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 § 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, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kawaura et al (U.S. Patent Application Publication 2012/0004503, hereinafter “Kawaura”). Kawaura teaches a medical manipulator, comprising:
a manipulator flexible portion extending in a longitudinal direction (figure 3 element 42)
two arms (figure 3 elements 33 and 34) arranged at a distal end of the manipulator flexible portion
wherein each of the two arms includes a first bending portion (figure 4 elements 37 bend)
wherein the first bending portion has an artificial muscle that drives the first bending portion to bend (paragraph 46 “curving operation wires are connected to the arms 33 and 34”)
a bending tube (paragraph 56 both arms have channels 48 and 49 through them that bend with the arm)
wherein the artificial muscle and the bending tube extend along the longitudinal direction and are arranged side by side (curving operation wires are located within the arms and therefore are side by side to the bending tubes)
Regarding claim 9, Kawaura teaches a medical manipulator wherein the first bending portion allows a treatment tool to be inserted, and the bending tube forms a channel through which the treatment tool can be inserted (paragraph 47 details treatment tool channels within each arm).
Regarding claim 10, Kawaura teaches a medical manipulator wherein:
each of the two arms includes a second bending portion through which the treatment tool can be inserted (figure 3 elements 38, paragraph 44 details them as “second arm curving portions”)
the second bending portion is connected to the proximal end side of the first bending portion (figure 3 elements 38 located proximally to element 37)
a wire is connected to the second bending portion (paragraph 46 details how the “curving operation wires” are connected to the arms)
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.
Claims 2, 3, and 4, 11-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kawaura in view of Reiner et al (U.S. Patent Application Publication 2023/0380765, hereinafter “Reiner”). Regarding claim 2, while Kawaura teaches the limitations of claim 2, it fails to teach a medical manipulator wherein a plurality of the artificial muscles are arranged around the bending tube. Reiner teaches a medical manipulator wherein a plurality of the artificial muscles are arranged around the bending tube (figure 1A artificial muscles 101). 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 bending tube of Kawaura with the artificial muscles of Reiner in order to increase the bending range of motion of the tube, as a plurality of muscles circumferentially surrounding the tube allows to a much greater range of motion than the single muscle in each tube of Kawaura.
Regarding claim 3, Kawaura fails to teach a medical manipulator wherein:
the first bending portion is bendable at least in the up-down direction and left-right direction perpendicular to the longitudinal direction
some of the plurality of artificial muscles are arranged on the upper side of the bending tube in the up-down direction
the remaining of the plurality of artificial muscles are arranged on the lower side of the bending tube in the up-down direction
Reiner teaches a medical manipulator wherein:
the first bending portion is bendable at least in the up-down direction and left-right direction perpendicular to the longitudinal direction (paragraph 135 details how artificial muscles acting independently of each other allow the bending tube to “twist, turn, and bend as if it was a living organism navigating through a small serpiginous space”.
some of the plurality of artificial muscles are arranged on the upper side of the bending tube in the up-down direction (the artificial muscles are arranged circumferentially about the bending tube as seen in figure 2, and so are on both the upper and lower side of the tube)
the remaining of the plurality of artificial muscles are arranged on the lower side of the bending tube in the up-down direction (the artificial muscles are arranged circumferentially about the bending tube as seen in figure 2, and so are on both the upper and lower side of the tube)
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 bending tube of Kawaura with the artificial muscles of Reiner in order to increase the bending range of motion of the tube, as a plurality of muscles circumferentially surrounding the tube allows to a much greater range of motion than the single muscle in each tube of Kawaura.
Regarding claim 4, Kawaura fails to teach a medical manipulator wherein the artificial muscle is coated with silicone. Reiner teaches a medical manipulator wherein the artificial muscle is coated with silicone (paragraph 10 details how shafts are made of silicone, and Reiner teaches artificial muscles embedded within the shaft wall). 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 bending tube of Kawaura with the silicone coated artificial muscles of Reiner in order to make the tube of a material that “improves catheter flexibility and navigation” as stated in paragraph 9).
