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 Amendment
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive. Applicant argues on page 6, the prior art Peterson et al. does not disclose “a proximal portion of each commissural post extends proximally from a juncture of two cusp struts of the plurality of cusp struts and wherein the commissural regions of the valve member material are sutured to the proximal portion of each commissural post. The examiner respectfully disagrees. Peterson et al. discloses a plurality of commissural posts that have a proximal portion that extends proximally from a juncture of two cusp struts and a commissural regions of the valve member material are indirectly coupled to the proximal portion of the commissural post via a material flap 2758 which is aligned with the commissure of the three leaflets and the commissure posts of the stent 2702 (see paragraph [0117]), wherein the examiner interprets the entire commissure constitutes the struts 2756A, 2756B and the post with eyelets that extends proximally and comprises the sutures used to attach said material flap (see Figure 29). The claims do not require the u-shaped leaflets to be directly attached to the proximal portion of each commissural post.
In light of the new limitation “wherein portions of the valve member material are disposed on an outer surface of the proximal portion of each commissural post” and “wherein a commissural regions of the valve member material are sutured to the proximal portion of each commissural post” (although the claim does not disclose wherein the commissural regions of the valve member material is directly sutured to the proximal portion of each commissural post, the new prior art discloses this feature as well) a new ground of rejections are presented in this Non-Final office action over Yohanan et al. U.S. Publication 2013/0150956 A1.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 32-33 and 35-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yohanan et al. U.S. Publication 2013/0150956 A1.
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Regarding Claim 32, Yohanan et al. discloses a prosthetic heart valve 300 having an inflow end 314 at a distal end of the prosthetic heart valve and an outflow end 320 at a proximal end of the prosthetic heart valve (paragraph [0072] and as seen in the annotated Figures 13 and 15), the prosthetic heart valve configured to open to allow blood flow from the inflow end 314 to the outflow end 320 and close to prevent blood flow from the outflow end 320 to the inflow end 314 (paragraphs [0009-0010], [0079]), the prosthetic heart valve comprising a stent frame 3302 that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraph [0070], [0072-0073], [0075]), the stent frame 302 comprising an expandable region comprising multiple rows of cells including a first row of cells at the inflow end (as seen in the annotated Figure 13 above); a cusp region comprising a row of cusp region cells at the outflow end (see annotated Figure 13 and 15 above), wherein a plurality of cusp struts define a proximal end of the row of cusp region cells; and a plurality of commissural posts, wherein a proximal portion of each commissural post 322 extends proximally from a juncture of two cusp struts of the plurality of cusp struts (as seen in annotated Figure 15 above and paragraph [0085]) and a valve member material 308 attached to the stent frame (paragraphs [0070], [0073], [0079] and [0085]) and comprising a plurality of U-shaped leaflets (as seen in Figures 13 and 19-20 and paragraph [0090]) and commissural regions between adjacent U- shaped leaflets of the plurality of U-shaped leaflets (as seen in Figures 6, 13-14 and 19),wherein the commissural regions of the valve member material are sutured to the proximal portion of each commissural post (as seen in the annotated Figure 13 above and paragraph [0085]), and wherein an inflow end 332 of the valve member material 308 is defined by curved edges 332 of the plurality of U-shaped leaflets that are sutured to the stent frame 302 at the expandable region (paragraph [0090]).
Regarding Claim 33, Yohanan et al. discloses wherein the curved edges 332 of the plurality of U-shaped leaflets 308 are sutured to the stent frame 302 using a suture pattern 368 that corresponds to the curved edges of the plurality of U-shaped leaflets (as seen in the annotated Figure 13 and paragraph [0090]).
Regarding Claim 35, Yohanan et al. discloses the curved edges of the plurality of U-shaped leaflets 308 are sutured to the stent frame 302 using a U-shaped suture pattern 368 that corresponds to the curved edges of the plurality of U-shaped leaflets (as seen in the annotated Figure 13 and paragraph [0090]).
Regarding Claim 36, Yohanan et al. discloses wherein the valve member material consists of the plurality of U-shaped leaflets and the
Regarding Claim 37, Yohanan et al. discloses wherein each commissural region defines a slit opening (as seen in Figure 20, the commissure region 330 has a space/gap in between region 338, paragraph [0085]).
Regarding Claim 38, Yohanan et al. discloses wherein each commissural post 322 of the plurality of commissural posts 322 defines an opening 344 (as seen in the annotated Figure 15 above, region 344 represents openings/recess).
