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 .
Claim Objections
Claim 15 is objected to because of the following informalities: in line 2, “comprise” should read --comprises--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, it is unclear whether the mounting member is mounted on the mesh structure or if it comprises the mesh structure (that is, whether the mounting member is separate from the mesh structure or the same structure). For examination purposes, this claim will be read as wherein the mounting member is provided along a circumference of the supporting body and comprises a mesh structure. Dependent claims 2-20 are necessarily rejected as depending upon a rejected base claim.
In claim 8, it is unclear whether the limitation “a mesh structure” is the same structure recited previously in claim 1. For examination purposes, this limitation will be read as a separate mesh structure from the structure recited in claim 1.
In claim 16, the limitation “the woven wire” is unclear because it is unclear which wire out of the plurality of woven wires the limitation refers to. For examination purposes, the claim will be read as wherein a diameter of each of the plurality of woven wires at a first end portion is smaller than a diameter of each of the plurality of woven wires at a second end portion.
In claim 19, it is unclear whether the ablation units are provided on the supporting body or located on the first or second region, which are on the mounting member. For examination purposes, the claim will be read as wherein the ablation units are located on the first region or the second region of the mounting member.
In claim 20, it is unclear what the limitation “a spacing distance at a portion away from the supporting body” means. For examination purposes, the claim will be read as wherein the two adjacent ablation units are provided at spaced intervals around the supporting body.
In the following claims, the corresponding limitations lack sufficient antecedent basis:
Claims 1-2, 5-6, and 14: “the mesh wires” (examiner recommends changing to --the plurality of mesh wires-- as recited earlier in claim 1)
Claim 3: “the amount of increase,” “the mesh density”
Claim 4: “the connection boundary,” “the transmission of force”
Claim 7: “the stiffness”
Claim 8: “the area,” “the smallest mesh”
Claim 9: “the cross-sectional area,” “the other end”
Claim 10: “the center”
Claim 12: “the inner side of the supporting body”
Claim 16: “the woven wire,” “the first end portion,” “the second end portion”
Claim 17: “the woven wires,” “the second end portion,” “the mesh wires,” “the first end portion”
Claim 18: “the circumferential lengths”
Claim 19: “the ablation units”
Claim 20: “the two adjacent ablation units” (since these units are only recited in claim 19, but the claim depends 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.
Claims 1-3, 6, 10, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cooke (US PGPub No. 2017/0204544) in view of Dickinson et al. (US PGPub No. 2015/0374486), hereinafter Dickinson.
Regarding claim 1, Cooke teaches a nerve ablation apparatus (Fig. 2: woven construct 200), comprising a supporting body (Fig. 2: end segments 231a,b) and a mounting member (Fig. 2: operative segment 225),
wherein the mounting member is provided along a circumference of the supporting body (Fig. 2: operative segment 225 circumferentially linked with end segments 231a,b);
the mounting member comprises a first region and a second region provided along the circumference of the supporting body (Figs. 1A-1B: region 105 circumferentially opposite region 110) and comprises a mesh structure formed by a plurality of mesh wires, wherein in the first region, the plurality of mesh wires intersect (Figs. 1A-1B: mesh 100).
Cooke does not explicitly teach wherein at least a portion of the mesh wires are fixedly connected at intersections. However, in an analogous art, Dickinson teaches a catheter with a braided mesh with filaments that may be fixedly connected or held together by a woven structure as obvious alternatives (par. 0127: “At filament crossings, filaments may be helically wrapped, cross in sliding relation, and/or combinations thereof. Filaments may be loose (e.g., held together by the weave) and/or include welds, coupling elements such as sleeves, and/or combinations thereof”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to couple the mesh wires at their intersections, as suggested by Dickinson, since Dickinson teaches that fixedly connecting filaments in a braided mesh is an obvious alternative to leaving the filaments loose.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Cooke further teaches wherein the plurality of mesh wires comprise woven wires, and the mesh structure is formed by weaving the woven wires (Fig. 2 and par. 0043: “a woven construct 200 can be formed from a plurality of interwoven, biocompatible, electrically conductive wires 201”).
Regarding claim 3, the combination teaches the device of claim 1 as described previously. Cooke further teaches wherein an amount of increase for a mesh density in the first region is less than an amount of increase for a mesh density in the second region when the mounting member is compressed towards an inner side of the supporting body (Figs. 1A-1B and par. 0040: “the undeformed mesh 100 is axially asymmetric, having a region 105 of relatively higher wire density positioned circumferentially opposite a region 110 of relatively lower wire density. When longitudinally axially compressed sufficiently to buckle, the mesh 100 expands in a circumferentially asymmetric manner to form a bulge 115 extending radially outwardly of the longitudinal axis 120”).
Regarding claim 6, the combination teaches the device of claim 1 as described previously. Cooke further teaches wherein the plurality of mesh wires are made of conductive material to make the mounting member form mesh electrodes (par. 0041: “The directional mesh shown in FIGS. 1A, 1B, and 1C is configured as an energizable, bipolar electrode suitable for use in providing an electrosurgical therapy”).
