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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/29/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/29/2026 have been fully considered but they are not persuasive. Applicant argues Spenser fails to disclose or suggest “a first commissure support post comprising a central portion, a first protrusion projecting away from the central portion, and a second protrusion projecting away from the central portion” such that “the adjacent tabs that form the first commissure tab assembly extend radially along opposite sides of the central portion of the first commissure post.” Examiner disagrees, Spenser includes a central portion at label 480 of figure 34c, and the adjacent tabs extend radially along opposite sides of this central portion, as seen in figure 34a.
New claims 21-24 are addressed below.
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Allowable Subject Matter
Claims 21 and 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.
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, 4-13, 15-16, 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spenser et al. (Pub. No.: US 2003/0114913).
Spenser et al. (hereinafter, Spenser) discloses a prosthetic heart valve (fig. 34a-c) comprising:
an annular frame 420 (e.g., para. 160-162) that is radially collapsible and expandable between a radially- compressed configuration and a radially-expanded configuration, the annular frame having an inflow end (e.g., fig. 27-28, bottom of the figure) and an outflow end (e.g., fig. 27-28, top of figure) separated from the inflow end along an axial direction of the frame, the annular frame comprising a first commissure support post 497 comprising a central portion (fig. 34c, at label 480), a first protrusion projecting away from the central portion, and a second protrusion projecting away from the central portion (see annotation below); and
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a valvular structure supported within the annular frame and comprising a first leaflet 430, a second leaflet 430, and a commissure tab assembly (fig. 34a, portion attached to frame commissure), each of the first leaflet and the second leaflet comprising a pair of tabs (fig. 34a), wherein adjacent tabs of the first leaflet and the second leaflet form a first commissure tab assembly (fig. 34a),
wherein the first commissure tab assembly is coupled to the first commissure support post (fig. 34a);
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;
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wherein the adjacent tabs that form the first commissure tab assembly extend radially along opposite sides of the central portion of the first commissure post (e.g., fig. 34a); and
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wherein the first protrusion is configured to limit axial movement of the first commissure tab assembly in a downstream direction (e.g., fig. 34a).
For claim 2, Spenser 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; and an end portion with a second width greater than the first width, 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 is formed between the first commissure support post and the end portion (e.g., fig. 34a-c).
For claim 4, Spenser disclose the prosthetic heart valve of claim 1, wherein each of the first protrusion and the second protrusion comprises at least one aperture (e.g., fig. 34C), and wherein the tabs of the first commissure tab assembly are coupled to the first commissure support post via one or more sutures 482 that pass through the at least one aperture (e.g., fig. 34a).
For claim 5, Spenser 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. 34a-c).
For claim 6, Spenser discloses the prosthetic heart valve of claim 5, further comprising a third protrusion and a fourth protrusion, wherein the third protrusion and the fourth protrusion are positioned axially apart from the first protrusion and the second protrusion, and wherein the third protrusion and the fourth protrusion project in opposite circumferential directions of the annular frame (see annotation below).
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For claim 7, Spenser’s commissure can be defined such that 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. 34a-c).
For claim 8 Spenser 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. 34a).
For claim 9, Spenser 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 (e.g. fig. 34a).
For claim 10, Spenser 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 (commissure support post is nitinol, see para. 160-162).
For claim 11, Spenser discloses a prosthetic heart valve comprising:
an annular frame 420 (e.g., para. 160-162) that is radially collapsible and expandable between a radially- compressed configuration and a radially-expanded configuration, the annular frame having an inflow end (e.g., fig. 27-28, bottom of the figure) and an outflow end (e.g., fig. 27-28, top of the figure) separated from the inflow end along an axial direction of the frame, the annular frame comprising a first commissure support post 497 comprising a central portion (fig. 34C, at label 480) and a first protrusion projecting away from the central portion (fig. 34C); and
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a valvular structure supported within the annular frame and comprising a first leaflet 430, a second leaflet 430, and a commissure tab assembly (fig. 34a, portion attached to frame commissure) each of the first leaflet and the second leaflet comprising a pair of tabs (fig. 34a), wherein adjacent tabs of the first leaflet and the second leaflet form a first commissure tab assembly (fig. 34a),
wherein the first commissure tab assembly is coupled to the first support post (fig. 34a);
wherein the first commissure tab assembly is disposed along the first 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 annotation);
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wherein the adjacent tabs that form the first commissure tab assembly extend radially along opposite sides of the central portion of the first commissure post (fig. 34a); and
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wherein the first protrusion projects along a radial direction toward the interior of the annular frame (e.g., fig. 34a, c).
For claim 12, Spenser discloses the prosthetic heart valve of claim 11, wherein the first protrusion includes at least one aperture (fig. 34a-c), and 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 of the set of first protrusion (fig. 34a)
For claim 13, Spenser discloses the prosthetic heart valve of claim 11, wherein the first protrusion comprises: a neck portion with a first width; and an end portion with a second width greater than the first width, 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 is formed between the first commissure support port and the end portion (fig. 34a-c).
For claim 15, Spenser 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 (e.g., fig. 34a).
For claim 16, Spenser 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 (commissure support post is nitinol, see para. 160-162).
For claim 22, Spenser 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 post (figs. 34a-c, the protrusions extend radially inwardly from the radially facing inner surface of the central portion).
For claim 23, Spenser discloses the prosthetic heart valve of claim 1, wherein the central portion of the first commissure 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 (figs. 34a-c).
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 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Spenser et al. (Pub. No.: US 2003/0114913).
For claims 3 and 14, Spenser is explained supra, however, Spenser lacks the tabs of the first commissure tab assembly as coupled to the first commissure support post via one or more sutures 482 that pass through the at least one slot (not disclosed). However, one of ordinary skill in the art would have found it obvious to use the slot defined by the neck of the protrusion as a suture tying post as an obvious alternate tie location suitable for attaching the leaflet tabs to the commissure posts. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774