CTNF 18/716,707 CTNF 97927 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/Restrictions Applicant’s election without traverse of the invention of Group I in the reply filed on 20 April 2026 is acknowledged. Claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claim Objections 07-29-01 AIA Claim s 4 and 8 are objected to because of the following informalities: In claim 4, line 2, “expendable” should read --expandable-- In claim 8, line 2, “configured assume” should read --configured to assume -- Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 2, 5, 9, 12, and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 2, it is unclear whether the plane intersecting each therapeutic element is the same plane for all elements, or one plane per therapeutic element, which renders the scope of the claim unclear. For examination purposes, this limitation will be read as wherein at least two therapeutic elements are intersected by the same plane, which is substantially orthogonal to a longitudinal axis of the elongated member. 07-34-03 AIA The term “ extended ” in claim s 5 and 9 is a relative term which renders the claim indefinite. The term “ extended ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In these claims, the tapered tip is rendered indefinite by the relative term . Claim 12 depends on claim 10, which does not recite an inner lumen for one or more expandable members of the plurality of expandable members. Accordingly, the limitation “the guide member being withdrawn proximally from the one or more expandable members” is unclear in scope. For examination purposes, this limitation will be read as the guide member being withdrawn proximally from an inner lumen of the one or more expandable members. In claim 14, the intended meaning of the limitation “common shape memory structure” is unclear, since “common” may have the meaning of shared or the meaning of occurring frequently; ordinary; usual . As such, the scope of the claim is rendered unclear. For examination purposes, the limitation will be read to mean a shared or connected shape memory structure. In claim 15, the limitation “corresponding shape memory structure” is unclear because it is not clear from the claim to what the shape memory structure corresponds, which renders the scope of the claim unclear. For examination purposes, this limitation will be read as wherein each expandable member of the plurality of expandable members comprises a shape corresponding to the other expandable member . Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-4, 6-8, 10, 13, and 16-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kelly et al. (US PGPub No. 2015/0257825), hereinafter Kelly . Regarding claim 1, Kelly discloses a system (Fig. 1: neuromodulation system 100) comprising: a catheter (Fig. 1: catheter 102) comprising: an elongated member configured to be navigated through vasculature of a patient to a target treatment site (Fig. 1: elongate shaft 108; par. 0016: “The shaft 108 can be configured to intravascularly locate the treatment assembly 116 at a treatment location within a body lumen, such as a suitable blood vessel”); and a plurality of expandable members arranged at a distal portion of the elongated member (Figs. 2A-2B: first and second struts 130 and 140), each expandable member comprising a corresponding two or more therapeutic elements arranged along a length of the expandable member (Figs. 2A-2B: energy delivery electrodes 154 arranged in pairs along lengths of struts 130 and 140), each expandable member of the plurality of expandable members being configured to assume a delivery configuration (Fig. 2A) and a radially expanded helical configuration (Fig. 2B), each expandable member being configured to position the corresponding two or more therapeutic elements near a vessel wall so that the therapeutic elements are spaced around a perimeter of the vessel wall (Fig. 6C and par. 0026: “The curved first and second struts 130/140 each have a selected twist/radial sweep such that, when they are in the deployed configuration, the electrodes 154a-d carried by corresponding struts 130/140 are urged into apposition with an inner wall of a body lumen at corresponding contact regions”), and wherein distal portions of the plurality of expandable members are connected to each other at a distal tip of the catheter (Figs. 2A-2C: struts 130 and 140 connected to each other at distal tip of shaft 108). Claim 16 is rejected for the same reasons set forth in the rejection for claim 1, since the claim merely recites the simple method steps for using the catheter of claim 1 to deliver treatment to a vessel wall, as disclosed by Kelly (see Fig. 6C and par. 0045: “After treatment assembly 116 is deployed at the treatment location, electrodes 154 can be energized to modulate one or more nerves at or near the treatment location”). Regarding claims 2 and 17, Kelly discloses the system and method of claims 1 and 