CTNF 18/687,213 CTNF 101535 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restriction 08-05 AIA Claim s 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 5, 2026 . The traversal is on the ground that, as amended, Claim 1 and Claim 15 now recite the special technical feature of "coupling points [that] are arranged such that, when the neuromodulation element is in the deployed state, the one or more coupling points are oriented along the coiled outer surface of the coiled shape of the elongated structure" . This is not found persuasive because this limitation is clearly obvious in view of EP 2664295 A1 ( Zirkle et al. ). Zirkle discloses that the thermocouples are mounted along the electrodes and the coiled outer surface of the coiled shape of the elongated structure ( see Fig. 22; see also para. 0117, " the thermocouple/rf wires which thermocouples 135 are mounted at or near the outermost diameter of the electrodes and at the outermost diameter of the helical shape for tissue contact." ). It would have been obvious in view of Zirkle for the coupling points to be oriented in the same manner at or near the outermost diameter of the helical shape for tissue contact. The requirement is still deemed proper and is therefore made FINAL . Information Disclosure Statement 06-52 The information disclosure statement (IDS) submitted on May 20, 2024 is acknowledged. 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 Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-8, 10-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2664295 A1 ( Zirkle et al. ) . Regarding Claim 1 , Zirkle discloses a catheter [10] comprising neuromodulation element [ 17 ] convertible between a low-profile delivery state and a radially expanded deployed state ( see Fig. 1; see also para. 0057, “catheter 10 is designed to allow the helical form 22 to be contracted and expanded, thus decreasing its radius and/or pitch ”), the neuromodulation element comprising: an elongated structure configured to have a substantially linear shape defining a longitudinal axis when the neuromodulation element is in a low-profile delivery state, and further configured to have a coiled shape defining a coiled outer surface when the neuromodulation element is in the radially expanded deployed state (s ee para. 0057, “the present catheter allows the overall configuration of the helical form 22 to be varied and adjusted, including significant expansion, whereby the helical form can be generally straightened” ); and one or more electrodes [ 19 ] spaced longitudinally apart along the longitudinal axis of the elongated structure ( see Fig. 22 ); and one or more wires [ 131 ], each wire electrically coupled to a corresponding electrode along the coiled outer surface ( see Figs. 14 & 22, see also para. 0089, “each AR electrode is connected to a respective pair of wires . . . fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode” ). Zirkle does not explicitly disclose coupling points that are arranged such that, when the neuromodulation element is in the deployed state, the one or more coupling points are oriented along the coiled outer surface of the coiled shape of the elongated structure. However, Zirkle discloses that the thermocouples are mounted along the electrodes and the coiled outer surface of the coiled shape of the elongated structure ( see Fig. 22; see also para. 0117, " the thermocouple/rf wires which thermocouples 135 are mounted at or near the outermost diameter of the electrodes and at the outermost diameter of the helical shape for tissue contact." ). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to orient the coupling points at the outermost diameter of the helical shape like with the thermocouples. Doing so could align the coupling points to the expected point of tissue contact. Regarding Claims 2, 3 , and 20, coupling points that are at the outermost diameter of the helical shape as discussed in Claim 1 above would correspond to being positioned at an origin line defined by a center of the coiled outer surface of the coiled shape of the elongated structure, and therefore, also be within a threshold arc length that circumferentially extends about 45 or 90 degrees on either side of the origin line ( see para. 0117, see also Fig. 22 ). Regarding Claim 4 , Zirkle teaches the elongated structure comprises a tubular structure defining an inner lumen [ 58 ] and one or more slots ( see Fig. 14 ); wherein the inner lumen is configured to receive the one or more wires [ 40, 41 ] ( see Fig. 14 ); and wherein each wire of the one or more wires is configured to extend through a respective slot of the one or more slots and electrically couple to a respective electrode of the one or more electrodes ( see Fig. 14; see also para. 0089, “The wires of each pair are electrically isolated from each other except at their distal ends where they are twisted together, fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode” ). Regarding Claim 5 , Zirkle teaches the one or more slots define relative positions of the one or more coupling points (see Fig. 14 and para. 0089). Zirkle does not explicitly teach the relative positions of the one or more coupling points are oriented along the coiled outer surface of the coiled shape of the elongated structure. As discussed in Claim 1, Zirkle discloses that the thermocouples are mounted along the electrodes and the coiled outer surface of the coiled shape of the elongated structure ( see Fig. 22; see also para. 0117, " the thermocouple/rf wires which thermocouples 135 are mounted at or near the outermost diameter of the electrodes and at the outermost diameter of the helical shape for tissue contact." ). