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 .
Status of Claims
Claims 1-15 are pending and examined below.
Claim Objections
Regarding claim 1, the claim reads “wherien the covering membrane is covered on the first stent”. Examiner suggests amending the claim to read “wherien the covering membrane covers the first stent” for clarity.
Claim Rejections - 35 USC § 102
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.
(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) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2016/0361153 (Shahriari)
Regarding claim 1, Shahriari discloses a membrane-covered stent (Fig. 5), comprising:
a first stent (Fig. 5, 400)
a second stent (Fig. 5, 532a), and
a covering membrane (Fig. 5, 502, ¶0109), wherein the covering membrane is covered on the first stent (¶0109, wherein “cover graft 502 that generally surrounds the stent frame 400” corresponds to covered on the first stent) to form a lumen structure (Fig. 5, wherein channel 504 corresponds to a lumen structure) provided with a recess in the middle portion (see Fig. 6, wherein 432 corresponds to a recess in the middle portion)
the second stent is at least partially accommodated in the recess (Fig. 6, see also ¶0114, wherein “cradle the first longitudinal arterial stent 532a” corresponds to at least partially accommodate in the recess); and a longitudinal central axis of the first stent (Fig. 5, 104) is parallel or substantially parallel to a longitudinal central axis of the second stent (Fig. 5, wherien 506a is substantially parallel to 104)
Claim Rejections - 35 USC § 103
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) 2, 3, 5, 6, 8-10, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0361153 (Shahriari) in view of US 2019/0328557 (Lostetter)
Regarding claim 2, Shahriari further discloses a first stent but doesn't explicitly teach or disclose wherein the first stent comprises a plurality of first waveform rings and at least one second waveform ring; the plurality of first waveform rings are located at two ends of the first stent; the second waveform ring is located in middle portions of the first stents; and the second waveform ring is radially opposite to the recess.
Lostetter discloses wherein the first stent comprises a plurality of first waveform rings (Fig. 1, 28 and 30) and at least one second waveform ring (see annotated Fig. 1 below); the plurality of first waveform rings are located at two ends of the first stent (see annotated Fig. 1 below, wherein 28 and 30 are located at two ends of the stent); the second waveform ring is located in middle portions of the first stents; and the second waveform ring is radially opposite to the recess (see annotated Fig. 1 below, wherein the second waveform ring is radially opposite the recess, see also Fig. 2A)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first stent of Shahriari with a first waveform ring and a second waveform ring, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Regarding claim 3, Shahriari discloses a membrane-covered stent (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the second waveform ring has a closed-loop structure with wave crests and wave troughs, or an open-loop structure with wave crests and wave troughs.
Lostetter discloses wherein the second waveform ring has a closed-loop structure with wave crests and wave troughs, or an open-loop structure with wave crests and wave troughs (see annotated Fig. 1 below, wherein the second waveform ring has crests and troughs)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first stent of Shahriari with a second waveform ring with an open-loop structure with crests and troughs, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Regarding claim 5, Shahriari discloses a second stent (see rejection of claim 1) but doesn't explicitly teach or disclose at least one third waveform ring; and the third waveform ring has a closed-loop structure with wave crests and wave troughs or an open-loop structure with wave crests and wave troughs
Lostetter discloses at least one third waveform ring; and the third waveform ring has a closed-loop structure with wave crests and wave troughs or an open-loop structure with wave crests and wave troughs (see annotated Fig. 1 below, wherein the third waveform rings have an open-loop structure with wave crests and wave troughs)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the second stent of Shahriari with at least one third waveform ring, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Regarding claim 6, Shahriari discloses a membrane covered stent comprising a second stent (see rejection of claim 1) but doesn't explicitly teach or disclose wherein a plurality of third waveform rings are provided; and the plurality of third waveform rings are axially arranged at intervals or are axially arranged in a non-spaced manner.
Lostetter discloses a plurality of third waveform rings are provided (see annotated Fig. 1 below); and the plurality of third waveform rings are axially arranged at intervals (see annotated Fig. 1 below wherein the third waveform rings are axially arranged at intervals) or are axially arranged in a non-spaced manner
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Shahriari with a plurality of third waveform rings that are axially spaced at intervals, as taught by Lostetter, in order to provide support axially along the membrane-covered stent.
Regarding claim 8, Shahriari discloses a membrane-covered stent with a recess (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface; each third waveform loop is at least partially accommodated in the recess; and the third waveform loop is not fixedly connected with the bottom surface.
Lostetter discloses wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface (see annotated Fig. 1 below); each third waveform loop is at least partially accommodated in the recess (see annotated Fig. 1 below); and the third waveform loop is not fixedly connected with the bottom surface (see annotated Fig. 1 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify membrane-covered stent of Ward with a recess comprising a bottom surface and a side surface which accommodates a third waveform loop, as taught by Lostetter, in order to accommodate blood flow to branch vessels.
Regarding claim 9, Shahriari further discloses wherein the second stent is an integrated stent (¶0114, wherein “cradle the first longitudinal arterial stent 532a” corresponds integrated) formed by braiding braided wires or an integrated stent formed by cutting (Fig. 5, wherein 510 is formed by cutting)
Regarding claim 10 Shahriari discloses a second stent (see rejection of claim 1) but doesn't explicitly teach or disclose wherein a first window is formed in one side of the second stent.