Regarding Claim 39, Yohanan et al. discloses wherein each commissural post 322 extends through the slit opening of one of the commissural regions (as seen in Figures 20-21 and paragraphs [0085-0087]).
Regarding Claim 40, Yohanan et al. discloses wherein portions 334 of the valve member material 308 are disposed on an outer surface of the stent frame (as seen in Figures 20-21 and paragraphs [0086-0087]).
Regarding Claim 41, Yohanan et al. discloses wherein portions 344 of the valve member material 308 are disposed on an outer surface of the proximal portion of each commissural post 322 (as seen in Figures 20-21 and paragraphs [0086-0087]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 22-23, 25-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan et al. U.S. Publication 2013/0150956 A1 in view of Fish et al. U.S. Publication 2012/0078356 A1.
Regarding Claim 22, Yohanan et al. discloses a prosthetic heart valve 300 having an inflow end 314 at a distal end of the prosthetic heart valve and an outflow end 320 at a proximal end of the prosthetic heart valve (paragraph [0072] and as seen in the annotated Figures 13 and 15), the prosthetic heart valve configured to open to allow blood flow from the inflow end 314 to the outflow end 320 and close to prevent blood flow from the outflow end 320 to the inflow end 314 (paragraphs [0009-0010], [0079]), the prosthetic heart valve comprising a stent frame 3302 that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraph [0070], [0072-0073], [0075]), the stent frame 302 comprising an expandable region comprising multiple rows of cells including a first row of cells at the inflow end (as seen in the annotated Figure 13 above); a cusp region comprising a row of cusp region cells at the outflow end (see annotated Figure 13 and 15 above), wherein a plurality of cusp struts define a proximal end of the row of cusp region cells; and a plurality of commissural posts, wherein a proximal portion of each commissural post 322 extends proximally from a juncture of two cusp struts of the plurality of cusp struts (paragraph [0085]) and a valve member material 308 made of a biomaterial (paragraph [0071]) attached to the stent frame (paragraphs [0070], [0073], [0079] and [0085]) and comprising a plurality of U-shaped leaflets that are molded and cross-linked to retain a three-dimensional shape (as seen in Figures 13 and 19-20 and paragraph [0090]) and commissural regions between adjacent U- shaped leaflets of the plurality of U-shaped leaflets (as seen in Figures 13-14 and 19),wherein the commissural regions of the valve member material are sutured to the proximal portion of each commissural post (as seen in the annotated Figure 13 above and paragraph [0085]), and wherein an inflow end 332 of the valve member material 308 is defined by curved edges 332 of the plurality of U-shaped leaflets that are sutured to the stent frame 302 at the expandable region (paragraph [0090]). However, Yohanan et al. does not expressly disclose the valve member material is a single piece of collagen-based biomaterial. Fish et al. teaches a prosthetic heart valve 100 as seen in Figure 1A in the same field of endeavor for treating impaired heart valves, the prosthetic heart valve having an inflow end and an outflow end (abstract and paragraphs [0026-0029]), a stent frame that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraph [0028], [0040], [0076]) and a valve member 108 made of a single piece of collagen-based biomaterial (paragraphs [0071], [0074-0076]) attached to the stent frame (paragraphs [0077-0078]) for the purpose of having leaflets that yields a leaflet material of suitable strength and durability and accommodates inward closure of the membrane sheet sufficiently to facilitate operational closure of the valve after being implanted (paragraphs [0074] and [0076]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Yohanan’s valve member material to be formed of a single piece of collagen-based biomaterial as taught by Fish et al. for the purpose of having leaflets that yields a leaflet material of suitable strength and durability and accommodates inward closure of the membrane sheet sufficiently to facilitate operational closure of the valve after being implanted.
Regarding Claim 23, Yohanan et al. discloses wherein the curved edges 332 of the plurality of U-shaped leaflets 308 are sutured to the stent frame 302 using a suture pattern 368 that corresponds to the curved edges of the plurality of U-shaped leaflets (as seen in the annotated Figure 13 and paragraph [0090]).
Regarding Claim 25, Yohanan et al. discloses the curved edges of the plurality of U-shaped leaflets 308 are sutured to the stent frame 302 using a U-shaped suture pattern 368 that corresponds to the curved edges of the plurality of U-shaped leaflets (as seen in the annotated Figure 13 and paragraph [0090]).
Regarding Claim 26, Yohanan et al. discloses wherein the valve member material consists of the plurality of U-shaped leaflets and the commissural regions (as seen in Figure 19 and paragraph [0081]).
Regarding Claim 27, Yohanan et al. discloses wherein each commissural region defines a slit opening (as seen in Figure 20, the commissure region 330 has a space/gap in between region 338, paragraph [0085]).
