DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 2022/097717 filed on 06/08/2022.
Specification
The disclosure is objected to because of the following informalities:
a. In paragraph [0077], line 3, “0.3 to 0.7 mm” should read “0.3 mm to 0.7 mm”
b. In paragraph [0092], line 9, “300 and 120°” should read “30° and 120°”
c. In paragraph [0094], line 3, “300 to 90° should read “30° to 90°”
d. In paragraph [0095], line 1, “900 to 140°” should read “90° to 140°”
e. In paragraph [0096], line 8, “35 to 60%” should read “35% to 60%”
f. In paragraph [0096], line 11, “900 to 140°” should read “90° to 140°”
Appropriate correction is required.
Claim Objections
Claim(s) 12, and 16 are objected to because of the following informalities:
In claim(s) 12, and 16, line 1, “range of 900 to 140°” should read “90° to 140°”
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 19 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19, recites the broad recitation “wherein at least one of the broadened sections comprise a cavity,” line 1, and the claim also recites “the broadened sections comprises 1 to 10 cavities,” line 2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 18/569042 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 under examination is anticipated, respectively, by claim 16 of the reference application. Every limitation in the application under examination claims is recited in the conflicting reference application claims, and the differences between the claims are highlighted below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant application (18/569145)
Reference application (18/569042)
1. A stent, comprising at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts,
wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints,
wherein the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section,
wherein the main section has a width smaller than a width of the broadened section; and
wherein in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh;
and wherein a radial strength of the stent ranges from 1 kPa to 300 kPa.
1. A stent, comprising at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts,
and wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of an angle at the joint,
wherein each stent strut comprises at least one main section and at least one broadened section that are alternately arranged with the at least one main section,
wherein the main section comprises a width smaller than a width of the broadened section,
wherein: in each stent mesh, the broadened sections of the adjacent stent struts are staggered along an axis of the stent mesh;
(Further limitations) and when the angle at each joint is minimized, at least one gap is provided between the broadened sections of the adjacent stent struts along the axis.
16. The stent according to claim 1, wherein the stent comprises a radial strength of 1 kPa to 300 kPa.
(Further limitations) and a radial strength of the stent ranges from 1 kPa to 300 kPa.
As shown in the mapping above:
Claim 16 of the reference application anticipates all the limitations of claim 1 of the instant application.
Claim 31 of the reference application anticipates all the limitations of claim 31 of the instant application, while also reciting further limitations.
Claims 1, 7-17, 19 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 6, 12-19, 24-26, and 28-29 of copending Application No. (18/569042) in view of Clinger et al. (US 2021/0161689).
This is a provisional nonstatutory double patenting rejection.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. (18/569042) in view of Kuperberg et al. (US 2019/0307930).
This is a provisional nonstatutory double patenting rejection.
Instant application (18/569145)
Reference application (18/569042)
1. A stent, comprising at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts,
wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints,
wherein the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section,
wherein the main section has a width smaller than a width of the broadened section; and
wherein in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh;
and wherein a radial strength of the stent ranges from 1 kPa to 300 kPa.
1. A stent, comprising at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts, and
wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of an angle at the joint,
wherein each stent strut comprises at least one main section and at least one broadened section that are alternately arranged with the at least one main section,
wherein the main section comprises a width smaller than a width of the broadened section,
wherein: in each stent mesh, the broadened sections of the adjacent stent struts are staggered along an axis of the stent mesh; and
(Further limitations) when the angle at each joint is minimized, at least one gap is provided between the broadened sections of the adjacent stent struts along the axis.
16. The stent according to claim 1, wherein the stent comprises a radial strength of 1 kPa to 300 kPa.
7. The stent according to claim 1, wherein the angle at each joint ranges from 0° to 140°.
8. The stent according to claim 1, wherein when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent mesh ranges from 30% to 99%.
9. The stent according to claim 1, wherein when the angle at each joint is in a range of 5° to 30°, a
metal coverage of the stent mesh ranges from 5% to 90%.
