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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/15/2025 has been entered.
Response to Amendment
The amendment filed 08/18/2025 has been entered. Claims 1 and 3-21 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and rejection previously set forth in the Final Office Action mailed 05/16/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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.
Claim 21 is 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.
Claim 21 recites “wherein the distal electrode assembly has an area coverage of about 7.2/cm2 to 12.6/cm2”. It is unclear as to how the applicant has calculated these areas of coverage as the specification simply recites the claim language. Further is unclear as to how the area coverage is per cm2 and not simply an area of cm2. It is unclear how the coverage area is per cm2 when there is only 4 or 7 microelectrodes per cm2 and they have small lengths of 300 um to 480 um as described in claim 17. Further explanation of how the applicant calculated this is needed to understand if the applicant had support for this claim at the time of filing.
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 and 3-21 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.
Claims 1 and 9 recite “a plurality of microelectrodes on each spine of the plurality of spines, the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal portion of the distal electrode assembly that is different from a distance D2 from the proximal portion of a second proximal-most microelectrode of the plurality of microelectrodes on the one or more second spines” and “the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal stem that is different from a distance D2 from the proximal stem of a second proximal-most microelectrode of the at least eight microelectrodes on the one or more second spines“ respectively. However it is unclear whether the applicant is referring to the adjacent two spines when referring to the one or more second spines or all of the one or more second spines comprising a proximal most electrode at a different distance than the proximal most electrode on a first spine. If applicant is referring to all of the one or more second spines then this statement is not true as all of the one or more second spines do not have a different distance as the first spine, only the adjacent two spines proximal most electrode have a different distance D2 than the first spine. The examiner suggests reciting the language that is described in the specification in Paragraph [00120] to further clarify what the applicant is trying to claim in regards to the differing sizes of the proximal most electrodes of the spines in reference to an adjacent spine. Claims 3-8 and 10-21 are rejected by virtue of dependency on claims 1 and 9 respectively.
Claim 9 recites the limitation "the at least eight microelectrodes" in line 21. There is insufficient antecedent basis for this limitation in the claim. Claims 10-21 are rejected by virtue of dependency on claim 9.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 9-12, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fang (U.S. PGPub. No. 2013/0253504) herein referred to as “Fang”, in view of Wu (U.S. Pat. No. 10,932,685), herein referred to as “Wu (685)”, further in view of Harrington et al. (U.S. PGPub. No. 2017/0020394) herein referred to as “Harrington” further in view of Just et al. (U.S. PGPub. No. 2013/0172715) herein referred to as “Just” further in view of Fleischman et al. (U.S. Pat. No. 7,048,734) herein referred to as “Fleischman”.
Regarding claim 1, Fang teaches an electrophysiology catheter (electrode catheter, Paragraph [0002]) comprising:
an elongated body (elongated catheter body 12, Figure 1);
and a distal electrode assembly comprising (distal assembly 18, comprising a plurality of spines 14 mounted at the distal end of the catheter body 12, where each spine carries at least one electrode mounted along its length or near its distal end, Figures 1 and 3, Paragraphs [0035] and [0040]):
a proximal portion (each spine 14 is fixed at its proximal end to the catheter body 12, Figure 1),
and a plurality of spines having a free distal end (distal assembly 18, comprising a plurality of spines 14 mounted at the distal end of the catheter body 12, wherein each spine has a free distal end, Figure 1).
and a plurality of nonconductive spine covers, each comprising an outer wall and an inner wall defining a sidewall therebetween with a thickness (each spine includes a nonconductive covering 26, wherein the nonconductive covering 26 defines a thickness, Figure 5, Paragraph [0011]), nonconductive spine cover surrounding a respective one of the plurality of spines (nonconductive coverings 26 each surround a respective spine, Figure 5) such that the respective one of the plurality of spines extends through a central lumen of the respective spine cover defined by the inner wall (support arms 24 (seen as the spines) extend through the central lumen defined by the inner wall of the nonconductive covering 26, Paragraph [0038], Figure 5).
However, Fang does not explicitly disclose where each of the plurality of spines comprise a tapered portion comprising proximal and distal ends and a linear taper such that the proximal end of the tapered portion is wider than the distal end of the tapered portion.