Regarding Claim 28, Yohanan et al. discloses wherein each commissural post 322 of the plurality of commissural posts 322 defines an opening 344 (as seen in the annotated Figure 15 above, region 344 represents openings/recess).
Regarding Claim 29, Yohanan et al. discloses wherein each commissural post 322 extends through the slit opening of one of the commissural regions (as seen in Figures 20-21 and paragraphs [0085-0087]).
Regarding Claim 30, Yohanan et al. discloses wherein portions 334 of the valve member material 308 are disposed on an outer surface of the stent frame (as seen in Figures 20-21 and paragraphs [0086-0087]).
Regarding Claim 31, Yohanan et al. discloses wherein portions 344 of the valve member material 308 are disposed on an outer surface of the proximal portion of each commissural post 322 (as seen in Figures 20-21 and paragraphs [0086-0087]).
Claim(s) 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. U.S. Publication 2020/0246141 A1 in view of Fish et al. U.S. Publication 2012/0078356 A1.
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Regarding Claim 22, Peterson et al. discloses a prosthetic heart valve 100 as seen in Figures 1, 3-12 having an inflow end at a distal end of the prosthetic heart valve and an outflow end at a proximal end of the prosthetic heart valve (abstract and paragraph [0051-0055]), the prosthetic heart valve configured to: (1) open to allow blood flow from the inflow end to the outflow end and (ii) close to prevent blood flow from the outflow end to the inflow end, the prosthetic heart valve comprising: a stent frame 102 that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraphs [0006-0007], [0045], [0050]), the stent frame 102 comprising an expandable region comprising multiple rows of cells 114 including a first row of cells at the inflow end (as seen in Figures 1, 4-7 and annotated Figure 3 above and paragraph [0053]); and a cusp region comprising a row of cusp region cells at the outflow end, wherein a plurality of cusp struts define a proximal end of the row of cusp region cells (see annotated Figure 3 above); and a plurality of commissural posts (see annotated Figure 3 above); valve member material 132 made of a collagen-based biomaterial attached to the stent frame (paragraphs [0046-0047]), and comprising a plurality of U-shaped leaflets (as seen in Figure 1, 3, 10, 12, MOA, margin of attachment of the leaflet is U-shaped), wherein an inflow end of the valve member material is defined by curved free edges of the plurality of U-shaped leaflets that are sutured to the stent frame at the first row of cells define an inflow end of the valve member (as seen in Figures 1, 3, 10, 12, see MOA, paragraphs [0059-0060]). The limitation “a plurality of leaflets that are molded and cross-linked to retain a three-dimensional shape” is a product by process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). However, in the embodiment used in the rejection above, Figures 3 and 6 does not expressly disclose a proximal portion of each commissural post extends proximally from a juncture of two cusp struts of the plurality of cusp struts and wherein the commissural regions of the valve member material are sutured to the proximal portion of each commissural post. In an alternative embodiment as seen in Figures 28-29, Peterson et al. teaches a plurality of commissural posts 2756A, 2756B that have a proximal portion that extends proximally (the bar with the eyelets, as seen in the annotated Figure 28 above) from a juncture of two cusp struts and a commissural regions of the valve member material are indirectly coupled to the proximal portion of the commissural post via a material flap 2758 which is aligned with the commissure of the three leaflets and the commissure posts of the stent 2702 (see paragraphs [0117-0118]), wherein the examiner interprets the entire commissure constitutes the struts 2756A, 2756B and the post with eyelets that extends proximally and comprises the sutures used to attach said material flap (see Figure 29, see paragraphs [0117-0118]) for the purpose of attaching the leaflets to the stent frame (paragraph [0117]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the commissure post of Figure 3 to further include a commissure post having a V-shaped strut and liner bar with eyelets as taught in Figures 28-29 for the purpose of attaching the leaflets to the stent frame. However, Peterson et al. does not expressly disclose the valve member material is a single piece of collagen-based biomaterial. Fish et al. teaches a prosthetic heart valve 100 as seen in Figure 1A in the same field of endeavor for treating impaired heart valves, the prosthetic heart valve having an inflow end and an outflow end (abstract and paragraphs [0026-0029]), a stent frame that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraph [0028], [0040], [0076]) and a valve member 108 made of a single piece of collagen-based biomaterial (paragraphs [0071], [0074-0076]) attached to the stent frame (paragraphs [0077-0078]) for the purpose of having leaflets that yields a leaflet material of suitable strength and durability and accommodates inward closure of the membrane sheet sufficiently to facilitate operational closure of the valve after being implanted (paragraphs [0074] and [0076]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson’s valve member material to be formed of a single piece of collagen-based biomaterial as taught by Fish et al. for the purpose of having leaflets that yields a leaflet material of suitable strength and durability and accommodates inward closure of the membrane sheet sufficiently to facilitate operational closure of the valve after being implanted.
