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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2026 has been entered.
Priority
This application claims priority from provisional application 62/923,657 filed 10/21/2019.
Status of Claims
Claims 1-19 and 21 are pending.
Claim 20 has been cancelled.
Drawings
The previous objections to the drawings have been withdrawn in view of the applicant’s amendments and explanation.
Claim Rejections - 35 USC § 112
The previous 112 rejections to the drawings have been withdrawn in view of the applicant’s amendments and explanation.
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.
Claim(s) 1-5, 8, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conklin et al (Conklin) USPN 10,456,246 B2.
1. Conklin discloses a transcatheter valve prosthesis (300 Figures 10A/B) comprising:
a stent 302/304 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve (Abstract), the stent having
an inflow portion (302 Figure 10A) formed proximate to an inflow end of the stent (entire bottom portion 302 is proximate the inflow end at the bottom of Figure 10A), and having a tubular shape (Figure 10A), the inflow portion having a proximal end and a distal end opposite the proximal end (top and bottom of 302), the inflow portion including a plurality of crowns (peaks 316 as well as other peaks throughout 302) and a plurality of struts with each crown being formed between a pair of opposing struts (318 connects to each side of 316 Figure 10A), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (openings below the struts 318 Figure 10A), the inflow portion having a plurality of distal most crowns formed at the distal end thereof (peaks 316), and
an outflow portion (304 Figure 10A) formed proximate to an outflow end of the stent (Figure 10B) and longitudinally extending from the distal end of the inflow portion (Figure 10B), wherein the outflow portion of the stent has exactly three commissure posts (304 Figure 10B), each commissure post longitudinally extending from and connected to the inflow portion via only a single distal most crown of the inflow portion (Figure 10B shows each post directly connected to peak 316 with no additional struts and longitudinally extending upward) and the three commissure posts being circumferentially spaced apart (Figure 10B), and wherein a thickness of each commissure post varies along a length thereof (Figures 10C/D) such that a first end is relatively thicker than an unattached second end that is opposite the first end (Figures 10C/D show the bottom near reference number 314 is thicker than the top near reference number 304), the first end being connected to the single distalmost crown of the inflow portion (Figure 10B); and
a prosthetic valve (308 Figures 10A/B) disposed within and secured to at least the outflow portion of the stent (valve 308 is positioned inside and attached to posts 304), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the stent (this is the principle function of all these types of heart valves).
2. 12. Conklin discloses the prosthetic valve includes three leaflets and three commissures (Figures 10A/B), each commissure being formed by attached adjacent lateral ends of an adjoining pair of the three leaflets (Figure 10B), and wherein the three commissure posts are aligned with and attached to a respective commissure of the three leaflets of the prosthetic valve (Figure 10B) (The method for attaching the leaflets to the posts is considered to be a product by process limitation and given limited weight, In this case the prosthesis of Conklin is fully capable of having the leaflet ends attached to the posts in any known manner including having to commissures of the leaflets).
3. 13. Conklin discloses each commissure post is a planar bar (304 Figure 10D).
4. Conklin discloses the thickness of each commissure post is configured to permit each commissure post to flex radially inward during loading of the transcatheter valve prosthesis (Conklin discloses the entire device is compressed radially inward to be loaded into a catheter prior to delivery. Therefore the entire device permits radially inward flexing).
5. Conklin discloses each strut of the inflow portion has a thickness along a length thereof and the thickness of each commissure post at the first end thereof is not greater than the thickness of the strut of the inflow portion (with respect to this claim the thicknesses is being interpreted differently than explained above, the unattached end at the top of Figure 10D is tapered as well as the edges along the entire length, therefore the first end at reference number 314 is thicker than the tapered thickness at the unattached end, furthermore the thickness at 314 matches the struts of the frame as seen in Figure 10B).
8. Conklin discloses each strut of the inflow portion has a first width along a length thereof and each commissure post has a second width along a length thereof, the first width being less than the second width (Figure 10B clearly shows the posts with more than double the width of the struts).
