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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 September 2025 was filed prior to the mailing date of this office correspondence. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 objected to because of the following informalities:
In claim 2, line 8: “a generally planar configuration” should read:
-- a planar configuration --
Application fails to define the term “generally planar”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 12 of U.S. Patent No. 11,039,773. Although the claims at issue are not identical, they are not patentably distinct from each other because:
claim 22 of the instant application recites in lines 7-8, “a portion of the inner and outer understructures being connected to each other via at least one connective portion”. However, conflicting patent claim 12, lines 2-3 recites “ a mounting portion connected to the inner understructure and the outer understructure”, in which, the claimed “one connection portion” in claim 22 is identical to “mounting portion” recited in the conflicting claim 12. Further, the conflicting claim 12 recites “mounting portion includes a plurality of contact pads electrically coupled with the plurality of microelectrodes via the plurality of conductive traces.”. However, claim 22 recites, “a plurality of conductive traces disposed on the flexible tip portion, each of the plurality of conductive traces electrically coupled with a respective one of the plurality of electrodes.”
Note: the limitations of both sets of claims are listed with the conflicting portions have been underlined.
Application 19/028,364
US 11,039,773
22. An integrated electrode structure comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft and adapted to conform to a tissue, wherein the flexible tip portion is formed from a planar substrate and includes an inner understructure and an outer understructure, the inner and outer understructure each having a planar top surface and a planar bottom surface and at least a portion of the inner and outer understructures being connected to each other via at least one connective portion; a first plurality of electrodes disposed on the top surfaces of the inner and outer understructure, and a second plurality of electrodes disposed on the bottom surfaces of the inner and outer understructure, wherein the first plurality of electrodes is parallel with the second plurality of electrodes, and each electrode in the first and second plurality of electrodes are longitudinally aligned with one another when the flexible tip portion is in an expanded configuration; and a plurality of conductive traces disposed on the flexible tip portion, each of the plurality of conductive traces electrically coupled with a respective one of the plurality of electrodes.
10. An integrated electrode structure comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft and adapted to conform to a tissue, wherein the flexible tip portion is formed from a planar substrate and includes an inner understructure and an outer understructure, the inner and outer understructure each having a top surface and a bottom surface; and a first array of microelectrodes patterned onto the top surfaces of the inner and outer understructure, and a second array of microelectrodes patterned onto the bottom surface of the inner and outer understructure, wherein the first array of microelectrodes is parallel with the second array of microelectrodes, and each electrode in the first and second array of microelectrodes are longitudinally aligned with one another, wherein the flexible tip portion is in an expanded configuration.
12. The integrated understructure of claim 10, further comprising a mounting portion connected to the inner understructure and the outer understructure, wherein the mounting portion includes a plurality of contact pads electrically coupled with the plurality of microelectrodes via the plurality of conductive traces.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of application 17/946,260 (now patent). Although the claims at issue are not identical, they are not patentably distinct from each other because:
though, conflicting claim 1 of the application 17/946,260 (now patent) recites “a flexible framework”, claim 22 of the application recites “the flexible tip portion is formed from a planar substrate and includes an inner understructure and an outer understructure”, in which, one of ordinary skill in the art would have known that unless otherwise defined, the flexible tip portion manifests a flexible framework. Further, claim 22 of the instant application recites in lines 7-8, “a portion of the inner and outer understructures being connected to each other via at least one connective portion”. However, from the limitation of conflicting patent claim 1, “a flexible tip portion coupled to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework formed from a planar substrate and including an inboard understructure and an outboard understructure, …and defining a planar structure in an expanded configuration”, it is obvious that the “inner and outer understructures being connected to each other via at least one connective portion” as recited in claim 22.
Note: the limitations of both sets of claims are listed with the conflicting portions have been underlined.
Application 19/028,364
Application 17/946,260 (Now patent)
22. An integrated electrode structure comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion located adjacent to the distal end of the catheter shaft and adapted to conform to a tissue, wherein the flexible tip portion is formed from a planar substrate and includes an inner understructure and an outer understructure, the inner and outer understructure each having a planar top surface and a planar bottom surface and at least a portion of the inner and outer understructures being connected to each other via at least one connective portion; a first plurality of electrodes disposed on the top surfaces of the inner and outer understructure, and a second plurality of electrodes disposed on the bottom surfaces of the inner and outer understructure, wherein the first plurality of electrodes is parallel with the second plurality of electrodes, and each electrode in the first and second plurality of electrodes are longitudinally aligned with one another when the flexible tip portion is in an expanded configuration; and a plurality of conductive traces disposed on the flexible tip portion, each of the plurality of conductive traces electrically coupled with a respective one of the plurality of electrodes.
