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 .
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.
Acknowledgments
This office action is in response to the reply filed on 6/11/2026. In the reply, Applicant amended claims 1, 9, and 16, as well as the specification. Thus, claims 1-12 and 15-18 are pending for examination. The amendments to the specification are acknowledged and overcome the previous specification objections.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/11/2026, with respect to the rejection(s) of claim(s) 1-19 under 35 USC 102(a)(1) as being anticipated by Nir et al. (US 2021/0369452) are persuasive 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 Therefore, the rejection has been withdrawn.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 Levi et al. (US 2019/0053897), Nir et al. (US 2021/0369452), and Peterson et al. (US 2003/0109922).
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi et al. (US 2019/0053897).
Regarding claim 1, Levi et al. discloses a valve prosthesis comprising: a prosthetic valve (10) (see Fig. 1); a stent structure comprising suture slots (see [0047] disclosing a frame (12) effectively functioning as the stent structure, with a plurality of circumferentially spaced slots or commissure windows (20); see Fig. 3 illustrating this configuration); an outer skirt (18) (see Fig. 1); and outer skirt sutures (70) attaching the outer skirt to an outer surface of the stent structure (see [0057] disclosing an outer skirt (18) positioned around the outer surface of the frame (12); Fig. 1 illustrating this configuration), the outer skirt sutures being located within the suture slots (see [0094] disclosing the outer skirt (18) can be constructed similarly as the inner skirt (16), to which the sutures are housed within the windows, thereby allowing the outer skirt to be attached to the frame by suturing through the frame facing windows (20)).
Regarding claim 2, Levi et al. discloses wherein the suture slots are on an inner surface of the stent structure (see [0060] disclosing the frame facing side (74) of the inner skirt (16) has sutures that are threaded through a fabric layer of the inner skirt (16) at the windows to secure it to the frame (12)).
Regarding claim 3, Levi et al. discloses wherein the outer skirt sutures are recessed within the suture slots (see [0094] disclosing the outer skirt (18) is constructed similarly to the inner skirt (16), to which there is recession of the sutures within the slots or windows) to be radially outward of the inner surface (see [0057] disclosing the outer skirt (18) configured to extend radially outward from the frame).
Regarding claim 4, Levi et al. discloses wherein by recessing the outer skirt sutures within the suture slots (see [0094] disclosing the outer skirt (18) is constructed similarly to the inner skirt (16), to which there is recession of the sutures within the slots or windows), contact between the outer skirt sutures and the prosthetic valve is prevented (see [0090] disclosing the sutures (98) are routed between covering members (84, 86) and the fabric layer (88) in order to keep the sutures covered on the inner surface, thereby preventing contact and potential abrasion against interior valve components).
Regarding claim 5, Levi et al. discloses wherein the stent structure comprises an inflow portion comprising a strut (see [0050] disclosing a frame (12) with a first, lower row of angled struts (22) arranged end-to-end and extending circumferentially at the inflow end of the frame), the suture slots being formed within the strut (see [0047] disclosing the frame (12) can be formed with a plurality of circumferentially spaced slots, or commissure windows (20) used to mount the commissures (58)).
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.
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.
Claims 6-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 2019/0053897) in view of Nir et al. (US 2021/0369452).
Regarding claim 6, Levi et al. fails to disclose wherein the strut has a length direction, a width direction, and a depth direction, the suture slots extending a depth in the depth direction less than a thickness of the strut in the depth direction.
Nir et al. also discloses an implantable prosthetic device comprising a frame and a plurality of struts (see [0016]). Nir et al. teaches wherein the strut has a length direction (see [0016] disclosing each strut having a length extending from the first end of the strut to the second end), a width direction (see [0016] disclosing the width of the strut), and a depth direction (see [0017] disclosing thickness of the strut, to which it is measured radially between the inner and outer surfaces, thereby creating depth direction as the radial axis which is perpendicular to both the length and width directions, forms a third spatial axis of the strut), the suture slots extending a depth in the depth direction less than a thickness of the strut in the depth direction (see [0086] disclosing recesses (42, 43) are formed as surface depressions extending into the edges or outer/inner faces of the struts (40); Fig. 7 illustrating the recesses (42) have a defined bottom wall within the strut (40) material rather than an opening completely through, to which the thickness (depth) of the slot is less than the total radial thickness of the strut).