11. Conklin discloses a transcatheter valve prosthesis (300 Figures 10A/B) comprising:
a stent 302/304 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve (Abstract), the stent having
an inflow portion (302 Figure 10A) formed proximate to an inflow end of the stent (Figure 10A) and having a tubular shape (Figure 10A), the inflow portion having a proximal end and a distal end opposite the proximal end (top and bottom of 302 Figure 10A), the inflow portion including a plurality of crowns (peaks 316 as well as other peaks throughout 302) and a plurality of struts with each crown being formed between a pair of opposing struts (318 connects to each side of 316 Figure 10A), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (openings below the struts 318 Figure 10A), the inflow portion having a plurality of distal most crowns formed at the distal end thereof (peaks 316), and
an outflow portion (304 Figure 10A) formed proximate to an outflow end of the stent (Figure 10B) and longitudinally extending from the distal end of the inflow portion (Figure 10B), wherein the outflow portion of the stent has exactly three commissure posts (304 Figure 10B), each commissure post longitudinally extending from and connected to the inflow portion via only a single distal most crown of the inflow portion (Figure 10B shows each post directly connected to peak 316 with no additional struts and longitudinally extending upward) and wherein each commissure post has a length that is greater than a length of each strut of the inflow portion (the struts are considered to be one angled portion of each diamond shaped cell or a single short segment 318, Figure 10B shows the posts are substantially longer than each strut), each commissure post has a thickness along the length thereof that is less than a thickness of each strut of the inflow portion along the length thereof (each post has a tapered tip near the unattached end that is less than the thickness of the struts as shown in Figures 10B and D), and each commissure post has a width that is greater than a width of each strut of the inflow portion (Figure 10B clearly shows posts being much wider than the struts of the stent); and
a prosthetic valve (308 Figures 10A/B) disposed within and secured to at least the outflow portion of the stent (valve 308 is positioned inside and attached to posts 304), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the stent (this is the principle function of all these types of heart valves).
14. Conklin discloses each commissure post has a yield strength that is greater than a yield strength of each strut of the inflow portion (the posts have a wider and thicker section which will inherently have a greater yield strength compared to the narrower/thinner struts of the inflow portion).
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.
Claim(s) 6, 7, 9, 10, 15-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conklin in view of Conklin (Conklin Pub) US 2012/0078357 A1.
6. 7. Conklin discloses the invention substantially as claimed being described above. However, Conklin does not disclose the preset curves of the posts.
Conklin Pub teaches the use of a frame supported heart valve comprising commissure posts 1216 Figure 26 having a preset inward curve in the same field of endeavor for the purpose of aiding with insertion and relieving forces from the implant site during opening and closing of the valve.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the preset radially inward commissure post curve shape as taught by Conklin Pub with the posts of Conklin in order to aid with insertion and relieving forces from the implant site during opening and closing of the valve.
In regards to claim 7, the applicant’s original disclosure failed to provide any indication of criticality for the claimed range of inward bend. The range is simply defined in the specification as an example for some embodiments with no additional explanation. Furthermore, there is no factual evidence in the record to support any unexpected results. The disclosure of these ranges is consistent with a routine optimization. Therefore it would have been obvious to a person of ordinary skill in the art to take the teaching of Conklin and to apply it to Conklin such that the posts extend radially inward about 1 to 2 mm. Finally, since the claims do not disclose what part of the post is measured for the curve there is inherently a portion of the curved post of Conklin that would curve in from 1 to 2 mm.
9. 10. 15. 16. Conklin discloses the invention substantially as claimed being described above. Additionally, with respect to materials, Conklin discloses that the inflow portion of the frame is formed from plastically deformable material such as stainless steel (8:40-46) and the posts are made from polymeric materials or plastics. Conklin also goes on to disclose the possible use of superelastic materials such as nitinol for some parts of the frame (8:40-46).
However, Conklin fails to disclose the use of a superelastic material for forming the posts in combination with the plastically deformable inflow portion.
