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 .
Claim Objections
Claim 3 is objected to because of the following informalities: “wherein the axial connections portions”. The examiner suggests amending this informality to “wherein the axial connection portions”. 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 11-14 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 11 recites the limitation “wherein the frame comprises” in line 1. It is unclear whether this claim is referring to the inner frame or the outer frame. For examination purposes, the limitation has been interpreted to be “wherein the inner frame comprises” (Specification Paragraph [0030] describes such inner frame).
Claims 12-14 are also rendered indefinite due to their dependency from indefinite claim 11.
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, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. (PG Pub No. US 2019/0262129 A1).
Regarding claim 1, Cooper discloses a valve prosthesis (prosthesis 100) adapted for non-uniform compression during loading into a capsule (curved and bendable axial connection portion structure allows for non-uniform compression; see Fig. 7A and Fig. 7B), the valve prosthesis comprising: a self-expanding frame (Paragraph [0103], outer frame 140) configured to transition between a compressed configuration (Fig. 7A) and an expanded configuration (Fig 7B) (Paragraph [0103]), the frame including at least one row of cells forming a ring (see Fig. 6A, Fig. 7A, and annotated Fig. 7B below); and a plurality of prosthetic valve leaflets (Paragraph [0151], frame 140 “can be incorporated into a prosthesis with any of the inner frames”, 120, 220, Paragraph [0135], Figs. 5F-5I, leaflets 231) coupled to the frame (Paragraph [0151], frame 140 “can be incorporated into a prosthesis with any of the inner frames”, 120, 220, Paragraph [0135], Figs. 5F-5I, leaflets 231) wherein the frame includes a plurality of pre-curved axial connection portions (156b), each axial connection portion extending between a top end and bottom end of each cell of the at least one row of cells (see Fig. 6A) wherein each axial connecting portion is adapted to bend in a predetermined manner (156b, see Fig. 6A and Fig. 7B) for accommodating changes in cell height during non-uniform compression of the valve prosthesis (Paragraph [0166]), and wherein the axial connection portions are curved in a circumferential direction (Paragraph [0167], see Figs. 6A and 7B).
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Regarding claim 3, Cooper discloses wherein the axial connections portions (156b) allow each cell of the at least one row of cells (see Fig. 6A) to foreshorten during loading (the curved and bendable structure of the axial connection portions 156b are structured as claimed thereby allows for non-uniform compression of the valve during loading a claimed).
Regarding claim 5, Cooper discloses wherein each axial connection portion (156b) comprises a pair of axial struts (156b, see annotated Fig. 7A above) forming a slot therebetween (see annotated Fig. 7A above) and wherein each axial strut of the pair of axial struts bends in an opposite direction (see Fig. 7B).
Claim(s) 10-14, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. (PG Pub No. US 2019/0262129 A1).
Regarding claim 10, Cooper discloses a valve prosthesis (prosthesis 100) adapted for non-uniform compression during loading into a capsule (curved and bendable axial connection portion structure allows for non-uniform compression; see annotated Fig. 5A below), the valve prosthesis comprising: a self-expandable outer frame (140) configured to transition back and forth between a compressed configuration and an expanded configuration (Paragraph [0103]); and a self-expandable inner frame (Paragraphs [0103] and [0130], inner frame 120 or 220) positioned within the self-expandable outer frame (Figs. 1 and 5J), the self-expandable inner frame (120 or 220) configured to transition back and forth between a compressed configuration and an expanded configuration (capable of being collapsed and expanded as needed), wherein the inner frame comprises a plurality of strut components (Fig. 2, struts 138) that are biased in a particular configuration or shape so as to bend or deform in a desired direction (Figs. 2, 3, 5A) during transition of the self-expandable inner frame (120 or 220) between the expanded configuration and the compressed configuration or between the compressed configuration and the expanded configuration (Figs. 2, 3, 5A).
Regarding claim 11, Cooper discloses wherein the frame (inner frame 120 or 220) comprises a plurality of rows of cells formed by struts (Fig. 2, cells 134a and 134b, struts 136a, 136b).
Regarding claim 12, Cooper discloses wherein at least a plurality of cells of a distal-most row of the plurality of rows of cells (Fig. 2, Cells 134b) includes the plurality of strut components (138; Fig. 2).
