DETAILED ACTION
Applicant's amendments and remarks, filed 12/23/25, are fully acknowledged by the Examiner. Currently, claims 1, 4, 6, 9-12, 14-24, and 26-27 are pending with claims 2 and 8 canceled, claims 26-27 added, and claims 1, 9-10, 14, 19, and 21 amended. The following is a complete response to the 12/23/25 communication.
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 .
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.
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.
Claim(s) 1, 4, 6, 9-10, 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malkowski (US 2011/0184459), in view of Low (US 2015/0209965), in view of Manzo (US 2012/0215220).
Regarding claim 1, Malkowski teaches a surgical instrument (100), comprising: an elongated shaft defining a longitudinal axis (210 with a longitudinal axis along the shaft as in Fig. 2), a proximal segment (214), and a distal segment (238), the elongated shaft including an articulating segment between the proximal segment and the distal segment (articulating segment of 230 with parts 234 and 232 as in Fig. 8);
the distal segment comprising a clevis having an opening along the longitudinal axis (clevis 222 and 220 as in Fig. 11a);
a jaw assembly extending from the distal segment of the elongated shaft (260 extending from 238), the jaw assembly including a first jaw member and a second jaw member (first and second members 262 and 264), the first jaw member configured to be actuated between a closed configuration and an open configuration with respect to the second jaw member (par. [0157] jaws open and close relative to each other); the clevis being positioned about at least a portion of the first jaw member and the second jaw member (222 and 220 as in Fig. 11a around the jaws);
a jaw cable operable coupled to the first jaw member, the jaw cable configured to actuate the first jaw member between the closed configuration and the open configuration (205 to rotate the jaws to open and close);
a pivot pin extending through proximal arms of the first jaw member and the second jaw member, the pivot pin pivotally coupling the first jaw member to the second jaw member (pivot member 446 through Fig. 11a through the proximal arms of the jaws, and allows 262 and 264 to rotate relative to each other as in par. [0175]); and
an articulation cable assembly, the articulation cable assembly including:
a first articulation cable extending along the longitudinal axis of the elongated shaft from the proximal segment to the distal segment (one of 240 along the longitudinal axis), the first articulation cable including a first extending portion (240 with an extending portion through the articulating joint), a first ferrule disposed about the first articulation cable (ferrule 452 as in Fig. 11a), wherein the first ferrule is disposed within the clevis (452 within 220) wherein the first articulation cable is operably coupled to the distal segment of the elongated shaft (240 coupled to distal segment 220 as in Fig. 11a);
wherein the first ferrule is engaged to the distal body within the distal segment of the elongated shaft (452 is connected to 222 via 220),
a second articulation cable extending along the longitudinal axis of the elongated shaft from the proximal segment to the distal segment (a second of 240 along the longitudinal axis), wherein the second ferrule is engaged to the distal body within the distal segment of the elongated shaft (240 is connected to 452), the second articulation cable including a first extending portion (240 with an extending portion through the articulating joint),
a second ferrule disposed about the loop portion of the second articulation cable (a second of 452 connecting to the second 240), wherein the second ferrule is disposed within the clevis (second ferrule 452 within 220) wherein the second articulation cable is operably coupled to the distal segment of the elongated shaft (240 and 452 is connected to 222 via 220).
Malkowski does not necessitate the cable as defining a continuous and uninterrupted length of cable, and the first ferrule disposed about the loop portion of the continuous and uninterrupted length of cable. Malkowski is further silent regarding a second extending portion spaced apart from the first extending portion, and a loop portion connecting distal ends of the first and second extending portions of the first and second articulation cables, and the ferrule at a loop portion of the device.
However, Low does teach that four independent cables for a similar articulating purpose of a forceps device may be two cable loops (par. [0099], four independent cables may be two cable loops). Low further teaches ferrules at a loop portion of two cables with a first end and second end between (beads 315a-b at a loop portion between halves of cable loops as in at least Fig. 3b).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the cables as cable loops such that it is continuous and uninterrupted as a simple substitution of a known element with another, regular cables for the bands, with the predictable result of allowing for motion of different elements and the articulation function desired. It would have further been obvious to one of ordinary skill in the art to modify Malkowski with the ferrule positioning of Low at the cable loops, to prevent cable slip (par. [0100]).Malkowski is further silent regarding a distal transition plug received at least partially in the opening of the clevis and configured to maintain paths of a first jaw wire, a second jaw wire, and the jaw cable in the distal transition plug.However, Manzo teaches a plug that is molded within a clevis to minimize interference of cables with the movement of the end effector (par. [0104], plug 1720 in clevis 1706 as in Figs. 17-18).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to help to keep the cables in position and minimize interference with end effector movement.
