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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-8, 10, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US Patent Pub. 20040044350 note this reference was previously cited) in view of Schultz (US Patent Pub. 20100168827 hereinafter “Schultz”), Ohline et al. (US Patent Pub. 20030045778 hereinafter “Ohline”), Whayne et al. (US Patent 6071279 hereinafter “Whayne”) and Roberts et al. (US Patent Pub. 20120259244 hereinafter “Roberts”).
Regarding Claim 1, Martin teaches (Figs 1-3) a delivery system (10) configured for delivery of an interventional device in an intravascular procedure (see [0035]), the delivery system comprising:
a handle (20) having one or more controls (22,24,26);
a delivery catheter (11) having a proximal end (12) and a distal end (15), the proximal end being coupled to the handle (see [0059]), the delivery catheter having a proximal section and a distal section (see annotated Fig 1),
wherein at least the distal section is configured to selectively form a compound curve (see [0034]; 40, 46) to enable positioning of the distal end relative to a targeted intravascular treatment site (see [0035] teaching treatment site to be the atrium), the compound curve includes a first curve (40) formable at a proximal portion of the distal section (see Fig 2A) and a second curve (46) formable at a distal portion of the distal section (See Fig 2B),
wherein the second curve is configured to be bendable to an angle of about 10 to about 50 degrees (see [0062] teaching the range of angle theta);
one or more control lines (80, 120,124; see [0081-0082]) each operatively coupled to a control of the handle (see [0059] teaching the actuators in handle 20 actuate pull wires) and each extending from the handle through a wall lumen (82) of the delivery catheter toward the distal end;
a distal coupler (Fig 11B, 126; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 126 in Fig 11B provided in the delivery catheter in Fig. 1-3 would assist with that curvature) disposed at or near the distal end of the delivery catheter and distal of the handle (20), the one or more control lines (124) extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve (see [0082]); and
an intermediate coupler (Fig 11B, 122; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 122 in Fig 11B would assist with that curvature) disposed at the distal section at a location proximal of the distal coupler (126) and distal of the handle (20), the intermediate coupler (122) cooperating with one or more intermediate control lines (120) each operatively coupled to a control of the handle (see [0059] teaching the actuators in handle 20 actuate pull wires).
Martin does not teach an inlet configured to allow an interventional device to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle, the proximal end of the handle forming a terminal proximal end of the delivery system. Martin does teach [0058] that a central lumen (16) is sized for passage of an interventional device therethrough.
Schultz teaches (fig 1 and [0038]) a handle (16) with an inlet (30) configured to allow an interventional device (20) to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle (See Fig 1, inlet 30 is on proximal end of handle 16), the proximal end of the handle forming a terminal proximal end of the delivery system (See Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle of Martin such that it includes an inlet configured to allow an interventional device to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle, the proximal end of the handle forming a terminal proximal end of the delivery system as taught by Schultz. One of ordinary skill in the art would have recognized this is an alternative design to allow for interventional devices to pass through the access sheath.
Martin does not teach two or more control lines each operatively coupled to the one or more controls of the handle and each of the two or more control lines extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve.
Ohline teaches (figs 3B-3F; [0062-0067]) a segment of the endoscope comprising three control lines (312) attached to a distal end of the segment and extend proximally to the actuator.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control lines of Martin such that two or more control lines each operatively coupled to the one or more controls of the handle and each of the two or more control lines extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve as taught by Ohline. One of ordinary skill in the art would have been motivated to do so in order to provide more control over the bending of the segment (Ohline [0064]).
Martin further teaches a valve (see [0085]), however, Martin does not specify that the valve is disposed distal of the one or more controls of the handle; the valve HV (in Fig. 12) being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle.
Whayne teaches a catheter assembly with a handle (18), a proximal section (34) of the sheath and a hemostatic valve that is in the proximal section (34; see Col 9 lines 11-16 teaching that this is not shown in the figures) and is locked about the catheter tube (12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a valve disposed distal of the one or more controls of the handle; the valve being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle as taught by Whayne. One of ordinary skill in the art would be motivated to do so as this would be a rearrangement of parts that would still allow for fluid infusion (Whayne Col 9 lines 11-16).
Martin does not specify a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation between the interventional device and the delivery catheter.
