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 .
Election/Restrictions
Applicant's election with traverse of Invention II in the reply filed on 06/04/2026 is acknowledged. The traversal is on the ground(s) that Invention I has been amended to recite the generally U-shaped outer wall and generally U-shaped inner wall. This is found persuasive and the restriction between invention I and invention II is withdrawn.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/04/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5-8 and 12, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Folan (Pub. No.: US 2020/0170776 A1), hereinafter Folan ‘776.
Regarding claim 1, Folan ‘776 discloses (fig. 8) a stent (400) comprising:
A tubular body (¶ 0059) formed of one or more interwoven wires (¶ 0043), the tubular body having first and second opposing ends (first end 412, second end 414) and a lumen (416) extending therebetween (fig. 8, ¶ 0060), the tubular body defining a longitudinal axis (fig. 8); and
A first anchor member (420) disposed adjacent the first open end and a second anchor member (422) disposed adjacent the second open end (fig. 8), the first and second anchor members spaced apart along the tubular body (fig. 8), the first and extend anchor members each extending radially outward from the tubular body such that the first and second anchor members each have an outer diameter larger than an outer diameter of the tubular body disposed between the first and second anchor members (fig. 8, ¶ 0067);
Wherein each of the first and second anchor members define a double-walled flange including a U-shaped outer wall (see wall characterized by coating, ¶ 0060, fig. 8) and a U-shaped inner wall (see wall characterized by wires, ¶ 0048) spaced apart from the outer wall (fig. 8, ¶ 0060), wherein the tubular body is defined by only a single wall (fig. 8, ¶ 0043).
Regarding claim 5, Folan ‘776 discloses wherein the first and second anchor members are formed as separate elements attached to the tubular body such that the tubular body extends across the base of each of the first and second anchor members and the inner wall defines an inner space separated from the lumen by the interwoven wires forming the tubular body (the first and second anchor members may be formed separately and then attached to the tubular body, ¶ 0048).
Regarding claim 6, Folan ‘776 discloses (annotated fig. 8) wherein the tubular body includes a first end region extending between the first open end and the first anchor member, a saddle region extending between the first anchor member and the second anchor member, and a second end region extending between the second open end and the second anchor member, wherein the outer diameter of the first and second anchor members is larger than an outer diameter of the first and second end regions (annotated fig. 8, ¶ 0014).
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Folan ‘776 Annotated Fig. 8
Regarding claim 7, Folan ‘776 discloses wherein the outer diameters of the saddle region, the first end region, and the second end region are all substantially the same (annotated fig. 8, ¶ 0014).
Regarding claim 8, Folan ‘776 discloses wherein the first and second anchor members are less flexible than the tubular body (¶ 0008).
Regarding claim 12, Folan ‘776 discloses wherein the first and second anchor members extend perpendicular to the longitudinal axis (¶ 0018).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4, 9-11, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Folan ‘776 as applied to claim 1 above, and further in view of Folan (Pub. No.: US 2022/0079784 A1), hereinafter Folan ‘784.
Regarding claim 4, Folan ‘776 fails to disclose wherein the outer wall is attached to the inner wall only at a base of each of the first and second anchor members, wherein the base is adjacent the tubular body.
Folan ‘784 teaches (annotated fig. 2B) a stent (200B) and thus in the same field of endeavor, comprising:
A tubular body (elongated body 200A, ¶ 0029), the tubular body having first and second opposing open ends and a lumen (212) extending therebetween (fig. 2B); and
A first anchor member (first flange 214) disposed adjacent a first opening and a second anchor member (second flange 216) disposed adjacent the second open end (fig. 2B), wherein the first and second anchor members define a double-walled flange (fig. 2B) including a U-shaped outer wall a U-shaped outer wall and an inner wall spaced apart from the outer wall (annotated fig. 2B), wherein the outer wall is attached to the inner wall only at a base of each of the first and second anchor members (see first welded termination 224 and second welded termination 226, ¶ 0028, ¶ 0035), wherein the base is adjacent the tubular body (¶ 0028, fig. 2B), in order to increase a strength of the anchors and prevent the anchors from freely deforming when a force is applied to the anchors (¶ 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second anchor members of Folan ‘776 such that the outer wall is attached to the inner wall only at a base of each of the first and second anchor members, wherein the base is adjacent the tubular body, as taught by Folan ‘784, in order to increase a strength of the anchors and prevent the anchors from freely deforming when a force is applied to the anchors (Folan ‘784 ¶ 0036).
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Folan ‘784 Annotated Fig. 2B
Regarding claim 9, Folan ‘776 fails to disclose a covering extending over the tubular body, wherein an entirety of each of the first and second anchor members are devoid of the covering.
