DETAILED ACTION
The following is a Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Response to Amendment
Acknowledgment is made to the amendment received 5/7/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejection set forth in the previous office action.
Claim Objections
Claims 1, 3, 7, 9, 12, 15 & 21-22 objected to because of the following informalities: amend the claims to be consistent when reciting “distal end portion” of the wire and “the wire” (the term “respective” is used only sometimes throughout the claims to refer to these structural limitations). Appropriate correction is required.
Claim Interpretation
Claims 1, 7 & 15 recite “a respective wire distal end portion defining a distal end of each respective wire of the plurality of wires”. Since the claims recite both a “wire distal end portion” and “a distal end”, the “distal end” recitation will be interpreted as either the distal-most end of the wire or as the distal end of the distal end portion.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7-12 & 14-23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Eliason et al. (2014/0257069, previously cited) in view of Buehlmann et al. (2006/0030846).
For purposes of examination, “intertwine” can be defined as: “to unite by twining one with another” and “twine” can be defined as “to cause to encircle or enfold something” (www.merriam-webster.com).
Concerning claim 1, as illustrated in at least Figs. 4-6, Eliason et al. disclose a catheter (electrophysiology catheter 18; [0025]) comprising:
an elongate shaft having a proximal end portion and a distal end portion (shaft 24 has distal and proximal end portions 34, 32; [0025] // or introducer sheath; [0028-0029]), the elongate shaft being configured to locate the distal end portion at a treatment site within a lumen of a patient (shaft 24 may be steered or guided through the body to a desired location such as tissue in a region of interest; [0028] // or introducer sheath can be steered to location of interest; [0028-0029]);
a plurality of wires positioned at the distal end portion of the elongate shaft (assembly 30 on the distal end 34 of shaft 24 // or // introducer sheath comprises splines 36, each spline 36 may include a tubular body 38 such as a wire 40; [0026], [0028-0029]); and
a plurality of electrodes (electrodes 42 are disposed on splines 36; [0029]),
a support structure positioned at the distal end portion of the elongate shaft and defining a plurality of elongated slots extending through a wall of the support structure, the plurality of elongated slots being adjacent a distal end of the support structure (central post 54, including connector 52, extends from shaft 24 or introducer sheath, where connector 52 defines a plurality of slots extending through the wall adjacent the distal end of central post 54, including connector 52; [0035], where slots 134 are elongated as disclosed in 13/340760 which is incorporated by reference), wherein a respective wire distal end portion defining a distal end of each wire of the plurality of wires is received within the support structure through a respective slot of the plurality of elongated slots (splines 52 are coupled at distal end 50 by hinge connector 52 via the slots; [0031]),
Eliason et al. fail to disclose the respective wire distal end portion being bent relative to a remaining portion of the respective wire and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state. However, Buehlmann et al. disclose a catheter (12) comprising a deployable wire (56) having a distal end portion (122) defining a distal end (124) that is received within an elongated slot (148) of a support structure (44, 46), the respective wire distal end portion (122) being bent relative to a remaining portion (middle portion) of the respective wire (56) and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot (124) holds the respective wire distal end portion (122) close to a surface of the support structure (44, 46) to prevent the respective wire distal end portion (122) from buckling when the wire is moved to the expanded deployed state.
At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Eliason et al. such that the respective wire distal end portion is bent relative to a remaining portion of the respective wire and extends in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state in order to provide the benefit of permitting the wire distal end of effectively pivot freely as the wire moves between the low-profile delivery state and the expanded deployed state and also reducing stress and improving the fatigue characteristics of the distal end of the wire as taught by Buehlmann et al. ([0060], [0066]; Fig. 22, 25 & 27A-B),
wherein each wire of the plurality of wires comprises at least one electrode of the plurality of electrodes positioned thereon (splines 36 are configured to support electrodes 42; [0026], [0029]), the plurality of wires forming a set of intertwined helixes winding around the support structure (splines 36 have a helical pitch surrounding post 54; [0035], [0037]) and being moveable between a low-profile delivery state and an expanded deployed state (assembly may assume a compressed state, for example, as catheter 18 is maneuvered through an introducer sheath within the body to the region of interest and assume the expanded state upon emerging from a distal end of the sheath; [0029]), and
wherein the plurality of wires is radially expanded in the expanded deployed state relative to the low-profile delivery state (assembly 30 may assume a compressed state, for example, as catheter 18 is maneuvered through an introducer sheath within the body to the region of interest and assume the expanded state upon emerging from a distal end of the sheath; [0028-0029]).
