Office Action 1: Non-Final Rejection (2024-06-27)
Rejection types: 102 - Lack of Novelty, 112 - Written Description/Enablement, Double Patenting

CLAIMS:
WHAT IS CLAIMED IS:
1\. 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\. 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\. 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\. 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\. 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\. The method of claim 5, wherein the braiding step includes guiding the filaments into the grooves with the raised projections.
7\. 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\. 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\. 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\. 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\. 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\. 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\. The method of claim 1, wherein braiding is achieved by moving the plurality of constant force braiding carriers in a circular and serpentine motion as the mandrel is longitudinally advanced.
14\. 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\. 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\. 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\. The method of claim 16, wherein the braiding step includes guiding the filaments into the grooves with the raised projections.
18\. 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\. 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\. 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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 1 needs to be updated.
Paragraph 53, the phrase “mandrel 20” is incorrect.  Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
Specifically, the phrase “the plurality of constant force braiding carriers” lacks proper antecedent basis.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA  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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1 and 4 is/are rejected under pre-AIA  35 U.S.C. 102(b) as being anticipated by Phillips (4893543).
In regards to Claim 1, Phillips teaches a method of making a stent (intended use) 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 (Column 2, lines 17-19); and
braiding the plurality of filaments along a cylindrical body of the mandrel toward a second end of the mandrel (Figure 4), wherein the mandrel includes a plurality of helical grooves defined between adjacent raised projections (Details 20 are raised projections, and the space between the details 20 would be the grooves) positioned along the cylindrical body of the mandrel, wherein braiding includes disposing the plurality of filaments into the plurality of grooves.
In regards to Claim 4, Phillips teaches the first end region of the mandrel (Detail 22) has a larger diameter than the cylindrical body of the mandrel.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 6 of the ‘682 patent.
Claim 4 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 7 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 8 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 9 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 11 of the instant application aligns with Claim 12 of the ‘682 patent.
Claim 13 of the instant application aligns with Claim 2 of the ‘682 patent.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 3-5 of the ‘874 patent.
Claim 7 of the instant application aligns with Claim 19 of the ‘874 patent.
Claim 8 of the instant application aligns with Claim 19 of the ‘874 patent.
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 U.S. Patent No. 10,947,651.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1, 4, 8, 9, 14, 17, and 18 of the ‘651 patent.
Claim 2 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 3 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 4 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 5 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 6 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 7 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 8 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 9 of the instant application aligns with Claim 2 of the ‘651 patent.
Claim 10 of the instant application aligns with Claim 2 of the ‘651 patent.
Claim 11 of the instant application aligns with Claim 12 of the ‘651 patent.
Claim 12 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 13 would be obvious of a braiding method, to form the over/under structure.
Claim 14 of the instant application aligns with Claims 14 and 16-18 of the ‘651 patent.
Claim 15 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 16 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 17 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 18 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 19 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 20 of the instant application aligns with Claim 15 of the ‘651 patent.
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 U.S. Patent No. 11,578,437.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 8 of the ‘437 patent.
Claim 4 of the instant application aligns with Claim 10 of the ‘437 patent.
Claim 5 of the instant application aligns with Claim 9 of the ‘437 patent.
Claim 6 of the instant application aligns with Claim 8 of the ‘437 patent.
Claim 7 of the instant application aligns with Claim 10 of the ‘437 patent.
Claim 8 of the instant application aligns with Claim 10 of the ‘437 patent.
Claim 9 of the instant application aligns with Claim 11 of the ‘437 patent.
Claim 10 of the instant application aligns with Claim 11 of the ‘437 patent.
Claim 13 of the instant application aligns with Claim 2 of the ‘437 patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Specifically, at least Kellems (1945195) Figure 1 teaches elements similar to those as currently claimed.

APPLICANT REBUTTAL: REMARKS
Applicant has received and carefully reviewed the Non-final Office Action dated June 27, 2024. Claims 1-20 are presented for examination. Claim 13 has been amended. Favorable consideration of the following remarks is respectfully requested.
Claim Re
j
ections Under 35 U.S.C.
Claim 13 stands rejected under 35 USC 112(b) as being indefinite. The phrase "the plurality of constant force braiding carriers" in claim 13 is characterized as lacking proper antecedent basis. Applicant has revised the claim to recite "a plurality of constant force braiding carriers" and it is believed that this revision overcomes the rejection.
Claim Rejections Under 35 U.S.C.
X102
Claims 1 and 4 have been rejected under 35 U.S.C.§ 102(b) as being unpatentable over Philips (US4893543A, hereinafter Philips). Applicant respectfully traverses these rejections.
