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
This office action is responsive to the amendment filed on 03/20/2026. As directed by the amendment: claims 1, 3-5, 7 have been amended and claims 8-10, 14-20 have been canceled. Thus, claims 1-7, 11-13 are presently pending in the application.
Response to Arguments
The amendment to the specification to correct a typographical error in paragraph [0064] has been reviewed and is acceptable. Therefore, the previous specification objection has been withdrawn.
Applicant argue on page 8, the prior art Ratz does not teach “a center portion of a stent that is sized to be positioned radially inside the native atrioventricular valve without pressing against the native atrioventricular valve.” The examiner respectfully disagrees. Ratz discloses in Figure 6, a stent frame having a center portion 20 which is spaced from the annulus 98 and along the length of the mitral valve 90 and is coupled to the mitral valve at the atrial end 26 and ventricular end 24, 28.
Applicant’s amendment to claim 1 to further include a first, second and third segment, wherein the second segment configured to stretch more than the first segment and the third segment has overcome the 102 rejection over Ratz et al. However, upon further consideration, a new ground(s) of rejection is made in view of Ratz et al. US 2014/0277390 in view of Nguyen-Thien et al. CN 11568606 A.
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) 1, 3, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ratz et al. US 2014/0277390 in view of Nguyen-Thien et al. CN 11568606 A.
Regarding claim 1, Ratz discloses a prosthetic heart valve (see Fig. 1, 3) for replacing a native atrioventricular valve, the prosthetic heart valve comprising: a self- expanding stent (10; see paragraph [0019]) formed as a monolithic structure (see paragraph [0021]), the stent including an atrial disk (formed of proximal anchors 22), a ventricular disk (formed of distal anchors 24), and a center portion (frame 20) extending between the atrial disk and the ventricular disk (see Fig. 1); a plurality of prosthetic leaflets directly coupled to the center portion of the stent (see paragraph [0040] and Fig. 6, valve 60 comprising a plurality of leaflets); and an outer fabric coupled to the stent (outer skirt 30'; see Fig. 3), wherein in an implanted condition of the prosthetic heart valve, the atrial disk is sized to contact an atrial side of the native atrioventricular valve (proximal anchors 22; see Fig. 6), the ventricular disk is sized to contact a ventricular side of the native atrioventricular valve (distal anchors 24; see Fig. 6), the center portion (20) is sized to be positioned radially inside the native atrioventricular valve without pressing against the native atrioventricular valve (see Fig. 6), and the outer fabric (30') is configured to directly contact the native atrioventricular valve (see Fig. 6 illustrating similar fabric 30). Ratz et al. further discloses wherein the outer fabric 30’ includes a first segment (portions 66, 68 coupled to the proximal anchors 22), a second segment (portion with reference to 30, intermediate portion), and a third segment (portion 70 coupled to the ventricular anchors 24, see Figures 2-3 for clarity on the location of segment 70, see paragraph [0052]), the first segment 66, 68 being directly coupled to the atrial disk 22 (as seen in Figure 3 and paragraph [0052]), the third segment 70 being directly coupled to the ventricular disk 24 (see paragraph [0052]), the second segment extending axially between the first segment and the third segment, the second segment not being directly coupled to the center portion (Ratz expressly discloses the outer skirt 30’ is attached to the proximal anchor 22 and distal anchor 24, and the portion 64, extending in the intermediate region remains unattached, see paragraph [0050]). However, Ratz et al. does not expressly disclose the second segment configured to stretch more than the first segment and the third segment. Nguyen-Thien et al. teaches a prosthetic heart valve 10 comprising a self-expanding frame 12 (paragraph [0005]) and an outer fabric 18 fixed to the frame 12 having a first edge 160 of the fabric coupled to a ventricular side of the frame and a second edge 162 located at a second end and an excess of material located between the first edge and the second edge to allow the frame 12 to be axially elongated when crimping without any resistance from the outer skirt portion (paragraph [0042]). 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 Ratz outer fabric to have excess material that is stretchable as taught by Nguyen-Thien et al. for the purpose of having an excess of material located between the first edge and the second edge to allow the frame to be axially elongated when crimping without any resistance from the outer skirt portion.
