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 1-16, 21-25 have been considered but are moot in view of the new grounds for rejection.
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, 5-11, 13, 15-16, 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arcaro et al. (Pub. No. 2019/0091014).
Arcaro et al. (hereinafter, Arcaro) discloses a prosthetic heart valve comprising:
an annular frame 102 that is radially collapsible and expandable between a radially-compressed configuration and a radially-expanded configuration (e.g., para. 3), the annular frame having an inflow end (fig. 1, Is) and an outflow end (fig. 1, Os) separated from the inflow end along an axial direction of the frame, the annular frame comprising a first commissure support post 1120 comprising a central portion (central post) a first protrusion (fig. 23, right hand projection around 2024R) projecting away from the central portion, and a second protrusion (e.g., left hand side projection around 2024R) projecting away from the central portion (e.g., fig. 23, para. 173); and
a valvular structure 104 (e.g., fig. 1, 11) supported within the annular frame and comprising a first leaflet 1180a, a second leaflet 1180b, and a commissure tab assembly 1192, each of the first leaflet and the second leaflet comprising a pair of tabs 1194, 1196, wherein adjacent tabs of the first leaflet and the second leaflet form a first commissure tab assembly (e.g., fig. 1-2),
wherein the first commissure tab assembly is coupled to the first commissure support post (e.g. fig. 1, 2);
wherein the first commissure tab assembly is disposed along the first commissure support post in the axial direction between the first protrusion and the inflow end of the annular frame such that respective downstream ends of the adjacent tabs that form the first commissure tab assembly are positioned upstream of an upstream end of the first protrusion (see leaflet attachment on figures 1-2, apply to location of the protrusions seen in figure 23);
wherein the adjacent tabs that form the first commissure tab assembly extend radially along opposing surface portions of the central portion of the first commissure support post (e.g., fig. 1, 2); and
wherein the first protrusion is configured to limit axial movement of the first commissure tab assembly in a downstream direction (leaflet does not extend beyond the protrusion, see fig. 1, 2, 23).
For claim 2, Arcaro discloses the prosthetic heart valve of claim 1, wherein each of the first protrusion and the second protrusion comprises: a neck portion with a first width (e.g., fig. 23, narrow portion above the slit which holds the leaflet); and an end portion with a second width greater than the first width (e.g., at distal-most portion of the protrusion), wherein the neck portion is disposed along the circumferential direction between the end portion and the first commissure support post such that at least one slot 2024R is formed between the first commissure support post and the end portion.
For claim 5, Arcaro discloses the prosthetic heart valve of claim 1, wherein the first protrusion and the second protrusion project in opposite circumferential directions of the annular frame (e.g., fig. 23).
For claim 6, Arcaro discloses the prosthetic heart valve of claim 5, further comprising a third protrusion and a fourth protrusion (struts 1102, e.g., fig. 5), wherein the third protrusion and the fourth protrusion are positioned axially apart from the first protrusion and the second protrusion (e.g., fig. 5, 23), and wherein the third protrusion and the fourth protrusion project in opposite circumferential directions of the annular frame (e.g., fig. 5).
For claim 7, Arcaro discloses the prosthetic heart valve of claim 1, wherein the second protrusion is positioned axially apart from the first protrusion, and wherein the first protrusion and the second protrusion project along a radial direction toward the interior of the annular frame (e.g., fig. 3, 23).
For claim 8, Arcaro discloses the prosthetic heart valve of claim 7, wherein the first commissure tab assembly is positioned between the first protrusion and the second protrusion (e.g., fig. 1, 2, 23).
For claim 9, Arcaro discloses the prosthetic heart valve of claim 7, wherein the second protrusion is configured to limit axial movement of the first commissure tab assembly in an upstream direction (leaflet longitudinal position is fixed at the commissure).
For claim 10, Arcaro discloses the prosthetic heart valve of claim 1, wherein the first commissure support post is a part of an actuator assembly configured to actuate the annular frame between the radially-compressed configuration and the radially-expanded configuration (e.g., para. 173, 121-123).