Roberts teaches (Figs 3A-3B) a keyway system (112, 214) configured to rotationally align at least a portion of the delivery catheter (100) to at least a portion of the interventional device (200; see [0055-0056]), the keyway system comprising a keyway (112) disposed in a catheter wall (wall of lumen 108) of the distal section (fig 3A) of the delivery catheter (100; also see [0057] teaching that the keyway could extend from proximal end to distal end portions or just a partial length between the proximal and distal ends), the keyway (112) configured to receive a complementary engaging key feature (214) of the interventional device (200) as the interventional device (200) passes through an inner lumen (108) of the delivery catheter (100) to maintain a predetermined rotational orientation between the interventional device and the delivery catheter (see [0054-0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation between the interventional device and the delivery catheter as taught by Roberts. One of ordinary skill in the art would have been motivated to do so in order to fix the rotational orientation of the inner interventional device relative to the outer delivery catheter about the longitudinal axis (see Roberts [0055]).
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Annotated Fig 1 (Martin)
Regarding Claim 2, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches (Figs 2A-2B) the delivery system wherein the first curve (40) and second curve (46) lie in different planes (See Figs 2A-2B, where the first curve in the x plane and the second curve is in the z plane; also see [0062] and [0083]).
Regarding Claim 3, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 2 as described above. Martin further teaches (Figs 2A-2B) the delivery system wherein the first curve (40) lies in a plane (X) that is substantially orthogonal to a plane (Z) in which the second curve (46) lies (See [0062]).
Regarding Claim 4, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin does not specify the delivery system of claim 1, wherein the first curve is configured to be bendable to an angle of about 70 to about 120 degrees. Martin does teach [0017] that “Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first curve of Martin such that the first curve is configured to be bendable to an angle of about 70 to about 120 degrees. One of ordinary skill in the art would have been motivated to do so in order to properly direct the device to the desired target tissue (Martin [0017]).
Regarding Claim 6, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin does not specify the delivery system of claim 1, wherein the distal section has a length of about 2 to 6 inches, with the first curve being formed in the proximal most 1 to 3 inches, and the second curve being formed in the distal most 1 to 3 inches. Martin does, however, teach [0058] that the distal end comprises articulating members 18, which can extend along the desired length of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal section of the catheter of Martin such that the distal section has a length of about 2 to 6 inches, with the first curve being formed in the proximal most 1 to 3 inches, and the second curve being formed in the distal most 1 to 3 inches. One of ordinary skill in the art would be motived to do in order to direct the device to the desired location of target tissue with the desired angle of approach (Martin [0017]).
Regarding Claim 7, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches [0026] that the curves of the device may be pre-formed. Martin does not specify the delivery system of claim 1, wherein the first curve is pre-curved to an angle of about 30 to about 80 degrees. Martin does teach [0017] that “Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first curve of Martin such that the first curve is pre-curved to an angle of about 30 to about 80 degrees. One of ordinary skill in the art would have been motivated to do so in order to properly direct the device to the desired target tissue (Martin [0017]).
Regarding Claim 8, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches [0026] that the curves of the device may be pre-formed. Martin does not specify the delivery system of claim 1, wherein the second curve is pre-curved to an angle of about 5 to about 30 degrees. Martin does teach [0017] that “Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second curve of Martin such that the second curve is pre-curved to an angle of about 5 to about 30 degrees. One of ordinary skill in the art would have been motivated to do so in order to properly direct the device to the desired target tissue (Martin [0017]).
Regarding Claim 10, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches the delivery system comprising a first pair of control lines circumferentially opposed to one another at the distal coupler, and a second pair of control lines circumferentially opposed to one another at the distal coupler, the first pair and the second pair being offset by about 90 degrees (see [0074-0075] teaching that there may be multiple wires; see Fig 7A where the wires and wire lumens 82 are offset about 90 degrees).
Regarding Claim 15, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches (Fig 1) the delivery system wherein at least the distal section includes a region of preferential bending (area with 18, see [0058-0061]), wherein one side of the distal section is formed from a relatively less stiff material and the opposite side of the distal section is formed from a relatively stiffer material (See [0079] teaching the area proximal to 18 is made of a more rigid material than the area with 18).
Regarding Claim 16, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches the delivery system wherein the handle (20) is configured to control positioning of the intermediate couple, wherein manipulation of the intermediate coupler controls the first curve and manipulation of the distal coupler controls the second curve (see [0081-0082]).