Regarding claim 3, Ratz discloses wherein in an expanded condition of the stent (10), the center portion (20) has a diameter, and the ventricular disk (formed of distal anchors 24) has a diameter that is between 1.5 and 2.5 times larger than the diameter of the central portion (see paragraph [0034], where the outermost tip diameter of the stent may range from 40-60 mm when the stent is expanded while the frame diameter may range from 20-40 mm when the stent is expanded).
Regarding claim 13, Ratz fails to disclose wherein the ventricular disk (formed of distal anchors 24) includes a plurality of diamond-shaped ventricular cells that extend substantially parallel to a center longitudinal axis of the stent in an expanded condition of the stent (see Fig. 6, tip 28 is substantially parallel to the longitudinal axis of the frame, and paragraph [0029], the ends can be parallel or substantially parallel with the longitudinal axis of the frame).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Nguyen-Thien et al. CN 11568606 A as applied in the claim rejections above, and further in view Morriss et al. U. S. Patent 9763780.
Regarding claim 2, Ratz discloses the prosthetic heart valve is delivered percutaneously with a catheter (paragraph [0066]). However, Ratz fails to disclose the prosthetic heart valve is sized to be received within a delivery catheter for delivery to the patient, the delivery catheter having an inner diameter of between 22 French and 32 French. Morriss teaches a prosthetic heart valve device (100) comprising an outer diameter of no larger than about 8-10 mm when in the delivery configuration (see col. 15, lines 3-5) which is about 24-30 French and thereby sized to be received within a delivery catheter for delivery to the patient, the delivery catheter having an inner diameter of between 22 French and 32 French (column 14, lines 61-67 and column 15, lines 1-6) for the purpose of having a prosthetic heart valve device that is suitable for low profile delivery through a small-diameter guide catheters (column 14, lines 61-67). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to be of no larger than about 24-30 French when in the delivery configuration as taught by Morriss, so that it is sized to be received within a small delivery catheter having an inner diameter between 22 and 32 French in order to position a prosthetic heart valve device in a low profile delivery through a small-diameter guide catheter using less invasive approaches (see column 8, lines 1-6).
Claim 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Nguyen-Thien et al. CN 11568606 A as applied to claim 1 above, and further in view of Schwartz et al. U.S. Publication 2021/0275303 A1.
Regarding Claim 4, Ratz discloses wherein the outer fabric 30’ includes a first segment (portions 66, 68 coupled to the proximal anchors 22), a second segment (portion with reference to 30, intermediate portion), and a third segment (portion 70 coupled to the ventricular anchors 24, see Figures 2-3 for clarity on the location of segment 70, see paragraph [0052]), wherein the first, second and third segments are formed from a knitted fabric or flexible fabric (paragraph [0045], [0056], [0063]), therefore disclosing the second segment is knitted. However, Ratz fails to disclose wherein the first and third segments are each formed as a woven fabric. Schwartz et al. teaches a prosthetic heart valve (see Figures 1-11) comprising an outer covering 112 having a first segment 122 coupled to an atrial portion 130 and a third segment 120 coupled to a ventricular portion 128 (paragraph [0116]) formed of a woven fabric such as Dacron or polyester (paragraph [0121]) and a second segment forming the intermediate portion between the first and second segment 122, 120 formed from a knitted fabric (paragraph [0122]) for the purpose of having a first and third segments that is strong enough to having the covering layer to be sutured the to ends of the frame and allow the prosthetic valve to be crimped without tearing and allowing the intermediate section of the outer layer to be formed of a plush knitted fabric to be porous, spongy and flexible (paragraph [0122-0123], [0126]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to have an outer covering comprising a first, second and third segment, wherein the first and third segment are formed of a woven fabric and the second segment is formed from a plush knitted fabric to have a first and third segments that is strong to have the cover layer to be sutured to the ends of the frame while allowing the intermediate region of the outer layer to be porous, spongy and flexible.
