DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-15 in the reply filed on 24 February 2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 February 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “vertical seam” of claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 2 refers to a “vertical seam” that is not found in the specification. Further clarification of the limitation is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 10-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gurovich et al. (US 2018/0028310 A1), “Gurovich”.
Regarding claim 1, Gurovich teaches
A prosthetic heart valve (Fig. 1A, prosthetic valve 10) comprising:
an annular frame (Fig. 1A, frame 12) comprising
an inflow end (Fig. 1B, inflow end 26) and
an outflow end (Fig. 1B, outflow end 28) and
being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration (radially collapsible and expandable frame (abstract)),
wherein the frame comprises a plurality of struts (Fig. 1B, struts 22);
a valvular structure mounted within the frame (Fig. 1A, valvular structure 14) and
comprising a plurality of leaflets (Fig. 33, leaflet 300),
wherein each leaflet comprises opposing tabs on opposite sides of the leaflet (Fig. 33, lower tabs 304) and
a cusp edge portion between the tabs (Fig. 33, lower edge portion 302),
wherein each tab is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are connected to the frame (Fig. 33, folded tab layers 306a, 306b of adjacent leaflets form commissures 32 (Fig. 1A) [0146-0150]); and
a plurality of connecting skirts (Fig. 8, connecting skirt 100),
each connecting skirt comprising side base portions (Fig 9, bottom left and right portions of connecting skirt 100) and
a central portion connected to each of the cusp edge portion of a corresponding leaflet of the plurality of leaflets and struts of the frame (Fig. 9, body 104 is folded along its center line to form folded portions 110a, 110b, which are placed surrounding the lower edge portion 102 [0114]),
each connecting skirt further comprising side extension portions that extend away from the cusp edge portion along a length of the frame (Figs. 11A and 12, flaps 106a, 106b extending up sides of leaflet 20 and around struts 22 [0115]),
wherein each side extension portion of each connecting skirt extends across struts of the frame, between cusp edge portions of adjacent leaflets and connects to an adjacent side extension portion of an adjacent connecting skirt (Fig. 8, flaps 106a, 106b surround struts 22 of frame 12 and extend along struts 22 between lower edge portions 102 of leaflets 20 [0113-0117]).
Regarding claim 2, Gurovich teaches
wherein each side extension portion (Fig. 9, regions of connecting skirt 100 comprising flaps 106a, 106b) is sutured to an adjacent side extension portion of the adjacent connecting skirt from a strut junction (Fig. 8, flaps 106a, 106b are connected to each other around frame 12) to which a corresponding commissure of the plurality of commissures is connected, to the inflow end of the frame along a vertical seam (Fig. 13A, tabs 60 are connected to adjacent tabs to form commissures secured to frame 12 [0121]).
Regarding claim 3, Gurovich teaches
wherein the struts form a plurality of circumferentially extending rows of cells (Fig. 1B, struts 22 of frame 12 define rows of cells 24 [0101]) including
a first row of cells defining the inflow end of the frame (Fig. 1B, row of bottom-most cells 24 nearest inflow end 26) and
a second row of cells downstream of the first row of cells (Fig. 1B, row of cells 24 directly above/in between bottom-most row of cells nearest inflow end 26), and
wherein each side extension portion and an adjacent side extension portion of an adjacent connecting skirt completely cover two cells of the first row of cells and one cell of the second row of cells (Fig. 8, connecting skirt 100 surrounds frame 12 along bottom two rows of cells and half of third row of cells from bottom).
Regarding claim 4, Gurovich teaches
wherein the connecting skirts (Fig. 8, connecting skirt 100) do not occlude any cells of the frame downstream of the cusp edge portions of the leaflets (Fig. 8, connecting skirt 100 does not extend upwards (downstream) past lower edge portion 102).
Regarding claim 10, Gurovich teaches
wherein each connecting skirt includes slits that partially separate the two side base portions from the central portion to allow the connecting skirt to be aligned along the cusp edge portion of the corresponding leaflet (Fig. 8, connecting skirt 100 comprises slits to differentiate between flaps 106a, 106b and body 104).
Regarding claim 11, Gurovich teaches
wherein the central portion of each connecting skirt is rectangular (Fig. 8, body 104 of connecting skirt 100 is rectangular).
Regarding claim 12, Gurovich teaches
A prosthetic heart valve (Fig. 1A, prosthetic valve 10) comprising:
a radially collapsible and expandable frame (Fig. 1A, frame 12 is radially collapsible and expandable frame (abstract)) comprising
an inflow end (Fig. 1B, inflow end 26) and
an outflow end (Fig. 1B, outflow end 28),
wherein the frame comprises a plurality of interconnected struts (Fig. 1B, struts 22); and
a plurality of leaflets arranged within the frame (Fig. 1A, valvular structure 14 comprises leaflets 20),
wherein each leaflet comprises two tabs disposed on opposite sides of the leaflet (Fig. 33, lower tabs 304) and
a cusp edge portion extending between the two tabs (Fig. 33, lower edge portion 302);
wherein the cusp edge portion of each leaflet is connected to the frame by a connecting skirt (Fig. 8, connecting skirt 100),
wherein each connecting skirt comprises a central portion (Fig. 9, body 104 is folded along its center line to form folded portions 110a, 110b, which are placed surrounding the lower edge portion 102 [0114]) and
opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edge portion of the leaflet (Figs. 11A and 12, flaps 106a, 106b extending up sides of leaflet 20 and around struts 22 [0115]), and
wherein each connecting skirt further comprises side extension portions that extend axially away from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of adjacent leaflets (Figs. 11A and 12, flaps 106a, 106b extending up sides of leaflet 20 and around struts 22 [0115]).