1. An integrated electrode structure comprising: a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis; a flexible tip portion coupled to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework formed from a planar substrate and including an inboard understructure and an outboard understructure, the inboard and outboard understructure each having a top surface and a bottom surface and defining a planar structure in an expanded configuration;
a plurality of microelectrodes patterned onto the top surface and bottom surface of the inboard and outboard understructure so as to form a flexible top planar array of microelectrodes on the top surface of the inboard and outboard understructure and a flexible bottom planar array of microelectrodes on the bottom surface of the inboard and outboard understructure, wherein the flexible top planar array of microelectrodes is parallel with the flexible bottom planar array of microelectrodes, wherein the plurality of microelectrodes comprise a plurality of rows of longitudinally-aligned microelectrodes aligned parallel to the catheter shaft longitudinal axis; and a plurality of conductive traces disposed on the flexible framework, each of the plurality of conductive traces electrically coupled with a respective one of the plurality of microelectrodes.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 2-5, 9, 11-16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Harrington (US 20140330267).
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Annotated Fig. 12A and 12B, Harrington.
Regarding claim 2, Harrington teaches, an apparatus (catheter 16g, Fig. 12A) comprising:
a catheter assembly having a proximal end and a distal end (see Fig. 12A), the catheter assembly defining a longitudinal axis, the catheter assembly including an outer sheath (sheath 25, Fig. 5, equipment for abdominal aorta and renal artery interventions including guided sheaths, steerable distal tip assemblies and over the wire configurations, para. [0047]);
a flexible tip portion (basket element 27, Fig. 12B, basket element is expanded allowing for tissue contact with radiofrequency electrode element, para. [0026]) associated with the distal end of the catheter assembly (see Fig. 12A), being configured to transition between a compressed state and an expanded state (basket element assembly 27 can be formed from a plurality of rib member 27a and can be configured to radially expand from a compressed configuration via a manual expansion mechanism, para. [0091]), the structure being configured to fit within the outer sheath in the compressed state (balloon element assembly 26 is replaced with a basket or malecot element assembly 27. Basket element assembly comprises thin rib members 27a of solid deformable material and tissue modifying element 18 attached to the outer surface of ribbon. Basket element assembly 27 is movable between a collapsed arrangement, FIG. 7a and an expanded arrangement, FIG. 7b with the intermediate segments of the ribbons 28 in the expanded arrangement moving laterally outward relative to the distal and proximal ends of the ribbons 28 with respect to the collapsed arrangement of FIG. 7a, see Figs. 7a and 7b, para. [0077-0078]), the structure being configured to expand outwardly away from the longitudinal axis into a generally planar configuration in the expanded state when deployed from the outer sheath (see Figs. 6a, 6b, 7a, 7b, para. [0077-0078], plurality of paddles or arms, Fig. 16, malecot element 27 in Fig. 12B is generally planar configuration), the structure comprising a flexible circuit (a closed electrical circuit occurs between electrosurgical generator 21 and electrodes 18 when in tissue contact, para. [0074]) and a plurality of arms (rib members 27a, Fig. 12B) extending along the longitudinal axis, at least a portion of the plurality of arms being connected to each other via planar connective portions (see annotated Fig. 12B); and
a plurality of microelectrodes (electrode element 18, or stimulating element 31, rib 27a of the basket 27 can include at least one stimulating element 31 and one modifying element 18, and more preferably, several of each elements on each rib, para. [0092]) disposed along the plurality of arms.
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Annotated Fig. 16, Harrington.
Though, Harrington teaches the catheter tip portion as a malecot structure in Fig. 12B, Harrington does not explicitly teach a paddle structure in Fig. 12B. However, Harrington further teaches in Fig. 16, a catheter assembly including paddle structure (catheter assembly 16k which is generally similar to the previously described embodiments, but includes a plurality of paddles or arms 40 having on or more of the stimulating elements 31 or the tissue modifying elements 18, para. [0103]). Therefore, in view of the teachings of Harrington, 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 modify the catheter assembly in Fig. 12A of Harrington and include a paddle structure as Harrington taught in Fig. 16 so that it enables forming the flexible tip portion as a radiopaque markers as Harrington disclosed in para. [0081, 0107]. Moreover, there is no indication in the instant invention that any surprising results were derived, or that any special steps were devised in the paddle structure. Such a combination would have been done by one of ordinary skill in the art without any need for experimentation and with reasonable expectations of success.