Concerning claim 2, Eliason et al. disclose a cap or cover (52) positioned at the distal end portion (34) of the shaft (24) or introducer sheath ([0031]; Fig. 3).
Concerning claim 3, Eliason et al. disclose the plurality of wires (36) terminating within the cap or cover (52) ([0031]; Fig. 3).
Concerning claim 4, Eliason et al. disclose the distal end portion of the elongate shaft (24) comprises a distal atraumatic tip (52) ([0031]; Fig. 3).
Concerning claim 5, Eliason et al. disclose the plurality of wires (36) is configured to create a circumferentially continuous contact with a wall of the lumen of the patient (Fig. 3).
Concerning claim 7, as illustrated in at least Figs. 4-6, Eliason et al. disclose a catheter (electrophysiology catheter 18; [0025]) comprising:
an elongate shaft having a proximal end portion and a distal end portion (shaft 24 has distal and proximal end portions 34, 32; [0025] // or introducer sheath; [0028-0029]), the elongate shaft being configured to locate the distal end portion at a treatment site within a lumen of a patient (shaft 24 may be steered or guided through the body to a desired location such as tissue in a region of interest; [0028] // or introducer sheath can be steered to location of interest; [0028-0029]);
a cap or cover positioned at the distal end portion of the elongate shaft (splines 36 may be coupled at distal end 50 by a hinge connector 52; [0031]);
a plurality of wires positioned at the distal end portion of the elongate shaft (splines 36 are configured to support electrodes 42; [0026], [0028-0029]); and
a plurality of electrodes (electrodes 42 are disposed on splines 36; [0029]); and
a support structure positioned at the distal end portion of the elongate shaft and defining a plurality of elongated slots extending through a wall of the support structure, the plurality of elongated slots being adjacent a distal end of the support structure (central post 54, including connector 52, extends from shaft 24 // or // introducer sheath, where connector 52 defines a plurality of slots extending through the wall adjacent the distal end of central post 54, including connector 52; [0028-0029] [0035], where slots 134 are elongated as disclosed in 13/340760 which is incorporated by reference), wherein a respective wire distal end portion defining a distal end of each wire of the plurality of wires is received within the support structure through a respective slot of the plurality of elongated slots (splines 52 are coupled at distal end 50 by hinge connector 52 via the slots; [0031]),
Eliason et al. fail to disclose the respective wire distal end portion being bent relative to a remaining portion of the respective wire and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state. However, Buehlmann et al. disclose a catheter (12) comprising a deployable wire (56) having a distal end portion (122) defining a distal end (124) that is received within an elongated slot (148) of a support structure (44, 46), the respective wire distal end portion (122) being bent relative to a remaining portion (middle portion) of the respective wire (56) and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot (124) holds the respective wire distal end portion (122) close to a surface of the support structure (44, 46) to prevent the respective wire distal end portion (122) from buckling when the wire is moved to the expanded deployed state.
At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Eliason et al. such that the respective wire distal end portion is bent relative to a remaining portion of the respective wire and extends in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state in order to provide the benefit of permitting the wire distal end of effectively pivot freely as the wire moves between the low-profile delivery state and the expanded deployed state and also reducing stress and improving the fatigue characteristics of the distal end of the wire as taught by Buehlmann et al. ([0060], [0066]; Fig. 22, 25 & 27A-B),
wherein each wire of the plurality of wires comprises at least one electrode of the plurality of electrodes positioned thereon (splines 36 are configured to support electrodes 42; [0026], [0029]), the plurality of wires being moveable between a low- profile delivery state and an expanded deployed state (assembly may assume a compressed state, for example, as catheter 18 is maneuvered through an introducer sheath within the body to the region of interest and assume the expanded state upon emerging from a distal end of the sheath; [0028-0029]), and
wherein the plurality of wires is radially expanded in the expanded deployed state relative to the low-profile delivery state (assembly 30 may assume a compressed state, for example, as catheter 18 is maneuvered through an introducer sheath within the body to the region of interest and assume the expanded state upon emerging from a distal end of the sheath; [0028-0029]).
