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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is 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 32 recites the limitation "a surgical robotic arm" in lines 1-2. However, first and second surgical robotic arms were already introduced in claim 20, and the claims are unclear on if this is one of the previously introduced surgical robotic arms or a third new surgical robotic arm. Applicant should amend claim 32 to clarify if this surgical robotic arm refers to a previously introduced surgical robotic arm, or is meant to be a third surgical robotic arm. For the purposes of examination, this surgical robotic arm will be assumed to be a third surgical robotic arm and not one of the previously introduced surgical robotic arms.
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.
Claim(s) 20-27 and 34-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuan et al. (U.S. Patent No. 12,690,921) in view of Ozawa et al. (Pub. No. 2022/0233190).
Regarding claim 20, McGuan et al. discloses a method for sewing an incision in a patient’s soft tissue (C5:L57-64: the robotic system can be used to suture a wound closed) using a surgical robot (100; FIG. 1) having a surgical robotic controller (150) and first and second robotic arms (105A; C5:L60: two 105A robotic arms can be used), said method comprising the following steps performed by the surgical robotic controller: controlling movement of the first and second surgical robotic arms automatically to close a wound using sutures (C5:L57-64); tracking positions of a plurality of markers placed on patient tissue (C6:L49-C7:L6: tracking system 115 keeps the robotic arms 105A from colliding with soft tissue, which C7:L38-57 states can be done through the use of fiducial markers); and adjusting movements of the first and second surgical robotic arms automatically in response to changes in tissue marker positions (C14:L9-17: surgical computer 150 can automatically move the robotic arm to prevent 105A from causing tension to the soft tissue).
McGuan et al. is silent regarding the closing the wound with sutures step comprising passing a surgical needle through opposite edges of the incision, wherein the surgical needle pulls a suture across the incision, and automatically tensioning the suture to close the opposite edges together, and that the tracking and adjusting steps are done as the suture is being tensioned.
Ozawa et al. teaches a method of closing a wound using sutures ([0026-28] and FIGs. 2A-2D), and discloses a suture needle (214) being passed through opposite edges of a wound (108) through the mucosal layer of tissue ([0026]), where the surgical needle pulls a suture (212) across the wound and then tightens the suture to close the wound ([0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date that the method of using a suture needle to bring opposite edges of a wound together taught in Ozawa et al. could be used in the closing of a wound by a robotic system in McGuan et al., as those would be known steps for suturing a wound closed.
Regarding claim 21, McGuan et al. as modified by Ozawa et al. further discloses controlling movement of the first and second surgical robotic arms to pass the surgical needle through opposite edges of the incision comprises the user inputting instructions to the surgical robotic controller via an interface to guide movement of the first and second surgical robotic arms (C85:L9-15: input devices 2636 allow a surgeon to input instructions for the surgical plan, where C86:L39-44 discloses that any steps can be automatically performed by the instructions without user direct initiation of the activity).
Regarding claim 22, McGuan et al. as modified by Ozawa et al. further discloses controlling movement of the first and second surgical robotic arms to tension the suture to close the opposite edges together comprises the user inputting instructions to the surgical robotic controller via the interface to guide movement of the first and second surgical robotic arms (C85:L9-15: input devices 2636 allow a surgeon to input instructions for the surgical plan, where C86:L39-44 discloses that any steps can be automatically performed by the instructions without user direct initiation of the activity).
Regarding claim 23, McGuan et al. as modified by Ozawa et al. further discloses at least some of the plurality of markers are located on the patient's skin on either side of the incision (C7:L38-57 has fiducial markers placed on soft tissue to track the movement of body parts, and the modification by Ozawa et al. would make either side of wound 108 ideal places for markers).
Regarding claim 24, McGuan et al. as modified by Ozawa et al. further discloses at least some of the plurality of markers are located on opposed surfaces of the patient's soft tissue exposed by the incision (C7:L38-57 has fiducial markers placed on soft tissue to track the movement of body parts, and the modification by Ozawa et al. would make either side of wound 108 ideal places for markers).
Regarding claim 25, McGuan et al. as modified by Ozawa et al. further discloses at least some of the plurality of markers are located on opposed surfaces of the patient's fascia exposed by the incision (C7:L38-57 has fiducial markers placed on soft tissue to track the movement of body parts, and the modification by Ozawa et al. would make either side of wound 108 ideal places for markers).
Regarding claim 26, McGuan et al. as modified by Ozawa et al. is silent regarding at least some of the plurality of markers are placed on the patient’s skin prior to making the incision. However, one of ordinary skill in the art before the effective filing date would understand that the tracking system 115 of McGuan et al. is used to observe movement of body parts relative to each other during the wound closing, and that the markers could be placed prior to the wound being made to observe how close the suturing has returned the edges of the wound to their prior position.
Regarding claim 27, McGuan et al. as modified by Ozawa et al. is silent regarding at least some of the plurality of markers are placed on the patient’s skin after making the incision. However, one of ordinary skill in the art before the effective filing date would understand that the tracking system 115 of McGuan et al. is used to observe movement of body parts relative to each other during the wound closing, and that the markers could be placed after the wound is made to ensure that the suturing process closes the sides of the wound together.