Claim(s) 9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279) and Roberts (US Patent Pub. 20120259244) as applied to claim 1 above, and further in view of Goldfarb et al. (US Patent Pub. 20040049207 hereinafter “Goldfarb”).
Regarding Claim 9, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin does not specify the delivery system of claim 1, wherein each control line extends from a control of the handle to the distal coupler and then loops back toward the handle.
Goldfarb teaches (Fig 64E) a delivery system wherein each control line (90) extends from a control of the handle to the distal coupler and then loops back toward the handle (see [0251] and Fig 64E, control line 90 is looped through the distal coupler 280, also see Figs. 52A-52B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the control line of Martin with a control line that extends from a control of the handle to the distal coupler and then loops back toward the handle as taught by Goldfarb. One of ordinary skill in the art would have recognized that substituting the pull wire design of Martin with the design disclosed in Goldfarb Fig 64E would be a simple substitution of known equivalents (see MPEP 2144.06).
Regarding Claim 11, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin further teaches the delivery system wherein the delivery catheter includes an outer jacket (105; [0079]). Martin does not teach the delivery system of claim 1, wherein the delivery catheter includes an outer jacket of a braided material.
Goldfarb teaches (Fig 65A-65B) a delivery system wherein the delivery catheter (1000) includes an outer jacket of a braided material (1150, 1151).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer jacket of Martin such that it is formed by a braided material as taught by Goldfarb. One of ordinary skill of the art would have been motivated to do so in order to provide increased column strength and torque transmission (Goldfarb [0256]).
Regarding Claim 12, the combination of Martin, Schultz, Ohline, Whayne, Roberts and Goldfarb teaches all elements of claim 11 as described above. The combination further teaches (Goldfarb Fig 65B) the delivery system wherein the outer jacket at the proximal section comprises two layers (Goldfarb 1151, [0256]) and at the distal section has a single layer (Goldfarb 1154, [0256]).
Regarding Claim 13, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin does not specify the delivery system of claim 1, wherein the proximal section has a greater hardness rating than the distal section.
Goldfarb teaches a delivery system wherein the proximal section has a greater hardness rating than the distal section (see [0256] teaching decreasing durometer towards the distal end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hardness of the delivery system of Martin such that the proximal section has a greater hardness rating than the distal section as taught by Goldfarb. One of ordinary skill in the art would have been motivated to do so in order to provide desired column strength, torque transmission and steerability of the device (Goldfarb [0256]).
Regarding Claim 14, the combination of Martin, Schultz, Ohline, Whayne, Roberts and Goldfarb teaches all elements of claim 13 as described above. The combination does not specify the delivery system of claim 13, wherein a catheter wall of the proximal section has a durometer of about 60D to about 90D, and wherein a catheter wall of the distal section has a durometer of about 35D to about 55D.
Goldfarb does teach in [0257-0258] a few different materials and durometer values of the sheath. Goldfarb also teaches [0255] a variety of materials that may be used to form catheter 1000 (some of the materials disclosed by Goldfarb are similar to the materials disclosed in the instant application, therefore it is interpreted that the durometer values would be similar as well).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the catheter wall of Martin with materials disclosed in Goldfarb. Doing so would result in a catheter wall of the proximal section has a durometer of about 60D to about 90D, and wherein a catheter wall of the distal section has a durometer of about 35D to about 55D. Goldfarb teaches that materials similar to the applicants are known (including those having durometers within the claimed ranges). It has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279) and Roberts (US Patent Pub. 20120259244) as applied to claim 1 above, and further in view of Paskar (US Patent Pub. 20030199960 note this reference was previously cited).
Regarding Claim 17, the combination of Martin, Schultz, Ohline, Whayne and Roberts teaches all elements of claim 1 as described above. Martin does not teach the delivery system wherein the compound curve comprises one or more regions of preferential bending with about 50% of a co-extruded catheter wall of the distal section being formed of a first material having a stiffness that is less than a second material , which forms a remaining about 50% of the catheter wall on an opposite side of the catheter wall from the first material, wherein the distal section preferentially bends in a direction from the remaining about 50% of the catheter wall formed with the second material towards the region of the catheter wall formed with the first material.
It is noted that the product-by-process limitation “co-extruded” has not been given weight in determining the patentability of the device claim. See MEPE §2113.
