Office Action 3: Notice of Allowance (2024-12-12)

CLAIMS:
Amendments to the Claims

This listing of claims will replace all prior versions, and listings, of claims in the application:

Listing of Claims

1\. (Original) A method of making a stent comprising:securing an intermediate portion of each of a plurality of filaments around a respective securement projection at a first end region of a mandrel; and
braiding the plurality of filaments along a cylindrical body of the mandrel toward a second end of the mandrel, wherein the mandrel includes a plurality of helical grooves defined between adjacent raised projections positioned along the cylindrical body of the mandrel, wherein braiding includes disposing the plurality of filaments into the plurality of grooves.

2\. (Original) The method of claim 1, further comprising:forming closed loops with the filaments at the second end of the mandrel, the closed loops defining an end of the stent.

3\. (Original) The method of claim 2, wherein the closed loops are formed by bending the filaments around projections at the second end of the mandrel.

4\. (Original) The method of claim 1, wherein the first end region of the mandrel has a larger diameter than the cylindrical body of the mandrel.

5\. (Original) The method of claim 1, wherein the raised projections along the cylindrical body have a pyramid shape with a truncated and/or rounded top portion.

6\. (Original) The method of claim 5, wherein the braiding step includes guiding the filaments into the grooves with the raised projections.

7\. (Original) The method of claim 1, wherein braiding includes forming the stent with a flared region at a first end of the stent, the flared region having a larger diameter than a body of the stent.

8\. (Original) The method of claim 7, wherein the flared region is formed around the first end region of the mandrel and the body of the stent is formed around the cylindrical body of the mandrel.

9\. (Original) The method of claim 8, wherein a braiding angle between intersecting braided filaments along the body of the stent is substantially equal to a braiding angle between intersecting braided filaments along the flared region.

10\. (Original) The method of claim 9, wherein the braiding angle is 110 degrees +/- 3 degrees in both the flared region and the body of the stent.

11\. (Original) The method of claim 9, wherein a braiding angle between intersecting braided filaments along a transition region of the stent is substantially equal to the braiding angle between intersecting braided filaments along the body of the stent and the braiding angle between intersecting braided filaments along the flared region, the transition region extending between the flared region and the body of the stent.

12\. (Original) The method of claim 11, wherein the braiding angle is 110 degrees +/- 3 degrees in each of the flared region, the body, and the transition region of the stent.

13\. (Previously Presented) The method of claim 1, wherein braiding is achieved by moving a plurality of constant force braiding carriers in a circular and serpentine motion as the mandrel is longitudinally advanced.

14\. (Original) A method of making a stent comprising:

securing an intermediate portion of each of a plurality of filaments around a respective securement projection at a first end region of a mandrel, the intermediate portions of the filaments defining a first end of the stent;
braiding the plurality of filaments along a cylindrical body of the mandrel toward a second end of the mandrel, wherein the mandrel includes a plurality of helical grooves defined between adjacent raised projections positioned along the cylindrical body of the mandrel, wherein braiding includes disposing the plurality of filaments into the plurality of grooves; and
forming closed loops with the filaments at the second end of the mandrel, the closed loops defining second end of the stent;
wherein the stent includes a flared region at the first end of the stent, the flared region having a larger diameter than a body of the stent.

15\. (Original) The method of claim 14, wherein the closed loops are formed by bending the filaments around projections at the second end of the mandrel.

16\. (Original) The method of claim 14, wherein the raised projections along the cylindrical body have a pyramid shape with a truncated and/or rounded top portion.

17\. (Original) The method of claim 16, wherein the braiding step includes guiding the filaments into the grooves with the raised projections.

18\. (Original) The method of claim 14, wherein a braiding angle between intersecting braided filaments along the body of the stent is substantially equal to a braiding angle between intersecting braided filaments along the flared region.

19\. (Original) The method of claim 18, wherein a braiding angle between intersecting braided filaments along a transition region of the stent is substantially equal to the braiding angle between intersecting braided filaments along the body of the stent and the braiding angle between intersecting braided filaments along the flared region, the transition region extending between the flared region and the body of the stent.