Regarding claim 10, the combination teaches the device of claim 1 as described previously. Cooke further teaches wherein at least a portion of the mounting member is bent towards a direction close to the center of the supporting body, and a side wall of the mounting member comprises an arcuate curved surface (Figs. 1A-1C: curved internal surface of the operative segment 125).
Regarding claim 14, the combination teaches the device of claim 1 as described previously. Cooke does not explicitly teach wherein the plurality of mesh wires are fixed connected in the first region and movably connected in the second region. However, Dickinson further teaches that braided filaments can be coupled in one region and uncoupled in another (par. 0172: “at least one of the proximal end portion 102, the distal end portion 104, and the intermediate portion 106 may include both a first parameter and a second parameter different than the first parameter. Filament parameters may include, for example, […] filament coupling or lack thereof”), which can be used to provide differences in flexibility (par. 0028: “The device may be relatively more flexible in the intermediate portion than in the end portions by way of absence of a mesh, or even when including a mesh with substantially uniform or uniform density or window size (e.g., due to factors other than mesh density or window size), or by including a mesh having a non-uniform density”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide coupled mesh wires in the first region, as taught by Dickinson, in order to provide a difference in flexibility, as taught by Dickinson.
Regarding claim 18, the combination teaches the device of claim 1 as described previously. Cooke further teaches wherein a ratio of circumferential lengths of the second region and the first region is 1.1-4 (Figs. 1B-1C: region 105 about twice as long circumferentially as region 110).
Claims 4-5, 7-9, 11, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cooke in view of Dickinson and further in view of Dubrul et al. (US PGPub No. 2014/0188127), hereinafter Dubrul.
Regarding claims 4-5, Cooke in view of Dickinson teaches the device of claim 1 as described previously. The combination does not explicitly teach further comprising a buffer structure comprising a reinforcing member, wherein the reinforcing member extends from the supporting body to the connection boundary of the first region and the second region and is configured to block transmission of force between the first region and the second region. However, in an analogous art, Dubrul teaches a catheter with a braided mesh having first and second regions with a reinforcing member that blocks transmission of force between the two regions in order to promote asymmetrical buckling (Fig. 41 and par. 0135: “A part of proximal portion 248 is coated with a polymer 256, which is typically somewhat elastic, to limit expansion of proximal portion 248 so it cannot fully expand and buckle. The remainder of sleeve 236 is uncoated to promote buckling at distal portion 246”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by providing a reinforcing member to block transmission of force between the first and second regions, as taught by Dubrul, in order to promote asymmetrical buckling, as taught by Dubrul.
Regarding claims 7-9, Cooke in view of Dickinson teaches the device of claim 1 as described previously. Cooke further teaches wherein the supporting body has a mesh structure (Fig. 2: woven segments 231a,b), but the combination does not explicitly teach wherein a stiffness of one end of the supporting body close to the mounting member is less than a stiffness of another end of the supporting body away from the mounting member, wherein an area of the smallest mesh of an end portion of the supporting body close to the mounting member is larger than an area of the smallest mesh of an end portion of the supporting body away from the mounting member, and the cross-sectional area of the supporting body gradually decreases from one end close to the mounting member to another end away from the mounting member. However, Dubrul further teaches providing variable pitch and taper in a braided mesh in order to create different areas of stiffness or flexibility and therefore control the behavior of the mesh under compressive force (Fig. 47 and par. 0139: “Variable pic funnel catheter 274 is shown partially expanded in a larger diameter vessel 250. Proximal taper portion 268 of braided structure 266 can fully expand but the taper is so gradual that it behaves more coil bound. Distal braid portion 270 must have a sufficiently low pic count to be sufficiently weak to yield first […] In this case it is beneficial to have a low pic count distally so distal taper portion 270 is weaker than proximal taper portion 268 and tends to buckle under compressive load”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by providing variable pitch and taper in the braided mesh of the supporting body and create different areas of stiffness, as taught by Dubrul, in order to control the behavior of the supporting body under compressive force, as taught by Dubrul.
