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 .
Response to Amendment
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Response to Arguments
Applicant’s arguments, filed 2/12/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and the previous rejection of the claims has been withdrawn in light of said amendments. Examiner agrees the previous rejection as written fails to specifically point out the limitation “the handle is configured to pivot relative to the distal connector at the ring”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kleyman in view of Lee and Cruz and Akahoshi.
Applicant's arguments filed 2/12/2026 regarding claims 16 and 19 have been fully considered but they are not persuasive.
Regarding claim 16, Applicant argues Kleyman is silent to the location of lumens 246 thus does not teach "wherein the plurality of lumens include, in order angularly disposed about an axis of the shaft, a first lumen, a second lumen, a third lumen, and a fourth lumen". Examiner respectfully disagrees, as Figure 8C shows a plurality of lumens 246 on one of a plurality flexible links, and as the links are attached together, the plurality of respective guide lumens 246 would form disposed about an axis of the shaft, a first lumen, a second lumen, a third lumen, and a fourth lumen.
Regarding claim 19, Applicant argues the references fail to teach "the second plurality of articulation wires are coupled to and spaced evenly around a surface of the ring that defines a central lumen of the ring" and that "the first plurality of articulation wires are disposed through the central lumen of the ring," Examiner respectfully disagrees.
Firstly, Applicant argues the cited cables 650A-B do not extend through the central lumen of the gimbal plate 706 but rather are shown going through the central lumen of lock plate 710. Applicant argues that the actuation wires must extend through the same lumen as is defined by the surface of the ring. However, a lumen is a channel with two openings, and one of the openings is on the surface of the lock plate 710 which is defined as part of the ring. The ring can include multiple annular pieces, as it does in the rejection, citing to both 706 and 710. Thus, as shown in Figure 63, the actuation wires do extend through the central lumen of the ring.
Further, Applicant argues the actuation wires 650A-B are not placed evenly around the surface of the lockplate and are irregularly placed. However, based on Figure 59, there are two wires, thus the wires would be placed evenly.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the handle is configured to pivot relative to the distal connector at the ring” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kleyman (US 20120253326 A1) (noted on IDS) in view of Lee et al. (US 20060095074 A1) (previously of record) and Cruz et al. (US 20200069300 A1) (previously of record).
Regarding claim 1, Kleyman discloses a medical device comprising:
a main shaft (200) extending from a proximal end to a distal end (Figure 1; Paragraph 0040);
a first articulation shaft (210) coupled to the distal end of the main shaft (Figure 1; Paragraph 0040-41);
a second articulation shaft (220+230) coupled to a distal end of the first articulation shaft (Figure 1; Paragraph 0040-42);
a first articulation wire (212) coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft and the first articulation shaft (Figure 8; Paragraph 0040-41);
and a second articulation wire (232) coupled proximate to a distal portion of the second articulation shaft and extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft (Paragraph 0040-42); and
a handle (300) coupled to a proximal end of the main shaft (Figure 1; Paragraph 0044), the handle comprising a first actuator (310) rotatably coupled to the handle wherein movement of the first actuator bends the first articulation shaft (Figure 1; Paragraph 0044; 0046).
Kleyman fails to specifically disclose the handle configured to pivot about a distal end portion of the handle relative to the proximal end of the main shaft, the handle comprising a first joystick actuator rotatably coupled to the handle, wherein the first joystick actuator includes a joystick and a ball, wherein movement of the first joystick actuator bends the first articulation shaft, wherein the handle is configured to pivot relative to the main shaft to bend the second articulation shaft independent of bending of the first articulation shaft, wherein the handle includes a ring at the distal end portion of the handle, wherein the second articulation wire is coupled to the ring, and wherein the ball and the ring are separated longitudinally along the handle and a distal connector including a central lumen configured to receive the main shaft, wherein the distal connector is configured to (i) couple to a working channel of an endoscope at a distal end of the distal connector and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector at the ring.
