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 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 5 and 15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Both claims contain the limitation “the camera unit is in the third state when the first wire and the second wire are pulled by bending the leaf spring”, but the drawings and specification do not contain this component of the operation of the invention. The examiner suggests that this claim is rewritten as “the camera unit is in the third state when the leaf spring is bent by pulling the first wire and the second wire”, which has support within the drawing and specification.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Herda et al (U.S. Patent Application Publication 2023/0123867, hereinafter “Herda”). Regarding claim 1, Herda teaches a medical manipulator, comprising:
a manipulator (figure 1A element 100)
a camera unit (paragraph 42 “camera 410”) provided at a distal end of the manipulator so as to be movable back and forth in a longitudinal direction (paragraph 67 “camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable”, wherein the camera unit includes a support portion (figure 2h pointed at with arrow below)
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a camera provided at a distal end side of the support portion, and the camera unit includes:
a first state in which the camera unit advances relative to the manipulator (paragraph 67 “camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable”)
a second state in which the camera unit retracts relative to the manipulator (paragraph 67 “camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable”)
a third state in which the camera unit bends downward (paragraph 67 “when extended, the distal portion of camera stalk 202 may be bendable”)
Regarding claim 2, Herda teaches a medical manipulator wherein the support portion includes:
a bending portion extending in the longitudinal direction (figure 2G circled below)
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a first wire connected to a proximal end of the camera unit (figure 2H pointed at with the upper arrow below), and a second wire connected to an underside of the camera unit (figure 2H pointed at with the lower arrow below)
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the camera unit is in the first state when the first wire is pulled, in the second state when the second wire is pulled, and in the third state when the first wire and the second wire are pulled, with the bending portion bending (camera unit is manipulated by the wires attached to it, so any combination of one or more wires being pulled puts the unit in a different state, ranging from advancing or retracting relative to the manipulator, and bending as shown in figures 2F and 2G)
Regarding claim 4, Herda teaches a medical manipulator wherein the second wire is connected to an underside of the camera (figure 2H pointed at below).
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Regarding claim 6, Herda teaches a medical manipulator wherein the manipulator further includes a channel tube, and the channel tube is disposed below the camera unit on a distal end surface of the manipulator (figure 1B channel tube pointed to by arrow exists below the distal end camera unit).
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Regarding claim 7, Herda teaches a medical manipulator wherein the manipulator further includes an outer sheath, and a bendable bending portion disposed at the distal end of the outer sheath, and the camera unit is disposed distal to the bending portion when retracted (see figure 2G outer sheath 132 and bendable portion distal to sheath with camera unit located on the very distal end of bendable portion).
Claim Rejections - 35 USC § 103
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Herda in view of Phee et al (U.S. Patent Application Publication 2015/0230697, hereinafter “Phee”). While Herda teaches the limitations of claims 1 and 2, it fails to teach a medical manipulator wherein the first wire is connected via a pulley at the proximal end side of the camera unit. Phee teaches a medical manipulator wherein the first wire is connected via a pulley at the proximal end side of the camera unit (paragraph 165 “or a cable 154 that wraps around a wheel or pulley” shown in figure 3H proximal to the camera unit 222). 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 of Herda with the pulley of Phee in order to allow for fine adjustments of the bending member’s position, allowing an operator to make minute changes in viewing angle to better focus on the target region within the patient.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Herda in view of Major et al (U.S. Patent Application 2023/0128263, hereinafter “Major”). Regarding claim 5, while Herda teaches the limitations of claims 1 and 2, it fails to teach a medical manipulator wherein the bending portion includes a leaf spring, and the camera unit is in the third state when the first wire and the second wire are pulled by bending the leaf spring. Major teaches a medical manipulator wherein the bending portion includes a leaf spring (see springs 146 in figure 2B bent by control wires 182), and the camera unit is in the third state when the first wire and the second wire are pulled by bending the leaf spring (the bending of the springs by the control wire bends the articulation member, and paragraph 35 details the attachment of a camera unit on the end of the articulation member). 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 of Herda with the springs of Major in order to promote axial stiffness and bending flexibility as stated in paragraph 2 of Major, which promotes control responsiveness and predictiveness as stated in paragraph 36 of major.
