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
This office action is responsive to the amendment filed on 12/05/2025. As directed by the amendment: claims 16-18, 20-21, 27-31, 33, and 35 have been amended, claims 1-15 and 32 have been cancelled and claims 19,22-26 and 34 remain withdrawn. Thus, claims 16-31 and 33-35 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 7-14, filed 12/05/2025 with respect to the rejections of claim 16, 28, and 31 under 35 U.S.C. 103 as being unpatentable over Martinez in view of Raschdorf and Okada et al (US 20050261711 A1), herein referenced to as “Okada” have been fully considered but they are not persuasive.
The applicant argues that Martinez does not disclose “a flexible insertion device” as the elongated catheter 24 that the examiner directs to does not explicitly disclose the word “flexible”. The examiner respectfully disagrees.
It is well known in the field of invention that catheters are flexible elongate members. Furthermore, according to the online Medical Dictionary the definition of catheter is “a tubular, flexible instrument, passed through body channels for withdrawal of fluid from (or introduction of fluid into) a body cavity”.
The applicant furthermore argues that Martinez does not disclose that the drive wire is coupled to an actuator or a physical actuator. The examiner respectfully disagrees.
Martinez in [0036] disclose that a force can be transmitted to the drive wire 22 and that furthermore, this force is administered through a control handle (see [0050] of Martinez, hence a force enacted through the control handle coupled to the drive is the actuator).
The applicant argues that the control wire as claimed is not analogous to the drive wire 22 in Martinez as it does not include a bend. They argue that the bend in the drive wire in the variant embodiment of Martinez does not cause the insertion section to bend. The examiner respectfully disagrees.
The examiner will not that Martinez is not relied upon the teach: the bend in the distal portion of the control wire being configured to cause the insertion section to bend through a predetermined arc at a selected bending radius when the insertion section is in a resting state. Instead Raschdorf was relied upon this.
The applicant argues that the element 1020 of Raschdorf does not equate to the claimed control wire, as a guide catheter does not preform the functions of the claimed control wire. The examiner respectfully disagrees.
It is known within the field of art that a control wire does not specifically be disclosed as a “control wire”, as noted in Martinez (see [0036], Although the term “wire” is used to refer to the drive wire 22, it will be recognized that any elongate control member capable of transmitting longitudinal force over a distance (such as is required in typical endoscopic, laparoscopic and similar procedures) may be used, and this includes plastic rods or tubes, single filament or multi-filament wires, metal rods and the like). Hence, 1020 of Raschdorf equates a “control wire”.
The applicant further argues that element 1000 + 1016 of Raschdorf does not equate the flexible insertion section because it does not have a proximal end which during use remains outside the body. The examiner respectfully disagrees.
Raschdorf explicitly teaches that 1014, the proximal end of 1000 remains outside the patient’s body during use in [0228].
The applicant additionally argues that Raschdorf does not teach “the bend in the distal portion of the control wire being configured to cause the insertion section to bend through a predetermined arc at a selected bending radius when the insertion section is in a resting state”. They argue that Raschdorf that 1000 and 1020 have separate mechanisms to bend, arc, or reshape. They argue that the planes which the primary curve 1100 and the secondary curve 1104 lie may be mutually dependent does not mean that the secondary curve affects the primary curve. The examiner respectfully disagrees.
Raschdorf explicitly teaches: see [0227], precurved/precurvature of 1020 creates a secondary curve, together the primary and secondary curves form a compound curve, hence the secondary curve affects the primary curve, see also [0234], the primary curve and the secondary curve are mutually dependent). A mutually dependent curvature means that one curve affects the other and vice versa. When 1020 is curved in a certain way, this affects the angle at which 1000 can bend in the same plane, hence causing it bend through a predetermined arc.
The applicant makes similar arguments in regards to claims 28 and 31.
The examiner respectfully disagrees for the same reasons. As such the rejections of the claims will be maintained.
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.
Claim(s) 16-18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez et al (US 20160220260 A1), herein referenced to as “Martinez” in view of Raschdorf et al (US 20090163934 A1), herein referenced to as “Raschdorf”.
