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 applicant’s amendment filed July 31st, 2026 has been entered. The amendments to the claims have resolved the 112(f) interpretation detailed in the Non-Final rejection mailed May 7th, 2026. Claims 1-14 remain pending, with new claims 15-17 pending as well within the application.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (U.S. Patent Application Publication 2021/0307591) in view of Nakashima (U.S. Patent Application Publication 2020/0100857). Ouyang teaches a medical manipulator system comprising:
a medical manipulator (figure 1 element 100) having an insertion portion (figure 1 element 110) configured to be intracorporeally inserted (paragraph 88 “distal tip 110 for inserting into a hollow organ or cavity of the body”)
wherein the controller (figure 4A element 140) has a groove (area circled in figure 4A below) engaged with a part of the medical manipulator (engagement circled in figure 3 below)
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the medical manipulator has a connection portion (figure 16 element 1638 circled below) and an extracorporeal flexible portion (figure 16 element 1602 pointed to with an arrow below)
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wherein the connection portion is configured to rotatably connect the insertion portion and the extracorporeal flexible portion around a rotation axis extending in a longitudinal direction of the medical manipulator (claim 1 the cannula element 120 rotates around the longitudinal axis relative to the connection portion element 1638, and the extracorporeal flexible portion element 1602 is attached to the connection portion)
wherein the connection portion has a fitting portion (figure 4b area including elements 450 and 452 circled below) fitted with the groove (figure 4b area including elements 470 and 472 circled below) of the controller (fitting shown in figure 3 above)
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the groove is formed in a tapered shape and has a taper portion extending in a vertical direction (see figure 4b above groove tapers off (rounded shape on the inside of the groove) and extends in the vertical direction)
the fitting portion is formed in a tapered shape fitted to the taper portion of the groove (the fitting portion fits flush with the groove as shown in figure 3 and so also is tapered in order to meet the tapered inside of the groove)
Ouyang fails to teach a medical manipulator system comprising:
a drive device detachably connected to the medical manipulator
a controller communicatively connected to the drive device and configured to receive a manipulation input for driving the medical manipulator
Nakashima teaches a medical manipulator system comprising:
a drive device (figure 3 element 38 circled below, paragraph 52 “motor unit 38”) detachably connected (see figures 1 and 3 where element 40 is missing from the drive device in figure 3) to the medical manipulator (figure 1 element 40)
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a controller (figure 1 element 30 pointed at with an arrow above) which is communicatively connected to the drive device and to which a manipulation input for driving the medical manipulator is input (paragraph 52 “operated and input by the operator”)
It would have been obvious before the effective filing date of the claimed invention to one of
ordinary skill in the art to modify the manipulator system of Ouyang with the drive device of Nakashima in order to provide the operator with the ability to remotely operate physical movement of the inserted end of the manipulator. This allows an operator to perform physical operations within the patient, such as opening and closing of grasping forceps as outlined in paragraph 89. These physical operations widen the treatment possibilities of the device, benefitting patient safety by combining multiple operational capabilities into one inserted device and reducing opportunities for infection.
Regarding claim 2, Ouyang and Nakashima combined teach the limitations of claim 1, and Ouyang further teaches a medical manipulator system wherein the fitting portion (figure 4b area including elements 450 and 452 circled below) is provided on the connection portion, and the connection portion is configured to rotate in cooperation with the extracorporeal flexible portion (figure 16 element 1602) (both the fitting portion and the extracorporeal flexible portion exist on the connection portion, and so rotate together in relation to the cannula).
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Regarding claim 3, Ouyang and Nakashima combined teach the limitations of claim 1, and Ouyang further teaches a medical manipulator system wherein the connection portion has an instruments port (figure 4A element 132 circled below) configured to communicate with an internal path of the medical manipulator, and the instruments port is provided on the connection portion configured to rotate in cooperation with the extracorporeal flexible portion (instruments port exists on the connection portion along with the extracorporeal flexible portion, and so both rotate in concert relative to the cannula).