20\. (Original) The method of claim 19, wherein the braiding angle is 110 degrees +/- 3 degrees in each of the flared region, the body, and the transition region of the stent.

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application is being examined under the pre-AIA  first to invent provisions.
Terminal Disclaimer
The terminal disclaimer filed on 21 November 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 8,151,682, 8,677,874, 10,947,651, and 11,578,437 has been reviewed and is accepted.  The terminal disclaimer has been recorded.
Allowable Subject Matter
Claims 1-20 are allowed.
Conclusion

APPLICANT REBUTTAL: REMARKS
Applicant has received and carefully reviewed the Final Office Action dated October 16, 2024. Paragraphs [0001] and [0053] of the specification has been amended. Claims 1-20 are presented for examination. No new subject matter has been added. Favorable consideration of the following remarks is respectfully requested.
Amendment to the S
p
ecification
To address the informality issues raised in the Final Office Action, Paragraphs [0001] and [0053] of the specification has been amended to overcome the objection.
Double Patenting Re
j
ection
Claims 1, 4, 7-9, 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 11 and 12 of U.S. Patent No. 8,151,682. Applicant responds to this rejection by enclosing herewith a Terminal Disclaimer in compliance with 37 CFR 1.321(c). Although not conceding the merits of this rejection, Applicants respectfully submit that the Terminal Disclaimer overcomes this rejection.
Claims 1, 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 19 of U.S. Patent No. 8,677,874. Applicant responds to this rejection by enclosing herewith a Terminal Disclaimer in compliance with 37 CFR 1.321(c). Although not conceding the merits of this rejection, Applicants respectfully submit that the Terminal Disclaimer overcomes this rejection.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1, 2, 4, 8-10, 12, and 14-18 of US. Patent No. 10,947,651. Applicant responds to this rejection by enclosing herewith a Terminal Disclaimer in compliance with 37 CFR 1.321(c). Although not conceding the merits of this rejection, Applicants respectfully submit that the Terminal Disclaimer overcomes this rejection.
Claims 1, 4-10 and 13 are rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1, 2 and 8-11 of US. Patent No. 11,578,437. Applicant responds to this rejection by enclosing herewith a Terminal Disclaimer in compliance with 37 CFR
(c). Although not conceding the merits of this rejection, Applicants respectfully submit that the Terminal Disclaimer overcomes this rejection.
Response to Examiner
'
s Comments
Applicant understands the current Office Action to indicate that the only remaining rejections are related to double patenting, as the rejection under 35 U.S.C. § 102 in view of Phillips has been withdrawn.
Regarding the Examiner's response and disagreement with Applicant's argument about the interpretation of the term "groove," Applicant respectfully disagrees and contends that the Examiner's interpretation does not align with the definition of "helical grooves" as set forth in Claim 1. The term "helical" is critical to understanding the structure of the groove and must not be overlooked.
The Examiner asserts in reference to FIG. 1 of Phillips that "Phillips teaches raised projections, with open areas defined therebetween. Those open areas, while wide, can be considered grooves; they are lower than the raised projections. And those grooves must be in a helical pattern, or the braided wires could not extend helically." The Examiner seems to imply that grooves of helical pattern must follow from braided wires that extend helically. This implication is unsupported by Phillips and does not align with the structural features required by Claim 1.
As emphasized in Applicant's response to the prior Office Action (see Page 7), the
helical grooves recited in Claim 1 are defined by the pattern of adjacent raised projections on the mandrel. These grooves are not defined by the placement or arrangement of filaments (20). The grooves exist independently of the braided wires and their helical extension. To determine whether Phillips teaches "a plurality of helical grooves defined between adjacent raised projections," the Examiner must focus on the structural pattern formed by the adjacent raised projections, independent of the placement or pattern of braided wires.
Examining marked FIG. 1 of Phillips, the marked black line does not represent grooves defined by adjacent raised projections because the cylindrical spacers (16) form a flat cylindrical surface. This flat surface lacks any structural features to define helical grooves. Thus, Phillips fails to teach "a plurality of helical grooves defined between adjacent raised projections" as claimed.
To further clarify the discrepancy, Applicant provides the example of a threaded bolt to illustrate the concept of a helical groove resembling the structure of the marked black line. (See marked FIG. 1 of Phillips of Final Office Action). The grooves of the thread are structurally defined by the raised ridges ("adjacent raised projections") on the bolt's surface, forming a helical pattern. Importantly, the existence of the grooves is entirely independent of whether a braided wire is wrapped around the bolt. Even if such a wire were arranged non-helically, the structure of the bolt's helical grooves would remain the same and not be affected. By contrast, Phillips lacks such structural grooves; the open areas in Phillips are merely flat cylindrical surfaces, not helical grooves defined by adjacent raised projections.
Conclusion


