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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-13 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 8-10, 12-15, 18 and 19 of U.S. Patent No. 11,951,000, hereinafter ‘000, in view of Spence et al. (WO 2013/114214), as disclosed in the IDS dated 03/25/2024, hereinafter Spence; and claims 1, 5, 6 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 19 and 20 of U.S. Patent No. 10,016,272, hereinafter ‘272, in view of Spence. Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims set forth similar limitations of a coiled anchor and/or a system for implanting at, and repairing, a native mitral valve.
Regarding claim 1, of the current application at hand, both ‘000 and ‘272 disclose a coiled anchor comprising a plurality of ventricular/central and lower turns; an atrial/upper turn connected to the plurality of ventricular/central and lower turns; wherein the coiled anchor is configured to be implanted at a native mitral valve with the plurality of ventricular/central and lower turns positioned in a left ventricle and around native leaflets, the ventricular/central and lower turns have different unbiased sizes, and wherein a first/central ventricular turn and a second/lower ventricular turn are configured such that when a radially outward pressure is applied to at least one of the plurality of ventricular turns, the sizes of the first/central ventricular turn and the second/lower ventricular turn become the same (claims 1 & 10 of ‘000 & claims 1 & 19 of ‘272); but, neither ‘000 or ‘272 disclose that the atrial/upper turn and the ventricular/central and lower turns are covered by a biocompatible fabric. However, Spence teaches a coiled implant, in the same field of endeavor, wherein the coiled implant/turns of the coiled implant are covered by a biocompatible fabric, in order to aid in tissue ingrowth (Spence: [00215]). In view of the teachings of Spence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the atrial/upper turn and the ventricular/central and lower turns, of the coiled anchor of ‘000 and ‘272, to be covered by a biocompatible fabric, in order to aid in tissue ingrowth, as taught by Spence.
Regarding claim 2, of the current application at hand, claim 5 of ‘000 discloses the same parameter of “the coiled anchor is configured for positioning such that the one or more atrial turns do not engage an inner wall of a left atrium when the coiled anchor is expanded”.
Regarding claim 3, of the current application at hand, claim 8 of ‘000 discloses the same parameter of “the one or more atrial turns is a single atrial turn”.
Regarding claim 4, of the current application at hand, claim 9 of ‘000 discloses the same parameter of “an axial distance between a centerline of a first cross-section the first ventricular turn and a centerline of a second cross-section of the second ventricular turn is less than a second axial distance between the centerline of the first cross-section of the first ventricular turn and a third centerline of a cross-section of the single atrial turn”.
Regarding claims 5 and 12, of the current application at hand, both ‘000 and ‘272 disclose a coiled anchor comprising a plurality of ventricular/central and lower turns; an atrial/upper turn connected to the plurality of ventricular/central and lower turns; wherein the coiled anchor is configured to be implanted at a native mitral valve with the plurality of ventricular/central and lower turns positioned in a left ventricle and around native leaflets, the plurality of ventricular turns comprise a first/central turn and a second/lower turn, wherein the first/central turn and the second/lower turn have different unbiased sizes; and a prosthetic valve comprising an expandable frame, configured to be expanded in an inner space defined by the plurality of ventricular turns, and a one way valve, comprising a plurality of leaflets, disposed within the expandable frame; and wherein the plurality of ventricular turns and the expandable frame are configured such that radially outward pressure applied to at least one of the plurality of ventricular turns due to expansion of the expandable frame causes the sizes of the first/central ventricular turn and the second/lower ventricular turn to become the same (claims 2 & 10 of ‘000 & claims 9 & 19 of ‘272); but, neither ‘000 or ‘272 disclose that the atrial/upper turn and the ventricular/central and lower turns are covered by a biocompatible fabric. However, Spence teaches a coiled implant, in the same field of endeavor, wherein the coiled implant/turns of the coiled implant are covered by a biocompatible fabric, in order to aid in tissue ingrowth (Spence: [00215]). In view of the teachings of Spence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the atrial/upper turn and the ventricular/central and lower turns of the coiled anchor, of the system of ‘000 and ‘272, to be covered by a biocompatible fabric, in order to aid in tissue ingrowth, as taught by Spence.
Regarding claim 6, of the current application at hand, claim 12 of ‘000 and claim 20 of ‘272 disclose the same parameter of “wherein at least one of the one or more atrial turns and the plurality of ventricular turns of the coiled anchor is configured to attach to an outer surface of the expandable frame”.
Regarding claim 7, of the current application at hand, claims 4 and 13 of ‘000 disclose the same parameter of “the coiled anchor is configured for positioning such that the one or more atrial turns are spaced apart from an outer surface of the expandable frame when the expandable frame is expanded”.