10. The stent according to claim 1, wherein when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent mesh ranges from 4% to 15%.
11. The stent according to claim 10, wherein when the angle at each joint is in the range of 30° to 90°, the metal coverage of the stent mesh ranges from 8% to 15%.
12. The stent according to claim 1, wherein when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent mesh ranges from 3% to 12%.
[AltContent: connector]
13. The stent according to claim 1, wherein when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent ranges from 20% to 60%.
6. The stent according to claim 1, wherein the angle at each joint ranges from 0° to 140°; and/or
wherein when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent mesh ranges from 30% to 99%; and/or
wherein when the angle at each joint is in a range of 5° to 30°, a metal coverage of the stent mesh ranges from 5% to 90%; and/or
wherein when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent mesh ranges from 4% to 15%, and
wherein the metal coverage of the stent mesh further ranges from 8% to 15%;
and/or wherein when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent mesh ranges from 3% to 12%.
12. The stent according to claim 1, wherein when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent ranges from 20% to 60%.
14. The stent according to claim 1, wherein when the angle at each joint is in a range of 5° to 30°, a metal coverage of the stent ranges from 5% to 45%.
13. The stent according to claim 1, wherein when the angle at each joint is in a range of 5° to 30°, a metal coverage of the stent ranges from 5% to 45%.
15. The stent according to claim 1, wherein when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent ranges from 3% to 15%.
14. The stent according to claim 1, wherein when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent ranges from 3% to 15%.
16. The stent according to claim 1, wherein when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent ranges from 2% to 15%.
15. The stent according to claim 1, wherein when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent ranges from 2% to 15%.
17. The stent according to claim 1, wherein each stent strut comprises two main sections and one broadened section located between the two main sections; and/or
wherein the stent mesh comprises 8 to 24 stent struts;
and/or wherein when the angle at each joint is minimized, in adjacent stent struts connected at a same joint, the broadened section of one of the stent struts does not overlap with the main section of the other one of the stent struts;
and/or wherein in at least one stent strut, the broadened section has margins of a same width or different widths beyond the main section at opposite sides of the stent strut along a lengthwise direction thereof;
and/or wherein in at least one stent strut, the broadened section is flush with the main section at one side of the stent strut along a lengthwise direction thereof, and
wherein in an expanded configuration of the stent, adjacent stent struts connected at a same joint form a V-shaped structure,
wherein the sides of the adjacent stent struts, at which the main sections are flush with the broadened sections, are simultaneously located at an inner side or an outer side of the V-shaped structure.
17. The stent according to claim 1, wherein the stent strut comprises two main sections and one broadened section located between the two main sections.
18. The stent according to claim 1, wherein the stent mesh comprises 8 to 24 stent struts.
24. The stent according to claim 1, wherein when the angle at the joint is minimized, in adjacent stent struts connected to a same joint, the broadened section of one of the stent struts does not overlap with the main section of the other one of the stent struts.
25. The stent according to claim 1, wherein in at least one of stent strut, the broadened section has margins of a same width or different widths beyond the main section at opposite sides of the stent strut along a lengthwise direction thereof.
26. The stent according to claim 1, wherein in at least one of stent strut, the broadened section is flush with the main section at one side of the stent strut along a lengthwise direction thereof, and
wherein in an expanded configuration of the stent, the adjacent stent struts connected to a same joint form a V-shaped structure,
wherein the sides of the adjacent stent struts, at which the main sections are flush with the broadened sections, are both located at an inner side or an outer side of the V-shaped structure.
19. The stent according to claim 1, wherein at least one of the broadened sections comprises a cavity, and
wherein: the broadened section comprises 1 to 10 cavities; and/or the cavity comprises a longitudinal cross-sectional shape comprising at least one of an arcuate shape, a quadrilateral shape and a triangular shape; and/or the cavity comprises a transverse cross-sectional shape comprising at least one of a circular shape, an elongate shape, a polygonal shape, a corrugated shape, an annular shape and an irregular shape;
and/or the cavity is configured for a drug or radiopaque agent to be filled therein.