Wu (685) discloses an electrophysiology catheter. Wu (685) embodiment 1 discloses a tapered portion comprising proximal and distal ends and a linear taper such that the proximal end of the tapered portion is wider than the distal end of the tapered portion (flexible wire assembly where the cross-section tapers from a first width W11 at the proximal end 146 of flexible wire 128 to a width W12 at the distal end 142 of the flexible wire, Figures 3A-3B, Col. 8 lines 30-56).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to include the teachings of Wu (685) embodiment 1 by tapering the spines where the proximal end is wider than the distal end. The motivation to do so being to provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
However, Fang does not explicitly disclose each nonconductive spine cover having one or more tensile members extending in a sidewall lumen in the thickness of the sidewall of the respective nonconductive spine cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive spine cover.
Harrington discloses a catheter (catheter 21A, Paragraph [0066]), wherein the catheter includes tensile members extending in a sidewall lumen extending within the thickness of the sidewall of the respective catheter cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive cover (one or more pull wires or push wires 50 slidably disposed (seen as being afforded longitudinal movement) in a passage in the wall of the elongate body (seen as extending in a sidewall lumen within the thickness of the sidewall of the cover) , Figures 11-18, Paragraphs [0066], [0070], [0073], [0078], [0081], and [0088]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Fang in view of Wu to incorporate the teachings of Harrington by including each nonconductive spine cover having one or more tensile members extending in a sidewall lumen in the thickness of the sidewall of the respective nonconductive spine cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive spine cover. The motivation to do so being to change the shape of the catheter in response to operation of the one or more push wires or pull wires slidably disposed in the passage within the wall of the cover of the catheter (Harrington, Paragraphs [0066], [0070], [0073], [0078], [0081], and [0088]).
Fang discloses a plurality of microelectrodes on each spine (each spine 14 carries at least one electrode, additional single or pair of ring electrodes 28b-28d may be mounted on each non-conductive spine covering 26 proximal the first ring electrode 28a, Paragraph [0040]). However Fang does not explicitly disclose a plurality of microelectrodes on each spine of the plurality of spines, the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines.
Just discloses an electrode support structure including a plurality of splines (Abstract) wherein the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines (The electrodes 54 along a spline 24, 124 or along each of the plurality of splines 2, 124 may be the same or different in size. In accordance with a third embodiment of the disclosure, the electrode support structure assembly 12, 112 comprises an electrode support structure 22, 122 including an even number of splines 24, 124. Each of the plurality of splines 24, 124 can include an equal number of electrodes 54 disposed thereon. Each of the electrodes 54 can be substantially evenly spaced along the length of each of the plurality of splines 24, 124. In accordance with the third embodiment of the disclosure, the plurality of splines 24, 124 includes at least a first spline 24 1, 124 1 and a second spline 24 2, 124 2. The first spline 24 1, 124 1 includes a first plurality of electrodes 54 1 substantially evenly spaced apart on the first spline. The distance between adjacent electrodes 54 1 on the first spline 24 1, 124 1 may be a selected length (l). The second spline 24 2, 124 2 includes a second plurality of electrodes 54 2 substantially evenly spaced apart on the second spline. The distance between adjacent electrodes 54 2 on the second spline 24 2, 124 2 may be a selected length (l) substantially equal to the selected length (l) between adjacent electrodes 54 1 on the first spline 24 1, 124 1. Each of the second plurality of electrodes 54 2 on the second spline 24 2, 124 2 is in a staggered position relative to the position of each of the first plurality of electrodes 54 1 on the first spline 24 1, 124 1. In particular, at least one of the second plurality of electrodes 54 2 on the second spline 24 2, 124 2 is located on the second spline 24 2, 124 2 at a position that is substantially in a plane that is transverse to a longitudinal axis of the second spline 24 2, 124 2 and containing the midpoint (m) between two of the first plurality of electrodes 54 1 on the first spline 24 1, 124 1. Accordingly, the electrodes 54 1, 54 2 are positioned alternately such that the electrodes 54 1, 54 2 on adjacent splines 24 1, 124 1, 24 2, 124 2 do not coincide with each other, but fall within the middle of the space of length (l) between electrodes 54 1, 54 2 on the adjacent spline 24 1, 124 1, 24 2, 124 2, Paragraph [0053], Figures 10-11).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to incorporate the teachings of Just by including wherein the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines. The motivation to do so being to provide a more uniform distribution about a surface of the electrode support structures resulting in improved mapping as well as to prevent electro to electrode short circuits when the electrode support structure is collapsed (Just, Paragraph [0054]).
