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 amendments to claims 26, and 27 in the response filed on 05/27/2026 are acknowledged.
Claims 1-2, 6-7, 9-10, 13-14, and 21-32 remain pending in the application
Claims 3-5, 8, 11-12, and 15-20 are cancelled.
Claims 1-2, 6-7, 9-10, 13-14, and 21-32 are examined.
Response to Arguments
Applicant’s arguments, see pages 10-13, filed 05/27/2026, with respect to claim 1 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claim 1 has been withdrawn.
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.
Claim(s) 1, 2, 6, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”) and in view of JP2007152028A to Fujie et al. (hereinafter “Fujie”).
Regarding claim 1, O’Keefe discloses a medical device, comprising: a handle (10, Fig. 25, [0207]) having at least one actuator (285, 295, 300, Fig. 25, [0207]); a shaft (15, Fig. 1, [0207]) having a proximal end and a distal end (Fig. 1), the proximal end connected to the handle (Fig. 1); and a distal assembly connected to the distal end of the shaft (210, Fig. 1B, [0185]), the distal assembly including an end effector (30, Fig. 1B, [0160]) wherein the handle is configured so that a single hand of a user can operate the plurality of actuators to (1) actuate the end effector (300, Fig. 25, [0207]), (2) rotate the end effector relative to the shaft (295, Fig. 25, [0207]), and (3) articulate a distal portion of the shaft (285, Fig. 25, [0207]).
O’Keefe fails to expressly teach a plurality of actuators; a first rack coupled to a first actuator of the plurality of actuators; a pinion gear meshed with the first rack; and a second rack meshed with the pinion gear and coupled to a control wire, and wherein, when the first rack is translated in a first or a second direction, the pinion gear rotates clockwise or counterclockwise, respectively, moving the second rack in a third direction or a fourth direction, to move the control wire in the third direction or the fourth direction, respectively, wherein the first and second directions are transverse to the third and fourth directions.
However, Shin teaches of a medical device (Shin: Fig. 1) including a plurality of actuators (Shin: 21, 22, 23, 24, Fig. 3, [0045]); a first rack coupled to a first actuator of the plurality of actuators (Shin: 110, Fig. 5, [0048]); a pinion gear meshed with the first rack (Shin: 150, Fig. 7, [0048]); and a second rack meshed with the pinion gear and coupled to a control wire (Shin: 120, Fig. 5, [0048]), and wherein, when the first rack is translated in a first or a second direction, the pinion gear rotates clockwise or counterclockwise, respectively, moving the second rack in a third direction or a fourth direction, to move the control wire in the third direction or the fourth direction, respectively (Shin: [0048]-[0078]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe to utilize a rack and gear in the manner as taught by Shin. It would have been advantageous to make the combination for the purpose of bendingly operate a front end of the insertion unit (Shin: [0013]).
O’Keefe, in view of Shin and Fujie , fails to expressly teach wherein the first and second directions are transverse to the third and fourth directions.
However, Fujie teaches of a medical device wherein the first and second directions (4, Fig. 4, [0021]) are transverse to the third and fourth directions (53, Fig. 6, [0025]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, so that the first and second directions are transverse to the third and fourth directions, as taught by Fujie. It would have been advantageous to make the combination for the purpose of moving the components ([0020]-[0025]) of Fujie).
Regarding claim 2, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 1, and O’Keefe further discloses wherein the at plurality of actuators further includes a first actuator (295, Fig. 25, [0207]), a second actuator (300, Fig. 25, [0207]), and a third actuator (285, Fig. 25, [0207]), wherein the second actuator rotates the end effector relative to the shaft (300, Fig. 25, [0207]), the first actuator actuates the end effector (295, Fig. 25, [0207]), and the third actuator articulates the distal portion of the shaft (285, Fig. 25, [0207]).
Regarding claim 6, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 1.
O’Keefe, in view of Shin and Fujie, fails to expressly teach wherein movement of the first rack is in the first or the second direction moves the first rack into or out of a handle body of the handle.
However, Shin further teaches wherein movement of the first rack is in the first or the second direction moves the first rack into or out of a handle body of the handle (Shin: 110, Fig. 5, [0048]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, to utilize a first rack in the manner as taught by Shin. It would have been advantageous to make the combination for the purpose of bendingly operate a front end of the insertion unit (Shin: [0013]).
Regarding claim 25, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 1, and O’Keefe discloses and wherein the first actuator includes a slot configured to receive a finger of the user (Fig 1A).
Claim(s) 9, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of Shin and JP2007152028A to Fujie et al. (hereinafter “Fujie”) and further in view of US 2019/0343521 to Williams et al. (hereinafter “Williams”).