Conklin Pub discloses an implantable heart valve comprising a two-piece frame 601 including a plastically expandable stent portion 602 and a self-expandable wire form portion 604 made which can be coupled together via one or more non-metallic components [0209] in order to provide the frame adjacent the valve with increased ability to flex and move with the opening and closing of the valve. Additionally Conklin Pub discloses the self-expanding materials used include superelastic materials such as nitinol [0028].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stent of Conklin to form posts from a superelastic material such as nitinol as taught by Conklin Pub in order to provide the frame adjacent the valve with increased ability to flex and move with the opening and closing of the valve.
17. Conklin discloses a transcatheter valve prosthesis (10 Figures 1-2B) comprising:
a stent 302/304 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve (Abstract), the stent having
an inflow portion (302 Figure 10A) formed proximate to an inflow end of the stent (entire bottom portion 302 is proximate the inflow end at the bottom of Figure 10A), and having a tubular shape (Figure 10A), the inflow portion having a proximal end and a distal end opposite the proximal end (top and bottom of 302), the inflow portion including a plurality of crowns (peaks 316 as well as other peaks throughout 302) and a plurality of struts with each crown being formed between a pair of opposing struts (318 connects to each side of 316 Figure 10A), a plurality of side openings being defined by the plurality of crowns and the plurality of struts (openings below the struts 318 Figure 10A), the inflow portion having a plurality of distal most crowns formed at the distal end thereof (peaks 316), wherein the inflow portion is formed from a first material (Stainless steel 8:40-46) and
an outflow portion (304 Figure 10A) formed proximate to an outflow end of the stent (Figure 10B) and longitudinally extending from the distal end of the inflow portion (Figure 10B), wherein the outflow portion of the stent has exactly three commissure posts (304 Figure 10B), each commissure post longitudinally extending a distal most crown of the inflow portion (Figure 10B shows each post directly connected to peak 316 with no additional struts and longitudinally extending upward) and the three commissure posts being circumferentially spaced apart (Figure 10B), each commissure having a first end (adjacent reference number 314 Figures 10B/D) and an unattached second end opposite the first end (adjacent reference number 304 Figures 10D), the first end being connected to the distalmost crown of the inflow portion (Figure 10B), wherein each commissure post is formed from a second material different than the first material (See modification above in view of Conklin Pub, making the posts out of nitinol), and wherein the first material is plastically deformable and the second material is superelastic (Stainless steel is plastically deformable and Nitinol is superelastic see modification in view of Conklin Pub above);
a prosthetic valve (308 Figures 10A/B) disposed within and secured to at least the outflow portion of the stent (valve 308 is positioned inside and attached to posts 304), the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the stent (this is the principle function of all these types of heart valves).
18. Conklin discloses the prosthetic valve includes three leaflets and three commissures (Figures 10A/B), each commissure being formed by attached adjacent lateral ends of an adjoining pair of the three leaflets (Figure 10B), and wherein the three commissure posts are aligned with and attached to a respective commissure of the three leaflets of the prosthetic valve (Figure 10B) (The method for attaching the leaflets to the posts is considered to be a product by process limitation and given limited weight, In this case the prosthesis of Conklin is fully capable of having the leaflet ends attached to the posts in any known manner including having to commissures of the leaflets).
19. Conklin discloses each commissure post is a planar bar (304 Figure 10D) and wherein each commissure post has a length that is greater than a length of each strut of the inflow portion (see explanation with respect to claim 1 above), each commissure post has a thickness along the length thereof that is less than a thickness of each strut of the inflow portion along the length thereof (see explanation with respect to claim 1 above), and each commissure post has a width that is greater than a width of each strut of the inflow portion (Figure 10B).
21. Conklin discloses each commissure post is longitudinally extending from and connected to the inflow portion via only a single distalmost crown of the inflow portion (see explanation with respect to claim 1 above).
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive. With respect to the prior art rejection, the applicant’s arguments are focused on the additional struts connected to the posts of Tuval. This argument is moot because the rejection has been changed to use the teachings of Conklin as the base reference, which does not include the additional side struts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached 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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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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