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 .
Election/Restrictions
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/3/2026.
Applicant’s election without traverse of the species depicted in Figures 2A-C and Figure 4C in the reply filed on 2/3/2026 is acknowledged.
Claim Objections
Claim 3 is objected to because of the following informalities: Line 2: “first openings” should read –first irrigation openings–;
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1-2, 4, 8-9, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kordis et al., US 20120271138, herein referred to as “Kordis”, in view of West et al., US 20050154386, herein referred to as “West”.
Regarding claim 1, Kordis discloses a spine retention hub for a basket type catheter (Figure 31D), comprising: a cylindrical member (Figure 31D) comprising: a first portion at a distal end of the spine retention hub having a first diameter (Figure 31D: spline tube 72); a second portion proximate the first portion and having a curved section with a first radius of curvature in a longitudinal direction (Figure 31D: hemostat plug 170), the first radius of curvature being approximately half the first diameter (Figure 31D: hemostat plug 170); and a third portion proximate to the second portion at a proximal end of the spine retention hub and having a third diameter that is approximately three times the first diameter (Figure 31D: slotted anchor 158 and Figure 31A: proximal anchor 18), the third portion comprising: a plurality of relief lands (Figure 31A: spline-receiving slots 168); a plurality of brackets (Figure 31C: slotted anchor 158 has brackets), each disposed at the proximal end of the spine retention hub (Figure 31D: slotted anchor 158 is at the proximal end), each overlapping a portion of a respective relief land of the plurality of relief lands (Figure 31B: each bracket of anchor 158 overlaps a portion of each slot 168), each bracket is, along with a respective relief land, configured to receive and retain a respective spine section (Figure 31D and [0148]: “The slots 168 are sized to fit the basket splines 14 and the slot length ensures splines 14 are positioned accurately, which aids in even collapsing of the basket 12.”). Kordis does not explicitly disclose a spine retention hub comprising a plurality of first irrigation openings, each proximate the distal end of the spine retention hub.
However, West teaches a spine retention hub (Figure 20: stem 124’) comprising a plurality of first irrigation openings (Figure 20: side openings 272 and [0195]: “The irrigation fluid F is intended to exit the passage 214' through an array of side openings 272 (see FIG. 20) formed near the cap 212'.”), each proximate the distal end of the spine retention hub (Figure 20: side openings 272 are proximate the distal end of stem 124’).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that it includes a plurality of first irrigation openings, each proximate the distal end of the spine retention hub as taught by West to cool surface tissue while energy is being applied to heat muscle or tissue beneath the surface, to thereby protect the surface tissue from thermal damage (West [0083]).
Regarding claim 2, Kordis in view of West discloses the spine retention hub according to claim 1, and West further discloses a spine retention hub wherein the plurality of first irrigation openings comprises six openings (Figure 20: side openings 272 and [0197]) which are aligned with the plurality of relief lands ([0199]: “In this way, irrigation fluid flowing into the manifold region 234' from the stem passage 214' (through the side openings 272) is free to enter the lumen 240 of each basket arm 202.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that the plurality of first irrigation openings comprises six openings which are aligned with the plurality of relief lands as taught by West to cool surface tissue while energy is being applied to heat muscle or tissue beneath the surface, to thereby protect the surface tissue from thermal damage (West [0083]).
Regarding claim 4, Kordis in view of West discloses the spine retention hub according to claim 1, and Kordis further discloses a spine retention hub further comprising at least one electrode disposed on the first portion (Figure 33B: electrodes 186 and [0150]).
Regarding claim 8, Kordis in view of West discloses the spine retention hub according to claim 1, and Kordis further discloses a spine retention hub wherein the second portion of the cylindrical member has a second diameter that transitions from the first diameter to the third diameter in the longitudinal direction about the curved section (Figure 31D: hemostat plug 170).
Regarding claim 9, Kordis in view of West discloses the spine retention hub according to claim 8, and Kordis further discloses a spine retention hub wherein the curved section comprises a concave section proximate the first portion (Figure 31D: the distal portion of hemostat plug 170) and a convex section proximate the third portion (Figure 31D: the proximal portion of hemostat plug 170).