Regarding claim 9, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 2, and O’Keefe further discloses wherein the first actuator is a trigger (300, Fig. 25, [0207]), the second actuator is a knob (295, Fig. 25, [0207]), and the third actuator (285, Fig. 25, [0207]) is a lever, and wherein the knob, the trigger, and the lever are configured such that the user may simultaneously place an index finger of the single hand on the knob, a thumb of the single hand on the lever, a middle finger of the single hand on the trigger, and a palm of the single hand against the handle (Fig. 25).
O’Keefe, in view of Shin and Fujie, fails to expressly teach wherein the third actuator is a lever.
However, Williams teaches of a medical device (Williams: 10, Fig. 1, [0051]) wherein the third actuator is a lever (Williams: 16, Fig. 1, [0052]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, so that the third actuator is a lever, as taught by Williams. It would have been advantageous to make the combination for the purpose of facilitating articulation of the jaw assembly (Williams: [0052]).
Claim(s) 10, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of Shin and Fujie and further in view of and US 2019/0343521 to Williams et al. (hereinafter “Williams”) and U.S. Publication No. 2009/0299141 to Downey et al. (hereinafter “Downey”).
Regarding claim 10, O’Keefe, in view of Shin and Fujie and Williams, teaches the medical device of claim 9, and O’Keefe further discloses wherein the handle is configured such that, in use, and the trigger is facing away from the user (O’Keefe: 300, Fig. 25, [0207]).
O’Keefe, in view of Shin and Fujie and Williams, fails to expressly teach the knob is facing away from the user, the lever is facing towards the user,
However, Downey further teaches the knob is facing away from the user (Downey: 50, Fig. 2, [0071]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie and Williams, so that the knob is facing away from the user, as taught by Downey. It would have been advantageous to make the combination for the purpose of facilitating rotation of the surgical tool (Downey: [0071]).
O’Keefe, in view of Shin and Fujie and Williams and Downey, fails to expressly teach the lever is facing towards the user.
However, Williams further teaches wherein the lever is facing towards the user (Williams: 16, Fig. 1, [0052]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie and Williams and Downey, so that the lever is facing towards the user, as taught by Williams. It would have been advantageous to make the combination for the purpose of facilitating articulation of the jaw assembly (Williams: [0052]).
Claim(s) 7, 21, 22, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) and further in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”) and Fujie and further in view of U.S. Publication No. 2014/0005705 to Weir et al. (hereinafter “Weir”).
Regarding claim 7, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 1.
O’Keefe, in view of Shin and Fujie, fails to expressly teach wherein the pinion gear is a first pinion gear, and wherein the medical device further comprises: a second actuator of the plurality of actuators to control rotation of the end effector relative to the shaft wherein the second actuator moves includes a second pinion gear, and a third pinion gear meshed with the second pinion gear, wherein the control wire is within fixed to the third pinion gear such that when the second pinion gear is rotated clockwise and counterclockwise, the third pinion gear rotates counterclockwise and clockwise respectively, thereby rotating the control wire.
However, Shin further teaches a second actuator of the plurality of actuators to control rotation of the end effector relative to the shaft (Shin: 21, 22, 23, 24, Fig. 3, [0045]), wherein the second actuator moves includes a second pinion gear (160, Fig. 7, [0048]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, to utilize pinion gears the manner as taught by Shin. It would have been advantageous to make the combination for the purpose of bendingly operate a front end of the insertion unit (Shin: [0013]).
O’Keefe, in view of Shin and Fujie, fails to expressly teach a third pinion gear meshed with the second pinion gear, wherein the control wire is within fixed to the third pinion gear such that when the second pinion gear is rotated clockwise and counterclockwise, the third pinion gear rotates counterclockwise and clockwise respectively, thereby rotating the control wire.
However, Weir teaches of a medical device (Weir: Fig. 1) including a third pinion gear meshed with the second pinion gear, wherein the control wire is within fixed to the third pinion gear such that when the second pinion gear is rotated clockwise and counterclockwise, the third pinion gear rotates counterclockwise and clockwise respectively, thereby rotating the control wire ([0200]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, to utilize a third pinion gear, as taught by Weir. It would have been advantageous to make the combination for the purpose of providing rotation ([0200] of Weir).
Regarding claim 21, O’Keefe, in view of Shin and Fujie and Weir, teaches the medical device of claim 7.
O’Keefe, in view of Shin and Fujie and Weir, fails to expressly teach wherein the third pinion gear is coupled to a distal end of the second rack.
However, Weir further teaches wherein the third pinion gear is coupled to a distal end of the second rack ([0200]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie and Weir, to utilize a third pinion gear, as taught by Weir. It would have been advantageous to make the combination for the purpose of providing rotation ([0200] of Weir).