Lostetter discloses wherein a first window (Fig. 2a, 38) is formed in one side of the second stent (Fig. 2A, wherein 38 is formed in second stent 36)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the second stent of Shahriari with a first window, as taught by Lostetter, in order to accommodate blood flow to branch vessels.
Regarding claim 12, Shahriari discloses a recess (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface; and at least one of the bottom surface and the side surface is provided with a through hole.
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Lostetter discloses a membrane-covered stent (Fig. 1) comprising wherein the recess comprises a bottom surface (see annotated Fig. 1 below) and a side surface surrounding the bottom surface (see annotated Fig. 1); and at least one of the bottom surface and the side surface is provided with a through hole (Fig. 2A, wherein both the bottom surface and side surface are provided with through hole 38)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the recess of Shahriari with a bottom surface and a side surface, as taught by Lostetter, in order to accommodate blood flow to branch vessels.
Regarding claim 15, Shahriari discloses a membrane-covered stent with a recess (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface; each third waveform loop is at least partially accommodated in the recess; and the third waveform loop is not fixedly connected with the bottom surface.
Lostetter discloses wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface (see annotated Fig. 1 below); each third waveform loop is at least partially accommodated in the recess (see annotated Fig. 1 below); and the third waveform loop is not fixedly connected with the bottom surface (see annotated Fig. 1 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify membrane-covered stent of Shahriari with a recess comprising a bottom surface and a side surface which accommodates a third waveform loop, as taught by Lostetter, in order to accommodate blood flow to branch vessels.
Claim(s) 4, 7, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0361153 (Shahriari) in view of US 2019/0328557 (Lostetter), as applied to claims above, and further in view of US 2008/0114446 (Hartley)
Regarding claim 4, Shahriari discloses a membrane-covered stent (see rejection of claim 1) but doesn't explicitly teach or disclose a second waveform ring.
Lostetter discloses:
(a) when the second waveform ring has a closed-loop structure with wave crests and wave troughs, the second waveform ring comprises a first non-closed waveform ring and a first closed portion; the first non-closed waveform ring is an open-loop waveform ring with wave crests and wave troughs; the open-loop waveform ring is provided with two free ends; the first closed portion comprises a straight rod; two ends of the straight rod are respectively directly or indirectly connected with the two free ends (see annotated Fig. 1 below wherein the prior art second waveform ring doesn’t have a closed loop structure therefore the limitations under (a) are not applicable);
(b) when the second waveform loop has an open-loop structure with wave crests and wave troughs (see annotated Fig. 1 below), the second waveform loop is an open-loop waveform ring with wave crests and wave troughs (see annotated Fig. 1 below); the open-loop waveform ring is provided with two free ends (see annotated Fig. 2A below);
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the membrane-covered stent of Shahriari with a second waveform ring with wave crest, wave troughs, and free ends, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Shahriari doesn't explicitly teach or disclose a second waveform ring with passivated structures on the free ends. Lostetter discloses a second waveform ring with free ends but doesn't explicitly teach or disclose passivated structures on the free ends.
Hartley discloses a membrane-covered stent (Fig. 13) wherein the two free ends of the second waveform ring have passivated structures (Fig. 13, 118, see also ¶0069, wherein “the cut ends are curved into a loop 118 so that the shape end does not present a point which could damage the vasculature” corresponds to a passivated structure)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two free ends of the open-loop waveform ring with passivated structures, as taught by Hartley, in order to reduce the risk of damaging the vasculature and/or the membrane.
Regarding claim 7, Shahriari discloses a membrane-covered stent (see rejection of claim 1) but doesn't explicitly teach or disclose a third waveform ring.
Lostetter discloses (a) when each third waveform ring has a closed-loop structure with wave crests and wave troughs, the third waveform ring comprises: a second non-closed waveform ring and a second closed portion; the second non-closed waveform ring is an open-loop waveform ring with wave crests and wave troughs; the open-loop waveform ring is provided with two free ends; the second closed portion comprises a straight connecting rod; two ends of the straight connecting rod are respectively directly or indirectly connected with the two free ends (see annotated Fig. 1 below wherein the prior art third waveform ring doesn’t have a closed loop structure therefore the limitations under (a) are not applicable)
(b) when the third waveform loop has an open-loop structure with wave crests and wave troughs (see annotated Fig. 1 below, wherein the third waveform loops have an open-loop structure), the third waveform loop is an open-loop waveform ring with wave crests and wave troughs (see annotated Fig. 1 below, wherein the third waveform loops have an open-loop structure); the open-loop waveform ring is provided with two free ends (see annotated Fig. 2 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the membrane-covered stent of Shahriari with a second waveform ring with wave crest, wave troughs, and free ends, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Shahriari doesn't explicitly teach or disclose a second waveform ring with passivated structures on the free ends. Lostetter discloses a second waveform ring with free ends but doesn't explicitly teach or disclose passivated structures on the free ends.