Regarding Claim 5, 6, Ratz discloses the first, second and third segments can be multiple pieces (paragraphs [0052], [0056]). However, Ratz fails to disclose wherein a first end of the second segment is coupled to the first segment at a first seam, and a second end of the second segment is coupled to a third segment at a second seam, wherein the first seam and second seam are formed via sutures or ultrasonic welding. Schwartz et al. teaches a prosthetic heart valve (see Figures 1-11) comprising an outer covering 112 having a first segment 122 coupled to an atrial portion 130 and a third segment 120 coupled to a ventricular portion 128 (paragraph [0116]) formed of a woven fabric such as Dacron or polyester (paragraph [0121]) and a second segment forming the intermediate portion between the first and second segment 122, 120, wherein the first end of the second segment 116 is coupled to a first segment at a first seam 156 and a second end of a second segment 116 is coupled to a third segment at a second seam 156 (see Figure 13-14, paragraph [0130]), wherein the seams are formed via sutures (paragraph [0130]) for the purpose of coupling the cushioning/plush layer to the first and third segments of the flexible layer (paragraph [0130]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to have an outer covering comprising a first, second and third segment, wherein the first end of the second segment is coupled to a first segment at a first seam and a second end of a second segment is coupled to a third segment at a second seam, wherein the seams are sutures as taught by Schwartz for the purpose of coupling the cushioning/plush layer to the first and third segments of the flexible layer.
Regarding claim 7, Ratz fails to disclose wherein as the prosthetic heart valve transitions from an expanded condition to a collapsed condition, the first outer fabric stretches to increase in length by a factor of greater than 1 and less than 3. Schwartz teaches a further embodiment wherein as the prosthetic heart valve transitions from an expanded condition to a collapsed condition, the first outer fabric stretches to increase in length by a factor of greater than 1 and less than 3 (see paragraph [0024]; the sealing members (outer fabrics) can be heat shrunk to achieve a stretchability between 80-160%). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz in view of Kovalsky, wherein the outer fabric stretches to increase in length by a factor of greater than 1 and less than 3, as taught by Schwartz, to better distribute forces applied by the prosthetic heart valve on the native atrioventricular valve tissue and reduce damage caused by the relative motion of the prosthetic heart valve (see paragraph [0003]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz et al. US 2014/0277390 in view of Nguyen-Thien et al. CN 11568606 A as applied to claim 1 above, and further in view Lane et al. (US 9241790).
Regarding claim 11, Ratz discloses the prosthetic heart valve as claimed in claim 1, and further discloses wherein the stent (10) includes a plurality of cells (16, 18; see Fig. 1). Ratz fails to disclose selected ones of the cells having a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the free end configured to press the outer fabric radially outwardly. Lane teaches a stent (valve 800, see Fig. 8a) that includes a plurality of cells. Lane teaches selected ones of the cells having a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent (the cells having barbs 823, see Fig. 8a), the free end configured to press the outer fabric radially outwardly (due to hooking radially outwardly). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz such that selected ones of the cells have a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the free end configured to press the outer fabric radially outwardly, as taught by Lane, in order to better secure the prosthetic heart valve in the native atrioventricular valve (see col 15-16, lines 49-51, 1-8).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz et al. US 2014/0277390 in view of Nguyen-Thien et al. CN 11568606 A as applied to claim 1 above, and further in view Quadri et al. (US 9333074).
Regarding claim 12, Ratz discloses the prosthetic heart valve as claimed in claim 1 and further discloses the stent includes a plurality of cells (16, 18; see Fig. 1). Ratz fails the disclose selected ones of the cells having protrusion extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly. Quadri teaches a stent (stent 140a, see Fig. 6) with a plurality of cells (see Fig. 6). Quadri teaches selected ones of the cells having a protrusion (outward flare 196, see Fig. 6) extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly (due to the protrusion extending radially outwardly). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to provide selected ones of the cells having a protrusion extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly, as taught by Quadri, in order to better anchor the stent to the native atrioventricular valve (see col 15, lines 15- 18).
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.
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