19. The stent according to claim 1, wherein at least one of the broadened sections comprises a cavity, and
wherein: the broadened section comprises 1 to 10 cavities; and/or a longitudinal cross-sectional shape of the cavity comprises at least one of an arcuate shape, a quadrilateral shape and a triangular shape; and/or a transverse cross-sectional shape of the cavity comprises at least one of a circular shape, an elongate shape, a polygonal shape, a corrugated shape, an annular shape and an irregular shape;
and/or the cavity is configured for a drug or radiopaque agent to be filled therein.
28. The stent according to claim 1, wherein the stent comprises at least two stent meshes that are axially connected,
wherein the stent comprises at least one linking strut,
wherein the joints in adjacent stent meshes are connected through the linking strut, and
wherein the linking strut comprises a shape comprising at least one of a linear shape, a corrugated shape, a serrated shape, a circular shape, an annular shape, a “Ω”-like shape and an “S”-like shape.
28. The stent according to claim 1, wherein the stent comprises at least two stent meshes that are axially connected.
29. The stent according to claim 28, wherein the stent comprises at least one linking strut, and
wherein the joints in adjacent stent meshes are connected through the at least one linking strut, and
wherein a shape of the linking strut comprises at least one of a linear shape, a corrugated shape, a serrated shape, a circular shape, an annular shape, a “Ω”-like shape and an “S”-like shape.
31. A drug-loaded stent, comprising at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts, and
wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints,
wherein the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section,
wherein the main section has a width smaller than a width of the broadened section;
wherein in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh; and
wherein the at least one of the broadened sections comprises a cavity configured for a drug to be filled therein;
(Further limitations) and a radial strength of the stent ranges from 1 kPa to 300 kPa.
31. A drug-loaded stent, comprising at least one stent mesh wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh,
wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts, and
wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of an angle at the joint,
wherein each stent strut comprises at least one main section and at least one broadened section that are alternately arranged with the at least one main section,
wherein the main section has a width smaller than a width of the broadened section,
wherein: in each stent mesh, the broadened sections of the adjacent stent struts are staggered along an axis of the stent mesh;
at least one broadened section comprises a cavity configured for a drug to be filled therein; and
(Further limitations) when the angle at each joint is minimized, at least one gap is provided between the broadened sections of the adjacent stent struts along the axis.
Claim 1
Claims 1, and 16 of the reference application recites the same limitations as claim 1 of the instant application, while also reciting further limitations.
Claims 7-12
Claim 6 of the reference application recites the same limitations as claim(s) 7-12 of the instant application.
Claim 11 of the reference application depends from and requires all of the limitations of claim 10.
Claim 13
Claim 12 of the reference application recites the same limitations as claim 13 of the instant application.
Claim 14
Claim 13 of the reference application recites the same limitations as claim 14 of the instant application.
Claim 15
Claim 14 of the reference application recites the same limitations as claim 15 of the instant application.
Claim 16
Claim 15 of the reference application recites the same limitations as claim 16 of the instant application.
Claim 17
Claims 17-18, and 24-26 of the reference application recites the same limitations as claim 17 of the instant application.
Claim 19
Claim 19 of the reference application recites the same limitations as claim 19 of the instant application.
Claim 28
Claim 29 of the reference application depends from and requires all of the limitations of claim 2.
Claims 28, and 29 of the reference application recites the same limitations as claim 28 of the instant application.
Claim 31
Claim 31 of the reference application recites all of the limitations of claim 31 of the instant application except “a radial strength of the stent ranges from 1 kPa to 300 kPa.” However, Kuperberg et al. (US 2019/0307930) teaches the bridging elements (38) can achieve baseline radial strength by providing enough radial strength to resist external compressive forces, and the design must allow for the stent to withstand constant radial pressure in order to maintain patency (see [0037] disclosing the function of the bridging element). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the bridging elements, as disclosed by Kuperberg et al., within the method of claim 31 of the reference application. Doing so would provide a means to select a specific radial strength range based on the intended clinical use.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Clinger et al. (US 2021/0161689) and further in view of Kuperberg et al. (US 2019/0307930).