Regarding claim 16, Kordis discloses a medical probe (Figure 2), comprising: a spine retention hub (Figure 31D), comprising: a cylindrical member (Figure 31D) comprising: a first portion at a distal end of the spine retention hub having a first diameter (Figure 31D: spline tube 72); a second portion proximate the first portion and having a curved section with a first radius of curvature in a longitudinal direction (Figure 31D: hemostat plug 170), the first radius of curvature being approximately half the first diameter (Figure 31D: hemostat plug 170); and a third portion proximate to the second portion at a proximal end of the spine retention hub and having a third diameter that is approximately three times the first diameter (Figure 31D: slotted anchor 158 and Figure 31A: proximal anchor 18), the third portion comprising: a plurality of relief lands (Figure 31A: spline-receiving slots 168); a plurality of brackets (Figure 31C: slotted anchor 158 has brackets), each disposed at the proximal end of the spine retention hub (Figure 31D: slotted anchor 158 is at the proximal end), each overlapping a portion of a respective relief land of the plurality of relief lands (Figure 31B: each bracket of anchor 158 overlaps a portion of each slot 168), each bracket is, along with a respective relief land, configured to receive and retain a respective spine section of a plurality of spine sections (Figure 31D and [0148]: “The slots 168 are sized to fit the basket splines 14 and the slot length ensures splines 14 are positioned accurately, which aids in even collapsing of the basket 12.”); a flexible insertion tube having a proximal end and a distal end (Figure 2: catheter body 20), the flexible insertion tube extending along a longitudinal axis (Figure 2: catheter body 20); an expandable basket assembly proximate the distal end of the flexible insertion tube (Figure 2: spline basket 12), the expandable basket assembly comprising: a single unitary structure that comprises the plurality of spine sections (Figure 2: spline basket 12 and splines 14), the spine sections converging at a central spine intersection (Figure 26A: distal tip 16), the central spine intersection having one or more cutouts that are configured to allow bending of the spine sections (Figures 26A-F), each spine section having a respective end connected to the distal end of the flexible insertion tube with a respective bracket and the respective relief land (Figure 31D and [0148]), the central spine intersection being positioned on the longitudinal axis at a distal end of the expandable basket assembly (Figure 2: distal tip 16); and one or more electrodes coupled to each of the spine sections (Figure 33B: electrodes 186), each electrode defining a lumen through the electrode so that a spine section extends through the lumen of each of the one or more electrodes (Figure 34A: splines 14 extend through spline tube assemblies 185 which includes electrodes 186). Kordis does not explicitly disclose a medical probe comprising a spine retention hub comprising a plurality of first irrigation openings, each proximate the distal end of the spine retention hub.
However, West teaches a medical probe (Figure 1) comprising a spine retention hub (Figure 20: stem 124’) comprising a plurality of first irrigation openings (Figure 20: side openings 272 and [0195]: “The irrigation fluid F is intended to exit the passage 214' through an array of side openings 272 (see FIG. 20) formed near the cap 212'.”), each proximate the distal end of the spine retention hub (Figure 20: side openings 272 are proximate the distal end of stem 124’).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical probe disclosed by Kordis so that it includes a plurality of first irrigation openings, each proximate the distal end of the spine retention hub as taught by West to cool surface tissue while energy is being applied to heat muscle or tissue beneath the surface, to thereby protect the surface tissue from thermal damage (West [0083]).
Regarding claim 18, Kordis in view of West discloses the medical probe according to claim 16, and Kordis further discloses a medical probe wherein the plurality of spine sections extend from the central spine intersection in an equiangular pattern such that respective angles between respectively adjacent spine sections are approximately equal (Figure 9 and [0113]).
