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 . Claims 1-19 are pending and examined below.
Response to Arguments
Applicant’s arguments, filed 11/26/2025, with respect to the rejection(s) of claim(s) 1-5, 10, & 13-14 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Liu. Please see the rejection below.
Claim Objections
Claim 13 & 14 objected to because of the following informalities:
Claims 13 & 14 recites “ a longitudinal direction” in lines 2-3. It is unclear if this is the same or different longitudinal direction from claim 1 of which claim 13 & 4 depends from. For the purpose of examination, they are regarded as the same.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, & 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 20120239142 A1) in view of Lock et al. (US 5591223 A).
Regarding claim 1, Liu teaches
a prosthetic heart valve (1, Fig. 1, Liu), comprising:
a stent body (12, Fig. 1, Liu) extending from an inflow end (26, Fig. 1, Liu) to an outflow end (27, Fig. 1, Liu) in a longitudinal direction,
the stent body (12, Fig. 1, Liu) including a generally tubular annulus section having a plurality of struts (16, Fig. 1, Liu) defining a first row of cells extending in a circumferential direction (Fig. 1, Liu),
the stent body (12, Fig. 1, Liu) being expandable from a delivery condition having a first diameter (Fig. 17B, Liu) to a deployed condition having a second diameter larger than the first diameter (Figs. 1 & 5A, Liu); and
a plurality of prosthetic leaflets (14, Fig. 1, Liu) mounted to the stent body (12, Fig. 1, Liu) and operative to allow flow in an antegrade direction from the inflow end to the outflow end, but to substantially block flow in a retrograde direction from the outflow end to the inflow end (¶0099, Liu), wherein
the first row of cells is circumferentially continuous in the delivery condition (Fig. 17B, Liu) and in the deployed condition (Figs. 1 & 5A, Liu).
Liu does not teach the stent body is further expandable from the deployed condition to an open condition in which the first row of cells is circumferentially discontinuous. However, Lock teaches a radially expandable endoprosthesis device (abstract, Lock) wherein
the stent body (12, Fig. 2, Lock) is further expandable from the deployed condition (Fig. 2, Lock) to an open condition in which the first row of cells is circumferentially discontinuous (row at first 22, Fig. 3, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu by incorporating the stent body is further expandable as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 2, Liu teaches
wherein a first cell in the first row of cells is coupled to a circumferentially adjacent second cell in the first row of cells by a first connector (18, Fig. 3, Liu).
Liu does not teach the first connector is configured to decouple the first cell from the second cell. However, Lock teaches wherein
the first connector (22, Fig. 2, Lock) is configured to decouple the first cell (cell from 26 side, Figs. 2 & 3, Lock) from the second cell (cell from 28 side, Figs. 2 & 3, Lock) when a predetermined force is applied to an inner surface of the stent body while transitioning the stent body from the deployed condition to the open condition (pressure four to ten atmospheres, col. 5 lines 10-14, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu by incorporating the teachings above as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 3, Liu teaches
wherein the first connector (18, Fig. 3, Liu) is formed by a first connector portion of the first cell (left portion of 18, Fig. 3, Liu), and a second connector portion of the second cell (right portion of 18, Fig. 3, Liu).
Regarding claim 4, Liu teaches
further comprising an isolator (weld at 18, Fig. 3, Liu) positioned at a point of engagement between the first connector portion (left portion of 18, Fig. 3, Liu) and the second connector portion (right portion of 18, Fig. 3, Liu) when the stent body is in the deployed condition (Fig. 3, Liu), the isolator configured to limit direct contact between the first connector portion and the second connector portion when the first cell is coupled to the second cell by the first connector (¶0091, Liu).
The phrase “…configured to limit direct contact between the first connector portion and the second connector portion when the first cell is coupled to the second cell by the connector” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing (or being manipulated to) the recited function in order to meet the claim requirements. In this case, the device discloses all the claimed structural features and is considered to be capable of limiting direct contact between the first connector portion and the second connector portion.
Regarding claim 10, Liu teaches
wherein the stent body (12, Fig. 1, Liu) is formed of a shape-memory material and is configured to self-expand from the delivery condition to the deployed condition (Figs. 1, 5A, & 17B, Nitinol, ¶0091, Liu).
Regarding claim 11, Liu teaches
wherein a first cell in a second row of cells is coupled to a circumferentially adjacent second cell in the second row of cells by a second connector (another one of 18, Fig. 3, Liu).