Regarding claim 4, Malkowski teaches wherein distal end portions of the first articulation cable and the second articulation cable are positioned in the clevis (240 are positioned in the clevis as in Fig. 11a).
Regarding claim 6, Malkowski is silent wherein the surgical instrument further including a skirt positioned about the articulating segment of the elongated shaft, the skirt including a first aperture, a second aperture, a third aperture, and a fourth aperture, wherein the first extending portion of the first articulation cable passes through the first aperture, the second extending portion of the first articulation cable passes through the second aperture, the first extending portion of the second articulation cable passes through the third aperture, and the second extending portion of the second articulation cable passes through the fourth aperture.
However, Manzo teaches skirt structures about an articulating segment of a shaft, with at least four apertures for articulation cables (par. [0061] links 12 with cables therethrough).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the skirt structures of Manzo, to protect the cables from being exposed during articulation of the end effector.
Regarding claim 9, Malkowski is silent regarding the instrument further including a proximal transition plug positioned at an opposite side of the articulating segment from the distal transition plug, the proximal transition plug configured to maintain positions of the second jaw wire, the jaw cable, the first articulation cable, and the second articulation cable within the proximal transition plug.
However, Manzo teaches an adapter plug (230 and 231) at a proximal end of an articulation segment (4) that maintains positions of cables (par. [0057] and Fig. 2a with 230 and 231 that routes cables to maintain position of the cables).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to maintain the cable positions and provide a smooth transition between the shaft and wrist.
Regarding claim 10, Malkowski is silent wherein the proximal transition plug is configured to allow longitudinal translation of the first and second extending portions of the first articulation cable and the first and second extending portions of the second articulation cable through the proximal transition plug.
However, Manzo teaches the adaptor plug (230 and 231 to allow for cables to route through as in Fig. 2a).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to maintain the cable positions and provide a smooth transition between the shaft and wrist.
Regarding claim 14, Malkowski teaches a surgical instrument (100), comprising:
an elongated shaft defining a longitudinal axis (210 with a longitudinal axis along the shaft as in Fig. 2), a proximal segment (214), and a distal segment (238), the distal segment comprising a clevis having an opening along the longitudinal axis (220 and 222), the elongated shaft including an articulating segment between the proximal segment and the distal segment (articulating segment of 230 with parts 234 and 232 as in Fig. 8);
a jaw assembly extending from the distal segment of the elongated shaft (260 extending from 238), the jaw assembly including a first jaw member and a second jaw member (first and second members 262 and 264), the first jaw member configured to be actuated between a closed configuration and an open configuration with respect to the second jaw member (par. [0157] jaws open and close relative to each other);
a pivot pin extending through proximal arms of the first jaw member and the second jaw member, the pivot pin pivotally coupling the first jaw member to the second jaw member (pivot member 446 through Fig. 11a through the proximal arms of the jaws, and allows 262 and 264 to rotate relative to each other as in par. [0175]), wherein the pivot pin is at least partially located within the clevis (446 at least partially within 222 through opening 298 as in par. [0176]);
an articulation cable assembly, the articulation cable assembly including:
a first articulation cable extending along the longitudinal axis of the elongated shaft from the proximal segment to the distal segment (one of 240 along the longitudinal axis), the first articulation cable including a first extending portion (240 with an extending portion through the articulating joint),
a first ferrule disposed about the first articulation cable (ferrule 452 as in Fig. 11a), disposed within the clevis (452 within 220), wherein the first articulation cable is operably coupled to the distal segment of the elongated shaft (240 coupled to distal segment of shaft as in Fig. 11a);a second articulation cable extending along the longitudinal axis of the elongated shaft from the proximal segment to the distal segment (a second of 240 along the longitudinal axis), the second articulation cable including a first extending portion (240 with an extending portion through the articulating joint), a second ferrule disposed about the loop portion of the second articulation cable (a second of 452 connecting to the second 240), disposed within the clevis (452 within 220), wherein the second articulation cable is operably coupled to the distal segment of the elongated shaft (240 and 452 is connected to 222 via 220).
