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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the valve prosthesis comprising valve leaflets, a valve inflow cylinder proximal the valve leaflets, first support stitching circumferentially around the inflow cylinder, second support stitching circumferentially around the inflow cylinder and longitudinally spaced from the first support stitching, a circumferential space between the first and second support stitching, and a stent structure coupled to the circumferential space by margin of attachment stitching (claim 15) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claims 9, 15 and 18 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.
Regarding claim 9, it is unclear what, if any, additional structural limitations are imparted on the final structure of the claimed device by the parameter set forth in this claim. Specifically, the parameter set forth in this claim merely seems to be reciting a function of the first supporting stitching, however does not include, or suggest, any additional structure which would be needed in order to meet this function/parameter. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 15, which sets forth the parameter of “margin of attachment (MOA) stitching coupling the circumferential space to the stent structure”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “margin of attachment (MOA) stitching”. Specifically, it is not clear what exact structure/pattern would be needed in order to meet the claimed parameter of having margin of attachment (MOA) stitching coupling the stent structure of the circumferential space; and the originally filed disclosure does not aid in clarifying what structure/pattern a “margin of attachment (MOA) stitching” would be. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 18, which sets forth the parameter of “the inner skirt comprising inner skirt cells matching the inflow portion cells” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “inner skirt cells”. Specifically, are inner skirt cells cellular agents/products in/on the inner skirt, or are they openings/windows in the inner skirt, or are they something else completely different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz et al. (WO 2019/144036), as disclosed in the IDS dated 06/23/2024, hereinafter Schwartz.
Regarding claims 5 and 6, Schwartz discloses a valve prosthesis (600), illustrated in Figures 32-36, comprising a stent structure (602); a prosthetic valve (612) coupled to the stent structure, wherein the stent structure (602) comprises an outflow portion (610) comprising an outflow portion crown ring comprising superior crowns (606) coupled to outflow portion struts (604); and a superior tissue bumper (616) covering the superior crowns (606) and the outflow portion struts (604), illustrated in Figures 32-36 ([0160] & [0162], Lines 3-5).
Claims 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duran et al. (US PG Pub. 2004/0215333), hereinafter Duran.
Regarding claims 8-10, Duran discloses a valve prosthesis comprising a prosthetic valve (15) comprising valve leaflets (3); a valve inflow cylinder (IC) proximal of the valve leaflets (3); and a first support stitching (17) extending in a circumferential direction around the valve inflow cylinder (IC), the first support stitching (17) being less elastic than, and supporting, the valve inflow cylinder/pericardium, and the first support stitching (17) extending in and out of the valve inflow cylinder from an outer surface of the valve inflow cylinder to an inner surface of the valve inflow cylinder through the valve inflow cylinder, illustrated in Figures 4-6 and modified figure 6, below ([0063] – [0065]).
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Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mathison (US Patent No. 7,998,196).
Regarding claims 16 and 20, Mathison teaches a valve prosthesis comprising an integral prosthetic valve (100’) comprising a cylindrical inflow end (104’); valve leaflets (outlined by cusps 108a-c); a valve inflow cylinder (a layer in the portion from 104’ to 107) extending distally from the cylindrical inflow end to the valve leaflets; and an inner skirt (the other layer extending from 104’ to 102’) extending distally from the cylindrical inflow end and overlapping the valve leaflets, illustrated in Figures 1D1 and 1E (Column 8, Lines 37-65).
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Braido et al. (US PG Pub. 2015/0289973), as disclosed in the IDS dated 06/23/2024, hereinafter Braido.
Regarding claims 1-4, Braido discloses a valve prosthesis (800), illustrated in Figure 8, comprising a stent structure (802); a prosthetic valve/leaflets coupled to the stent structure, wherein the stent structure (802) comprises an inflow portion (IP) comprising an outflow crown ring (CR) comprising outflow struts (803), outflow crowns (OC) coupled to the outflow struts (803), and central crowns (CC); and an inferior tissue bumper (850) covers the outflow crowns (OC), the outflow struts (803), and the central crowns (CC), wherein the inferior tissue bumper prevents the prosthetic valve/leaflets from contacting the outflow crowns, illustrated in Figure 8 and modified figure 8, below ([0038] & [0039] – to clarify, it is stated that the tissue bumper/buffer strip 850 can include at tops, and/or bottoms, of a full row of cells 812; thereby teaching and/or being obvious to one having ordinary skill in the art before the effective filing date of the invention for the tissue bumper/buffer strip 850 to cover the outflow struts, outflow crowns, and central crowns, of the outflow crown ring CR of the inflow portion IP, of the valve prosthesis, as claimed).