Regarding claim 22, O’Keefe, in view of Shin and Fujie and Weir, teaches the medical device of claim 7.
O’Keefe, in view of Shin and Fujie and Weir, fails to expressly teach wherein, upon actuating the second actuator, the third pinion gear translates proximally and distally relative to the second pinion gear.
However, Weir further teaches wherein, upon actuating the second actuator, the third pinion gear translates proximally and distally relative to the second pinion gear ([0200]).
Regarding claim 23, O’Keefe, in view of Shin and Fujie and Weir, teaches the medical device of claim 7, but O’Keefe, in view of Shin and Fujie and Weir, fails to expressly teach wherein the second pinion gear is coupled to a first end of a rotatable shaft, and a fourth pinion gear is coupled to a second, opposite end of the rotatable shaft, wherein the fourth pinion gear is configured to mesh with a fifth pinion gear, wherein the fifth pinion gear is coupled to the second actuator.
However, it would've been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of O’Keefe, in view of Shin and Fujie and Weir, to add fourth and fifth pinion gears, since the mere duplication of the essential working parts of a device involves only routine skill in the art (MPEP 2144.04(VI)(B)).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) and further in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”) and Fujie and further in view of U.S. Publication No. 2014/0005705 to Weir et al. (hereinafter “Weir”) and U.S. Publication No. 2009/0299141 to Downey et al. (hereinafter “Downey”).
Regarding claim 24, O’Keefe, in view of Shin and Fujie and Weir, teaches the medical device of claim 23.
O’Keefe, in view of Shin and Fujie and Weir, fails to expressly teach wherein the second actuator is a knob, wherein the knob is configured to rotate in a plane that is perpendicular to a central axis of the handle.
However, Downey teaches of a medical device (Downey: 10, Fig. 1, [0057]) the first actuator is a knob (Downey: 50, Fig. 2, [0071]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’ Keefe so that the first actuator is a knob, as taught by Downey. It would have been advantageous to make the combination for the purpose of facilitating rotation of the surgical tool (Downey: [0071]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of U.S. Publication No. 2019/0343521 to Williams et al. (hereinafter “Williams”) in view of U.S. Publication No. 2021/0113068 to Shin.
Regarding claim 26, O’keefe discloses a medical device, comprising: a shaft; a handle (10, Fig. 25, [0207]) having:a knob configured to rotate in a plane that is perpendicular to a longitudinal axis of the medical device (395, Fig. 38, [0216]), wherein the knob is disposed on a first side of the handle (Fig. 38), and wherein the longitudinal axis extends through the shaft, a trigger configured to translate in a direction that is perpendicular to the longitudinal axis of the medical device (300, Fig. 25, [0217]) wherein the trigger is disposed on the first side of the handle (Fig. 25), and wherein the trigger is distal to the knob (Fig. 25); wherein the trigger is configured to actuate the end effector (Fig. 25),
O’keefe fails to expressly teach a lever configured to rotate about an axis that is perpendicular to the longitudinal axis of the medical device, wherein the lever is disposed on a second side of the handle that is opposite to the first side; and an end effector at a distal end of the shaft, wherein the knob is configured to rotate the end effector, wherein the lever is configured to articulate the end effector in one or more directions.
However, Williams teaches of a medical device (Williams: 10, Fig. 1, [0051]) including a lever configured to rotate about an axis that is perpendicular to the longitudinal axis of the medical device, wherein the lever is disposed on a second side of the handle that is opposite to the first side; and an end effector at a distal end of the shaft, wherein the knob is configured to rotate the end effector, wherein the lever is configured to articulate the end effector in one or more directions (Williams: 16, Fig. 1, [0052]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe to utilize a lever, as taught by Williams. It would have been advantageous to make the combination for the purpose of facilitating articulation of the jaw assembly (Williams: [0052]).
O’Keefe, in view of Williams, fails to expressly teach wherein the trigger includes a first rack configured to interact with a pinion gear, wherein, upon translation of the first rack in a first or a second direction, the pinion gear rotates clockwise or counterclockwise, thereby moving a second rack in a third direction or a fourth direction, respectively.
However, Shin teaches of a medical device wherein the trigger (16, Fig. 1, [0004]) includes a first rack (233, Fig. 8, [0070]) configured to interact with a pinion gear (250, Fig. 9, [0071]), wherein, upon translation of the first rack in a first or a second direction, the pinion gear rotates clockwise or counterclockwise, thereby moving a second rack in a third direction or a fourth direction, respectively ([0070]-[0075]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Williams to utilize a trigger in the manner as taught by Shin. It would have been advantageous to make the combination for the purpose of changing the movement of the distal end ([0071] of Shin).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of Williams and further in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”).
