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 claims 1-2, 5-6, 8-12, 15-20 have been considered but are moot in view of the new grounds for rejection. Applicant has amended independent claims 1, 11, and 16 to recite a plurality of anchors extending radially from the distal portion of the inner frame shaped to hold native leaflets. In response to Applicant’s amendment, Examiner now cites Cooper et al. (Pub. No.: US 2019/0262129).
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 1-2, 5-6, 8-10 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 1 recites “the outer frame is adapted to move axially or tilt with respect to the inner frame,” and also recites “a flexible body . . . coupling the distal end portion of the outer frame to the distal portion of the inner frame (i) in a manner that spans and closes the annular gap.” These limitations together are indefinite, as it is unclear what the claim limitation “closes the annular gap” refers to.
The tilting outer frame/sealing body is described in relation to figures 86-88 and paragraphs 379-380. In these figures, annular gap 493 is not closed because it remains throughout the tilting process. Examiner suggests specifying the annular gap is closed at the distal portion of the outer frame (language from canceled claim 4) to specify that the closure referred to is at the distal end, and is not closure of the entire annular gap (as in figures 28-35 with a braid material 172 and sealing skirt 190 which fill the annular gap).
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 1-2, 5-6, 8-12, 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. (Pub. No.: US 2019/0262129).
Cooper et al. (hereinafter, Cooper) discloses a prosthetic heart valve for deployment in a native mitral valve (abstract), the prosthetic heart valve comprising:
a plurality of prosthetic leaflets (abstract);
an inner frame 120 supporting the plurality of prosthetic leaflets (e.g., abstract) and having a proximal portion 126 and a distal portion 130;
an outer frame 140 positioned radially outward from the inner frame, spaced from the inner frame with an annular gap (e.g., fig. 5J), and having a proximal end portion 146 and a distal end portion 150; and
a flexible body 180 comprising a cloth material (e.g., para. 189-190) coupling the distal end portion of the outer frame to the distal portion of the inner frame (e.g., fig. 9-11, 14A, 14B, para. 183, 191-193) (i) in a manner that spans and closes the annular gap (e.g., fig. 9-11, 14A, para. 183, 196), and (ii) such that the outer frame is adapted to move axially or tilt with respect to the inner frame (e.g., fig. 14A-14B); and
a plurality of anchors 124 extending, from the distal portion of the inner frame, radially past the annular gap and the flexible body and beyond the outer frame (e.g., fig. 5J, 14A), and hooking proximally around the distal end portion to terminate radially outward from the distal end portion to form hooks (fig. 5J. 14A) that are shaped to hold the native leaflets medially against an outer surface of the outer frame (e.g., fig. 33).
For claim 2, Cooper discloses the prosthetic heart valve of claim 1, wherein the inner frame extends about a first axis and the outer frame extends about a second axis, and the outer frame is adapted to tilt with respect to the inner frame to offset the first axis from the second axis (fig. 14B, outer frame arm is parallel to the longitudinal axis; 14A outer frame is angled with respect to the longitudinal axis).
For claim 5, Cooper discloses the prosthetic heart valve of claim 1, wherein the proximal end portion of the outer frame forms an opening for the annular gap (e.g., para. 151, skirt attaches the inner and outer frames and thus exists between frames, see also fig. 29).
For claim 6, Cooper discloses the prosthetic heart valve of claim 1, further comprising a sealing skirt 1580 positioned upon the outer frame (e.g., fig. 18B).
For claim 8, Cooper discloses the prosthetic heart valve of claim 1, wherein the proximal portion of the inner frame includes a coupler for coupling to a delivery system, and the proximal end portion of the outer frame includes a coupler for coupling to the delivery system (e.g., fig. 19).
For claim 9, Cooper discloses the prosthetic heart valve of claim 1, wherein the inner frame is self-expanding and the outer frame is self-expanding (e.g., para. 103).
For claim 10, Cooper discloses the prosthetic heart valve of claim 1, wherein the cloth material comprises the only coupling of the distal end portion of the outer frame to the distal portion of the inner frame (e.g., para. 151).
For claim 11, Cooper discloses a prosthetic heart valve for deployment in a native heart valve (abstract), the prosthetic heart valve comprising:
a plurality of prosthetic valve leaflets (e.g., abstract);
an inner frame 120 supporting the plurality of prosthetic valve leaflets, the inner frame having a proximal portion 126 and a distal portion 130;
a sealing body 140 positioned radially outward from the inner frame so as to define an annular gap (e.g., fig. 5J, 14A) between the sealing body 140 and the inner frame 120, the sealing body having a proximal end portion 146 and a distal end portion 150; and
a flexible body 180 comprising a cloth material (e.g., para. 189-190) coupling the distal end portion of the sealing body to the distal portion of the inner frame (e.g., fig. 9-11, 14A, 14B, para. 183, 191-193) (i) in a manner that spans and closes the annular gap (e.g., fig. 9-11, 14A, para. 183, 196), and (ii) such that the sealing body is adapted to move with respect to the inner frame (e.g., fig. 14A-14B); and
a plurality of anchors 124 extending, from the distal portion of the inner frame, radially past the annular gap and the flexible body (e.g., fig. 9, 14A), and hooking proximally around the distal end portion such that tips of the anchors are disposed radially outward from the sealing body to hold the native leaflets medially against an outer surface of the sealing body (e.g., fig. 33).
For claim 12, Cooped discloses the prosthetic heart valve of claim 11, wherein the cloth material is adapted to deflect to allow the sealing body to move with respect to the inner frame (e.g., fig. 14A-B).
For claim 15, Cooper discloses the prosthetic heart valve of claim 11, wherein each of the plurality of anchors is adapted to hook around a distal end of the native leaflet of the native heart valve to anchor to the native leaflet (e.g., fig. 33).
For claim 16, Cooper discloses a prosthetic heart valve for deployment in a native heart valve, the prosthetic heart valve comprising:
a plurality of prosthetic leaflets (e.g., abstract);
an inner frame120 supporting the plurality of prosthetic leaflets and having a proximal portion 126 and a distal portion 130;
a sealing body 140 positioned radially outwardly from the inner frame and having a proximal end portion 146 and a distal end portion 150 that is coupled to the distal portion of the inner frame such that the sealing body is allowed to move with respect to the inner frame (e.g., fig. 14A-14B); and
a plurality of anchors 124 extending radially from the distal portion of the inner frame (e.g., fig. 9, 14A), and hooking proximally around the distal end portion to terminate radially outward from the distal end portion to form hooks that are shaped to hold the native leaflets medially against an outer surface of the sealing body (e.g., fig. 33).
For claim 17, Cooper discloses the prosthetic heart valve of claim 16, wherein one or more flexible bodies 180 couple the distal end portion of the sealing body to the distal portion of the inner frame and allow the sealing body to move with respect to the inner frame (e.g., fig. 9-11, 14A, 14B, para. 183, 191-193).
For claim 18, Cooper discloses the prosthetic heart valve of claim 17, wherein the one or more flexible bodies comprise a fabric or a shape memory material (e.g., para. 189-190).
For claim 19, Cooper discloses the prosthetic heart valve of claim 16, wherein the sealing body is spaced from the inner frame with an annular gap (e.g., fig. 9, 14A).
For claim 20, Cooper discloses the prosthetic heart valve of claim 16, wherein each of the anchors is shaped to hook around a distal end of the native leaflet of the native heart valve (e.g., fig. 33).
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774