Regarding claim 3, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, the outer sheath being operable to translate relative to the flexible tip portion between a first longitudinal position (see Fig. 7a) and a second longitudinal position (see Fig. 7b), the outer sheath being configured to contain the flexible tip portion in the first longitudinal position (see Fig. 4a), the outer sheath being configured to deploy the flexible tip portion in the second longitudinal position (basket element assembly 27 can be formed from a plurality of rib member 27a and can be configured to radially expand from a compressed configuration via a manual expansion mechanism, para. [0091]).
Regarding claim 4, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, the flexible tip portion being operable to translate relative to the outer sheath between a first longitudinal position (see Fig. 7a) and a second longitudinal position (see Fig. 7b), the flexible tip portion being configured to be inserted into the outer sheath in the first longitudinal position (see Fig. 4a), the flexible tip portion being configured to be deployed from the outer sheath in the second longitudinal position (para. [0091]).
Regarding claim 5, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, the plurality of arms being expandable outwardly away from the longitudinal axis in the expanded state when deployed from the outer sheath (see Fig. 12B).
Regarding claim 9, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, further comprising a position sensor (physiological measurement element 32, Fig. 12B, reduction in inner luminal diameter of the vessel is detected by sensor 32, para. [0090]), the position sensor being operable to generate data indicative of a position of one or both of at least a portion of the catheter assembly or at least a portion of the flexible tip portion in a three-dimensional space, the position sensor being located on a portion of the paddle structure (see the physiological measurement element 32, Fig. 12B).
Regarding claim 11, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, the plurality of arms comprising a super elastic understructure (a plurality of rib member 27a, e.g., between 3 and 10 rib members 27a,…superelastic shape memory material, para. [0091]; the arms 40 are composed of superelastic material, para. [0103).
Regarding claim 12, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein the plurality of arms comprise at least four arms (a plurality of rib member 27a e.g., between 3 and 10 rib members 27a, para. [0091]).
Regarding claim 13, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein the plurality of microelectrodes comprise a plurality of rows of longitudinally-aligned microelectrodes aligned parallel to the longitudinal axis (see annotated Fig. 12B below).
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Annotated Fig. 12B, Harrington.
Regarding claim 14, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein the catheter assembly comprises an elongated shaft (see annotated Fig. 12B below) coaxially located within the outer sheath.
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Annotated Fig. 12B, Harrington.
Regarding claim 15, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein the flexible circuit further comprises a plurality of conductive traces (arms 40 may each include a wire or similar conductive path which connects to the stimulating element 31 or the tissue modifying element 18 at its tip, para. [0103]), wherein each of the plurality of conductive traces is electrically coupled with a respective one of the plurality of microelectrodes.
Regarding claim 16, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein at least the portion of the plurality of arms are connected at a distal portion of the flexible tip portion to form the planar connective portions between the plurality of arms (see Fig. 12B).
Regarding claim 21, Harrington teaches the recited limitations with respect to claim 2. Harrington further teaches, the apparatus of claim 2, wherein the plurality of arms are formed from a unitary piece of material (basket element assembly comprises thin rib members 27a of solid deformable material and tissue modifying element 18 attached to the outer surface of ribbon, para. [0078], see Fig. 12B).
Claim(s) 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over De La Rama (US 20140200639) in view of Goldreyer (US 5385146).
Regarding claim 22, De La Rama teaches, an integrated electrode structure (neurostimulating structure, Figs. 1 and 2A) comprising:
a catheter shaft (self-expandable lead 200, see annotated Fig. 2A) comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis (lead 200 includes a lead body 202 having a distal body end 204, a proximal body end 206, Figs. 1 and 2A, para. [0038]);
a flexible tip portion (see self-expandable lead 200, Fig. 2A) located adjacent to the distal end of the catheter shaft and adapted to conform to a tissue, wherein the flexible tip portion is formed from a planar substrate (the arms 211-215 may be substantially coplanar, para. [0042], see Fig. 6, the cross-section of the arms 211-215 have a substantially circular shape or substantially square shape, para. [0051]) and includes an inner understructure (inner arms 212, 213, see annotated Fig. 2A above) and an
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Annotated Fig. 2A, De La Rama.