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Regarding claim 4, Ouyang and Nakashima combined teach the limitations of claims 1 and 3, and Ouyang further teaches a medical manipulator system wherein the instruments port has at least one joint (figure 7 see joint between elements 132 and 732 below).
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Regarding claim 5, Ouyang and Nakashima combined teach the limitations of claims 1 and 3, and Ouyang further teaches a medical manipulator system wherein an outer circumferential surface of the fitting portion is formed from a flat surface (figure 4A surface pointed to with the downwards arrow below) and a curved surface (figure 4A surface pointed to with the upwards arrow below) and the flat surface is provided on an opposite side of the instruments port with respect to the rotation axis (instruments port 132 is on the opposite side of the flat surface below).
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Regarding claim 6, Ouyang and Nakashima combined teach the limitations of claims 1 and 3, and Ouyang further teaches a medical manipulator system wherein the instruments port is rotatably provided on the connection portion (the instruments port rotates with the rotation of the connection portion it exists on, and so is rotatably provided upon the member).
Regarding claim 7, Ouyang and Nakashima combined teach the limitations of claims 1, 3, and 5, and Ouyang further teaches a medical manipulator system wherein the groove of the controller is a groove formed on a left surface facing left (figure 4B see groove labeled 440 on the left side of the view) and extending in a vertical direction (defined by the arrow in the image below aligning with the longitudinal direction of the groove), and the groove of the controller is formed from a curved surface configured to fit with the curved surface of the fitting portion (see curve of groove in figure 4B and the mated configuration of the fitting portion with the groove in figure 3 shown earlier above).
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Regarding claim 8, Ouyang and Nakashima combined teach the limitations of claims 1, 3, 5, and 7, and Ouyang further teaches a medical manipulator system wherein the groove of the controller is provided at a position not overlapping another portion of the controller when viewed in the vertical direction (the vertical direction as shown by the arrow above dictates a view without overlap of the groove of the controller with another portion of the controller).
Regarding claim 9, Ouyang and Nakashima combined teach the limitations of claims 1, 3, 5, and 7, and Ouyang further teaches a medical manipulator system wherein the controller has a grip (paragraph 65 “a multiple-use handle with a pistol grip configured for grasping with a user's hand”), and the grip is arranged side by side with the connection portion when the groove is fitted to the fitting portion (figure 3 seen below the grip area circled is side by side with the connection portion 138).
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Regarding claim 10, Ouyang and Nakashima combined teach the limitations of claims 1, 3, 5, 7, and 9, and Ouyang further teaches a medical manipulator system wherein the controller has a touchpad (abstract “touch screen control”, figure 1 element 350), and a first central axis of the grip in the vertical direction is arranged to be offset to the left of a second central axis in the vertical direction passing through a center of the touchpad (figure 3 see both axis’ drawn by the large arrows, and that the axis going through the grip is to the left of the axis going through the touchpad, with the dotted line labelled 124 being the vertical direction).
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Regarding claim 11, Ouyang teaches a medical manipulator having:
an insertion portion (figure 4A element 110) configured to be intracorporeally inserted (paragraph 88 “distal tip 110 for inserting into a hollow organ or cavity of the body”)
a connection portion (figure 1 element 138) configured to rotatably connect the insertion portion around a longitudinal axis (claim 1 the cannula element 120 rotates around the longitudinal axis relative to the connection portion element)
a controller comprising:
a groove (figure 4b area including elements 470 and 472 circled below) engaged with the connection portion of the medical manipulator (engagement shown in figure 3 below)
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wherein the connection portion has a fitting portion (figure 4b area including elements 450 and 452 circled below) fitted with the groove of the controller (fitting shown in figure 3 above)
the groove is formed in a tapered shape and has a taper portion extending in a vertical direction (see figure 4a groove (area circled below) tapers off (rounded shape on the inside of the groove) and extends in the vertical direction)
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the fitting portion is formed in a tapered shape fitted to the taper portion of the groove (the fitting portion fits flush with the groove as shown in figure 3 and so also is tapered in order to meet the tapered inside of the groove)
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the controller further comprises a grip (paragraph 65 “a multiple-use handle with a pistol grip configured for grasping with a user's hand”)
the grip is arranged side by side with the connection portion when the groove is fitted to the fitting portion (figure 3 seen below the grip area circled is side by side with the connection portion 138)
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Ouyang fails to teach a controller configured to drive a medical manipulator. Nakashima teaches a controller configured to drive a medical manipulator (figure 1 element 30). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the manipulator system of Ouyang with the drive device of Nakashima in order to provide the operator with the ability to remotely operate physical movement of the inserted end of the manipulator. This allows an operator to perform physical operations within the patient, such as opening and closing of grasping forceps as outlined in paragraph 89. These physical operations widen the treatment possibilities of the device, benefitting patient safety by combining multiple operational capabilities into one inserted device and reducing opportunities for infection.