CITED REFERENCE SUMMARIES: Ref US8151682: Claims:
1. A method of braiding a stent comprising:
(a) providing a number of elongate filaments, each of the filaments having opposed ends and an intermediate portion between the opposed ends;
(b) providing a number of tensioned braiding carriers;
(c) providing a braiding mandrel having opposed proximal and distal ends, the braiding mandrel comprising a number of circumferentially spaced-apart securement projections at the distal end of the braiding mandrel;
(d) securably disposing the intermediate portion of one of the filaments to one of the securement projections;
(e) securing one of the opposed ends of the one filament to one of the tensioned braiding carriers;
(f) securing the other opposed end of the one filament to a different second tensioned braiding carrier;
(g) repeating steps (d) through (f) until all of the intermediate portions of the filaments are securably disposed to different ones of the securement projections and until each end of the number of filaments are secured to a different one of the tensioned braiding carriers;
(h) moving the tensioned braiding carriers around the mandrel; and
(i) longitudinally advancing the mandrel in a direction substantially perpendicular to the motion of the tensioned braiding carriers to braid the filaments to form a braided stent.
2. The method of claim 1, wherein step (h) includes moving the tensioned braiding carriers in a generally circular and serpentine motion about a circumferential plane of the mandrel.
3. The method of claim 1,
wherein the tensioned braiding carriers each comprise a retractable carrier filament and further
wherein step (e) includes securing the one opposed end of the one filament to the retractable carrier filament of the one tensioned braiding carrier and step (f) includes securing the other opposed end of the one filament to the retractable carrier filament of the second tensioned braiding carrier.
4. The method of claim 2, wherein the tensioned braiding carriers each comprise a wheel and wherein the retractable carrier filament of the tensioned braiding carrier is coiled about the wheel.
5. The method of claim 1, further comprising:
applying a constant tension from the tensioned braiding carriers to the filaments, wherein the constant tension force is from about 0.25 pound-force to about 5 pound-force.
6. The method of claim 1, wherein the mandrel comprises a plurality of grooves and further wherein the filaments are disposed into the grooves during the braiding of steps (h) through (i).
7. The method of claim 1, wherein the securement projections at the distal end of the braiding mandrel are selected from the group consisting of hooks, pins, tabs, screws and combinations thereof.
8. The method of claim 1, wherein the securement projections at the distal end of the braiding mandrel are removable from the mandrel.
9. The method of claim 6, wherein steps (h) through (i) are continued until the filaments are braided to a portion of the mandrel near the proximal end of the mandrel, and further comprising the step of securing the filaments to the portion of the mandrel while maintaining the filaments under a tension force from about 0.25 pound-force to about 5 pound-force.
10. The method of claim 9, further comprising heat treating the filaments while the filaments are disposed on the mandrel.
11. The method of claim 6, wherein the mandrel comprises a first portion having a first diameter, and a second portion having a second diameter, wherein the first diameter is different from the second diameter, and wherein the grooves are disposed throughout said first and second portion, and further comprising the step of applying a tension from the constant force braiding carriers to the filaments so that a braiding angle between intersecting braided filaments is substantially equal in the first and second portions.
12. The method of claim 11, wherein the mandrel further comprises a transition portion between the first and second portions and further wherein the braiding angle is substantially equal in the first portion, the transition portion and the second portion.
13. The method of claim 1, wherein the filaments are metallic filaments comprising nitinol.
14. The method of claim 1, wherein step (e) is performed without spooling the one filament to the one tensioned braiding carrier and step (f) is performed without spooling the one filament to the second tensioned braiding carrier.
Ref US8677874: Claims:
1. A method of making a stent comprising:
looping filaments around a plurality of securement projections of a mandrel, the plurality of securement projections being longitudinally staggered and circumferentially spaced; and
braiding the filaments to form a stent with longitudinally staggered loops at a first end and closed loops at a second end of the stent.
2. The method of claim 1, wherein each securement projection has a single filament looped therearound.
3. The method of claim 1, each filament having an intermediate portion and opposed ends, wherein the intermediate portion is looped around the securement projection and the opposed ends are secured to a braiding machine.