Regarding claim 13, Cooper discloses wherein the plurality of strut components (138, see annotated Fig. 5A below) comprise axial struts (see annotated Fig. 5A below) connecting a distal apex (lower apices of 134b, see annotated Fig. 5A below) of each cell of the plurality of cells with a distal apex of a bordering cell in a row immediately above the distal-most row (see annotated Fig. 5A below).
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Regarding claim 14, Cooper discloses wherein the axial struts (138) are adapted to prevent cell ovality during transition of the self-expandable inner frame (120, 220) between the expanded configuration and the compressed configuration, and/or vice-versa (the axial struts 138 are structured as claimed; therefore, they are adapted to perform the function of preventing cell ovality as claimed; see also Figs. 2, 3, 5A).
Regarding claim 16, Cooper discloses wherein the cells comprise chevron-shaped cells (Paragraph [0120]).
Regarding claim 20, Cooper discloses wherein the outflow end of the inner frame (Figs. 2, 5A, Lower end 130, 230) comprises a plurality of anchors (124), and wherein at least some of the plurality of anchors (124) comprise a metallic cushion anchor tip (Fig. 2, paragraph [0116]; Anchor tip 124a) configured to distribute and dampen a load exerted on native tissue in contact with the anchor tip (Paragraph [0111]).
Claim(s) 10, 15-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. (PG Pub No. US 2019/0262129 A1).
Regarding claim 10, Cooper discloses a valve prosthesis (prosthesis 100) adapted for non-uniform compression during loading into a capsule (curved and bendable strut structure allows for non-uniform compression), the valve prosthesis comprising: a self-expandable outer frame (Fig. 1, outer frame 140) configured to transition back and forth between a compressed configuration and an expanded configuration (Paragraph [0103]); and a self-expandable inner frame (Paragraph [0103], Figs. 1-3, inner frame 120) positioned within the self-expandable outer frame (Fig. 1), the self-expandable inner frame (120) configured to transition back and forth between a compressed configuration and an expanded configuration (capable of being collapsed and expanded as needed), wherein the inner frame comprises a plurality of strut components (Figs. 2 and 3, struts 136b) that are biased in a particular configuration or shape so as to bend or deform in a desired direction (Figs. 2, 3) during transition of the self-expandable inner frame (120) between the expanded configuration and the compressed configuration or between the compressed configuration and the expanded configuration (Figs. 2, 3).
Regarding claim 15, Cooper discloses wherein the plurality of strut components (136b) comprise dual bow-spring structures (Fig. 3, adjacent pairs of 136b’s bow outward in opposite directions when expanded) comprising two axial strut segments (two adjacent 136b’s) connected at their proximal and distal ends (to 138 and 124, respectively) but separated along their lengths (see Fig. 2).
Regarding claim 16, Cooper discloses wherein the cells comprise chevron-shaped cells (Paragraph [0120]).
Regarding claim 17, Cooper discloses wherein the plurality of strut components (136b) comprise a single bow-spring structure (Fig. 2, each 136b bows outward in opposite directions when expanded) adapted to prevent cell ovality of the chevron- shaped cells (Fig. 2) during the transition between the compressed configuration (Fig. 3) and the expanded configuration (Fig. 2) and/or between the expanded configuration (Fig. 2) and the compressed configuration (Fig. 3).
Regarding claim 19, Cooper discloses wherein the bow-spring structures are symmetric (Fig. 2).
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.
Claim(s) 1-4, and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (PG Pub No. US 2019/0262129 A1) in view of Wang et al. (PG Pub No. US 2021/0205077).
Regarding claim 1, Cooper discloses a valve prosthesis (prosthesis 100) adapted for non-uniform compression during loading into a capsule (curved and bendable axial connection portion structure allows for non-uniform compression; see annotated Fig. 5A below), the valve prosthesis comprising: a self-expanding frame (Paragraphs [0103] and [0130], inner frame 120 or 220) configured to transition between a compressed configuration and an expanded configuration (Paragraph [0103]), the frame including at least one row of cells forming a ring (134a, 134b; see Fig. 4 and annotated Fig. 5A below); and a plurality of prosthetic valve leaflets (Paragraph [0135], Figs. 5F-5I, leaflets 231) coupled to the frame (Paragraph [0135], Figs. 5F-5I, leaflets 231) wherein the frame includes a plurality of pre-curved axial connection portions (138; see Fig. 4 and annotated Fig. 5A below), each axial connection portion extending between a top end and bottom end of each cell of the at least one row of cells (see annotated Fig. 5A below) wherein each axial connecting portion is adapted to bend in a predetermined manner (see annotated Fig. 5A below) for accommodating changes in cell height during non-uniform compression of the valve prosthesis (Paragraph [0123]).
