DETAILED ACTION
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 II, claims 11-20 in the reply filed on 1 June 2026 is acknowledged.
Claims 1-10 and 21-30 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 June 2026.
Claim Status
Applicant’s Remarks and Amendments filed 1 June 2026 have been entered. Claim 14 is canceled. Claims 11-13 and 15-20 are pending.
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses. See claim 11, lines 18-19.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim 1 is objected to because of the following informalities: line 22 ends in a period rather than a comma. Appropriate correction is required.
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.
Claims 11-13, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Myung (US 2020/0315821 A1), “Myung” in view of Ehnes et al. (US 2018/0110609 A1), “Ehnes”.
Regarding claim 11, Myung teaches an anti-migration stent having a first stent (100) configured to expand a lesion area (1a) narrowed and blocked in a lumen (1) of a body (Fig. 12A, stent 100 is anti-sliding and used to expand an occluded lesion in a lumen 2 [0047]) and to have a first cylindrical body (110) formed in a hollow cylindrical shape by weaving or crossing wires (2) made of a super elastic shape memory alloy in a mesh shape so that multiple first space parts (111) are formed between the wires (2) (Fig. 1, inner stent 10 formed by weaving or crossing wires 1 to form spaces 11 [0048]), a first film part (120) made of polytetrafluoroethylene (PTFE) formed on an entire inner surface of the first cylindrical body (110) (Fig. 12C, inner stent 10 is covered by inner side of membrane 12 made of PTFE [0100]), and a second film part (130) made of polytetrafluoroethylene (PTFE) formed on an outer surface of the first cylindrical body (110) (Fig. 12C, inner stent 10 is covered by outer side of membrane 12 made of PTFE [0100]), the anti-migration stent comprising: a second stent (200) having multiple second space parts (211) formed by weaving or crossing the wires (2) made of a super elastic shape memory alloy in a mesh shape (Fig. 1, outer sent 20 formed by weaving or crossing wires 1 made of shape memory alloy to form spaces 21 [0048]) Fig. 12C, inner stent 10 is covered by inner side of membrane 12 made of PTFE [0100], with the second stent (200) being shorter in length than the first stent (100) (Fig. 1, outer stent 20 is shorter than inner stent 10 [0049]) and fitted over and connected to one side of the first stent (100) from the outside so that the second stent (200) is held in the lumen (1) in which the lesion area (1a) has occurred (Figs. 12A, 13A, outer stent 20 is fitted over ends of inner stent 10 and together positioned within lumen 2 [0051]), wherein the second stent (200) is composed of a second cylindrical body (210) formed in a hollow cylindrical shape (Fig. 1, outer stent 20 forms a hollow cylindrical net shape [0048]), and a connection part (220) formed by having a diameter decreasing at one side of the second cylindrical body 210 so as to be connected to the first stent (100) (Fig. 1, conical bending section 23 formed by bending inward a side of the enlarged section 22 (i.e., smaller diameter on one end) [0050]), with the second cylindrical body (210) and the connection part (220) having a third film part 230 made of silicone formed thereon (Fig. 12A, outer stent 20 comprising conical bending section 23 is covered by membrane 24 made of silicon [0090]), wherein a protruding part (140) is formed to protrude on one side of the first cylindrical body (110) located at a side opposite to the second stent (200) (Fig. 12A, bottom outer stent 20). wherein the protruding part (140) has no first and second film parts (120) (130) formed thereon (Fig. 10A, membrane 24 may only cover certain portions of spaces 21 on outer stent 20 (i.e., bottom outer stent is uncovered) [0090]), but fails to teach with the second film part (130) formed in a spiral shape to have predetermined intervals defined therein and bonded to the first film part (120).
Ehnes teaches a flexible stent-graft with the second film part (130) formed in a spiral shape to have predetermined intervals defined therein and bonded to the first film part (120) (Fig. 24, stent-graft 10’ comprises bottom ribbon 62 that is helically wound with longitudinal spaces and bonded to top ribbon 60 [0074-0075]). Ehnes discloses that the ribbons freely move with movement of the wire forming the stent-graft and do not inhibit movement of the wire upon longitudinal movement and bending of the stent-graft [0075]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the second film part taught by Ehnes with the first film part taught by Myung in order to provide an uninhibited stent-graft that adapts better to movement.