4. The method of claim 1, the mandrel further defines first parallel helical pathways and second parallel helical pathways that intersect the first parallel helical pathways,
wherein during the step of braiding the filaments, a filament is laid in each helical pathway.
5. The method of claim 4, the mandrel having raised projections that define the first parallel helical pathways and the second parallel helical pathways,
wherein during the step of braiding the filaments, the raised projections provide for a substantially constant braiding angle for the filaments.
6. The method of claim 5, the raised projections having a different shape than a shape of the securement projections.
7. The method of claim 1, the mandrel further comprising raised projections aligned in a plurality bands, the plurality of bands including circumferential bands and longitudinal bands, wherein the raised projections in each circumferential band are circumferentially offset from the raised projections of at least one other circumferential band, and the raised projections in each longitudinal band are longitudinally offset form the raised projections of at least one other longitudinal band.
8. A method of making a stent comprising:
looping filaments around securement projections secured to a mandrel; and
braiding the filaments at a substantially constant braiding angle to form a stent with a loops at a first end; and
forming loops at a second end of the stent.
9. The method of claim 8, wherein raised projections are secured to the mandrel, the raised projections being aligned in a plurality bands, the plurality of bands including circumferential bands and longitudinal bands, wherein the raised projections in each circumferential band are circumferentially offset from the raised projections of at least one other circumferential band, and the raised projections in each longitudinal band are longitudinally offset form the raised projections of at least one other longitudinal band, wherein during the step of braiding the filaments are laid in the channels.
10. The method of claim 9, wherein the raised projections provide for one substantially constant braiding angle.
11. The method of claim 9, wherein a first portion of the mandrel has a first diameter and a second portion of the mandrel has a second diameter different than the first diameter.
12. The method of claim 9, wherein a sleeve includes the raised projections and the sleeve is releaseably secured to the mandrel.
13. A method of making a stent comprising:
providing filaments;
forming first loops from the filaments;
forming second loops from the filaments; and
forming filament crossings from the filaments, the filament crossings being positioned between the first and second loops, each filament crossing having an angle, the angle being substantially constant for all of the filament crossings.
14. The method of claim 13, wherein the step of forming the filament crossings includes laying the filaments in a plurality of channels defined by raised projections secured to a mandrel, each filament crossing formed at a crossing of two of the plurality of channels.
15. The method of claim 14, wherein the raised projections are aligned in a plurality bands, the plurality of bands including circumferential bands and longitudinal bands, wherein the raised projections in each circumferential band are circumferentially offset from the raised projections of at least one other circumferential band, and the raised projections in each longitudinal band are longitudinally offset form the raised projections of at least one other longitudinal band.
16. The method of claim 14, wherein the step of forming first loops includes looping the filaments around circumferentially spaced securement projections that are secured to a first end region of the mandrel.
17. The method of claim 16, wherein the step of forming second loops includes bending the filaments around circumferentially spaced projections that are secured to a second end region of the mandrel.
18. The method of claim 13, wherein the stent includes portions of different diameters.
19. The method of claim 1, wherein the stent includes a first portion and a second portion, wherein the first portion has a different diameter than the second portion, and a braiding angle of the filaments in the first portion is different than a braiding angle of the filaments in the second portion.
20. The method of claim 1, wherein a braiding angle at one end of the stent is different from a braiding angle at an opposed second end of the stent.
Ref US10947651: Claims:
1. A method of making a braided stent comprising:
securing a plurality of filaments to a first end of a mandrel, the first end of the mandrel having a larger diameter than a body of the mandrel; and
braiding the plurality of filaments along the first end and the body of the mandrel to form a stent with a flared region at a first end, the flared region having a larger diameter than a body of the stent, wherein a braid angle in the flared region of the stent is substantially the same as a braid angle in the body of the stent.
2. The method of claim 1, wherein the braid angle is 110 degrees+/−3 degrees in both the flared region and body of the stent.