Regarding claim 8, while Herda teaches the limitations of claims 1, 6, and 7, it fails to teach a medical manipulator wherein the bending portion of the manipulator includes a plurality of ring members through which a bending wire is inserted, and the camera unit is, in a retracted state, disposed on the distal side of the ring member disposed at the most distal end of the plurality of ring members. Major teaches a medical manipulator wherein the bending portion of the manipulator includes a plurality of ring members (figure 1 elements 120) through which a bending wire (figure 1 element 112) is inserted, and the camera unit is, in a retracted state, disposed on the distal side of the ring member disposed at the most distal end of the plurality of ring members (paragraph 35 details the attachment of a camera unit on the end of the articulation member). 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 of Herda with the ring members of Major in order to create a bending design that can be adapted to a variety of operation types. The ring configuration allows for easier manufacture of longer or shorter bending members by adding or removing individual rings, allowing for operation specific bending lengths to be used by operators, promoting the correct level of reach and control for that individual operation.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Herda and Major in view of Phee. While Herda and Major combined teach the limitations of claims 1, 6, 7, and 8, they fail to teach a medical manipulator further comprising a spring formed in a spiral shape along the longitudinal direction, wherein the outer sheath is disposed outside the spring, and the channel tube passes through the spring. Phee teaches a medical manipulator further comprising a spring (figure 7c spring coil 312) formed in a spiral shape along the longitudinal direction, wherein the outer sheath (figure 7c protection layer 310) is disposed outside the spring, and the channel tube (figure 7c labeled “space”) passes through the spring. 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 manipulators of Herda and Major with the sheathed spring configuration of Phee in order to add a layer of protection to the bending member, promoting longevity of the medical manipulators bending ability.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Herda, Major, and Phee in further view of Major. Herda, Major, and Phee combined teach the limitations of claims 1, 6, 7, 8, and 9, and Major further teaches a medical manipulator wherein each of the plurality of ring members has a slit into which the spring is fitted (figure 2A slit circled below), and each of the plurality of ring members is attached to the spring by fitting the spring into the slit (figure 2A below see spring fitted into the slit).
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It would have been obvious to modify the medical manipulators of Herda and Phee with the spring and slit configuration of Major in order to promote axial stiffness and bending flexibility as stated in paragraph 2 of Major, which promotes control responsiveness and predictiveness as stated in paragraph 36 of major.
Claims 11, 12, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Herda in view of Murdeshwar et al (U.S. Patent Application Publication 2024/0016483, hereinafter “Murdeshwar”). Regarding claim 11, Herda teaches a medical manipulator system comprising:
an insertion manipulator (figure 1A element 100) including a manipulator and a camera unit (paragraph 42 “camera 410”) provided at a distal end of the manipulator so as to be movable back and forth in a longitudinal direction
wherein the camera unit includes a support portion (figure 2H pointed at with upper arrow below), and a camera (figure 2H pointed at with lower arrow below) provided at a distal end side of the support portion, and wherein the camera unit includes:
a first state in which the camera unit advances relative to the manipulator (paragraph 67 “camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable”)
a second state in which the camera unit retracts relative to the manipulator (paragraph 67 “camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable”)
a third state in which the camera unit bends downward (paragraph 67 “when extended, the distal portion of camera stalk 202 may be bendable”)
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Herda fails to teach a medical manipulator system comprising:
a drive unit that drives the insertion manipulator
a control device that controls the drive unit
Murdeshwar teaches a medical manipulator system comprising:
a drive unit (paragraph 55 “drive unit 46”) that drives the insertion manipulator
a control device (paragraph 55 “control system 12”) that controls the drive unit
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 of Herda with the drive and control unit of Murdeshwar in order to allow for machine precision in the articulation of camera unit at the distal end of the medical manipulator, reducing the chance of error or injury to the patient associated with an operator themselves physically manipulating the camera with control wires.
Regarding claim 12, Herda further teaches a medical manipulator wherein the support portion includes:
a bending portion extending in the longitudinal direction (figure 2G circled below)
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a first wire connected to a proximal end of the camera unit (figure 2H pointed at with the upper arrow below), and a second wire connected to an underside of the camera unit (figure 2H pointed at with the lower arrow below)
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the camera unit is in the first state when the first wire is pulled, in the second state when the second wire is pulled, and in the third state when the first wire and the second wire are pulled, with the bending portion bending (camera unit is manipulated by the wires attached to it, so any combination of one or more wires being pulled puts the unit in a different state, ranging from advancing or retracting relative to the manipulator, and bending as shown in figures 2F and 2G)
Regarding claim 14, Herda further teaches a medical manipulator system wherein the second wire is connected to an underside of the camera (figure 2H pointed at below).
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Regarding claim 16, Herda further teaches a medical manipulator system wherein the manipulator further includes a channel tube, and the channel tube is disposed below the camera unit on a distal end surface of the manipulator (figure 1B channel tube pointed to by arrow exists below the distal end camera unit).