Folan ‘784 teaches (fig. 4B) a stent (400B) and thus in the same field of endeavor, comprising:
A tubular body (fig. 4B, ¶ 0029);
A first anchor member (first flange 214) and a second anchor member (second flange 216); and
A covering (220) extending over an entirety of the tubular body, wherein an entirety of each of the first and second anchor members are devoid of the covering (in some embodiments, all or a portion of an elongate body, a first flange, a second flange, a cylindrical saddle region, or any combination thereof may comprise a coating or a cover, ¶ 0034), the cover configured to be a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (¶ 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Folan ‘776, such that it comprises a covering extending over the tubular body, wherein an entirety of each of the first and second anchor members are devoid of the covering, as taught by Folan ‘784, in order to provide a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (Folan ‘784, ¶ 0035).
Regarding claim 10, Folan ‘776 fails to disclose a covering extending over an entirety of the tubular body and the inner wall of each of the first and second anchor members.
Folan ‘784 teaches (annotated fig. 4B) a stent (400B) and thus in the same field of endeavor, comprising:
A tubular body (fig. 4B, ¶ 0029);
A first anchor member (first flange 214) and a second anchor member (second flange 216); wherein each of the first and second anchor members define a double-walled flange including a U-shaped outer wall and an inner wall (annotated fig. 4B); and
A covering (220) extending over an entirety of the tubular body and the inner wall of each of the first and second anchor members (a radially interior wall of the lumen may be coated or covered ¶ 0033, in some embodiments, all or a portion of an elongate body, a first flange, a second flange, a cylindrical saddle region, or any combination thereof may comprise a coating or a cover, ¶ 0034), the cover configured to separate the lumen from a cavity between the outer and inner walls in order to prevent an accumulation of material carried by flow through the lumen and thereby reducing risk of occlusion of the lumen, reducing potential loci for a gathering of infectious material or both (¶ 0033) and be a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (¶ 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Folan ‘776, such that it comprises a covering extending over an entirety of the tubular body and the inner wall of each of the first and second anchor members, as taught by Folan ‘784, in order to separate the lumen from a cavity between the outer and inner walls in order to prevent an accumulation of material carried by flow through the lumen and thereby reducing risk of occlusion of the lumen, reducing potential loci for a gathering of infectious material or both (Folan ‘784¶ 0033) and provide a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (Folan ‘784 ¶ 0035).
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Folan ‘784 Annotated fig. 4B
Regarding claim 11¸ Folan ‘776 in view of Folan ‘784 fail to disclose wherein the outer wall of each of the first and second anchor members is devoid of the covering.
Folan ‘784 further teaches wherein the outer wall of each of the first and second anchor members is devoid of the covering (in some embodiments, all or a portion of an elongate body, a first flange, a second flange, a cylindrical saddle region, or any combination thereof may comprise a coating or a cover, ¶ 0034), the cover configured to be a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (¶ 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Folan ‘776, such that it comprises a covering extending over the tubular body, wherein an entirety of each of the first and second anchor members are devoid of the covering, as taught by Folan ‘784, in order to provide a binding or securing agent to hold a first portion and/or a second portion, for example, by a first welded termination or a second welded termination, in a location with respect to a wall of the central portion of the elongated body (Folan ‘784, ¶ 0035).
Regarding claim 13, Folan ‘776 discloses (fig. 8) a stent (400) comprising:
A tubular body (¶ 0059) formed of one or more interwoven wires (¶ 0043), the tubular body having first and second opposing ends (first end 412, second end 414) and a lumen (416) extending therebetween (fig. 8, ¶ 0060), the tubular body defining a longitudinal axis (fig. 8); and
First and second longitudinally spaced anchor members (420, 422) each having a base adjacent the tubular body and extending radially outward to a free end (fig. 8), the first and second anchor members each having an outer diameter that is larger than an outer diameter of the tubular body disposed between the first and second anchor members (fig. 8, ¶ 0067), each of the first and second anchor members defining a double-walled flange including a generally U-shaped outer wall (characterized by coating, ¶ 0060, fig. 8) and a generally U-shaped inner wall (characterized by wires, ¶ 0048), wherein the inner wall is fixed to the outer wall such that a radially outermost free end of the inner wall floats freely within the outer wall (¶ 0060-¶ 0061).
Folan ‘776 fails to disclose that the inner wall is fixed to the outer wall only at the base.
