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 .
Claim Status
Applicant’s Remarks and Amendments filed 26 December 2025 have been entered. Claims 7-20, 25-28, and 30-32 are cancelled. Claim 35 is new. Claims 1-6, 21-24, 29, and 33-35 are pending.
Response to Arguments
Applicant’s arguments, see page 7 of remarks, filed 26 December 2025, with respect to the rejection of claims 1-3 and 21-24 have been fully considered and are persuasive. The 112(b) rejection of claims 1-3 and 21-24 has been withdrawn.
Applicant’s arguments with respect to claims 1-6, 21-24, 29, and 33-34 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-3, 21, and 29-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2013/0325141 A1), “Gill” in view of Yachia et al. (US 2004/0167635 A1), “Yachia”.
Regarding claim 1, Gill teaches an implantable device comprising: a tubular member (Fig. 9, stent 900) defining a longitudinal axis (Fig. 1, longitudinal axis AL of stent 100 (similar to stent 900)) and a lumen (Fig. 1, lumen 101 of stent 100 (similar to stent 900)), the tubular member (Fig. 9, stent 900) configured to be disposed within venous sinuses () and having: a plurality of interconnected (Fig. 13, stent 1300 (similar to stent 900) is laser cut [0166]) filaments (Fig. 9, scaffolding structure 910) defining a plurality of openings (Fig. 9, regions of stent 900 have more open or more dense scaffolding structure 910 [0153]) therebetween; a distal end portion (Fig. 9, distal end 904) having a first cross-sectional dimension (Fig. 9, distal end diameter D3); and a proximal end portion (Fig. 9, proximal end 902) having a second cross-sectional dimension (Fig. 9, proximal end diameter D2) larger than the first cross-sectional dimension (Fig. 9, diameter increases of proximal and distal ends 902, 904 may be different (i.e., one end may be larger/smaller than the other) [0150]) and configured to have a circular or oval cross-sectional shape (Fig. 9B, stent 900 comprises a circular cross-section), but fails to teach the tubular member configured to be disposed within venous sinuses and a distal end portion configured to have a triangular cross-sectional shape.
Yachia teaches a prostatic luminal stent configured to be disposed within venous sinuses (Fig. 3a, stent 300 is adapted for use in any body lumen having a non-circular cross-sectional shape [0033] (i.e., venous sinuses)) comprising a triangular cross-sectional shape (Fig. 3a, stent 300 has a triangular cross-section [0034]). Yachia discloses that the stent may be adapted for use in any body lumen having a non-circular cross-sectional shape [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the distal end of the stent taught by Gill to comprise a triangular cross-section in order to adapt to various body lumens.
Regarding claim 2, Gill teaches wherein the second cross-sectional dimension (Fig. 9, proximal end diameter D2) is from 10 mm to 14 mm (Fig. 9, diameters of flared sections (i.e., proximal and distal ends 902, 904) may increase from about 2 mm to 8 mm greater than the mid-body diameter [0150]) and the first cross-sectional dimension (Fig. 9, distal end diameter D3) is from 4 mm to 8 mm (Fig. 9, diameters of flared sections (i.e., proximal and distal ends 902, 904) may increase from about 2 mm to 8 mm greater than the mid-body diameter [0150])
Regarding claim 3, Gill teaches wherein the second cross-sectional dimension (Fig. 9, proximal end diameter D2) is larger than the first cross-sectional dimension (Fig. 9, distal end diameter D3) by a factor from 2 to 3 (Fig. 9, diameter increases of proximal and distal ends 902, 904 may be different (i.e., one end may be larger/smaller than the other) and D2 may be about 5 mm greater than D1 while D3 may be about 3 mm greater than D1 [0150]).
Regarding claim 21, Gill teaches wherein when the tubular member is compressed to 30% of a nominal state, a radial pressure of the tubular member is from 20 mmHg to 50 mmHg (Fig. 1, stent 100 (similar to stent 900) may be partially collapsed such as by forces F5, F10 of about 2 pounds thereby creating forces that act against forces F5, F10 [0117-0118]).
