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 10 is objected to because of the following informalities: “the outer extension portions” should be –the plurality of outer extension portions—, as introduced in claim 10. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: “at least two of the spline portions” should be – at least two of the plurality of spline portions—, as introduced in claim 1. 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 3, 6-13, & 16 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.
Claim 3 recites “a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions”; claim 1 introduces “a counterclockwise spline portion” and “a clockwise spline portion”; it is unclear how a singular counterclockwise spline portion and a singular clockwise spline portion can each comprise a plurality. For examination purposes the examiner is considering there to be at least one counterclockwise spline portion and at least one clockwise spline portion such that there can be a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions. The examiner recommends amending independent claim 1 to include “at least one counterclockwise spline portion” and “at least one clockwise spline portion”. Claim 7 is rejected by virtue of its dependency on claim 3.
Claim 6 recites “wherein the electrode assembly has a mesh shape formed by a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions in the continuous conductive path”; claim 1 introduces a counterclockwise spline portion” and “a clockwise spline portion”; it is unclear how a singular counterclockwise spline portion and a clockwise spline portion can each comprise a plurality. For examination purposes the examiner is considering there to be at least one counterclockwise spline portion and at least one clockwise spline portion such that there can be a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions. The examiner recommends amending independent claim 1 to include “at least one counterclockwise spline portion” and “at least one clockwise spline portion”.
Claim 7 recites “wherein the electrode assembly comprises an intermediate region forming the mesh shape and a pair of end regions provided on respective both sides of the intermediate region in the axial direction, and an angular variation Δθ1 per unit axial length in at least part of the intermediate region is larger than a maximum angular variation Δθ2(max) per unit axial length in the end region”; it is unclear what “an angular variation Δθ1 per unit axial length in at least part of the intermediate region” and “a maximum angular variation Δθ2(max) per unit axial length in the end region” are in relationship to, more specifically, it unclear what the angular variation per unit axial length of the intermediate region and the end region are defined by (e.g. does the intermediate region bow out from the central axis at an angular variation that is greater than a maximum angular variation than the end region or do the intermediate region spline portions have a greater pitch variation than the end portion), which renders the claim indefinite. For examination purposes, the examiner is considering the angular variation to be related to the pitch of the spline portions. The examiner further notes that “end region” should be –end regions— (in plural), as introduced in claim 7.
Claim 8 recites “wherein one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction”; it is unclear how many end portions/one end portions/end portions groups are required by the claim limitation; more specifically, it is unclear if the claim requires there to be one end portion of the distal end portion and one end portion of the proximal end portion that both form an end portion group or if the claim is meant to be in the alternative such that one of the distal end portion and the proximal end portion forms an end portion group (e.g. it is unclear if both the distal end portion and the proximal end portion forms the end portion group or if just one of the distal end portion and the proximal end portion form the end portion group), which renders the claim indefinite. For examination purposes the examiner is considering the claim to be in the alternative such that one of the distal end portion and the proximal end portion forms an end portion group. The examiner further notes that claim 8 introduces “an end portion group” and further recites “end portions groups” (e.g. in plural), if there is only one end portion group, “end portions groups” needs to be amended to reflect that.
Claim 9 recites “one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction”. First, there is insufficient antecedent basis for the limitation “the axial direction” in the claim; for examination purposes the examiner is considering “the axial direction” to be –a axial direction—. Second, it is unclear how many end portion groups/one end portions are required by the claim limitation; more specifically, it is unclear if the claim requires there to be one end portion of the distal end portion and one end portion of the proximal end portion that both form an end portion group or if the claim is meant to be in the alternative such that one of the distal end portion and the proximal end portion forms an end portion group (e.g. it is unclear if both the distal end portion and the proximal end portion forms the end portion group or if just one of the distal end portion and the proximal end portion form the end portion group), which renders the claim indefinite; for examination purposes the examiner is considering the claim to be in the alternative such that one of the distal end portion and the proximal end portion forms an end portion group; the examiner further notes that claim 9 introduces “an end portion group”(singular) and further recites “end portions groups” (e.g. in plural), if there is only one end portion group, “end portions groups” needs to be amended to reflect that. Dependent claims 10-13 are rejected by virtue of their dependency on independent claim 9.