Lee is directed to a surgical instrument and teaches a handle (12) configured to pivot about a distal end portion of the handle relative to the proximal end of the main shaft (14) and wherein the handle is configured to pivot relative to the main shaft to bend the second articulation shaft (20) (Figure 2A-C; Paragraph 0054). Since Kleyman’s articulation shafts are configured to bend independently (Kleyman Paragraph 0046), the combination would result in the second articulation shaft bending independently of the first articulation shaft. Lee further teaches wherein the handle includes a ring (18) at the distal end portion of the handle (Figure 8; Paragraph 0074), wherein the second articulation wire (any of cables 100) is coupled to the ring (clearance holes 134 allow for the cables to be coupled to the individual discs 130 of bendable member 18) (Figure 14; Paragraph 0074; 0085), and a distal connector (26) including a central lumen configured to receive the main shaft (Figure 19; Paragraph 0052), wherein the distal connector is configured to (i) couple to a working channel of an endoscope at a distal end of the distal connector (the language “configured to couple to a working channel is functional language, and if the instrument is placed in the working channel of an endoscope, cover 26 would serve to couple the channel as it abuts from the shaft of the instrument. Thus, the distal connector is fully capable of performing such a function, thus it reads on the limitation.) (Figure 8; Paragraph 0057) and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector at the ring (Figure 2A-C; Paragraph 0054).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that the handle is configured to pivot about a distal end portion of the handle relative to the proximal end of the main shaft and wherein the handle is configured to pivot relative to the main shaft to bend the second articulation shaft, wherein the handle includes a ring at the distal end portion of the handle, wherein the second articulation wire is coupled to the ring, and a distal connector including a central lumen configured to receive the main shaft as taught by Lee, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Lee by incorporating the handle is configured to pivot about a distal end portion of the handle relative to the proximal end of the main shaft and wherein the handle is configured to pivot relative to the main shaft to bend the second articulation shaft, wherein the handle includes a ring at the distal end portion of the handle, wherein the second articulation wire is coupled to the ring, and a distal connector including a central lumen configured to receive the main shaft in order to allow the surgeon to manipulate the surgical instrument with greater dexterity (Lee Paragraph 0004) and provide a very precise and ergonomically comfortable degree of control for the surgeon (Lee Paragraph 0058). Further, a person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device of Kleyman to include a distal connector including a central lumen configured to receive the main shaft, wherein the distal connector is configured to (i) couple to a working channel of an endoscope at a distal end of the distal connector and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector, as taught by Lee, as the references and the claimed invention are directed to surgical instruments, and Kleyman suggests using the device endoscopically (Kleyman Paragraph 0005) (Kleyman discloses a laparoscopic instrument but states “Throughout the present disclosure, the term minimally invasive is to be understood as encompassing both endoscopic and laparoscopic procedures”, thus the device is understood to be used in both endoscopic and laparoscopic procedures).
Further, Cruz is directed to a surgical instrument and teaches the handle (10) comprising a first joystick actuator (310) rotatably coupled to the handle, wherein the first joystick actuator includes a joystick (315) and a ball (345), wherein movement of the first joystick actuator bends the first articulation shaft (25) (Figure 28; Paragraph 0227-28). The combination of Kleyman with Lee and Cruz would further teach wherein the ball and the ring are separated longitudinally along the handle, as the ball of Cruz would be placed in a separate location from the ring of Lee.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that the first actuator is a first joystick actuator rotatably coupled to the handle, wherein the first joystick actuator includes a joystick and a ball, wherein movement of the first joystick actuator bends the first articulation shaft, as taught by Cruz, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Cruz by incorporating the first actuator being a first joystick actuator rotatably coupled to the handle, wherein the first joystick actuator includes a joystick and a ball, wherein movement of the first joystick actuator bends the first articulation shaft in order to articulate the device with a range of different motions and precise control (Cruz Paragraph 0176). Further, the modification would be obvious as a simple substitution of a knob for a joystick, and the results of such a modification would have been obvious, namely replacing one form of an actuator with another to control articulation of a shaft.
Regarding claim 2, Kleyman further discloses wherein the first articulation shaft is configured to bend independent of bending of the second articulation shaft, via movement of the first articulation wire (Paragraph 0046); and wherein the second articulation shaft is configured to bend independently of bending of the first articulation shaft, via movement of the second articulation wire (Paragraph 0041; 0046).
Regarding claim 3, Kleyman as modified by Lee and Cruz teaches the medical device of claim 1 but fails to specifically disclose a tool coupled to a distal end of the second articulation shaft, and a tool actuation wire extending through the main shaft, the first articulation shaft, and the second articulation shaft, to actuate the tool.
Cruz teaches a tool (30) coupled to a distal end of the second articulation shaft (25), and a tool actuation wire (230) extending through the main shaft (15), the first articulation shaft (20), and the second articulation shaft, to actuate the tool (Figure 1B; Paragraph 0186; 0207).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman as modified by Lee and Cruz with the teachings of Cruz by incorporating a tool coupled to a distal end of the second articulation shaft, and a tool actuation wire extending through the main shaft, the first articulation shaft, and the second articulation shaft, to actuate the tool since Kleyman states “the surgical articulation apparatus provides for an easy and intuitive way of articulating a distal end of the surgical articulation apparatus through the use of a gimbal structure” (Kleyman Paragraph 0008) and discloses their device would be useful with a surgical instrument “S”, but doesn’t specify the type of instrument or the actuation of said instrument (Kleyman Paragraph 0043-44), thus the modification by including Cruz’s tool and actuation wires would allow a user to easily perform a surgical task, such as grasping or cutting.