Lastly, Fang does not explicitly disclose wherein the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal portion of the distal electrode assembly that is different from a distance D2 from the proximal portion of a second proximal-most microelectrode of the plurality of microelectrodes on the one or more second spines.
Fleischman discloses a catheter based ablation device comprising splines (Col. 5, lines 35-67, Figure 6) plurality of microelectrodes on each spine of the plurality of spines (the splines 102 include regions 104 that are electrically conductive, Col. 11, lines 1-5, Figures 5/5B and 6), the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal portion of the distal electrode assembly that is different from a distance D2 from the proximal portion of a second proximal-most microelectrode of the plurality of microelectrodes on the one or more second spines (the conductive regions 104 are formed by coating the exterior surfaces with an electrically conducting material, like platinum or gold, Col. 11, lines 32-35, the relative position of the conductive regions 104 and the nonconductive regions 106 on each spline 102, and the spaced apart relationship of the splines 102 and the bridge splines 108 depend upon the particular pattern of curvilinear lesions L that the physician seeks to form, Col. 11, lines 44-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to incorporate the teachings of Fleischman by including wherein the plurality of microelectrodes on a first spine of the plurality of spines being staggered relative to the plurality of microelectrodes on one or more second spines of the plurality of spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal portion of the distal electrode assembly that is different from a distance D2 from the proximal portion of a second proximal-most microelectrode of the plurality of microelectrodes on the one or more second spines. The motivation to do so being to create a particular pattern of curvilinear lesions L that the physician seeks to form (Fleischman, Col. 11, lines 44-49).
Regarding claim 3, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 1.
However, Fang does not explicitly disclose wherein the linear taper is continuous.
Wu (685) embodiment 1 discloses wherein the linear taper is continuous (Figure 3A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685), Harrington, Just and Fleischman to include the teachings of Wu (685) by including a continuous linear taper. The motivation to do so being provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 4, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 3.
However, Fang does not explicitly disclose wherein the tapered portion comprises: a proximal section having a first width that is generally uniform; an intermediate section having the continuous linear taper; and a distal section having a second width that is generally uniform, the second width of the distal section being lesser than the first width of the proximal section.
Wu (685) embodiment 1 discloses a proximal section having a first width that is generally uniform; an intermediate section having the continuous linear taper; and a distal section having a second width that is generally uniform, the second width of the distal section being lesser than the first width of the proximal section (flexible wire assembly where the cross-section continuously tapers from a first width W11 at the proximal end 146 of flexible wire 128 to a width W12 at the distal end 142 of the flexible wire, Figures 3A-3B, Col. 8 lines 30-56).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) by providing a spline with taper comprising a proximal, intermediate, and distal section. The motivation to do so being provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 5, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 4.
However, Fang does not explicitly disclose wherein the continuous linear taper of the intermediate section comprises a continuously gradual increase in flexibility from a proximal end of the intermediate section to a distal end of the intermediate section.
