CTNF 18/413,126 CTNF 84989 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 08-25-01 AIA Applicant’s election without traverse of Group I in the reply filed on 6/1/2026 is acknowledged. 08-06 AIA Claim (s) 17-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026 . Priority The application data sheet and the first paragraph of the specifications list the priority differently (the application data sheet lists 18/413126 as a CIP of 17/130864, while the first paragraph of the specification lists 18/413126 as a continuation of 17/130864). Correction of one is required. Claim Objections 07-29-01 AIA Claim (s) 5 is/are objected to because of the following informalities: Within claim 5, line 3: “the constrained configuration” should be replaced with --the first constrained configuration-- (in order to maintain consistent claim terminology). Within claim 5, line 3: “the deployed configuration” should be replaced with --the second deployed configuration-- (in order to maintain consistent claim terminology) . 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 Claim(s) 1-16 is/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. Claim 1 recites the limitation "the remaining portion" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 2-8, which depend from claim 1, inherit all the problems associated with claim 1. Within claim 2, lines 1-2: Applicant claims, “the inner member transitions between a first length and a second length”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement is a method step (as Applicant is positively reciting the transition between two different states); however, the claim is directed to the delivery system alone (as determined by the preamble). As such, it is unclear, if Applicant is trying to claim the delivery system alone OR the method of operating/ using the delivery system. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --the inner member is configured to transition between a first length and a second length--. Claim(s) 3-4, which depend from claim 2, inherit all the problems associated with claim 2. Within claim 3, line 1: Applicant claims, “wherein the stent is unconstrained”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement is a method step (as Applicant is positively reciting the unconstraining); however, the claim is directed to the delivery system alone (as determined by the preamble). As such, it is unclear, if Applicant is trying to claim the delivery system alone OR the method of operating/ using the delivery system. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --wherein the stent is configured to be unconstrained--. Claim(s) 4, which depend from claim 3, inherit all the problems associated with claim 3. Within claim 9, line 8: Applicant claims, “a distal portion of the inner member”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the distal portion of the inner member within claim 9, line 5. Claim(s) 10-16, which depend from claim 9, inherit all the problems associated with claim 9. 07-34-05 AIA Claim 9 recites the limitation " the remaining portion " in lines 12-13 . There is insufficient antecedent basis for this limitation in the claim. Within claim 10, lines 1-2: Applicant claims, “the inner member transitions between a first length and a second length”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement is a method step (as Applicant is positively reciting the transition between two different states); however, the claim is directed to the delivery system alone (as determined by the preamble). As such, it is unclear, if Applicant is trying to claim the delivery system alone OR the method of operating/ using the delivery system. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --the inner member is configured to transition between a first length and a second length--. Within claim 11, line 2: Applicant claims, “the inner member moves from the second length to the first length”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement is a method step (as Applicant is positively reciting the movement); however, the claim is directed to the delivery system alone (as determined by the preamble). As such, it is unclear, if Applicant is trying to claim the delivery system alone OR the method of operating/ using the delivery system. For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --the inner member is configured to move from the second length to the first length--. Within claim 11, liens 1-2: Applicant claims, “wherein, when the flexible elongate member is distally extended, the distal portion of the inner member moves from the second length to the first length”; it is unclear, and therefore indefinite, how the distal portion of the inner member can move (transition) from the first Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-6, 9-11, 13-14 is/are rejected under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bertolino et al. (US 2012/0041533 A1) . With respect to claim 1: A delivery system, as can be seen in figs. 1-2, comprising: a flexible elongate member (outer sheath 22) (paragraph [0017]); an inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) slidably disposed within a lumen (working channel 21) of the flexible elongate member (outer sheath 22) (paragraphs [0071-0018]); and a stent (stent 20) disposed in a first constrained configuration, as can be seen in fig. 1, between a distal portion (portion closer to distal end 18) of the flexible elongate member (outer sheath 22) and a distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) (paragraphs [0017-0018]); wherein the stent (stent 20) is configured to move from the first constrained configuration, as can be seen in fig. 1, to a second deployed configuration, as can be seen in fig. 2, when unconstrained