Regarding claims 1-3, Clinger et al. discloses a stent (100) (see [0033]), comprising at least one stent mesh (e.g. Fig, 3), wherein: each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh (see [0034] disclosing the plurality of stent struts), wherein: the plurality of the stent struts are sequentially connected end to end (see [0021] disclosing the struts connected end to end at nodes), and a joint is formed at the connected ends of adjacent stent struts (see [0021] disclosing the nodes, which function as the joints at the ends of the struts), wherein: the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints (see [0036] disclosing the structural segments responsible for mechanical behavior, thereby allowing the stent to collapse or expand), wherein: the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section (see Fig. 1B illustrating a thin (315) and thick (325) width of intermediate branches (310, 324), thereby functioning as the main and broadened sections that are alternating), wherein: the main section has a width smaller than a width of the broadened section (see Fig. 1B illustrating a thin (315) width and a thick (325) width); and wherein: in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh (see [Fig. 1C illustrating the staggered arrangement).
Clinger et al. fails to disclose wherein: a radial strength of the stent ranges from 1 kPa to 300 kPa; wherein: when the angle at each joint is minimized, the radial strength of the stent ranges from 50 kPa to 300 kPa; and wherein: when the angle at each joint is minimized, the radial strength of the stent ranges from 100 kPa to 200 kPa.
Kuperberg et al. also discloses a stent with a bridging element (38) (see [0037]), and ductile hinges (39) (see [0037]). Kuperberg et al. teaches the bridging elements (38) can achieve baseline radial strength by providing enough radial strength to resist external compressive forces, and the design must allow for the stent to withstand constant radial pressure in order to maintain patency (see [0037] disclosing the function of the bridging element); and the ductile hinges (39), which function as joints, are designed to allow the stent mesh to better withstand contractile forces when the stent expands or constricts (see [0037] disclosing the function of the ductile hinges). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the alternating variable-width stent-mesh of Clinger et al., by incorporating the radial strength optimization principles and ductile hinges performance criteria, as taught by Kuperberg et al. Doing so would provide a means to optimize deployment safety and prevent stent migration by calibrating structural dimensions to specific radial pressure thresholds.
Regarding claims 4-6, Clinger et al./Kuperberg et al., discloses the stent according to claim 1.
Clinger et al. fails to disclose wherein: when the stent is in an expanded configuration with a diameter of 2.0 mm to 5.0 mm, the radial strength of the stent ranges from 1 kPa to 30 kPa; wherein: when the stent is in the expanded configuration with the diameter of 2.0 mm to 5.0 mm, the radial strength of the stent ranges from 1 kPa to 15 kPa; and wherein: when the stent is in the expanded configuration with the diameter of 2.0 mm to 5.0 mm, the radial strength of the stent ranges from 1 kPa to 12 kPa.
Kuperberg et al. also discloses an open stent body (see [0037] disclosing the opened state), and bridging elements (38) connected to a circumferential ring (see [0037]). Kuperberg et al. teaches the stent’s layout must be very flexible in order to expand or constrict while possessing enough radial strength, thereby making the radial strength a variable property linked to geometric dimensions (see [0037] disclosing expanded and constricted configuration of the stent); the bridging elements (38) must provide increased radial tensile strength to account for radial expansion and contraction (see [0037] disclosing the tensile strength mechanism); and the outward radial pressure must be calibrated to withstand constant environmental pressure without failing, thereby necessitating capping the maximum outward radial force at a low, safe threshold (e.g. 12 to 30 kPa) when the device is at its maximum expanded diameter (see [0046] disclosing the functional motivation to cap the maximum outward force to limit tissue trauma). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the alternating variable-width stent-mesh of Clinger et al., by incorporating the expansion-flexibility and tissue-trauma mitigation criteria, as taught by Kuperberg et al. Doing so would provide a means to precisely size and scale the width and thickness ratios of alternating main and broadened sections, in order to cap the outward radial strength of the expanded stent mesh.