For claim 21, Arcaro discloses the prosthetic heart valve of claim 1, wherein the central portion of the first commissure support post comprises a radially facing inner surface, an opposing radially facing outer surface, and a pair of opposing side surfaces connecting the inner surface to the outer surface (e.g., fig. 1), and wherein the adjacent tabs that form the first commissure tab assembly extend along one or both of the inner surface and the outer surface (e.g., fig. 1, 2).
For claim 22, Arcaro discloses the prosthetic heart valve of claim 1, wherein each of the first protrusion and the second protrusion extends radially inwardly from a radially facing inner surface of the central portion of the first commissure support post (e.g., fig. 7).
For claim 23, Arcaro discloses the prosthetic heart valve of claim 1, wherein the central portion of the first commissure support post comprises a radially facing inner surface, an opposing radially facing outer surface, and a pair of opposing side surfaces connecting the inner surface to the outer surface, and wherein the first protrusion and the second protrusion extend away from the side surfaces of the central portion (e.g., fig. 23).
For claim 11, Arcaro discloses a prosthetic heart valve comprising:
an annular frame 102 that is radially collapsible and expandable between a radially- compressed configuration and a radially-expanded configuration (e.g., para. 3), the annular frame having an inflow end (fig. 1, Is) and an outflow end (fig. 1, Os) separated from the inflow end along an axial direction of the frame, the annular frame comprising a first commissure support post 1120 comprising a central portion (central post) and a first protrusion projecting away from the central portion (fig. 23, right hand protrusion around 2024R); and
a valvular structure 104 supported within the annular frame and comprising a first leaflet 1180a, a second leaflet 1180b, and a commissure tab assembly 1192, each of the first leaflet and the second leaflet comprising a pair of tabs 1194, 1196, wherein adjacent tabs of the first leaflet and the second leaflet form a first commissure tab assembly (e.g., fig. 1-2),
wherein the first commissure tab assembly is coupled to the first commissure support post (e.g., fig. 1-2);
wherein the first commissure tab assembly is disposed along the first commissure support post in the axial direction between the first protrusion and the inflow end of the annular frame such that respective downstream ends of the adjacent tabs that form the first commissure tab assembly are positioned upstream of an upstream end of the first protrusion (see leaflet attachment on figures 1-2, apply to location of the protrusions seen in figure 23);;
wherein the adjacent tabs that form the first commissure tab assembly extend radially along opposing surface portions of the central portion of the first commissure support post (e.g., fig. 1, 2); and
wherein the first protrusion projects along a radial direction toward the interior of the annular frame (e.g., fig. 7).
For claim 13, Arcaro discloses the prosthetic heart valve of claim 11, wherein the first protrusion comprises: a neck portion with a first width (e.g., fig. 23, narrow portion above the slit which holds the leaflet); and an end portion with a second width greater than the first width (e.g., at distal-most portion of the protrusion), wherein the neck portion is disposed along the circumferential direction between the end portion and the first commissure support post such that at least one slot 2024R is formed between the first commissure support post and the end portion.
For claim 15, Arcaro discloses the prosthetic heart valve of claim 11, wherein the first protrusion is configured to limit axial movement of the first commissure tab assembly in a downstream direction (leaflet does not extend beyond the protrusion, see fig. 1, 2, 23).
For claim 16, Arcaro discloses the prosthetic heart valve of claim 11, wherein the first commissure support post is a part of an actuator assembly configured to actuate the annular frame between the radially-compressed configuration and the radially-expanded configuration (e.g., para. 173, 121-123).
Allowable Subject Matter
Claim 25 is allowed.
Claims 3-4, 12, 14, 24 are 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.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Arcaro et al. (Pub. No. 2019/0091014), however, Arcaro lacks a protrusion with an aperture wherein the tabs of the first commissure tab assembly are coupled to the first commissure support post via one or more sutures that pass through the at least one aperture.
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
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