Regarding claim 4, Kleyman further discloses a first articulation ring (240) coupled to a distal end of the first articulation shaft and coupled to a proximal end of the second articulation shaft (see Figure 1), wherein the first articulation wire is fixedly coupled to the first articulation ring (Figure 8, 8A-C; Paragraph 0041).
Regarding claim 5, Kleyman further discloses a second articulation ring (250) coupled to a distal end of the second articulation shaft, wherein the second articulation wire is fixedly coupled to the second articulation ring (Figure 8; Paragraph 0042).
Regarding claim 14, Kleyman as modified by Lee and Cruz discloses the medical device of claim 1, and Kleyman further discloses wherein: the handle is L-shaped (Figure 1; Paragraph 0044); the main shaft extends distally from a distal end of the handle (Figure 1). The combination of Kleyman with the actuator of Cruz teaches the first joystick actuator extends outward from an exterior surface of the handle (Cruz Figure 28).
Regarding claim 15, Kleyman as modified by Lee and Cruz teaches the medical device of claim 14 but fails to specifically disclose wherein the first joystick actuator is positioned at a corner of the handle.
However, Cruz further teaches wherein the first joystick actuator is positioned at a corner of the handle (Figure 27).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Cruz by incorporating wherein the first joystick actuator is positioned at a corner of the handle in order to be easily engaged by a user (Cruz Paragraph 0225).
Regarding claim 16, Kleyman discloses a medical device comprising:
a main shaft (200) extending from a proximal end to a distal end (Figure 1; Paragraph 0040); wherein the main shaft includes a plurality of lumens (246), wherein the plurality of lumens include, in order angularly disposed about an axis of the shaft, a first lumen (1st of 246 corresponding with able 212), a second (2nd of 246 corresponding with cable 214) lumen, a third lumen (3rd of 246 corresponding with cable 222), and a fourth lumen (4th of 246 corresponding with cable 224) (Figure 8C; Paragraph 0041);
a first articulation shaft (210) coupled to the distal end of the main shaft (Figure 1; Paragraph 0040-41);
a second articulation shaft (220+230) coupled to a distal end of the first articulation shaft (Figure 1; Paragraph 0040-42);
a handle (300) coupled to the proximal end of the main shaft, the handle comprising a first actuator (310) rotatably coupled to the handle, wherein movement of the first actuator bends the first articulation shaft independent of bending the second articulation shaft (Figure 1; Paragraph 0044; 0046); and
wherein a first articulation wire (212) and a second articulation (214) (Paragraph 0041);
a second actuator (330) coupled to the handle, wherein the second actuator Is movable relative to the main shaft (Figure 1; Paragraph 0045-46; 0051), wherein each of a third articulation wire (222) and a fourth articulation wire (224) is coupled to the second actuator (Paragraph 0041; 0045), and wherein the first articulation wire is in the first lumen, the third articulation wire is in the second lumen, the second articulation wire is in the third lumen, and the fourth articulation wire is in the fourth lumen (Figure 1, 8C; Paragraph 0041).
Kleyman fails to disclose wherein a first joystick actuator coupled to the handle wherein the first joystick actuator is pivotable in any direction from a neutral position of the first joystick actuator wherein the first joystick actuator includes a joystick and a ball, and wherein each of a first articulation wire and a second articulation wire is coupled to the ball and pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending the first articulation shaft.
Cruz teaches a first joystick actuator (310) rotatably coupled to the handle (10), wherein movement of the first joystick actuator bends the first articulation shaft (25) (Figure 28; Paragraph 0227-28), wherein the first joystick actuator is pivotable in any direction from a neutral position of the first joystick actuator (Paragraph 0230) (Cruz discloses “free movement of thumbstick ball assembly 310, thus the joystick is capable of being pivotable in any direction), wherein the first joystick actuator includes a joystick (315) and a ball (345+350) (Figure 28; Paragraph 227), and wherein each of a first articulation wire and a second articulation wire (220) is coupled to the ball (Paragraph 0227).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that the first actuator is a first joystick actuator rotatably coupled to the handle, wherein movement of the first joystick actuator bends the first articulation shaft wherein the first joystick actuator includes a joystick and a ball, and wherein each of a first articulation wire and a second articulation wire is coupled to the ball, as taught by Cruz, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Cruz by incorporating the first actuator is a first joystick actuator rotatably coupled to the handle, wherein movement of the first joystick actuator bends the first articulation shaft wherein the first joystick actuator includes a joystick and a ball, and wherein each of a first articulation wire and a second articulation wire is coupled to the ball in order to articulate the device with a range of different motions and precise control (Cruz Paragraph 0176). Further, the modification would be obvious as a simple substitution of a knob for a joystick, and the results of such a modification would have been obvious, namely replacing one form of an actuator with another to control articulation of a shaft.
