DETAILED ACTION
Applicant's amendments and remarks, filed 7/8/26, are fully acknowledged by the Examiner. Currently, claims 22-23, 29-30, 32-33, 35-37, 39-46, 48, 50-54 are pending with claim 54 added, and claims 22-23, 30, 35-36, 39, 41-42, 44, and 48 amended. The following is a complete response to the 7/8/26 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 7/8/26 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22, 29-30, 36, 40, 42, 43 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerhardt (US 2011/0276049) in view of Manzo (US 2012/0215220), in view of Aldridge (US 2012/0022526), in further view of Kerver (US 2009/0198272).
Regarding claim 22, Gerhardt teaches a surgical system, comprising: an end effector (14), comprising: a first jaw (32); a second jaw rotatable relative to said first jaw between an open position and a closed position (34 rotatable with respect to 32 as in par. [0022]); and a firing beam (40) movable through:
an elongate shaft (16); and a drive tube configured to axially drive said firing beam through said first and second stroke (knife tube 72 to drive 40 allowing 82 to cut tissue longitudinally).
Gerhardt is silent regarding a multi-axis articulation joint, wherein said end effector is rotatable relative to said elongate shaft about said multi-axis articulation joint; a flexible tube extending through said multi-axis articulation joint; and a drive member located inside of the flexible tube.
Manzo teaches a wrist (4) for a forceps device such that the end effector rotates relative to the shaft
about the articulation joint (3 moves relative to 2 about 4 in multiple axes), a flexible tube through the articulation joint (hollow drive shaft 218), and further the drive member as flexible (a drive member 20 flexible as in par. [0088)).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Gerhardt is further silent regarding the firing beam as a flanged beam comprising first and second beam flanges to engage said first and second jaws;
a first stroke in which said firing bear moves said second jaw from said open position toward said closed position; and
a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw, and the beam as a flanged beam comprising first beam flanges to engage said first jaw and second beam flanges to engage said second jaw.
Aldridge teaches a first stroke in which said flanged beam comprising first beam flanges to engage said first jaw and second beam flanges to engage said second jaw (cam surfaces 144a-b to engages jaws 120a-b), and moves said second jaw from said open position toward said closed position (par. [0138] a first stroke for trigger 1110 to close jaws at second position 1114); and
a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw (second stroke to pass the cutting assembly 1106 through the jaws to cut tissue as in par. [0138)).
Kerver shows another drive beam and knife mechanism wherein one section (150 as in Fig. 16) is the part of the drive shaft that interacts with the articulation joint (Figs. 15-16 and par. [0054]), and the distal section with knife (161), equivalent to the beam with beam flanges, such that the beam would not pass through the articulation joint.
It would have further been obvious to one of ordinary skill in the art to modify Gerhardt with the multi stroke movement of the actuating handle, as well as the beam with beam flanges replacing the knife, as taught by Aldridge, allowing for treatment via actuation in a desired order. In the combination, the beam would be distal of the drive tube, similar as to how the knife of Kerver is well clear of the articulation joint.
Regarding claim 29, Gerhardt teaches said end effector further comprises an electrode configured to deliver RF energy to tissue between said first and second jaw (electrode 86 for electrosurgical energy).
Regarding claim 30, Gerhardt teaches a surgical system, comprising: an end effector (14),
comprising:a first jaw (32); a second jaw movable relative to said first jaw between an open position and a closed position (34 that opens and closes with respect to 32 to grasp tissue); an end effector axis (longitudinal axis through 32 and 34 with channel for cutting member 82); and
a cutting member axially movable along said end effector axis between a proximal position and a distal position (82 moves axially along the longitudinal axis to cut tissue);
an elongate shaft extending proximally from said end effector (16); and
a flexible drive shaft assembly operably coupled to said cutting member (20 coupled to 19), wherein said cutting member is movable toward said distal position based on the axial movement of said flexible drive shaft assembly (19 moves distally from movement of 20).
Gerhardt is silent regarding a first articulation joint; a second articulation joint wherein said end effector is rotatable relative to said elongate shaft about said first articulation joint and said second articulation joint, a flexible tube extending through said multi-axis articulation joint; and a drive member located inside of the flexible tube.
However, Manzo teaches a first articulation joint (joint 12 in a pitch configuration as in par. [0060] and Figs. 3-5); a second articulation joint (joint 12 in a yaw configuration as in par. [0060] and Figs. 3-5) wherein said end effector is rotatable relative to said elongate shaft about said first articulation joint and said second articulation joint (3 rotates relative to 2 about joints 12 of articulation wrist 4), a flexible tube through the articulation joint (hollow drive shaft 218) with a drive member through the shaft (20 through 218), and further the drive member as flexible (a drive member 20 flexible as in par. [0088]).It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Gehardt is further silent regarding a first stroke in which said firing beam moves said second jaw from said open position toward said closed position; and
a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw.
