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 .
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 catheter wall of the distal section comprising an integrated tubular wall having a first longitudinal segment formed of a first material and an opposite second longitudinal wall formed of a second material having a stiffness greater than the first material to define an asymmetric bending profile, the wall lumen through which the two or more control lines extends is disposed in the integrated tubular wall at a fixed circumferential position relative to the first longitudinal segment and the second longitudinal segment’ of claims 1 and 18 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-14 and 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has not pointed out where the amended claims 1 and 18 are supported, nor does there appear to be a written description of the claim limitation ‘the catheter wall of the distal section comprising an integrated tubular wall having a first longitudinal segment formed of a first material and an opposite second longitudinal wall formed of a second material having a stiffness greater than the first material to define an asymmetric bending profile, the wall lumen through which the two or more control lines extends is disposed in the integrated tubular wall at a fixed circumferential position relative to the first longitudinal segment and the second longitudinal segment’ in the application as filed.
Claims 2-4, 6-14 and 16-17 are rejected due to their dependence on claim 1.
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) 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), the wall lumen through with the two or more control lines extend is disposed in the co-extruded catheter wall of the distal section of the delivery catheter (80, 120,124; see [0081-0082] teaching the various control lines; the co-extruded catheter wall is considered a product by process limitation);
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. The examiner also notes that through this interpretation it is also interpretated that the interventional device is rotationally locked in alignment with the one or more regions or preferential bending (See [0055] teaching that the key joint component is fixed relative to the rotational orientation and see [0053] teaching how the bend portion 205 is not shown in Figs 3A-3B but is still prevalent to the embodiment).
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]).
The combination teaches the keyway system comprising a keyway disposed in the co-extruded catheter wall of the distal section of the delivery catheter, the keyway being formed into the co-extruded catheter wall at a fixed circumferential position relative to the first material and the second material (see the modification done in view of Paskar for the materials; the co-extruded catheter is a product by process limitation as such the keyway is in the catheter that is made of multiple materials (a first and second material).
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Annotated Fig 1 (Martin)
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 with respect to claim(s) 1, 18 and 19 have been considered but are moot because the new ground of rejection takes into consideration the amendments field 6/4/2026. See rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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