Claim 11 recites “wherein the plurality of rows of the end portion groups comprises an inner end portion group composed of a plurality of inner end portions that are the plurality of the one end portions and an outer end portion group composed of a plurality of outer end portions that are the plurality of the one end portions, the electrode catheter comprises at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions, and the grouping linear member comprises a connecting portion connecting an inner end portion of the inner end portions of one of the spline portions and an outer end portion of the outer end portions of another of the spline portions.” It is unclear how the plurality of the one end portions are the inner end portions but also are the outer end portions, more specifically it is unclear how all of the one end portions are the inner end portion and all of the one end portions are also the outer end portion; For examination purposes the examiner is considering the plurality of the one end portions comprising a plurality of inner end portions and a plurality of outer end portions. The examiner further notes that “at least two of the spline portions” should be –at least two of the plurality of spline portions—, as introduced in claim 9, and “an inner end portion of the inner end portions of one of the spline portions and an outer end portion of the outer end portions of another of the spline portions” should be – an inner end portion of the plurality of inner end portions of one of the plurality of spline portions and an outer end portion of the plurality of outer end portions of another of the plurality of spline portions—, as introduced in claims 9 & 11. Claims 12-14 are rejected by virtue of their dependency on claim 11.
Claim 12 recites “wherein in a cross-section perpendicular to the axial direction passing through the inner end portion group and the outer end portion group, a circumferential range having two of the inner end portions adjacent to each other on both sides in a circumferential direction with respect to the inner end portions of the one of the spline portions is defined as a reference range, and at least some of the outer end portions connected to the inner end portion of the one of the spline portions by the connecting portion is located outside the reference range. It is unclear as to what component “both sides” is referring to, more specifically it is unclear if “both sides” is referring to the circumferential range, the two of the inner end portions, or the one of the spline portions, and further if both sides is referring to two of inner end portions it is unclear how two of the inner end portions can be adjacent to each other on both sides (e.g. it is unclear how two components can be next to each other on both sides of the two components), and therefore it is unclear how the reference range is defined, which renders the claim indefinite; for examination purposes the examiner is considering the reference range to be defined by two adjacent inner portions. The examiner further notes that “two of the inner end portions” should be –two of the plurality of inner end portions—, “the inner end portions” should be –the plurality of inner end portions—, “one of the spline portions” should be – one of the plurality of spline portions—, and “the outer end portions” should be –the plurality of outer end portions—, as introduced in claims 9-12. Claim 13 is rejected by virtue of its dependency on claim 12.
Claim 13 recites “wherein at least some of the outer end portions connected to the inner end portion of the one of the spline portions by the connecting portion is located closest to the reference range on one side in the circumferential direction outside the reference range”; it is unclear what “one side” is referring to; more specifically it is unclear if “one side” is referring to the circumferential range, the circumferential direction, the two of the inner end portions, or the one of the spline portions, which renders the claim indefinite. The examiner further notes that “the outer end portions” should be – the plurality of outer end portions—, “the inner end portion of the one of the spline portions” should be –the inner end portion of the one of the plurality of spline portions—, as introduced in claims 9-12.
Claim 16 recites “wherein the distal-side bundling component comprises a plurality of insertion holes, the distal end portion of each of the plurality of spline portions being inserted through an insertion hole of the plurality of insertion holes, and the distal end portion of each of the two of the spline portions formed by the grouping linear member is inserted through the insertion hole different in the distal-side bundling component”. It is unclear what is meant by “the insertion hole different” in the claim, it is unclear if each of the two of the spline portions are inserted through an insertion hole that is different than the plurality of insertion holes, as introduced in claim 16, or if each of the two spline portions are inserted into a respective insertion hole (e.g. they are separated at their insertion holes), which renders the claim indefinite. For examination purposes the examiner is considering each of the two spline portions are inserted into a respective insertion hole (e.g. they are separated at their insertion holes). The examiner further notes that claim 16, on pages 3 & 4 of the Claims filed 12/12/2023, contains a large blank space spanning half-way through page 4 before the rest of the limitations of claim 16 are listed; it is unclear if there are limitations missing from claim 16 that were meant to fill this space or not; the limitations of claim 16 on page 4 should immediately follow the limitations of claim 16 on page 3 (e.g. the gap/space between the limitations should be removed).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waldstreicher et al. (US 20190201089 A1), hereinafter “Waldstreicher”.