Aldridge teaches said flanged beam comprising first beam flanges to engage said first jaw and second
beam flanges to engage said second jaw (cam surfaces 144a-b to engages jaws 120a-b), a first stroke in
which said firing beam moves said second jaw from said open position toward said closed position (par.
[0138] a first stroke for trigger 1110 to close jaws at second position 1114); and a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw (second stroke to pass the cutting assembly 1106 through the jaws to cut tissue as in par. [0138)).
Kerver shows another drive beam and knife mechanism wherein one section (150 as in Fig. 16) is the part of the drive shaft that interacts with the articulation joint (Figs. 15-16 and par. [0054]), and the distal section with knife (161), equivalent to the beam with beam flanges, such that the beam would not
pass through the articulation joint.
It would have further been obvious to one of ordinary skill in the art to modify Gehardt with the multi stroke movement of the actuating handle, as well as the beam with beam flanges replacing the knife, as taught by Aldridge, allowing for treatment via actuation in a desired order. In the combination, the beam would be distal of the drive tube, similar as to how the knife of Kerver is well clear of the articulation joint.
Regarding claim 36, Gerhardt is silent, but Manzo teaches wherein said multi-axis articulation joint comprises articulation joint segments (wrist 4 with articulation joints 12), wherein said articulation joint segments comprise a first articulation joint segment (joint 12 in a pitch configuration as in par. [0060] and Figs. 3-5) and a second articulation joint segment rotatable relative to said first articulation joint segment (joint 12 in a yaw configuration as in par. [0060] and Figs. 3-5), wherein said articulation joint segments define a passage therethrough (passage through wrist 4), and wherein said passage is
configured to: receive said flexible tube (receives a drive member 18);
constrain transverse movements between said first annular joint and said second annular joint (a filled passage through wrist 4 by drive member 18 limits movement of the joints); and permit relative movement between said first annular joint and said second annular joint (joints 12 move relative to each other depending on the structure of the material in the passage of 4).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Regarding claim 40, Gerhardt is not explicit, but Manzo teaches wherein said multi-axis articulation joint comprises a first articulation joint and a second articulation joint (joint 12 in a pitch configuration as in par. [0060] and Figs. 3-5, and a second joint 12 a yaw configuration as in par. [0060] and Figs. 3-5), wherein said end effector is rotatable relative to said elongate shaft about said first articulation joint in a first articulation plane (joint 12 with a pitch such that the end effector rotates in a pitch movement), and wherein said end effector is rotatable relative to said elongate shaft about said second articulation joint in a second articulation plane transverse said first articulation plane (joint 12 with a yaw such that the end effector rotates in a yaw movement).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Regarding claim 42, Gerhardt is silent, but Manzo teaches wherein said articulation joint comprises articulation joint segments (wrist 4 with articulation joints 12), wherein said articulation joint segments comprise a first articulation joint segment (joint 12 in a pitch configuration as in par. [0060] and Figs. 3-5) and a second articulation joint segment rotatable relative to said first articulation joint segment (joint 12 in a yaw configuration as in par. [0060] and Figs. 3-5), wherein said articulation joint segments define a passage therethrough (passage through wrist 4), and wherein said passage is
configured to: receive said drive tube (receives a drive member 18);
constrain transverse movements between said first annular joint and said second annular joint (a filled passage through wrist 4 by drive member 18 limits movement of the joints); and permit relative movement between said first annular joint and said second annular joint (joints 12 move relative to each other depending on the structure of the material in the passage of 4).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Regarding claim 43, Gerhardt is silent, but Manzo teaches the system further comprising a constraining member configured to limit movement between said first annular joint and said second annular joint (45 limits movement between the joints).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the flexible drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Regarding claim 44, Gerhardt teaches a surgical system, comprising: an end effector (14), comprising: a first jaw (32); a second jaw rotatable relative to said first jaw between an open position and a closed position (34 moves with respect to 32 as in par. [0022]), wherein said second jaw comprises a channel flange (channel 84); and a knife (82); and a firing beam comprising a beam flange (40 with a beam flange),
an elongate shaft extending proximally from said end effector (shaft 16).
Gerhardt is silent regarding wherein said firing beam is movable through:
an articulation joint, wherein said end effector is rotatable relative to said elongate shaft about said articulation joint in both a first plane and a second plane, wherein the second plane is transverse to the first plane; a shaft having a lumen therein; andand a drive member located in the lumen of the shaft and configured to axially drive said firing beam through said first stroke and said second stroke, wherein said shaft comprises a flexible region cut therein, and wherein said flexible region extends through said articulation joint.