Malkowski is silent regarding a distal transition plug disposed at a proximal end portion of the jaw assembly; the clevis positioned about the distal transition plug; and wherein the first ferrule and second ferrule are between the distal transition plug and the clevis, wherein the opening of the clevis is positioned about the distal transition plug.
However, Manzo teaches a plug that is molded to minimize interference of cables with the movement of the end effector (par. [0104], plug 1720 as in Figs. 17-18).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to help to keep the cables in position and minimize interference with end effector movement. In the combination, the ferrule 814a would be connected to the plug and the clevis to allow for the cables to run through and be managed. One of ordinary skill in the art would appreciate that the opening of clevis part 220 would be about the plug of Manzo, as the opening to connect to 222.
Malkowski does not necessitate the cable as defining a continuous and uninterrupted length of cable, and the first ferrule disposed about the loop portion of the continuous and uninterrupted length of cable. Malkowski is further silent regarding a second extending portion spaced apart from the first extending portion, and a loop portion connecting distal ends of the first and second extending portions of the first and second articulation cables, and the ferrule at a loop portion of the device.
However, Low does teach that four independent cables for a similar articulating purpose of a forceps device may be two cable loops (par. [0099], four independent cables may be two cable loops). Low further teaches ferrules at a loop portion of two cables with a first end and second end between (beads 315a-b at a loop portion between halves of cable loops as in at least Fig. 3b).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the cables as cable loops such that it is continuous and uninterrupted as a simple substitution of a known element with another, regular cables for the bands, with the predictable result of allowing for motion of different elements and the articulation function desired. It would have further been obvious to one of ordinary skill in the art to modify Malkowski with the ferrule positioning of Low at the cable loops, to prevent cable slip (par. [0100]).
Regarding claims 15-16, Malkowski is silent wherein the first jaw member includes a first jaw wire extending proximally therefrom, and wherein the second jaw member includes a second jaw wire extending proximally therefrom.
However, Manzo teaches wires 11a-b attached to jaws for electrosurgical transmission to the jaws (par. [0058] and Fig. 5).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the wires of Manzo for the jaws, allowing for electrode use of the end effector.
Regarding claim 17, Malkowski is silent wherein the surgical instrument further including a skirt positioned about the articulating segment of the elongated shaft, the skirt including a first aperture, a second aperture, a third aperture, and a fourth aperture, wherein the first extending portion of the first articulation cable passes through the first aperture, the second extending portion of the first articulation cable passes through the second aperture, the first extending portion of the second articulation cable passes through the third aperture, and the second extending portion of the second articulation cable passes through the fourth aperture.
However, Manzo teaches skirt structures about an articulating segment of a shaft, with at least four apertures for articulation cables (par. [0061] links 12 with cables therethrough).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the skirt structures of Manzo, to protect the cables from being exposed during articulation of the end effector.
Regarding claim 18, Malkowski teaches further including a jaw cable operably coupled to the first jaw member, the jaw cable configured to actuate the first jaw member between the closed configuration and the open configuration (par. [0159] jaws with cables to open or close via 205).
Regarding claim 19, Malkowski is silent regarding the distal transition plug includes a plurality of apertures to separate the at least one of the first jaw wire or the second jaw wire, and the jaw cable from each other within the elongated shaft.
However, Manzo teaches a plug that is molded to minimize interference of cables with the movement of the end effector (par. [0104], plug 1720 as in Figs. 17-18 with separate apertures for cables and wires). It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to help to keep the cables in position and minimize interference with end effector movement.
Regarding claim 20, Malkowski is silent regarding the instrument further including a proximal transition plug positioned at an opposite side of the articulating segment from the distal transition plug, the proximal transition plug configured to maintain positions of the second jaw wire, the jaw cable, the first articulation cable, and the second articulation cable within the proximal segment of the elongated shaft.
However, Manzo teaches an adapter plug (230 and 231) at a proximal end of an articulation segment (4) that maintains positions of cables (par. [0057] and Fig. 2a with 230 and 231 that routes cables to maintain position of the cables).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to maintain the cable positions and provide a smooth transition between the shaft and wrist.