Regarding claim 12, Ouyang and Nakashima combined teach the limitations of claim 11, and Ouyang further teaches a controller wherein the groove is a groove formed on a left surface facing left (figure 4B see groove labeled 440 on the left side of the view) and extending in a vertical direction (defined by the arrow in the image below aligning with the longitudinal direction of the groove), and the groove is formed from a curved surface configured to fit with a curved surface of the fitting portion (see curve of groove in figure 4B and the mated configuration of the fitting portion with the groove in figure 3 above).
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Regarding claim 13, Ouyang and Nakashima combined teach the limitations of claims 11 and 12, and Ouyang further teaches a controller wherein the groove is provided at a position not overlapping another portion of the controller when viewed in the vertical direction (the vertical direction as shown by the arrow above dictates a view without overlap of the groove of the controller with another portion of the controller).
Regarding claim 14, Ouyang and Nakashima combined teach the limitations of claim 11, and Ouyang further teaches a controller further comprising a touchpad (abstract “touch screen control”, figure 1 element 350), wherein a first central axis of the grip in the vertical direction is arranged to be offset to a left of a second central axis in the vertical direction passing through a center of the touchpad (figure 3 see both axis’ drawn by the large arrows, and that the axis going through the grip is to the left of the axis going through the touchpad, with the dotted line labelled 124 being the vertical direction).
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portion.
Regarding claim 16, Ouyang and Nakashima combined teach the limitations of claim 1, and Ouyang further teaches a medical manipulator system wherein the connection portion is fitted to the controller such that the controller and the connection portion can be simultaneously grasped by a user with one hand (see figure 3 showing mated configuration of controller and connection portion, where an operator would be able to simultaneously grasp both with one hand).
Regarding claim 17, Ouyang further teaches a medical manipulator system wherein in a state in which the controller and the connection portion are simultaneously grasped by the user with one hand, operation inputs can be made to the controller, and a rotational operation can be applied to the insertion portion via the connection portion (figure 3 shows that the touch screen will still be in view and operational when a hand is holding both the controller and connection portion, and the other hand of the user can perform a rotational operation to the insertion portion via the connection portion).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang and Nakashima in view of Motoki et al (U.S. Patent Application Publication 2004/0133075, hereinafter “Motoki”). Ouyang and Nakashima combined teach the limitations of claim 1, but fail to teach a medical manipulator system wherein the groove is fitted to the fitting portion by sliding and moving the controller to a distal side while arranging the groove along the extracorporeal flexible portion.
Motoki teaches a medical manipulator system wherein the groove (figure 21 grooves 61a) is fitted to the fitting portion (figure 21 elements 62a) by sliding and moving the controller to a distal side (figure 21 moving controller 16 with the fitting portions inserted into the grooves 61a locks the intermediate linking portion 4b against the controller) while arranging the groove along the extracorporeal flexible portion (figure 21 grooves 61a and extracorporeal flexible portion 4c are arranged along each other).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical manipulator systems of Ouyang and Nakashima with the groove configuration of Motoki in order to create a locking mechanism to hold the controller against the fitting portion, preventing the configuration from detaching during an operation and potentially causing injury to the patient.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached Monday-Friday from 9:00 – 5:00 PM.
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, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/ Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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