Regarding claim 1, Waldstreicher discloses an electrode catheter, comprising: a catheter shaft ([0250]; Figures 5, 6, 24, & 26—element 106); and an electrode assembly ([0250] & [0251]; Figures 5, 6, 24, & 26—element 108) and a distal-side bundling component disposed at least partially distal to the catheter shaft ([0251]; Figures 5, 6, 24, & 26—element 124), wherein the electrode assembly comprises a plurality of spline portions each having a proximal end portion bundled by the catheter shaft and a distal end portion bundled by the distal-side bundling component ([0251] & [0380]; Figures 5, 6, 24, & 26—elements 120, 122, & 124; the plurality or spline portions are constrained by the proximal end constraint 122 and distal end constraint 124), and the plurality of spline portions comprises, when viewed from a distal side in an axial direction of the catheter shaft, a counterclockwise spline portion extending counterclockwise from a side of the distal end portion toward a side of the proximal end portion and a clockwise spline portion extending clockwise from the side of the distal end portion toward the side of the proximal end portion ([0251], [0380], [0387], & [0391]; Figures 5, 6, 24, & 26—elements 120; the plurality of splines 120 are interwoven/braided and form a spiral shaped basket; the examiner is considering the counterclockwise spline portion to be the splines 120 that are shown to extend in a counterclockwise manner and the clockwise spline portion to be the splines 120 that are shown to extend in a clockwise manner).
Regarding claim 2, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher further discloses wherein the clockwise spline portion and the counterclockwise spline portion are provided intersecting in a contactable manner ([0251], [0380], [0387], & [0391]; Figures 5, 6, 24, & 26—elements 120; the splines 120 are interwoven/braided such that each splines is supported by multiple splines next to it).
Regarding claim 3, as best understood in view of the 112(b) rejection above, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher further discloses wherein the electrode assembly has a mesh shape formed by a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions ([0251], [0380], [0387], & [0391]; Figures 5, 6, 24, & 26—element 108).
Regarding claim 4, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher further discloses wherein each of the plurality of spline portions is provided with an electrode portion, and the electrode assembly can form a continuous conductive path that is continuous with the electrode portion of the clockwise spline portion and the electrode portion of the counterclockwise spline portion ([0173], [0381], & [0393]; Figures 5, 6, 24, 26, & 29—elements 107 & 120; each spline 120 forms an electrode 107 that can be electrically connected to the other electrodes 107 to form a set that act as a monopolar electrode).
Regarding claim 5, Waldstreicher discloses all of the limitations of claim 4, as described above.
Waldstreicher further discloses wherein the continuous conductive path is continuous along an entire circumference around a centerline of the catheter shaft ([0173], [0381], & [0393]; Figures 5, 6, 24, 26, & 29—elements 107 & 120; each spline 120 forms an electrode 107 that can be electrically connected to the other electrodes 107 to form a set that act as a monopolar electrode).
Regarding claim 6, as best understood in view of the 112(b) rejection above, Waldstreicher discloses all of the limitations of claim 4, as described above.
Waldstreicher further discloses wherein the electrode assembly has a mesh shape formed by a plurality of the clockwise spline portions and a plurality of the counterclockwise spline portions in the continuous conductive path ([0251], [0380], [0387], & [0391]; Figures 5, 6, 24, & 26—element 108).
Claims 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keane (US 20180014786 A1), hereinafter “Keane”.
Regarding claim 9, as best understood in view of the 112(b) rejection above, Keane discloses an electrode catheter comprising: a catheter shaft ([0030]; Figure 3A—element 40); and an electrode assembly ([0030] & [0031]; Figure 3A—elements 31) and a distal-side bundling component disposed at least partially distal to the catheter shaft ([0046]; Figure 3A—element 50), wherein the electrode assembly comprises a plurality of spline portions each having a proximal end portion bundled by the catheter shaft and a distal end portion bundled by the distal-side bundling component ([0030], [0031], [0046], & [0047]; Figure 3A—elements 31, 41, & 50), one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction ([0044]; Figure 2C—elements 41a & 4b).
Regarding claim 10, Keane discloses all of the limitations of claim 9, as described above.