Regarding claim 21, Malkowski is silent wherein the proximal transition plug is configured to allow longitudinal translation of the first and second extending portions of the first articulation cable and the first and second extending portions of the second articulation cable through the proximal transition plug.
However, Manzo teaches the adaptor plug (230 and 231 to allow for cables to route through as in Fig. 2a).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the plug of Manzo to maintain the cable positions and provide a smooth transition between the shaft and wrist.
Regarding claim 26, Malkowski is silent, but Manzo teaches wherein the distal transition plug is disposed about a proximal end portion of the jaw assembly (at least Fig. 17 with 1720 about the jaw assembly).
Regarding claim 27, Malkowski teaches wherein the first ferrule is secured in a first pocket at least partially defined by the clevis and the second ferrule is secured in a second pocket at least partially defined by the clevis, where in the second pocket is spaced form the first pocket (pockets 286 to hold the ferrules 452, individual retaining walls 286 separated from each other as in at least Fig. 13).
Claim(s) 11-12 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malkowski in view of Low, in view of Manzo, in further view of Ward (US 2017/0196648).
Regarding claim 11, Malkowski is silent wherein the jaw assembly further includes a blade slidably disposed between the first jaw member and the second jaw member to cut tissue grasped between the first jaw member and the second jaw member.
However, Ward teaches jaw members with a blade in the jaw members (par. [0052]).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the knife mechanism, allowing for additional functionality of the end effector for surgical procedures.
Regarding claim 12, Malkowski is silent wherein the blade is laterally offset from a center of the first jaw member and the second jaw member.
However, Ward teaches jaw members with a blade that is offset from a center of the jaw members (par. [0052], [0085] with a cut blade offset to one side of a slot axis of jaws).
It would have been obvious to one of ordinary skill in the art to modify Malkowski with the cut blade of Ward being offset in the jaws, allowing for additional functionality of the end effector for surgical procedures.
Regarding claim 22, Malkowski is silent wherein the jaw assembly further includes a blade slidably disposed between the first jaw member and the second jaw member to cut tissue grasped between the first jaw member and the second jaw member.
However, Ward teaches jaw members with a blade in the jaw members (par. [0052]). It would have been obvious to one of ordinary skill in the art to modify Malkowski with the knife mechanism, allowing for additional functionality of the end effector for surgical procedures.
Regarding claim 23, Malkowski is silent regarding a blade cable.
However, Manzo teaches a blade 190 with a cable 20 as in Fig. 10.
It would have been obvious to one of ordinary skill in the art to modify the combination with the blade cable of Manzo, allowing for articulation of a blade through a plug as in at least Fig. 2a of Manzo.
Regarding claim 24, Malkowski is silent wherein the blade is laterally offset from a center of the first jaw member and the second jaw member. However, Ward teaches jaw members with a blade that is offset from a center of the jaw members (par. [0052], [0085] with a cut blade offset to one side of a slot axis of jaws). It would have been obvious to one of ordinary skill in the art to modify Malkowski with the cut blade of Ward being offset in the jaws, allowing for additional functionality of the end effector for surgical procedures.
Response to Arguments
Applicant’s arguments, see the remarks, filed 12/23/25, with respect to the rejection(s) of claim(s) 1, 4, 6, 9-12, 14-24 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Malkowski and Low alone do not teach the claims as amended. However, upon further consideration, a new ground(s) of rejection is made in view of Manzo as a secondary reference.
Applicant's arguments filed 12/23/25 have been fully considered but they are not persuasive. Applicant argues that one of ordinary skill in the art would not modify Malkowski with the plug of Manzo to arrive at the claimed invention. Applicant argues that there is no room for the plug of Manzo in the clevis of Malkowski. However, modifying the plug 1720 of Manzo to fit in the clevis of Malkowski would allow for securing cables, especially given the retaining wall 286 is only on one side of the ferrule. Applicant further argues that the ferrules of Malkowski are radially outward of 222. However, looking to at least Fig. 20, ferrules 452 are clearly radially inward of 222 and 220.
Applicant further argues to claim 11 that Malkowski does not teach the pivot pin is not at least partially in in the clevis. However, as in par. [0176], pivot pin 446 is within 222 through openings 298.
Applicant’s remaining arguments are dependent on arguments addressed above and are not persuasive for the same reasoning.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794