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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been submitted to the International Bureau in compliance with Rule 17.1(a), (b) or (b-bis) International Application No. PCT/CN2021/113827, filed on July 7th, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/20/2023 and 11/08/2024 are being considered by the examiner.
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 4-10 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.
Claim 4 recites the limitation "a plurality of skirts" in line 2. Claim 4 recites “a plurality of skirts” without specifying whether these skirts are the same as, or different from, the “first skirt” and “second skirt” recited in Claim 1. The specification describes multiple embodiments with various numbers of skirts (see ¶[0416]–[0418], ¶[0427]), but does not define “plurality of skirts” as used in dependent claims. If “plurality” refers only to the first and second skirts of Claim 1, Claim 4 is narrower. If it includes additional skirts beyond those in Claim 1, Claim 4 is broader. This ambiguity affects novelty/obviousness determinations and makes it unclear to the public what is covered. Examiner suggests applicant to clarify whether “plurality of skirts” means exactly the first and second skirts of Claim 1, or any skirts in addition to those.
Claim 5 recites the limitation “the skirt that is closer to the outflow end” and “an adjacent skirt that is father away from the outflow end.” It is unclear whether “the skirt” and “adjacent skirt” refer to the first and second skirts of Claim 1 or to different skirts introduced in Claim 4. The specification uses “skirt” generically in multiple embodiments without consistent numbering (see ¶[0416], Fig. 13a, Fig. 15). Ambiguity in which skirts are referenced prevents clear determination of overlap and functional relationship between skirts. Examiner suggests applicant to replace generic “the skirt” with “the first skirt” or “the second skirt” if referring to Claim 1’s skirts, or define new skirt identifiers.
Claim 6 recites the limitation “by enclosing the stent and axially adjacent skirts.” The phrase “enclosing the stent” is grammatically ambiguous — it could mean: The stent encloses something, or the stent is enclosed by skirts. The specification does not use “enclosing” in this context; it describes skirts as “surrounding” or “bounded by” the stent (see ¶[0370], ¶[0416]). Ambiguity in enclosure direction makes it unclear what structure defines the claimed “swirling cavity.” Examiner suggests applicant to replace “enclosing the stent” with “bounded radially inward by the stent frame and radially outward by axially adjacent skirts.”
Claim 7 recites the limitation “the skirt” in line 1. It is unclear if “the skirt” in line 1 as claimed in claim 7 is the same with first skirt or second skirt or another skirt. The specification uses “skirt” generically; no definition ties “the skirt” to a specific element (see ¶[0421]–[0423]). Ambiguity prevents a POSITA from knowing which structural features apply to which skirt. Examiner suggest applicant to identify the specific skirt by reference to Claim 1 or define in Claim 4.
Claims 8–10 recite “third surface” and “inwardly tapered section. ” Claims 8–10 introduce “third surface” and “inwardly tapered section” without prior definition in the specification or earlier claims. While the specification shows folded and double-layer skirts (see Fig. 14f, ¶[0431]–[0434]), it does not label surfaces as “first,” “second,” or “third.” Without clear definitions, a POSITA cannot determine whether the “third surface” is part of the inner layer, outer layer, or a fold, nor whether the taper is structural or functional. Examiner suggests applicant to Define “first surface,” “second surface,” and “third surface” in Claim 1 or the specification, and ensure taper is structurally described
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.
Claim(s) 1 and 4, is/are rejected under 35 U.S.C. 102(a) as being anticipated by Cohen-Tzemach et al. US 20170231761 A1.
Regarding claim 1, Cohen-Tzemach et al. disclose a valve prosthesis, comprising a stent and a skirt assembly,
wherein the stent (102) comprises an inflow end and an outflow end opposite to the inflow end along an axial direction of the stent, wherein the skirt assembly comprises at least two skirts (104, 106, 108) each surrounding the stent in a shape of a ring and having an inner edge (110) and an outer edge (112), wherein the inner edge is an edge of the skirt closer to an axis of the stent (Figs. 7A and 7B),
wherein the outer edge is an edge of the skirt farther away from the axis of the stent [0055], and wherein the inner edge is attached to the stent, and the outer edge forms a free end [0055],
wherein the at least two skirts are arranged with a spacing along the axial direction of the stent (Figs. 7A and 7B), and have different radial outer dimensions, and wherein the outer edge of at least one of the skirts is configured to be brought into contact with a native tissue [0053].