Lee is directed to a surgical instrument and teaches pivoting the handle (12) relative to the main shaft (10) bends the second articulation shaft (20) (Figure 2A-C; Paragraph 0054). Since Kleyman’s articulation shafts are configured to bend independently (Kleyman Paragraph 0046), the combination would result in the second articulation shaft bending independently of the first articulation shaft.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending of the first articulation shaft, as taught by Lee, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Lee by incorporating pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending of the first articulation shaft in order to allow the surgeon to manipulate the surgical instrument with greater dexterity (Lee Paragraph 0004) and provide a very precise and ergonomically comfortable degree of control for the surgeon (Lee Paragraph 0058).
Regarding claim 17, Kleyman as modified by Cruz, Lee and Akahoshi discloses the medical device of claim 16, but fails to disclose wherein the handle further comprises a third actuator configured to actuate a tool at a distal portion of the medical device, wherein the third actuator is a trigger on the handle.
However, Cruz teaches wherein the handle (10) further comprises a third actuator (415) configured to actuate a tool (30) at a distal portion of the medical device, wherein the third actuator is a trigger on the handle (Figure 42; Paragraph 0236).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman, as modified by Cruz and Lee, with the teachings of Cruz by incorporating the handle further comprises a third actuator configured to actuate a tool at a distal portion of the medical device, wherein the third actuator is a trigger on the handle in order to actuate a tool since Kleyman states “the surgical articulation apparatus provides for an easy and intuitive way of articulating a distal end of the surgical articulation apparatus through the use of a gimbal structure” (Kleyman Paragraph 0008) and discloses their device would be useful with a surgical instrument “S”, but doesn’t specify the type of instrument or the actuation of said instrument (Kleyman Paragraph 0043-44), thus the modification by including Cruz’s tool and actuation wires would allow a user to perform a surgical task, such as grasping or cutting.
Claims 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Lee, Cruz, as applied to claim 5 above, and further in view of Hassoun (US 20150305797 A1) (previously of record) and Weitzner et al. (US 20080221391 A1) (previously of record).
Regarding claim 6, Kleyman, as modified by Lee and Cruz, discloses the medical device of claim 5, and further discloses: a third articulation wire (214) extending longitudinally through the main shaft and the first articulation shaft and fixedly coupled to the first articulation ring (Figure 8; Paragraph 0040); a fourth articulation wire (236) extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft, wherein the fourth articulation wire is fixedly coupled to the second articulation ring (Figure 8; Paragraph 0040; 0050). Kleyman fails to disclose a tool coupled to a distal portion of the second articulation ring; and a tool actuation wire extending longitudinally through the main shaft, the first articulation shaft, the first articulation ring, the second articulation shaft, and the second articulation ring, wherein the tool actuation wire is configured to actuate the tool when moved proximally or distally and wherein the main shaft includes: an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen; wherein a first articulation wire is positioned between a radially-inward facing surface of the overtube and one of the plurality of curved, convex, radially outer-facing surfaces, wherein the overtube and the plurality of outer-facing surfaces form a plurality of lumens of the main shaft.
However, Hassoun is directed to an articulatable surgical instrument and teaches a tool (142) coupled to a distal end of the second articulation shaft (104) (Paragraph 0029), and a tool actuation wire (108e+108f) extending through the main shaft (102) and the second articulation shaft, wherein the tool actuation wire is configured to actuate the tool when moved proximally or distally (Figure 5A; Paragraph 0050).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman, as modified by Lee and Cruz, such that a tool coupled to a distal portion of the second articulation ring; and a tool actuation wire extending longitudinally through the main shaft, the first articulation shaft, the first articulation ring, the second articulation shaft, and the second articulation ring, wherein the tool actuation wire is configured to actuate the tool when moved proximally or distally (when modified with the shaft the Kleyman, the tool would be coupled to the distal potion of the second articulation ring and the articulation wire would have to extend through the main shaft, the first articulation shaft, the first articulation ring, the second articulation shaft, and the second articulation ring), as taught by Hassoun, as the references and the claimed invention are directed to articulatable surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman, as modified by Lee and Cruz with the teachings of Hassoun by incorporating a tool coupled to a distal portion of the second articulation ring; and a tool actuation wire extending longitudinally through the main shaft, the first articulation shaft, the first articulation ring, the second articulation shaft, and the second articulation ring, wherein the tool actuation wire is configured to actuate the tool when moved proximally or distally since Kleyman states “the surgical articulation apparatus provides for an easy and intuitive way of articulating a distal end of the surgical articulation apparatus through the use of a gimbal structure” (Kleyman Paragraph 0008) and discloses their device would be useful with a surgical instrument “S”, but doesn’t specify the type of instrument or the actuation of said instrument (Kleyman Paragraph 0043-44), thus the modification by including Hassoun’s tool and actuation wires would allow a user to perform a surgical task, such as grasping or cutting tissue.