Regarding claim 11, Cooke in view of Dickinson teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the supporting body comprises a disc-shaped woven body formed by weaving at least one woven wire, and the mounting member is arranged on a circumferential side wall of the disc-shaped woven body. However, Dubrul teaches wherein a supporting body is a disc-shaped woven body (Figs. 46-47: funnel catheter 272, 274 having two tapered sides; examiner interprets a body with two tapered sides to be disc-shaped, as broadly as claimed). It would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by using the shape taught by Dubrul, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 15, Cooke in view of Dickinson teaches the device of claim 1 as described previously. Dickinson further teaches that lower density of woven wires provides additional flexibility (par. 0028: “The device may be relatively more flexible in the intermediate portion than in the end portions by way of absence of a mesh, […] or by including a mesh having a non-uniform density”), but the combination does not explicitly teach wherein the mounting member comprises a third region located between the first region and the second region, the third region comprising a plurality of woven wires, and the density of the woven wires is lower than the first region and the second region. However, Dubrul further teaches placing a third region with greater flexibility between a first region with low flexibility and a second region with high flexibility (Fig. 42 and par. 0136: “a relatively stiff, relatively stretch resistant polymer coating 256 at proximal portion 248 and a relatively soft, relatively easily stretched polymer coating 258 at distal portion 246. Polymer coating 256 keeps the proximal braid from fully expanding and buckling. The soft distal covering provided by polymer coating 258 allows full expansion, buckling […] the central portion 260 of sleeve 236 may also be covered with the same, soft, easily stretchable polymer 258 or a different polymer that may be even more easily stretched than polymer 258”). To provide the device of the combined reference with a third, more flexible region between the first and second regions, as taught by Dubrul, would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, because it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Dubrul to the device of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system wherein the third, more flexible region would prevent transmission of force between the first and second regions.
Regarding claim 17, the combination teaches the device of claim 7 as described previously. Cooke further teaches wherein the supporting body comprises a plurality of woven wires that intersect (Fig. 2: woven segments 231a,b), and the combination in view of Dickinson also teaches wherein the plurality of woven wires are fixedly connected in one section and movably connected in another, for the same reasons set forth previously in the rejection of claim 14.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cooke in view of Dickinson and further in view of Ingle (US PGPub No. 2011/0264086).
Cooke in view of Dickinson teaches the device of claim 1 as described previously. The combination does not explicitly teach further comprising a cooling balloon, wherein the cooling balloon is arranged in the inner side of the supporting body, and after the cooling balloon is inflated, a side wall of the cooling balloon attaches to a side wall of the supporting body and covers heat conduction holes in the side wall of the supporting body. However, in an analogous art, Ingle teaches a nerve ablation apparatus with a cooling balloon arranged inside a supporting mesh (Figs. 22A-22B: balloon 310, braid member 301, electrically conductive pattern 303), wherein when the balloon is inflated, the balloon is attached to the supporting mesh and covers heat conduction holes in the supporting mesh, which provides cooling at the supporting mesh and the wall of the ablated tissue in contact with the mesh and reduce damage to non-targeted tissue (par. 0132: “Provision of a cooling fluid to the circulation arrangement of the balloon 310 facilitates controlled cooling at the braid member 301 and the wall of the renal artery in contact with the braid member 301, which serves to reduce thermal damage to non-targeted renal artery tissue”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by providing a cooling balloon, as taught by Ingle, in order to reduce damage to non-targeted tissue, as taught by Ingle.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cooke in view of Dickinson and Dubrul further in view of Buessler et al. (US PGPub No. 2015/0270634), hereinafter Buessler.
Cooke in view of Dickinson and Dubrul teaches the device of claim 7 as described previously. Cooke further teaches wherein the supporting body comprises a plurality of woven wires, but the combination does not explicitly teach wherein a diameter of each of the plurality of woven wires at a first end portion is smaller than a diameter of each of the plurality of woven wires at a second end portion. However, in an analogous art, Buessler teaches that varying strut diameters in an ablation device allows for customizing the bending properties of each strut and thus enhance overall device performance as related to radial force, flexibility, and stiffness (par. 0028: “By varying the thickness of the one or more struts along their length in the electrode assembly, at least the bending moment of inertia of the strut is altered and may be customized to enhance overall device performance as related to radial force, flexibility, stiffness, apposition, and/or tracking, for example”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by varying the woven wire diameters, as suggested by Buessler, in order to enhance overall device performance as related to radial force, flexibility, and stiffness, as taught by Buessler.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cooke in view of Dickinson and further in view of Waldhauser et al. (US PGPub No. 2021/0001116), hereinafter Waldhauser.
Cooke in view of Dickinson teaches the device of claim 1 as described previously. Cooke further teaches wherein the mounting member comprises a plurality of ablation units provided along the first region or the second region (Figs. 1A-1C: energizable operative segment 125 and opposed electrodes 130a,b), but does not explicitly teach wherein two circumferentially adjacent ablation units are provided at spaced intervals around the supporting body. However, in an analogous art, Waldhauser teaches a nerve ablation catheter with circumferentially adjacent ablation units provided at spaced intervals around a supporting body (Figs. 2G-2I: electrodes 203; Fig. 4A: electrodes 418; par. 0674: “The electrodes 203 are generally aligned longitudinally and circumferentially), which allows a nerve to be targeted in a generally transverse manner (par. 0676: “The electrodes 203a, 203b can be used to target the nerve 215, for example, in a generally transverse manner”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by providing circumferentially adjacent ablation units at spaced intervals around the supporting body, as taught by Waldhauser, in order to target a nerve in a generally transverse manner, as taught by Waldhauser.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794