Philips pertains to a braiding mandrel used in the creation of cable grips and strain relief assemblies. This technology significantly differs from the field and purpose of the instant application, which focuses on a method for
braiding stents,
specifically aiming to produce stents by braiding elongate filaments around a mandrel. The fundamental differences in the end product and technical requirements between cable grips and medical stents underscore that the cited reference cannot be considered analogous art. Cable grips and strain relief assemblies involve mechanical components designed for durability and load management, whereas the instant application involves delicate medical devices requiring precise biocompatibility and atraumatic properties. Therefore, the methods, and objectives of the cited reference are not reasonably pertinent to the problem addressed by the instant application and cannot be considered analogous art. Claim 1 of the instant application is directed to a method of
making a stent.
Philips does not disclose such a method.
While respectfully disagreeing with the characterization of the cited reference as analogous art, in the interest of advancing prosecution, Applicant asserts Philips fails to anticipate claims 1 and 4.
Regarding claim 1, the Examiner referred to Figure 4 of Philips and recited that the
details 20 of Philips corresponds to the raised projections of the instant application, and the space between the details 20 of Philips corresponds to the plurality of helical grooves defined between adjacent raised projections of the instant application. Philips cannot be considered to teach or suggest "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"
(emphasis added). As recited by claim 1, a plurality of helical grooves is defined between the adjacent raised projections where a plurality of filaments is disposed into the plurality of grooves. As shown in FIG. 7 of the instant application, a plurality of helical grooves (58) is defined between the adjacent raised projections (52, 56), and a plurality of filaments (20) is disposed into the plurality of grooves (58). Although the plurality of filaments is also in helical pattern, the plurality of helical grooves is specifically defined by the adjacent raised projections as claimed.
In contrast, FIG. 4 of Philips shows a braiding mandrel including a central rod 12 and a plurality of five-pronged hook-rings 14 and cylindrical spacers 16. See Philips, at line 48 of col.
1 to line 2 of col. 2. Thus, the braiding mandrel is cylindrical in nature with protruding hook- rings 14. There are no "helical grooves" and the spacing between the hook-rings 14 cannot be fairly described as helical in nature. Only the braiding wires can be construed as extending helically. The mandrel does not include any corresponding "helical grooves."
FIG. 4 of Philips
Hence, Philip fails to teach or suggest "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."
Thus, for at least the above reasons, claim 1 is believed to be clearly patentable over Philips. Reconsideration and withdrawal of the rejection is respectfully requested.
For similar and other reasons, because claim 4 depends on claim 1 and include significant additional distinguishing features, claim 4 is also believed to be clearly patentable over Philips. Reconsideration and withdrawal of the rejection is respectfully requested.
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 respectfully traverses the rejection of claims 1, 4, 7-9, 11 and 13 under the judicially created doctrine of obviousness-type double patenting. However, at such time as the claims of the current application would otherwise be considered allowable except for a double patenting rejection, Applicant will consider filing a terminal disclaimer in compliance with 37 CFR
(c) with respect to the reference patent. In considering a terminal disclaimer, Applicant does not make any statement as to the appropriateness of the double-patenting rejection or to the patentability of any one of the claims of the current application.
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 respectfully traverses the rejection of claims 1, 7 and 8 under the judicially created doctrine of obviousness- type double patenting. However, at such time as the claims of the current application would otherwise be considered allowable except for a double patenting rejection, Applicant will consider filing a terminal disclaimer in compliance with 37 CFR 1.321(c) with respect to the reference patent. In considering a terminal disclaimer, Applicant does not make any statement as to the appropriateness of the double-patenting rejection or to the patentability of any one of the claims of the current application.
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 respectfully traverses the rejection of claims 1-20 under the judicially created doctrine of obviousness-type double patenting. However, at such time as the claims of the current
application would otherwise be considered allowable except for a double patenting rejection, Applicant will consider filing a terminal disclaimer in compliance with 37 CFR 1.321(c) with respect to the reference patent. In considering a terminal disclaimer, Applicant does not make any statement as to the appropriateness of the double-patenting rejection or to the patentability of any one of the claims of the current application.
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 respectfully traverses the rejection of claims 1, 4-10 and 13 under the judicially created doctrine of obviousness-type double patenting. However, at such time as the claims of the current application would otherwise be considered allowable except for a double patenting rejection, Applicant will consider filing a terminal disclaimer in compliance with 37 CFR 1.321(c) with respect to the reference patent. In considering a terminal disclaimer, Applicant does not make any statement as to the appropriateness of the double-patenting rejection or to the patentability of any one of the claims of the current application.