Liu does not teach the second connector configured to decouple the first cell in the second row of cells from the second cell in the second row of cells when the predetermined force is applied to the inner surface of the stent body. However, Lock teaches
the second connector (another of 22, Fig, 2, Lock) configured to decouple the first cell in the second row of cells (another cell from 26 side, Figs. 2 & 3, Lock) from the second cell in the second row of cells (another cell from 28 side, Figs. 2 & 3, Lock) when the predetermined force is applied to the inner surface of the stent body while transitioning the stent body from the deployed condition to the open condition (pressure four to ten atmospheres, col. 5 lines 10-14, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu by incorporating the teachings above as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 12, Liu teaches
wherein the first row of cells includes a first connector (18, Fig. 3, Liu) having a first connector portion (first portion of 18, Fig. 3, Liu) and a second connector portion (second portion of 18, Fig. 3, Liu),
the first connector portion (first portion of 18, Fig. 3, Liu) is integral with a first portion of a strut (16, Fig. 1, Liu) in the first row of cells and the second connector portion (second portion of 18, Fig. 3, Liu) is integral with a second portion of the strut (16, Fig. 1, Liu) in the first row of cells,
the first portion of the strut is coupled to the second portion of the strut by the first connector (18, Fig. 3, Liu).
Liu does not teach the first connector is configured to decouple the first portion of the strut from the second portion of the strut. However, Lock teaches
and the first connector (22, Fig. 2, Lock) is configured to decouple the first portion of the strut from the second portion of the strut (22, Fig. 3, Lock) when a predetermined force is applied to an inner surface of the stent body while transitioning the stent body from the deployed condition to the open condition (pressure four to ten atmospheres, col. 5 lines 10-14, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu by incorporating the teaching above as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 13, Liu teaches
wherein the cells of the stent body (12, Fig. 1, Liu) are substantially diamond shaped with two ends pointing in a longitudinal direction and two ends pointing in the circumferential directions when in the deployed condition (12, Figs. 1 & 3, Liu).
Regarding claim 14, Liu teaches
wherein the cells of the stent body (12, Fig. 1, Liu) are substantially diamond shaped with two ends pointing in a longitudinal direction and two ends pointing in the circumferential direction, the first connector (18, Fig. 3, Liu) coupling a circumferential point of the first cell to a circumferential point of the second cell (12, Figs. 1 & 3, Liu).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu, in view of Lock, and further in view of Conklin (US 20140188219 A1).
Regarding claim 5, Liu teaches
wherein the first connector portion and the second connector portion are each formed of metal (nickel titanium alloy, ¶0091, Liu).
Liu in view of Lock does not teach the isolator is formed of tissue or fabric. However, Conklin teaches a prosthetic heart valve and having a support frame (abstract, Conklin) wherein
the isolator (256, Fig. 12C & 12F, Conklin) is formed of tissue or fabric (silk suture, ¶0092, Conklin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu and Lock by incorporating the teaching above as taught by Conklin in order to form a weakened spot on the first band 242, where the suture 256 will break before the remaining parts of the support portion will fail when the support portion is subjected to a dilation force (¶0093, Conklin).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu, in view of Lock, in view of Andreas et al. (US 20070219612 A1) hereinafter, Andreas, and further in view of Hanson et al. (US 20060248698 A1) hereinafter, Hanson.
Regarding claim 6, Liu does not teach wherein the first connector portion is hook-shaped and wraps around the second connector portion when the first cell is coupled to the second cell by the first connector. However, Andreas teaches a luminal prosthesis comprises a plurality of radially expandable prosthetic stent segments (abstract, Andreas)
wherein the first connector portion (552, Fig. 8F, Andreas) is hook-shaped and wraps around the second connector portion (554, Fig. 8F, Andreas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Konno by incorporating the hook shaped as taught by Andreas in order to engage one another and lock together, coupling the expanded stent segments to one another (¶0120, Andreas).
Lui in view of Lock and Andreas does not teach the first cell coupled to the second cell. However, Hanson teaches a tubular structure having a pattern configured to provide expansion and an opening defining a first edge and a second edge (¶0005, Hanson)
when the first cell is coupled to the second cell by the first connector (240, Figs. 3A, & 3D, Hanson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu, Lock and Andreas by incorporating the first cell is coupled to the second cell as taught by Hanson in order to retain and/or manipulate the tubular structure 270 during a subsequent manufacturing process (¶0036, Hanson).
Regarding claim 7, Liu teaches
wherein when the first cell is coupled to the second cell by the first connector (18, Fig. 3, Liu).
Liu does not teach a thinned neck portion. However, Andreas teaches
the first connector portion (552, Fig. 8F, Andreas) includes a thinned neck portion (one of 550, Fig. 8F, Andreas) positioned where the first connector portion wraps around the second connector portion (554, Fig. 8F, Andreas), the thinned neck portion having a thickness that is smaller than a thickness of the first connector portion adjacent the thinned neck portion (Fig. 8F, Andreas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lui and Lock by incorporating the hook shaped as taught by Andreas in order to engage one another and lock together, coupling the expanded stent segments to one another (¶0120, Andreas).
Regarding claim 8, Liu does not teach upon application of the predetermined force to the inner surface of the stent body, the first connector portion is configured to preferentially deform. However, Lock
wherein upon application of the predetermined force to the inner surface of the stent body, the first connector portion is configured to preferentially deform to decouple the first cell from the second cell (pressure four to ten atmospheres, col. 5 lines 10-14, Lock).
