DETAILED ACTION
Applicant's amendments and remarks, filed 7/2/26, are fully acknowledged by the Examiner. Currently, claims 1, 3-19, 27-29 are pending with claim 2 canceled, claims 27-29 added, and claims 1, 3-6, 9-12, 14-16, and 19 amended. The following is a complete response to the 7/2/26 communication.
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 .
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.
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(s) 1, 3-4, 7-19, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki (US 2015/0351652) in view of Nahon (US 2015/0351652).
Regarding claim 1, Marecki teaches a catheter comprising:an elongate shaft including a proximal portion and a distal portion including a neuromodulation element (shaft 30b with distal portion near 60 and proximal portion away from 60 as in Fig. 3b having neuromodulation element 64), wherein the neuromodulation element comprises:
a plurality of electrodes disposed along a length of an elongate structure (electrodes 64 as in par. [0077]); and
a bend between a first segment of the length of the elongate structure and second segment of the length of the elongate structure such that the second segment extends in a proximal direction from the bend (proximal bend in Fig. 3b).Marecki is silent wherein the elongate structure further comprises a guidewire port at the bend, and wherein the guidewire port is configured to receive a guidewire.
Nahon teaches a guidewire port at a bend of an elongate structure (guidewire 260 out of opening 240 at a bend), allowing guiding to particular structures of the body.
It would have been obvious to one of ordinary skill in the art to modify Marecki with the guidewire port of Nahon, allowing for locating of different points of interest in tissue.
Regarding claim 3, Marecki teaches wherein the bend is a first bend (Fig. 3b) and the elongate structure comprises a second bend such that a third segment of the length of the elongate structure extends in a distal direction from the second bend (second bend bending 60 distally as in Fig. 3b).
Regarding claim 4, Marecki teaches wherein the bend is a first bend (Fig. 3b) and the elongate structure comprises a second bend such that a third segment of the length of the elongate structure extends in a distal direction from the second bend (second bend bending 60 distally as in Fig. 3b).Marecki is silent regarding the guidewires, but Nahon teaches wherein the guidewire port is a first guidewire port (240),
wherein the elongate structure further comprises a second guidewire port at the second bend, and wherein the second guidewire port is configured to receive a guidewire (230 port with guidewire 250). Nahon teaches a guidewire port at a bend of an elongate structure (guidewire 260 out of opening 240 at a bend), allowing guiding to particular structures of the body.
It would have been obvious to one of ordinary skill in the art to modify Marecki with the guidewires of Nahon, allowing for locating of different points of interest in tissue.
Regarding claim 7, Marecki teaches wherein a first electrode of the plurality of electrodes is
disposed along the first segment and a second electrode of the plurality of electrodes is disposed along the second segment (electrodes 64 on different sections of the bend).
Regarding claim 8, Marecki teaches wherein the first electrode and the second electrode are disposed at a first longitudinal position along the elongate structure (electrodes 64 in a first longitudinal position).
Regarding claim 9, Marecki teaches wherein the first electrode and the second electrode are configured to provide a neuromodulation treatment to tissue of the patient at the first longitudinal position and at different circumferential positions within the vasculature of the patient (64 as in par. [0080]).
Regarding claim 10, Marecki teaches wherein the bend is a first bend (Fig. 3b), wherein the elongate structure comprises a second bend such that a third segment of the length of the elongate structure extends in a distal direction from the second bend (Fig. 3b, bends in a spiral), wherein a third electrode of the plurality of electrodes is disposed along the second segment (Fig. 3b with electrodes 64 in different segments of the structure).
Regarding claim 11, Marecki teaches wherein the third electrode is disposed at the first longitudinal position along the elongate structure (64 along different longitudinal positions including the first longitudinal position).
Regarding claim 12, Marecki teaches wherein the third electrode is configured to provide a neuromodulation treatment to tissue of a patient at the first longitudinal position and at a circumferential position within vasculature of the patient different from the circumferential position of the first electrode and the circumferential position of the second electrode (par. [0080] electrodes at different positions providing treatment).
Regarding claim 13, Marecki teaches wherein the elongate structure comprises a third bend such that a fourth segment of the length of the elongate structure extends in a proximal direction from the third bend (Fig. 3b, bends in a spiral), wherein a fourth electrode of the plurality of electrodes is disposed along the fourth segment (Fig. 3b with electrodes 64 in different segments of the structure).