Regarding claim 19, Kordis discloses a medical probe (Figure 2), comprising: a spine retention hub (Figure 31D), comprising: a cylindrical member (Figure 31D) comprising: a first portion at a distal end of the spine retention hub having a first diameter (Figure 31D: spline tube 72); a second portion proximate the first portion and having a curved section in a longitudinal direction (Figure 31D: hemostat plug 170); and a third portion proximate to the second portion at a proximal end of the spine retention hub and having a third diameter that is different from the first diameter (Figure 31D: slotted anchor 158 and Figure 31A: proximal anchor 18), the third portion comprising: a plurality of relief lands (Figure 31A: spline-receiving slots 168); a plurality of brackets (Figure 31C: slotted anchor 158 has brackets), each disposed at the proximal end of the spine retention hub (Figure 31D: slotted anchor 158 is at the proximal end), each overlapping a portion of a respective relief land of the plurality of relief lands (Figure 31B: each bracket of anchor 158 overlaps a portion of each slot 168), each bracket is, along with a respective relief land, configured to receive and retain a respective spine section of a plurality of spine sections (Figure 31D and [0148]: “The slots 168 are sized to fit the basket splines 14 and the slot length ensures splines 14 are positioned accurately, which aids in even collapsing of the basket 12.”); a flexible insertion tube having a proximal end and a distal end (Figure 2: catheter body 20), the flexible insertion tube extending along a longitudinal axis (Figure 2: catheter body 20); and an expandable basket assembly proximate the distal end of the flexible insertion tube (Figure 2: spline basket 12). Kordis does not explicitly disclose a medical probe comprising a spine retention hub comprising a plurality of first irrigation openings, each proximate the distal end of the spine retention hub.
However, West teaches a medical probe (Figure 1) comprising a spine retention hub (Figure 20: stem 124’) comprising a plurality of first irrigation openings (Figure 20: side openings 272 and [0195]: “The irrigation fluid F is intended to exit the passage 214' through an array of side openings 272 (see FIG. 20) formed near the cap 212'.”), each proximate the distal end of the spine retention hub (Figure 20: side openings 272 are proximate the distal end of stem 124’).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical probe disclosed by Kordis so that it includes a plurality of first irrigation openings, each proximate the distal end of the spine retention hub as taught by West to cool surface tissue while energy is being applied to heat muscle or tissue beneath the surface, to thereby protect the surface tissue from thermal damage (West [0083]).
Regarding claim 20, Kordis in view of West discloses the medical probe according to claim 19, and Kordis further discloses a medical probe wherein the expandable basket assembly (Figure 2: spline basket 12) comprises: a single unitary structure that comprises the plurality of spine sections (Figure 2: spline basket 12 and splines 14), the spine sections converging at a central spine intersection (Figure 26A: distal tip 16), the central spine intersection having one or more cutouts that allows for bending of the spine sections (Figures 26A-F), each spine section having a respective end connected to the distal end of the flexible insertion tube with a respective curved bracket and the respective relief land (Figure 31D and [0148]), the central spine intersection being positioned on the longitudinal axis at a distal end of the expandable basket assembly (Figure 2: distal tip 16); and one or more electrodes coupled to each of the spine sections (Figure 33B: electrodes 186), each electrode defining a lumen through the electrode so that a spine section extends through the lumen of each of the one or more electrodes (Figure 34A: splines 14 extend through spline tube assemblies 185 which includes electrodes 186).
Claims 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kordis in view of West, further in view of Erbey, II et al., US 20190091442, herein referred to as “Erbey”.
Regarding claims 3 and 17, Kordis in view of West discloses the spine retention hub according to claim 1 and the medical probe according to claim 16, respectively, but does not explicitly disclose a spine retention hub wherein each opening of the plurality of first irrigation openings comprises a flow area of approximately 0.05 mm2 to approximately 0.6 mm2.
However, Erbey teaches a device wherein each opening of the plurality of first openings comprises a flow area of approximately 0.05 mm2 to approximately 0.6 mm2 (Figure 10E: openings 1232 and [0257]: “In some examples, a diameter D11 of each of the openings 1232 can range independently from about 0.05 mm to about 2.5 mm and have an area of about 0.002 mm.sup.2 to about 5 mm.sup.2.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that each opening of the plurality of first openings comprises a flow area of approximately 0.05 mm2 to approximately 0.6 mm2 as taught by Erbey for a desired volumetric flow rate for each opening (Erbey [0257]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kordis in view of West, further in view of Olson, US 20190282116, herein referred to as “Olson”.
Regarding claim 5, Kordis in view of West discloses the spine retention hub according to claim 4, but does not explicitly disclose a spine retention hub wherein the at least one electrode comprises a cylindrical electrode.