Regarding claim 13, Gurovich teaches
wherein the plurality of interconnected struts form a plurality of apices at the inflow end and the outflow end of the frame (Fig. 1B, inflow end 26 and outflow end 28 comprise frame 12 that forms peaks between struts (i.e., apices)), and
wherein each side extension portion of each connecting skirt extends across the struts of the frame that are disposed between cusp edge portions of adjacent leaflets such that an inner surface of each apex of the plurality of apices that are disposed at the inflow end of the frame, between adjacent leaflets, is covered by a corresponding side extension portion of a corresponding connecting skirt (Fig. 4, flaps 106a, 106b engage each other around frame 12 struts and apices from inflow end 26 and outflow end 28 and around leaflet 20 edges).
Regarding claim 14, Gurovich teaches
wherein each side extension portion is secured to an adjacent side extension portion of an adjacent connecting skirt (Fig. 8, flaps 106a, 106b connect to each other over frame 12).
Regarding claim 15, Gurovich teaches
further comprising an outer sealing member mounted on an outer surface of the frame and secured to each connecting skirt (Fig. 3, sealing member 16 is connected to outer surface of frame 12 [0102-103]).
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.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gurovich et al. (US 2018/0028310 A1), “Gurovich”.
Regarding claim 5, Gurovich teaches an embodiment wherein each extension portion and an adjacent extension portion of an adjacent connecting skirt collectively form an isosceles triangle (Fig. 59, sealing member 602 comprises triangular shaped portions 608 [0172]). Gurovich discloses that the triangular sealing member is shaped to correspond to the shape of the lower edge portions of the leaflets and cover the openings of the edge portions [0178]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the connecting skirt taught by the embodiment of Gurovich with the valve of the main embodiment of Gurovich in order to prevent leakage within the device by best fitting the shapes of the members together.
Regarding claim 6, Gurovich teaches an embodiment wherein each connecting skirt includes two side base portions (Fig. 59, upper edge portions 612 below triangular shaped portions 608), each arranged on an opposite side of the central portion (Fig. 59, upper edge portions 612 below triangular shaped portions 608 are on either sides of rectangular shaped portions (i.e., non-triangular portions)), and two side extension portions (Fig. 59, triangular shaped portions 608), each side extension portion extending outward from a corresponding side base portion of the two side base portions (Fig. 59, triangular shaped portions 608 extend outward above upper edge portions 612). Gurovich discloses that the triangular sealing member is shaped to correspond to the shape of the lower edge portions of the leaflets and cover the openings of the edge portions [0178]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the connecting skirt taught by the embodiment of Gurovich with the valve of the main embodiment of Gurovich in order to prevent leakage within the device by best fitting the shapes of the members together.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gurovich et al. (US 2018/0028310 A1), “Gurovich” in view of Armstrong et al. (US 2016/0100939 A1), “Armstrong”.
Regarding claim 7, Gurovich teaches an embodiment having each connecting skirt (Fig. 59, sealing member 602) comprising a central portion (Fig. 59, non-triangular portions of sealing member 602 between triangular portions 608) and two side base portions (Fig. 59, upper edge portions 612 below triangular shaped portions 608), but fails to teach a plurality of rows of apertures, and wherein each row of apertures includes a plurality of apertures spaced apart from one another and extending from a free end of one side base portion of the two side base portions to another side base portion of the two side base portions.
Armstrong teaches a valved conduit comprising a plurality of rows of apertures (Fig. 7, valved conduit 1100 comprises member 1210 comprising holes), and wherein each row of apertures includes a plurality of apertures spaced apart from one another and extending from a free end of one side base portion of the two side base portions to another side base portion of the two side base portions (Fig. 7, holes extend from rectangular portions to triangular portions of member 1210). Armstrong discloses that the apertures are in a staggered relationship with the leaflet apertures which allows for a zig-zag stitch pattern and further allows for more leaflet material between leaflet apertures [0106]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the connecting skirt taught by Gurovich with the apertures taught by Armstrong in order to increase the strength of the leaflet attachment edge of the device.
Regarding claim 8, Gurovich teaches wherein each connecting skirt is secured to the cusp edge portion of the corresponding leaflet via one or more sutures that extend through a first row of apertures of the plurality of rows of apertures (Fig. 59, lower edge portions 102 of leaflets 20 are connected directly to upper edge portion 610 of sealing member 602 with sutures [0173]).
Regarding claim 9, Gurovich teaches an embodiment wherein each connecting skirt is secured to the struts of the frame (Fig. 3, sealing member 16 is connected to outer surface of frame 12 [0102-103]) but fails to teach via one or more sutures that extend through a second row of apertures of the plurality of rows of apertures.
Armstrong teaches a valved conduit comprising one or more sutures that extend through a second row of apertures of the plurality of rows of apertures (Fig. 7, valved conduit 1100 comprises member 1210 comprising multiple rows of holes). Armstrong discloses that the apertures are in a staggered relationship with the leaflet apertures which allows for a zig-zag stitch pattern and further allows for more leaflet material between leaflet apertures [0106]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the connecting skirt taught by Gurovich with the apertures taught by Armstrong in order to increase the strength of the leaflet attachment edge of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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