Further, Weitzner is directed to a surgical instrument and teaches wherein the main shaft includes: an overtube (54) (Figure 4A; Paragraph 0143); and an inner shaft (26+700) positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces (44a, 44b) and a central lumen (42) (Figure 7A; Paragraph 0177; 0182); wherein a first articulation wire (40a) is positioned between a radially-inward facing surface of the overtube and one of the plurality of curved, convex, radially outer-facing surfaces (Figure 4A, 7A; Paragraph 0143; 0179). When combined with the guide lumens 246 of Kleyman, the modification would result in wherein the overtube and the plurality of outer-facing surfaces form a plurality of lumens of the main shaft (Kleyman Paragraph 0041).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman as modified by Lee and Cruz such that wherein the main shaft includes: an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen; wherein a first articulation wire is positioned between a radially-inward facing surface of the overtube and one of the plurality of curved, convex, radially outer-facing surfaces, as taught by Weitzner, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman as modified by Lee and Cruz with the teachings of Weitzner by incorporating wherein the main shaft includes: an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen; wherein a first articulation wire is positioned between a radially-inward facing surface of the overtube and one of the plurality of curved, convex, radially outer-facing surfaces in order to improve lubricity (Weitzner Paragraph 0147) or direct surgical instruments away from one another as they pass through openings and facilitate triangulation (Paragraph 0188).
Regarding claim 8, Kleyman as modified by Lee, Cruz, and Weitzner discloses the medical device of claim 6, but fails to disclose wherein the handle further comprises a third actuator configured to actuate a tool.
However, Cruz teaches a handle (10) comprises an actuator (300) configured to actuate a tool (30) (Figure 42; Paragraph 0236).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Cruz by incorporating the handle further comprises an actuator configured to actuate a tool in order to grasp tissue (Cruz Paragraph 0241).
Regarding claim 10, Kleyman as modified by Lee, Cruz, and Weitzner teaches the medical device of claim 8, and Kleyman further discloses wherein the handle includes wherein the first articulation wire extends through a central lumen (lumen of elongate potion 334) of the ring portion (Figure 7) and wherein the handle pivots about a center of the ring portion to move the second articulation wire (the handle encompasses the ring portion 420 and the ring member is configured to rotate and move the wires, thus the handle pivots about a center to move the wire) (Figure 6; Paragraph 0051).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Lee and Cruz, as applied to claim 1 above and further in view of Weitzner.
Regarding claim 7, Kleyman as modified by Lee and Cruz discloses the medical device of claim 1 but fails to further disclose wherein the main shaft includes an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen, wherein the overtube and the plurality of outer-facing surfaces form a plurality of lumens of the main shaft.
Weitzner is directed to a surgical instrument and teaches wherein the main shaft includes: an overtube (54) (Figure 4A; Paragraph 0143); and an inner shaft (26+700) positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces (44a, 44b) and a central lumen (42) (Figure 7A; Paragraph 0177; 0182). When combined with the guide lumens 246 of Kleyman, the modification would result in wherein the overtube and the plurality of outer-facing surfaces form a plurality of lumens of the main shaft (Kleyman Paragraph 0041).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman as modified by Lee and Cruz such that wherein the main shaft includes: an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen, as taught by Weitzner, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman as modified by Lee and Cruz with the teachings of Weitzner by incorporating wherein the main shaft includes: an overtube; and an inner shaft positioned within the overtube, wherein the inner shaft includes a plurality of curved, convex, radially outer-facing surfaces and a central lumen to improve lubricity (Weitzner Paragraph 0147) or direct surgical instruments away from one another as they pass through openings and facilitate triangulation (Paragraph 0188).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Lee and Cruz as applied to claim 1 above, and further in view of Danitz et al. (US 20040236316 A1) (previously of record).
Regarding claim 11, Kleyman as modified by Lee and Cruz discloses the medical device of claim 7, and further discloses a third articulation wire (214) coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft and the first articulation shaft, wherein the third articulation wire is coupled to the first actuator (Figure 8; Paragraph 0040) and a sixth articulation wire (236) coupled proximate to a distal portion of the second articulation shaft and extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft, wherein the sixth articulation wire is coupled to the second actuator (Figure 8; Paragraph 0041).
Kleyman as modified by Lee and Cruz fails to disclose fourth and fifth articulation wires coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft and the first articulation shaft, wherein the fourth and fifth articulation wires are coupled to the first actuator; and seventh, and eighth articulation wires coupled proximate to a distal portion of the second articulation shaft and extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft, wherein the seventh, and eighth articulation wires are coupled to the handle.
