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 2022/097719, filed on 06/08/2022.
Specification
The disclosure is objected to because of the following informalities:
a. In paragraph [0008], line 1, “0 to 90%” should read “0% to 90%”
b. In paragraph [0077], line 3, “0.3 to 0.7 mm” should read “0.3 mm to 0.7 mm”
c. In paragraph [0079], line 1, “0 to 90%” should read “0% to 90%”
d. In paragraph [0095], line 8, “35 to 60%” should read “35% to 60%”
e. In paragraph [0105], line 16, “0 to 90%” should read “0% to 90%”
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 1, “for 0 to 90%” should read “for 0% to 90%”
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.
Claims 6, and 19 are 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 6 recites the broad recitation “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%,” lines 9 to 11, and the claim also recites “when the angle at each joint is in the range of 30° to 90°, the metal coverage of the stent mesh further ranges from 8% to 15%,” lines 9-10, and 12 which is the narrower statement of the range/limitation. 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.
Claims(s) 16, and 31 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, and 31 of U.S. Patent No. (18/569145). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant application (18/569042)
Reference application (18/569145)
(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.
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.
As shown in the mapping above:
Claim 1 of the reference application anticipates all the limitations of claim 16 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.
Claim(s) 1, 6, 12-19, 24-26, 28-29, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 7-17, 19, 28, and 31 of copending Application No. (18/569145) in view of Brown et al. (US 7204848).
This is a provisional nonstatutory double patenting rejection.
Instant application (18/569042)
Reference application (18/569145)
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.
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.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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.
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.
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.
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.
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.
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.
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;
(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.
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.
Claim(s) 1, and 16
Claim 1 of the reference application recites all of the limitations of claim(s) 1, and 16 of the instant application except “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.” However, Brown et al. (US 7204848) teaches interconnecting elements (144) connect to peaks (136) and troughs (140), that function as the joints that makeup undulating bands that open and close when the stent is expanded or crimped, resulting in the angles at the peaks and troughs to be minimized (see Col. 6, lines 6-17 disclosing these elements); and the interconnecting elements are specifically positioned to maintain a defined open space between the bands (see Col. 6, lines 6-17 disclosing the open spacing; Fig . 2 illustrating the gap provided by the interconnecting elements (144) in order to prevent the peaks of one undulating band from making direct, flush contact with the troughs of the adjacent band). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to integrate the placement of the interconnecting elements, and spacing, as disclosed by Brown et al., within the method of claim 1 of the reference patent. Doing so would provide a means to have a mechanical spacer to ensure the axial gap exists when the joints close. ensuring that when the expansion angle is minimized, the wider portions of the struts align with the narrower portions of the adjacent struts, which inherently maintains a clearance or gap between structural features allowing for the smallest crimped diameter).
Claim 6
Claim(s) 7-12 of the reference application recites the same limitations as the claimed alternatives in claim 6 of the instant application.
Claim 11 of the reference application depends from and requires all of the limitations of claim 10.
Claim 12
Claim 13 of the reference application recites the same limitations as claim 12 of the instant application.
Claim 13
Claim 14 of the reference application recites the same limitations as claim 13 of the instant application.
Claim 14
Claim 15 of the reference application recites the same limitations as claim 14 of the instant application.
Claim 15
Claim 16 of the reference application recites the same limitations as claim 15 of the instant application.
Claim(s) 17-18, and 24-26
Claim 17 of the reference application recites the same limitations as claim(s) 17-18, and 24-26 of the instant application.
Claim 19
Claim 19 of the reference application recites the same limitations as claim 19 of the instant application.
Claim(s) 28-29
Claim 28 of the reference application recites the same limitations as claim 28-29 of the instant application.
Claim 31
Claim 31 of the reference application recites the same limitations as claim 31 of the instant application except “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.” However, Brown et al. (US 7204848) teaches interconnecting elements (144) connect to peaks (136) and troughs (140), function as the joints that makeup undulating bands that open and close when the stent is expanded or crimped, resulting in the angles at the peaks and troughs to be minimized (see Col. 6, lines 6-17 disclosing these elements); and the interconnecting elements are specifically positioned to maintain a defined open space between the bands (see Col. 6, lines 6-17 disclosing the open spacing; Fig . 2 illustrating the gap provided by the interconnecting elements (144) in order to prevent the peaks of one undulating band from making direct, flush contact with the troughs of the adjacent band). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to integrate the placement of the interconnecting elements, and spacing, as disclosed by Brown et al., within the method of claim 31 of the reference application. Doing so would provide a means to have a mechanical spacer to ensure the axial gap exists when the joints close.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Clinger et al. (US 2021/0161689), and further in view of Brown et al. (US 7204848).
Regarding claims 1-5, Clinger et al. discloses a stent (100) (see [0033]), comprising 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), and wherein the stent mesh is configured to expand or collapse as a result of widening or narrowing of an angle at the joint (see [0036] disclosing the structural segments responsible for mechanical behavior, thereby allowing the stent to collapse or expand), 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 (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 comprises a width smaller than a width of the broadened section (see Fig. 1B illustrating a thin (315) width and a thick (325) width), wherein: in each stent mesh, the broadened sections of the 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 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;
wherein: when the angle at the joint is minimized, a length of the gap accounts for 0 to 90% of a length of the stent strut; wherein: when the angle at the joint is minimized, the length of the gap accounts for 10% to 75% of the length of the stent strut; wherein: when the angle at the joint is minimized, the length of the gap accounts for 20% to 50% of the length of the stent strut; and wherein: when the angle at the joint is minimized, the gap has a length of 0.1 mm to 0.3 mm.
