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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 23rd, 2026 has been entered.
Response to Amendment
The amendment filed February 23rd, 2026 has been entered. Applicant’s amendments to the Claims have overcome the claim objections and the 112(b) rejections previously set forth in the Final Office Action mailed November 26th, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted February 23rd, 2026 has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed February 23rd, 2026, with respect to the rejection(s) of claim(s) 1 &11 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly disclosed claim limitations and a new interpretation of the current prior art of record.
The following new grounds of rejection are set forth:
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, 8 & 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Just et al. (U.S. Pub. No. 20130172715, previously cited), herein referred to as “Just”.
Regarding claim 1, Just teaches a medical probe (Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines; [0033]: Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional), comprising:
a tubular shaft (catheter body 20) including a proximal end (proximal end of catheter body 20) and a distal end (distal end of catheter body 20), the tubular shaft extending along a longitudinal axis ([0037]: The electrode support structure 22 defines a longitudinal axis (A); see Figs. 1-2 where this axis lies along both the electrode support structure 22 and catheter body 20);
an expandable basket assembly (electrode support assembly 112) proximate the distal end of the tubular shaft ([0046]: The electrode support structure assembly 112 can be similarly mounted to the distal end of the elongated catheter body 20 (see FIG. 1); see Fig. 12C where the distal end of the basket assembly is within the distal end of the catheter body), the expandable basket assembly comprising:
a structure (electrode support structure 122) that includes a plurality of spine sections (plurality of splines 124) and a central spine intersection (distal end of electrode support structure comprising the distal end portions 128 of splines 124 first element 130 & second element 140) being positioned on the longitudinal axis at a distal end of the expandable basket assembly (see Fig. 4 for relationship to longitudinal axis A), each spine section of the plurality of spine sections including a proximal spine end (proximal end of spline 14/portion connected to proximal anchor 18) connected to the distal end of the tubular shaft ([0051]: third element 42 can comprise a generally cylindrical member having an outer radial surface 44 including a plurality of channels 46. Each of the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124; see Fig. 1 & 4) and a stopper (distal end portion 128, stopper is distal end 138) positioned at a distal spine end ([0047]: Each of the plurality of slots 134 is configured to receive the distal end portion 128 of each of the plurality of splines 124);
a loop retention hub (first element 130 & second element 140) comprising a first portion (first element 130) and a second portion (second element 140) configured to mate with each other ([0050]: a second element 140 configured for engagement with the first element 130), and define a body that decreases in width in a proximal direction along the longitudinal axis (see Fig. 7 where the first element 130 and second element 140 define a body that decreases in width in a proximal direction (where in Fig. 7, the proximal direction is in the leftward direction) along the longitudinal axis), a plurality of slots (plurality of slots 134) defined through the body into a hollow (see hollow interior of first element 130 & second element 140 in Fig. 7), the loop retention hub retaining the stopper of each of the plurality of spine sections through a respective slot of the plurality of slots ([0047]: Each of the plurality of slots 134 is configured to receive the distal end portion 128 of each of the plurality of splines 124), and allowing the plurality of spine sections to rotate relative to the loop retention hub ([0048]: The slots 134 are configured to allow each of the plurality of splines 124 to articulate relative to the axis (a) of the first element 130 Accordingly, the first element 130 is configured to provide freedom for the splines 124 to distally articulate relative to the axis (a) of the first element 130, thereby allowing for increased distal flexibility of the electrode support structure 122, improved collapsibility of the electrode support structure 122; see Fig. 7); and
one or more electrodes (electrodes 54), each comprising a lumen so that one of plurality of spine sections extends through the lumen ([0052]: The electrodes 54 mounted on each of the plurality of splines 24, 124 can comprise ring electrodes).