Manzo teaches a wrist (4) for a forceps device such that the end effector rotates relative to the shaft about the articulation joint in two transverse planes (3 moves relative to 2 about 4, movable in multiple planes transverse to each other as in par. [0060]), a flexible tube through the articulation joint (hollow drive shaft 218) with a drive member through the shaft (20 through 218), and further the drive member as flexible (a drive member 20 flexible as in par. [0088]).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the wrist and the shaft and drive member of Manzo, allowing for articulation of the end effector, allowing for greater mobility and control over the end effector.
Gehardt is further silent regarding the firing beam as a flanged beam comprising first and second beam flanges to engages said first and second jaws; a first stroke in which said firing beam moves said second jaw from said open position toward said closed position; and
a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw.
Aldridge teaches a first stroke in which said flanged beam comprising first beam flanges to engage said first jaw and second beam flanges to engage said second jaw (cam surfaces 144a-b to engages jaws 120a-b), a first stroke in which said firing beam moves said second jaw from said open position toward said closed position (par. [0138] a first stroke for trigger 1110 to close jaws at second position 1114);
and a second stroke in which said firing beam drives said knife distally to cut tissue captured between said first jaw and said second jaw (second stroke to pass the cutting assembly 1106 through the jaws to cut tissue as in par. [0138)).
Kerver shows another drive beam and knife mechanism wherein one section (150 as in Fig. 16) is the part of the drive shaft that interacts with the articulation joint (Figs. 15-16 and par. [0054]), and the distal section with knife (161), equivalent to the beam with beam flanges, such that the beam would not pass through the articulation joint.
It would have further been obvious to one of ordinary skill in the art to modify Gehardt with the multi stroke movement of the actuating handle, as well as the beam with beam flanges replacing the knife, as taught by Aldridge, allowing for treatment via actuation in a desired order. In the combination, the beam would be distal of the drive tube, similar as to how the knife of Kerver is well clear of the articulation joint.
Regarding claim 50, Gerhardt is silent regarding the second stroke.
However, Aldridge teaches the second stroke is distal to said first stroke (portions of 1110 are moved about 1166 in a distal direction toward the end effector as in at least Fig. 37 as 1110 is moved through the stroke motions).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the second stroke distal to said first stroke, as a consequence of the gating system and pivot of the trigger of Aldridge, allowing for movement through the strokes in sequential order.
Claims 32-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerhardt in view of Manzo, in view of Aldridge, in view of Kerver, and in further view of Yates (US 2008/0077131).
Regarding claim 32, Gerhardt is silent regarding a staple cartridge comprising staples removably stored therein. However, Yates teaches a similar forceps device with a staple cartridge with staples (cartridge 50 with staples 53). It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the staple system of Yates, as an additional way to seal tissue.
Regarding claim 33, Gerhardt is silent regarding wherein said staples are deployable from said staple cartridge based on said cutting member axially moving toward said distal position. However, Yates teaches a similar forceps device with a staple cartridge with staples (cartridge 50 with staples 53), and does so before the cutting as in par. [0031]. It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the staple system of Yates, as an additional way to seal tissue before cutting to prevent excess bleeding.
Claims 37-39 and 46-48 is/are rejected under pre-AIA 35 U.S.C. 103{a) as being unpatentable over Gerhardt in view of Manzo, in view of Aldridge, in view of Kerver, in further view of Cooper (US 2003/0036748).
Regarding claim 37, Gerhardt is silent regarding a constraining member configured to limit movement between said first annular joint and said second annular joint.However, Cooper teaches a constraining member configured to limit movement between a first and second annular joint (Fig. 3, par. [0107] with spring 54 to stabilize rotation).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the constraining member of Cooper, to stabilize the wrist member.
Regarding claim 38, Gerhardt is silent wherein said constraining member comprises a spring.
However, Cooper teaches a constraining member as a spring configured to limit movement between a first and second annular joint (Fig. 3, par. [0107] with spring 54 to stabilize rotation).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the constraining member of Cooper, to stabilize the wrist member.
Regarding claim 39, Gerhardt is silent, but Cooper teaches wherein said drive tube defines an internal cavity (inner cavity between each vertebrae), and wherein said constraining member is positioned in said internal cavity (spring 54 within cavity). It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the spring between the vertebrae as in Cooper, to stabilize rotation of the wrist as in par. [0107].
Regarding claim 46, Gerhardt is silent regarding a constraining member configured to limit movement between said first annular joint and said second annular joint. However, Cooper teaches a constraining member configured to limit movement between a first and second annular joint (Fig. 3, par. [0107] with spring 54 to stabilize rotation). It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the constraining member of Cooper, to stabilize the wrist member.
Regarding claim 47, Gerhardt is silent wherein said constraining member comprises a spring.