Brown et al. also discloses a stent formed by undulating band-like elements connected to interconnecting elements (see Col. 2, line 37-55), and peaks and troughs (see Col. 2, lines 42-43). Brown et al. teaches the peaks and troughs are bulbous, thereby serving as broadened sections that increase mass/surface area (see Col. 12, lines 22-26 disclosing the shape); an expanded and unexpanded state, to which the angles of the peaks (136) and troughs (140) which function as joints, are minimized when the stent is in an unexpanded or crimped state (see Col. 5, lines 46-55 disclosing the expanded and unexpanded states); and the interconnecting elements are specifically positioned to maintain a defined open space between the bands creating variable open or gap dimensions, which also accounts for the percentages of the length of the stent (see Col. 6, lines 6-17 disclosing the open spacing; Fig. 2 illustrating the gaps and dimensions provided by the interconnecting elements (144) in order to prevent the peaks of one undulating band from making direct, flush contact with the troughs of the adjacent band). 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 placement of the interconnecting elements and spacing geometry, as taught by Brown et al. Doing so would provide a means to optimize the stent for delivery by enforcing a specific axial gap that prevents the broadened sections of adjacent struts from colliding during high-compression crimping.
Claims 6, and 12-16 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 Brown et al. (US 7204848), and further in view of Kuperberg et al. (US 2019/0307930).
Regarding claims 6, and 12-15, Clinger et al./Brown et al., discloses the stent according to claim 1, but fails to disclose 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%; wherein when the angle at each joint is in a range of 00 to 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%; and 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 have the alternating variable-width stent-mesh of Clinger et al., as modified by Brown et al., with 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.
Regarding claim 16, Clinger et al./Brown et al., discloses the stent according to claim 1, but fails to disclose wherein: the stent comprises a radial strength of 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 alternating variable-width stent-mesh of Clinger et al., as modified by Brown et al., with 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.
Claims 17, 18, 24-26, 28, and 29 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 Brown et al. (US 7204848), and further in view of Jang (US 2002/0161430).
Regarding claim 17, Clinger et al./Brown et al., discloses the stent according to claim 1, but fails to disclose wherein: the stent strut comprises two main sections and one broadened section located between the two main sections.
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). 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 Brown et al., with the central portion of the connecting struts (38) providing similar function as a broadened section within the expansion columns to strengthen the strut against vessel pressure while ensuring that the gap remains clear for high-density packing during stent delivery, as taught by Jang. Doing so would provide centralized radial reinforcement while maintaining joint flexibility and non-nesting compact packing.
Regarding claim 18, Clinger et al./Brown et al., discloses the stent according to claim 1, but fails to disclose wherein: the stent mesh comprises 8 to 24 stent struts.
Jang also discloses expansion columns (24) with expansion struts (28) around the circumference of the stent (10) (see [0050] disclosing the columns and struts). Jang teaches specific stent embodiments can have varying strut counts around the stents (10) circumference (see [0051]; [0052] disclosing strut counts). 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 Brown et al., with the necessary scaffolding defined by the number of struts (28) required to cover the vessel surface adequately, as taught by Jang. Doing so would provide for a stent to have high radial strength in a low-profile delivery system.
Regarding claims 24-26, Clinger et al./Brown et al., discloses the stent according to claim 1, but fails to disclose wherein: when the angle at the joint is minimize 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; 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; and 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.
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 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 Brown et al., with varying the width of a pair of struts (32) so that larger portions exist alongside smaller portions, as taught by Jang. Doing so would provide a means to maximize packing density and minimize the delivery profile of the stent without mechanical interference.
Regarding claim 28, Clinger et. al/Brown 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.
Jang also discloses a stent (10) as having multiple expansion (34) and strut (26) columns (see [0049] disclosing the stent and its components). Jang teaches the total length of the stent (10) is determined by the number of the repeating columns (34, 26), with each repeating unit constituting a mesh like section, thereby linking them through an axial connection. 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 Brown et al., with a stent’s length being modular and based on repeating column (34, 26) units, as taught by Jang. Doing so would provide a means to treat long vascular legions while maintaining longitudinal flexibility and a low delivery profile.
Regarding claim 29, Clinger et al./Brown et al./Jang, discloses the stent according to claim 28.
Clinger et al./Brown et al. fails to disclose 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.
Furthermore, 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 Brown 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 Brown et al. (US 7204848), and further in view of Dinh (US 2004/0204750).
Clinger et al./Brown 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 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.
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 Brown 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 Brown et al. (US 7204848).
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 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; 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.
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), and wherein: the stent mesh is configured to expand or collapse as a result of widening or narrowing of an angle at the joint (see [0036] disclosing the structural segments responsible for mechanical behavior, thereby allowing the stent to collapse or expand), 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 (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 the 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 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.
Brown et al. also discloses a stent formed by undulating band-like elements connected to interconnecting elements (see Col. 2, line 37-55), and peaks and troughs (see Col. 2, lines 42-43). Brown et al. teaches the interconnecting elements are specifically positioned to maintain a defined open space between the bands creating variable open or gap dimensions (see Col. 6, lines 6-17 disclosing the open spacing; Fig. 2 illustrating the gaps and dimensions provided by the interconnecting elements (144) in order to prevent the peaks of one undulating band from making direct, flush contact with the troughs of the adjacent band). 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 geometric clearance constraints of a gap, as taught by Brown et al. Doing so would provide a means to utilize bridge geometry as a mechanical spacer to allow for high-mass, drug-loaded strut sections while maintaining a low-profile crimped state.
Conclusion
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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