However, Danitz is directed to an articulatable surgical instrument and teaches a first articulation shaft (106) with four articulation wires (104) coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft (100) and the first articulation shaft and the wires are coupled to a first actuator (steering mechanism) (Figure 1A-D; Paragraph 0033; 0050-52) and a second articulation shaft (108) with four articulation wires (104) coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft (100) and the first articulation shaft and the wires are coupled to a handle (steering mechanism) (Figure 1A-D; Paragraph 0033; 0050-52).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman as modified by Lee and Cruz such that fourth and fifth articulation wires coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft and the first articulation shaft, wherein the fourth and fifth articulation wires are coupled to the first actuator; and seventh, and eighth articulation wires coupled proximate to a distal portion of the second articulation shaft and extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft, wherein the seventh, and eighth articulation wires are coupled to the handle, essentially adding two articulation wires to each articulation shaft for a total of four wires, as taught by Danitz, as the references and the claimed invention are directed to articulatable surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman as modified by Lee and Cruz with the teachings of Danitz by incorporating fourth and fifth articulation wires coupled proximate to a distal portion of the first articulation shaft and extending longitudinally through the main shaft and the first articulation shaft, wherein the fourth and fifth articulation wires are coupled to the first actuator; and seventh, and eighth articulation wires coupled proximate to a distal portion of the second articulation shaft and extending longitudinally through the main shaft, the first articulation shaft, and the second articulation shaft, wherein the seventh, and eighth articulation wires are coupled to the handle in order to increase the ability of portions the mechanism to bend in different directions at the same time and create active complex configurations (Danitz Paragraph 0054).
Regarding claim 12, Kleyman as modified by Lee and Cruz and further by Danitz teaches the medical device of claim 11, and Cruz further teaches wherein each of the first, third, fourth, and fifth articulation wires (220) are coupled to the ball (Figure 28, 31; Paragraph 0226-27).
Regarding claim 13, Kleyman as modified by Lee and Cruz and Danitz teaches the medical device of claim 11, and the combination further discloses wherein: the first articulation wire is positioned within a first lumen (246) of the main shaft and the first articulation shaft (Figure 8; Paragraph 0040), the first lumen being directly adjacent to lumens of the main shaft and the first articulation shaft in which the second and sixth articulation wires are positioned; and the fourth articulation wire is positioned within a second lumen (246) of the main shaft and the first articulation shaft, the second lumen being directly adjacent to lumens of the main shaft and the first articulation shaft in which the seventh and eighth articulation wires are positioned (Figure 8; Paragraph 0040).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Lee, Cruz, and Akahoshi (US 20100022826 A1) (previously of record).
Regarding claim 18, Kleyman as modified by Cruz and Lee discloses the medical device of claim 16, wherein the handle is a first handle (Kleyman Figure 1; Paragraph 0044-46) but fail to disclose a first connector configured to fixedly couple to a working channel port of an endoscope at a distal end of the first connector, wherein the first connector is configured to space the first handle from a second handle of the endoscope.
However, Akahoshi further teaches wherein a first connector (44) (Figure 4; Paragraph 0039; 0041), wherein the first connector is configured to fixedly couple to a working channel of an endoscope (45) at a distal end of the first connector (Figure 4; Paragraph 0039), the first connector is configured to space the first handle from a second handle (43) of the endoscope (Figure 4; Paragraph 0038).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kleyman as modified by Lee and Cruz with the teachings of Akahoshi by incorporating a first connector configured to fixedly couple to a working channel port of an endoscope at a distal end of the first connector, wherein the first connector is configured to space the first handle from a second handle of the endoscope, which would allow the user to have a hands-free connection between the device and endoscope and improve visualization of the surgical field, allowing for easy operation. Further, the addition of an endoscope would allow for an improved optical observation means for the user (Akahoshi Paragraph 0045). A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device of Kleyman as modified by Lee and Cruz to include a first connector configured to fixedly couple to a working channel port of an endoscope at a distal end of the first connector, wherein the first connector is configured to space the first handle from a second handle of the endoscope, as taught by Akahoshi, as the references and the claimed invention are directed to surgical instruments, and Kleyman suggests using the device endoscopically (Kleyman Paragraph 0005) (Kleyman discloses a laparoscopic instrument but states “Throughout the present disclosure, the term minimally invasive is to be understood as encompassing both endoscopic and laparoscopic procedures”, thus the device is understood to be used in both endoscopic and laparoscopic procedures).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Cruz, Lee and further in view of Cooper et al. (US 20030036748 A1) (previously of record).
Regarding claim 19, Kleyman discloses a medical device comprising:
a main shaft (200) extending from a proximal end to a distal end (Figure 1; Paragraph 0040);
a first articulation shaft (210) coupled to the distal end of the main shaft (Figure 1; Paragraph 0040-41);
a second articulation shaft (220+230) coupled to a distal end of the first articulation shaft (Figure 1; Paragraph 0040-42);
a handle (300) coupled to the main shaft, the handle comprising a first actuator (310) and a second actuator (330) (Figure 1; Paragraph 0044-46);
wherein the first articulation shaft is configured to bend independent of bending of the second articulation shaft upon actuation of the first actuator (Paragraph 0046); and
wherein the second articulation shaft is configured to bend independent of bending of the first articulation shaft upon actuation of the second actuator (Paragraph 0046);
a first actuator (310) rotatably coupled to the handle, wherein movement of the first actuator bends the first articulation shaft independent of bending the second articulation shaft (Figure 1; Paragraph 0044; 0046); and
a first plurality of articulation wires (212, 214) (Paragraph 0052);
a second actuator (330) coupled to the handle, wherein the second actuator Is rotatable relative to the main shaft (Figure 1; Paragraph 0045-46; 0051), wherein the second actuator includes a second plurality of articulation wires (222, 224) (Paragraph 0052).
Kleyman fails to disclose a first joystick actuator, wherein the first joystick actuator is pivotable in any direction from a neutral position of the first joystick actuator wherein the first joystick actuator includes a ball and a first plurality of articulation wires, wherein the first plurality of articulation wires are coupled to and spaced evenly around the ball; and pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending of the first articulation shaft wherein the second actuator includes a ring and a second plurality of articulation wires, wherein the second plurality of articulation wires are coupled to and spaced evenly around a surface of the ring that defines a central lumen of the ring, and wherein the first plurality of articulation wires are disposed through the central lumen of the ring and a third actuator configured to actuate a tool at a distal portion of the medical device, wherein the third actuator is a trigger on the handle.
However, Cruz teaches a first joystick actuator (310) rotatably coupled to the handle (10), wherein movement of the first joystick actuator bends the first articulation shaft (25) (Figure 28; Paragraph 0227-28), wherein the first joystick actuator is pivotable in any direction from a neutral position of the first joystick actuator (Paragraph 0230), wherein the first joystick actuator includes a ball (345+355) wherein the first plurality of articulation wires (220) are coupled to and spaced evenly around the ball (Cruz discloses “free movement of thumbstick ball assembly 310, thus the joystick is capable of being pivotable in any direction) and wherein the handle (10) further comprises a third actuator (415) configured to actuate a tool (30) at a distal portion of the medical device, wherein the third actuator is a trigger on the handle (Figure 42; Paragraph 0226; 0236).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that the first actuator is a first joystick actuator rotatably coupled to the handle, wherein movement of the first joystick actuator bends the first articulation shaft, as taught by Cruz, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Cruz by incorporating the first actuator is a first joystick actuator rotatably coupled to the handle, wherein movement of the first joystick actuator bends the first articulation shaft in order to articulate the device with a range of different motions and precise control (Cruz Paragraph 0176). Further, the modification would be obvious as a simple substitution of a knob for a joystick, and the results of such a modification would have been obvious, namely replacing one form of an actuator with another to control articulation of a shaft. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman, as modified by Cruz and Lee, with the teachings of Cruz by incorporating the handle further comprises a third actuator configured to actuate a tool at a distal portion of the medical device, wherein the third actuator is a trigger on the handle in order to actuate a tool since Kleyman states “the surgical articulation apparatus provides for an easy and intuitive way of articulating a distal end of the surgical articulation apparatus through the use of a gimbal structure” (Kleyman Paragraph 0008) and discloses their device would be useful with a surgical instrument “S”, but doesn’t specify the type of instrument or the actuation of said instrument (Kleyman Paragraph 0043-44), thus the modification by including Cruz’s tool and actuation wires would allow a user to perform a surgical task, such as grasping or cutting.
Further, Lee is directed to a surgical instrument and teaches pivoting the handle (12) relative to the main shaft (10) bends the second articulation shaft (20) (Figure 2A-C; Paragraph 0054). Since Kleyman’s articulation shafts are configured to bend independently (Kleyman Paragraph 0046), the combination would result in the second articulation shaft bending independently of the first articulation shaft.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman such that pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending of the first articulation shaft, as taught by Lee, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman with the teachings of Lee by incorporating pivoting the handle relative to the main shaft bends the second articulation shaft independent of bending of the first articulation shaft in order to allow the surgeon to manipulate the surgical instrument with greater dexterity (Lee Paragraph 0004) and provide a very precise and ergonomically comfortable degree of control for the surgeon (Lee Paragraph 0058).
Furthermore, Cooper is directed to a surgical device and teaches wherein the second actuator (700) includes a ring (706+710) (Figure 59-63; Paragraph , wherein the second plurality of articulation wires (650A) are coupled to and spaced evenly around a surface of the ring (through apertures 714) that defines a central lumen (central lumen of 710) of the ring (Figure 59, 62; Paragraph 0171), and wherein the first plurality of articulation wires (650B) are disposed through the central lumen of the ring (Figure 63; Paragraph 0173).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman as modified by Cruz and Lee such that wherein the second actuator includes a ring and a second plurality of articulation wires, wherein the second plurality of articulation wires are coupled to and spaced evenly around a surface of the ring that defines a central lumen of the ring, and wherein the first plurality of articulation wires are disposed through the central lumen of the ring, as taught by Cooper, as the references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman as modified by Cruz and Lee with the teachings of Cooper by incorporating wherein the second actuator includes a ring and a second plurality of articulation wires, wherein the second plurality of articulation wires are coupled to and spaced evenly around a surface of the ring that defines a central lumen of the ring, and wherein the first plurality of articulation wires are disposed through the central lumen of the ring in order to selectively lock or actuate movement of the wires (Cooper Paragraph 0171).
