CTFR 18/365,673 CTFR 93622 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. Response to Amendment The amendments filed on 05/19/2026 have been entered. Claims 1-20 remain pending in the application. The amendments overcome the previous rejections under 35 USC 112(b) set forth in the previous office action dated 01/22/2026. Response to Arguments 07-37 AIA Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive. Applicant argues on page 14-16 that Ikeuchi fails to teach “the at least one link portion connecting two annular members adjacent to teach other is connected to a first bent portion of the wavy unit of each of the two annular members”. However, applicants’ arguments are presented such that element 61 is interpreted as the link portion and is described as not meeting the claimed limitation. However, in the rejection as provided by examiner, there is a plurality of strut segments interpreted as the link portion, as shown in the annotated figure. Interpreted a region of the device as a “link portion” is believed to be appropriate under broadest reasonable interpretation because “portion” can be a segment of a region and is not limited to a singular linear strut. As such, the segment interpreted as the link portion below is shown to connect two adjacent annular members (member 51 to another adjacent 51, not 51 to an adjacent 52 as presented in the arguments), and shows connection between a first bent portion of the wavy unit of respective members 51, see annotated where the circled regions on either end of the link portion show connection of bent portions of respective wavy units. Therefore, it is the examiners position that the claim limitations have been met by the prior art and the previous rejection is maintained . Allowable Subject Matter 12-151-07 AIA 07-97 12-51-07 Claim s 10-18 are allowed. 13-03 AIA The following is an examiner’s statement of reasons for allowance: Regarding claim 10, the prior art of record fails to teach or render obvious the balloon protrudes outward from a radial position of an inner surface of the stent only at a position between the first linear portion and the second linear portion, in combination with the remaining limitations of the claim. The closest prior art is Ikeuchi et al., which teaches the limitations of claim 10 as set forth above in claim 1 and further teaches a balloon catheter (10, FIG 1) having an inflatable and deflatable balloon (13, FIG 1-2, [0017-0022]); the stent being retained in contact with the balloon, which has been deflated, in a contracted state ([0021]). However, Ikeuchi is silent regarding the balloon protrudes outward from a radial position of an inner surface of the stent only at a position between the first linear portion and the second linear portion . Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” 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. 07-15 AIA Claim (s) 1-3, 6-9, and 19-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Ikeuchi et al (US 2017/0273811) . Regarding claims 1-3 and 19-20, Ikeuchi et al. discloses a stent (20, FIGs 1-3) of a cylindrical shape ([0018]) that is configured to be expandable and contractible in a radial direction ([0040, 0045-0048]), the stent comprising: a plurality of annular members (51, FIG 3-4) formed in an annular shape ([0028]) by a linear component (struts 30) folded in a wave shape (See zig zag shape formed in FIGs 3-4) and disposed along a longitudinal direction of the cylindrical shape to form the cylindrical shape (FIG 3); at least one link portion (See annotated FIG 3 below; the link portion is interpreted as one link 61, one link 62, and the strut portion of 52 which connects 61 and 62 as outlined in the box below) connecting two annular members adjacent to each other (The segment outlined below connects adjacent annular portions 51); wherein each annular member is formed by disposing a plurality of basic units (See annotated FIG 3 and 4 below) in a circumferential direction of the cylindrical shape and connecting each pair of basic units adjacent to each other by a second bent portion (See annotated FIG 4 below, each adjacent basic unit is connected by a second bent portion); each of the basic units including: a wavy unit (See annotated FIG 4 below) which has a plurality of first linear portions (Each linear strut in the unit) each extending from a proximal end side to a distal end side in the longitudinal direction (From left to right or right to left as viewed in FIG 4) and disposed continuously in the circumferential direction (Each of the linear portions extends continuously in the circumferential direction because they are formed of the same strut 30) and each of first bent portions (See annotated FIG 4 below) connecting end portions on the proximal end side or the distal end side of two of the first linear portions adjacent in the circumferential direction (See first bent portion connecting each of the first linear portions); second linear portions extending from the proximal end side to the distal end side in the longitudinal direction and are disposed at a position adjacent to a first linear portion of an adjacent wavy unit in the circumferential direction (See annotated FIG 4 below); and the second bent portions connect end portions on the proximal end side or the distal end side of a first linear portion and a second linear portion adjacent to each other in the circumferential direction (As shown in FIG 4); a second distance, which is a separation distance in the circumferential direction between an end point in the longitudinal direction of each of the second bent portions connected to an end portion on one end side of the second linear portion and an end point in the longitudinal direction of each of the second bent portions connected to an end portion on an other end side of the second linear portion (See FIG 4 below which shows the length considered to be the second distance), is longer than a first distance which is a separation distance in the circumferential direction between an end point in the longitudinal direction of each of the first bent portions connected to an end portion on one end side of any of the first linear portions and an end point in the longitudinal direction of each of the first bent portions or the second bent portions connected to an end portion on an other end side of the first linear portion (See FIG 4 below which shows the length considered to be the first distance. The second distance is longer than the first distance); wherein the at least one link portion connecting the two annular members adjacent to each other is connected to a first bent portion of the wavy unit of each of the two annular members (see annotated FIG 3 wherein the region interpreted as the link portion connect one bent portion on a left annular member 51 and another bent portion on the left annular member 51) and a number