Wu (685) embodiment 1 discloses that the continuous linear taper of the intermediate section comprises a continuously gradual increase in flexibility from a proximal end of the intermediate section to a distal end of the intermediate section (continuous linear taper of intermediate section of flexible wire 128 from W11 to W12, Figure 3A, increases the flexibility towards the distal end Col. 8 lines 30-56).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) by utilizing a continuous linear taper of the intermediate section. The motivation to do so being to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 9, Fang discloses an electrophysiology catheter (electrode catheter, Paragraph [0002]), comprising:
an elongated body (elongated catheter body 12, Figure 1);
and a distal electrode assembly comprising (distal assembly 18, comprising a plurality of spines 14 mounted at the distal end of the catheter body 12, where each spine carries at least one electrode mounted along its length or near its distal end, Figures 1 and 3, Paragraphs [0035] and [0040]):
a proximal stem (each spine 14 is fixed at its proximal end to the catheter body 12, Figure 1),
at least eight spines having a free distal end (the number of spines 14 can vary as desired depending on the particular application, as many as eight or ten spines can be used, Paragraph [0039], each having a free distal end, Figure 1),
at least eight nonconductive spine covers (each spine 14 also comprises a non-conductive covering 26, Paragraph [0038]), each comprising an outer wall and an inner wall defining a sidewall therebetween with a thickness (each spine includes a nonconductive covering 26, wherein the nonconductive covering 26 defines a thickness, Figure 5, Paragraph [0011]), each of the at least eight nonconductive spine covers surrounding a respective one of each of the at least eight spines (each spine 14 also comprises a non-conductive covering 26, Paragraph [0038]) such that the respective one of the at least eight spines extends through a central lumen of the respective one of the at least eight spine covers defined by the inner wall (support arms 24 (seen as the spines) extend through the central lumen defined by the inner wall of the nonconductive covering 26, Paragraph [0038], Figure 5);
and a plurality of microelectrodes on the at least eight spines (each spine 14 carries at least one electrode mounted along its length at or near its distal end, (Paragraph [0040]).
However, Fang does not explicitly disclose where each of the plurality of spines comprise a tapered portion comprising proximal and distal ends and a linear taper such that the proximal end of the tapered portion is wider than the distal end of the tapered portion.
Wu (685) embodiment 1 discloses each of the at least eight spines having a tapered portion comprising proximal and distal ends and a linear taper such that the proximal end of the tapered portion is wider than the distal end of the tapered portion (flexible wire assembly where the cross-section tapers from a first width W11 at the proximal end 146 of flexible wire 128 to a width W12 at the distal end 142 of the flexible wire, Figures 3A-3B, Col. 8 lines 30-56).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to include the teachings of Wu (685) embodiment 1 by tapering the spines where the proximal end is wider than the distal end. The motivation to do so being provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
However, Fang does not explicitly disclose wherein each nonconductive spine cover having one or more tensile members extending in a sidewall lumen in the thickness of the sidewall of the respective nonconductive spine cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive spine cover.
Harrington discloses a catheter (catheter 21A, Paragraph [0066]), wherein the catheter includes tensile members extending in a sidewall lumen extending within the thickness of the sidewall of the respective catheter cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive cover (one or more pull wires or push wires 50 slidably disposed (seen as being afforded longitudinal movement) in a passage in the wall of the elongate body (seen as extending in a sidewall lumen within the thickness of the sidewall of the cover) , Figures 11-18, Paragraphs [0066], [0070], [0073], [0078], [0081], and [0088]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Fang in view of Wu to incorporate the teachings of Harrington by including each nonconductive spine cover having one or more tensile members extending in a sidewall lumen in the thickness of the sidewall of the respective nonconductive spine cover such that the tensile members are afforded longitudinal movement within the sidewall lumen relative to the nonconductive spine cover. The motivation to do so being to change the shape of the catheter in response to operation of the one or more push wires or pull wires slidably disposed in the passage within the wall of the cover of the catheter (Harrington, Paragraphs [0066], [0070], [0073], [0078], [0081], and [0088]).
Fang discloses a plurality of microelectrodes on each spine (each spine 14 carries at least one electrode, additional single or pair of ring electrodes 28b-28d may be mounted on each non-conductive spine covering 26 proximal the first ring electrode 28a, Paragraph [0040]). However Fang does not explicitly disclose wherein
the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines.