Hartley discloses a membrane-covered stent (Fig. 13) wherein the two free ends of the third waveform ring have passivated structures (Fig. 13, 118, see also ¶0069, wherein “the cut ends are curved into a loop 118 so that the shape end does not present a point which could damage the vasculature” corresponds to a passivated structure)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two free ends of the open-loop waveform ring with passivated structures, as taught by Hartley, in order to reduce the risk of damaging the vasculature and/or the membrane.
Regarding claim 14, Shahriari discloses a membrane-covered stent (see rejection of claim 1) but doesn't explicitly teach or disclose a third waveform ring.
Lostetter discloses (a) when each third waveform ring has a closed-loop structure with wave crests and wave troughs, the third waveform ring comprises: a second non-closed waveform ring and a second closed portion; the second non-closed waveform ring is an open-loop waveform ring with wave crests and wave troughs; the open-loop waveform ring is provided with two free ends; the second closed portion comprises a straight connecting rod; two ends of the straight connecting rod are respectively directly or indirectly connected with the two free ends (see rejection of claim 5, wherein the prior art discloses at least one third waveform ring with a closed-loop structure)
(b) when the third waveform loop has an open-loop structure with wave crests and wave troughs (see annotated Fig. 1 below, wherein the third waveform loops have an open-loop structure), the third waveform loop is an open-loop waveform ring with wave crests and wave troughs (see annotated Fig. 1 below, wherein the third waveform loops have an open-loop structure); the open-loop waveform ring is provided with two free ends (see annotated Fig. 2 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the membrane-covered stent of Shahriari with a second waveform ring with wave crest, wave troughs, and free ends, as taught by Lostetter, in order to radially support the blood vessel while still allowing for a branching stent.
Shahriari doesn't explicitly teach or disclose a second waveform ring with passivated structures on the free ends. Lostetter discloses a second waveform ring with free ends but doesn't explicitly teach or disclose passivated structures on the free ends.
Hartley discloses a membrane-covered stent (Fig. 13) wherein the two free ends of the third waveform ring have passivated structures (Fig. 13, 118, see also ¶0069, wherein “the cut ends are curved into a loop 118 so that the shape end does not present a point which could damage the vasculature” corresponds to a passivated structure)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the two free ends of the open-loop waveform ring with passivated structures, as taught by Hartley, in order to reduce the risk of damaging the vasculature and/or the membrane.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0361153 (Shahriari) in view of US 2019/0328557 (Lostetter), as applied to claims above, and further in view of US 2016/0030209 (Shalev)
Regarding claim 11, Shahriari discloses a membrane-covered stent comprising a recess (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface; a first window is formed in one side of the second stent close to the bottom surface;
Lostetter discloses wherein the recess comprises a bottom surface and a side surface surrounding the bottom surface (see annotated Fig. 1); a first window is formed in one side of the second stent close to the bottom surface (Fig. 2, wherein 38 is formed closed to the bottom surface);
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the recess of Shahriari with a bottom surface and a side surface, as taught by Lostetter, in order to accommodate branching stents
Shahriari doesn't explicitly teach or disclose the second stent is further provided with a second window; and the first window and the second window are radially opposite. Lostetter doesn't explicitly teach or disclose the second stent is further provided with a second window; and the first window and the second window are radially opposite.
Shalev discloses the second stent is further provided with a second window (Fig. 12, 368); and the first window and the second window are radially opposite (Fig. 12, wherein 34 and 368 are radially opposite)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the second stent of Shahriari in view of Lostetter with a first window and a second window radially opposite each other, as taught by Shalev, in order to accommodate two branching vessels simultaneously while maintaining adequate blood flow.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0361153 (Shahriari) in view of US 2019/0328557 (Lostetter), as applied to claims above, and further in view of US 2020/0206004 (Lin)
Regarding claim 13, Shahriari discloses a first stent and a second stent but doesn't explicitly teach or disclose wherein the radial support strength of the first stent (P1) and the radial supporting strength of the second stent (P2) satisfy this relationship 1/2 < (P2/P1) < 1 or this relationship 1 ≤ (P2/P1) ≤ 2. Lostetter doesn't explicitly teach or disclose wherein the radial support strength of the first stent (P1) and the radial supporting strength of the second stent (P2) satisfy this relationship 1/2 < (P2/P1) < 1 or this relationship 1 ≤ (P2/P1) ≤ 2
Lin discloses wherein the radial supporting strength of the first stent is P1 (¶0062, wherein 90kPa or more corresponds to P1), and the radial supporting strength of the second stent is P2 (¶0066,wherein 60 kPA corresponds to P2; and wherein P1 and P2 satisfy this relationship: 1/2<(P2/P1)<1 (¶0066, wherein 60/90 = 2/3, which satisfies the relationship because ½ < 2/3 < 1); or P1 and P2 satisfy this relationship: 1 ≤ (P2/P1) ≤ 2
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the radial support strength of the first stent, i.e. P1, and the radial supporting strength of the second stent, i.e. P2 of Shahriari in view of Lostetter, to satisfy this relationship ½ < (P2/P1) < 1, as taught by Lin, in order to provide the appropriate amount of support for the blood vessel (¶0062).
Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774