DETAILED ACTION
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 .
Response to Amendment
The amendments filed on 05/22/2026 have been entered. Claims 1-3, 6, 9-11, 13-21, and 26-29 remain pending in the application. The amendments overcome the rejections under 35 USC 112(b) set forth in the previous office action dated 02/24/2026.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 05/22/2026, with respect to the rejection(s) of claim(s) 1 and 16 under 35 USC 102 over Roeder and Hartley have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zhao (claim 16) and Roeder/ Hehrlein (claims 1 and 16).
Claim Rejections - 35 USC § 102
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.
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 –
(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.
Claim(s) 16-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhao (US 2022/0218460; having the foreign priority date of 5/28/2019).
Regarding claim 16, Zhao et al. discloses a covered stent (Stent graft 100 in combination with bare stent 200, [0007]) comprises a main body stent (111 and 131, [0018], FIG 4A)), a window (121) being formed in a surface of the main body stent ([0068, 0074, 0077]), wherein the covered stent further comprises an internal covering film (graft material of 110, 120, 130, [0009]); an edge of the internal covering film is connected to the main body stent (Its understood that the graft body is in contact and therefore connected to the stent body), and a through hole (140) communicating with an inner cavity of the covered stent (FIG 1A, 4A) is also formed in the internal covering film (Cross section FIG 1B and 1C show 140 is formed in part by a channel of the graft body); the covered stent further comprises a window supporting member (220, FIG 5C, where 200 is placed surrounding 100, [0023, 0090-0096]), the window supporting member being arranged outside the internal covering film (122 and 220 are radially outward of the graft body) and protruding outwardly from a surface of the internal film covering (by being layered radially outward thereof); the window supporting member comprises a net structure with meshes ([0023 and 0090-0096]); and the size of each mesh is changeable by an external force (The size of the mesh is interpreted to mean the spacing of the apertures between the wires forming the mesh. This spacing can be changed by an external force due to the flexible assembly of the loose braid as described. For example, an external pressure directed radially inward on the window supporting member can cause a collapse of the structure thereby reducing the size); wherein the window supporting member is formed separately from the main body stent (because 200 is a separate element from 100), and the main body stent comprises a main body supporting member (The struts within 120 as shown in FIG 5A-5B) that has an open structure such that the main body support member is not a complete ring (FIGS 3A-5B show that the stent elements within region 120 do not extend fully around the stent body and therefore do not form a complete ring); and wherein the internal covering film comprises a bottom portion (Portion of the graft within 120), a proximal end folding portion (Portion of the graft within 110, [0007], FIG 4A) and a distal end folding portion (Portion of the graft within 120, [0007], FIG 4A); the proximal end folding portion and the distal end folding portion are arranged at two ends of the bottom portion respectively (FIG 4A); and at least one of the proximal end folding portion and the distal end folding portion is arranged on an inner surface of the main body stent (As shown in FIG 4A, the stent body is radially outward), and both of the proximal end folding portion and the distal end folding portion are recessed toward the inner cavity of the covered stent (Recess which forms 141 and 143) to form a receiving cavity ([0007, 0009, 0068, 0072]).
Regarding claim 17, Zhao discloses the window supporting member comprises portions formed by cross braiding braided wires ([0092] discloses 200 can be formed as a braided stent), and intersections of the braided wires are movable ([0092-0095] disclose features of the mesh that would be slidable at the woven intersections).
Regarding claim 18, Zhao discloses the window supporting member comprises at least two supporting sections (220 can be divides into at least two segments); the supporting sections are formed by cross braiding braided wires ([0092]); and the at least two supporting sections are movably connected by mutual hooking (It is understood that wires of a braided mesh are movably connected by mutual hooking due to the braided structure and ability to expand and contract).
Regarding claim 19, Zhao discloses a portion of each supporting section cross braided by the braided wires is located at a proximal end portion and/or a distal end portion of the window supporting member (the braided segment extends the full window supporting member, therefore there is a portion of it located at the proximal end and distal end of the window supporting member).
Regarding claim 20, Zhao discloses in the net structure, an aperture of the mesh close to the proximal end portion and/or a distal end portion of the window supporting member is greater than the apertures of the meshes of other portions ([0093-0094], wherein a “sparser mesh” is interpreted as a larger aperture of the mesh).
Regarding claim 21, Zhao discloses part of the main body supporting member is located on the other side of the internal covering film opposite to the window supporting member (As shown in FIG 4A and 5A); the braiding density of the window supporting member is greater than the braiding density of a part among the main body supporting member which is opposite to the window supporting member (See large stent frame openings of FIG 5A versus mesh structure of FIG 6).