Just discloses an electrode support structure including a plurality of splines (Abstract) wherein the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines (The electrodes 54 along a spline 24, 124 or along each of the plurality of splines 2, 124 may be the same or different in size. In accordance with a third embodiment of the disclosure, the electrode support structure assembly 12, 112 comprises an electrode support structure 22, 122 including an even number of splines 24, 124. Each of the plurality of splines 24, 124 can include an equal number of electrodes 54 disposed thereon. Each of the electrodes 54 can be substantially evenly spaced along the length of each of the plurality of splines 24, 124. In accordance with the third embodiment of the disclosure, the plurality of splines 24, 124 includes at least a first spline 24 1, 124 1 and a second spline 24 2, 124 2. The first spline 24 1, 124 1 includes a first plurality of electrodes 54 1 substantially evenly spaced apart on the first spline. The distance between adjacent electrodes 54 1 on the first spline 24 1, 124 1 may be a selected length (l). The second spline 24 2, 124 2 includes a second plurality of electrodes 54 2 substantially evenly spaced apart on the second spline. The distance between adjacent electrodes 54 2 on the second spline 24 2, 124 2 may be a selected length (l) substantially equal to the selected length (l) between adjacent electrodes 54 1 on the first spline 24 1, 124 1. Each of the second plurality of electrodes 54 2 on the second spline 24 2, 124 2 is in a staggered position relative to the position of each of the first plurality of electrodes 54 1 on the first spline 24 1, 124 1. In particular, at least one of the second plurality of electrodes 54 2 on the second spline 24 2, 124 2 is located on the second spline 24 2, 124 2 at a position that is substantially in a plane that is transverse to a longitudinal axis of the second spline 24 2, 124 2 and containing the midpoint (m) between two of the first plurality of electrodes 54 1 on the first spline 24 1, 124 1. Accordingly, the electrodes 54 1, 54 2 are positioned alternately such that the electrodes 54 1, 54 2 on adjacent splines 24 1, 124 1, 24 2, 124 2 do not coincide with each other, but fall within the middle of the space of length (l) between electrodes 54 1, 54 2 on the adjacent spline 24 1, 124 1, 24 2, 124 2, Paragraph [0053], Figures 10-11).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to incorporate the teachings of Just by including the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines. The motivation to do so being to provide a more uniform distribution about a surface of the electrode support structures resulting in improved mapping as well as to prevent electro to electrode short circuits when the electrode support structure is collapsed (Just, Paragraph [0054]).
Lastly, Fang does not explicitly disclose wherein the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal stem that is different from a distance D2 from the proximal stem of a second proximal-most microelectrode of the at least eight microelectrodes on the one or more second spines.
Fleischman discloses a catheter based ablation device comprising splines (Col. 5, lines 35-67, Figure 6) plurality of microelectrodes on each spine of the plurality of spines (the splines 102 include regions 104 that are electrically conductive, Col. 11, lines 1-5, Figures 5/5B and 6), wherein the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal stem that is different from a distance D2 from the proximal stem of a second proximal-most microelectrode of the at least eight microelectrodes on the one or more second spines (the conductive regions 104 are formed by coating the exterior surfaces with an electrically conducting material, like platinum or gold, Col. 11, lines 32-35, the relative position of the conductive regions 104 and the nonconductive regions 106 on each spline 102, and the spaced apart relationship of the splines 102 and the bridge splines 108 depend upon the particular pattern of curvilinear lesions L that the physician seeks to form, Col. 11, lines 44-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang to incorporate the teachings of Fleischman by including wherein the plurality of microelectrodes on a first spine of the at least eight spines being staggered relative to the plurality of microelectrodes on one or more second spines of the at least eight spines such that a first proximal-most microelectrode of the plurality of microelectrodes on the first spine is at a distance D1 from the proximal stem that is different from a distance D2 from the proximal stem of a second proximal-most microelectrode of the at least eight microelectrodes on the one or more second spines. The motivation to do so being to create a particular pattern of curvilinear lesions L that the physician seeks to form (Fleischman, Col. 11, lines 44-49).
Regarding claim 10, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However, Fang does not explicitly disclose wherein the linear taper is continuous.
Wu (685) embodiment 1 discloses wherein the linear taper is continuous (Figures 3A and 3B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685), Harrington, Just and Fleischman to include the teachings of Wu (685) by including a continuous linear taper. The motivation to do so being provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 11, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 10.
However, Fang does not explicitly disclose wherein the tapered portion comprises: a proximal section having a first width that is generally uniform; an intermediate section having the continuous linear taper; and a distal section having a second width that is generally uniform, the second width of the distal section being lesser than the first width of the proximal section.
