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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed August 13, 2024 is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Lines 3 and 5 of claim 1 both have an extra comma or semicolon.
Appropriate correction is required.
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 1-4, 7-9, 12-14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Yoon (US6,066,090).
Regarding claim 1, Yoon discloses a medical device comprising: a handle (Fig. 7: handpiece 116 [col. 7, line 29]) including; a first actuator rotatable about a first axis (Fig. 7: control knob 118a); and a second actuator rotatable about a second axis, different from the first axis of rotation (Fig. 7: control knob 118d rotatable on a axis appearing perpendicular to the first axis); a shaft extending from the handle (branched endoscope 42), wherein shaft includes an articulation member having a first portion and a second portion independently movable relative to the first portion (two branch endoscope 42 comprises a first endoscope branch 44, first portion, and a second endoscope branch 46, second portion [col. 6, lines 44-47]); wherein the first actuator is configured to move the first portion along a first plane (control knob 118a moves first branch 44 in the up-down direction, first plane [col. 7, lines 40-41]), and wherein the second actuator is configured to move the second portion along a second plane, wherein the second plane is perpendicular to the first plane (although it appears to be incorrectly printed, it is understood that control knob 118d moves the second branch 46 in the left-right direction [col. 7, lines 44-47], second plane which is perpendicular to the first plane).
Regarding claim 2, Yoon discloses the medical device according to claim 1, further disclosing wherein the second portion includes a port configured for grasping a material (Fig. 3: operating channel or cannula 58b on branch 46 [col. 5, line 50]; aspiration and instruments may be applied through port 117b [col. 7, line 32], configured for grasping material).
Regarding claim 3, Yoon discloses the medical device according to claim 2, further disclosing wherein, upon movement of the second portion relative to the first portion, the port is exposed (Fig. 5-6: upon movement of branch 46 relative to branch 44, cannula 58b is exposed).
Regarding claim 4, Yoon discloses the medical device according to claim 2, further disclosing wherein the port includes a vacuum port or a hook (aspiration or passage of instruments may be applied through port 117b [col. 7, line 32]).
Regarding claim 7, Yoon discloses the medical device according to claim 1, further disclosing wherein at least one lumen extends through the shaft and the first portion, and wherein a distal opening of the at least one lumen is disposed on a distal face of the first portion (Fig. 7: distal end 47 of first branch 44 comprises operating channel or cannula 58a [col. 7, lines 33 and 52]).
Regarding claim 8, Yoon discloses the medical device according to claim 1, further disclosing the device comprising a third actuator rotatable about the first axis (Fig. 7: control knob 118c rotatable on the first axis, axis shared with control knob 118a), wherein the third actuator is configured to extend the second portion distally relative to the first portion or retract the second portion proximally relative to the first portion (control knob 118c moves the second branch 46 in the up-down direction [col. 7, lines 45-46], which allows the second branch 46 to retract proximally relative to the first branch 44, as seen in Fig. 6).
Regarding claim 9, Yoon discloses the medical device according to claim 1, further disclosing wherein the first axis is perpendicular to a longitudinal axis of the handle (Fig. 7: rotational axis of knob 118a and knob 118c is perpendicular to the longitudinal axis handpiece 116).
Regarding claim 12, Yoon discloses a medical device comprising: a handle, the handle having: a first actuator and a second actuator (Fig. 7: handpiece 116 comprises control knobs 118a-118c, 118a is analogous to applicant’s first actuator, 188c is analogous to applicant’s second actuator), each rotatable about a first axis of rotation (Fig. 7: control knob 118a and 118c are rotatable on the same axis, although extending from opposite sides of the axis); and a third actuator rotatable about a second axis of rotation different from the first axis of rotation (118d is analogous to applicant’s third actuator, rotating on a second axis that is perpendicular to the first axis of 118a and 118c); and a shaft extending from the handle, wherein a distal end of the shaft includes an articulation member having a first portion movable relative to a second portion (two branch endoscope 42 comprises a first endoscope branch 44, first portion, and a second endoscope branch 46, second portion [col. 6, lines 44-47]), wherein the first actuator is configured to articulate the first portion (control knob 118a moves first branch 44 in the first plane of up and down [col. 7, lines 40-41]), wherein the second actuator is configured to extend or retract the second portion relative to the first portion (control knob 118c extends and retracts the second branch 46, relative to the first branch 44, by moving the second branch 46 up or down in the first plane [col. 7, lines 45-46]; as seen in Fig. 6, second branch 46 is retracted relative to first branch 44), and wherein the third actuator is configured to articulate the second portion relative to the first portion (although incorrectly printed, it is understood that control knob 118d moves the second branch 46 in the left-right direction [col. 7, lines 44-47]).