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Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz as applied to claim 5 above, and further in view of Ben Zaken et al. (WO 2022/076508), as disclosed in the IDS dated 06/23/2024, hereinafter Ben Zaken.
Regarding claim 7, Schwartz discloses the valve prosthesis of claim 5, wherein the outflow portion (610) further comprises non-commissure posts, illustrated in Figures 33-36; but does not specifically disclose the superior tissue bumper further covering the non-commissure posts.
However, Ben Zaken teaches a valve prosthesis, in the same field of endeavor, comprising non-commissure posts covered with a tissue bumper/pad (170b), illustrated in Figures 19 and 20; the tissue bumper/pad configured to be placed at any location/struts that would contact leaflets, in order to protect the leaflets from damage as they open against the frame/stent ([0592], Last 2 Lines & [0604]).
In view of the teachings of Ben Zaken, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the non-commissure posts, of the valve prosthesis of Schwartz, to further be covered by the superior tissue bumper, in order to protect valve leaflets from damage as they open against the stent, as taught by Ben Zaken.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Duran.
Regarding claims 11-14, Duran discloses the valve prosthesis of claim 8, wherein the support stitching (17) comprises sutures ([0064], Lines 10-14); and though it is not specifically disclosed that a second support stitching, less elastic than the valve inflow cylinder, extends in the circumferential direction around the valve inflow cylinder, longitudinally spaced from the first support stitching, such that there is a circumferential space defined between the first and second support stitching, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate amount of supports stitching to have in the inflow cylinder, including a second support stitching longitudinally spaced from the first support stitching such that there is a circumferential space between the two, since doing so amounts to mere duplication of the essential working parts, i.e. support stitching, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Alon et al. (US Patent No. 8,652,202), hereinafter Alon.
Regarding claims 16 and 17, Alon discloses a valve prosthesis (10), illustrated in Figures 6 and 7, comprising a prosthetic valve (14) comprising a cylindrical inflow end (44); valve leaflets (34a-c); a valve inflow cylinder (IFC) extending distally from the cylindrical inflow end (44) to the valve leaflets; an inner skirt (42) extending distally from the cylindrical inflow end (44), and a stent structure (20) coupled to the prosthetic valve, the inner skirt (42) being between the valve inflow cylinder (IFC) and the stent structure (12), illustrated in Figures 6, 7 and modified figure 6, below (Column 10, Lines 5-22); and though it is not specifically disclosed the prosthetic valve is integral, the term “integral” is considered to be sufficiently broad to embrace constructions united by different means such as fastening, suturing etc., and it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the prosthetic valve, of the valve prosthesis of Along, be integral, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04).
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Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US PG Pub. 2015/0209136), hereinafter Braido’136.
Regarding claims 16 and 19, Braido’136 discloses a valve prosthesis (1000), illustrated in Figures 10A and 10B, comprising a prosthetic valve/valve assembly (1008) comprising a cylindrical inflow end (1011); valve leaflets (1010); a valve inflow cylinder (1012), extending distally from the cylindrical inflow end (1011) to the valve leaflets (1010); an inner skirt (1020), extending distally from the cylindrical inflow end (1011); and cusps (C) between the valve leaflets (1010) and the valve inflow cylinder (1012), wherein the inner skirt (1020) extends distally to a cylindrical outflow end (1052) proximal of the cusps (C), illustrated in Figures 10A, 10B and modified figure 10A, below ([0139]; [0140] & [0142]); and though it is not specifically disclosed the prosthetic valve/valve assembly (1008) is integral, the term “integral” is considered to be sufficiently broad to embrace constructions united by different means such as fastening, suturing etc., and it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the prosthetic valve/valve assembly, of the valve prosthesis of Braido‘136, be integral, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 03/05/2026