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Regarding claim 17, Herda further teaches a medical manipulator system wherein the manipulator further includes an outer sheath, and a bendable bending portion disposed at the distal end of the outer sheath, and the camera unit is disposed distal to the bending portion when retracted (see figure 2G outer sheath 132 and bendable portion distal to sheath with camera unit located on the very distal end of bendable portion).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Herda and Murdeshwar in view of Phee. While Herda and Murdeshwar combined teach the limitations of claims 11 and 12, they fail to teach a medical manipulator system wherein the first wire is connected via a pulley at the proximal end side of the camera unit. Phee teaches a medical manipulator system wherein the first wire is connected via a pulley at the proximal end side of the camera unit (paragraph 165 “or a cable 154 that wraps around a wheel or pulley” shown in figure 3H proximal to the camera unit 222). 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 of Herda and Murdeshwar with the pulley of Phee in order to allow for fine adjustments of the bending member’s position, allowing an operator to make minute changes in viewing angle to better focus on the target region within the patient.
Claim 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Herda and Murdeshwar in view of Major. While Herda and Murdeshwar combined teach the limitations of claims 11 and 12, they fail to teach a medical manipulator system wherein the bending portion includes a leaf spring, and the camera unit is in the third state when the first wire and the second wire are pulled by bending the leaf spring. Major teaches a medical manipulator wherein the bending portion includes a leaf spring (see springs 146 in figure 2B bent by control wires 182), and the camera unit is in the third state when the first wire and the second wire are pulled by bending the leaf spring (the bending of the springs by the control wire bends the articulation member, and paragraph 35 details the attachment of a camera unit on the end of the articulation member). 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 of Herda and Murdeshwar with the springs of Major in order to promote axial stiffness and bending flexibility as stated in paragraph 2 of Major, which promotes control responsiveness and predictiveness as stated in paragraph 36 of major.
Regarding Claim 18, while Herda and Murdeshwar combined teach the limitations of claims 11, 16, and 17, they fail to teach a medical manipulator system wherein the bending portion of the manipulator includes a plurality of ring members through which a bending wire is inserted, and the camera unit is, in a retracted state, disposed on the distal side of the ring member disposed at the most distal end of the plurality of ring members. Major teaches a medical manipulator system wherein the bending portion of the manipulator includes a plurality of ring members (figure 1 elements 120) through which a bending wire (figure 1 element 112) is inserted, and the camera unit is, in a retracted state, disposed on the distal side of the ring member disposed at the most distal end of the plurality of ring members (paragraph 35 details the attachment of a camera unit on the end of the articulation member). 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 of Herda and Murdeshwar with the ring members of Major in order to create a bending design that can be adapted to a variety of operation types. The ring configuration allows for easier manufacture of longer or shorter bending members by adding or removing individual rings, allowing for operation specific bending lengths to be used by operators, promoting the correct level of reach and control for that individual operation.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Herda, Murdeshwar, and Major in view of Phee. While Herda, Murdeshwar, and Major combined teach the limitations of claims 11, 16, 17, and 18, they fail to teach a medical manipulator system further comprising a spring formed in a spiral shape along the longitudinal direction, wherein the outer sheath is disposed outside the spring, and the channel tube passes through the spring. Phee teaches a medical manipulator system further comprising a spring (figure 7c spring coil 312) formed in a spiral shape along the longitudinal direction, wherein the outer sheath (figure 7c protection layer 310) is disposed outside the spring, and the channel tube (figure 7c labeled “space”) passes through the spring. 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 manipulators of Herda, Murdeshwar, and Major with the sheathed spring configuration of Phee in order to add a layer of protection to the bending member, promoting longevity of the medical manipulators bending ability.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Herda, Murdeshwar, Major, and Phee in further view of Major. Herda, Murdeshwar, Major, and Phee combined teach the limitations of claims 11, 16, 17, 18, and 19, and Major further teaches a medical manipulator system wherein each of the plurality of ring members has a slit into which the spring is fitted (figure 2A slit circled below), and each of the plurality of ring members is attached to the spring by fitting the spring into the slit (figure 2A below see spring fitted into the slit).
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It would have been obvious to modify the medical manipulators of Herda, Murdeshwar, and Phee with the spring and slit configuration of Major in order to promote axial stiffness and bending flexibility as stated in paragraph 2 of Major, which promotes control responsiveness and predictiveness as stated in paragraph 36 of major.
Conclusion
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 between 9:00 and 5:00 PM EST Mondays through Fridays.
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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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