Concerning claim 8, Eliason et al. disclose the cap or cover (52) is rounded (circumferential outer surface), and wherein the plurality of wires (62) forms a set of intertwined helixes ([0037]; Fig. 7, where Eliason et al. provides for the combination of embodiments in Par. [0023]), or in the alternative, Eliason et al. disclose in an alternative embodiment of Fig. 7 the wires (62) forming a set of intertwined helixes. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Eliason et al. such that the plurality of wires forms a set of intertwined helixes in order to provide the benefit to enable a physician to change the distribution of the electrodes with respect to the radius from the centroid of the basket as taught by Eliason et al. ([0037]; Fig. 7)
Claim 9 is rejected upon the same rationale as provided for claim 3.
Claim 10 is rejected upon the same rationale as provided for claim 5.
Claim 11 is rejected upon the same rationale as provided for claim 6.
Concerning claim 12, Eliason et al. disclose each wire of the plurality of wires (36) exits the elongate shaft (24) at the distal end portion (32) or exits the introducer sheath and terminates within the cap or cover (52) ([0028-0029], [0031]; Fig. 3).
Concerning claim 14, Eliason et al. disclose the elongate shaft (24 or introducer sheath) defines an exit port (any of wire exits or entire distal opening of introducer sheath) at the distal end portion, wherein the elongate shaft (24) further defines a shaft lumen, and wherein a portion (proximal ends) of the plurality of wires (36) is disposed within the shaft lumen in the low-profile delivery state of the plurality of wires ([0028-0029], [0052-0053]; Fig. 10).
Concerning claim 15, as illustrated in at least Figs. 4-6, Eliason et al. disclose a catheter (electrophysiology catheter 18; [0025]) comprising:
an elongate shaft having a proximal end portion and a distal end portion (shaft 24 has distal and proximal end portions 34, 32; [0025] // or introducer sheath; [0028-0029]), the elongate shaft being configured to locate the distal end portion at a treatment site within a lumen of a patient (shaft 24 may be steered or guided through the body to a desired location such as tissue in a region of interest; [0028] // or introducer sheath can be steered to location of interest; [0028-0029]);
an atraumatic tip positioned at the distal end portion of the elongate shaft (splines 36 may be coupled at distal end 50 by a hinge connector 52 which can be considered atraumatic as it has a flat distal edge; [0031]);
a plurality of wires positioned at the distal end portion of the elongate shaft (splines 36 are configured to support electrodes 42; [0026], [0029]); and
a plurality of electrodes (electrodes 42 are disposed on splines 36; [0029]),
a support structure positioned at the distal end portion of the elongate shaft and defining a plurality of elongated slots extending through a wall of the support structure, the plurality of elongated slots being adjacent a distal end of the support structure (central post 54, including connector 52, extends from shaft 24 // or // introducer sheath, where connector 52 defines a plurality of slots extending through the wall adjacent the distal end of central post 54, including connector 52; [0028-0029], [0035], where slots 134 are elongated as disclosed in 13/340760 which is incorporated by reference), wherein a respective wire distal end portion defining a distal end of each wire of the plurality of wires is received within the support structure through a respective slot of the plurality of elongated slots (splines 52 are coupled at distal end 50 by hinge connector 52 via the slots; [0031]),
Eliason et al. fail to disclose the respective wire distal end portion being bent relative to a remaining portion of the respective wire and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state. However, Buehlmann et al. disclose a catheter (12) comprising a deployable wire (56) having a distal end portion (122) defining a distal end (124) that is received within an elongated slot (148) of a support structure (44, 46), the respective wire distal end portion (122) being bent relative to a remaining portion (middle portion) of the respective wire (56) and extending in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot (124) holds the respective wire distal end portion (122) close to a surface of the support structure (44, 46) to prevent the respective wire distal end portion (122) from buckling when the wire is moved to the expanded deployed state.