16 as described previously. Kelly further discloses wherein, when the plurality of expandable members are in the radially expanded helical configuration, at least two therapeutic elements are intersected by the same plane, which is substantially orthogonal to a longitudinal axis of the elongated member (par. 0022: “when the treatment assembly 116 is transformed to the expanded deployed configuration, the pairs of electrodes (the first pair 154a/154b and the second pair 154c/154d) are aligned along electrode axes that are orthogonal relative to the longitudinal axis A”). Regarding claims 3-4, 6, and 18, Kelly discloses the system and method of claims 1 and 16 as described previously. Kelly further discloses wherein the plurality of expandable members comprises a first expandable member and a second expendable member, and each expandable member of the plurality of expandable members is configured to, in the radially expanded helical configuration, rotate about a corresponding helical axis in a different direction than the other expandable member, and wherein one or more helical axes are substantially parallel to a longitudinal axis of the elongated member (Fig. 2C: struts 130 and 140 rotating in opposite directions about helical axis parallel with longitudinal axis A). Regarding claims 7-8 and 19, Kelly discloses the system and method of claims 1 and 19 as described previously. Kelly further discloses further comprising a guide sheath (Fig. 6A: delivery sheath 506), wherein the plurality of expandable members are configured to assume the radially expanded helical configuration when the plurality of expandable members extend from a distal port of the guide sheath (Figs. 6B-6C: treatment assembly 116 only expanding after extending from distal opening of delivery sheath 506; examiner notes that the prior art reads on this limitation as broadly as claimed, because the claims do not recite wherein the plurality of expandable members are configured to automatically assume the radially expanded configuration upon retraction of the guide sheath). Regarding claim 10, Kelly discloses the system of claim 1 as described previously. Kelly further discloses further comprising a guide member (par. 0044: “It will be understood by persons familiar with the field of catheterization that catheter 102 and sheath 506 would typically be guided, simultaneously or separately, from a vascular puncture site to renal artery 500 using a guiding catheter and/or a medical guidewire, both of which are omitted from FIGS. 6A-6C for simplicity of illustration”). Regarding claim 13, Kelly discloses the system of claim 1 as described previously. Kelly further discloses wherein the plurality of expandable members comprise a shape memory structure (par. 0020: “The first and second struts 130 and 140 may be composed of metal (e.g., titanium nickel alloy commonly known as nitinol)”) . 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim s 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Toth et al. (US PGPub No. 2015/0289929), hereinafter Toth . Kelly teaches the systems of claims and 7 as described previously but does not explicitly teach wherein either the distal tip or the guide sheath comprises a tapered tip configured to facilitate navigation through the vasculature of the patient. However, in a related neuromodulation art, Toth teaches a catheter comprising a tapered tip to assist with ease of insertion into the lumen of a vessel (par. 0366: “the sheath 2110 may include a tapered tip 2118 to assist with ease of insertion into the lumen of a vessel”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Kelly by providing the distal tip or guide sheath with a tapered tip, as taught by Toth, in order to assist with ease of insertion into the lumen of a vessel, as taught by Toth . 07-21-aia AIA Claim s 11-12, 14-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Chang et al. (US Patent No. 10,512,504), hereinafter Chang . Regarding claims 11-12 and 20, Kelly teaches the system of claim 10 and the method of claim 16 as described previously. Kelly further teaches wherein the guide member may comprise a guidewire (par. 0044) but does not teach wherein one or more expandable members of the plurality of expandable members comprises an inner lumen, and wherein the guidewire is configured to be positioned within the inner lumen when the plurality of expandable members is in the delivery configuration, and wherein the plurality of expandable members are configured to transition from the delivery configuration to the radially expanded helical configuration in response to the guide member being withdrawn proximally from the one or more expandable members. However, in a related neuromodulation art, Chang teaches a guidewire configured to be positioned within an inner lumen of an expandable member when the expandable member is in the delivery configuration, and wherein the expandable member is configured to