Regarding claim 29, Gill teaches an implantable device comprising: a tubular member (Fig. 9, stent 900) defining a longitudinal axis (Fig. 1, longitudinal axis AL of stent 100 (similar to stent 900)) and a lumen (Fig. 1, lumen 101 of stent 100 (similar to stent 900)), the tubular member (Fig. 9, stent 900) having: a plurality of interconnected filaments (Fig. 9, scaffolding structure 910) defining a plurality of openings therebetween (Fig. 9, regions of stent 900 have more open or more dense scaffolding structure 910 [0153]); a distal end portion (Fig. 9, distal end 904); and a proximal end portion (Fig. 9, proximal end 902) opposite the distal end portion and configured to have a circular or oval cross-sectional shape (Fig. 9B, stent 900 comprises a circular cross-section), but fails to teach the tubular member configured to be disposed within venous sinuses and a distal end portion configured to have a triangular cross-sectional shape.
Yachia teaches a prostatic luminal stent configured to be disposed within venous sinuses (Fig. 3a, stent 300 is adapted for use in any body lumen having a non-circular cross-sectional shape [0033] (i.e., venous sinuses)) comprising a triangular cross-sectional shape (Fig. 3a, stent 300 has a triangular cross-section [0034]). Yachia discloses that the stent may be adapted for use in any body lumen having a non-circular cross-sectional shape [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the distal end of the stent taught by Gill to comprise a triangular cross-section in order to adapt to various body lumens.
Regarding claim 33, Gill teaches wherein the distal end portion (Fig. 9, distal end 904) has a distal cross-sectional dimension (Fig. 9, distal end diameter D3), and the proximal end portion (Fig. 9, proximal end 902) has a proximal cross-sectional dimension (Fig. 9, proximal end diameter D2), and wherein the implantable device further comprises: an intermediate portion (Fig. 9, mid-body section 903) having an intermediate cross-sectional dimension (Fig. 9, mid-body diameter D1) smaller than at least one of the distal cross-sectional dimension or the proximal cross-sectional dimension (Fig. 9, mid-body diameter D1 is smaller than D2 and D3 [0150]).
Regarding claim 34, Gill teaches wherein the distal end portion (Fig. 9, distal end 904) has a distal cross-sectional dimension (Fig. 9, distal end diameter D3), and the proximal end portion (Fig. 9, proximal end 902) has a proximal cross-sectional dimension (Fig. 9, proximal end diameter D2), and wherein the implantable device (Fig. 9, stent 900) further comprises: an intermediate portion (Fig. 9, mid-body section 903) having an intermediate cross-sectional dimension (Fig. 9, mid-body diameter D1) smaller than both the distal cross-sectional dimension and the proximal cross-sectional dimension such that the tubular member has an hour-glass shape (Fig. 9, mid-body diameter D1 is smaller than D2 and D3 [0150]).
Regarding claim 35, Gill teaches further comprising an intermediate portion (Fig. 9, mid-body section 903) between the distal end portion (Fig. 9, distal end 904) and the proximal end portion (Fig. 9, proximal end 902), but fails to teach wherein a cross-sectional shape of the intermediate portion is increasingly triangular in a distal direction toward the distal end portion.
Yaschia teaches a prostatic luminal stent wherein a cross-sectional shape of the intermediate portion is increasingly triangular in a distal direction toward the distal end portion (Fig. 5, luminal lining 510 comprises a shape wherein one end is a triangle and the other end is round at the end of the system 500 [0038]). Yachia discloses that the stent may be adapted for use in any body lumen having a non-circular cross-sectional shape [0033]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the intermediate portion of the stent taught by Gill to comprise an increasingly triangular cross-section in order to adapt to various body lumens.
Claims 4, 6, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2013/0325141 A1), “Gill” in view of Yachia et al. (US 2004/0167635 A1), “Yachia” and further in view of Ziapour (US 2017/0128187 A1), “Ziapour”.
Regarding claim 4, Gill in view of Yachia fails to teach the limitations of claim 4. However, Ziapour teaches an ileal stent comprising an attachment member (Fig. 2, tripod structure 27) including a plurality of attachment filaments (Fig. 4, legs 28) and a hook (Fig. 4, collar 29) coupled to the plurality of attachment filaments (Fig. 4, legs 28 are connected at their proximal ends to central collar 29 [0011]). Ziapour discloses that the anti-intussusception structure holds the stent against food passage and likely intussusceptions [0021]. 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 stent taught by Gill with the attachment member taught by Ziapour in order to provide additional means of securing the stent in the body lumen.
Regarding claim 6, Gill teaches wherein the tubular member (Fig. 9, stent 900) is formed from a non-biodegradable material (Fig. 13, stent 1300 (similar to stent 900) may be formed from a memory alloy [0166]), but Gill in view of Yachia fails to teach the attachment member is formed from a biodegradable material.