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to orient the slots that define the relative positions of the one or more coupling points at the outermost diameter of the helical shape as with the thermocouples. Doing so could align the coupling points to the expected point of tissue contact. Regarding Claim 6 , Zirkle teaches the elongated structure comprises a shape memory structure [ 121 ] and an outer jacket [ 132 ], and wherein the shape memory structure is pre-formed to urge the neuromodulation element toward the radially expanded deployed state ( see Fig. 22; see also para. 0117, “an additional lumen 132 houses the nitinol wire 121 [which] provides the shape to the helix when it is unconstrained by a sheath, mandrel or guidewire ). Regarding Claim 7 , Zirkle teaches the one or more coupling points comprise at least two coupling points ( see Fig. 22 ), but doesn’t explicitly teach the at least two coupling points are arranged such that, when the neuromodulation element is in the low-profile delivery state, the at least two coupling points extend helically around the longitudinal axis of the elongated structure. However, it would have been obvious for a person having ordinary skill in the art to arrange the at least two coupling points to extend helically around the longitudinal axis of the elongated structure when in the low-profile delivery state. Doing so would be an obvious way to achieve the desired orientation of the coupling points when in the radially expanded deployed (helical) state discussed in Claim 1 above. Regarding Claim 8 , Zirkle teaches the one or more electrodes comprise one or more band electrodes [ 19 ], wherein each band electrode of the one or more band electrodes extends circumferentially around the longitudinal axis of the elongated structure ( see Fig. 22 ). Regarding Claim 10 , a distal end of the elongated structure is oriented at an oblique angle to the longitudinal axis of the elongated structure ( see Figs. 1, 3, and 22; see also para. 0056, “The helical form is oriented obliquely relative to a longitudinal axis of the intermediate section 14” ). Regarding Claims 11-12 , Zirkle teaches the one or more electrodes comprise 3-4 electrodes. ( see para. 0088, "The number of AR electrodes on the distal assembly 17 can vary as desired. Preferably the number of AR electrodes ranges from about 3 to about 12" ). Regarding Claim 13 , Zirkle teaches each wire of the one or more wires comprises a wire pair, and wherein each coupling point of the one or more coupling points comprises a thermocouple point ( see para. 0089, "the wire pairs inclusive of their respective constantan wire can also function as temperature sensors or thermocouples sensing temperature of each AR electrode" ). Regarding Claim 14 , Zirkle teaches the wire pair comprises a copper wire [ 40 ] and a constantan wire [ 41 ] ( see para. 0089 ) . 07-21-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over EP 2664295 A1 ( Zirkle et al. ) in view of US 20150209104 A1 ( Tran et al. ) . Regarding Claim 9, Tran discloses a neuromodulation element with an elongated structure that defines one or more reduced-diameter segments spaced longitudinally apart along the longitudinal axis of the elongated structure ( see Fig. 10; see also para. 0033, “The distal jacket 200 can include reduced-diameter segments 202 (individually identified as reduced-diameter segments 202a-202d) extending through its outer surface) ”; and wherein each of the one or more band electrodes is seated in a respective reduced- diameter segment of the one or more reduced-diameter segments of the elongated structure ( see Fig. 11; see also para. 0033, “band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202” . It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zirkle and Tran to provide for reduced-diameter segments spaced longitudinally apart along the longitudinal axis of the elongated structure of Zirkle wherein each of the band electrodes is seated. Doing so could reduce or eliminate potentially problematic ridges at distal and proximal ends of the individual band electrodes, as recognized by Tran ( see para. 0036 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.S./Examiner, Art Unit 3794 /JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794 Application/Control Number: 18/687,213 Page 2 Art Unit: 3794 Application/Control Number: 18/687,213 Page 3 Art Unit: 3794 Application/Control Number: 18/687,213 Page 4 Art Unit: 3794 Application/Control Number: 18/687,213 Page 5 Art Unit: 3794 Application/Control Number: 18/687,213 Page 6 Art Unit: 3794 Application/Control Number: 18/687,213 Page 7 Art Unit: 3794
Prosecution Insights