Regarding claim 14, Marecki teaches wherein the fourth electrode is disposed at the first longitudinal position along the elongate structure (64 at a first longitudinal position).
Regarding claim 15, Marecki teaches wherein the fourth electrode is configured to provide a neuromodulation treatment to tissue of a patient at the first longitudinal position and at a circumferential position within vasculature of the patient different from the circumferential position of any of the first, second, and third electrodes (par. [0080] electrodes at different positions providing treatment as in Fig. 3b).
Regarding claim 16, Marecki teaches further comprising a distal electrode disposed at a distal tip of the elongate structure (distalmost electrode 64).
Regarding claim 17, Marecki teaches wherein a distal tip of the elongate structure is radiopaque (par. [0098] material is gold which is radiopaque).
Regarding claim 18, Marecki teaches wherein a distal tip of the elongate structure comprises
gold (par. [0098]).
Regarding claim 19, Marecki teaches a method comprising:
navigating a catheter through vasculature of a patient to a target treatment site in a vessel of the patient (par. [0070]), wherein the catheter comprises an elongate shaft including a proximal portion and a distal portion including a neuromodulation element (shaft 30b with distal portion near 60 and proximal portion away from 60 as in Fig. 3b having neuromodulation element 64), wherein the neuromodulation element comprises:
a plurality of electrodes disposed along a length of an elongate structure (64 as electrodes along 60);
and
a bend between a first segment of the length of the elongate structure and second segment of the length of the elongate structure such that the second segment extends in a proximal direction from the bend (bend in 60 as in Fig. 3b that moves the second segment proximal).Marecki is silent wherein the elongate structure further comprises a guidewire port at the bend, and wherein navigating the catheter comprises at least one of advancing or retracting the neuromodulation element along a guidewire configured to enter or exit a lumen of the elongate structure at the guidewire port.
Nahon teaches a guidewire port at a bend of an elongate structure (guidewire 260 out of opening 240 at a bend), allowing guiding to particular structures of the body.
It would have been obvious to one of ordinary skill in the art to modify Marecki with the guidewire port of Nahon, allowing for locating of different points of interest in tissue.
Regarding claim 27, Marecki is not explicit wherein the guidewire extends through the guidewire port, the guidewire extends along a longitudinal axis of the elongate shaft. However, Nahon teaches the guidewire extends through the guidewire port, along a longitudinal axis of the elongate shaft (Fig. 5b).It would have been obvious to one of ordinary skill in the art to modify Marecki with the guidewire port of Nahon, allowing for locating of different points of interest in tissue.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki in view of Nahon, in further view of Patel (US 2021/0059713).
Regarding claim 29, Marecki is not explicit wherein the elongate shaft is configured to transform between a compressed delivery configuration and an expanded deployed configuration, and wherein the elongate shaft defines the bend in both the compressed delivery configuration and the expanded deployed configuration.However, Patel teaches a bending feature of a shaft that elongates and compresses according to a degree of bending (par. [0132]).It would have been obvious to one of ordinary skill in the art to modify Marecki with the bending features of Patel, to allow a mechanical way for selective bending of a shaft.
Allowable Subject Matter
Claims 5-6 and 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Marecki, Nahon, and Patel do not teach the bend with the segments and bends in the order and arrangement of at least claim 5. Rather, the order of the bends and segments of Mareck would not align with the arrangement of claim 5. Examiner has not found any piece of art that discloses, fairly suggests, or makes obvious the arrangement.
Regarding claim 28, the prior art does not teach the first and second segments of the length of the elongate structure are parallel. Rather, the segments of Mareck as in Fig. 3b are not parallel. Examiner has not found any piece of art that discloses, fairly suggests, or makes obvious the arrangement.
Response to Arguments
Applicant's arguments filed 7/2/26 have been fully considered but they are not persuasive. Applicant argues that Marecki does not teach a guidewire port, and so would not have a guidewire. However, Nahon is used to teach the guidewire and associated structure, allowing for the device to be guided to the target tissue. One of ordinary skill in the art would appreciate that as guidewires are thinner, they can more easily navigate body lumens to arrive at a target location.
Applicant further argues that the guidewire ports of Nahon are not at a bend. However, looking to figure 2 of Nahon, 240 is at a bend in the device, allowing for positioning in the case of Fig. 2 at the pancreatic duct, as the 230 opening is at the biliary duct. As such, the openings are oriented to allow access to anatomical orifices of interest, taking into account the organic architecture of the human body to include bends.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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