Regarding claim 13, Yoon discloses the medical device according to claim 12, further disclosing wherein the second portion includes a port configured for grasping a material (Fig. 3: second branch 46 comprises an operating channel or cannula 58b [col. 5, line 50]), and wherein, upon articulation of the second portion relative to the first portion, the port is exposed (cannula 58b is exposed when second branch 46 is articulated).
Regarding claim 14, Yoon discloses the medical device according to claim 13, further disclosing wherein the port includes a vacuum port or a hook (introduction of surgical instruments or passing fluids for irrigation or aspiration to cannula 58b [col. 7, line 32]).
Regarding claim 17, Yoon discloses the medical device according to claim 12, further disclosing wherein at least one lumen extends through the shaft and the first portion, and wherein a distal opening of the at least one lumen is disposed on a distal face of the first portion (Fig. 3: operating channel or cannula 58a extends through first branch 44 and endoscope 42 to terminate at the angled port 117a [col. 7, lines 50-53], distal opening of the operating channel or cannula 58a depicted on the distal end view of Fig. 3 [col. 7, lines 33 and 52]).
Claims 1-6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Mitsuya et al. (US2019/0246877).
The following is a first line of rejection using Mitsuya:
Regarding claim 1, Mitsuya discloses a medical device comprising: a handle (operation section 14 [0027]) including; a first actuator rotatable about a first axis (rotating member 132 on axis R2 [0056]); and a second actuator rotatable about a second axis, different from the first axis of rotation (rotating member 104 on axis R1 [0047]); a shaft extending from the handle (insertion section 12), wherein shaft includes an articulation member having a first portion and a second portion independently movable relative to the first portion (Fig. 1A: section 44 and 42 is analogous to applicant’s second portion, section 46 is analogous to applicant’s first portion, both sections are bendable); wherein the first actuator is configured to move the first portion along a first plane (rotating member 132 used to bend section 46 in the up down direction, first plane [0055]), and wherein the second actuator is configured to move the second portion along a second plane (rotating member 104 used to bend section 44 in the right left direction, second plane [0047]), wherein the second plane is perpendicular to the first plane (up down direction is perpendicular to the left right direction).
Regarding claim 2, Mitsuya discloses the medical device according to claim 1, further disclosing wherein the second portion includes a port configured for grasping a material (second portion comprising section 44 and 42 includes channel 26 for treatment instruments or suction [0031]).
Regarding claim 3, Mitsuya discloses the medical device according to claim 2, further disclosing wherein, upon movement of the second portion relative to the first portion, the port is exposed (as section 44 is moved relative to section 46, channel 26 is exposed).
Regarding claim 4, Mitsuya discloses the medical device according to claim 2, further disclosing wherein the port includes a vacuum port or a hook (suction tube 28 disposed within insertion section 12 terminating at channel 26 [0028, 0031]).
Regarding claim 5, Mitsuya discloses the medical device according to claim 1, further disclosing the device comprising a first locking mechanism configured to inhibit rotational movement of the first actuator (brake handle 134 [0055-0056]).
Regarding claim 6, Mitsuya discloses the medical device according to claim 1, further disclosing the device comprising a second locking mechanism configured to inhibit rotational movement of the second actuator (brake handle 108 [0049]).
Regarding claim 9, Mitsuya discloses the medical device according to claim 1, further disclosing wherein the first axis is perpendicular to a longitudinal axis of the handle (Fig. 3A: R1 and R2 are perpendicular to the longitudinal axis of the handle L).