Regarding claim 8, of the current application at hand, claims 5 and 14 of ‘000 disclose the same parameter of “the one or more atrial turns do not engage an inner wall of a left atrium when the expandable frame is expanded”.
Regarding claim 9, of the current application at hand, claims 6 and 15 of ‘000 disclose the same parameter of “at least one of the plurality of ventricular turns is configured to compress the valve leaflets of the native mitral valve against an outer surface of the expandable frame of the prosthetic valve when the expandable frame is expanded”.
Regarding claim 10, of the current application at hand, claim 18 of ‘000 discloses the same parameter of “the one or more atrial turns is a single atrial turn and wherein an axial distance between a centerline of a first cross-section of the first ventricular turn and a centerline of a second cross-section of the second ventricular turn is less than a second axial distance between the centerline of the first cross-section of the first ventricular turn and a centerline of a third cross-section of the single atrial turn”.
Regarding claim 11, of the current application at hand, claim 19 of ‘000 discloses the same parameter of “a clip configured to hold respective ends of the valve leaflets of the native mitral valve together”.
Regarding claim 13, of the current application at hand, claim 18 of ‘000 discloses a coiled anchor comprising a plurality of ventricular/central and lower turns that are configured to extend around native leaflets of a native mitral valve; a single atrial/upper turn connected to the plurality of ventricular/central and lower turns, wherein the coiled anchor is configured to be implanted at the native mitral valve with the plurality of ventricular/central and lower turns positioned in a left ventricle and around the native leaflets, the plurality of ventricular turns comprise a first/central turn and a second/lower turn, wherein the first/central turn and the second/lower turn have different unbiased sizes; and a prosthetic valve comprising an expandable frame, a plurality of leaflets disposed within the expandable frame for controlling blood flow through the prosthetic valve; and wherein the plurality of ventricular/central and lower turns and the expandable frame are configured such that applied pressure to at least one of the plurality of ventricular turns due to expansion of the expandable frame causes the sizes of the first/central ventricular turn and the second/lower ventricular turn to become the same; but does not disclose that the coiled anchor comprises shape memory material, the single atrial/upper turn and the ventricular/central and lower turns are covered by a biocompatible fabric, and a balloon for expanding/inflating the expandable frame. However, Spence teaches a coiled implant with a prosthetic valve, comprising an expandable frame, therewithin, in the same field of endeavor, wherein the coiled implant comprise a shape memory material, the coiled implant/turns of the coiled implant are covered by a biocompatible fabric, in order to aid in tissue ingrowth, and a balloon to inflate/expand the expandable frame of the prosthetic valve within the coiled implant (Spence:[0022], 10th to Last Line; [00159] & [00215]). In view of the teachings of Spence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the atrial/upper turn and the ventricular/central and lower turns of the coiled anchor, of the system of ‘000, to be covered by a biocompatible fabric, in order to aid in tissue ingrowth; for the coiled anchor to comprise a shape memory material; and to further comprise a balloon in order to inflate/expand the expandable frame of the prosthetic valve within the coiled implant, as taught by Spence.
Regarding claim 18, of the current application at hand, claim 18 of ‘000 discloses the same parameter of “an axial distance between a centerline of a first cross-section of the first ventricular turn and a centerline of a second cross-section of the second ventricular turn is less than a second axial distance between the centerline of the first cross-section of the first ventricular turn and a centerline of a third cross-section of the single atrial turn.
Allowable Subject Matter
Claims 1-19 would be allowable if the Double Patenting rejection(s), set forth in this Office Action are overcome by filing an e-Terminal Disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches a coiled anchor, and/or a system, for implanting in, and repairing, a native mitral valve including all the structural limitations set forth in independent claims 1, 5 and 13. The closest related art of Spence et al. (WO 2013/114214), as disclosed in the IDS dated 03/25/2024, hereinafter Spence, teaches a coiled anchor (72), illustrated in Figures 1G-1K, comprising a plurality of ventricular turns (104), comprising first and second ventricular turns which have different unbiased sizes, one or more atrial turns (108a/108b) connected to the plurality of ventricular turns, wherein the ventricular and atrial turns are covered by a biocompatible fabric, the coiled anchor (72) configured to be implanted at a native mitral valve (44) with the plurality of ventricular turns (104) positioned in a left ventricle (10) and around valve leaflets (38/42); and a prosthetic valve (120) comprising an expandable frame (126) configured to be expanded in an inner space defined by the plurality of ventricular turns of the coiled anchor (72); a one way valve comprising leaflets (122/124) disposed within the expandable frame (126), illustrated in Figures 1G-1K ([0014] – [00117] & [0215]). However, Spence does not teach the plurality, i.e. first and second, ventricular turns (and the expandable frame if applicable) are configured such that radially outward pressure applied to at least one of the plurality of ventricular turns causes the sizes of the first and second ventricular turns to become the same.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 01/07/2026