from the flexible elongate member (outer sheath 22); and wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) includes a first thickness (diameter of distal portion 15) and the remaining portion (proximal portion 13) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) includes a second thickness (diameter of proximal portion 13), the first thickness (diameter of distal portion 15) being less than the second thickness (diameter of proximal portion 13) (paragraph [0018]). With respect to claim 2: Wherein the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) transitions between a first length (measured between the end of the proximal portion 13 and the end of the distal tip 14, as can be seen in fig. 1) and a second length (measured between the end of the proximal portion 13 and the bend, as can be seen in fig. 2) as the stent (stent 20) is unconstrained (paragraphs [0022-0025]). With respect to claim 3: Wherein the stent (stent 20) is unconstrained from the flexible elongate member (outer sheath 22) by moving the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) relative to the flexible elongate member (outer sheath 22), moving the flexible elongate member (outer sheath 22) relative to the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24), or moving both the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) and the flexible elongate member (outer sheath 22) relative to each other (paragraph [0056]). With respect to claim 4: Further comprising a handle (either handle or any other structure at the proximal most end of the outer sheath 22) operatively attached to a proximal end of the flexible elongate member (outer sheath 22) (paragraphs [0028, 0031]), wherein the handle (either handle or any other structure at the proximal most end of the outer sheath 22) is configured to move between a first position to proximally retract the flexible elongate member (outer sheath 22) relative to the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) and a second position to distally extend the flexible elongate member (outer sheath 22) relative to the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) (paragraph [0056]). (PLEASE NOTE: Applicant has not claimed any structure defining a “handle” as such Examiner can consider either: the handle, as disclosed by Bertolino et al., or any structure at the proximal end of the outer sheath 22, as disclosed by Bertolino et al., the handle as currently claimed. Additionally, the stent (stent 20) is released by retracting the entire flexible elongate member (outer sheath 22) (paragraph [0056]), including the proximal end/ handle thereof, and is therefore capable of transitioning between the first and second positions as claimed.) With respect to claim 5: Wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) is disposed within (is at least partially inside) a distal portion (half of stent 20 closer to distal tip 14) of the stent (stent 20) in the first constrained configuration, as can be seen in fig. 1, in the second deployed configuration, or in both the constrained configuration and the deployed configuration. With respect to claim 6: Wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) is formed of a shape-memory material (paragraphs [0022-0025]). With respect to claim 9: A delivery system, as can be seen in figs. 1-2, comprising: a flexible elongate member (outer sheath 22) (paragraph [0017]); an inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) slidably disposed within a lumen (working channel 21) of the flexible elongate member (outer sheath 22) (paragraphs [0071-0018]); and a stent (stent 20) loaded in a first constrained configuration, as can be seen in fig. 1, between a distal portion (portion closer to distal end 18) of the flexible elongate member (outer sheath 22) and a distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) (paragraphs [0017-0018]); wherein the stent (stent 20) is configured to move from the first constrained configuration, as can be seen in fig. 1, to a second deployed configuration, as can be seen in fig. 2, when unconstrained from the flexible elongate member (outer sheath 22); and wherein a distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) is configured to move between a first length (measured between the end of the proximal portion 13 and the end of the distal tip 14, as can be seen in fig. 1) when disposed within the distal portion (portion closer to distal end 18) of the flexible elongate member (outer sheath 22) and a second length (measured between the end of the proximal portion 13 and the bend, as can be seen in fig. 2) when the stent is unconstrained from the flexible elongate member (outer sheath 22), the first length (measured between the end of the proximal portion 13 and the end of the distal tip 14, as can be seen in fig. 1) being greater (prior to being compressed) than the second length (measured between the end of the proximal portion 13 and the bend, as can be seen in fig. 2) (paragraphs [0022-0025]); and wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) includes a first thickness (diameter of distal portion 15) and the remaining portion (proximal portion 13) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) includes a second thickness (diameter of proximal portion 13), the first thickness (diameter of distal portion 15) being less than the second thickness (diameter of proximal portion 13) (paragraph [0018]). With respect to claim 10: Wherein the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) transitions between the first length (measured between the end of the proximal portion 13 and the end of the distal tip 14, as can be seen in fig. 1) and the second length (measured between the end of the proximal portion 13 and the bend, as