outer understructure (outer arms 211, 214, see Fig. 2A), the inner and outer understructure each having a planar top surface and a planar bottom surface and at least a portion of the inner and outer understructures being connected to each other via at least one connective portion (paddle lead has an elongated planar body with a thin rectangular shape, para. [0005], the lead profile 225 of the lead body 202 may be substantially planar widthwise and lengthwise…the arms 211-215 may be substantially coplanar e.g., substantially coincide along a common plane, para. [0042] see annotated Fig. 2A above);
a first plurality of electrodes (lead 200 also includes a plurality of electrodes 250 that are disposed along the outer arms 211, 214 and the inner arms 212, 213, para. [0044]) disposed on the top surfaces of the inner and outer understructure, and a second plurality of electrodes disposed on the bottom surfaces of the inner and outer understructure (electrodes 250, Fig. 2A, each of the outer arms 211, 214 and each of the inner arms 212, 213 include a series or column of electrodes 250 that are spaced apart from each other along a length of the respective arm, para. [0046]); and
a plurality of conductive traces (conductive pathways 286, arms 211-214 also include conductive pathways 286, Fig. 3) disposed on the flexible tip portion, each of the plurality of conductive traces electrically coupled with a respective one of the plurality of electrodes (conductive pathways 286 comprise a conductive material, such as copper, and are configured to transmit electrical signals e.g., current to corresponding electrodes 250, para. [0052]).
De La Rama does not teach, the microelectrodes patterned on top surface and bottom surfaces, wherein the first plurality of electrodes is parallel with the second plurality of electrodes, and each electrode in the first and second plurality of electrodes are longitudinally aligned with one another when the flexible tip portion is in an expanded configuration. However, Goldreyer teaches, a cardiac mapping catheter comprising a catheter shaft (catheter body 20, Fig. 1), a flexible tip portion (see Figs. 1 and 2), in which,
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Annotated Fig. 2, Goldreyer.
the microelectrodes patterned on top surface and bottom surfaces, wherein the first plurality of electrodes is parallel with the second plurality of electrodes, and each electrode in the first and second plurality of electrodes are longitudinally aligned with one another when the flexible tip portion is in an expanded configuration (see Fig. 2, a plurality of sets of orthogonal electrodes 34-46…each set is illustrated as being comprised of at least two electrodes and seven such sets are shown along the longitudinal length of catheter 32, col. 5, lines 5-10).
De La Rama teaches in para. [0005, 0051], paddle lead comprising an elongated planar body having thin rectangular shape. Goldreyer teaches, a catheter in Fig. 2, employed with a plurality of sets of orthogonal electrodes 34-46 having the first plurality of electrodes parallel with the second plurality of electrodes. Therefore, in view of the teachings of Goldreyer, 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 modify the catheter assembly in Fig. 2A of De La Rama and replace the electrodes 250 in Fig. 2B with the plurality of parallel electrodes 34 to 46, as Goldreyer taught in Fig. 2 so that it enables the flexible tip portion to monitor the direction of electrical activation as Goldreyer disclosed in col 5, lines 15-20. Moreover, there is no indication in the instant invention that any surprising results were derived, or that any special steps were devised in the parallel electrode structure. Such a simple substitution would have been done by one of ordinary skill in the art without any need for experimentation and with reasonable expectations of success.
Regarding claim 23, De La Rama in view of Goldreyer teaches the recited limitations with respect to claim 22. De La Rama further teaches, the electrode structure of claim 22, wherein at least the portion of the inner and outer understructures are connected at a distal portion of the flexible tip portion to form planar connective portions between the plurality of arms (see distal arm end 218, Figs. 2A and 2B).
Regarding claims 24-25, De La Rama does not teach, a mapping electrode or ablation electrode. However, Goldreyer further teaches,
24. The electrode structure of claim 22, wherein the first and second plurality of electrodes comprise mapping electrodes (see Abstract).
25. The electrode structure of claim 22, wherein the first and second plurality of electrodes comprise mapping and ablation electrodes (see abstract).
Therefore, in view of the teachings of Goldreyer, 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 modify the catheter assembly in Fig. 2A of De La Rama and replace the electrodes 250 in Fig. 2B with the plurality of parallel electrodes 34 to 46, as Goldreyer taught in Fig. 2 so that it enables the flexible tip portion to monitor the direction of electrical activation as Goldreyer disclosed in col 5, lines 15-20..
Regarding claim 26, De La Rama in view of Goldreyer teaches the recited limitations with respect to claim 22. De La Rama further teaches, the electrode structure of claim 22, wherein the first and second plurality of electrodes define square shaped areas (cross-section of the arms 211-215 have a… substantially square shape such that the arm width 281 and the arm height 283 are substantially equal, para. [0051], it which it is obvious that the electrodes define a square shape).
