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 .
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 PCT/CN2021/130046, filed on January 24th, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/19/2023 and 01/15/2025 are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: the specification discloses a semi-releasing device 20 connected to the tubular main body 11, however, there is no reference number 20 in any drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3 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. Claim 3 — Unclear numeric relationship and ambiguous coordinate terms Claim 3 recites: “… in a natural state, the distance between two adjacent limiting ring buckles along the circumferential direction … is m; the vertical distance between a fixed point of the limiting ring buckle and the wave trough located below the limiting ring buckle and closest to the limiting ring buckle is n; and m and n satisfy the relationship m:52n.” (as claimed) The specification contains the same relationship as “m<=2n” (Detailed Description discussing Fig. 7–8: “The variables m and the n satisfy this relationship m<=2n.”), which is likewise unintelligible.
Indefiniteness: The notation “m:52n” (claim) and “m<=2n” (spec) is not a recognized mathematical relation and fails to inform, with reasonable certainty, what numerical relationship is required between m and n. As drafted, a POSITA cannot determine claim scope. See MPEP 2173.05(g).
Additionally, the terms “vertical distance” and “located below” are used without a defined coordinate frame for the stent (e.g., axial vs. radial vs. circumferential). Although the spec attempts to illustrate with Figs. 6–8, the claims do not define the axes. Considerable ambiguity remains as to how “vertical” is measured on a cylindrical lattice. See MPEP 2173.02. Therefore, claim 3 is rejected under § 112(b) as indefinite.
Also, it is unclear whether “a plurality of limiting ring buckles” of claim 3 are the same or different from “a plurality of limiting ring buckles” from claim 2.
Claim 10 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. Claim 10 — “size of the guide head in a radial direction” Claim 10 recites “the ratio of a size of the guide head in a radial direction … to a diameter of the limiting rod is 1–1.5.”
Indefiniteness: “size … in a radial direction” does not specify whether it means diameter, radius, or maximum radial extent. The spec elsewhere expressly uses “diameter” for the ball head and even gives exemplary values (Detailed Description: “The diameter of the ball head may be about 100%–150% of the diameter of the limiting rod … 0.3–0.6 mm”). The claim should recite “guide head diameter” or “maximum radial dimension.” Therefore, claim 10 is rejected under § 112(b).
Claim 12 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. Claim 12 — Angular ranges not constrained to sum to 360° Claim 12 recites: non‑binding area 180°–340°, binding area 20°–180°. The spec clarifies these are complementary (“that is, … so that … would be controlled within a reasonable range,” Detailed Description after Fig. 3–4), but the claim as written does not require that the two arcs together equal 360°. As drafted, claim scope includes inoperative combinations exceeding or below a complete circumference.
Indefiniteness/Inconsistency: Without an explicit complementarity constraint (sum equals 360°), the metes and bounds are not reasonably certain. See MPEP 2173.05(g), 2173.05(q). Therefore, claim 12 is rejected under § 112(b).
Claim 14 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. Claim 14 — Mismatched dimensional quantities Claim 14 recites “the size of the limiting ring buckle is 100%–200% of a cross‑sectional area of the binding line.” The spec repeats this wording and rationale (Detailed Description: “The size of the limiting ring buckle 24 is about 100%–200% of the cross‑sectional area of the binding line 22 …”), but “size” of a ring buckle is not a defined quantity and juxtaposes a dimensionless “size” with an area.
Indefiniteness: The claim does not specify which ring‑buckle dimension (e.g., inner cross‑sectional area of the through‑hole, inner diameter, slot width) is being compared to the line’s cross‑sectional area. This renders the scope uncertain. See MPEP 2173.05(e). Therefore, claim 14 is rejected under § 112(b).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(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 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipate by Eller et al. (US 20170189212 A1).