Paskar teaches (Fig 9) a catheter with a wall portion that is weaker (71) than the rest of the wall. Paskar teaches that the weaker region may be made by using a different material that is weaker than the material that makes up the rest of the wall ([0090]). Paskar further teaches that the catheter will bend towards this specific region of the catheter (see [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter wall of Martin such that it comprises a first material having a stiffness that is less than a second material as taught by Paskar. One of ordinary skill in the art would have been motivated to do so in order to form a region of predetermined weakness to allow for bending in that specific region (See [0090] and [0086]).
While Paskar does not specify that the weaker material is about 50% of the catheter wall, it is interpreted that one of ordinary skill in the art would have been aware of this strategy of using two different materials in the wall of a tube to cause preferential bending so deciding on what percent of the wall to be made of each material would be a matter of design choice based on how flexible the user would want the catheter to be.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279), Leeflang et al. (US Patent Pub. 20050197623 hereinafter “Leeflang”) and Roberts (US Patent Pub. 20120259244).
Regarding Claim 18, Martin teaches (Figs 1-3) a delivery system configures for delivery of an interventional device in an intravascular procedure, the delivery system comprising:
a handle (20) having one or more controls (22,24,26);
a delivery catheter (11) having a proximal end (12) and a distal end (15), the proximal end being coupled to the handle (see [0059]), the delivery catheter having a proximal section and a distal section (see annotated Fig 1),
wherein at least the distal section is configured to selectively form a compound curve (see [0034]; 40, 46) to enable positioning of the distal end relative to a targeted intravascular treatment site (see [0035] teaching treatment site to be the atrium),
wherein the compound curve includes a first curve (40) formable at a proximal portion of the distal section (see Fig 2A) and a second curve (46) formable at a distal portion of the distal section (See Fig 2B), the first and second curves being formable in different planes (See [0062])
wherein the first curve is pre-curved, and wherein the second curve is pre-curved (See [0026]);
one or more control lines (80, 120,124; see [0081-0082]) each operatively coupled to a control of the handle (see [0059] teaching the actuators in handle 20 actuate pull wires) and each extending from the handle through a wall lumen (82) of the delivery catheter toward the distal end;
a distal coupler (Fig 11B, 126; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 126 in Fig 11B provided in the delivery catheter in Fig. 1-3 would assist with that curvature) disposed at or near the distal end of the delivery catheter and distal of the handle (20), the one or more control lines (124) extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve (see [0082]); and
an intermediate coupler (Fig 11B, 122; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 122 in Fig 11B would assist with that curvature) disposed at the distal section at a location proximal of the distal coupler (126) and distal of the handle (20), the intermediate coupler (122) cooperating with one or more intermediate control lines (120) each operatively coupled to a control of the handle (see [0059] teaching the actuators in handle 20 actuate pull wires).
Martin does not teach an inlet disposed coplanar with a proximal end surface of the handle, the proximal end surface forming a terminal proximal end of the delivery system. Martin does teach [0058] that a central lumen (16) is sized for passage of an interventional device therethrough.
Schultz teaches (fig 1 and [0038]) a handle (16) with an inlet (30) configured to allow an interventional device (20) to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle (See Fig 1, inlet 30 is on proximal end of handle 16), the proximal end of the handle forming a terminal proximal end of the delivery system (See Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle of Martin such that it includes an inlet configured to allow an interventional device to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle, the proximal end of the handle forming a terminal proximal end of the delivery system as taught by Schultz. One of ordinary skill in the art would have recognized this is an alternative design to allow for interventional devices to pass through the access sheath.
Martin does not teach two or more control lines each operatively coupled to the one or more controls of the handle and each of the two or more control lines extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve.
Ohline teaches (figs 3B-3F; [0062-0067]) a segment of the endoscope comprising three control lines (312) attached to a distal end of the segment and extend proximally to the actuator.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control lines of Martin such that two or more control lines each operatively coupled to the one or more controls of the handle and each of the two or more control lines extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve as taught by Ohline. One of ordinary skill in the art would have been motivated to do so in order to provide more control over the bending of the segment (Ohline [0064]).
Martin further teaches a valve (see [0085]), however, Martin does not specify that the valve is disposed distal of the one or more controls of the handle; the valve being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle.
Whayne teaches a catheter assembly with a handle (18), a proximal section (34) of the sheath and a hemostatic valve that is in the proximal section (34; see Col 9 lines 11-16 teaching that this is not shown in the figures) and is locked about the catheter tube (12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a valve disposed distal of the one or more controls of the handle; the valve being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle as taught by Whayne. One of ordinary skill in the art would be motivated to do so as this would be a rearrangement of parts that would still allow for fluid infusion (Whayne Col 9 lines 11-16).