Regarding claim 34, McGuan et al. as modified by Ozawa et al. further discloses tracking positions of the plurality of markers placed on patient tissue on each side of the incision automatically as the surgical needle is passed through the opposite edges (C85:L9-15: input devices 2636 allow a surgeon to input instructions for the surgical plan, where C86:L39-44 discloses that any steps can be automatically performed by the instructions without user direct initiation of the activity, which would include tracking the markers throughout the operation) and adjusting movements of the first and second surgical robotic arms automatically in response to changes in tissue marker positions to properly align the opposite edges of the incision as the surgical needle is passed through said opposite edges (C85:L9-15: input devices 2636 allow a surgeon to input instructions for the surgical plan, where C86:L39-44 discloses that any steps can be automatically performed by the instructions without user direct initiation of the activity, which would include adjusting the robotic arms 105A in response to changes in the marker placement).
Regarding claim 35, McGuan et al. as modified by Ozawa et al. further discloses tracking positions of the plurality of markers placed on patient tissue on each side of the incision comprises scanning the tissue with a sensor controlled by the surgical robotic controller (C6:L49-51: the tracking system 115 uses one or more sensors to collect real-time position data from the markers).
Regarding claim 36, McGuan et al. as modified by Ozawa et al. further discloses scanning the tissue with a sensor controlled by the surgical robotic controller comprises controlling movement of a third surgical robotic arm to position a camera held by the third surgical robotic arm to optically scan the plurality of markers (C7:L26-28: a camera can be mounted on a robotic arm 105A; C13:L64-68: multiple robotic arms 105A can be used for various functions, which would include holding the camera; C6:L57-C7:L4: the camera can use the tracker array on 105A to scan the markers in image-based tracking systems).
Regarding claim 37, McGuan et al. as modified by Ozawa et al. is silent regarding tracking the positions of the plurality of markers placed on patient tissue on each side of the incision comprises scanning the tissue with the sensor prior to tensioning the suture to close the opposite edges together to establish a baseline marker pattern from which changes can be determined. However, one of ordinary skill in the art before the effective filing date would understand that the initial position of the markers would be taken for the tracking system to determine what relative movement occurred during the procedure.
Regarding claim 38, McGuan et al. as modified by Ozawa et al. is silent regarding tracking the positions of the plurality of markers placed on patient tissue on each side of the incision comprises scanning the tissue with the sensor prior to passing the surgical needle through opposite edges of the incision to establish a baseline marker pattern from which changes can be determined. However, one of ordinary skill in the art before the effective filing date would understand that the initial position of the markers would be taken for the tracking system to determine what relative movement occurred during the procedure.
Regarding claim 39, McGuan et al. as modified by Ozawa et al. is silent regarding tracking the positions of the plurality of markers placed on patient tissue on each side of the incision comprises scanning the tissue with the sensor prior to forming the incision to establish a baseline marker pattern from which changes can be determined. However, one of ordinary skill in the art before the effective filing date would understand that the initial position of the markers would be taken for the tracking system to determine what relative movement occurred during the procedure.
Regarding claim 40, McGuan et al. as modified by Ozawa et al. is silent regarding scanning the patient's tissue with the sensor after the suture has been tensioned to confirm that the markers on the opposite edges of the incision remain properly aligned. However, one of ordinary skill in the art before the effective filing date would understand that the final position of the markers would be taken for the tracking system to determine what relative movement occurred during the procedure.
Claim(s) 28-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuan et al. in view of Ozawa et al., and in further view of Berube et al. (Pub. No. 2025/0001216).
Regarding claims 28-32, McGuan et al. as modified by Ozawa et al. discloses the invention as claimed in claim 20, as discussed above. The modified invention does not disclose at least some of the plurality of markers are two-dimensional, and can also be flexible stickers adhesively attached to the patient tissue or an ink either manually applied with a marking pen or using a surgical robotic arm.
Berube et al. discloses placing markers on skin for aiding in surgical operations ([0190] and [0210]), and discloses placing erasable ink ([0190]) or flat stickers ([0210]) for the purpose of reducing the profile of the markers on the skin.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used two-dimensional markers, as taught by Berube et al., for the purpose of reducing the profile of the markers on the skin. This modification includes the use of a marking pen to manually apply the ink ([0190]), and the modification to McGuan et al. means that the robotic arm can be used to apply the ink, as C86:L39-44 discloses that any steps can be automatically performed by the robotic arms according to the instructions without user direct initiation of the activity.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuan et al. in view of Ozawa et al., and in further view of Lamba et al. (Pub. No. 2026/0137454).
Regarding claim 33, McGuan et al. as modified by Ozawa et al. discloses the invention as claimed in claim 20, as discussed above. The modified invention does not disclose at least some of the plurality of markers are three-dimensional.
Lamba et al. teaches using imaging instruments to aid in suturing applications ([0032]), and discloses that markers can be two-dimensional or three-dimensional objects ([0041]) based on user selection, proximity of tools in the field of view, or other user or system criteria.
It would have been obvious to one of ordinary skill in the art before the effective filing date that McGuan et al. could be modified to use three-dimensional markers, as taught by Lamba et al., based on user selection, proximity of tools in the field of view, or other user or system criteria.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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