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 .
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.
Response to Amendment
This action is in response to the applicant’s amendment received 10/23/2025. The amendments made to the claims do not place the application in condition for allowance for the reasons set forth below. Claims 1, 3-5, 8-11, 13, and 14 are pending.
Response to Arguments
Applicant’s arguments with respect to amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Claims 1, 3-5, 8-11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (US 2008/0195191) in view of Kang (US 2010/0249901).
Regarding claim 1, Luo discloses a stent graft (see Fig, 7) comprising a tubular member (4) extending between a proximal end that is an end portion on a proximal side in a predetermined axial direction (top side; see annotated figure below), and a distal end that is an end portion a distal side in the predetermined axial direction (bottom side; see annotated figure below), a plurality of stent rings (2, 3s) fixed to a side wall of the tubular member (4) and formed of struts extending in a ring shape in a circumferential direction of the tubular member (see Fig. 7), while alternatingly bending toward the proximal side and toward the distal side (see Fig. 7), the plurality of stent rings (2, 3s) including at least a fluctuating ring (first ring 3 that is adjacent ring 2; see annotated figure) including a first region in which an amplitude (at 32) in the predetermined axial direction is a first value, and a second region in which an amplitude (at 33) is a second value that is smaller than the first value (see Fig. 3), and a small fixed ring (2 being “fixed” to the tubular member 4 and described in [0036] as being a “mini-stent member 2”) in which a maximum value of an amplitude is a third value that is smaller than the first value and the second value (see Figs. 2, 3; amplitude of ring 2 is smaller than the amplitude at 32 and 33; see [0036] describing ring 2 being a “mini-stent member”, thereby smaller than rings 3), and an uncovered section (1) formed of a strut (see Figs. 1, 7), at least a portion of which is disposed on the proximal end of the tubular member (1 is disposed on the proximal end of tubular member 4 which is opposite the distal end of the tubular member 4; see Fig. 7), the strut extending in a ring shape while alternatingly bending toward a base end side (comprised of 11s) that is an end portion on a distal end side of the uncovered section (a distal end side of 1), and toward a tip end side (comprised of 12s/13s) that is an end portion on a proximal end side of the uncovered section (on a proximal end side of 1 which is opposite the distal end side of 1; see annotated Fig. 7), wherein the small fixed ring (2) is adjacent the base end side of the uncovered section (2 is adjacent the distal end side of 1; see Fig. 7), the fluctuating ring is adjacent a distal end side of the small fixed ring (first ring 3 is adjacent a distal end side of 2; see Fig. 7), the uncovered section (1) is such that an extending direction from the base end side toward the tip end side (from 11s to 12s/13s) extends in a direction away from a center line passing through a center of the tubular member and extending in the predetermined axial direction (see Fig. 7), and the uncovered section (1) includes a first portion (for example, the portion distal to the tip end including 11s; see Fig. 7) where an angle of the extending direction with respect to a reference direction (for example, the direction of the longitudinal axis; see Fig. 7) is a first angle (see Fig. 7), the reference direction extending on the side opposite the distal end side with respect to the proximal end and being parallel to the center line (see Fig. 7), and a second portion (for example, the portion proximal to the base end including 12s/13s) connected to the first portion at a position between the base end side and the tip end side in the extending direction (see Fig. 7), the second portion including the tip end side (see Fig. 7).
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Luo fails to disclose an angle of the extending direction with respect to the reference direction of the second portion is smaller than the first angle. Kang also discloses a stent having uncovered end portions (see Figs. 2-3). Kang teaches the end portions are bent towards the lengthwise central axis of the stent so that damage to the vessel wall or lumen wall is prevented by minimizing the contact with the vessel wall or lumen wall when the stent is introduced into the human body (see Fig. 3 and paragraph [0015]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Luo’s second portion to be bent towards the lengthwise central axis of the stent as taught by Kang such that the angle of the extending direction with respect to the reference direction of the second portion is smaller than the first angle in order to prevent damage to the vessel wall or lumen wall by minimizing the contact with the vessel wall or lumen wall when the stent is introduced into the human body (see Fig. 3 and paragraph [0015]).
Regarding claim 3, Luo as modified discloses the base end side (comprised of 11s) of the uncovered section (1) is positioned on the distal end side of the small fixed ring (the distal base end side of 1 is positioned on a proximal end side of 2; see Fig. 7).
Regarding claim 4, Luo as modified discloses positions in the circumferential direction of a plurality of poles (11s) of the base end side of the uncovered section (1) and a plurality of poles (22s) on a proximal end side of the small fixed ring (2) are different (see Fig. 7 in which 11s and 22s alternate circumferentially, thereby are different as claimed).
Regarding claim 5, Luo as modified discloses positions in the circumferential direction of a plurality of poles (11s) of the base end side of the uncovered section (1) and a plurality of poles (23s) on a proximal end side of the small fixed ring (2) are the same (see Fig. 7 in which 11s and 23s align circumferentially, thereby are the same as claimed).
Regarding claim 8, Luo as modified discloses the plurality of stent rings further include a large fixed ring (second ring 3 adjacent to first ring 3 which is also “fixed” to the tubular member 4 and large compared to small fixed ring 2; see annotated figure above) in which a maximum value of an amplitude (at 32) is a fourth value that is larger than the third value (see Fig. 7 illustrating amplitude at 32 being larger than the amplitude at 22), and which is disposed on a distal end side of the fluctuating ring and the small fixed ring (second ring 3 is disposed on a distal end side of the first ring 3 and ring 2, see annotated figure above).
Regarding claim 9, Luo as modified discloses the uncovered section (1) is such that the base end side (comprised of 11s) is fixed to an inner surface of the proximal end of the tubular member (4; see paragraph [0039] describing each of the stent rings being disposed about the outer diameter of the graft, within the inner diameter of the graft, or within the wall of the graft).
Regarding claim 10, Luo as modified discloses the plurality of stent rings (2, 3s) are fixed to an outer surface of the tubular member (4; see paragraph [0039] describing each of the stent rings being disposed about the outer diameter of the graft, within the inner diameter of the graft, or within the wall of the graft).
Regarding claim 11, Luo as modified discloses the plurality of stent rings (2, 3s) are fixed to an inner surface of the tubular member (4; see paragraph [0039] describing each of the stent rings being disposed about the outer diameter of the graft, within the inner diameter of the graft, or within the wall of the graft).
Regarding claim 13, Luo as modified discloses there are a plurality of the fluctuating rings (first ring 3 and any or all bottom 3 rings 3) and the small fixed ring (2; see Fig. 7).
Regarding claim 14, Luo as modified discloses a plurality of poles (31) on a proximal end side of the fluctuating ring (first ring 3) are arranged on a virtual line extending in a direction orthogonal to the predetermined axial direction along the circumferential direction (see Figs. 3 and 7).
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.
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774