Keane further discloses wherein the plurality of rows of the end portion groups comprises an inner end portion group ([0044]; Figure 2C—element 41b) and an outer end portion group ([0044]; Figure 2C—element 41a), the plurality of spline portions forms a plurality of inner extension portions extending radially outward in a radial direction from the inner end portion group and a plurality of outer extension portions extending radially outward in the radial direction from the outer end portion group, and each of the plurality of inner extension portions extends passing between the outer extension portions adjacent to each other in a circumferential direction when viewed along the axial direction ([0044]; Figures 2B, 2C, & 3A—elements 31, 41a, & 41b; the examiner is considering the plurality of inner extension portions to be the spline portion 31 that extend radially outward in a radial direction from the inner end portion group 41b, the plurality of outer extension portions to be the spline portions 31 that extend radially outward in the radial direction from the outer end portion group 41a; it is the examiners position that each of the plurality of inner extension portions pass between the outer extension portions adjacent to each other in a circumferential direction, as each of the inner exit ports formed in inner row 41b are located between adjacent outer exit ports formed in outer row 41a, as shown in figures 2B & 2C).
Claims 9-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Waldstreicher in view of Nedved et al. (US 20230000550 A1), hereinafter “Nedved”.
Regarding claim 9, as best understood in view of the 112(b) rejection above, Nedved discloses an electrode catheter comprising: a catheter shaft ([0049]; Figure 4—element 303); and an electrode assembly ([0044], & [0062]-[0063]; Figure 4—element 409) and a distal-side bundling component disposed at least partially distal to the catheter shaft ([0063]; Figure 4—element 411), wherein the electrode assembly comprises a plurality of spline portions each having a proximal end portion bundled by the catheter shaft and a distal end portion bundled by the distal-side bundling component ([0063] & [0070]; Figure 4—elements 415), one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction ([0072] & [0099]; Figure 9—elements 415; see figure below; Figure 9 portrays an end portion group comprising rows that are disposed in a nested manner).
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Regarding claim 10, Nedved discloses all of the limitations of claim 9, as described above.
Nedved further discloses wherein the plurality of rows of the end portion groups comprises an inner end portion group and an outer end portion group, the plurality of spline portions forms a plurality of inner extension portions extending radially outward in a radial direction from the inner end portion group and a plurality of outer extension portions extending radially outward in the radial direction from the outer end portion group, and each of the plurality of inner extension portions extends passing between the outer extension portions adjacent to each other in a circumferential direction when viewed along the axial direction ([0072] & [0099]; Figure 9—elements 415; see figure below; the examiner is considering the inner end portion group to be the end portions that are disposed inwardly with inner extension portions extending distally therefor and the outer end portion group to be the end portions that are disposed outwardly with outer extension portions extending distally thereof, as shown in figure below).
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Regarding claim 11, as best understood in view of the 112(b) rejection above, Nedved discloses all of the limitations of claim 9, as described above.
Nedved further discloses wherein the plurality of rows of the end portion groups comprises an inner end portion group composed of a plurality of inner end portions that are the plurality of the one end portions and an outer end portion group composed of a plurality of outer end portions that are the plurality of the one end portions ([0072] & [0099]; Figure 9—elements 415; see figure above in rejection of claim 10; the examiner is considering the inner end portion group to be the end portions that are disposed inwardly and the outer end portion group to be the end portions that are disposed outwardly), the electrode catheter comprises at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions, and the grouping linear member comprises a connecting portion connecting an inner end portion of the inner end portions of one of the spline portions and an outer end portion of the outer end portions of another of the spline portions ([0075]; Figure 20—element 2001; the spline portions are joined together at mutual crossing points; the examiner is considering the grouping linear member connecting potion to be the ring structure for joining spline portions together at their crossing portions).
Regarding claims 12 & 13, as best understood in view of the 112(b) rejection above, Nedved discloses all of the limitations of claim 11, as described above.
Nedved further disclose wherein in a cross-section perpendicular to the axial direction passing through the inner end portion group and the outer end portion group, a circumferential range having two of the inner end portions adjacent to each other on both sides in a circumferential direction with respect to the inner end portions of the one of the spline portions is defined as a reference range, and at least some of the outer end portions connected to the inner end portion of the one of the spline portions by the connecting portion is located outside the reference range; wherein at least some of the outer end portions connected to the inner end portion of the one of the spline portions by the connecting portion is located closest to the reference range on one side in the circumferential direction outside the reference range ([0075]; Figures 9 & 20—elements 415 & 2001; the spline portions are joined together at mutual crossing points; it is the examiner position that at least some of the outer end portion connected to the inner end portion of the one of the spline portions by the connecting portion is located outside and located closest to the reference range on one side in the circumferential direction outside the reference range a reference range defined by at least two of the inner end portions adjacent to each other on both sides in a circumferential direction with respect to the inner end portions of the one of the spline portions, as the connecting portions are located at any region of mutual crossing points along the mesh structure).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view of Olson (US 20220304745 A1), hereinafter “Olson”.