Regarding claim 27, O’Keefe, in view of Williams, teaches the medical device of claim 26.O’Keefe, in view of Williams fails to expressly teach wherein the pinion gear is a first pinion gear, and wherein the medical device further comprises: a control wire fixed to the end effector; and a second pinion gear coupled to a proximal end of the control wire, wherein the knob is configured to rotate the second pinion gear clockwise or counterclockwise to rotate the end effector clockwise or counterclockwise, and wherein the trigger is configured to translate the first pinion gear proximally and distally to actuate the end effector.
However, Shin further teaches wherein the pinion gear is a first pinion gear (250, Fig. 9, [0071]), and wherein the medical device further comprises: a control wire fixed to the end effector (260, Fig. 8, [0073]); and a second pinion gear coupled to a proximal end of the control wire(250, Fig. 9, [0071]), wherein the knob is configured to rotate the second pinion gear clockwise or counterclockwise to rotate the end effector clockwise or counterclockwise ([0050]), and wherein the trigger is configured to translate the first pinion gear proximally and distally to actuate the end effector (Fig. 1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe to utilize a wire and gear in the manner as taught by Shin. It would have been advantageous to make the combination for the purpose of bendingly operate a front end of the insertion unit (Shin: [0013]).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of Williams and U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”) and further in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”).
Regarding claim 28, O’Keefe, in view of Williams and Shin , teaches the medical device of claim 27.
O’Keefe, in view of Williams and Shin, fails to expressly teach wherein the control wire is a first control wire, wherein the medical device further comprises a second control wire and a third control wire, and wherein, upon rotating the lever, the end effector is articulated via the second control wire and the third control wire (Shin: 21, 22, 23, 24, Fig. 3, [0045]).
However, Shin further teaches wherein the control wire is a first control wire, wherein the medical device further comprises a second control wire and a third control wire, and wherein, upon rotating the lever, the end effector is articulated via the second control wire and the third control wire.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0105746 to O’Keefe et al. (hereinafter “O’Keefe”) in view of U.S. Publication No. 2021/0068621 to Shin et al. (hereinafter “Shin”) and in view of JP2007152028A to Fujie et al. (hereinafter “Fujie”) and further in view of U.S. Publication No. 2012/0232567 to Fairneny.
Regarding claim 14, O’Keefe, in view of Shin and Fujie, teaches the medical device of claim 1.
O’Keefe, in view of Shin and Fujie, fails to expressly teach wherein the control wire is a first control wire, wherein the handle further comprises a second actuator to control articulation of the distal portion of the shaft, wherein the second actuator includes a cam coupled to a second control wire and a third control wire coupled to the cam such that, when the cam is rotated clockwise, the first control wire is pulled into tension, and, when the cam is rotated counterclockwise, the second control wire is pulled into tension.
However, Fairneny teaches of a medical device (Fairneny: Fig. 1A) wherein the control wire is a first control wire, wherein the handle further comprises a second actuator to control articulation of the distal portion of the shaft, wherein the second actuator includes a cam coupled to a second control wire and a third control wire coupled to the cam such that, when the cam is rotated clockwise, the first control wire is pulled into tension, and, when the cam is rotated counterclockwise, the second control wire is pulled into tension (Fairneny: [0061]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Keefe, in view of Shin and Fujie, to utilize a cam, as taught by Fairneny. It would have been advantageous to make the combination for the purpose of moving the first and second wires ([0061] of Fairneny).
Allowable Subject Matter
Claims 13 and 29-32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner's statement of reasons for allowance:
The subject matter of the independent claim 29 and similarly claim 13 in the amendment submitted on 05/27/2026, could either not be found or was not suggested in the prior art of record. With respect to claim 29 (and similarly claim 13), the prior art of record does not disclose or render obvious at the effective filing date of the invention: the feature of a third pinion gear fixed to a second, opposite end of the drive shaft; and a fourth pinion gear that meshes with the third pinion gear; a control wire fixedly coupled to the fourth pinion gear; and an end effector, wherein, upon rotating the first actuator, the end effector rotates via rotation of the control wire, and wherein each of the first pinion gear, the second pinion gear, the third pinion gear, and the fourth pinion gear is within the handle, as recited in claim 29 and 13.
The closest relevant art is Shin (U.S. Publication No. 2021/0068621) which teaches an endoscope except for the third and fourth pinion gears.
The prior art when considered in combination or individually does not teach the claimed invention as seen in claim 29 (and similarly claim 13), and therefore the claimed invention was not obvious before the effective filing date. There is no reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, and the only reason to modify the references would be based on the Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795