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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al. (US2004/0249367) in view of Yoon (US6,066,090).
Regarding claim 1, Saadat discloses a medical device comprising:
a shaft extending from a handle (Fig. 29 illustrates a similar proximal end of main body 10 extending from handle 22 that appears in Fig. 30), wherein shaft includes an articulation member having a first portion (Fig. 30: scope 28 may be steered any angle in relation to the suction cap 1160 [0164]) and a second portion independently movable relative to the first portion (Fig. 30: portion including suction tube 1202, instrument guide 1170, and suction cap 1160 is steerable [0164]);
wherein the second portion includes a port, wherein a distal opening of the port is proximal of a distal end of the second portion (Fig. 30: portion including suction tube 1202, instrument guide 1170 and suction cap 1160 comprises port 1162 that is proximal the distal end of the suction cap 1160).
While Saadat disclose a handle, pull wires and a variety of mechanisms ([0135]) and discloses wherein the first portion and the second portion are steerable, Saadat fails to disclose the details of the steering control of the first portion and the second portion, thus failing to disclose
a first actuator rotatable about a first axis; and a second actuator rotatable about a second axis, different from the first axis of rotation;
wherein the first actuator is configured to move the first portion along a first plane,
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,
wherein, in a first configuration of the second portion, the distal opening of the port is proximal of a distal end of the first portion, and
wherein, in a second configuration of the second portion, the distal opening of the port is distal of the distal end of the first portion.
In the same field of endeavor, Yoon teaches 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). Saadat, modified to include the handle and actuators of Yoon, teaches wherein, in a first configuration of the second portion, the distal opening of the port is proximal of a distal end of the first portion (Saadat Fig. 29: a first configuration of the portion including suction tube 1202, instrument guide 1170 and suction cap 1160, wherein the distal opening of port 1162 is proximal the distal end of scope 28), and
wherein, in a second configuration of the second portion, the distal opening of the port is distal of the distal end of the first portion (Saadat Fig. 30: a second configuration of the portion including suction tube 1202, instrument guide 1170 and suction cap 1160, wherein the distal opening of port 1162 is distal of the distal end of scope 28). Since Saadat fails to disclose the details of the pull wires and features for steering the first portion and second portion, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any known steering mechanism, including the actuators taught by Yoon, as the steering mechanism of Saadat.
Regarding claim 3, Saadat, modified by Yoon, discloses the medical device according to claim 1, further teaching wherein, upon movement of the second portion relative to the first portion from the first configuration to the second configuration, the port is exposed (as the portion including suction tube 1202, instrument guide 1170 and suction cap 1160 is moved relative to the distal end of scope 28 from the first configuration shown in Saadat Fig. 29 to the second configuration shown in Saadat Fig. 30, the port 1162 is exposed; port 1162 appears to be exposed in any configuration).
Regarding claim 4, Saadat, modified by Yoon, discloses the medical device according to claim 1. Saadat further teaches wherein the port includes a vacuum port or a hook (port 1162 may be used for suction [0155]).
Regarding claim 7, Saadat, modified by Yoon, discloses the medical device according to claim 1. Saadat further discloses 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 (scope 28 appears to comprise three lumens and three openings at the distal end 28a, as seen in Figs. 30 and 31; Fig. 31 demonstrates a similar scope 28 to the scope of Fig. 30, wherein the a grasper 1206 is extending through a working lumen of scope 28 [0165]).
Regarding claim 8, Saadat, modified by Yoon, discloses the medical device according to claim 1. Yoon further teaches 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).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Yoon and Mitsuya et al. (US2019/0246877)
Regarding claim 5, Saadat, modified by Yoon, discloses the medical device according to claim 1. Yoon is silent regarding any locking mechanism configured to inhibit rotational movement of the first actuator, however in the same field of endeavor, Mitsuya teaches 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 moveable 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]), 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).
Mitsuya further teaches the medical device comprising a first locking mechanism to inhibit rotational movement of the first actuator (brake handle 134 [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 Saadat and 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, Saadat, modified by Yoon, discloses the medical device according to claim 1.
Yoon is silent regarding any locking mechanism configured to inhibit rotational movement of the second actuator, however in the same field of endeavor, Mitsuya teaches 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 moveable 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]), 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).
Mitsuya further teaches the medical device comprising a second locking mechanism to inhibit rotational movement of the second actuator (brake handle 108 [0049]). 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 Saadat and 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Yoon and Campbell (US2014/0088497).
Regarding claim 9, Saadat, modified by Yoon, discloses the medical device according to claim 1. Yoon further teaches wherein the first axis is perpendicular to a longitudinal axis of the handle, and wherein the second axis is parallel to the first axis (Fig. 7: rotational axis of knob 118a and knob 118c is perpendicular to the longitudinal axis handpiece 116) but fails to disclose wherein the second axis is distal to the first axis.
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.
Response to Arguments
Applicant has amended claim 1 to recite “wherein the second portion includes a port, wherein a distal opening of the port is proximal of a distal end of the second portion, wherein in a first configuration of the second portion, the distal opening of the port is proximal of a distal end of the first portion, and wherein, in a second configuration of the second portion, the distal opening of the port is distal of the distal end of the first portion” and argues that neither Yoon nor Mitsuya disclose or suggest subject matter. This argument has been considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Instead, a new ground of rejection based on Saadat et al. (US2004/0249367) is presented above to evidence the Office’s position.
Allowable Subject Matter
Claims 11-22 are allowed.
Claim 12 and 18 have been amended to include limitations that overcome the prior art rejection on record. Claim 12 recites wherein the second portion retracts and extends “only along the longitudinal axis” relative to the first portion by the second actuator. Claim 18 recites “wherein the first portion includes a slot configured to receive the second portion, wherein the slot has a size and a shape complementary to a size and shape of the second portion”. These limitations, in addition to the other limitations of the independent claims, overcome the prior art rejection on record. Additionally, there is no reason, teaching or suggesting with any prior art of record to modify the medical devices of Saadat and Yoon, to include a slot in the first portion, complementarily sized and shaped to receive the second portion, or to include wherein the second portion only extends and retracts along the longitudinal axis. After carefully reviewing the application in light of the prior art of record and the searches of all the possible areas relevant to the present application, a set of prior art references have been found, but the prior art references are not deemed proper to make the application unpatentable. A hypothetical prior art rejection would require impermissible hindsight.
Claims 11 and 21 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 a statement of reasons for the indication of allowable subject matter: Claim 11 recites the device further comprising a fourth actuator rotatable about the first axis, wherein the fourth actuator is configured to move the first portion in the second plane. The prior art on record fails to teach this limitation, further, there is no reason, teaching or suggesting with any prior art of record to modify the medical devices of Saadat and Yoon, to include a fourth actuator rotatable about the first axis, wherein the fourth actuator is configured to move the first portion in the second plane. A hypothetical prior art rejection would require impermissible hindsight.
Claim 21 recites wherein the first portion includes a slot configured to receive the second portion, and wherein, in the first configured of the second portion, the second portion is received by the slot. The prior art on record fails to teach this limitation, further, there is no reason, teaching or suggesting with any prior art of record to modify the medical devices of Saadat and Yoon, to include a slot in the first portion to receive the second portion. A hypothetical prior art rejection would require impermissible hindsight. For the reasons stated above, claims 11-22 were found allowed over the prior art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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/LI-TING SONG/Examiner, Art Unit 3795
/TIMOTHY J NEAL/Primary Examiner, Art Unit 3795
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