Claim 16
Martinez discloses: A device 20 (see Figs. 1-16, [0035]) for treating tissue T (see Figs. 11-12, [0035]), comprising: a flexible insertion section 24 (see Figs. 1-2, [0035]) extending from a distal end 23 (see Figs. 1-2, [0035]) which, during use is inserted to a target site within a living body (see [0035]-[0036], the catheter is inserted into a body, as typical in endoscopic procedures) to a proximal end the proximal end of the catheter 24 which is connected to the medical system (see [0035]-[0037]) which, during use remains outside the body (a proximal end of the a catheter in typical endoscopic procedures is outside of the body, see [0035]); an end effector 40 (see Figs. 1-4, [0035]) coupled to the distal end 23 of the flexible insertion section 24; and a control wire 22 (see Figs. 1-16, [0035]-[0036], wire is noted to be interchangeable with tubes or multi-filament wires) including a distal end 32 (see Figs. 1-16, [0037]) coupled to the end effector 40 (see Figs. 1-4, [0037]), the control wire 22 received within the flexible insertion section 24 (see Figs. 1-4, [0036], 22 slidably extends through 24) and extending from a proximal end the proximal end (see [0036], a rotational/transitional force from the proximal end to the distal end) coupled to an actuator (see [0036], transmitting a rotational/transitional force, the force being the actuator, [0050], control handle) so that operation of the actuator (see [0036] and [0050]) moves the control wire (see [0036], slidably) relative to the flexible insertion section 14 to operate the end effector (see [0036], to rotate the medical device and jaws), a distal portion a distal portion of 22 of the control wire 22 being configured to pass into and through a working channel working channel (see [0035]) of a flexible endoscope an endoscope (see [0035]) without plastic deformation (see [0036], the drive wire 22 is made of nitinol, which is a superelastic material, which can be set to a shape that it will change back to) of the control wire 22.
Martinez does not explicitly disclose: the control wire including a bend in the distal portion thereof, the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state.
However, a variant embodiment of Martinez (Figs. 19-21) in the same field of invention teaches a device (see Figs. 19-21) with a control wire 122 (see Figs. 19-21) with a distal portion 132 (see Figs. 19-21). Martinez further teaches: the control wire 122 including a bend semicircular shape (see Figs. 20-21, [0053]) in the distal portion 132 thereof.
The substitution for one known element (the ball-like distal portion as shown in Figs. 1-16 of Martinez) for another (hook-like distal portion as shown in Figs. 19-21 of Martinez) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of hook-like distal portion shown in the variant embodiment (Figs. 19-21) of Martinez would have yielded predictable results, namely, allowing for a simpler disengagement as there is a relatively flat point of contact with the hook-like distal portion whereas the ball-like portion has a circular point of contact. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Martinez does not explicitly teach: the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state.
However, Raschdorf in a similar field of invention teaches a device for treating tissues (see Figs. 61A-61B, [0020], a system for delving an implantable fixation device) with a flexible insertion section 1016 (see Figs. 61A-61B) and a control tube 1020 (see Fig. 61B) with a bend 1104 (see Fig. 61B) in a distal portion 1104 is a distal portion of 1020 (see Fig. 61B). Raschdorf further teaches: the bend 1104 in the distal portion 1104 is a distal portion of 1020 of the control wire 1020 being configured to cause the flexible insertion section 1016 to bend through a predetermined arc (see [0227], precurved/precurvature of 1020 creates a secondary curve, together the primary and secondary curves form a compound curve, hence the secondary curve affects the primary curve, see also [0234], the primary curve and the secondary curve are mutually dependent) at a selected bending radius when the flexible insertion section 1016 is in a resting state (see [0227], precurved).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martinez to incorporate the teachings of Raschdorf and teach a device for treating tissue with the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state. Motivation for such can be found in Raschdorf as this allows the creation of a compound curve toward a desired direction to allow interventional navigation of vasculature (see [0226]-[0227]).
Claim 17
The combination of Martinez and Raschdorf teaches: The device of claim 16, see 103 rejection above. Martinez further discloses: wherein the flexible insertion section 24 includes a bushing 26 + 28 (see Figs. 1-4, [0036]-[0037], per the online Merriam-Webster dictionary a bushing is “a usually removable cylindrical lining for an opening (as of a mechanical part) used to limit the size of the opening, resist abrasion, or serve as a guide”, in this case a bore meets the definition of a cylindrical lining to limit the size of the opening of 40 for 22) at a distal end distal end of 26 is connected to 40 (see Figs. 1-2) of which is coupled to the end effector 40, the end effector 40 being a tissue clipping device (see [0035], engaging tissue, see also Figs. 11-12).