The combination does not specify each of the first curve and the second curve being bound by radiopaque markers.
Leeflang teaches [0115] a catheter system including one or more markers, such as radiopaque bands at a distal end.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first curve and second curve of Martin such that it includes radiopaque markers as taught by Leeflang. One of ordinary skill in the art would have been motivated to do so in order to facilitate the use of external imaging systems to more precisely manipulate the device (Leeflang [0115]).
Martin does not specify a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter wherein the compound curve is formed, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation of the interventional device during navigation through the compound curve.
Roberts teaches (Figs 3A-3B) a keyway system (112, 214) configured to rotationally align at least a portion of the delivery catheter (100) to at least a portion of the interventional device (200; see [0055-0056]), the keyway system comprising a keyway (112) disposed in a catheter wall (wall of lumen 108) of the distal section (fig 3A) of the delivery catheter (100; also see [0057] teaching that the keyway could extend from proximal end to distal end portions or just a partial length between the proximal and distal ends), the keyway (112) configured to receive a complementary engaging key feature (214) of the interventional device (200) as the interventional device (200) passes through an inner lumen (108) of the delivery catheter (100) to maintain a predetermined rotational orientation between the interventional device and the delivery catheter (see [0054-0056]). The examiner also notes that Roberts Figs 3A-3B shows the delivery catheter 100 curved, therefore it is interpreted that the interventional device (200) maintains a predetermined rotational orientation during navigation through the curve as shown in Fig 3B.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter wherein the compound curve is formed, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation of the interventional device during navigation through the compound curve as taught by Roberts. One of ordinary skill in the art would have been motivated to do so in order to fix the rotational orientation of the inner interventional device relative to the outer delivery catheter about the longitudinal axis (see Roberts [0055]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279), Paskar (US Patent Pub. 20030199960), Vanney (US Patent Pub. 20050004516) and Roberts (US Patent Pub. 20120259244).
Regarding Claim 19, Martin teaches (Figs 1-3) a method of delivering an interventional device intravascularly to a targeted treatment area using a delivery system, the method comprising:
providing a delivery system comprising:
a handle (20) having one or more controls (22,24,26);
a delivery catheter (11) having a proximal end (12) and a distal end (15), the proximal end being coupled to the handle (see [0059]), the delivery catheter having a proximal section and a distal section (see annotated Fig 1), wherein at least the distal section is configured to selectively form a compound curve to enable positioning of the distal end relative to a targeted intravascular treatment site (see [0034]), and
wherein the compound curve includes a first curve (40) formable at a proximal portion of the distal section and a second curve (46) formable at a distal portion of the distal section;
one or more control lines (80, 120,124; see [0081-0082]) each operatively coupled to a control of the handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end (see [0059] teaching the actuators in handle 20 actuate pull wires);
a distal coupler (Fig 11B, 126; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 126 in Fig 11B provided in the delivery catheter in Fig. 1-3 would assist with that curvature) disposed at or near the distal end of the delivery catheter and distal of the handle (20), the one or more control lines (124) extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve (see [0082]); and
an intermediate coupler (Fig 11B, 122; As seen in [0079] and [0081-0082] the access sheath (10) of Fig 11A-11B includes various access points to assist with articulation. Figs 1-3 already show that the device has various degrees of curvature, and the coupler 122 in Fig 11B would assist with that curvature) disposed at the distal section at a location proximal of the distal coupler (126) and distal of the handle (20), the intermediate coupler (122) cooperating with one or more intermediate control lines (120) each operatively coupled to a control of the handle (see [0059] teaching the actuators in handle 20 actuate pull wires);
wherein the handle is configured to control positioning of the intermediate coupler, wherein manipulation of the intermediate coupler controls the first curve and manipulation of the distal coupler controls the second curve (See [0059] teaching the actuators in the handle 20 actuate pull wire; also see [0082] teaching how changes of the distal coupler adjust the compound curve);
routing the distal end of the delivery catheter to the targeted treatment site and positioning at least one of the distal coupler and the intermediate coupler to position the interventional device at the targeted treatment site (see [0036] and [0066]); and
delivering the interventional device (70) through the lumen of the delivery catheter (see [0058] and [0068]).