Regarding claims 7-16, Clinger et al./Kuperberg et al., discloses the stent according to claim 1.
Clinger et al. fail to disclose wherein: the angle at each joint ranges from 0° to 140°; wherein: when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent mesh ranges from 30% to 99%; wherein: when the angle at each joint is in a range of 5° to 30°, a metal coverage of the stent mesh ranges from 5% to 90%; wherein: when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent mesh ranges from 4% to 15%; wherein: when the angle at each joint is in the range of 30° to 90°, the metal coverage of the stent mesh ranges from 8% to 15%; wherein: when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent mesh ranges from 3% to 12%; wherein: when the angle at each joint is in a range of 0° to 5°, a metal coverage of the stent ranges from 20% to 60%; wherein: when the angle at each joint is in a range of 5° to 30°, a metal coverage of the stent ranges from 5% to 45%; wherein: when the angle at each joint is in a range of 30° to 90°, a metal coverage of the stent ranges from 3% to 15%; wherein: when the angle at each joint is in a range of 90° to 140°, a metal coverage of the stent ranges from 2% to 15%.
Kuperberg et al. also discloses a stent mesh with a peak and valley configuration of struts (34) (see [0037]), and bridging element (38) (see [0037]). Kuperberg et al. teaches the strut (34) configuration is engineered to be flexible in order to expand and constrict, while possessing enough radial strength, so when the stent is fully crimped/collapsed (joint angles minimized down to 0° to 5°), the struts pack tightly together, driving metal coverage to its highest point (20% to 60%, or 30 to 99%), and as the angles widen up to 140°, there is a drop in metal coverage to its lowest operational density (see [0037] disclosing the strut configuration); and the bridging elements (38) must withstand greater radial pressure, while providing increased radial tensile strength, therefore the ratio of metal mass to open cells is an adjustable performance variable, allowing the bridging elements to naturally force the metal coverage percentages to fall within standard predictable ranges at corresponding joint intervals (see [0037] disclosing the function of the bridging elements). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the alternating variable-width stent-mesh of Clinger et al., by incorporating the expansion-constriction dynamics and radial tensile strength guidelines, as taught by Kuperberg et al. Doing so would provide a means to mathematically plot and optimize the metal mass footprint of alternating main and broadened sections, relative to the cellular open space across the stent’s full kinematic deformation range.
Claims 17, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Clinger et al. (US 2021/0161689) as applied to claim 1 above, in view of Kuperberg et al. (US 2019/0307930), and further in view of Jang (US 2002/0161430).
Regarding claim 17, Clinger et al./Kuperberg et al., discloses the stent according to claim 1, but fails to disclose wherein: each stent strut comprises two main sections and one broadened section located between the two main sections; and/or wherein: the stent mesh comprises 8 to 24 stent struts; and/or wherein: when the angle at each joint is minimized, in adjacent stent struts connected at a same joint, the broadened section of one of the stent struts does not overlap with the main section of the other one of the stent struts; and/or wherein: in at least one stent strut, the broadened section has margins of a same width or different widths beyond the main section at opposite sides of the stent strut along a lengthwise direction thereof; and/or wherein: in at least one stent strut, the broadened section is flush with the main section at one side of the stent strut along a lengthwise direction thereof, and wherein: in an expanded configuration of the stent, adjacent stent struts connected at a same joint form a V-shaped structure, wherein: the sides of the adjacent stent struts, at which the main sections are flush with the broadened sections, are simultaneously located at an inner side or an outer side of the V-shaped structure.