Claim 18
The combination of Martinez and Raschdorf teaches: The device of claim 17, see 103 rejection above. Martinez further teaches: wherein the tissue clipping device 40 includes a slidable element 48 (see Figs. 1-16, [0038]-[0039], longitudinal translation of the driver) coupled to the distal end 32 of the control wire 22, the slidable element 48 being coupled to tissue gripping arms 44 + 46 (see Figs. 1-16, [0039]) of the tissue clipping device 40 so that, as the control wire 22 is moved proximally and distally (see [0043]) within the flexible insertion section 24, the slidable element 48 slides proximally and distally (see [0043], translated distally) within a capsule 42 (see Figs. 1-16, [0043]-[0044]) of the tissue clipping device 40 to move the arms into and out (see Figs. 10-11) of the capsule 42.
Claim 20
The combination of Martinez and Raschdorf teaches: The device of claim 16, see 103 rejection above. Raschdorf further teaches: wherein the bend 1104 in the control wire 1020 is configured so that, in the resting state, the flexible insertion section 1016 bends through an arc 1100 of approximately 90 degrees (see [0231]-[0234], the angles can be within ranges of 180 to -180 degrees, which includes 90 degrees).
Claim 21
The combination of Martinez and Raschdorf teaches: The device of claim 16, see 103 rejection above. Raschdorf further teaches: wherein the bend 1104 in the control wire 1020 is configured so that, in the resting state, the flexible insertion section 1016 bends through an arc 1100 of approximately 45 degrees (see [0231]-[0234], the angles can be within ranges of 180 to -180 degrees, which includes 45 degrees).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez in view of Raschdorf as applied to claim 16 above, and further in view of Brennen et al (US 5439006 A), herein referenced to as “Brennen”.
Claim 27
The combination of Martinez and Raschdorf teaches: The device of claim 16, see 103 rejection above.
The combination of Martinez and Raschdorf does not explicitly teach: a first hole at a proximal end of the bend; a second hole at a proximal end of the end effector; and an actuation cord, extending from a proximal end coupled to the actuator that remains accessible to a user during use to a distal end coupled to the end effector, wherein the cord passes through the flexible insertion section, exits the first hole, enters the second hole, and couples to a portion of the device distal of the bend.
Brennen teaches a device for treating tissue (1, fig. 1) having a first hole (18, fig. 1) at a proximal end of the bend (fig. 1); a second hole (20, fig. 1) at a proximal end of (fig. 1) the end effector (22, fig. 1); and an actuation cord (12, fig. 1), extending from a proximal end (14, fig. 1) coupled to the actuator (34, fig. 1) that remains accessible to a user during use (fig. 2, 3, col. 6, lines 53-62) to a distal end (16, fig. 1) coupled to the end effector (22, fig. 1), wherein the cord passes through the flexible insertion section (10, fig. 1), exits the first hole (18, fig. 1), enters the second hole (20, fig. 1), and couples to a portion of the device distal of the bend (fig. 1, col. 6, lines 40-47).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination device of Martinez and Raschdorf with Brennen and have a device with the first and second holes and actuation cord in order to impart a dynamic curvature of desired radius on the distal end of the device (abstract).
Claim(s) 28-29, 31, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martinez in view of Raschdorf and Okada et al (US 20050261711 A1), herein referenced to as “Okada”.
Claim 28
Martinez discloses: A system 20 + endoscope (see Figs. 1-16, [0035]) for clipping tissues, comprising: an insertion device endoscope (see [0035]), the insertion device endoscope including a port a distal opening of the working channel (see [0035], as it is known in the art a working channel of a endoscope has a port at its distal end) and a working channel working channel (see [0035]) extending therethrough along a longitudinal axis the longitudinal axis of the endoscope; and a tissue treating device 20 (see Figs. 1-16, [0035]), comprising: a flexible insertion section 24 (see Figs. 1-2, [0035]) extending from a distal end 23 (see Figs. 1-2, [0035]) which, during use is inserted to a target site within a living body (see [0035]-[0036], the catheter is inserted into a body, as typical in endoscopic procedures) to a proximal end the proximal end of the catheter 24 which is connected to the medical system (see [0035]-[0037]) which, during use remains outside the body (a proximal end of the a catheter in typical endoscopic procedures is outside of the body, see [0035]); a hemostatic clip 40 (see Figs. 1-4, [0035], hemostasis) configured to be releasably coupled (see Fig. 16, 42 which is part of 40, detaches, see also [0008] and [0049]) to the distal end 23 of the flexible insertion section 24; and a control wire 22 (see Figs. 1-16, [0035]-[0036], wire is noted to be interchangeable with tubes or multi-filament wires), the control wire received within the insertion 24 (see Figs. 1-4, [0036], 22 slidably extends through 24) and extending from a proximal end the proximal end (see [0036], a rotational/transitional force from the proximal end to the distal end) coupled to an actuator (see [0036], transmitting a rotational/transitional force, the force being the actuator, [0050], control handle) to a distal end 32 (see Figs. 1-16, [0037]-[0038]) coupled to the hemostatic clip 40 so that operation of the actuator (see [0036] and [0043]-[0044]) moves the control wire 22 relative to the flexible insertion section 24 to control operation of the hemostatic clip 40 (see [0043]-[0044]) and separation (see Fig. 16, [0049]) of the hemostatic clip 40 from the flexible insertion section 24, a distal portion a distal portion of 22 of the control wire 22 being configured to pass into and through a working channel working channel (see [0035]) of the insertion device an endoscope (see [0035]) without plastic deformation (see [0036], the drive wire 22 is made of nitinol, which is a superelastic material, which can be set to a shape that it will change back to) of the control wire 22.
