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 .
Status of Claims
This office action is responsive to the amendment filed on 06/11/2026. As directed by the amendment: claims 5-8, 16 and 18 have been amended, claims 1-4, 9, 11-15 and 17 have been cancelled and no new claims have been added. Thus, claims 5-8, 10, 16 and 18-20 are presently pending in this application, and currently examined in the Office Action.
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.
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi et al. (US PG Pub. 2019/0053897), hereinafter Levi.
Regarding claim 5, Levi discloses a valve prosthesis (10), illustrated in Figures 1 and 2, comprising a stent structure (12), illustrated in Figures 3 and 4, comprising an inflow portion (IP) comprising a plurality of rows of cells (36 & 38) formed by inflow struts (22,24,26,28) and inflow crowns (54), the inflow portion including a distal crown ring (formed by struts 28) at an outflow end (portion IV) of the inflow portion (IP); and an outflow portion (OP) comprising an outflow portion crown ring (formed by struts 32) comprising outflow struts (32), outflow superior crowns (56), and outflow inferior crowns (46), commissure posts (30) extending between the outflow portion crown ring (formed by struts 32) and the inflow portion distal crown ring (formed by struts 28), and non-commissure posts (31) extending between the outflow portion crown ring (formed by struts 32) and the inflow portion distal crown ring (formed by struts 28), illustrated in Figures 3, 4 and modified figure 4, below; a prosthetic valve (14) coupled to the stent structure (12); and a tissue bumper (16) covering the non-commissure posts (31), illustrated in Figures 1 and 2 ([0044]; [0047]; [0050] – [0053]; [0055], Line 2 & [0058], Lines 7-8).
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Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quadri et al. (US PG Pub. 2010/0082094), hereinafter Quadri.
Regarding claims 16 and 20, Quadri discloses a valve prosthesis (600) comprising a stent structure (500) and an integral prosthetic valve (330) disposed within and coupled to the stent structure (500), illustrated in Figure 12 ([0108]), the integral prosthetic valve (330), illustrated in Figures 7-9B, comprising a cylindrical inflow end (352); valve leaflets (354); a valve inflow cylinder extending distally from the cylindrical inflow end (352) to the valve leaflets; an inner skirt (340) extending distally from the cylindrical inflow end (352); a fold at the cylindrical inflow end (352) and wherein the inner skirt (340) overlaps the valve leaflets (354), illustrated in Figures 7 and 8, wherein the integral prosthetic valve (330) is coupled to the stent structure (500) such that the inner skirt (340) is disposed between the stent structure (500) and the valve inflow cylinder, illustrated in Figures 8 and 12 ([0091] – [0094] & [0108]).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Levi as applied to claim 5 above, and in view of Nguyen-Thien-Nhon et al. (US PG Pub. 2017/0014229), as disclosed in the IDS dated 04/05/2026, hereinafter Nguyen.
Regarding claim 6, Levi discloses the valve prosthesis of claim 5, but does not specifically teach the tissue bumper comprises pericardial tissue.
However, Nguyen teaches a valve prosthesis, in the same filed of endeavor, comprising a tissue bumper (16) covering non-commissure posts (31), wherein the tissue bumper comprises pericardial tissue, illustrated in Figures 1-3 ([0053]).
In view of the teachings of Nguyen, 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 material for the tissue bumper, of the valve prosthesis of Levi, including pericardial tissue, as taught by Nguyen; since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Levi.
Regarding claim 7, Levi discloses the valve prosthesis of claim 5, wherein the tissue bumper (16) covers the shape of the non-commissure posts (31), illustrated in Figures 1 and 2 ([0055], Line 2 & [0058], Lines 7-8); and though it is not specifically disclosed that the non-commissure posts are shaped as a figure eight, 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 shape/from for the non-commissure posts, including a figure eight, since doing so amounts to a mere change in shape/from of a known structure; and a change in shape/form is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alon et al. (US Patent No. 8,652,202), as previously disclosed, hereinafter Alon.
Regarding claims 16 and 19, Alon discloses a valve prosthesis (10) comprising a stent structure (12) and a prosthetic valve (14) disposed within and coupled to the stent structure (12), illustrated in Figure 1 (Column 8, Lines 23-25 & Column 10, Lines 17-19); the prosthetic valve (14), illustrated in Figures 6 and 7, comprising a cylindrical inflow end (IFE); valve leaflets (34a-c); a valve inflow cylinder (IFC) extending distally from the cylindrical inflow end (IFE) to the valve leaflets; an inner skirt (42) extending distally from the cylindrical inflow end; cusps (C) between the valve leaflets and the valve inflow cylinder (IFC), the inner skirt (42) extending distally to a cylindrical outflow end (COE) which is proximal of the cusps (C), wherein the prosthetic valve (14) is coupled to the stent structure (12) such that the inner skirt (42) is disposed between the stent structure (12) and the valve inflow cylinder (IFC), 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, such that there is a fold at the cylindrical inflow end; the term “integral” is considered to be sufficiently broad to embrace constructions united by different means such as fastening, suturing etc. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the prosthetic valve, of the valve prosthesis of Alon, be integral such that there is a fold at the cylindrical inflow end between the leaflets and the inner skirt portions, 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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Allowable Subject Matter
Claims 8 and 10 are allowed.
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to independent claims 5 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 08/15/2026
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