Claim Rejections - 35 USC § 103
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.
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, 2, 6, 9-11, 14-16, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al. (US 2019/0021887) in view of Hehrlein (US 2016/0022450).
Regarding claim 1, Roeder et al. discloses a covered stent (FIG 8, [0034-0035] discloses prosthesis 54 connected to a plurality of stents 52, wherein the stent can be Z-stents, annular, or helical stents depending on the particular anatomy of the treatment site), wherein the covered stent has a hollow tubular structure (tubular body 12, [0024-0025]) with openings at two ends (Openings at 16 and 18), and comprises a main body stent (plurality of stents 52), a window (44, FIG 8, 9, and 11, [0036-0040]) being arranged in a surface of the main body stent (The window is formed from a slit in the graft material and between struts 62, 64 of the stent, [0038]); the covered stent further comprises an internal covering film (48, FIG 9-10 showing the internal placement of 48, [0033, 0036-0037, 0039-0040]); an edge of the internal covering film is connected to the main body stent (FIG 8, [0038], via stitches/sewing, the edge is attached to the quadrilateral formed between 62, 64 of the stent that forms window 44), and a through hole (Lumen 42 formed within 48, FIG 9-10) communicating with an inner cavity of the covered stent is also formed in the internal covering film (wherein openings at 74 and 76 are communicating with inner cavity 46 of the covered stent); and the main body stent comprises a main body supporting member (The 4 straight segments of 62, 64 which form the quadrilateral outline of window 44) that has an open structure (because the respective apexes 60 do not contact, FIG 6 and 8) such that the main body support member is not a complete ring (The 4 segments which form the quadrilateral surrounding 44 are not in continuous contact and therefore do not form a ring); and wherein the internal covering film comprises a bottom portion (34c), a proximal end folding portion (34b) and a distal end folding portion (34d): the proximal end folding portion and the distal end folding portion are arranged at two ends of the bottom portion respectively (FIG 6); and at least one of the proximal end folding portion and the distal end folding portion is arranged on an inner surface of the main body stent (FIG 8-9 shows that one edge along both 34b and 34d contacts the inner surface of the main body stent), and both of the proximal end folding portion and the distal end folding portion are recessed toward the inner cavity of the covered stent (See recessing in FIGs 8-10) to form a receiving cavity (The opening forms a recessed cavity for receiving cannulas 80, FIG 11, [0040]).
Roeder is silent regarding the covered stent further comprises a window supporting member, the window supporting member being arranged outside the internal covering film and protruding outwardly from a surface of the internal covering film, wherein the window supporting member is formed separately from the main body stent, and is opposite to the main body supporting member.
However, Hehrlein teaches in the same field of endeavor a main body stent (3, FIGs 1b-1c, [0042]) having a main body supporting member (the portion of 2 which surrounds 7), a window (7) arranged in a surface of the main body stent (FIG 1b-1c, [0043-0044]), a window supporting member (2’, FIG 1b and 2a-2e, [0043-0044, 0047-0052]), wherein the window supporting member is formed separately from the main body stent ([0048-0051] discloses the different methods of formation of struts 2’ and how it differs from the struts 2. Therefore, it is shown that they are formed separately), and is opposite to the main body supporting member (FIGs 1b and 2a-2e, by being formed separately, 2’ and 2 are shown to be positioned opposite one another).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Roeder such that the main body supporting member is filled with the window supporting member taught by Hehrlein, for the purpose of forming a temporary covering of the window which then dissolves upon implantation to allow access to the window. In the device as modified, the window supporting member is arranged outside the internal covering film and protruding outwardly from a surface of the internal covering film because of its placement within the quadrilateral shape formed by the main body support segments, which is positioned outwardly form the internal covering film.
Regarding claim 2, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified by Hehrlein further discloses the window supporting member comprises a plurality of supporting sections (Each segment of strut 2’) connected axially (The struts are connected such that they form a mesh, which extends in at least some axial direction); the supporting sections and the main body stent are connected to an edge of the window (Connected at the perimeter of the window, which forms the edge, as shown in FIGs 2a-2e. The window edge is also formed int eh device as modified wherein the main body supporting member surrounds the window), or the supporting sections partially cover an edge of the window.
Regarding claim 6, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 2. The device as modified by Hehrlein further discloses the plurality of supporting sections of the window supporting member is movably connected by means of mutual hooking (The stent struts 2 and 2’ are body movably/slidably connected, thereby forming the ability to move from the collapsed configuration of FIG 1a to the expanded configuration of FIG 1b. In the process of such expanding or collapsing, the struts of the window supporting sections are movably connected by mutual hooking i.e. the braided structure of the stent).
Regarding claim 9, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. Roeder et al. further discloses a sinking section is formed on a surface of the window supporting member (See annotated FIG 10 below), and an area of a cross section of the covered stent where the sinking section is located is smaller than areas of cross sections of other portions of the covered stent far from the sinking section (See cross section of FIG 10, the region comprising the sinking section makes of a smaller area of the cross section than a remaining portion of the device).
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Regarding claim 10, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. Roeder et al. further discloses along the same cross section (For example a cross section as shown in FIG 1), the circumferential ratio of the window supporting member is less than the circumferential ratio of the main body supporting member (The portions of the circumference defined by the window supporting member which is defined by the perimeter of the quadrilateral shape around 44, as shown in FIG 11 taken in combination with FIG 8 and 10 is smaller than a remainder of the circumference which is formed of the main body).
Regarding claim 11, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the window supporting member comprises a net structure with meshes (FIGs 1b and 2a-2e, [0036]; the uniform mesh pattern is interpreted as a net structure with meshes), and the size of each mesh is changeable by an external force (The size of the mesh is interpreted to mean the spacing of the apertures between the wires forming the mesh. This spacing can be changed by an external force due to the flexible assembly of the loose braid as described. For example, an external pressure directed radially inward on the window supporting member can cause a collapse of the structure thereby reducing the size).
Regarding claim 14, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. Roeder et al. further discloses the window comprises a first edge (Top edge formed by two straight segments of 64, FIG 8) and a second edge (Bottom edge formed by two straight segments of 62, FIG 8) extending along a longitudinal direction of the covered stent (FIG 8); the internal covering film comprises a bottom portion (34c) connected between the first edge and the second edge (FIG 8-9); the internal covering film is provided with a supporting unit (Wire 50, [0031]); and the supporting unit makes the bottom portion at least partially protrude outwardly or parallel to a plane where the first edge and the second edge are located (FIG 8-10 show the positioning of 50 which helps the bottom portion to protrude in a direction away from the first and second edge).
Regarding claim 15, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 1. Roeder et al. further discloses the main body stent comprises a main body covering film (Graft material forming 32, [0025]); a window is formed in a surface of the main body covering film (Formed from a slit as shown in FIG 5-6); and the internal covering film and the main body covering film are spliced and connected after being formed separately (Connected by stitching 40, [0028]. “after being formed separately” is interpreted as a product-by-process limitation wherein the device disclosed by Roeder is equivalent to that which is connected “after being formed separately” and therefore is interpreted as meeting the limitation of the claim.
Regarding claim 16, Roeder et al. discloses a covered stent (FIG 8, [0034-0035] discloses prosthesis 54 connected to a plurality of stents 52, wherein the stent can be Z-stents, annular, or helical stents depending on the particular anatomy of the treatment site) comprises a main body stent (plurality of stents 52), a window (44, FIG 8, 9, and 11, [0036-0040]) being formed in a surface of the main body stent (The window is formed from a slit in the graft material and between struts 62, 64 of the stent, [0038]), wherein the covered stent further comprises an internal covering film (48, FIG 9-10 showing the internal placement of 48, [0033, 0036-0037, 0039-0040]); an edge of the internal covering film is connected to the main body stent (FIG 8, [0038], via stitches/sewing, the edge is attached to the quadrilateral formed between 62, 64 of the stent that forms window 44), and a through hole (Lumen 42 formed within 48, FIG 9-10) communicating with an inner cavity of the covered stent is also formed in the internal covering film (wherein openings at 74 and 76 are communicating with inner cavity 46 of the covered stent); and the main body stent comprises a main body supporting member (The 4 straight segments of 62, 64 which form the quadrilateral outline of window 44) that has an open structure (because the respective apexes 60 do not contact, FIG 6 and 8) such that the main body support member is not a complete ring (The 4 segments which form the quadrilateral surrounding 44 are not in continuous contact and therefore do not form a ring); and wherein the internal covering film comprises a bottom portion (34c), a proximal end folding portion (34b) and a distal end folding portion (34d): the proximal end folding portion and the distal end folding portion are arranged at two ends of the bottom portion respectively (FIG 6); and at least one of the proximal end folding portion and the distal end folding portion is arranged on an inner surface of the main body stent (FIG 8-9 shows that one edge along both 34b and 34d contacts the inner surface of the main body stent), and both of the proximal end folding portion and the distal end folding portion are recessed toward the inner cavity of the covered stent (See recessing in FIGs 8-10) to form a receiving cavity (The opening forms a recessed cavity for receiving cannulas 80, FIG 11, [0040]).