Martin does not teach an inlet disposed coplanar with a proximal end surface of the handle, the proximal end surface of the handle forming a terminal proximal end of the delivery system. Martin does teach [0058] that a central lumen (16) is sized for passage of an interventional device therethrough.
Schultz teaches (fig 1 and [0038]) a handle (16) with an inlet (30) configured to allow an interventional device (20) to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle (See Fig 1, inlet 30 is on proximal end of handle 16), the proximal end of the handle forming a terminal proximal end of the delivery system (See Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle of Martin such that it includes an inlet configured to allow an interventional device to be delivered through the delivery system, the inlet disposed coplanar with a proximal end surface of the handle, the proximal end of the handle forming a terminal proximal end of the delivery system as taught by Schultz. One of ordinary skill in the art would have recognized this is an alternative design to allow for interventional devices to pass through the access sheath.
Martin does not teach two or more control lines each operatively coupled to a control handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve.
Ohline teaches (figs 3B-3F; [0062-0067]) a segment of the endoscope comprising three control lines (312) attached to a distal end of the segment and extend proximally to the actuator.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control lines of Martin such that two or more control lines each operatively coupled to a control handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end; the two or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning at least one of the two or more control lines changes position of the distal couple to thereby form or adjust the compound curve as taught by Ohline. One of ordinary skill in the art would have been motivated to do so in order to provide more control over the bending of the segment (Ohline [0064]).
Martin further teaches a valve (see [0085]), however, Martin does not specify that the valve is disposed distal of the one or more controls of the handle; the valve being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle.
Whayne teaches a catheter assembly with a handle (18), a proximal section (34) of the sheath and a hemostatic valve that is in the proximal section (34; see Col 9 lines 11-16 teaching that this is not shown in the figures) and is locked about the catheter tube (12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a valve disposed distal of the one or more controls of the handle; the valve being coupled to a terminal proximal end of the proximal section of the delivery catheter and a distal end of the handle supporting the one or more controls, the valve being disposed between the proximal section and distal a distal end of the one or more controls of the handle as taught by Whayne. One of ordinary skill in the art would be motivated to do so as this would be a rearrangement of parts that would still allow for fluid infusion (Whayne Col 9 lines 11-16).
Martin does not teach the delivery system wherein the compound curve comprises one or more regions of preferential bending with about 50% of a co-extruded catheter wall of the distal section being formed of a first material having a stiffness that is less than a second material , which forms a remaining about 50% of the catheter wall on an opposite side of the catheter wall from the first material; wherein at least the distal section includes a region of preferential bending, wherein one side of the distal section is formed from a relatively less stiff material and the opposite side of the distal section is formed from a relatively stiffer material.
Paskar teaches (Fig 9) a catheter with a wall portion that is weaker (71) than the rest of the wall. Paskar teaches that the weaker region may be made by using a different material that is weaker than the material that makes up the rest of the wall ([0090]). Paskar further teaches that the catheter will bend towards this specific region of the catheter (see [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter wall of Martin such that it comprises a first material having a stiffness that is less than a second material as taught by Paskar. One of ordinary skill in the art would have been motivated to do so in order to form a region of predetermined weakness to allow for bending in that specific region (See [0090] and [0086]).
While Paskar does not specify that the weaker material is about 50% of the catheter wall, it is interpreted that one of ordinary skill in the art would have been aware of this strategy of using two different materials in the wall of a tube to cause preferential bending so deciding on what percent of the wall to be made of each material would be a matter of design choice based on how flexible the user would want the catheter to be.
The combination does not teach the method comprising a delivery system comprising the one or more regions comprising a first region and a second region, the first region having a first pre-curved shape at an angle of about 30 to about 80 degrees and is configured to be further bendable to an angle of about 70 to about 120 degree and the second region having a second pre-curved shape at an angle of about 5 to about 30 degrees and is configured to be further bendable to an angle of about 10 to about 50 degrees.
While Martin does not specify the delivery catheter wherein the first curve is pre-curved to an angle of about 30 to about 80 degrees and is configured to be further bendable to an angle of about 70 to about 120 degrees, and wherein the second curve is pre-curved to an angle of about 5 to about 30 degrees and is configured to be further bendable to an angle of about 10 to about 50 degrees. Martin does, however, teach in [0017] that “Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second curves of Martin such that the first curve is pre-curved to an angle of about 30 to about 80 degrees and is configured to be further bendable to an angle of about 70 to about 120 degrees, and the second curve is pre-curved to an angle of about 5 to about 30 degrees and is configured to be further bendable to an angle of about 10 to about 50 degrees. One of ordinary skill in the art would have been motivated to do so in order to properly direct the device to the desired target tissue (Martin [0017]).