Regarding claim 4, Cohen-Tzemach et al. disclose the valve prosthesis according to claim 1, wherein the skirt assembly comprises a plurality of skirts with radial outer dimensions increasing or decreasing non-linearly in the direction from the outflow end to the inflow end.
Claim(s) 1, 4-10 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Qi US 20200289261 A1 .
Regarding claim 1, Qi discloses a valve prosthesis Fig. 15 ¶[0416], ¶[0436], comprising a stent and a skirt assembly,
wherein the stent (1) comprises an inflow end and an outflow end opposite to the inflow end along an axial direction of the stent, wherein the skirt assembly comprises at least two skirts (2a and 2b, Fig. 15) each surrounding the stent in a shape of a ring and having an inner edge and an outer edge wherein the inner edge is an edge of the skirt closer to an axis of the stent,
wherein the outer edge is an edge of the skirt farther away from the axis of the stent, and wherein the inner edge is attached to the stent, and the outer edge forms a free end (Fig. 15 ¶[0416], ¶[0427]),
wherein the at least two skirts are arranged with a spacing along the axial direction of the stent, and have different radial outer dimensions, and wherein the outer edge of at least one of the skirts is configured to be brought into contact with a native tissue (Fig. 15 ¶[0376], ¶[0416]) .
Regarding claim 4, Qui discloses the valve prosthesis according to claim 1, wherein the skirt assembly comprises a plurality of skirts with radial outer dimensions increasing or decreasing non-linearly in the direction from the outflow end to the inflow end. Qi’s disclosure of two skirts with different lengths and resulting radial profiles (¶[0132], ¶[0416]) and non-linear because it is based on skirt length, stacking method, and overlap
Regarding claim 5, Qi discloses a valve prosthesis comprising a stent (1) and a plurality of skirts (2a, 2b) arranged along the axial direction of the stent (Fig. 15 ¶[0416]-[0418], ¶[0132]). Qi’s Fig. 15 shows the first skirt (2a) positioned nearer to the outflow end of the stent (Fig. 15 ¶[0416], ¶[0427). Qi describes the arrangement of the first skirt (2a) overlapping the second skirt (2b), which is positioned farther away from the outflow end (closer to the inflow end). The overlap occurs due to skirt length and stacking configuration (Fig. 15 ¶[0055], ¶[0416]-[0418]). Qi explicitly states that the skirts are arranged one above the other in the axial direction, with portions overlapping to form multiple peripheral leakage occluders (Fig. 15 ¶[0055], ¶[0416]-[0418]).
Regarding claim 6, Qi discloses a valve prosthesis comprising a stent (1) and at least two skirts (2a, 2b) arranged with spacing along the axial direction (Fig. 15 ¶[0416]-[0418]). While Qi does not use the phrase “swirling cavity,” it inherently discloses a cavity between overlapping or axially adjacent skirts and the stent frame that would produce swirling flow under operation. This cavity is formed by the geometry of the skirts, their spacing, and their attachment points, as described in ¶[0416], ¶[0427], and shown in Fig. 15. Qi discloses that the cavity is bounded radially inward by the stent frame (1) and radially outward by the skirts (2a, 2b). The skirts surround the stent’s outer periphery, creating an enclosed annular space. Qi shows first and second skirts (2a, 2b) positioned one above the other along the axial direction, with spacing between them (axially adjacent).
Regarding claim 7, Qi discloses Qi’s skirts are formed from flexible biocompatible material (e.g., pericardium) that defines an inner surface facing the stent and an outer surface facing native tissue. These two surfaces are shown in folded/double-layer skirt embodiments (Fig. 14f, 14h and ¶[0431]-[0434] and Fig. 45c). Qi describes the inner edge of each skirt as the portion fixed to the stent, where the inner and outer surfaces meet and are joined (e.g., by stitching or fixing bands). Fig. 14f, Fig. 14h ¶[0421],[0431]-[0434]). Qi’s folded/double-layer skirt structures inherently cause the inner and outer surfaces to diverge as they extend toward the free outer edge, creating an expanded profile for sealing. This is shown in the stacked configuration illustrations and described in the context of forming a radial protrusion (Fig. 14f, Fig. 14h, Fig. 45c ¶[0431]-[0434], ¶[0456]-[0459]).