Regarding claim 27, De La Rama in view of Goldreyer teaches the recited limitations with respect to claim 22. De La Rama further teaches, the electrode structure of claim 22, wherein the first and second plurality of electrodes have a longitudinal length approximately equal to a lateral width (substantially square shape, it which it is obvious that a length approximately equal to a width).
Regarding claim 28, De La Rama teaches, an integrated electrode structure (neurostimulating structure, Figs. 1 and 2A) comprising:
a catheter shaft (self-expandable lead 200, see annotated Fig. 2A) comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis (lead 200 includes a lead body 202 having a distal body end 204, a proximal body end 206, Figs. 1 and 2A, para. [0038]); and
a flexible tip portion (self-expandable lead 200, Fig. 2A) located adjacent to the distal end of the catheter shaft and adapted to conform to a tissue, the flexible tip portion comprising:
a flexible framework formed from a planar substrate (the arms 211-215 may be substantially coplanar, para. [0042], see Fig. 6, the cross-section of the arms 211-215 have a substantially circular shape or substantially square shape, para. [0051]);
a first inboard arm (inner arm 212, see annotated Fig. 2A above), second inboard arm (inner arm 213), first outboard arm (outer arm 211, see Fig. 2A), and second outboard arm (outer arm 214, see Fig. 2A), each of the first and second inboard and outboard arms defining a planar top surface and a planar bottom surface (see Fig. 6, the cross-section of the arms 211-215 have a substantially circular shape or substantially square shape, para. [0051]), the bottom surface being parallel with the top surface, wherein at least a portion of the first inboard arm is connected to the first outboard arm via a first planar connective portion and at least a portion of the second inboard arm is connected to the second outboard arm via a second planar connective portion (see Fig. 2B below).
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Annotated Fig. 2B, De La Rama.
De La Rama does not teach, a first plurality of electrodes disposed on each of the top surfaces of the inboard and outboard arms and a second plurality of electrodes disposed on each of the bottom surfaces of the inboard and outboard arms, wherein the first plurality of electrodes is parallel with the second plurality of electrodes. However, Goldreyer teaches, a cardiac mapping catheter comprising a catheter shaft (catheter body 20, Fig. 1), a flexible tip portion (see Figs. 1 and 2), in which, a first plurality of electrodes disposed on each of the top surfaces of the inboard and outboard arms and a second plurality of electrodes disposed on each of the bottom surfaces of the inboard and outboard arms, wherein the first plurality of electrodes is parallel with the second plurality of electrodes (see Fig. 2, a plurality of sets of orthogonal electrodes 34-46…each set is illustrated as being comprised of at least two electrodes and seven such sets are shown along the longitudinal length of catheter 32, col. 5, lines 5-10). Therefore, in view of the teachings of Goldreyer, 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 modify the catheter assembly in Fig. 2A of De La Rama and replace the electrodes 250 in Fig. 2B with the plurality of parallel electrodes 34 to 46, as Goldreyer taught in Fig. 2 so that it enables the flexible tip portion to monitor the direction of electrical activation as Goldreyer disclosed in col 5, lines 15-20. Moreover, there is no indication in the instant invention that any surprising results were derived, or that any special steps were devised in the disposed parallel electrode structure. Such a simple substitution would have been done by one of ordinary skill in the art without any need for experimentation and with reasonable expectations of success.
Regarding claim 29, De La Rama in view of Goldreyer teaches the recited limitations with respect to claim 28. De La Rama further teaches, the electrode structure of claim 28, further comprising a plurality of conductive traces disposed on the flexible tip portion (conductive pathways 286, arms 211-214 also include conductive pathways 286, Fig. 3), each of the plurality of conductive traces electrically coupled with a respective one of the first and second plurality of electrodes (conductive pathways 286 comprise a conductive material, such as copper, and are configured to transmit electrical signals e.g., current to corresponding electrodes 250, para. [0052]).
Conclusion
Prior art Crow (US 20120265198) teaches, an apparatus comprising a catheter assembly including a flexible tip portion comprising a paddle structure, and a plurality of microelectrodes disposed along the plurality of arms.
Prior art Siekmeyer (US 5846196) teaches, a catheter assembly including a flexible tip portion comprising a paddle structure, and a plurality of microelectrodes disposed along the plurality of arms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE K. ABRAHAM whose telephone number is (571)270-1087. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS J. HONG can be reached at (571) 272-0993. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSE K ABRAHAM/Examiner, Art Unit 3729
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