Jang also discloses an elongate hollow tubular stent (10) (see [0048]) with connecting struts (38) within adjacent expansion columns (24) (see [0052]), and expansion struts (28,32) being circumferentially offset relative to one another (see [0051]). Jang teaches the connecting struts (38) have a non-uniform width along their longitudinal length, featuring a central portion that functions as a broadened section, that is wider than the terminal ends, and the middle of the strut is the area most susceptible to buckling during high pressure expansion, thereby requiring a broadened section to be placed at the center of the strut in order to localize radial strength precisely where the structural load is highest, without making the entire mesh overly rigid (see [0083]; [0084] disclosing the sections of the stent, and struts; Figs. 7B, 8A illustrating the connecting strut (38) with its ends, and expansion columns (24) providing radial reinforcement); specific stent embodiments can have varying strut counts around the stents (10) circumference (see [0051]; [0052] disclosing strut counts); and that by varying the widths of the struts, specifically having larger portions (e.g., broadened sections) and smaller portions (e.g., main sections), the stent can achieve a higher packing density, to which in the crimped state the larger portions of one strut are designed to align with the smaller portions or the open gaps of the adjacent strut; a flush side alignment maintained by the asymmetrical strut profile and that orienting flush sides of the struts (28, 32) (e.g., both on the inner side of a V-joint) acts as a means prevent bottoming out or mechanical interference when the stent is crimped (see [0083] disclosing the geometry of the expansion struts (28, 32); Figs. 6A, 6B illustrating strut profiles where one longitudinal edge is substantially linear (flush side) while the opposite edge is stepped or curved to create wider, broadened sections)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the alternating variable-width stent-mesh of Clinger et al., as modified by Kuperberg et al., with an intravascular stent framework comprising repeating expansion columns made of expansion struts and joints forming a mesh network, as taught by Jang. Doing so would provide a means to optimize structural strength and crimp compactness while preserving a uniform, non-obstructive surface profile along the vessel boundaries.
Regarding claim 28, Clinger et al./Kuperberg et al., discloses the stent according to claim 1, but fails to disclose wherein: the stent comprises at least two stent meshes that are axially connected, wherein: the stent comprises at least one linking strut, wherein: the joints in adjacent stent meshes are connected through the linking strut, and wherein: the linking strut comprises a shape comprising at least one of a linear shape, a corrugated shape, a serrated shape, a circular shape, an annular shape, a “Ω”-like shape and an “S”-like shape.
Jang also discloses a stent (10) as having multiple expansion columns (24) (see [0052]) joined by a plurality of connecting struts (38) and connecting strut columns (26) (see [0051] disclosing the connections, thereby forming a mesh-like structure). Jang teaches the total length of the stent (10) is determined by the number of the repeating expansion columns (24) (see [0049] disclosing the stent construction), with each repeating unit constituting a mesh like section, thereby linking them through an axial connection; and the connections struts (38) have at least one linear section, curvatures (106, 108), and slopes that accommodate expansion and provide longitudinal flexibility using curved (e.g., S-like or Ω-like) struts (see [0083] disclosing the curvatures), the stent can bend more easily as it is pushed through curved blood vessels (see [0083] disclosing the connecting strut design; Fig. 4A illustrating an undulating or s-shaped/curved paths). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the alternating variable-width stent-mesh of Clinger et al., as modified by Kuperberg et al., with a stent matrix having columns that are axially aligned and connected, as taught by Jang. Doing so would provide a structural means to allow independent multi-axis articulation between adjacent stent columns while tracking through tortuous lumens, in order to maximize tracking efficiency and reducing the risk of vascular trauma.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Clinger et al. (US 2021/0161689) as applied to claim 1 above, in view of Kuperberg et al. (US 2019/0307930), and further in view of Dinh (US 2004/0204750).