of the first linear portions disposed in the wavy unit is four in each basic unit (See annotated FIG below. The number of first linear portions in the wavy unit is four). PNG media_image1.png 637 631 media_image1.png Greyscale PNG media_image2.png 708 525 media_image2.png Greyscale PNG media_image3.png 376 639 media_image3.png Greyscale Regarding claim 6, Ikeuchi et al. discloses a second radius, which is a radius of curvature on an inner curved side of each of the second bent portions, is larger than a first radius which is a radius of curvature on an inner curved side of each of the first bent portions (See annotated FIG 4 below which shows a radius of curvature in the second bent portion being larger than a radius of curvature in the first bent portion). PNG media_image4.png 692 345 media_image4.png Greyscale Regarding claim 7, Ikeuchi et al. discloses a radius of curvature on an inner curved side of each first bent portion to which the link portion is connected is larger than a radius of curvature on an inner curved side of each first bent portion to which the link portion is not connected (See annotated FIG 4 above). Regarding claim 8, Ikeuchi et al. discloses the first linear portion has an axis-parallel linear portion parallel to the longitudinal direction (For example the linear portion that falls of line 71 is parallel to the longitudinal direction); the annular members are disposed with aligned phases in the circumferential direction (FIG 3); the at least one link portion (As defined above in FIG 3) connects each first bent portion connected to a distal end side of the axially parallel linear portion of the annular member disposed on the proximal end side and each first bent portion connected to a proximal end side of the axially parallel linear portion of the annular member disposed on the distal end side and adjacent to the annular member disposed on the proximal end side (See the circled portions in annotated FIG 3 above which show the distal end of one parallel linear portion being connected to the proximal end of another parallel linear portion of a more distal annular member, wherein connection is completed by the link portion); and a portion from a proximal end side of the axially parallel linear portion of the annular member on the proximal end side to a distal end side of the axially parallel linear portion of the annular member on the distal end side via the link portion is parallel to the longitudinal direction before and after expansion (FIG 5 shows the position of the struts in the expanded state, [0015, 0023]. All of the parallel linear portions remain parallel to the longitudinal axis in the expanded state). Regarding claim 9, Ikeuchi et al. discloses wherein the at least one link portion comprises a pair of the link portions is disposed in each of gaps between the adjacent annular members to face each other in a radial direction of the annular member (FIG 3 shows there are at least two link portions in between each annular member); and a phase of the link portion disposed in one gap and a phase of the link portion disposed in another gap adjacent to the one gap in the longitudinal direction are shifted by 90 degrees in the circumferential direction ([0038] discloses “the plurality of second link portions 62 preferably connect the annular bodies 40 at an axially central position (in the present embodiment, a position which is at 90° (offset at a rotational angle of 90°) to the first link portion 61 in the circumferential direction D2) between the first link portions 61 adjacent to each other in the circumferential direction D2”. This relationship creates a phase shift of 90 degrees of the annotated link portion as well) . Claim Rejections - 35 USC § 103 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. 07-20-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) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeuchi et al (US 2017/0273811) in view of Drasler et al. (US 8,016,873) . Regarding claims 4-5, Ikeuchi et al. discloses the invention substantially as claimed, as set forth above for claim 1. Ikeuchi et al. is silent regarding a width of each first bent portion is smaller than a width of each of first linear portions connected to a first bent portion and a width of each of the second bent portions is smaller than widths of the first linear portion and the second linear portion connected to each of the second bent portions. However, Drasler et al. teaches in the same field of endeavor a stent (5, FIG 17A, ) having annular bands formed by linear portions (345, 350) and bent portions (340) wherein a width of the bent portion is smaller than a width of the linear portion connected to the bent portion (FIG 19-20, wherein 105 is the width of the bent portion and 150 is the width of the linear portion, col 33 line 58- col 34 line 22), and further teaches that a smaller width facilitates greater radial of curvature (“The hinge width 105 is significantly smaller than the strut width 150 for either the upper strut 345 or lower strut 350 to allow the hinge to deform the hinge width radius of curvature 380 in going from a nondeployed state to a deployed state”). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the width of each first bent portion is smaller than a width of each of first linear portions connected to a first bent portion and a width of each of the second bent portions is smaller than widths of the first linear portion and the second linear portion connected to each of the second bent portions, as taught by Drasler et al., for the purpose of being constructed in a manner that allows for the desired radius of curvature in the bent portions to allow radial expansion of the stent without fracture, and for the added benefit that when the strut width is significantly greater than the hinge width, the moment provided by the hinge to hold the blood vessel outward is transferred via the strut to the vessel wall without bending in the direction of the strut width. Conclusion 07-40 AIA 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5. 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, Elizabeth Houston can be reached at 5712727134. 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. /BROOKE LABRANCHE/Primary Examiner, Art Unit 3771 Application/Control Number: 18/365,673 Page 2 Art Unit: 3771 Application/Control Number: 18/365,673 Page 3 Art Unit: 3771 Application/Control Number: 18/365,673 Page 4 Art Unit: 3771 Application/Control Number: 18/365,673 Page 5 Art Unit: 3771 Application/Control Number: 18/365,673 Page 6 Art Unit: 3771 Application/Control Number: 18/365,673 Page 7 Art Unit: 3771 Application/Control Number: 18/365,673 Page 8 Art Unit: 3771 Application/Control Number: 18/365,673 Page 9 Art Unit: 3771 Application/Control Number: 18/365,673 Page 10 Art Unit: 3771
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