Martinez does not explicitly disclose: a camera; the control wire including a bend in the distal portion thereof, the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state.
However, a variant embodiment of Martinez (Figs. 19-21) in the same field of invention teaches a device (see Figs. 19-21) with a control wire 122 (see Figs. 19-21) with a distal portion 132 (see Figs. 19-21). Martinez further teaches: the control wire 122 including a bend semicircular shape (see Figs. 20-21, [0053]) in the distal portion 132 thereof.
The substitution for one known element (the ball-like distal portion as shown in Figs. 1-16 of Martinez) for another (hook-like distal portion as shown in Figs. 19-21 of Martinez) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of hook-like distal portion shown in the variant embodiment (Figs. 19-21) of Martinez would have yielded predictable results, namely, allowing for a simpler disengagement as there is a relatively flat point of contact with the hook-like distal portion whereas the ball-like portion has a circular point of contact. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Martinez does not explicitly teach: a camera; the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state.
However, Raschdorf in a similar field of invention teaches a device for treating tissues (see Figs. 61A-61B, [0020], a system for delving an implantable fixation device) with a flexible insertion section 1016 (see Figs. 61A-61B) and a control tube 1020 (see Fig. 61B) with a bend 1104 (see Fig. 61B) in a distal portion 1104 is a distal portion of 1020 (see Fig. 61B). Raschdorf further teaches: the bend 1104 in the distal portion 1104 is a distal portion of 1020 of the control wire 1020 being configured to cause the flexible insertion section 1016 to bend through a predetermined arc (see [0227], precurved/precurvature of 1020 creates a secondary curve, together the primary and secondary curves form a compound curve, hence the secondary curve affects the primary curve, see also [0234], the primary curve and the secondary curve are mutually dependent) at a selected bending radius when the flexible insertion section 1016 is in a resting state (see [0227], precurved).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martinez to incorporate the teachings of Raschdorf and teach a device for treating tissue with the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state. Motivation for such can be found in Raschdorf as this allows the creation of a compound curve toward a desired direction to allow interventional navigation of vasculature (see [0226]-[0227]).
The combination of Martinez and Raschdorf does not explicitly teach: a camera.
However, Okada in a similar field of invention teaches a device for treating tissue (22, fig. 3a) having an insertion device (25, fig. 3a) including a port (46, fig. 3a) and a camera (26, fig. 3a).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Martinez with a port in order to allow the end effector to project out of the flexible insertion section to a desired surgical site (para. 0087), and with a camera in order to observe the surgical site (para. 0010).
Claim 29
The combination of Martinez, Raschdorf, and Okada teaches: the system of claim 28, see 103 rejection above. Okada further teaches: further comprising an elevator 38 (see Fig. 3A, [0087]) at a distal end 36 (see Fig. 3A, [0081]) of the insertion device 25.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martinez to incorporate the teachings of Okada and teach a system for clipping tissue with an elevator at a distal end of the insertion device. Motivation for such can be found in Okada as this allows further adjustment of the direction of the clip application device (see [0081]).
The combination of Martinez and Okada further teaches: that changes the bend (the elevator changes the bend of flexible insertion section, which is similar to 34 of Okada, and the control wire within that flexible insertion section) of each of the control wire 22 and the flexible insertion section 24.