Ziapour teaches an ileal stent wherein the attachment member (Fig. 2, tripod structure 27) is formed from a biodegradable material (Fig. 2, tripod structure 27 is made from biocompatible biodegradable materials [0020]). Ziapour discloses that the anti-intussusception structure holds the stent against food passage and likely intussusceptions [0021]. 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 stent taught by Gill with the attachment member taught by Ziapour in order to provide additional means of securing the stent in the body lumen.
Regarding claim 22, Gill teaches a nominal state (Fig. 9) but Gill in view of Yachia fails to teach the radial pressure of the tubular member is from 10 mmHg to 30 mmHg.
Ziapour teaches an ileal stent wherein a radial pressure of the tubular member is from 10 mmHg to 30 mmHg (Fig. 1, stent 10 has a radial force lower than 30-35 mmHg [0019]). Ziapour discloses that the lower force limit decreases migration risk and the upper force limit decreases the risk of injury [0019]. 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 stent taught by Gill with the radial force features of the stent taught by Ziapour in order to decrease migration risk and injury.
Regarding claim 23, Gill teaches the tubular member (Fig. 9, stent 900), but Gill in view of Yachia fails to teach wherein when fully compressed, the radial pressure of the tubular member is from 30 mmHg to 200 mmHg.
Ziapour teaches an ileal stent wherein the radial force of the tubular member is from 30 mmHg to 200 mmHg (Fig. 1, stent 10 has a radial force greater than 4 N but lower than 30-35 mmHg [0019]). Ziapour discloses that the lower force limit decreases migration risk and the upper force limit decreases the risk of injury [0019]. 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 stent taught by Gill with the radial force features of the stent taught by Ziapour in order to decrease migration risk and injury.
Regarding claim 24, Gill teaches the tubular member (Fig. 9, stent 900), but Gill in view of Yachia fails to teach wherein when fully compressed, the radial pressure of the tubular member is from 40 mmHg to 60 mmHg.
Ziapour teaches an ileal stent wherein the radial pressure of the tubular member is from 40 mmHg to 60 mmHg (Fig. 1, stent 10 has a radial force greater than 4 N but lower than 30-35 mmHg [0019]). Ziapour discloses that the lower force limit decreases migration risk and the upper force limit decreases the risk of injury [0019]. 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 stent taught by Gill with the radial force features of the stent taught by Ziapour in order to decrease migration risk and injury.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2013/0325141 A1), “Gill” in view of Gill et al. (US 2013/0325141 A1), “Gill” in view of Yachia et al. (US 2004/0167635 A1), “Yachia” and Ziapour (US 2017/0128187 A1), “Ziapour” and further in view of Cartledge et al. (US 2012/0239133 A1), “Cartledge”.
Regarding claim 5, Gill teaches the tubular member (Fig. 9, stent 900) and the longitudinal axis (Fig. 9, longitudinal axis AL), but Gill in view of Yachia fails to teach wherein rotation of the attachment member about the longitudinal axis in a first direction expands the tubular member and a rotation of the attachment member about the longitudinal axis in a second direction, opposite the first direction, constrains the tubular member.
Ziapour teaches an ileal stent comprising the attachment member (Fig. 2, tripod structure 27). Ziapour discloses that the anti-intussusception structure holds the stent against food passage and likely intussusceptions [0021]. 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 stent taught by Gill with the attachment member taught by Ziapour in order to provide additional means of securing the stent in the body lumen. However, Gill in view of Ziapour fails to teach wherein rotation of the attachment member about the longitudinal axis in a first direction expands the tubular member and rotation of the attachment member about the longitudinal axis in a second direction, opposite the first direction, constrains the tubular member.
Cartledge teaches a deployable endograft system wherein rotation of the attachment member about the longitudinal axis in a first direction expands the tubular member (Figs. 14A-B, control system 2400 comprising torque wire 2410 rotates to bring points 2420 and 2430 together to expand lattice structure 2100 [0104]) and rotation of the attachment member about the longitudinal axis in a second direction, opposite the first direction, constrains the tubular member (Figs. 14A-B, control system 2400 comprising torque wire 2410 rotates to distance points 2420 and 2430 away from each other to contract lattice structure 2100 [0104]). Cartledge discloses that the expansion and contraction of the stent is actively controlled by the user [0104]. 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 attachment member taught by Ziapour with the control system taught by Cartledge and the stent taught by Gill in order to provide an implant that is adjustable in real time by the user.
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799