Regarding claim 7, as best understood in view of the 112(b) rejection above, Waldstreicher discloses all of the limitations of claim 3, as described above.
Waldstreicher further discloses wherein the electrode assembly comprises an intermediate region forming the mesh shape and a pair of end regions provided on respective both sides of the intermediate region in the axial direction ([0251]; Figure 5, 6, 24, & 26—element 108; the intermediate region being the central region of the mesh shape 108 and the pair of end regions being the end regions located near end constraints 122 & 124).
Waldstreicher does not disclose an angular variation Δθ1 per unit axial length in at least part of the intermediate region is larger than a maximum angular variation Δθ2(max) per unit axial length in the end region.
Olson teaches an electrode assembly comprising an intermediate region and a pair of end regions ([0043] & [0044]; Figure 3—elements 216, 218, & 220), wherein an angular variation Δθ1 per unit axial length in at least part of the intermediate region is larger than a maximum angular variation Δθ2(max) per unit axial length in the end region ([0043]-[0045], & [0056]; Figure 3—elements 216 & 224).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the intermediate region, as disclosed by Waldstreicher, to include the angular variation Δθ1 per unit axial length in at least part of the intermediate region being larger than the maximum angular variation Δθ2(max) per unit axial length in the end region, as taught by Olson, as both references and the claimed invention are directed toward expandable electrode assemblies. As disclosed by Olson, the intermediate region may be a highly pitched region relative to the adjacent end portions, the highly pitched region decreases the spacing between adjacent splines and adjacent electrodes which improves electrode density about the circumference of the expandable electrode assembly which is desirable in mapping and ablation procedures leading to more consistent and improved patient outcomes ([0009] & [0023]). 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 intermediate region, as disclosed by Waldstreicher, to include the angular variation Δθ1 per unit axial length in at least part of the intermediate region being larger than the maximum angular variation Δθ2(max) per unit axial length in the end region, as taught by Olson, as such a modification would decreases the spacing between adjacent splines and adjacent electrodes thereby improving electrode density about the circumference of the expandable electrode assembly which is desirable in mapping and ablation procedures and leads to more consistent and improved patient outcomes.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view of Keane.
Regarding claim 8, as best understood in view of the 112(b) rejection above, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher does not disclose wherein one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction.
Keane teaches an electrode assembly comprising a plurality of spline portion ([0030] & [0031]; Figure 3A—elements 31), wherein one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction ([0044]; Figure 2C—elements 31, 41a, & 41b).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end portion of each of the plurality of spline portion, as disclosed by Waldstreicher, to include wherein one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction, as taught by Keane, as both references and the claimed invention are directed toward expandable electrode assemblies comprising a plurality of spline portions. As disclosed by Waldstreicher, the plurality of splines can be accommodated within the catheter shaft ([0251]). As disclosed by Keane, the splines can be accommodated by a plurality of lumens extending within the catheter shaft, the lumens may be in the form of a single row, such that the end portion group is arranged in a single row, or alternatively the lumens may be in the form of a plurality or rows such that end portion group may form a plurality of rows that are disposed in a nested manner ([0030], [0031], [0044], & [0045]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end portion of each of the plurality of spline portion, as disclosed by Waldstreicher, to include wherein one end portion of the distal end portion and the proximal end portion of each of the plurality of spline portions forms an end portion group composed of a plurality of the one end portions annularly arranged, and a plurality of rows of the end portion groups is disposed in a nested manner when viewed along the axial direction, as taught by Keane, as such a modification would provide for a known and suitable configuration for producing the predictable result of accommodating an end portion group of the plurality of splines within the catheter shaft.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view of Nedved.
Regarding claims 14-16, as best understood in view of the 112(b) rejection above, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher does not disclose at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions (claim 14); wherein the set of spline portions comprises at least the clockwise spline portion and the counterclockwise spline portion (claim 15); wherein the distal-side bundling component comprises a plurality of insertion holes, the distal end portion of each of the plurality of spline portions being inserted through an insertion hole of the plurality of insertion holes, and the distal end portion of each of the two of the spline portions formed by the grouping linear member is inserted through the insertion hole different in the distal-side bundling component (claim 16).