Liu in view of Lock does not teach preferentially deform at the thinned neck portion. However, Andreas teaches
wherein upon application of the predetermined force to the inner surface of the stent body, the first connector portion is configured to preferentially deform at the thinned neck portion to decouple the first cell from the second cell (deformed outwardly to be co-cylindrical with the struts of stent segment 504 as balloon 514 is expanded, ¶0120, and decoupling the two J-shaped ends, ¶0123, Andreas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Liu and Lock by incorporating the hook shaped as taught by Andreas in order to engage one another and lock together, coupling the expanded stent segments to one another (¶0120, Andreas).
Regarding claim 9, Liu teaches
the isolator (weld at 18, Fig. 3, Liu) being coupled to a face of the second connector portion that confronts the first connector portion when the first cell is coupled to the second cell by the first connector (Fig. 3, Liu).
Liu does not teach the second connector portion is hook-shaped. However, Andreas teaches
wherein the second connector (554, Fig. 8F, Andreas) portion is hook-shaped, the isolator being coupled to a face of the second connector portion that confronts the first connector portion when the first cell is coupled to the second cell by the first connector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Konno by incorporating the hook shaped as taught by Andreas in order to engage one another and lock together, coupling the expanded stent segments to one another (¶0120, Andreas).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Konno (US 20100076548 A1) in view of Lock.
Regarding claim 15, Konno teaches
a method of implanting a first prosthetic heart valve ( implanting the prosthetic heart valve in a heart valve annulus, ¶0021), the method comprising: loading the first prosthetic heart valve into a sheath of a delivery device so that a stent body of the first prosthetic heart valve is maintained in a delivery condition with a first diameter (Figs. 8B-8D, Konno);
advancing the first prosthetic heart valve through a patient until the first prosthetic heart valve is positioned adjacent a native heart valve of the patient (Fig. 1, Konno);
deploying the first prosthetic heart valve from the sheath of the delivery device into the native heart valve of the patient so that the stent body of the first prosthetic heart valve expands to a deployed condition with a second diameter larger than the first diameter (Fig. 1, ¶0076, Konno),
and withdrawing the delivery device from the patient and completing the implantation of the first prosthetic heart valve without further expanding the stent body from the deployed condition to the open condition (previously-deployed prosthetic heart valve 10 may have been deployed using any methods, including methods currently known in the art, ¶0076 & 0080).
Konno does not teach the stent body being further expandable, However, Lock teaches
the stent body (12, Fig. 2, Lock) being further expandable, upon the application of a predetermined force (pressure four to ten atmospheres, col. 5 lines 10-14, Lock) to an inner surface of the stent body, from the deployed condition (Fig. 2, Lock) to an open condition in which a first row of cells of the stent body is circumferentially discontinuous (Fig. 3, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Konno by incorporating the stent body is further expandable as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 16, Konno teaches
further comprising inserting a secondary device (230, Fig. 8B, Konno) into the patient, positioning the secondary device within the first prosthetic heart valve (10, Figs. 8B-8D), and using the secondary device to apply the predetermined force to the inner surface of the stent body to transition the stent body from the deployed condition to the open condition (dilation force, ¶0060 & ¶0079, Figs. 8B-8D).
Konno does not specify the stent body from the deployed condition to the open condition. However, Lock teaches
using the secondary device to apply the predetermined force (balloon catheter, col. 5 lines 9-10, Lock) to the inner surface of the stent body to transition the stent body (12, Fig. 2, Lock) from the deployed condition to the open condition (Fig. 3, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Konno by incorporating the teachings above as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 17, Konno teaches
wherein inserting the secondary device into the patient is performed as part of an implantation of a second prosthetic heart valve being performed after completing the implantation of the first prosthetic heart valve (Figs. 8B-8D, ¶0076, Konno).
Regarding claim 18, Konno does not teach a connector couples a first cell in the first row of cells to a circumferentially adjacent second cell in the first row of cells, and transitioning the stent body from the deployed condition to the open condition. However, Lock teaches
wherein a connector (22, Fig. 2, Lock) couples a first cell in the first row of cells (cell from 26 side, Figs. 2 & 3, Lock) to a circumferentially adjacent second cell in the first row of cells (cell from 28 side, Figs. 2 & 3, Lock), and transitioning the stent body (12, Fig. 2, Lock) from the deployed condition to the open condition includes disengaging the connector to decouple the first cell from the second cell (Figs. 2 & 3, Lock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Konno by incorporating the teachings above as taught by Lock in order to accommodate vessel growth or prevent restenosis (col. 5 lines 9-10, Lock).
Regarding claim 19, Konno teaches
wherein the secondary device is a balloon catheter (230, Fig. 8B, Konno).
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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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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