DETAILED ACTION
Applicant's amendments and remarks, filed 5/30/25, are fully acknowledged by the Examiner. Currently, claims 1-18 are pending with claims 1 and 16 amended. The following is a complete response to the 5/30/25 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) 1-11, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duque (US 2012/0209289) in view of Goliszek (US 2020/0085491), in further view of Malkowski (US 10,881,391).
Regarding claim 1, Duque teaches an apparatus comprising: (a) a body (handle as in par. [0004]); (b) a shaft assembly extending distally from the body, wherein the shaft assembly includes a distal end (shaft 118 extending from the body, with a distal end away from the body); (c) an end effector (par. [0052)); (d) a coupling member disposed at the distal end of the shaft assembly to movably couple the end effector to the shaft assembly (coupling member 70 as in Fig. 7); and (e) a seal feature engaged with the coupling member (seal assembly 100 coupled to coupling member), wherein the seal feature includes a first seal body (top portion of 104 as in Fig. 8b with holes for elongate members), a second seal body (bottom portion of 104 with opposing holes as in Fig. 8b), a gap between the first and second seal bodies (gap for o-rings 106), wherein the gap is surrounded by the shaft assembly (gap is surrounded distally and proximally by shaft 118 as in at least Fig. 9).
Duque is not explicit regarding the plurality of protrusions extending into the gap from the first seal body, wherein each protrusion of the plurality of protrusions is configured to slidably receive a respective elongate member associated with the end effector therethrough.
However, Goliszek teaches a sealing block 260 as part of a shaft design having a tube receiving member 265 to receive a member as in par. [0073] and Fig. 4.
It would have been obvious to one of ordinary skill in the art to modify Duque with protrusions as in Goliszek in place of the o-rings of Duque, to assist in longitudinally guiding the cables through the shaft.Duque is not explicit regarding the shaft assembly radially surrounds the gap.However, Malkowski teaches multiple layers of seals, spaced apart with gaps, with a shaft radially surrounding the gap (col. 5, lines 23-41 and Fig. 6, with 122 radially surrounding the seal gaps as in at least Fig. 3).It would have been obvious to one of ordinary skill in the art to modify Duque with the arrangement of Malkowski with the gaps between the seals radially surrounded by a shaft, allowing for a fluid tight seal from all directions. This would allow for protecting from fluid in all directions, and allowing for replacement of the seals when the shaft is removed.
Regarding claim 2, Duque is not explicit regarding the protrusions.
However, Goliszek teaches wherein each protrusion defines a receiving portion and a sealing portion, wherein the sealing portion is configured to sealingly engage the elongate member (265 with a hole to receive a portion such as tube 272, and sealingly engages via gas sealing block 260).
It would have been obvious to one of ordinary skill in the art to modify Duque with the protrusions having a receiving and sealing portion to sealingly engage the elongate member, allowing for directing cables and tubes inside to the desired location.
Regarding claim 3, Duque teaches wherein the sealing portion is configured to flex in response to transverse movement of the elongate member relative to a longitudinal axis of the shaft assembly (par. [0013] seal with cross-sectional radius to accommodate lateral displacement).
Regarding claim 4, Duque teaches wherein the sealing portion is configured to flex in response to transverse movement of the elongate member relative to a longitudinal axis of the shaft assembly while maintaining sealing engagement with the elongate member (par. [0013] seal with cross-sectional radius to accommodate lateral displacement without moving out of contact).
Regarding claim 5, Duque wherein the sealing portion defines a seal bore, wherein the seal bore defines a diameter that is approximately equal to a diameter of the elongate member (As in Fig. 9, with o-ring 106 having a bore with an inner diameter similar to shafts 124).
Regarding claim 6, Duque teaches wherein the receiving portion defines a tapered bore extending therethrough and in communication with at least a portion of the sealing portion (o-ring 106 is tapered around the hole owing to shape as in Fig. 9).
