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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 7-14, and 29 have been considered, but are moot in view of the new grounds of rejection.
Claim Objections
Claim 3 is objected to because of the following informalities: a typographical error in line 8 which recites the “commissure-receiving portion of the commissure.” It appears that it should recite the commissure-receiving portion of the commissure window. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 29 and its dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 29 recites that a first distance from an upper end of the commissure to the upper ends of the first and second axially extending window struts is greater than a second distance from a lower end of the commissure to the lower ends of the first and second axially extending window struts. The disclosure does not appear to have adequate support for this limitation. Appropriate correction is required.
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 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yohanan et al. (WO 2013/086413 A1; hereinafter “Yohanan”).
Yohanan discloses the following regarding claim 1: a prosthetic heart valve, comprising: an annular frame (302), comprising: a plurality of interconnected struts (310) defining a plurality of rows of cells (e.g., Fig. 15), the plurality of rows arranged between an outflow end (320) and an inflow end (314) of the frame and including an upper row of cells arranged at the outflow end (e.g., Fig. 15); and a plurality of commissure windows (openings formed by elements 322) formed between axially extending window struts of the frame (Fig. 15), each commissure window arranged between axially extending window struts of two adjacent cells of the upper row of cells (Fig. 15), each commissure window having a commissure-receiving portion (central space of window) that is spaced away from an upper end of the two adjacent cells (Fig. 15), the upper end arranged at the outflow end of the frame (Fig. 15), and wherein each commissure window has an open end (at its upper end) disposed closer to the upper end of the two adjacent cells than a lower end of the two adjacent cells (Figs. 15-15A); and a leaflet assembly (304) comprising a plurality of leaflets (308), each leaflet comprising opposing commissure tabs (e.g., 44; paras. 049-050, 072) on opposite sides of the leaflet (Figs. 6, 14), each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure (Figs. 6, 14; paras. 049-050, 072), wherein each commissure is arranged within the commissure-receiving portion of a respective commissure window (Figs. 14-15A; paras. 049-050, 072).
Yohanan discloses the following regarding claim 2: the prosthetic heart valve of claim 1, wherein the open end of each commissure window is formed by upper ends of the axially extending window struts that are spaced apart from one another (Fig. 15), in a circumferential direction (Fig. 15), and not directly connected to one another (Fig. 15), the circumferential direction relative to a circumference of the frame and arranged tangent to the axial direction (Fig. 15).
Yohanan discloses the following regarding claim 3: the prosthetic heart valve of claim 1, wherein each commissure window is formed between a first axially extending window strut (left side strut) of a first cell (left side cell) of the two adjacent cells (Fig. 15) and a second axially extending window strut (right side strut) of a second cell (right side cell) of the two adjacent cells, the first and second axially extending window struts spaced apart from one another at their upper ends and along their lengths and connected together at their lower ends by a lateral window strut portion (Figs. 15-15A), wherein each of the first and second axially extending window struts comprise a lower window strut portion (Fig. 15) and an upper window strut portion (Fig. 15), and wherein the commissure-receiving portion of the commissure is formed in a space between the lower window strut portion of the first axially extending window strut and the lower window strut portion of the second axially extending window strut (Fig. 15).
Yohanan discloses the following regarding claim 7: the prosthetic heart valve of claim 1, wherein the annular frame is radially expandable to an expanded configuration (para. 068).
Yohanan discloses the following regarding claim 8: a prosthetic heart valve, comprising: an annular frame (302) including a plurality of interconnected struts (310) defining a plurality of rows of cells (e.g., Fig. 15), the plurality of rows of cells arranged between an outflow end (320) and an inflow end (310) of the frame (e.g., Fig. 15) and including an upper row of cells arranged at the outflow end (Fig. 15); and a plurality of leaflets (308) situated within the frame (Fig. 14), each leaflet comprising opposing commissure tabs (e.g., 44) on opposite sides of the leaflet (Figs. 6, 14), each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure (Figs. 6, 14; paras. 049-050, 072); wherein struts defining the upper row of cells further define a plurality of open commissure windows (openings formed by element 322) that are open at an upper end (e.g., Figs. 15-15A) and formed between adjacent cells of the upper row of cells (Fig. 15), each commissure window formed between two axially extending window struts that are spaced apart from one another in a circumferential direction (Fig. 15), each commissure window comprising a lower region (lower open portion) configured to receive commissure tabs of the commissure (Fig. 15; para. 072).