Regarding claim 8, Just teaches wherein the plurality of slots (plurality of slots 134) is configured such that the stopper of each spine section of the plurality of spine sections is configured to move longitudinally within each of the plurality of slots as the plurality of spine sections rotate relative to the loop retention hub between a collapsed configuration and an expanded configuration ([0048]: The slots 134 are configured to allow each of the plurality of splines 124 to articulate relative to the axis (a) of the first element 130 Accordingly, the first element 130 is configured to provide freedom for the splines 124 to distally articulate relative to the axis (a) of the first element 130, thereby allowing for increased distal flexibility of the electrode support structure 122, improved collapsibility of the electrode support structure 122; see Fig. 7)
Regarding claim 10, Just teaches a central member disposed within the tubular shaft and moveable along the longitudinal axis, wherein each spine section of the plurality of spine sections is moveable from an expanded configuration to a collapsed configuration when the central member moves along the longitudinal axis ([0040]: an expander or tensor (not shown) may be coaxial with the elongated catheter body 20. The expander or tensor can have a distal end at the distal end portion 26 of the electrode support structure 22 and a proximal end extending out the proximal end of the elongated catheter body 20 and attached to the control handle 14. Longitudinal movement of the tensor relative to the elongated catheter body 20 can cause expansion and contraction of the electrode support structure 22. The tensor can comprise any material sufficiently rigid to achieve this function).
Regarding claim 11, Just teaches a medical probe (Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines; [0033]: Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional), comprising:
a tubular shaft (catheter body 20) including a proximal end (proximal end of catheter body 20) and a distal end (distal end of catheter body 20), the tubular shaft extending along a longitudinal axis ([0037]: The electrode support structure 22 defines a longitudinal axis (A); see Figs. 1-2 where this axis lies along both the electrode support structure 22 and catheter body 20);
an expandable basket assembly (electrode support assembly 112) proximate the distal end of the tubular shaft ([0046]: The electrode support structure assembly 112 can be similarly mounted to the distal end of the elongated catheter body 20 (see FIG. 1); see Fig. 12C where the distal end of the basket assembly is within the distal end of the catheter body), comprising a plurality of spines (plurality of splines 124) each comprising a distal end comprising a stopper (distal end portion 128, stopper is distal end 138) extending therefrom ([0047]: Each of the plurality of slots 134 is configured to receive the distal end portion 128 of each of the plurality of splines 124) and a proximal end connected to the distal end of the tubular shaft ([0051]: third element 42 can comprise a generally cylindrical member having an outer radial surface 44 including a plurality of channels 46. Each of the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124; see Fig. 1 & 4), the plurality of spines being configured to bow radially from the longitudinal axis ([0037]: one or more of the plurality of splines 24 can splay or bow radially outwardly substantially uniformly along the length of the electrode support structure 22, away from longitudinal axis (A), or one or more of the plurality of splines 24 can splay or bow radially outwardly in varying amounts along the length of the electrode support structure 22);
a loop retention hub (first element 130 & second element 140) securing the distal ends of the plurality of spines ([0047]: Each of the plurality of slots 134 is configured to receive the distal end portion 128 of each of the plurality of splines 124) such that the stoppers are configured to rotate with respect to the loop retention hub to allow the plurality of spines to bow radially from the longitudinal axis ([0048]: The slots 134 are configured to allow each of the plurality of splines 124 to articulate relative to the axis (a) of the first element 130 Accordingly, the first element 130 is configured to provide freedom for the splines 124 to distally articulate relative to the axis (a) of the first element 130, thereby allowing for increased distal flexibility of the electrode support structure 122, improved collapsibility of the electrode support structure 122; see Fig. 7), the loop retention hub comprising a body (first element 130 & second element 140) comprising a width that decreases relative to the longitudinal axis in a proximal direction (see Fig. 7 where the first element 130 and second element 140 define a body that decreases in width in a proximal direction (where in Fig. 7, the proximal direction is in the leftward direction) along the longitudinal axis), a plurality of slots (a plurality of slots 134) defined through the body into a hollow (see hollow interior of first element 130 & second element 140 in Fig. 7), the loop retention hub retaining the stopper of each of the plurality of spines through a respective slot of the plurality of slots ([0047]: Each of the plurality of slots 134 is configured to receive the distal end portion 128 of each of the plurality of splines 124), and allowing the plurality of spines to rotate relative to the loop retention hub ([0048]: The slots 134 are configured to allow each of the plurality of splines 124 to articulate relative to the axis (a) of the first element 130 Accordingly, the first element 130 is configured to provide freedom for the splines 124 to distally articulate relative to the axis (a) of the first element 130, thereby allowing for increased distal flexibility of the electrode support structure 122, improved collapsibility of the electrode support structure 122; see Fig. 7); and
one or more electrodes (electrodes 54) coupled to each of the plurality of spines, each electrode of the one or more electrodes defining a lumen therethrough so that a respective spine of the plurality of spines extends through the lumen of each of the one or more electrodes ([0052]: The electrodes 54 mounted on each of the plurality of splines 24, 124 can comprise ring electrodes).