Claim 31
Martinez discloses: A method for treating tissue (see Figs. 1-16, [0035] and [0043]-[0049]), comprising: inserting into a working channel working channel (see [0035], structured for operation through the working channel of an endoscope) of an insertion device an endoscope (see [0035]) a flexible insertion section 24 (see Figs. 1-2, [0035]) extending from a distal end 23 (see Figs. 1-2, [0035]) which, during use is inserted to a target site within a living body (see [0035]-[0036], the catheter is inserted into a body, as typical in endoscopic procedures) to a proximal end the proximal end of the catheter 24 which is connected to the medical system (see [0035]-[0037]) which, during use remains outside the body (a proximal end of the a catheter in typical endoscopic procedures is outside of the body, see [0035]); inserting the insertion device an endoscope to a target location in the body (see [0002], introduced into a body cavity through an endoscope,[0050], body); and moving a control wire 22 (see Figs. 1-16, [0035]-[0036], wire is noted to be interchangeable with tubes or multi-filament wires) slidably received within the flexible insertion section 24 (see Figs. 1-4, [0036], 22 slidably extends through 24) to operate a hemostatic clip 40 (see Figs. 1-4, [0035]) and to separate the hemostatic clip (see Fig. 16, 42 which is part of 40, detaches, see also [0008] and [0049]) from the flexible insertion section 24.
Martinez does not explicitly disclose: and advancing the flexible insertion section through the working channel of the insertion device until the hemostatic clip releasably coupled to the distal end of the flexible insertion section exits the insertion device via a port, the working channel of the insertion device extending substantially parallel to a longitudinal axis of the insertion device and the port extending substantially transverse to the longitudinal axis; wherein the control wire including a bend in the distal portion thereof, the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through an arc, when the flexible insertion section is in a resting state, the arc substantially corresponding to an arc of a transition from the working channel to the port.
However, a variant embodiment of Martinez (Figs. 19-21) in the same field of invention teaches a device (see Figs. 19-21) with a control wire 122 (see Figs. 19-21) with a distal portion 132 (see Figs. 19-21). Martinez further teaches: the control wire 122 including a bend semicircular shape (see Figs. 20-21, [0053]) in the distal portion 132 thereof.
The substitution for one known element (the ball-like distal portion as shown in Figs. 1-16 of Martinez) for another (hook-like distal portion as shown in Figs. 19-21 of Martinez) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of hook-like distal portion shown in the variant embodiment (Figs. 19-21) of Martinez would have yielded predictable results, namely, allowing for a simpler disengagement as there is a relatively flat point of contact with the hook-like distal portion whereas the ball-like portion has a circular point of contact. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Martinez does not explicitly teach: and advancing the flexible insertion section through the working channel of the insertion device until the hemostatic clip releasably coupled to the distal end of the flexible insertion section exits the insertion device via a port, the working channel of the insertion device extending substantially parallel to a longitudinal axis of the insertion device and the port extending substantially transverse to the longitudinal axis, the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through an arc, when the flexible insertion section is in a resting state, the arc substantially corresponding to an arc of a transition from the working channel to the port.
However, Raschdorf in a similar field of invention teaches a device for treating tissues (see Figs. 61A-61B, [0020], a system for delving an implantable fixation device) with a flexible insertion section 1016 (see Figs. 61A-61B) and a control tube 1020 (see Fig. 61B) with a bend 1104 (see Fig. 61B) in a distal portion 1104 is a distal portion of 1020 (see Fig. 61B). Raschdorf further teaches: the bend 1104 in the distal portion 1104 is a distal portion of 1020 of the control wire 1020 being configured to cause the flexible insertion section 1016 to bend through a predetermined arc (see [0227], precurved/precurvature of 1020 creates a secondary curve, together the primary and secondary curves form a compound curve, hence the secondary curve affects the primary curve, see also [0234], the primary curve and the secondary curve are mutually dependent) at a selected bending radius when the flexible insertion section 1016 is in a resting state (see [0227], precurved).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Martinez to incorporate the teachings of Raschdorf and teach a device for treating tissue with the bend in the distal portion of the control wire being configured to cause the flexible insertion section to bend through a predetermined arc at a selected bending radius when the flexible insertion section is in a resting state. Motivation for such can be found in Raschdorf as this allows the creation of a compound curve toward a desired direction to allow interventional navigation of vasculature (see [0226]-[0227]).