Wu (685) embodiment 1 discloses wherein the tapered portion comprises: a proximal section having a first width that is generally uniform; an intermediate section having the continuous linear taper; and a distal section having a second width that is generally uniform, the second width of the distal section being lesser than the first width of the proximal section (flexible wire assembly where the cross-section continuously tapers from a first width W11 at the proximal end 146 of flexible wire 128 to a width W12 at the distal end 142 of the flexible wire, Figures 3A-3B, Col. 8 lines 30-56).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685), Harrington, Just and Fleischman to include the teachings of Wu (685) by providing a spline with taper comprising a proximal, intermediate, and distal section. The motivation to do so being provide a stiffer base at the proximal end to better support the spine and a narrower distal width to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 12, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 11.
However, Fang does not explicitly disclose wherein the continuous linear taper of the intermediate section comprises a continuously gradual increase in flexibility from a proximal end of the intermediate section to a distal end of the intermediate section.
Wu (685) embodiment 1 discloses that the continuous linear taper of the intermediate section comprises a continuously gradual increase in flexibility from a proximal end of the intermediate section to a distal end of the intermediate section (continuous linear taper of intermediate section of flexible wire 128 from W11 to W12, Figure 3A, increases the flexibility towards the distal end Col. 8 lines 30-56).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685), Harrington, Just and Fleischman to include the teachings of Wu (685) by utilizing a continuous linear taper of the intermediate section. The motivation to do so being to increase the flexibility of the spine and provide better electrode contact with the tissue to be treated (Wu (685), Col. 8 lines 36-41).
Regarding claim 18, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
Fang further discloses wherein the microelectrodes on each spine are separated by a distance ranging between about 1mm and 3mm, as measured between leading edges of the microelectrodes (the distance between the first ring electrode 28a and adjacent electrode 28b ranges from about 0.5 mm to about 2 mm, which falls within the range (Paragraph [0040])).
Claims 6, 7, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of “Wu (685)”.
Regarding claim 6, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 1.
However, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman does not explicitly disclose wherein the linear taper is noncontinuous.
Wu (685) discloses in embodiment 2 wherein the linear taper is noncontinuous (Figures 5A and 5B).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) embodiment 2 by including a noncontinuous taper. The motivation to do so being to provide a close fit to the area of the patient being investigated such as the right or left atria (Wu (685), Col. 9 lines 37-47).
Regarding claim 7, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Wu (685) embodiment 2 discloses the catheter of claim 6.
However, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman does not explicitly disclose wherein the noncontinuous linear taper comprises: an indented portion comprising a first width; a proximal stem proximal of the indented portion and comprising a second width; and a distal portion distal of the indented portion and comprising a third width, wherein the first width of the indented portion is lesser than the second width of the proximal stem and the third width of the distal portion.
Wu (685) embodiment 2 does disclose wherein the noncontinuous linear taper comprises: an indented portion comprising a first width (indented portion T1, first width T1, Figures 5A and 5B);
a proximal stem proximal of the indented portion and comprising a second width (second width T2, Figures 5A and 5B);
and a distal portion distal of the indented portion and comprising a third width (third width T3, Figures 5A and 5B),
wherein the first width of the indented portion is lesser than the second width of the proximal stem and the third width of the distal portion (thickness varies from T1 to T2 to T3 where T1 is the smallest and T3 is the biggest, Figures 5A and 5B, Col 9 lines 56-63).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) embodiment 2 by including a noncontinuous taper with different sections that have different widths. The motivation to do so being to provide a close fit to the area of the patient being investigated such as the right or left atria (Wu (685), Col. 9 lines 37-47).
Regarding claim 13, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman does not explicitly disclose wherein the linear taper is noncontinuous.
Wu (685) discloses in embodiment 2 wherein the linear taper is noncontinuous (Figures 5A and 5B).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) embodiment 2 by including a noncontinuous taper. The motivation to do so being to provide a close fit to the area of the patient being investigated such as the right or left atria (Wu (685), Col. 9 lines 37-47).
Regarding claim 14, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Wu (685) embodiment 2 discloses the catheter of claim 6.
However, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman does not explicitly disclose wherein the noncontinuous linear taper comprises: an indented portion comprising a first width; a proximal stem proximal of the indented portion and comprising a second width; and a distal portion distal of the indented portion and comprising a third width, wherein the first width of the indented portion is lesser than the second width of the proximal stem and the third width of the distal portion.
Wu (685) embodiment 2 does disclose wherein the noncontinuous linear taper comprises: an indented portion comprising a first width (indented portion T1, first width T1, Figures 5A and 5B);
a proximal stem proximal of the indented portion and comprising a second width (second width T2, Figures 5A and 5B);
and a distal portion distal of the indented portion and comprising a third width (third width T3, Figures 5A and 5B),
wherein the first width of the indented portion is lesser than the second width of the proximal stem and the third width of the distal portion (thickness varies from T1 to T2 to T3 where T1 is the smallest and T3 is the biggest, Figures 5A and 5B, Col 9 lines 56-63).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (685) embodiment 2 by including a noncontinuous taper with different sections that have different widths. The motivation to do so being to provide a close fit to the area of the patient being investigated such as the right or left atria (Wu (685), Col. 9 lines 37-47).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Wu et al. (U.S. PGPub. No. 2014/0303618) herein referred to as “Wu (618)”.
Regarding claim 8, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 1.
However, Fang does not explicitly disclose wherein at least one of the plurality of spines comprises a hinge along a lateral edge, the hinge configured for in-plane deflection of the spine.
Wu (618) discloses a multi-directional deflectable catheter apparatus. Wu discloses wherein at least one of the plurality of spines comprises a hinge along a lateral edge (flexure zone 34 has hinge joint L3, Figures 8A-8D), the hinge configured for in-plane deflection of the spine (Figures 8B-8D).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (618) by including a hinge on the spine. The motivation to do so being to include the mechanical properties to accommodate flexure and bending for navigating through arteries (Wu (618), Paragraph [0138]).
Regarding claim 15, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However, Fang does not explicitly disclose wherein at least one of the at least eight spines comprises a hinge along a lateral edge, the hinge configured for in-plane deflection of the spine.
Wu (618) discloses wherein at least one of the plurality of spines comprises a hinge along a lateral edge (flexure zone 34 has hinge joint L3, Figures 8A-8D), the hinge configured for in-plane deflection of the spine (Figures 8B-8D).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Wu (618) by including a hinge on the spine. The motivation to do so being to include the mechanical properties to accommodate flexure and bending for navigating through arteries (Wu (618), Paragraph [0138]).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Marecki et al. (U.S. Pat. No. 9,585,588) herein referred to as “Marecki”.
Regarding claim 16, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However, Fang does not explicitly disclose wherein the plurality of microelectrodes comprises at least 48 microelectrodes.
Marecki discloses a catheter with an expandable electrode assembly. Marecki discloses wherein the at least eight microelectrodes comprises at least 48 microelectrodes (up to sixty-four sensing electrodes may be distributed over and along the various splines, (Col 10, lines 38- 63)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Marecki by utilizing at least 48 microelectrodes. The motivation to do so being that one or more electrodes may be used for cardiac mapping or diagnosis, ablation and/or other therapies involving the application of electrical energy to a patient’s heart (Marecki, Col 6, lines 11-50).
Regarding claim 19, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
Fang does disclose with leading edges of microelectrodes within a pair separated by a first distance ranging between about 1mm and 3mm (the distance between the first ring electrode 28a and adjacent electrode 28b ranges from about 0.5 mm to about 2 mm (Paragraph [0040])), and with leading edges of leading microelectrodes between pairs separated by a second distance ranging between 1mm and 6mm (the distance between adjacent pairs of electrodes ranges from about 2.0 mm to 8.0 mm, (Paragraph [0040])).
However, Fang does not explicitly disclose wherein the microelectrodes on each spine are arranged as bipole pairs.
Marecki discloses wherein the microelectrodes on each spine are arranged as bipole pairs (the electrodes 64 may form a number of bipolar electrode pairs on a spline surface, Col 7, lines 38-63).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Marecki by utilizing bipolar electrode pairs. The motivation to do so being that certain electrode distributions may be advantageous for non-contact cardiac mapping while others may be more suited for contact mapping (Marecki, Col 7, lines 27-37).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Hoitink et al. (U.S. PGPub. No. 2016/0143588) herein referred to as “Hoitink (588)”.