Regarding claim 8, Qi disclose (Fig. 14f, 14h, 15, and Fig. 45c) each of the skirt further comprises a third surface joined to each of the first surface and the second surface, wherein the first surface, the second surface and the third surface enclose to form the skirt, and wherein the outer edge is located on the third surface.
Regarding claim 9, Qi discloses the valve prosthesis according to claim 8, wherein the third surface comprises an inwardly tapered section, wherein the inwardly tapered section extends from the outer edge to the inflow end, and is inwardly inclined toward the axis of the stent (Fig. 45c).
Regarding claim 10, Qi discloses the valve prosthesis according to claim 8, wherein the first surface, the second surface and the third surface form a curved surface with smooth transitions (Fig. 45c).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qi (US 2020/0289261 A1) in view of Morriss et al. (US 2015/0142100 A1).
Qi teaches a valve prosthesis having at least two skirts arranged axially around a stent, the skirts having different radial outer dimensions and differing axial lengths (Qi ¶[0132], ¶[0416]–[0418]; Fig. 15). However, regarding claim 2, Qi silents wherein in a direction from the outflow end to the inflow end, the radial outer dimensions of the at least two skirts gradually increase or decrease. Regarding claim 3, Qi silents wherein the skirt assembly comprises a plurality of skirts with radial outer dimensions varying at a constant rate in the direction from the outflow end to the inflow end
Morriss teaches tapering of skirt radial dimension along the axial direction and specifically teaches embodiments where the radial outer dimension increases or decreases gradually along the axial length (Morriss ¶[0068]–[0070], Fig. 8) and wherein the radial dimension changes at a substantially constant rate along the axial direction (Morriss ¶[0070], Fig. 8/profile showing linear taper).
It would have been obvious to one of ordinary skill to apply Morriss’s gradual tapering profile to Qi’s multi‑skirt assembly so that the skirts’ radial outer dimensions change gradually from the outflow to the inflow end. Qi discloses the multi‑skirt baseline that addresses sealing; Morriss provides a known skirt‑profile modification that improves sealing/hemodynamics. Applying Morriss’s gradual variation to Qi’s skirts is a predictable design modification within ordinary skill.
Regarding claim 3, A POSITA would have been motivated to and would reasonably expect success in applying Morriss’s constant‑rate tapering to the skirts of Qi to achieve uniform linear change in radial outer dimension along the stent axis. This modification is within routine design choices to optimize sealing and is predictable in outcome.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen-Tzemach et al. US 20170231761 A1 in view of Morriss et al. US 20150142100 A1.
Cohen-Tzemach et al. disclose all the limitations as claimed in claim 1 and also disclose in paragraph [0053] that “the number of skirts in the two or more skirts may be variable and may depend on valve design and on leak obstruction optimization. Additionally and/or alternatively, locations of the two or more skirts along the valve height as well as the height of each skirt may vary depending on the particular application.”
Morriss teaches tapering of skirt radial dimension along the axial direction and specifically teaches embodiments where the radial outer dimension increases or decreases gradually along the axial length (Morriss ¶[0068]–[0070], Fig. 8) and wherein the radial dimension changes at a substantially constant rate along the axial direction (Morriss ¶[0070], Fig. 8/profile showing linear taper).
It would have been obvious to one of ordinary skill to apply Morriss’s gradual tapering profile to Cohen-Tzemach et al.’s multi‑skirt assembly so that the skirts’ radial outer dimensions change gradually from the outflow to the inflow end. Cohen-Tzemach et al. disclose the multi‑skirt baseline that addresses sealing; Morriss provides a known skirt‑profile modification that improves sealing/hemodynamics. Applying Morriss’s gradual variation to Cohen-Tzemach et al.’s skirts is a predictable design modification within ordinary skill.
Regarding claim 3, A POSITA would have been motivated to and would reasonably expect success in applying Morriss’s constant‑rate tapering to the skirts of Cohen- Tzemach et al. to achieve uniform linear change in radial outer dimension along the stent axis. This modification is within routine design choices to optimize sealing and is predictable in outcome.
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/TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771