microforceps tools work based on a grasping mechanism actuated by a motor inside the tool body” [p. 2, col. 1]. The membrane tissue is within an eye (within the patient) [p. 1, col. 1]. See also Fig. 1 and its caption.); and
releasing the tissue from a grasp of the surgical instrument in response to signals… (See “we programmed our micro-forceps to automatically open and release the grasped tissue if the detected tissue manipulation forces reach 7.5 mN” as detected by sensors in the tool shaft (surgical instrument) [p. 2, section II. Force-Based Automatic Tissue Release]. See also the rest of page 2.).
Given Kopp/Thornberry/Ye teaches “causing the robotic manipulator to automatically withdraw the tip of the surgical instrument into the trocar in response to signals from the position sensor indicating movement of the support” and Gonenc teaches “releasing the tissue from a grasp of the surgical instrument in response to signals” from sensors, it would have been obvious to respond to signals from the position sensor indicating movement of the support by automatically releasing tissue from the grasp of a surgical instrument. Thus, the combination of Kopp/Thornberry and Gonenc teaches “releasing the tissue from a grasp of the surgical instrument in response to signals from the position sensor indicating movement of the support.”
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the surgical method of Kopp/Thornberry to grasp and release the grasp of tissue in response to sensor data as taught by Gonenc. One of ordinary skill in the art would have been motivated to make this modification because “opening the forceps and releasing the grasped membrane can be an effective and simple aid to prevent direct transfer of excessive forces and hence damage to the retina” (patient tissue) (Gonenc, p. 2, col. 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MOYA LY/Examiner, Art Unit 3658
/Ramon A. Mercado/Supervisory Patent Examiner, Art Unit 3658