Conclusion

NEXT 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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 1 needs to be updated.
Paragraph 53, the phrase “mandrel 20” is incorrect.  Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 6 of the ‘682 patent.
Claim 4 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 7 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 8 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 9 of the instant application aligns with Claim 11 of the ‘682 patent.
Claim 11 of the instant application aligns with Claim 12 of the ‘682 patent.
Claim 13 of the instant application aligns with Claim 2 of the ‘682 patent.
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.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 3-5 of the ‘874 patent.
Claim 7 of the instant application aligns with Claim 19 of the ‘874 patent.
Claim 8 of the instant application aligns with Claim 19 of the ‘874 patent.
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 U.S. Patent No. 10,947,651.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1, 4, 8, 9, 14, 17, and 18 of the ‘651 patent.
Claim 2 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 3 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 4 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 5 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 6 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 7 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 8 of the instant application aligns with Claim 1 of the ‘651 patent.
Claim 9 of the instant application aligns with Claim 2 of the ‘651 patent.
Claim 10 of the instant application aligns with Claim 2 of the ‘651 patent.
Claim 11 of the instant application aligns with Claim 12 of the ‘651 patent.
Claim 12 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 13 would be obvious of a braiding method, to form the over/under structure.
Claim 14 of the instant application aligns with Claims 14 and 16-18 of the ‘651 patent.
Claim 15 of the instant application aligns with Claim 16 of the ‘651 patent.
Claim 16 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 17 of the instant application aligns with Claims 9 and 10 of the ‘651 patent.
Claim 18 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 19 of the instant application aligns with Claim 15 of the ‘651 patent.
Claim 20 of the instant application aligns with Claim 15 of the ‘651 patent.
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 U.S. Patent No. 11,578,437.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the same method of making a stent, with the claims aligned as follows.
Claim 1 of the instant application aligns with Claims 1 and 8 of the ‘437 patent.
Claim 4 of the instant application aligns with Claim 10 of the ‘437 patent.
Claim 5 of the instant application aligns with Claim 9 of the ‘437 patent.
Claim 6 of the instant application aligns with Claim 8 of the ‘437 patent.
Claim 7 of the instant application aligns with Claim 10 of the ‘437 patent.
Claim 8 of the instant application aligns with Claim 10 of the ‘437 patent.
Claims 9 and 10 of the instant application align with Claim 11 of the ‘437 patent.
Claim 13 of the instant application aligns with Claim 2 of the ‘437 patent.
Response to Arguments
Applicant's arguments filed 26 September 2024 have been fully considered but they are not fully persuasive.
To begin, Examiner has withdrawn the 102 rejection regarding Phillips (4893543).  Examiner has done this in view of the arguments concerning method steps, and having to take a step of forming a stent.  Examiner does not, however, agree with the arguments concerning grooves.  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 grooves may be bigger than Applicant intends; the projections may be of a different shape than Applicant intends, but Phillips satisfies the structure as currently written, which only requires the helical grooves are defined between adjacent raised projections.
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In regards to the nonstatutory double patenting rejections, Applicant has elected not to address the rejections.  As such, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL.  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 extension fee 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.

CITED REFERENCE SUMMARIES: Ref US10947651B2: [content unavailable]
Ref US11578437B2: Claims:
A method of making a stent comprising: securing an intermediate portion of each of a plurality of filaments to a first end of a mandrel; securing at least one end of each of the plurality of filaments to one of a plurality of constant force braiding carriers; and braiding the plurality of filaments along the mandrel to form the stent while applying and maintaining constant tension from the constant force braiding carriers to the filaments directly within a braiding zone defined by a cone formed by the plurality of filaments extending between the plurality of constant force braiding carriers and the mandrel; wherein the mandrel includes a plurality of grooves, wherein braiding includes disposing the plurality of filaments into the plurality of grooves.
securing an intermediate portion of each of a plurality of filaments to a first end of a mandrel;
securing at least one end of each of the plurality of filaments to one of a plurality of constant force braiding carriers; and
braiding the plurality of filaments along the mandrel to form the stent while applying and maintaining constant tension from the constant force braiding carriers to the filaments directly within a braiding zone defined by a cone formed by the plurality of filaments extending between the plurality of constant force braiding carriers and the mandrel;
wherein the mandrel includes a plurality of grooves, wherein braiding includes disposing the plurality of filaments into the plurality of grooves.