Regarding claim 11, Kawaura teaches a medical manipulator system comprising:
a medical manipulator having a manipulator flexible portion (figure 3 element 42) extending in a longitudinal direction and two arms arranged at a distal end of the manipulator flexible portion (figure 3 elements 33 and 34)
wherein each of the two arms includes a first bending portion (figure 4 elements 37 bend)
the first bending portion includes an artificial muscle for driving the first bending portion to bend (paragraph 46 “curving operation wires are connected to the arms 33 and 34”)
a bending tube through which a treatment tool can be inserted (paragraph 47 details treatment tool channels within each arm)
wherein the artificial muscle and the bending tube extend along the longitudinal direction and arranged side by side (the curving operation wires extend longitudinally with each arm)
However, Kawaura fails to teach a medical manipulator system comprising:
a drive unit that drives the medical manipulator
a control device that controls the drive unit
Reiner teaches a medical manipulator system comprising:
a drive unit that drives the medical manipulator (paragraphs 73 and 74 detail actuation of the individual artificial muscles in response to the computer control device signal)
a control device that controls the drive unit (paragraphs 73 and 74 detail actuation of the individual artificial muscles in response to the computer control device signal)
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 system of Kawaura with the drive unit and control device of Reiner in order to incorporate machine level fine adjustments to bending position and angle, whereas Kawaura relies on a control wire that is human operated to control bending. Machine control allows for more precision during an operation, reducing risk of injury to the patient.
Regarding claim 12, Kawaura fails to teach a medical manipulator system wherein a plurality of the artificial muscles are arranged around the bending tube. Reiner teaches a medical manipulator system wherein a plurality of the artificial muscles are arranged around the bending tube (figure 1A artificial muscles 101). 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 bending tube of Kawaura with the artificial muscles of Reiner in order to increase the bending range of motion of the tube, as a plurality of muscles circumferentially surrounding the tube allows to a much greater range of motion than the single muscle in each tube of Kawaura.
Regarding claim 13, Kawaura fails to teach a medical manipulator system wherein:
the first bending portion can be bent in the up-down and left-right directions perpendicular to the longitudinal direction
some of the artificial muscles are arranged on the upper side of the bending tube in the up-down direction
the remaining artificial muscles are arranged on the lower side of the bending tube in the up-down direction
Reiner teaches a medical manipulator system wherein:
the first bending portion can be bent in the up-down and left-right directions perpendicular to the longitudinal direction (paragraph 135 details how artificial muscles acting independently of each other allow the bending tube to “twist, turn, and bend as if it was a living organism navigating through a small serpiginous space”)
some of the artificial muscles are arranged on the upper side of the bending tube in the up-down direction (the artificial muscles are arranged circumferentially about the bending tube as seen in figure 2, and so are on both the upper and lower side of the tube)
the remaining artificial muscles are arranged on the lower side of the bending tube in the up-down direction (the artificial muscles are arranged circumferentially about the bending tube as seen in figure 2, and so are on both the upper and lower side of the tube)
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 bending tube of Kawaura with the artificial muscles of Reiner in order to increase the bending range of motion of the tube, as a plurality of muscles circumferentially surrounding the tube allows to a much greater range of motion than the single muscle in each tube of Kawaura.
Regarding claim 14, Kawaura fails to teach a medical manipulator system wherein the artificial muscles are silicone coated. Reiner teaches a medical manipulator system wherein the artificial muscles are silicone coated (paragraph 10 details how shafts are made of silicone, and Reiner teaches artificial muscles embedded within the shaft wall). 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 bending tube of Kawaura with the silicone coated artificial muscles of Reiner in order to make the tube of a material that “improves catheter flexibility and navigation” as stated in paragraph 9).
Regarding claim 19, Kawaura and Reiner combined teach the limitations of claim 11, and Kawaura further teaches a medical manipulator system wherein the first bending portion allows a treatment tool to be inserted, and the bending tube forms a channel through which the treatment tool can be inserted (paragraph 47 details treatment tool channels within each arm).
Regarding claim 20, Kawaura further teaches a medical manipulator system wherein each of the two arms includes a second bending portion through which the treatment tool can be inserted (figure 3 elements 38, paragraph 44 details them as “second arm curving portions”), the second bending portion is connected to the proximal end side of the first bending portion (figure 3 elements 38 located proximally to element 37), and a wire is connected to the second bending portion (paragraph 46 details how the “curving operation wires” are connected to the arms).
Claims 5, 6, 7, 8, and 15-18 are rejected under U.S.C. 103 as being unpatentable over Kawaura and Reiner in view of Tsuji et al (U.S. Patent Application Publication 2021/0022818, hereinafter “Tsuji”). Regarding claim 5, while Kawaura and Reiner combined teach the limitations of claims 1-4, they fail to teach a medical manipulator wherein the bending tube has a plurality of grooves formed along a circumferential direction with respect to the longitudinal direction. Tsuji teaches a medical manipulator wherein the bending tube has a plurality of grooves formed along a circumferential direction with respect to the longitudinal direction (figure 7 grooves pointed to by arrows below).
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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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections.
Regarding claim 6, Kawaura and Reiner fail to teach a medical manipulator wherein:
each of the plurality of grooves has a first gap and a second gap,
a longitudinal length of the first gap is longer than a longitudinal length of the second gap,
the second gap of a first groove that is one of the plurality of grooves and the second gap of a second groove that is adjacent to the first groove among the plurality of grooves are arranged adjacent to each other along the longitudinal direction.