can be seen in fig. 2) as the stent (stent 20) is unconstrained (paragraphs [0022-0025]). With respect to claim 11: Wherein, when the flexible elongate (outer sheath 22) member is distally extended (recovering the articulating tubular member 24 for removal thereof), the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) moves ( is capable of moving ) from the second length (measured between the end of the proximal portion 13 and the bend, as can be seen in fig. 2) to the first length (measured between the end of the proximal portion 13 and the end of the distal tip 14, as can be seen in fig. 1) (paragraphs [0025, 0057]). With respect to claim 13: Wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) is disposed within (is at least partially inside) a distal portion (half of stent 20 closer to distal tip 14) of the stent (stent 20) in the first constrained configuration, as can be seen in fig. 1, in the second deployed configuration, or in both the constrained configuration and the deployed configuration. With respect to claim 14: Wherein the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24) is formed of a shape-memory material (paragraphs [0022-0025]) . 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) 7-8, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertolino et al. (US 2012/0041533 A1) in view of Shin et al. (US 2019/0254741 A1) . With respect to claim(s) 7-8 and 15-16: Bertolino et al. discloses the invention substantially as claimed, as discussed above. However, Bertolino et al. does not disclose the delivery system to further comprise an electrically conductive tissue penetrating element on a distal end of the inner member, the electrically conductive tissue penetrating element configured to form an opening in tissue (as required by claim(s) 7-8, 15-16). Shin et al. teaches a stent delivery system used to deliver a stent (stent 150) to create an anastomosis between two body tissue areas (T1, T2), as can be seen in figs. 27-31 (paragraphs [0162-0163]). The delivery system to comprises an electrically conductive tissue penetrating element (tip electrode body 310) on a distal end of an inner member (internal tube 410 over which stent 150 is held) (paragraphs [0079, 0098, 0112]), the electrically conductive tissue penetrating element configured to form an opening in two body tissue areas (T1, T2) (paragraphs [0112, 0158]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the electrically conductive tissue penetrating element (tip electrode body 310), as taught by Shin et al., on/ as part of the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24), as disclosed by Bertolino et al., as the electrically conductive tissue penetrating element (tip electrode body 310), as taught by Shin et al., allows for the stent to be used in more situations/ to treat more types of conditions (such as: vessel blockages created by plaque that must be cut through prior to stenting or in situation in which an anastomosis needs to be created between two body tissue areas) . Allowable Subject Matter 07-43-02 AIA Claim (s) 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious: A delivery system (as required by claim 9) wherein the distal portion of the inner member includes a plurality of loops (of different diameter) while the stent is in both the first constrained configuration and in the second deployed configuration. (Examiner does not consider it obvious to one of ordinary skill in the art at the time the invention was made to change the distal portion (distal portion 15) of the inner member (proximal portion 13 and distal portion 15 of articulating tubular member 24), as disclosed by Bertolino et al., from a straight configuration (while the stent in a first constrained configuration) to a looped configuration as this would require the entire delivery system to have a larger diameter (to accommodate the loops) thus creating new limitations during delivery thereof.) Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mauch et al. (US 8998894 A1) discloses a catheter system including an elongate member and a flexible inner member with a distal portion comprising a plurality of loops of different diameter in different configurations (as can be seen in figs. 3A-3B). However, the catheter system, as disclosed by Mauch et al. does not include a stent nor does Examiner consider it obvious to one of ordinary skill in the art at the time the invention was made to add a stent which would engage/ be positioned in the claimed manner in relation to the elongate member and the distal end of the inner member (as required by claim 12). COPE et al. (US 2019/0060068 A1) discloses a delivery system comprising a flexible elongate catheter, inner member, and stent, where the inner member assumed a looped configuration when the stent is delivered to it’s second deployed configuration. However, COPE et al. does not disclose the inner member to a looped configuration while the stent is in it’s first constrained configuration (as required by claim 12). Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1. 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, Jerrah Edwards can be reached at (408)918-7557. 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. REBECCA STRASZHEIM PRESTON Primary Examiner Art Unit 3774 /REBECCA S PRESTON/ Primary Examiner, Art Unit 3774 Application/Control Number: 18/413,126 Page 2 Art Unit: 3774 Application/Control Number: 18/413,126 Page 3 Art Unit: 3774 Application/Control Number: 18/413,126 Page 4 Art Unit: 3774 Application/Control Number: 18/413,126 Page 5 Art Unit: 3774 Application/Control Number: 18/413,126 Page 6 Art Unit: 3774 Application/Control Number: 18/413,126 Page 7 Art Unit: 3774
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