Regarding claim 17, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However Fang does not explicitly disclose wherein each of the plurality of microelectrodes has a length of about 300 um to about 480 um.
Hoitink (588) discloses wherein each of the plurality of microelectrodes has a length of about 300 um to about 480 um (preferably each ring electrode is relatively short, having a length ranging from about 0.4 mm to about 0.75 mm (comprises 400 um to 480 um), Paragraph [0052]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685), Harrington, Just and Fleischman to include the teachings of Hoitink (588) by including wherein each of the plurality of microelectrodes has a length of about 300 um to about 480 um. The motivation to do so being to allow for more accurate detection of near filed pulmonary vein potential versus far field atrial signals (Hoitink (588), Paragraph [0052]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Hoitink et al. (U.S. Pat. No. 9,820,664) herein referred to as “Hoitink (644)”.
Regarding claim 20, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim 9.
However, Fang does not explicitly disclose where the catheter further comprising: a first ring electrode carried on the proximal stem of the distal electrode assembly; and second and third ring electrodes carried on a distal portion of the elongated body.
Hoitink (644) discloses a catheter with a high-density electrode spine array. Hoitink discloses where the catheter further comprising: a first ring electrode carried on the proximal stem of the distal electrode assembly; and second and third ring electrodes carried on a distal portion of the elongated body (Hoitink, electrodes 38D and 38P, Figure 5A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to include the teachings of Hoitink (644) by utilizing a first ring electrode on the proximal stem and a second and third ring electrode on the distal portion of the elongated body. The motivation to do so being for visualization of the catheter on a 3D mapping system (Hoitink, Col 10, lines 47-55).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman further in view of Viswanathan et al (U.S. PGPub. No. 20180085160) herein referred to as “Viswanathan” further in view of Ruppersberg et al. (WO 2017041890) herein referred to as “Ruppersberg”.
Regarding claim 21, Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman discloses the catheter of claim catheter of claim 1.
However Fang does not explicitly disclose wherein the distal electrode assembly has an area coverage of about 7.2/cm2 to 12.6/cm2, and- a microelectrode density of 4 microelectrodes/cm2 to 7 microelectrodes/cm2.
Viswanathan discloses wherein the catheter comprises a distal electrode assembly having an area coverage of about 7.2/cm2 to 12.6/cm2 (each electrode of the set may have a surface area between 0.5 mm2 to about 20 mm2, the set of electrodes may range from 2 to 64 electrodes (48 electrodes x 0.2 cm2 area of each electrode = 9.6 cm2 of coverage of the electrodes), Paragraph [0163]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to incorporate the teachings of Viswanathan by including wherein the catheter comprises a distal electrode assembly having an area coverage of about 7.2/cm2 to 12.6/cm2. The motivation to do so being to provide a contiguous, transmural lesion resulting in electrical isolation of the pulmonary vein, which is a desired therapeutic outcome (Viswanathan, Paragraph [0126]).
Ruppersberg discloses wherein the catheter further comprises a plurality of microelectrodes on the plurality of spines, the distal electrode assembly having a microelectrode density of 4 microelectrodes/cm2 to 7 microelectrodes/cm2 (a resolution of 1 to 36 electrodes per cm2 are achieved (4 microelectrodes/cm2 to 7 microelectrodes/cm2 falls within this range), wherein the electrodes are disposed on support arms (seen as spines), Page 7, lines 27-30, (see attached)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fang in view of Wu (685) embodiment 1, Harrington, Just and Fleischman to incorporate the teachings of Ruppersberg by including wherein the catheter further comprises a plurality of microelectrodes on the plurality of spines, the distal electrode assembly having a microelectrode density of 4 microelectrodes/cm2 to 7 microelectrodes/cm2. The motivation to do so being to provide a high resolution for recording electrophysiological data (Ruppersberg, Page 7, lines 5-30 (see attached)).
Conclusion
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/D.S./ Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794