transition to a radially expanded helical configuration in response to the guide member being withdrawn proximally from the expandable member (col 9, lines 27-39: “a guide wire may be either inserted into or at least partially withdrawn from the distal portion 20 to transform the therapeutic assembly 21 between the delivery state (FIG. 3A) and the deployed state (FIG. 3B). For example, as shown in FIG. 3A, a guide wire (not shown) extending through at least a portion of the length of the catheter 12 may be configured to straighten a pre-shaped spiral/helical control member 50 (shown schematically in broken lines) of the catheter 12 during delivery, and the guide wire may be at least partially withdrawn or slidably moved relative to the distal portion 20 to allow the therapeutic assembly 21 to transform to the deployed state (FIG. 3B);” col 12, lines 44-48: “the guide wire 66 may be withdrawn completely from the therapeutic assembly 21 (e.g., a distalmost end portion of the guide wire 66 is proximal of the therapeutic assembly 21) to permit the transformation”), which Chang further teaches allows the expandable member to be transformed back to the delivery configuration (col 12, lines 63-66: “After treatment, the therapeutic assembly 21 may be transformed back to the low-profile delivery configuration by axially advancing the guide wire 66 relative to the therapeutic assembly 21”) and provides the benefit of using a single element to both guide the catheter and restrain the treatment assembly in a low-profile delivery state (col 13, lines 9-11: “a procedural guide wire to guide the catheter to the treatment site and also to restrain the therapeutic assembly or treatment section in a low-profile delivery state”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Kelly by configuring the expandable members to receive the guidewire for actuation between a delivery configuration and a radially expanded helical configuration, as taught by Chang, so that a single element can be used to both guide the catheter and restrain the treatment assembly in a low-profile delivery state, as taught by Chang. Regarding claims 14-15, Kelly teaches the system of claim 13 as described previously, and further teaches wherein each expandable member of the plurality of expandable members comprises a shape corresponding to the other expandable member (Fig. 2C), but does not explicitly teach wherein the shape memory structure is configured to urge the plurality of expandable members from the delivery configuration to the radially expanded helical configuration. However, Chang further teaches a shape memory structure configured to urge the expandable member from the delivery configuration to the radially expanded helical configuration (col 9, lines 54-56: “the pre-shaped control member 50 may be used to provide a spiral/helical shape to the relatively flexible distal portion 20 of the catheter 12”), which allows electrodes on the expandable member to be positioned in stable apposition with a vessel wall (col 10, lines 3-10: “the control member 50 in the present embodiment has a pre-set spiral/helical configuration that defines the deployed state of the therapeutic assembly 21 such that the energy delivery elements 24 of the therapeutic assembly 21 […] may be positioned in stable apposition with a wall of the renal artery (FIG. 2) for treatment”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Kelly by configuring the shape memory structure to urge the expandable members to the radially expanded helical configuration, as taught by Chang, in order to position the therapeutic elements in stable apposition with a vessel wall, as taught by Chang. The combination further does not explicitly teach wherein the plurality of expandable members comprise a shared or connected shape memory structure. However, such a modification would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works , 150 U.S. 164 (1893). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET). 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, JOANNE M RODDEN can be reached at (303) 297-4276. 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. /D.E.L./Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794 Application/Control Number: 18/716,707 Page 2 Art Unit: 3794 Application/Control Number: 18/716,707 Page 3 Art Unit: 3794 Application/Control Number: 18/716,707 Page 4 Art Unit: 3794 Application/Control Number: 18/716,707 Page 5 Art Unit: 3794 Application/Control Number: 18/716,707 Page 6 Art Unit: 3794 Application/Control Number: 18/716,707 Page 7 Art Unit: 3794 Application/Control Number: 18/716,707 Page 8 Art Unit: 3794 Application/Control Number: 18/716,707 Page 9 Art Unit: 3794 Application/Control Number: 18/716,707 Page 10 Art Unit: 3794 Application/Control Number: 18/716,707 Page 11 Art Unit: 3794 Application/Control Number: 18/716,707 Page 12 Art Unit: 3794
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