Regarding Claim 23, Peterson et al. discloses wherein the curved free edges of the plurality of U-shaped leaflets are sutured to the stent frame 102 using a suture pattern that corresponds to the curved edges of the plurality of U-shaped leaflets (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 24, Peterson et al. discloses wherein the curved free edges of the plurality of U-shaped leaflets comprise semi-circular shapes (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 25, Peterson et al. discloses wherein the curved edges of the plurality of U-shaped leaflets are sutured to the stent frame using a U-shaped suture pattern that corresponds to the curved edges of the plurality of U-shaped leaflets (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 26, Peterson et al. discloses wherein the valve member material consists of the plurality of U-shaped leaflets and the plurality of commissural regions 136 (as seen in Figure 1, 1A, 3, 10, 12).
Regarding Claim 27, Peterson et al. discloses wherein each commissural region defines a slit opening (as seen in Figure 1A, commissure regions 136 include a slit opening).
Regarding Claim 28, Peterson et al. discloses wherein each commissural posts 126A, 126B of the plurality of commissural posts having eyelets therefore, defining said opening in the commissural post (paragraph [0056] and as seen in Figure 6).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. U.S. Publication 2020/0246141 A1 in view of Fish et al. U.S. Publication 2012/0078356 A1 and further in view of Tuval et al. U.S. Publication 2010/0262231 A1.
Regarding Claim 29, Peterson et al. does not expressly disclose wherein each commissural post extends through the slit opening of one of the commissural regions. Tuval et al. teaches a prosthetic heart valve 10 in the same field of endeavor for treating impaired heart valves (as seen in Figures 1 and 4A), wherein the prosthetic heart valve comprises a stent frame 12 having a plurality of commissure structures 30 (paragraph [0579]) and a valve member 104 formed of a single piece of collagen based tissue 105 (as seen in Figure 4A and paragraph [0582]) having a plurality of leaflets and a plurality of commissural regions (see split portion by 130, as seen in Figures 1 and 4A and paragraph [0596]), wherein each commissural region defines a slit for the purpose of allowing the leaflets to extend over the commissure strut 30 of the stent frame 12 and disposed on an outer surface of the stent frame on the commissural strut 30 (as seen in Figure 4A) to couple the strut and leaflets together and provide a strain relief to reduce the stresses applied on the leaflets (paragraph [0596]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fish’s valve member having commissure structures to further include a slit as taught by Tuval et al. for the purpose of allowing the leaflets to extend over the commissure strut of the stent frame to couple the strut and leaflets together and provide a strain relief to reduce the stresses applied on the leaflets.
Regarding Claim 30, Peterson et al. discloses wherein portions of the valve member are disposed on an outer surface of the stent frame (paragraphs [0056-0057] and as seen in Figures 1, 3).
Regarding Claim 31, Peterson et al. discloses wherein portions of the valve member are disposed on an outer surface of each commissural post (paragraphs [0056-0057] and as seen in Figures 1, 3).
Claim(s) 32-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. U.S. Publication 2020/0246141 A1.