Regarding claim 12, Just teaches wherein the loop retention hub (first element 130 & second element 140) comprises a first portion (first element 130) and a second portion (second element 140) clamped over the stoppers of the plurality of spines ([0050]: the electrode support structure assembly 112 comprises a second element 140 configured for engagement with the first element 130 to retain the distal end portion 128 of the each of the plurality of splines 124 within the plurality of slots 134 of the first element 130; wherein “configured for engagement” is seen as a functional equivalent to “clamped”).
Regarding claim 13, Just teaches wherein the plurality of slots is (plurality of slots 134) configured such that the stopper of each spine of the plurality of spines is configured to move longitudinally within each of the plurality of slots as the plurality of spines to rotate relative to the loop retention hub ([0048]: The slots 134 are configured to allow each of the plurality of splines 124 to articulate relative to the axis (a) of the first element 130 Accordingly, the first element 130 is configured to provide freedom for the splines 124 to distally articulate relative to the axis (a) of the first element 130, thereby allowing for increased distal flexibility of the electrode support structure 122, improved collapsibility of the electrode support structure 122; see Fig. 7).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Just in as applied to claim 1 above, and further in view of Olson (U.S. Pub. No. 20220304745, previously cited), herein referred to as “Olson”.
Regarding claim 2, Just discloses a spine retention hub (third element 42) disposed proximate the distal end of the tubular shaft (see Fig. 1 & 4), the spine retention hub comprising a cylindrical member ([0051]: third element 42 can comprise a generally cylindrical member) including a plurality of relief lands (plurality of channels 46) disposed on an outer surface of the cylindrical member to allow each spine section of the plurality of spine sections to be fitted into a respective relief land of the plurality of relief lands and retained therein ([0051]: third element 42 can comprise a generally cylindrical member having an outer radial surface 44 including a plurality of channels 46. Each of the plurality of channels 46 can be configured to receive the proximal end portion 126 of each of the plurality of splines 124),
But Just fails to disclose the spine retention hub further comprising at least one electrode disposed at a distal portion of the spine retention hub.
However, Olson discloses the spine retention hub further comprising at least one electrode disposed at a distal portion of the spine retention hub ([0041]: splines 202 are coupled together at proximal end 204 and distal end 206, such that electrode basket 200 is “closed” at both ends 204, 206 thereof; [0058]: a second return electrode 240B is positioned proximate to proximal end 204 of electrode basket 200; wherein the proximal end 204 of Olson is seen as a spline retention hub since the splines are all joined and the electrode 240B is disposed at a distal end of this joinery). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the spine retention hub of Just to include at least one electrode disposed at a distal portion of the spine retention hub, as taught by Olson, for the purpose of the electrode enabling the formation of wide bipoles for ablation therapies (Olson: [0059]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Just as applied to claim 1 above, and further in view of Teague et al. (U.S. Pub. No. 20060058813, previously cited), herein referred to as “Teague”.
Regarding claim 5, Just fails to disclose wherein the loop retention hub further comprises:
two or more protrusions positioned on the first portion or the second portion; and
two or more indentations positioned on the opposite portion of the first portion and the second portion, the two or more indentations engaging the two or more protrusions to clamp the first portion to the second portion.