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Cooper fails to disclose wherein the axial connection portions (138) are curved in a circumferential direction. Wang also discloses a valve prosthesis (Fig. 1, tubular body 5) comprising axial connection portions (9) extending between a top end and bottom end of each cell (103) of a row of cells (Fig. 1). Wang teaches wherein the axial connection portions (9) are curved in a circumferential direction (Fig. 1 s-shaped). 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 modified Cooper’s axial connection portions to be curved in a circumferential direction, as taught by Wang, in order to impart flexibility to the axial connection portions enabling stretching and compressing as needed (Paragraph [0046]).
Regarding claim 2, Cooper in view of Wang discloses wherein the axial connection portions have an asymmetric shape (Fig. 1, s-shaped).
Regarding claim 3, Cooper in view of Wang discloses wherein the axial connections portions (138; see Fig. 4 and annotated Fig. 5A above) allow each cell (134a, 134b; see Fig. 4 and annotated Fig. 5A above) of the at least one row of cells to foreshorten during loading (the curved and bendable structure of the axial connection portions 138 are structured as claimed thereby allows for non-uniform compression of the valve during loading a claimed).
Regarding claim 4, Cooper in view of Wang discloses wherein each axial connection portion comprises a single, curved axial strut (axial struts 138, see annotated Fig. 5A above, with s-shape as modified by Wang).
Regarding claim 6, Cooper in view of Wang further discloses further comprising a conformable outer frame (Fig. 1, outer frame 140) for engaging tissue in a native heart valve (Figs. 1 and 5J).
Regarding claim 7, Cooper in view of Wang further discloses wherein each cell of the at least one row of cells has a chevron shape (Paragraph [0120]).
Regarding claim 8, Cooper in view of Wang further discloses wherein each cell of the at least one row of cells has a diamond shape (Paragraph [0120]).
Regarding claim 9, Cooper in view of Wang further discloses wherein the self-expanding frame is an inner frame (Paragraph [0103], inner frame 120) of a dual-frame assembly (Fig. 1, Outer frame 140, inner frame 120, prosthesis 100) and wherein the valve prosthesis further comprises an outer self-expanding frame (Paragraph [0103], outer frame 140) coupled to and surrounding the inner frame (Figs. 1 and 5J), wherein the outer self-expanding frame (140) is configured to transition back and forth between a compressed configuration and an expanded configuration when constrained and when unconstrained, respectively (Paragraph [0103]; capable of being collapsed and expanded as needed).
Claim(s) 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (PG Pub No. US 2019/0262129 A1) as applied to claim 16 under the first interpretation above, and further in view of Wang et al. (PG Pub No. US2021/0205077).
Regarding claim 17, Cooper fails to disclose wherein the plurality of strut components comprise a single bow-spring structure.
Wang also discloses a prosthesis (Fig. 1, tubular body 5) comprising a plurality of strut components (9) extending between a top end and bottom end of each cell (103) of a row of cells (Fig. 1). Wang teaches the plurality of strut components (9) comprise a single bow-spring structure (Fig. 1 s-shaped strut). 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 modified Cooper’s plurality of strut components to comprise a single bow-spring structure, as taught by Wang, in order to impart flexibility to the plurality of strut components enabling stretching and compressing as needed (Paragraph [0046]). Cooper in view of Wang discloses each single-bow structure is adapted to prevent cell ovality of the chevron-shaped cells during the transition between the compressed configuration and the expanded configuration and/or between the expanded configuration and the compressed configuration (the structures are structured as claimed; therefore, they are adapted to perform the function of preventing cell ovality as claimed).
Regarding claim 18, Cooper in view of Wang discloses the bow-spring structures are asymmetric (Fig. 1 s-shaped struts 9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI L COCHRAN/ Patent Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774