Regarding claim 10, Mitsuya discloses medical device according to claim 9, further disclosing wherein the second axis is parallel to the first axis and distal to the first axis (R1 and R2 are parallel [0056]; Fig. 1A: R1, analogous to applicant’s second axis, is more distal than R2, analogous to applicant’s first axis).
The following is a Second line of rejection using Mitsuya
Regarding claim 1, Mitsuya discloses a medical device comprising: a handle (operation section 14 [0027]) including; a first actuator rotatable about a first axis (rotating member 104 on axis R1 [0047]); and a second actuator rotatable about a second axis, different from the first axis of rotation (rotating member 132 on axis R2 [0056]); a shaft extending from the handle (insertion section 12), wherein shaft includes an articulation member having a first portion and a second portion independently movable relative to the first portion (Fig. 1A: section 44 and 42 is analogous to applicant’s first portion, section 46 is analogous to applicant’s second portion, both sections are bendable); wherein the first actuator is configured to move the first portion along a first plane (rotating member 104 used to bend section 44 in the right left direction, first plane [0047]), and wherein the second actuator is configured to move the second portion along a second plane (rotating member 132 used to bend section 46 in the up down direction, second plane [0055]), wherein the second plane is perpendicular to the first plane (up down direction is perpendicular to the left right direction).
Regarding claim 5, Mitsuya discloses the medical device according to claim 1, further disclosing the device comprising a first locking mechanism configured to inhibit rotational movement of the first actuator (brake handle 108 [0049]).
Regarding claim 6, Mitsuya discloses the medical device according to claim 1, further disclosing the device comprising a second locking mechanism configured to inhibit rotational movement of the second actuator (brake handle 134 [0055-0056]).
Regarding claim 9, Mitsuya discloses the medical device according to claim 1, further disclosing wherein the first axis is perpendicular to a longitudinal axis of the handle (Fig. 3A: R1 and R2 are perpendicular to the longitudinal axis of the handle L).
Regarding claim 11, Mitsuya discloses the medical device according to claim 1, further disclosing the device comprising a fourth actuator rotatable about the first axis, wherein the fourth actuator is configured to move the first portion in the second plane (rotating member 102 on axis R1 used to bend section 44 in the up down direction [0047]).
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 5, 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Mitsuya.
Regarding claim 5, Yoon discloses the medical device according to claim 1, but fails to disclose the medical device further comprising a first locking mechanism configured to inhibit rotational movement of the first actuator. In the same field of endeavor, Mitsuya teaches a substantially similar medical device comprising actuators, wherein each actuator comprises a locking mechanism (brake levers 106, 108 and 134 are well known in the art and commonly used with actuators [0048-0049, 0055-0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a locking mechanism as taught by Mitsuya, to the device of Yoon, as it is very well known in the endoscope art that actuators are typically coupled to locking mechanism to hold an articulated section in an articulated position without an external forced exerted by the user, preventing hand fatigue.
Regarding claim 6, Yoon discloses the medical device according to claim 1, but fails to disclose the medical device further comprising a second locking mechanism configured to inhibit rotational movement of the second actuator. In the same field of endeavor, Mitsuya teaches a substantially similar medical device comprising actuators, wherein each actuator comprises a locking mechanism (brake levers 106, 108 and 134 are well known in the art and commonly used with actuators [0048-0049, 0055-0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a locking mechanism as taught by Mitsuya, to the device of Yoon, as it is very well known in the endoscope art that actuators are typically coupled to locking mechanism to hold an articulated section in an articulated position without an external forced exerted by the user, preventing hand fatigue.
Regarding claim 15, Yoon discloses the medical device according to claim 12, but fails to disclose the device further comprising: a first locking mechanism configured to inhibit rotational movement of the first actuator; and a second locking mechanism configured to inhibit rotational movement of the second actuator. In the same field of endeavor, Mitsuya teaches a substantially similar medical device comprising actuators, wherein each actuator comprises a locking mechanism (brake levers 106, 108 and 134 are well known in the art and commonly used with actuators [0048-0049, 0055-0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a locking mechanism as taught by Mitsuya, to the device of Yoon, as it is very well known in the endoscope art that actuators are typically coupled to locking mechanism to hold an articulated section in an articulated position without an external forced exerted by the user, preventing hand fatigue.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Mitsuya in view of Hatano (US2022/0233057).