Tsuji teaches a medical manipulator wherein:
each of the plurality of grooves has a first gap (figure 7 pointed to by the downwards arrows below) and a second gap (figure 7 shown by upwards arrows below)
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a longitudinal length of the first gap is longer than a longitudinal length of the second gap (see distance from closest edge to closest opposite edge of groove in figure 7 above between the two downwards arrows and the two upwards arrows is different, with the downwards arrows having a larger longitudinal gap)
the second gap of a first groove that is one of the plurality of grooves and the second gap of a second groove that is adjacent to the first groove among the plurality of grooves are arranged adjacent to each other along the longitudinal direction (figure 7 see than every groove is arranged longitudinally on the bending tube, and so all of the gaps are adjacent in the longitudinal direction)
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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
Regarding claim 7, Kawaura and Reiner fail to teach a medical manipulator wherein the second gap of the first groove and the first gap of a third groove other than the first groove and the second groove among the plurality of grooves are arranged along the longitudinal direction. Tsuji teaches a medical manipulator wherein the second gap of the first groove and the first gap of a third groove other than the first groove and the second groove among the plurality of grooves are arranged along the longitudinal direction (all the grooves and therefore all the gaps are arranged in the same longitudinal direction).
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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
Regarding claim 8, Kawaura and Reiner fail to teach a medical manipulator wherein the first gap and the second gap are evenly arranged in the circumferential direction. Tsuji teaches a medical manipulator wherein the first gap and the second gap are evenly arranged in the circumferential direction (both the first and second gaps are arranged circumferentially about the bending tube). 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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
Regarding claim 15, Kawaura and Reiner fail to teach a medical manipulator system wherein the bending tube has a plurality of grooves formed along the circumferential direction relative to the longitudinal direction. Tsuji teaches a medical manipulator wherein the bending tube has a plurality of grooves formed along a circumferential direction with respect to the longitudinal direction (figure 7 grooves pointed to by arrows below).
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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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections.
Regarding claim 16, Kawaura and Reiner fail to teach a medical manipulator system wherein:
each of the plurality of grooves has a first gap and a second gap
the longitudinal length of the first gap is longer than the longitudinal length of the second gap
the second gap of a first groove that is one of the plurality of grooves and the second gap of a second groove that is adjacent to the first groove among the plurality of grooves are arranged adjacent to each other along the longitudinal direction
Tsuji teaches a medical manipulator system wherein:
each of the plurality of grooves has a first gap (figure 7 pointed to by the downwards arrows below) and a second gap (figure 7 shown by upwards arrows below)
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a longitudinal length of the first gap is longer than a longitudinal length of the second gap (see distance from closest edge to closest opposite edge of groove in figure 7 above between the two downwards arrows and the two upwards arrows is different, with the downwards arrows having a larger longitudinal gap)
the second gap of a first groove that is one of the plurality of grooves and the second gap of a second groove that is adjacent to the first groove among the plurality of grooves are arranged adjacent to each other along the longitudinal direction (figure 7 see than every groove is arranged longitudinally on the bending tube, and so all of the gaps are adjacent in the longitudinal direction)
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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
Regarding claim 17, Kawaura and Reiner fail to teach a medical manipulator system wherein the second gap of the first groove and the first gap of a third groove other than the first groove and the second groove among the plurality of grooves are arranged along the longitudinal direction. Tsuji teaches a medical manipulator system wherein the second gap of the first groove and the first gap of a third groove other than the first groove and the second groove among the plurality of grooves are arranged along the longitudinal direction. (all the grooves and therefore all the gaps are arranged in the same longitudinal direction).
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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
Regarding claim 18, Kawaura and Reiner fail to teach a medical manipulator system wherein the first gap and the second gap are evenly arranged in the circumferential direction. Tsuji teaches a medical manipulator system wherein the first gap and the second gap are evenly arranged in the circumferential direction (both the first and second gaps are arranged evenly circumferentially about the bending tube).
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 bending tubes of Kawaura and Reiner with the grooves of Tsuji in order to facilitate a bending tube that can be adapted in length depending on the surgical application. The connected linkages that make up the grooves allow for an adaptable tube length in that more or less linkages can be added or removed to fit the specific need of the operation, and the grooves allow connected linkages to rotate against their connections. The gap orientation of Tsuji allows for the linkages to bend and still connect, as the space in the gap is occupied by the linkages during a bending operation, and the different longitudinal lengths along the grooves allows for a connection to still be made to the next linkage at the shorter gap length location.
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-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