Regarding claim 7, Duque teaches further comprising a plurality of cables extending from the body to the end effector through the shaft assembly (par. [0063] control cables), wherein each cable is movable relative to the body to drive movement of the end effector (control cables drive movement of the end effector as in par. [0007]), and a cable to permit movement of the end effector via one or more cables of the plurality of cables (cables to actuate the end effector as in par. [0063]).
Duque is silent regarding wherein each protrusion of the plurality of protrusions is configured to slidably receive a corresponding cable.
However, Goliszek teaches a sealing block 260 as part of a shaft design having a tube receiving member 265 as a protrusion to receive a cable 270 as in par. [0073] and Fig. 4.
It would have been obvious to one of ordinary skill in the art to modify Duque with protrusions as in Goliszek rather than the holes of Duque, to assist in guiding the cables through the shaft.
Regarding claim 8, Duque teaches wherein each seal is configured to transversely flex in response to transverse deflection of a corresponding cable via movement of the end effector (par. [0013] seal with cross-sectional radius to accommodate lateral displacement).
Goliszek teaches protrusions of a seal member as in claim 1.
Regarding claim 9, Duque teaches further comprising a plurality of cables configured to drive the end effector (par. [0063] control cables through the shaft to the end effector to control the end effector), wherein the plurality of cables extend from the body to the end effector through the shaft assembly (par. [0063] control cables through the shaft to the end effector), and wires and cables through sealing member (104) for controlling the end effector (par. [0063]), but is not explicit wherein one or more protrusions of the plurality of protrusions is configured to slidably receive a cable of the plurality of cables, wherein one or more protrusions of the plurality of protrusions is configured to slidably receive a wire of the one or more wires. Duque is further silent regarding one or more wires configured to communicate RF energy to the end effector.
However, Goliszek teaches a cable through a protrusion of a sealing member (265 of sealing member 265, with cable 270 running through). Goliszek teaches wires of an electrosurgical device with a wrist, with a conductive wire coupled to an electrode to provide electrosurgical energy thereto (par. [0021)). It would have been obvious to one of ordinary skill in the art to modify Duque with cables and wires through protrusions as in Goliszek, to guide the cables through the seal member and shaft, and also with the wire of Goliszek, allowing for energy to be delivered to electrosurgical end effectors.
Regarding claim 10, Duque teaches wherein each seal is configured to flex in response to transverse movement of a respective cable or respective wire (par. [0013] seal with cross-sectional radius to accommodate lateral displacement).
Goliszek teaches protrusions of a seal member as in claim 1.
Regarding claim 11, Duque is not explicit wherein each protrusion of the plurality of protrusions extends proximally from the seal body.
However, Goliszek teaches a sealing block 260 as part of a shaft design having a tube receiving member 265 as a protrusion to receive a cable 270 as in par. [0073] and Fig. 4.
It would have been obvious to one of ordinary skill in the art to modify Duque with protrusions as in Goliszek rather than the holes of Duque, to assist in guiding the cables through the shaft.
Regarding claim 14, Duque teaches wherein the seal feature is integrated into the structure of the coupling member (104 integrated into the structure with coupling member with Fig. 6).
Regarding claim 15, Duque teaches wherein the seal body includes a distal portion and a proximal portion with a gap defined between the proximal portion and the distal portion (distal portion distal to 104 and proximal portion proximal to 104 as in Figs. 8a-b with a gap between), wherein a portion of the coupling member extends through the gap between the proximal portion and the distal portion (portion of cables that interact with the wrist go through the gap of the seal member).