However, Teague discloses wherein the loop retention hub (retainer 124, Figs. 14-16) further comprises:
two or more protrusions (risers 256) positioned on the first portion or the second portion ([0060]: the first member 248 includes an inner face 254 and two risers 256. Alternatively, the first member 248 may include any number of risers 256. A riser 256 is a projection that extends substantially vertically from the inner face 254 of the first member 248); and
two or more indentations positioned on the opposite portion of the first portion and the second portion ([0062]: The second member 252 includes a first end 247, a second end 249, a lumen 251 that extends at least from the first end 247 towards the second end 249; see Fig. 15 where the risers 256 mate with lumen 251 such that lumen 251 is seen as a functional equivalent to two or more indentations since the lumen performs the same function as mating with the risers 256), the two or more indentations engaging the two or more protrusions to clamp the first portion to the second portion ([0062]: the second member 252 is attached to the first member 248 … the risers 256 of the first member 248 contact the inner surface 250 of the second member 252. The risers 256 are forcibly slid along the tapered inner surface 250 of the second member 252 in the direction indicated by arrows 253, thereby providing a force fit between the first member 248 and the second member 252).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the loop retention hub of Just to comprise two or more protrusions and two or more indentations, as taught by Teague, for the purpose of the intermediate portions of the legs/splines are, therefore, firmly encapsulated between the inner face of the first member and the second member (Teague: [0062]).
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise two or more indentations positioned on the opposite portion of the first portion and the second portion, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 6, Just in view of Teague discloses wherein the plurality of spine sections fit within paths formed between the two or more protrusions (Teague: [0161]: To join the intermediate portions 172 of the legs 164 together with the retainer 124 at the distal end 166 of the retrieval basket 120, the intermediate portions 172 of the legs 164 are initially placed across the inner face 254 of the first member 248. For instance, the intermediate portions 172 of the legs 164 may pass between the risers 256. In one embodiment, as illustrated in FIG. 14, the intermediate portions 172 of the legs 164 are side-by-side, but do not cross one another. In another embodiment, referring now to FIG. 15, the intermediate portions 172 of the legs 164 cross one another at the distal end 166 of the retrieval basket 120).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Just as applied to claim 1 above, and further in view of Marecki et al. (U.S. Pat. No. 9848795, cited in IDS), herein referred to as “Marecki”.
Regarding claim 7, Just in fails to disclose wherein the plurality of spine sections are cut from a singular tube and the proximal spine end comprises a single tubular shape.
However, Marecki discloses wherein the plurality of spine sections (splines 60) are cut from a singular tube (Col. 5, lines 2-4: the step of separating the flexible layered sheet into two or more splines comprises laser cutting the flexible layered sheet into two or more splines; Col. 15, lines 51-56: Next, as shown in FIG. 9B, the planar flexible sheet 80 may be wound around a major axis 130, bringing first edge 132 toward a second edge 134 of the flexible sheet 80. FIG. 9C shows the two edges 132, 134 juxtaposed with both edges 132, 134 fixed to define a generally cylindrical structure) and the proximal spine end comprises a single tubular shape (termination section 120, see Figs. 9C & 9D).
The recitation of “wherein the plurality of spine sections are cut from a singular tube” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of spline sections and proximal spine end of Just to be a plurality of spine sections cut from a singular tube and for the proximal spine end to comprise a single tubular shape, as taught by Marecki, for the purpose of the termination section/single tubular shape may be used to bond the electrode assembly to the catheter body (Marecki: Col. 15, lines 50-51).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Just as applied to claim 1 above, and further in view of Kimmell (U.S. Pat. No. 3952747, previously cited), herein referred to as “Kimmell”.
Regarding claim 9, Just fails to disclose wherein the loop retention hub comprises two substantially hemispherical members coupled to each other to retain the plurality of spines.
However, Kimmell discloses wherein the loop retention hub comprises two substantially hemispherical members coupled to each other to retain the plurality of spines (Col. 5, lines 14-16: The filter 10 includes an apical hub 14 of overall egg-shaped or tear drop configuration and which has a generally hemispherically shaped end portion 14a). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the loop retention hub of Just to the shape of the loop retention hub of Kimmell for the purpose of the construction avoiding impalement of the filter on the blood vessel walls during emplacement, and also avoiding irritation or scratching of the blood vessel during insertion (Kimmell: Col. 5, lines 16-19). Wherein in this modification, it is only to the shape of the loop retention hub, the teaching of two members coupled to each other is already taught by Just.
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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