At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Eliason et al. such that the respective wire distal end portion is bent relative to a remaining portion of the respective wire and extends in a direction aligned with a major axis of the respective elongated slot, wherein the respective elongated slot holds the respective wire distal end portion close to a surface of the support structure to prevent the respective wire distal end portion from buckling when the plurality of wires is moved to the expanded deployed state in order to provide the benefit of permitting the wire distal end of effectively pivot freely as the wire moves between the low-profile delivery state and the expanded deployed state and also reducing stress and improving the fatigue characteristics of the distal end of the wire as taught by Buehlmann et al. ([0060], [0066]; Fig. 22, 25 & 27A-B),
wherein each wire of the plurality of wires comprises at least one electrode of the plurality of electrodes positioned thereon (splines 36 are configured to support electrodes 42; [0026], [0029]), the distal end of each wire of the plurality of wires terminating within the atraumatic tip (splines 36 may be coupled at distal end 50 by a hinge connector 52; [0031]) and the plurality of wires being moveable between a low-profile delivery state and an expanded deployed state in which the plurality of wires is radially expanded relative to the low-profile delivery state (assembly may assume a compressed state, for example, as catheter 18 is maneuvered through an introducer sheath within the body to the region of interest and assume the expanded state upon emerging from a distal end of the sheath 24 or introducer sheath; [0028-0029]).
Claim 16 is rejected upon the same rationale as applied to claim 1.
Concerning claim 17, Eliason et al. disclose a support structure (54) is axially fixed relative to the distal end portion (32) of the elongate shaft (24) ([0035]; Fig. 3).
Claim 18 is rejected upon the same rationale as applied to claim 5.
Claim 19 is rejected upon the same rationale as applied to claim 14.
Claim 20 is rejected upon the same rationale as applied to claim 1.
Concerning claim 21, Eliason et al. disclose the plurality of wires (36) comprises at least a first wire defining a first wire distal end portion and a second wire defining a second wire distal end portion, and wherein the first wire distal end portion is circumferentially opposed to the second wire distal end portion across the elongate shaft (24) (Fig. 3).
Concerning claim 22, Daniel et al. further discloses the respective wire distal end portion of each respective wire (108) extends distally away from the remaining portion of the respective wire in the direction aligned with the major axis (longitudinal axis of cylindrical hole) of the respective elongated slot (holes in 502) (Fig .5).
Concerning claim 23, Daniel et al. further discloses the major axis (longitudinal axis of cylindrical hole) of the respective elongated slot (holes in 502) is aligned with one or both of a longitudinal axis of the elongated shaft (106) or a longitudinal axis of the support structure (112 & 502) (Fig. 5).
Claim(s) 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Eliason et al. (2014/0257069, previously cited) in view of Buehlmann et al. (2006/0030846), as applied to claim 7, in further view of Deem et al. (2010/0222851, previously cited).
Concerning claim 13, while Eliason et al. disclose the wire (36) to have insulation (38) ([0030-0032]), Eliason et al. in view of Buehlmann et al. fail to disclose each wire of the plurality of wires has discrete sections of insulation along a respective length of the wire, wherein the at least one electrode is positioned between the discrete sections of insulation. However, Deem et al. disclose a catheter comprising a plurality of wires have discrete sections of insulation along its length to allow the wire to create the portion that is the electrode in between the discrete sections of insulation or having electrodes affixed to the plurality of wires. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Eliason et al. in view of Buehlmann et al. such that each wire of the plurality of wires has discrete sections of insulation along a respective length of the wire, wherein the at least one electrode is positioned between the discrete sections of insulation in order to provide the benefit of ease of manufacturing and since Deem et al. teach equivalence of the art for the purposes of forming electrodes on a wire ([0098-0099]).
Response to Arguments
Applicant’s arguments with respect to the claims 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 Examiner notes: the claims do not require the distal end portion to be “close to a surface of the support structure” and also “aligned with a major axis of the respective elongated slot” during both the low-profile and expanded deployed states.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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