However, Cooper teaches a constraining member as a spring configured to limit movement between a first and second annular joint (Fig. 3, par. [0107] with spring 54 to stabilize rotation). It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the constraining member of Cooper, to stabilize the wrist member.
Regarding claim 48, Gerhardt is silent, but Cooper teaches wherein said drive tube defines an internal cavity (inner cavity between each vertebrae), and wherein said constraining member is positioned in said internal cavity (spring 54 within cavity). It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the spring between the vertebrae as in Cooper, to stabilize rotation of the wrist as in par. [0107].
Claims 23, 35, 41, 45 and 51-54 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gerhardt in view of Manzo, in view of Aldridge, in further view of Kerver, in further view of Zaver (US 2007/0135826).
Regarding claim 54, Gehardt is silent wherein said flexible tube comprises a laser-cut region defined therein, and wherein said laser-cut region extends through said multi-axis articulation joint.However, Zaver teaches slots in a tubular body for flexibility, which may be laser cut (par. [0236] with laser cuts on the tubular body 306 housing a torque rod).
It would have been obvious to one of ordinary skill in the art to have laser cut regions in the flexible tube as in Zaver, allowing for flexibility of the tube to work alongside the articulating wrist. One of ordinary skill in the art would appreciate that the laser-cut region would be where bending/articulating occurs, at the articulation joint.
Regarding claim 23, Gerhardt is silent regarding the laser-cut region.
However, Zaver teaches wherein said laser-cut region comprises: a first annular joint comprising a first plurality of connectors around a perimeter thereof (Fig. 25a); and a second annular joint comprising a second plurality of connectors around a perimeter thereof (interlocking joints 600), wherein said first plurality of connectors are interlocked with said second plurality of connectors to facilitate angular movement between said first annular joint and said second annular joint in a plurality of angular directions (first and second joints are interwoven to allow for flexibility in multiple directions).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the joints of Zaver, allowing for the knife actuation system to articulate with the end effector about the articulation wrist.
Regarding claim 35, Gerhardt teaches wherein said flexible tube comprises a hollow tube (72 as a hollow tube), but not explicitly made of metal.However, Zaver teaches a metal tube as a drive tube as in par. [0256].It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the metal tube of Zaver, allowing for the flexibility desired in the combination.
Regarding claim 41, Gerhardt is silent regarding the laser cut zone.
However, Zaver teaches wherein said flexible tube comprises a laser-cut region defined therein, and wherein said laser-cut region extends through said first and second articulation joints (par. [0236] with laser cuts on the tubular body 306 housing a torque rod), the laser cut zone comprises:a first annular joint comprising a first plurality of connectors around a perimeter thereof (Fig. 25a); and a second annular joint comprising a second plurality of connectors around a perimeter thereof (interlocking joints 600), wherein said first plurality of connectors are interlocked with said second plurality of connectors to facilitate angular movement between said first annular joint and said second annular joint in a plurality of angular directions (first and second joints are interwoven to allow for flexibility in multiple directions).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the joints of Zaver, allowing for the knife actuation system to articulate with the end effector about the articulation wrist.
Regarding claim 45, Gerhardt is silent regarding the laser-cut region.
However, Zaver teaches wherein said laser-cut region comprises: a first annular joint comprising a first plurality of connectors around a perimeter thereof (Fig. 25a); and a second annular joint comprising a second plurality of connectors around a perimeter thereof (interlocking joints 600), wherein said first plurality of connectors are interlocked with said second plurality of connectors to facilitate angular movement between said first annular joint and said second annular joint in a plurality of angular directions (first and second joints are interwoven to allow for flexibility in multiple directions).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the joints of Zaver, allowing for the knife actuation system to articulate with the end effector about the articulation wrist.
Regarding claim 51, Gerhardt is silent regarding the flexible region comprises a plurality of interlocking shapes.
However, Zaver teaches interlocking shapes to create a flexible region (Fig. 25 and par. [0256]).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the interlocking shapes of Zaver, to have a flexible profile.
Regarding claim 52, Gerhardt is silent regarding said plurality of interlocking shapes comprises a plurality of interlocking dovetails.However, Zaver teaches interlocking dovetail shapes to create a flexible region (Fig. 25 and par. [0256]).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the interlocking dovetail shapes of Zaver, to have a flexible profile.
Regarding claim 53, Gerhardt teaches wherein said plurality of interlocking shapes comprise a
plurality of sockets and a plurality of lugs.However, Zaver teaches interlocking shapes as sockets and lugs to create a flexible region (Fig. 25 and par. [0256]).
It would have been obvious to one of ordinary skill in the art to modify Gerhardt with the interlocking shapes of Zaver, to have a flexible profile.
Response to Arguments
Applicant's arguments filed 7/8/26 have been fully considered but they are not persuasive. The extensive amendments have resulted in a new rejection being made using previously cited art.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
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
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