Regard claim 1, Eller et al. disclose a luminal stent, comprises a tubular main body, and a semi-releasing device connected to the tubular main body, wherein the tubular main body comprises a binding area and a non-binding area distributed in a circumferential direction; the semi-releasing device comprises a limiting rod (78) located outside the tubular main body (38), and binding lines (84, 86, 88, 90, 92, 94) and limiting fasteners (apexes 66 of a stent 48, paragraph 59) arranged on the tubular main body; the binding lines (84, 86, 88, 90, 92, 94) are arranged in the binding area; the binding lines each comprise a fixed end, a binding portion and a locking portion (Figs. 3 and 4) which are connected to one another; the fixed ends are fixedly connected to the tubular main body; both the locking portions (where pair lines join together) and the limiting fasteners (apices 66, figs 2, 3, 4, 6) are detachably connected to the limiting rod (78); when both the locking portions and the limiting fasteners are connected to the limiting rod, the binding lines circumferentially constrain the binding area.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Xiao et al. (WO2020/125226 PCT Publication date June 25th, 2020)
Regarding claim 1, Xiao et al. disclose a luminal stent in Figs. 14-28, comprises a tubular main body, and a semi-releasing device connected to the tubular main body, wherein the tubular main body comprises a binding area and a non-binding area distributed in a circumferential direction; the semi-releasing device comprises a limiting rod (21) located outside the tubular main body, and binding lines (231, 232) and limiting fasteners (233) arranged on the tubular main body; the binding lines (231, 232) are arranged in the binding area; the binding lines each comprise a fixed end, a binding portion and a locking portion (23) which are connected to one another; the fixed ends are fixedly connected to the tubular main body; both the locking portions and the limiting fasteners are detachably connected to the limiting rod (21); when both the locking portions and the limiting fasteners are connected to the limiting rod, the binding lines circumferentially constrain the binding area.
Regarding claim 2, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein the semi-releasing device further comprises a limiting ring buckle (24); the limiting ring buckle is arranged on an outer surface of the tubular main body; and the binding lines are threaded through the limiting ring buckle.
Regarding claim 3, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 2, wherein the tubular main body comprises a plurality of circles of waveform rings comprising a plurality of wave crests, a plurality of wave troughs, and a plurality of connecting rods respectively connected to the adjacent wave crests and wave troughs; and there is a plurality of limiting ring buckles; in a natural state, the distance between two adjacent limiting ring buckles along the circumferential direction of the tubular main body is m; the vertical distance between a fixed point of the limiting ring buckle and the wave trough located below the limiting ring buckle and closest to the limiting ring buckle is n; and m and n satisfy the relationship m:52n (as best understood).
Regarding claim 4, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein the semi-releasing device comprises at least one group of paired binding lines; and in the circumferential direction of the tubular main body, the fixed ends of the paired binding lines are respectively located on two sides of the limiting fasteners (Figs. .
Regarding claim 5, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 4, wherein the ratio of lengths of the paired binding lines is T1, and the ratio of distances between the fixed ends of the paired binding lines and central axes of the limiting fasteners is T2, and T1=T2.
Regarding claim 6, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 4, wherein the paired binding lines have equal lengths; and in the circumferential direction of the tubular main body, the distances between the fixed ends of the paired binding lines and the limiting fasteners are equal (the lengths of the two binding wires 22 are equal).
Regarding claim 7, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 4, wherein when the paired binding lines circumferentially constrain the binding area under the circumferential limitation of the limiting rod, the locking portions of the paired binding lines are axially limited to each other.
Regarding claim 8, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 7, wherein each locking portion is a circular or semicircular structure formed by coiling the binding line; when the paired binding lines circumferentially constrain the binding area under the circumferential limitation of the limiting rod, the locking portions of the paired binding lines are not hooked to each other, so that when the limiting rod is separated from the limiting fasteners, the paired binding lines are separated from each other.
Regarding to claim 9, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 7, wherein in the paired binding lines, the binding line covering the limiting rod has two traction sections; and at least one of the two traction sections is threaded through the locking portion of the other binding line.
Regarding to claim 10, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein a proximal end of the limiting rod is provided with a guide head; and the ratio of a size of the guide head in a radial direction of the limiting rod to a diameter of the limiting rod is 1-1.5.
Regarding to claim 11, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein the ratio of a diameter of the circumcircle of the cross section when the luminal stent is in a semi-released state to the diameter of the circumcircle of the cross section when the luminal stent expands is 0.6-0.8.
Regarding to claim 12, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein the angle of circumference covered by the non-binding area is 180°-340°, and the angle of circumference covered by the binding area is 20°-180°.
Regarding to claim 13, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 1, wherein a branch opening is formed in the non-binding area, and an edge of the branch opening is provided with an imaging structure.
Regarding claim 14, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 2, wherein the size of the limiting ring buckle is 100%-200% of a cross-sectional area of the binding line.
Regarding claim 15, Xiao et al. disclose in Figs. 14-28, the luminal stent according to claim 3, wherein the limiting ring buckle is located in the middle of the connecting rod of the waveform ring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771