Regarding claim 12, Myung teaches wherein a first space part (111) of one end of the first stent (100) and a second space part (211) of the connection part (220) are sewn and connected to each other with a connecting thread (300) (Fig. 12A, pulling string 50 is threaded into spaces 11 at an end of inner stent 10 through outer stent 20 (reference number 30 in Fig. 12A) [0055-0057]).
Regarding claim 13, Myung teaches wherein one end of the first stent (100) and the connection part (220) are integrally formed and connected to each other (Fig. 12A, pulling string 50 is threaded into spaces 11 at an end of inner stent 10 through outer stent 20 (reference number 30 in Fig. 12A) to connect inner and outer stents together [0055-0057]).
Regarding claim 15, Myung teaches wherein one side of the first cylindrical body (110) overlapping with the connection part (220) has no first and second film parts (120)(130) formed thereon (Fig. 6A, inner stent 10 comprises membrane 12 at predetermined portions or positions so that only some spaces 11 are covered [0072]).
Regarding claim 16, Myung teaches wherein the connection part (220) has no third film part (230) formed thereon (Fig. 10A, membrane 24 may only cover certain portions of spaces 21 on outer stent 20 (i.e., conical bending section 23 is left uncovered) [0090]).
Regarding claim 17, Myung teaches wherein one side of the first cylindrical body (110) overlapping with the connection part (220) has no first and second film parts (120)(130) formed thereon (Fig. 6A, inner stent 10 comprises membrane 12 at predetermined portions or positions so that only some spaces 11 are covered [0072]), and the connection part (220) has no third film part (230) formed thereon (Fig. 10A, membrane 24 may only cover certain portions of spaces 21 on outer stent 20 (i.e., conical bending section 23 is left uncovered) [0090]).
Regarding claim 20, Myung teaches wherein the first stent (100) protrudes by a predetermined length L from the connection part (220) (Fig. 12A, outer stent 20 is shorter than inner stent 10 (i.e., inner stent comprises standard longer length than outer stent) [0014]) and is connected to the connection part (220) (Fig. 12A, pulling string 50 is threaded into spaces 11 at an end of inner stent 10 through outer stent 20 (reference number 30 in Fig. 12A) [0055-0057]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Myung (US 2020/0315821 A1), “Myung” in view of Ehnes et al. (US 2018/0110609 A1), “Ehnes”, and further in view of Walzman (US 2021/0137671 A1), “Walzman”.
Regarding claim 18, Myung teaches wherein a first space part (111) at one side of the first cylindrical body (110) overlapping with the second stent (200) (Fig. 12A, spaces 11 covered by outer stent 20) and a remaining part of the first cylindrical body (110) which does not overlap with the second stent (200) (Fig. 12A, spaces 11 not covered by outer stent 20), but Myung in view of Ehnes fails to teach the first space part overlapping with the second stent is greater in size than a first space part of a remaining part of the first cylindrical body.
Walzman teaches a caped stent wherein the first space part overlapping with the second stent is greater in size than a first space part of a remaining part of the first cylindrical body (Fig. 19B, inner stent of a multi-layered stent comprises larger openings formed by laser cut [0146]). Walzman discloses that the outer stent may have small enough interstices so that the second inner stent cannot herniate through those interstices [0146]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the space sizes taught by Walzman with the first and second stents taught by Myung in order to prevent the inner stent protruding through the outer stent due to unforeseen forces.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Myung (US 2020/0315821 A1), “Myung” in view of Ehnes et al. (US 2018/0110609 A1), “Ehnes”, and further in view of Shank et al. (US 2005/0110214 A1), “Shank”.
Regarding claim 19, Myung teaches the second space parts (Fig. 12A, spaces 21) and first space parts (Fig. 12A, spaces 11), but Myung in view of Ehnes fails to teach wherein each of the second space parts (211) is greater in size than each of the first space parts (111).
Shank teaches an endoprosthesis wherein each of the second space parts (211) is greater in size than each of the first space parts (111) (Fig. 20, outer layer of stent cover 2003 comprises greater porosity than inner layer [0078]). Shank discloses that leaving portions of the stent uncovered and increasing the outside surface roughness of the stent reduce movement and migration of the stent [0006]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the larger spaces of the outer layer taught by Shank with the second stent taught by Myung in order to prevent stent migration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0167455.
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/G.G.R./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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