The combination of Martinez and Raschdorf does not explicitly disclose: and advancing the flexible insertion section through the working channel of the insertion device until the hemostatic clip releasably coupled to the distal end of the flexible insertion section exits the insertion device via a port, the working channel of the insertion device extending substantially parallel to a longitudinal axis of the insertion device and the port extending substantially transverse to the longitudinal axis, the arc substantially corresponding to an arc of a transition from the working channel to the port.
Okada teaches a device for treating tissue (22, fig. 3a) wherein advancing the flexible insertion section (34, fig. 3a) through the working channel (36, fig. 3a) of the insertion device (25, fig. 3a) until the hemostatic clip (40, fig. 3a) releasably coupled (see Fig. 4b) to a distal end of the flexible insertion section (34, fig. 3a) exits the insertion device (25, fig. 3a) via a port (46, fig. 3a), the port (46, fig. 3a) extending substantially transverse (fig. 3a) to the longitudinal axis (fig. 3a), and the arc substantially corresponding to an arc of a transition from the working channel (36, fig. 3a) to the port (46, fig. 3a).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Martinez with the method of Okada in order to insert the end effector through the insertion portion to a desired area and axis in the patient’s body (para. 0081, 0087).
Claim 33
The combination of Martinez, Raschdorf, and Okada teaches: the method of claim 31, see 103 rejection above. Okada further teaches: positioning and orienting (para. 0087) the flexible insertion section (34, fig. 3a) so that the distal portion (fig. 3a) of the flexible insertion section (34, fig. 3a) is substantially in the resting state as the hemostatic clip (40, figs. 3a-4b) passes out of the port (46, fig. 3a). (Examiner notes that it is well- known in the art that the distal portion of the flexible insertion section would be in the resting state when the tissue clipping device passes out of the port to yield the predictable result of the tissue clipping device being directed safely and effectively to the desired surgical site).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen in view of Raschdorf and Okada and further in view of Remiszewski et al (US 20070282358 A1), herein referred to as “Remiszewski”.
Claim 30
The combination of Martinez, Raschdorf, and Okada teaches: the system of claim 28, see 103 rejection above. The combination of Martinez, Raschdorf, and Okada fails to teach: wherein the camera of the insertion device is aimed transverse to the longitudinal axis of the insertion device, producing a viewing area in a generally conic volume extending radially away from the longitudinal axis.
Remiszewski teaches a medical instrument (fig. 2a) wherein the camera (123, fig. 2a) of the insertion device (112, fig. 2a) is aimed transverse to the longitudinal axis (fig. 2a) of the insertion device (112, fig. 2a), producing a viewing area in a generally conic volume extending radially away from the longitudinal axis (124, fig. 2a).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the camera of Jorgensen in view of Okada with the camera of Remiszewski in order for the user to view any of the desired angles captured by the camera (para. 0071).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen in view of Raschdorf and Okada, and further in view of Brennen.
Claim 35
The combination of Martinez, Raschdorf, and Okada teaches: the method of claim 31, see 103 rejection above. The combination of Martinez, Raschdorf, and Okada fails to teach: wherein the flexible insertion section includes an actuation cord, extending from a proximal end to a distal end, passing through the flexible insertion section, exiting a first hole at a proximal end of the bend, entering a second hole at a proximal end of the hemostatic clip, and coupling to the hemostatic clip, further comprising pulling on the proximal end of the actuation cord until the actuation cord bends the hemostatic clip into a desired shape.
Brennen teaches a device for treating tissue (1, fig. 1) wherein the flexible insertion section (10, fig. 1) includes an actuation cord (12, fig. 1), extending from a proximal end to a distal end (fig. 1), passing through the flexible insertion section (10, fig. 1), exiting a first hole (18, fig. 1) ata proximal end of the bend (fig. 1), entering a second hole (20, fig. 1) at a proximal end (fig. 1) of the tissue clipping device (col. 6, lines 40-47), and coupling to the tissue clipping device (22, fig. 1), further comprising pulling on (col. 6, lines 34-37) the proximal end of the actuation cord (12, fig. 1) until the actuation cord (12, fig. 1) bends the tissue clipping device into a desired shape (col. 6, lines 40-47). (Examiner notes that the end effector of Jorgensen in view of Okada is a tissue clipping device. Therefore, the teachings of Brennen would be modifying the tissue clipping device of Jorgensen in view of Okada).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jorgensen in view of Okada with the method of Brennen in order to impart a dynamic curvature of desired radius on the distal end of the device (abstract).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771