Regarding claim 21, Kleyman, as modified by Cruz, Lee and Cooper teach the medical device of claim 19, but fails to explicitly disclose a distal connector including a central lumen configured to receive the main shaft, wherein the distal connector is configured to (i) couple to a working channel of a medical device at a distal end of the distal connector and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector at the second actuator.
However, Lee teaches a distal connector (26) including a central lumen configured to receive the main shaft (Figure 19; Paragraph 0052), wherein the distal connector is configured to (i) couple to a working channel of an endoscope at a distal end of the distal connector (the language “configured to couple to a working channel is functional language, and if the instrument is placed in the working channel of an endoscope, cover 26 would serve to couple the channel as it abuts from the shaft of the instrument. Thus, the distal connector is fully capable of performing such a function, thus it reads on the limitation.) (Figure 8; Paragraph 0057) and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector at the ring (Figure 2A-C; Paragraph 0054).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman, as modified by Cruz, Lee and Cooper with the teachings of Lee by incorporating a distal connector including a central lumen configured to receive the main shaft, wherein the distal connector is configured to (i) couple to a working channel of a medical device at a distal end of the distal connector and (ii) pivotably couple to the handle at a proximal end of the distal connector such that the handle is configured to pivot relative to the distal connector at the second actuator, as the references and the claimed invention are directed to surgical instruments, and Kleyman suggests using the device endoscopically (Kleyman Paragraph 0005) (Kleyman discloses a laparoscopic instrument but states “Throughout the present disclosure, the term minimally invasive is to be understood as encompassing both endoscopic and laparoscopic procedures”, thus the device is understood to be used in both endoscopic and laparoscopic procedures)..
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kleyman in view of Cruz, Lee and Cooper and further in view of Hinman (US 20060111210 A1) (previously of record).
Regarding claim 20, Kleyman as modified by Cruz, Lee and Cooper teaches the medical device of claim 19, and Kleyman further teaches wherein the first articulation shaft includes: a first plurality of links (240), wherein each link of the first plurality of links is cylindrical (Figure 8; Paragraph 0041); and a first plurality of lumens (246) extending through each of the first plurality of links (Figure 8; Paragraph 0041); wherein the second articulation shaft includes: a second plurality of links (250), wherein each link of the second plurality of links is cylindrical (Figure 8; Paragraph 0042) a second plurality of lumens (256) extending through each link of the second plurality of links (Figure 8; Paragraph 0042) and wherein the first articulation shaft includes at least one more lumen than the second articulation shaft (Figure 8A-C; Paragraph 0041-42) (Kleyman states “Flexible links 240 also include guide lumens 246 for the reception of cables 212, 214, 222 and 224 therethrough”, thus disclosing four lumens, and states “Articulating links 250 include lumens 256 which are substantially aligned with channels 270 for the reception of cables 232 and 236 therethrough”, thus disclosing two lumens).
Kleyman fails to explicitly disclose wherein each link of the first plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end; and wherein each link of the second plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end wherein each spherical cavity of the first plurality of links is configured to receive a curved distal end of an immediately adjacent, more-proximal link of the first plurality of links or the second plurality of links.
However, Hinman is directed to a surgical device and teaches wherein each link (1000) of a plurality of links includes (i) a curved distal end (1002) and (ii) a spherical cavity (1004) at its proximal end (depending on the orientation of the link chain, the orientation of the proximal end and distal end can be as such that the distal end of each link is curved and the proximal end of each link has a spherical cavity) (Figure 17A-C; Paragraph 0153).; wherein each spherical cavity of the first plurality of links is configured to receive a curved distal end (1002) of an immediately adjacent, more-proximal link of the first plurality of links or the second plurality of links (Figure 17A-C; Paragraph 0153).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Kleyman, Cruz, Lee, and Cooper such that each link of the first plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end; and wherein each link of the second plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end, as taught by Hinman, as the references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kleyman, Cruz, Lee and Cooper with the teachings of Hinman by incorporating each link of the first plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end; and wherein each link of the second plurality of links includes (i) a curved distal end and (ii) a spherical cavity at its proximal end in order to allow the links to have increased pivotability and range of motion (Hinman Paragraph 0156), improving dexterity of the device.
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.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771