Folan ‘784 teaches (annotated fig. 2B) a stent (200B) and thus in the same field of endeavor, comprising:
A tubular body (elongated body 200A, ¶ 0029); and
First and second longitudinally spaced anchor members (first flange 214, second flange 216) each having a base (see first welded termination 224 and second welded termination 226) adjacent the tubular body and extending radially outward to a free end (fig. 2B), each of the first and second anchor members defined by a double-walled flange including a generally U-shaped outer wall and an inner wall spaced apart from the outer wall (annotated fig. 2B), wherein the inner wall is fixed to the outer wall only at the base (¶ 0028, ¶ 0035), in order to increase a strength of the anchors and prevent the anchors from freely deforming when a force is applied to the anchors (¶ 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second anchor members of Folan ‘776 such that the inner wall is fixed to the outer wall only at the base, as taught by Folan ‘784, in order to increase a strength of the anchors and prevent the anchors from freely deforming when a force is applied to the anchors (Folan ‘784 ¶ 0036).
Regarding claim 14, Folan ‘776 discloses wherein the outer walls and/or the inner walls of each of the first and second anchor members are interwoven with the tubular body (¶ 0048).
Regarding claim 15, Folan ‘776 discloses wherein the inner wall defines an inner space within each of the first and second anchor members that is continuous with the lumen of the tubular body (¶ 0048).
Regarding claim 16, Folan ‘776 discloses wherein the first and second anchor members are formed as separate elements attached to the tubular body such that the tubular body extends across the base of each of the first and second anchor members and the inner wall defines an inner space separated from the lumen by the interwoven wires forming the tubular body (the first and second anchor members may be formed separately and then attached to the tubular body, ¶ 0048).
Regarding claim 17, Folan ‘776 discloses wherein the tubular body includes a first end region extending between the first open end and the first anchor member and a second end region extending between the second open end and the second anchor member, wherein the outer diameter of the first and second anchor members is larger than an outer diameter of the first and second end regions, wherein the outer diameters of the tubular body between the first and second anchor members, the first end region, and the second end region are all substantially the same (¶ 0014, annotated fig. 8).
Allowable Subject Matter
Claims 2-3 and 18-19 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 2 recites “wherein the outer walls of each of the first and second anchor members are interwoven with the tubular body”. The closest prior art is Folan ‘776 which discloses anchors defined by a double-walled flange including a U-shaped outer wall and a U-shaped inner wall. Folan ‘776 fails to disclose the outer wall being interwoven with the tubular body. Rather, Folan ‘776 discloses the outer wall being a covering. While Folan ‘784 discloses a double-walled flange including a U-shaped outer wall and an inner wall, the outer wall being interwoven with the tubular body (¶ 0027, ¶ 0029), Folan ‘784 teaches away from a U-shaped inner wall. Folan ‘784 discloses that a U-shaped inner wall provides a loci for infection and related inflammation (¶ 0023). Accordingly, the combination of the first and second anchor members defining a double-walled flange including a U-shaped outer wall and a U-shaped inner wall, the outer wall of each the first and second anchor members are interwoven with the tubular body is novel.
Claim 3 depends from claim 2 and also includes allowable subject matter.
Claim 18 recites “a covering extending over the tubular body, wherein the inner wall and the outer wall of each of the first and second anchor members are devoid of the covering”. While Folan ‘784 discloses a covering and that all or a portion of an elongate body, a first flange, a second flange, a cylindrical saddle region, or any combination thereof may comprise a coating or a cover (¶ 0034), the covering of Folan ‘784 is configured to hold the first welded termination 224 and the second welded termination 226 into place (¶ 0035). Thus, Folan ‘784 requires a covering at the base of the first and second anchor members. Therefore, Folan ‘776 in view of Folan ‘784 require the cover to be disposed at at least a portion of the inner wall and the outer wall in order to fix the inner wall to the outer wall at the base, as required by claim 13 from which claim 18 depends. Accordingly, the combination the inner wall being fixed to the outer wall only at the base and the inner wall and the outer wall of each the first and second anchor members being devoid of the covering is novel.
Claim 19 recites “a covering extending over an entirety of the tubular body and the inner wall of each of the first and second anchor members, wherein the outer wall of each of the first and second anchor members is devoid of the covering. Similarly, to claim 18 above, Folan ‘776 in view of Folan ‘784 require the cover to be disposed at at least a portion of the inner wall and the outer wall in order to fix the inner wall to the outer wall at the base, as required by claim 13 from which claim 19 depends. Accordingly, the combination the inner wall being fixed to the outer wall only at the base and the outer wall of each the first and second anchor members being devoid of the covering is novel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gupta et al. (Pub. No.: US 2021/0307943 A1) discloses a stent having a double-wall anchor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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