3. The method of claim 1, wherein braiding includes forming the stent with closed loops at the first end of the stent and closed loops at a second end of the stent.
4. The method of claim 1, wherein securing the plurality of filaments to the mandrel includes looping an intermediate portion of each filament around one of a plurality of securement projections on the first end of the mandrel, wherein braiding the plurality of filaments includes braiding opposing ends of each filament, thereby forming the stent with closed loops at the first end.
5. The method of claim 4, wherein a second end of the stent is formed by bending the plurality of filaments into closed loops.
6. The method of claim 4, wherein each securement projection is longitudinally and circumferentially staggered from a circumferentially adjacent securement projection.
7. The method of claim 4, wherein each securement projection has a single filament looped therearound.
8. The method of claim 1, wherein the mandrel defines first parallel helical pathways and second parallel helical pathways that intersect the first parallel helical pathways, wherein during the step of braiding the plurality of filaments, one filament is positioned in each helical pathway.
9. The method of claim 8, wherein the mandrel has a plurality of raised projections that define the first parallel helical pathways and the second parallel helical pathways, wherein during the step of braiding the plurality of filaments, the plurality of raised projections provide for a substantially constant braiding angle for the plurality of filaments along an entirety of the stent.
10. The method of claim 9, wherein at least one of the plurality of raised projections has a pyramid shape.
11. The method of claim 9, wherein securing the plurality of filaments to the mandrel includes looping the plurality of filaments around a plurality of securement projections on the first end of the mandrel, wherein the plurality of raised projections have a different shape than a shape of the plurality of securement projections.
12. The method of claim 9, wherein the mandrel includes a transition region between the first end and the body of the mandrel, the transition region being sloped and including some of the plurality of raised projections.
13. The method of claim 1, wherein the mandrel further comprises raised projections aligned in a plurality bands, the plurality of bands including circumferential bands and longitudinal bands, wherein the raised projections in each circumferential band are circumferentially offset from the raised projections of at least one other circumferential band, and the raised projections in each longitudinal band are longitudinally offset from the raised projections of at least one other longitudinal band.
14. A method of making a stent comprising:
securing an intermediate portion of a plurality of filaments to a first end of a mandrel, the mandrel having a second end and a body extending between the first and second ends, the first end having a larger diameter than the body;
braiding opposing ends of each of the plurality of filaments with a substantially constant braid angle along an entirety of the mandrel, thereby forming a stent having a flared first end region with a diameter larger than a body of the stent and a substantially constant braid angle along an entire length of the stent.
15. The method of claim 14, wherein the braid angle is 110 degrees+/−3 degrees in both the flared first end region and body of the stent.
16. The method of claim 14, wherein braiding includes forming the stent with closed loops at a second end of the stent.
17. The method of claim 14, wherein the mandrel has a plurality of raised projections that define first parallel helical pathways and second parallel helical pathways that intersect the first parallel helical pathways, wherein during the step of braiding, one filament is positioned in each helical pathway and the plurality of raised projections provide for the substantially constant braid angle along the entire length of the stent.
18. The method of claim 17, wherein securing the intermediate portion of the plurality of filaments includes looping the intermediate portion of each filament around one of a plurality of securement projections on the first end of the mandrel, wherein each securement projection is longitudinally and circumferentially staggered from a circumferentially adjacent securement projection.
19. The method of claim 18, wherein the plurality of raised projections all have a different shape than the plurality of securement projections.
20. A method of making a stent comprising:
looping in an intermediate portion of each of a plurality of filaments around projections at a first end of a mandrel;
braiding opposing ends of each of the plurality of filaments around a body of the mandrel to form a stent having a flared first end, a body, and a second end, wherein the flared first end has a larger diameter than the body, wherein a braid angle in the flared first end is substantially the same as a braid angle in the body and the second end; and
forming loops at the second end of the stent.