The combination does not teach the method comprising a delivery system comprising the first region and the second region being substantially straightened, when not subjected to an overriding bending force, during routing of the distal end of the delivery catheter to the targeted treatment site and reverting to the first pre-curved shape and the second pre-curved shape at the targeted treatment site.
Vanney teaches a delivery system with a catheter that may straighten or curve based on the manipulation of a pull wire (116; see [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery system of Martin to include a pull wire as taught by Vanney. This addition of a pull wire would result the first region and the second region being substantially straightened, when not subjected to an overriding bending force, during routing of the distal end of the delivery catheter to the targeted treatment site and reverting to the first pre-curved shape and the second pre-curved shape at the targeted treatment site. One of ordinary skill in the art would have been motivated to do so in order to manipulate the shape of the catheter while using the device (See Vanney [0108]).
Martin does not specify a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation of the interventional device as the interventional device navigated through the first curve and the second curve lying in different planes.
Roberts teaches (Figs 3A-3B) a keyway system (112, 214) configured to rotationally align at least a portion of the delivery catheter (100) to at least a portion of the interventional device (200; see [0055-0056]), the keyway system comprising a keyway (112) disposed in a catheter wall (wall of lumen 108) of the distal section (fig 3A) of the delivery catheter (100; also see [0057] teaching that the keyway could extend from proximal end to distal end portions or just a partial length between the proximal and distal ends), the keyway (112) configured to receive a complementary engaging key feature (214) of the interventional device (200) as the interventional device (200) passes through an inner lumen (108) of the delivery catheter (100) to maintain a predetermined rotational orientation between the interventional device and the delivery catheter (see [0054-0056]). The examiner also notes that Roberts Figs 3A-3B shows the delivery catheter 100 curved, therefore it is interpreted that the interventional device (200) maintains a predetermined rotational orientation during navigation through the curve as shown in Fig 3B.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter assembly of Martin such that it includes a keyway system configured to rotationally align at least a portion of the delivery catheter to at least a portion of the interventional device, the keyway system comprising a keyway disposed in a catheter wall of the distal section of the delivery catheter, the keyway configured to receive a complementary engaging key feature of the interventional device as the interventional device passes through an inner lumen of the delivery catheter to maintain a predetermined rotational orientation of the interventional device as the interventional device navigated through the first curve and the second curve lying in different planes as taught by Roberts. One of ordinary skill in the art would have been motivated to do so in order to fix the rotational orientation of the inner interventional device relative to the outer delivery catheter about the longitudinal axis (see Roberts [0055]).
Regarding Claim 20, the combination of Martin, Schultz, Ohline, Whayne, Paskar, Vanney and Roberts teaches all elements of claim 19 as described above. Martin further teaches (Figs 2A-2B) the method wherein the first curve (40) lies in a plane (X) that is substantially orthogonal to a plane (Z) in which the second curve (46) lies (see [0062]).
Response to Arguments
Applicant’s arguments, see Pgs. 9-11 and 13-15, filed 1/20/2026, with respect to the rejection(s) of claim(s) 1, 18 and 19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Martin (US Patent Pub. 20040044350 note this reference was previously cited) in view of Schultz (US Patent Pub. 20100168827 hereinafter “Schultz”), Ohline et al. (US Patent Pub. 20030045778 hereinafter “Ohline”), Whayne et al. (US Patent 6071279 hereinafter “Whayne”) and Roberts et al. (US Patent Pub. 20120259244 hereinafter “Roberts”) for claim 1; Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279), Leeflang et al. (US Patent Pub. 20050197623 hereinafter “Leeflang”) and Roberts (US Patent Pub. 20120259244) for claim 18; and Martin (US Patent Pub. 20040044350) in view of Schultz (US Patent Pub. 20100168827), Ohline (US Patent Pub. 20030045778), Whayne (US Patent 6071279), Paskar (US Patent Pub. 20030199960), Vanney (US Patent Pub. 20050004516) and Roberts (US Patent Pub. 20120259244) for claim 19.
Conclusion
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783