Regarding Claim 32, Peterson et al. discloses a prosthetic heart valve 100 as seen in Figures 1, 3-12 having an inflow end and an outflow end (abstract and paragraph [0051-0055]), the prosthetic heart valve configured to: (1) open to allow blood flow from the inflow end to the outflow end and (ii) close to prevent blood flow from the outflow end to the inflow end, the prosthetic heart valve comprising: a stent frame 102 that is reconfigurable between a low-profile delivery configuration and an expanded operable configuration (paragraphs [0006-0007], [0045], [0050]), the stent frame comprising an expandable region comprising multiple rows of cells 114 including a first row of cells at the inflow end (see annotated Figure 3 above and paragraph [0053]); and a cusp region comprising a row of cusp region cells at the outflow end, wherein a plurality of cusp struts define a proximal end of the row of cusp region cells (see annotated Figure 3 above); and a plurality of commissural posts (see annotated Figure 3 above); and a valve member material 132 leaflets attached to the stent frame 102 (paragraphs [0046-0047]) and comprising a plurality of U-shaped leaflets and commissural regions between adjacent U-shaped leaflets of the plurality of U-shaped (as seen in Figure 1A) and wherein an inflow end of the valve member material is defined by curved free edges of the plurality of U-shaped leaflets that are sutured to the stent frame at the expandable region (as seen in Figure 1, 10, 12, and the annotated Figure 3 above, MOA, margin of attachment of the leaflet is U-shaped). However, in the embodiment used in the rejection above, Figures 3 and 6 does not expressly disclose a proximal portion of each commissural post extends proximally from a juncture of two cusp struts of the plurality of cusp struts and wherein the commissural regions of the valve member material are sutured to the proximal portion of each commissural post. In an alternative embodiment as seen in Figures 28-29, Peterson et al. teaches a plurality of commissural posts 2756A, 2756B that have a proximal portion that extends proximally (the bar with the eyelets, as seen in the annotated Figure 28 above) from a juncture of two cusp struts and a commissural regions of the valve member material are indirectly coupled to the proximal portion of the commissural post via a material flap 2758 which is aligned with the commissure of the three leaflets and the commissure posts of the stent 2702 (see paragraphs [0117-0118]), wherein the examiner interprets the entire commissure constitutes the struts 2756A, 2756B and the post with eyelets that extends proximally and comprises the sutures used to attach said material flap (see Figure 29, see paragraphs [0117-0118]) for the purpose of attaching the leaflets to the stent frame (paragraph [0117]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the commissure post of Figure 3 to further include a commissure post having a V-shaped strut and liner bar with eyelets as taught in Figures 28-29 for the purpose of attaching the leaflets to the stent frame.
Regarding Claim 33, Peterson et al. discloses wherein the curved free edges of the plurality of U-shaped leaflets are sutured to the stent frame 102 using a suture pattern that corresponds to the curved edges of the plurality of U-shaped leaflets (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 34, Peterson et al. discloses wherein the curved free edges of the plurality of U-shaped leaflets comprise semi-circular shapes (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 35, Peterson et al. discloses wherein the curved edges of the plurality of U-shaped leaflets are sutured to the stent frame using a U-shaped suture pattern that corresponds to the curved edges of the plurality of U-shaped leaflets (see MOA, Figures 1, 3, 10, 12 and paragraphs [0059-0060]).
Regarding Claim 36, Peterson et al. discloses wherein the valve member material consists of the plurality of U-shaped leaflets and a plurality of commissural regions 136 (as seen in Figure 1, 1A, 3, 10, 12).
Regarding Claim 37, Peterson et al. discloses wherein each commissural region defines a slit opening (as seen in Figure 1A, commissure regions 136 include a slit opening).
Regarding Claim 38, Peterson et al. discloses wherein each of the commissural post of the plurality of commissural posts 126A defines an opening (having eyelets therefore, defining said opening in the commissural post, see Figure 6 and paragraph [0056]).
Claim 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. U.S. Publication 2020/0246141 A1 in view of Tuval et al. U.S. Publication 2010/0262231 A1.
Regarding Claim 39, Peterson et al. does not expressly disclose wherein each commissural post extends through the slit opening of one commissural region. Tuval et al. teaches a prosthetic heart valve 10 in the same field of endeavor for treating impaired heart valves (as seen in Figures 1 and 4A), wherein the prosthetic heart valve comprises a stent frame 12 having a plurality of commissure structures 30 (paragraph [0579]) and a valve member 104 formed of a single piece of collagen based tissue 105 (as seen in Figure 4A and paragraph [0582]) having a plurality of leaflets and a plurality of commissural regions (see split portion by 130, as seen in Figures 1 and 4A and paragraph [0596]), wherein each commissural region defines a slit for the purpose of allowing the leaflets to extend over the commissure strut 30 of the stent frame 12 and disposed on an outer surface of the stent frame on the commissural strut 30 (as seen in Figure 4A) to couple the strut and leaflets together and provide a strain relief to reduce the stresses applied on the leaflets (paragraph [0596]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fish’s valve member having commissure structures to further include a slit as taught by Tuval et al. for the purpose of allowing the leaflets to extend over the commissure strut of the stent frame to couple the strut and leaflets together and provide a strain relief to reduce the stresses applied on the leaflets.
Regarding Claim 40, Peterson et al. discloses wherein portions of the valve member are disposed on an outer surface of the stent frame (paragraphs [0056-0057] and as seen in Figures 1, 3).
Regarding Claim 41, Peterson et al. discloses wherein portions of the valve member are disposed on an outer surface of each commissural post (paragraphs [0056-0057] and as seen in Figures 1, 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774