However, Olson teaches a spine retention hub (Figure 2A: catheter shaft 205, bushing 208, and strut 2103) wherein the at least one electrode comprises a cylindrical electrode (Figure 2A: electrodes 211 and [0080]: “While various embodiments of the planar array 201 disclosed in the present disclosure are depicted with ring electrodes 211.sub.1-N coupled to the struts 210.sub.1-5”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that the at least one electrode comprises a cylindrical electrode as taught by Olson to ensure that the electrode spacing facilitates desirable electrophysiology mapping granularity in a number of cardiovascular applications (Olson [0044]).
Regarding claim 6, Kordis in view of West discloses the spine retention hub according to claim 4, but does not explicitly disclose a spine retention hub wherein the at least one electrode comprises a cylindrical shape that is truncated at two ends.
However, Olson teaches a spine retention hub (Figure 2A: catheter shaft 205, bushing 208, and strut 2103) wherein the at least one electrode comprises a cylindrical shape that is truncated at two ends (Figure 2A: electrodes 211 and [0080]: “While various embodiments of the planar array 201 disclosed in the present disclosure are depicted with ring electrodes 211.sub.1-N coupled to the struts 210.sub.1-5”; wherein the shape is truncated at the top and bottom of the cylinder).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that the at least one electrode comprises a cylindrical shape that is truncated at two ends as taught by Olson to ensure that the electrode spacing facilitates desirable electrophysiology mapping granularity in a number of cardiovascular applications (Olson [0044]).
Claims 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kordis in view of West, further in view of Aujla, US 20170156790, herein referred to as “Aujla”.
Regarding claim 10, Kordis in view of West discloses the spine retention hub according to claim 9, but does not explicitly disclose a spine retention hub wherein each bracket comprises a curved bracket and overlaps a proximal end of a respective relief land.
However, Aujla teaches a spine retention hub (Figures 3 and 6: spine collar 20) wherein each bracket comprises a curved bracket and overlaps a proximal end of a respective relief land (Figures 3 and 6: outer lumens 36 are curved and thus, the brackets are curved and overlap a proximal end of outer lumens 36 and [0041]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the spine retention hub disclosed by Kordis so that each bracket comprises a curved bracket and overlaps a proximal end of a respective relief land as taught by Aujla to ensure that the spines stay in place (Aujla [0041]).
Regarding claim 11, Kordis in view of West and Aujla discloses the spine retention hub according to claim 10, and Kordis further discloses a spine retention hub wherein each bracket is raised above an outer surface of the spine retention hub (Figure 31B: brackets are raised above spline-receiving slots 168).
Regarding claim 12, Kordis in view of West and Aujla discloses the spine retention hub according to claim 11, and Kordis further discloses a spine retention hub wherein each bracket comprises a first cutout extending in the longitudinal direction and a radial direction of the spine retention hub (Figure 31B: each bracket comprises a spline-receiving slot 168, which is a cutout that extends in the longitudinal direction and a radial direction of the spine retention hub).
Regarding claim 13, Kordis in view of West and Aujla discloses the spine retention hub according to claim 12, and Kordis further discloses a spine retention hub wherein each bracket comprises a second cutout that extends in the longitudinal direction and radial direction of the spine retention hub and separates each backet into two sections (Figure 31B: each bracket comprises two spline-receiving slots 168, which are cutouts that extends in the longitudinal direction and a radial direction of the spine retention hub, thus separating each bracket into two sections).
Regarding claim 14, Kordis in view of West and Aujla discloses the spine retention hub according to claim 13, and Kordis further discloses a spine retention hub wherein: the third portion of the cylindrical member comprises a plurality of elongated cavities configured to receive one or more wires (Figure 31A: spline-receiving slots 168 and [0147]: “The open diameter or lumen 164 allows wires, flex circuits, etc from the spline basket 12 to pass through the anchor 158. ”), and the second portion of the cylindrical member comprises a ring extending radially (Figure 31D: the proximal part of hemostat plug 170 is a ring that extends radially) and having a plurality of third cutouts configured to receive the one or more wires ([0147] and Figure 31D: the splines extend through hemostat plug 170).
Regarding claim 15, Kordis in view of West and Aujla discloses the spine retention hub according to claim 14, and Kordis further discloses a spine retention hub wherein the plurality of third cutouts are aligned about with the plurality of elongated cavities in the longitudinal direction (Figure 31D and [0147]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794