The method of claim 1 , wherein braiding is achieved by moving the plurality of constant force braiding carriers in a circular and serpentine motion as the mandrel is longitudinally advanced.
The method of claim 1 , wherein the plurality of filaments are metallic.
The method of claim 3 , wherein maintaining constant tension includes maintaining a constant tension force of from about 0.125 pound-force (about 0.5 Newtons) to about 10 pound-force (45 Newtons).
The method of claim 4 , wherein maintaining constant tension includes maintaining a constant tension force of from about 0.25 pound-force (1.1 Newton) to about 5 pound-force (22.2 Newtons).
The method of claim 5 , wherein maintaining constant tension includes maintaining a constant tension force of from about 0.5 pound-force (about 2 Newtons) to about 3 pound-force (about 13 Newtons).
the method of claim 1 , wherein the plurality of filaments are polymeric, wherein maintaining constant tension includes maintaining a constant tension force of from about 0.5 pound-force (about 2 Newtons) to about 1 pound-force (about 4.4 Newtons).
The method of claim 1 , wherein the mandrel has a plurality of spaced apart raised projections defining the grooves therebetween, 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.
The method of claim 8 , wherein at least one of the plurality of raised projections has a pyramid shape with a truncated and/or rounded top portion for guiding the filaments into the grooves.
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, wherein a braiding angle between intersecting braided filaments that is substantially the same along the flared region and the body.
The method of claim 10 , wherein the braiding angle is 110 degrees +/−3 degrees in both the flared region and the body of the stent.
The method of claim 1 , wherein the first and second ends of the plurality of filaments are secured to the plurality of constant force braiding carriers without spooling the filaments to the constant force braiding carriers.
The method of claim 12 , wherein each of the plurality of constant force braiding carriers includes a retractable carrier filament removably secured to one of the plurality of filaments.
A method of making a stent comprising: securing a first portion of each of a plurality of filaments to a mandrel; securing a second portion of each of the plurality of filaments to one of a plurality of constant force braiding carriers; and braiding the plurality of filaments along the mandrel to form the stent while applying and maintaining constant tension from the constant force braiding carriers to the filaments directly within a braiding zone defined by a cone formed by the plurality of filaments extending between the plurality of constant force braiding carriers and the mandrel; wherein the mandrel includes a plurality of grooves, wherein braiding includes disposing the plurality of filaments into the plurality of grooves; wherein maintaining constant tension includes maintaining a constant tension force of from about 0.125 pound-force (about 0.5 Newtons) to about 10 pound-force (45 Newtons).
securing a first portion of each of a plurality of filaments to a mandrel;
securing a second portion of each of the plurality of filaments to one of a plurality of constant force braiding carriers; and
wherein the mandrel includes a plurality of grooves, wherein braiding includes disposing the plurality of filaments into the plurality of grooves;
wherein maintaining constant tension includes maintaining a constant tension force of from about 0.125 pound-force (about 0.5 Newtons) to about 10 pound-force (45 Newtons).
The method of claim 14 , wherein braiding includes forming the stent with a flared region at a first end, the flared region having a larger diameter than a body of the stent, wherein a braiding angle between intersecting braided filaments that is substantially the same along the flared region and the body.
The method of claim 15 , wherein the braiding angle is 110 degrees +/−3 degrees in both the flared region and the body of the stent.
The method of claim 14 , wherein the first and second ends of the plurality of filaments are secured to the plurality of constant force braiding carriers without spooling the filaments to the constant force braiding carriers.
The method of claim 14 , wherein maintaining constant tension includes maintaining a constant tension force of from about 0.5 pound-force (about 2 Newtons) to about 3 pound-force (about 13 Newtons).
A method of making a stent comprising: securing an intermediate portion of each of a plurality of filaments to a first end of a mandrel; securing at least one end of each of the plurality of filaments to one of a plurality of constant force braiding carriers; and braiding the plurality of filaments along the mandrel to form the stent while applying and maintaining constant tension from the constant force braiding carriers to the filaments directly within a braiding zone defined by a cone formed by the plurality of filaments extending between the plurality of constant force braiding carriers and the mandrel; wherein the first and second ends of the plurality of filaments are secured to the plurality of constant force braiding carriers without spooling the filaments to the constant force braiding carriers.
wherein the first and second ends of the plurality of filaments are secured to the plurality of constant force braiding carriers without spooling the filaments to the constant force braiding carriers.
The method of claim 19 , wherein each of the plurality of constant force braiding carriers includes a retractable carrier filament removably secured to one of the plurality of filaments.
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 o
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