Regarding claim 16, Yoon, modified by Mitsuya, discloses the medical device according to claim 15. Mitsuya further wherein the third actuator includes a third locking mechanism configured to inhibit rotational movement of the third actuator (brake levers 106, 108 and 134 well-known in the art and commonly used with actuators [0048-0049, 0055-0056]). While Mitsuya discloses the locking mechanism to appear as levers, Hatano teaches wherein locking mechanism may appear as various structures including a button (angle lock button of the bending section 7 [0120]). In view of Hatano, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the various alternative locking mechanism structure well known in the art may be substituted for one another to hold articulation section in an articulated position.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Campbell (US2014/0088497).
Regarding claim 18, Yoon discloses a medical device comprising: a handle defining a longitudinal axis (Fig. 7: handpiece 116 [col. 7, line 29]), the handle having; a first actuator (control knob 118a); a second actuator (control knob 118b); and a third actuator (control knob 118c), wherein each of the first actuator and the third actuator are rotatable about a first axis of rotation (Fig. 7: control knobs 118a and 118c rotate on the same axis), wherein the first axis is perpendicular to the longitudinal axis (Fig. 7: axis in which control knobs 118a and 118c rotate appears to be perpendicular to the longitudinal axis); and a shaft extending from the handle (branched endoscope 42), wherein a distal end of the shaft includes an articulation member having a first portion and a second portion (two branch endoscope 42 comprises a first endoscope branch 44, first portion, and a second endoscope branch 46, second portion [col. 6, lines 44-47]), wherein the first actuator is configured to move the first portion in a first plane (control knob 118a moves branch 44 in the up down direction/first plane [col. 7, lines 40-41]), wherein the second actuator is configured to move the first portion in a second plane (control knob 118b moves the branch 44 in the left right direction/second plane [col. 7, lines 42-43]), and wherein the third actuator is configured to move the second portion proximally or distally with respect to the first portion (control knob 118c moves branch 46 proximally relative to branch 44 by moving the second branch 46 in the up down direction; seen in Fig. 6). Yoon fails to disclose wherein the second actuator is on the same axis as the first and third actuator (Fig. 7: knob 118b is not on the same axis as 118a and 118c).
In the same field of endeavor, Campbell teaches a substantially similar medical device comprising an articulation member and a handle, the articulation member configured to be moved by multiple actuators, wherein the actuators may be positioned in various configurations of on the handle including on opposite sides of the handle or stacked and rotated on the same axis ([0032]). In view of Campbell, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the various configuration of actuators, whether stacked and rotated on the same axis or non-stacked and at different position of the handle, are equivalent alternatives for one another that both function to bend an articulation member.
Regarding claim 19, Yoon, modified by Campbell, discloses the medical device according to claim 18. Campbell further teaches the medical device comprising: a first locking mechanism configured to inhibit rotational movement of the first actuator; a second locking mechanism configured to inhibit rotational movement of the second actuator; and a third locking mechanism configured to inhibit rotational movement of the third actuator (stacked control wheels comprise a singular or multiple brake levers [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included locking mechanisms as taught by Campbell, to the control knobs of Yoon, as it is very well known in the endoscope art that actuators are typically coupled to locking mechanism to hold an articulated section in an articulated position without an external forced exerted by the user, preventing hand fatigue.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Campbell in view of Hatano.
Regarding claim 20, Yoon, modified by Campbell, discloses the medical device of claim 19, but fails to disclose wherein the third locking mechanism is a button disposed on the third actuator. Hatano teaches wherein locking mechanism may appear as various structures including a button (angle lock button of the bending section 7 [0120]). In view of Hatano, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the various alternative locking mechanism structure well known in the art may be substituted for one another to hold an articulation section in an articulated position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
2/23/26