Regarding claim 16, Duque teaches an apparatus comprising:
(a) a body (handle as in par. [0004]);
(b) a shaft extending distally from the body (shaft 118 extending from the body);
(c) an end effector (end effector as in par. [0052]);
(d) a plurality of cables extending distally from the body through the shaft and to the end effector (par. [0063] control cables through the shaft to the end effector); and
(e) a seal feature disposed between the end effector and a portion of the shaft (100), wherein the seal feature includes a first seal body (top portion of 104 as in Fig. 8b), a second seal body (bottom portion of 104 with opposing holes as in Fig. 8b), a gap between the first and second seal bodies (gap for o-rings 106), wherein the gap is surrounded by the shaft assembly (gap is surrounded distally and proximally by shaft 118 as in at least Fig. 9).
Duque is silent regarding a plurality of protrusions extending into the gap from the first seal body, wherein each protrusion of the plurality of protrusions is configured to sealingly engage a corresponding cable while permitting movement of each cable relative to the shaft, but teaches cables for o-rings that allow movement of the cables through the o-rings (par. [0063]).
However, Goliszek teaches a sealing block 260 as part of a shaft design having a tube receiving member 265 to receive a cable 270 as in par. [0073] and Fig. 4.
It would have been obvious to one of ordinary skill in the art to modify Duque with protrusions as in Goliszek in place of the o-rings of Duque, to assist in longitudinally guiding the cables through the shaft.Duque is not explicit regarding the shaft assembly radially surrounds the gap.However, Malkowski teaches multiple layers of seals, spaced apart with gaps, with a shaft radially surrounding the gap (col. 5, lines 23-41 and Fig. 6, with 122 radially surrounding the seal gaps as in at least Fig. 3).It would have been obvious to one of ordinary skill in the art to modify Duque with the arrangement of Malkowski with the gaps between the seals radially surrounded by a shaft, allowing for a fluid tight seal from all directions. This would allow for protecting from fluid in all directions, and allowing for replacement of the seals when the shaft is removed.
Regarding claim 17, Duque teaches a wire extending from the body to the end effector (control wire), but is silent wherein the wire is configured to communicate RF energy from the body to the end effector, wherein a protrusion of the plurality of protrusions is configured to slidably receive the wire. However, Goliszek teaches wires of an electrosurgical device with a wrist, with a conductive wire coupled to an electrode to provide electrosurgical energy thereto (par. [0021]).
It would have been obvious to one of ordinary skill in the art to modify Duque with the wire of Goliszek, allowing for energy to be delivered to electrosurgical end effectors.
Claim(s) 12-13, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duque in view of Goliszek, in view of Malkowski, in view of Park (US 2016/0175060).
Regarding claim 12, Duque is not explicit wherein the seal feature comprises a compliant material.
However, Park teaches seal features made of silicone rubber that are flexible (par. [0094] and [0103]). It would have been obvious to one of ordinary skill in the art to modify Duque with the seal features comprising rubber, as in Park, as a material that allows for sealing and is compliant for accommodating movement.
Regarding claim 13, Duque is silent regarding wherein the seal feature comprises silicone. However, Park teaches seal features made of silicone rubber (par. [0094] and [0103]). It would have been obvious to one of ordinary skill in the art to modify Duque with the seal features comprising silicone rubber, as in Park, as a material that allows for sealing and is bio-compatible.
Regarding claim 18, Duque is silent regarding further comprising a clevis secured to the distal end of the shaft, wherein the clevis connects the end effector to the distal end of the shaft to permit movement of the end effector relative to the shaft via actuation of the cables, wherein the seal feature is overmolded into an interior of the clevis. However, Park teaches a clevis 307 attached to a shaft and distal end 306, the clevis permitting movement of the end effector relative to the shaft via cable actuation (tendon 452 to actuate the tip including the clevis as in the abst.). Park further teaches sealing material overmolded to the device tip including the clevis (par. [0115]). It would have been obvious to one of ordinary skill in the art to modify Duque with the clevis structure of Park, allowing for structure for actuation of the end effector to position the device to treat tissue.
Response to Arguments
Applicant’s arguments, see the remarks, filed 5/30/25, with respect to the rejection(s) of claim(s) 1-18 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Malkowski as a secondary reference.
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
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794