Clinger et al./Kuperberg et al., discloses the stent according to claim 1, but fails to disclose wherein: at least one of the broadened sections comprises a cavity, and wherein: the broadened section comprises 1 to 10 cavities; and/or the cavity comprises a longitudinal cross-sectional shape comprising at least one of an arcuate shape, a quadrilateral shape and a triangular shape; and/or the cavity comprises a transverse cross-sectional shape comprising at least one of a circular shape, an elongate shape, a polygonal shape, a corrugated shape, an annular shape and an irregular shape; and/or the cavity is configured for a drug or radiopaque agent to be filled therein.
Dinh also discloses a drug-polymer stent (100) comprising a stent framework (110) with a plurality of reservoirs (120) (see Fig. 1). Dinh teaches the reservoirs (120) function as cavities, which are configured to hold a drug polymer (see [0010] disclosing the plurality of reservoirs); the reservoirs (120) that are laser cut (see [0060] disclosing the manufacturing of the reservoirs), can have varying shapes, sizes, quantities and locations, inherently allowing one to create reservoirs of any specific shape (e.g., triangular, arcuate), or sections (e.g., broadened) (see [0032] disclosing the formation of the reservoirs). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the alternating variable-width stent-mesh of Clinger et al., as modified by Kuperberg et al., with the reservoir technology that optimizes the method for achieving controlled elution of drugs, as taught by Dinh. Doing so would provide a means to leverage the additional mass/width of the broadened sections to house therapeutic or diagnostic agents without compromising the integrity of the stent.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Dinh (US 2004/0204750) in view of Clinger et al. (US 2021/0161689), and further in view of Kuperberg et al. (US 2019/0307930).
Dinh discloses a drug-loaded stent (100) (see Fig. 1); and at least one broadened section comprises a cavity configured for a drug to be filled therein (see [0032] disclosing the formation of the reservoirs).
Dinh fails to disclose at least one stent mesh, wherein each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh, wherein the plurality of the stent struts are sequentially connected end to end, and a joint is formed at the connected ends of adjacent stent struts, and wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints, wherein the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section, wherein the main section has a width smaller than a width of the broadened section; wherein in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh; and a radial strength of the stent ranges from 1 kPa to 300 kPa.
Furthermore, Clinger et al. discloses at least one stent mesh (see [0038] disclosing the stent body interconnected with struts, thereby creating a mesh), wherein: each stent mesh comprises a plurality of stent struts sequentially connected circumferentially around the stent mesh (see [0034] disclosing the plurality of stent struts), wherein: the plurality of the stent struts are sequentially connected end to end (see [0021] disclosing the struts connected end to end at nodes), and a joint is formed at the connected ends of adjacent stent struts (see [0021] disclosing the nodes, which function as the joints at the ends of the struts), wherein: the stent mesh is configured to expand or collapse as a result of widening or narrowing of angles at the joints (see [0036] disclosing the structural segments responsible for mechanical behavior, thereby allowing the stent to collapse or expand), wherein: the stent strut comprises at least one main section and at least one broadened section alternately arranged with the at least one main section (see Fig. 1B illustrating a thin (315) and thick (325) width of intermediate branches (310, 324), thereby functioning as the main and broadened sections that are alternating), wherein: the main section has a width smaller than a width of the broadened section (see Fig. 1B illustrating a thin (315) width and a thick (325) width); and wherein: in each stent mesh, the broadened sections of adjacent stent struts are staggered along an axis of the stent mesh (see [Fig. 1C illustrating the staggered arrangement).
Clinger et al. fails to disclose a radial strength of the stent ranges from 1 kPa to 300 kPa.
Kuperberg et al. also discloses a stent with a bridging element (38) (see [0037]). Kuperberg et al. teaches the bridging elements (38) can achieve baseline radial strength by providing enough radial strength to resist external compressive forces, and the design must allow for the stent to withstand constant radial pressure in order to maintain patency (see [0037] disclosing the function of the bridging element). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the therapeutic delivery features of Dinh, as modified by Clinger et al., with the localized structural modifications across strut patterns, as taught by Kuperberg et al. Doing so would provide a means to maximize local drug volume inside thick, low-stress zones of the strut while preserving an ultra-dense, non-interlocking crimp configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights