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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 01/26/2026 is acknowledged. Applicant further states that claim 1, 2, 6, and 9-22 are readable on the elected species B and as such, these claims have been examined below. Applicant further states claim 3, 7, and 8 have been cancelled. However, in the claims filed on 01/26/2026, claim 3 is still listed as an original claim, although the heading of the page requests cancellation of claim 3. Contrarily, the response to election lists claim 3 as pending. Examiner requests clarification as to the status of claim 3. In either case, claim 3 is drawn to nonelected Species A and will be withdrawn from consideration at this time.
Claim Rejections - 35 USC § 112
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.
Claim 9 and 20 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.
The term “far” in claim 9 is a relative term which renders the claim indefinite. The term “far” 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. Therefore, it is unclear what location along the covered stent would be considered “far” from the sinking section. Examiner suggests alternative language such as “opposite” or “spaced apart”.
The term “close to” in claim 20 is a relative term which renders the claim indefinite. The term “close” 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. Therefore, it is unclear what positioning of an aperture relative to the proximal or distal end portions would be considered “close”. Examiner suggests alternative language such as “adjacent”.
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)(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.
Claim(s) 1, 9, 10, 12, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roeder et al. (US 2019/0021887).
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 qualdralateral 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); the covered stent further comprises a window supporting member (The 4 straight segments of 62, 64 which form the quadrilateral outline of window 44), the window supporting member being arranged outside the internal covering film (See FIG 7-8 wherein internal covering film 48 is radially inward of 62, 64, which forms the window supporting member) and protruding outwardly from a surface of the internal covering film (FIGs 7-8 show the outward protrusion, because 62, 64 is located on an outer surface of 22, [0034], and 48 is internal to surface 22, therefore the window supporting member is protruding outwardly from a surface of the internal covering film).
Regarding claim 9, Roeder et al. 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 et al. discloses the main body stent comprises a main body supporting member (Struts of 62 and 64 shown in FIG 7 and 11 except for the 4 segments which form the window supporting member); the window supporting member is a part of the main body supporting member (The segments forming the window supporting member are integral and continuously formed with the remainder of the stent struts of 62 and 63); and 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, 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 supporting member).
Regarding claim 12, Roeder et al. discloses the internal covering film comprises a bottom portion (34c), a proximal end folding portion (34b) and a distal end folding portion (34d, FIG 5-9); the proximal end folding portion and the distal end folding portion are arranged at two ends of the bottom portion respectively (FIGs 5-9); 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 8-10 shows both 34b and 34d are arranged on an inner surface of 54), and is recessed toward the inner cavity of the main body stent (FIG 9-11 shows the recessed positioning) to form a receiving cavity (The opening forms a recessed cavity for receiving cannulas 80, FIG 11, [0040]).
Regarding claim 14, Roeder et al. 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 et al. 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.
Claim(s) 1, 2, 6, 11, 13, and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartley (US 2007/0219621).
Regarding claim 1, Hartley discloses a covered stent (FIG 1 and 7), wherein the covered stent has a hollow tubular structure (tubular body 12, [0043]) with openings at two ends (Openings at Top and bottom, such as in FIG 2), and comprises a main body stent (16), a window (18) being arranged in a surface of the main body stent (FIG 1 and 7, [0044 and 0056]); the covered stent further comprises an internal covering film (Graft body 10, which is a covering internal to the struts 16 of the main
body stent); an edge of the internal covering film is connected to the main body stent ([0055] the tubular body is supported by stents 16 such as self expanding Gianturco zig zag Z stents. This stent type is understood to be connected to the graft body along its length and therefore is connected at a proximal and distal edge as well), and a through hole (20, FIG 7) communicating with an inner cavity of the covered stent is also formed in the internal covering film (FIG 2 and 11 shows 20 in communication with an inner cavity, the central lumen); the covered stent further comprises a window supporting member (40, FIG 8 [0049-0050, 0052, 0063-0066], which supports window 18 by being inserted within the window and aiding in preventing its collapse), the window supporting member being arranged outside the internal covering film (See portions in FIG 8 which is arranged outside of covering film 10. Best shown in FIG 2 wherein 22 inserted into window 18 is equivalent to the positioning of 40) and protruding outwardly from a surface of the internal covering film (FIG 2 show the outward protrusion).
Regarding claim 2, Hartley discloses the window supporting member comprises a plurality of supporting sections (FIGs 8-10C wherein the plurality of supporting sections include 45, 49, 47, [0063-0067]) connected axially (FIG 10A shows the axial connection of 45, 49, and 47); 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, [0066]), or the supporting sections partially cover an edge of the window.
Regarding claim 6, Hartley discloses the plurality of supporting sections of the window supporting member is movably connected by means of mutual hooking ([0047] discloses the winding of the wire that forms the supporting sections forms ‘a loose braid’. This structure is capable of being movably connected because the wires can flex and slide relative to one another in response to pressures being applied within the vasculature. The loops 57, 59, and the structure of a loose braid is interpreted as mutual hooking which allows for the movement).
Regarding claim 11, Hartley discloses the window supporting member comprises a net structure with meshes ([0067]; the twisting and bending of the wire to form the loose braid structure 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 13, Hartley discloses a proximal end and/or distal end of the window supporting member extends beyond an edge of the window in the lengthwise direction of the covered stent (FIG7 shows the bottom end of the window supporting member 40 extends beyond an edge of the window in a lengthwise direction of the stent).
Regarding claim 16, Hartley discloses a covered stent (FIG 1 and 7), comprising a main body stent (16), a window (18) being formed in a surface of the main body stent (FIG 1 and 7, [0044 and 0056]), wherein the covered stent further comprises an internal covering film (Graft body 10, which is a covering internal to the struts 16 of the main body stent); an edge of the internal covering film is connected to the main body stent ([0055] the tubular body is supported by stents 16 such as self-expanding Gianturco zig zag Z stents. This stent type is understood to be connected to the graft body along its length and therefore is connected at a proximal and distal edge as well), and a through hole (20, FIG 7) communicating with an inner cavity of the covered stent is also formed in the internal covering film (FIG 2 and 11 shows 20 in communication with an inner cavity, the central lumen); the covered stent further comprises a window supporting member (40, FIG 8 [0049-0050, 0052, 0063-0066], which supports window 18 by being inserted within the window and aiding in preventing its collapse), the window supporting member being arranged outside the internal covering film (See portions in FIG 8 which is arranged outside of covering film 10. Best shown in FIG 2 wherein 22 inserted into window 18 is equivalent to the positioning of 40) and protruding outwardly from a surface of the internal covering film (FIG 2 show the outward protrusion), the window supporting member comprises a net structure with meshes ([0067]; the twisting and bending of the wire to form the loose braid structure 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 17, Hartley discloses the window supporting member comprises portions formed by cross braiding braided wires (See cross braiding of wires in FIG 10A, [0067] discloses the formation of a loose braid), and intersections of the braided wires are movable (Particularly due to rings 57 and 59 which are movably attached, thereby allowing for flexibility and movement of the wires forming the loose braid structure).
Regarding claim 18, Hartley discloses the window supporting member comprises at least two supporting sections (At least the top region at 45 and bottom region at 47, FIG 10A); the supporting sections are formed by cross braiding braided wires ([0067] discloses the particular twisting and braiding of the wires to form the loose braid structures); and the at least two supporting sections are movably connected by mutual hooking (End loops 57 and 59 allow for movement and are interpreted as mutually hooking because they hook a respective wire to constrain the device at least around rings 45, 47, while allowing for other degrees of freedom).
Regarding claim 19, Hartley 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 (FIG 10A, the regions are positioned at both the proximal end and distal end of window supporting member 40).
Regarding claim 20, Hartley 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 (Due to the variety of spacing formed by the loose braid structure, there is understood to be at least some aperture at the proximal end, for example the aperture formed by ring 47, FIG 10C, which is greater than an aperture of another portion of the mesh structure, for example the aperture of 57 or 45, FIG 10B).
Regarding claim 21, Hartley discloses the main body stent comprises a main body supporting member (At least one segment of zig zag stent 16); part of the main body supporting member is located on the other side of the internal covering film opposite to the window supporting member (For example at the bottom of the device as viewed in FIG 7 is interpreted as being positioned opposite to the window supporting member); 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 (FIG 7, 8, and 10A show the wires are braided more tightly to form 40 than they are to form the zig zag stent).
Regarding claim 22, Hartley discloses the internal covering film comprises a bottom portion (The tapered portion 14 is interpreted as a bottom portion), a proximal end folding portion (15, FIG 7) and a distal end folding portion (Top region relative to 14); the proximal end folding portion and the distal end folding portion are arranged at two ends of the bottom portion respectively (Above and below, as viewed in FIG 7); 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 (Stents 16 are located on the outer surface of covering film, therefore both the proximal end folding portion and the distal end folding portion are arranged on an inner surface of the main body stent), and is recessed toward the inner cavity of the main body stent to form a receiving cavity (branch 24, FIG 7, is a part of proximal end folding region 15 and is recessed towards the inner lumen, see FIG 11, to form a receiving cavity. The lumen of 24 is interpreted as the receiving cavity).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hehrlein (US 2016/0022450) which discloses a stent (1) having a window (7) and a window supporting member in the form of a mesh (FIG 1b, stent struts 2’ located inside the surface region 6, [0043]).
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