Nedved teaches an electrode catheter ([0062]; Figure 4—element 401) comprising a distal-side bundling component ([0063]; Figure 4—element 411), a plurality of splines comprising a clockwise spline portion and a counterclockwise spline portion ([0072]; Figure 4—elements 415); at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions ([0075]; Figure 20—element 2001; the spline portions may be joined together at their mutual crossing points 2001; the examiner is considering the joining via a ring structure to be the grouping linear member); wherein the set of spline portions comprises at least the clockwise spline portion and the counterclockwise spline portion (claim 15) ([0075]; Figure 20); wherein the distal-side bundling component comprises a plurality of insertion holes, the distal end portion of each of the plurality of spline portions being inserted through an insertion hole of the plurality of insertion holes, and the distal end portion of each of the two of the spline portions formed by the grouping linear member is inserted through the insertion hole different in the distal-side bundling component ([0064]-[0066]; Figure 18—elements 1811; one or more splines may be inserted into respective holes 1811 of the distal-side bundling component) (claim 16).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the plurality or spline portions and the distal-side bundling component, as disclosed by Waldstreicher, to include at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions, wherein the distal-side bundling component comprises a plurality of insertion holes for inserting each of the plurality of spline portions, as taught by Nedved, as both references and the claimed invention are directed toward expandable electrode assemblies. As disclosed by Nedved, the plurality of spline portions may be joined together via a ring structure at their mutual crossing point in order to improve the structure stability of the expandable electrode assembly, the distal-side bundling component may comprise a plurality of insertion holes each receiving one or more spline portions, the configuration of the distal-side bundling component provides for easier radial movement of the plurality of spline portions in the area of the distal-side bundling component which is advantageous during the transition between the collapsed and expanded configuration ([0066], [0067], & [0075]). 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 plurality or spline portions and the distal-side bundling component, as disclosed by Waldstreicher, to include at least one grouping linear member forming a set of spline portions composed of at least two of the spline portions, wherein the distal-side bundling component comprises a plurality of insertion holes for inserting each of the plurality of spline portions, as taught by Nedved, as such a modification would improve the structure stability of the expandable electrode assembly and provide for easier radial movement of the plurality of spline portions in the area of the distal-side bundling component which is advantageous during the transition between the collapsed and expanded configuration.
Regarding claim 17, Waldstreicher discloses all of the limitations of claim 1, as described above.
Waldstreicher does not disclose wherein each of the plurality of spline portions comprises a folded portion that is provided on the distal side from the distal-side bundling component and is folded back in the axial direction.
Nedved teaches an electrode catheter ([0062]; Figure 4—element 401) comprising a distal-side bundling component ([0063]; Figure 4—element 411), a plurality of splines comprising a clockwise spline portion and a counterclockwise spline portion ([0072]; Figure 4—elements 415), wherein each of the plurality of spline portions comprises a folded portion that is provided on the distal side from the distal-side bundling component and is folded back in the axial direction ([0072]; the spline portions may be bent at a distal portion and attached adjacent the distal-side bundling component and directed back into the electrode catheter).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the distal end of the plurality or spline portions and the distal-side bundling component, as disclosed by Waldstreicher, to include wherein each of the plurality of spline portions comprises a folded portion that is provided on the distal side from the distal-side bundling component and is folded back in the axial direction, as taught by Nedved, as both references and the claimed invention are directed toward expandable electrode assemblies comprising distal-side bundling components. As disclosed Waldstreicher, the plurality of spline portion may terminate at the distal-side bundling component ([0251]). by As disclosed by Nedved, the plurality of spline portions may be cut to terminate at the distal-side bundling component or may rather be bent at the distal portion and then directed back into the outer shaft ([0063] & [0072]). 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 distal end of the plurality or spline portions and the distal-side bundling component, as disclosed by Waldstreicher, to include wherein each of the plurality of spline portions comprises a folded portion that is provided on the distal side from the distal-side bundling component and is folded back in the axial direction, as taught by Nedved, as such a modification is a known and suitable alternative to the plurality of spline portion terminating at the distal-side bundling component.
Conclusion
Accordingly, claims 1-17 are rejected.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794