Roeder is silent regarding the covered stent further comprises a window supporting member, the window supporting member being arranged outside the internal covering film and protruding outwardly from a surface of the internal covering film; the window supporting member comprises a net structure with meshes and the size of each mesh is changeable by an external force, wherein the window supporting member is formed separately from the main body stent, and is opposite to the main body supporting member.
However, Hehrlein teaches in the same field of endeavor a main body stent (3, FIGs 1b-1c, [0042]) having a main body supporting member (the portion of 2 which surrounds 7), a window (7) arranged in a surface of the main body stent (FIG 1b-1c, [0043-0044]), a window supporting member (2’, FIG 1b and 2a-2e, [0043-0044, 0047-0052]), the window supporting member comprises a net structure with meshes (FIGs 1b and 2a-2e, [0036]; the uniform mesh pattern is interpreted as a net structure with meshes), and the size of each mesh is changeable by an external force (The size of the mesh is interpreted to mean the spacing of the apertures between the wires forming the mesh. This spacing can be changed by an external force due to the flexible assembly of the loose braid as described. For example, an external pressure directed radially inward on the window supporting member can cause a collapse of the structure thereby reducing the size), wherein the window supporting member is formed separately from the main body stent ([0048-0051] discloses the different methods of formation of struts 2’ and how it differs from the struts 2. Therefore, it is shown that they are formed separately), and is opposite to the main body supporting member (FIGs 1b and 2a-2e, by being formed separately, 2’ and 2 are shown to be positioned opposite one another).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Roeder such that the main body supporting member is filled with the window supporting member taught by Hehrlein, for the purpose of forming a temporary covering of the window which then dissolves upon implantation to allow access to the window. In the device as modified, the window supporting member is arranged outside the internal covering film and protruding outwardly from a surface of the internal covering film because of its placement within the quadrilateral shape formed by the main body support segments, which is positioned outwardly form the internal covering film.
Regarding claim 29, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 14. Roeder et al. further discloses a stiffener (50) positioned at an upper edge of either the proximal end folding portion or the distal end folding portion (FIG 3, [0031])
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al. (US 2019/0021887) in view of Hehrlein (US 2016/0022450), further in view of Lostetter (US 2017/0340462).
Regarding claim 26, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 14.
Roeder is silent regarding each folding portion having an inner cavity that is gradually reduced from the opening toward the through hole.
However, Lostetter teaches in the same field of endeavor a covered stent (10, FIGs 1-2A) having a window (20), and an internal covering film comprising a bottom portion (38), a proximal end folding portion (44, [0030], FIGs 2B-3B) and a distal end folding portion (52, FIGs 2B-3B) and each folding portion having an inner cavity that is gradually reduced (See flaring of both ends in FIG 3A and 3B, [0014 and 0032]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify each of the folding portion of Roeder to have an inner cavity that is gradually reduced from the opening toward the through hole, as taught by Lostetter, for the purpose of providing guidance to the surgeon during placement of a branch stent graft into a respective tunnel graft ([0032]).
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al. (US 2019/0021887) in view of Hehrlein (US 2016/0022450), further in view of Venkatsean (US 11,318,030).
Regarding claim 27, Roeder/ Hehrlein disclose the invention substantially as claimed, as set forth above for claim 14.
Roeder further discloses use of the device for branched endovascular procedure ([0001, 0006, 0007]) but does not disclose the branch stent having a cylindrical first section and a frustoconical second section connected to one end of the first section.
However, Venkatsean teaches a covered stent (35, FIG 2A-2B), having a window (70) which receives a branch stent (36, FIG 3A-3B) having a cylindrical first section (51) and a frustoconical second (52) section connected to one end of the first section (col 7 lines 58-61 and col 8 lines 19-49).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Roeder to comprise the branch stent having a cylindrical first section and a frustoconical second section connected to one end of the first section, as taught by Venkatsean, for the purpose of providing a branch stent commonly known in the art to achieve the predictable result of providing patency to a side branch vessel, while the frustoconical section provides an anchoring element positioned within the window to secure the connection between the stent main body and the branch stent.
Allowable Subject Matter
Claim 28 is 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record fails to teach or render obvious a branch stent that has an open structure, the branch stent having an arc-shaped plate structure with a C- shaped cross section; wherein the branch stent has two side edges extending between a proximal end of the branch stent and a distal end of the branch stent, with the two side edges connected to the inner surface of the main body stent such that a space enclosed by the branch stent and the inner surface of the main body stent forms the inner cavity of the branch stent.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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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.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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