Yohanan discloses the following regarding claim 9: the prosthetic heart valve of claim 8, wherein each axially extending window strut of the two axially extending window struts defines an axial side of a different cell of two adjacent cells (at the lower left and right side cells adjacent the commissure windows) of the upper row of cells (Fig. 15).
Yohanan discloses the following regarding claim 10: the prosthetic heart valve of claim 8, wherein each commissure window is closed at a lower end by a lateral window strut portion connecting lower ends of the two axially extending window struts together (Figs. 15-15A), the lower end arranged opposite the upper end in the axial direction (Figs. 15-15A).
Yohanan discloses the following regarding claim 11: the prosthetic heart valve of claim 10, wherein the lateral window strut portion (horizontal lower strut) further connects to angled struts (Figs. 15-15A) defining a portion of a cell of a second row of cells arranged adjacent to the upper row of cells (Figs. 15-15A).
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.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan in view of Gurovich et al. (Pub. No.: US 2018/0325665 A1; hereinafter “Gurovich”).
Yohanan discloses the limitations of the claimed invention, as described above. Yohanan teaches a window strut of the two axially extending window struts of each commissure window includes a lower window strut portion and an upper window strut portion (Fig. 15). However, it does not explicitly recite the commissure windows comprising a recessed portion. Gurovich teaches that it is well known in the art that each axially extending window strut (e.g., 456) of the two axially extending window struts of each commissure window (e.g., 480) includes a lower window strut portion and an upper window strut portion (please see, for example, annotated Figure A, below), wherein a first gap (e.g., Figure A) between upper window strut portions of the two axially extending window struts forms the upper region of the commissure window (Figure A; e.g., Figs. 39, 59, 77-80), wherein a second gap (e.g., Figure A) between lower window strut portions of the two axially extending window struts forms the lower region of the commissure window (Figure A; e.g., Figs. 39, 59, 77-80), wherein each upper window strut portion includes a recessed portion (e.g., 486, 510, etc.) , and wherein the first gap is greater than the second gap (Figure A; e.g., Figs. 39, 59, 77-80). This configuration aid in securing the leaflets to the frame (paras. 0144, 0157-0158). Gurovich further teaches a window fastener (e.g., 704, 1002) positioned within the upper region of each commissure window and configured to maintain a relatively constant distance between the two axially extending window struts (paras. 0165-0167, 0174-0177). This configuration helps to better securing the leaflets to the frame (paras. 0144, 0157-0158, 0165-0167, 0174-0177). Gurovich teaches that the window fastener comprises a middle portion (e.g., central portions of elements 704, 1002) and two opposing end portions (left and right side portions), the middle portion extending between the two end portions (e.g., Figs. 79-80), the two end portions having a width that is wider than a width of the middle portion (e.g., Figs. 79-80), the widths arranged in the circumferential direction, and wherein the middle portion is arranged within the first gap (e.g., Figs. 79-80), a first end portion of the two end portions extending circumferentially along and between radially outward facing sides of the upper window strut portions of the two axially extending window struts (e.g., Figs. 79-80) (as it is placed in the recesses), and a second end portion of the two end portions extending circumferentially along and between radially inward facing sides of the upper window strut portions (e.g., Figs. 79-80). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the shape and configuration of the commissure window of Yohanan, according to the teachings of Gurovich, in order to better secure the leaflets to the frame. Such a modification would be made with a reasonable expectation of success.
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Figure A.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan in view of Levi et al. (AU 2015268755 A1; hereinafter “Levi”).
Yohanan discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that a first distance from an upper end of the commissure to the upper ends of the first and second axially extending window struts is greater than a second distance from a lower end of the commissure to the lower ends of the first and second axially extending window struts. Levi teaches that it is well known in the art that the leaflet’s commissure is arranged within the commissure receiving portion of a respective commissure window such that a first distance from an upper end of the commissure to the upper ends of the first and second axially extending window struts is greater than a second distance from a lower end of the commissure to the lower ends of the first and second axially extending window struts (paras. 0017-0018, 0059-0060; Figs. 34-35). This configuration protects the leaflets and provide them with the desired positions and flexibility. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the position of the commissure of Yohanan, according to the teachings of Levi, in order to protect the leaflets and provide them with the desired positions and flexibility. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774
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