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 provided Levi et al.’s implantable prosthetic valve with an inner and outer skirt and slots or windows (20), wherein the strut has a length direction, a width direction, and a depth direction, the suture slots extending a depth in the depth direction less than a thickness of the strut in the depth direction, as further taught by Nir et al. Doing so would provide a means to anchor the prosthetic skirt assembly using sutures retained within partial-depth slots where the slot depth in the depth direction is less than the thickness of the strut, in order to maintain the attachment sutures inward of the frame’s outermost periphery (see [0086]).
Regarding claim 7, Nir et al. further teaches wherein the depth of the suture slots is greater than a thickness of the outer skirt sutures in the depth direction (see [0086] disclosing the recesses (42, 43) positioned radially inward of the outermost surface of the strut periphery (41), to which the depth of the recess provides sufficient clearance to house the thickness of the sutures (17) with the profile of the strut body, thereby allowing the sutures (17) to be secured without extending radially beyond the outer surface; Fig. 7 illustrating the side walls of the recess (42) extend radially outward past the positioned suture (17), thereby showing the depth is greater than the sutures thickness).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein the depth of the suture slots is greater than a thickness of the outer skirt sutures in the depth direction, as further taught by Nir et al. Doing so would provide a means to couple a skirt assembly to an annular frame using suture slots configured such that the depth of the suture slots is greater than a thickness of the outer skirt sutures in the depth direction, in order to recess the attachment sutures inward of the outermost periphery of the frame (see [0086]).
Regarding claim 8, Nir et al. further teaches wherein the suture slots extend across a width of the strut in the width direction (see [0016] disclosing each strut comprises a plurality of recesses disposed on one or more longitudinal edges of the strut extending into a width of the strut).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein the suture slots extend across a width of the strut in the width direction, as further taught by Nir et al. Doing so would provide a means to do couple a skirt assembly to an annular frame using suture slots configured such that the suture slots extend across a width of the strut in the width direction, in order to recess attachment sutures inward of the frame’s outermost periphery (see [0016]).
Regarding claim 9, Levi et al. discloses a valve prosthesis comprising: a prosthetic valve (10) (see Fig. 2); a stent structure comprising an inflow portion comprising a strut (see [0050] disclosing an inflow end of the frame (12) comprising of angled struts (22)), an outer skirt (18) (see Fig. 2); and outer skirt sutures attaching the outer skirt to an outer surface of the stent structure (see [0057] disclosing an outer skirt (18) positioned around the outer surface of the frame (12); Fig. 2 illustrating this configuration).
Levi et al. fails to disclose a strut including suture holes formed within the strut, wherein the strut has a length direction, a width direction, and a depth direction, the suture holes extending in the width direction through the strut; the outer skirt sutures being located within the suture holes.
Nir et al. also discloses an implantable prosthetic device comprising a frame and a plurality of struts (see [0016]). Nir et al. teaches a strut including suture holes formed within the strut (see [0014] disclosing the struts can have passages (e.g., holes) along their length, with sutures disposed through the passages), wherein the strut has a length direction (see [0016] disclosing each strut having a length extending from the first end of the strut to the second end), a width direction (see [0016] disclosing the width of the strut), and a depth direction (see [0017] disclosing thickness of the strut, to which it is measured radially between the inner and outer surfaces, thereby creating depth direction as the radial axis which is perpendicular to both the length and width directions, forms a third spatial axis of the strut), the suture holes extending in the width direction through the strut (see Fig. 4 illustrating holes (110) pass directly through the strut (40) entirely in the circumferential/width direction); the outer skirt sutures being located within the suture holes (see Fig. 4 illustrating the prosthetic valve assembly (30) including the first end (80) of a skirt and frame struts having recesses (42) or holes (110) that retain attachment sutures (17) radially inward of the outermost surface of the frame periphery).
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 provided Levi et al.’s modified implantable prosthetic valve, with a strut including suture holes formed within the strut, wherein the strut has a length direction, a width direction, and a depth direction, the suture holes extending in the width direction through the strut; the outer skirt sutures being located within the suture holes, as further taught by Nir et al. Doing so would provide a means to attach an outer skirt to an outer surface of a stent structure using outer skirt sutures located within suture holes that extend in the width direction through the strut, in order to recess the attachment sutures inward of the outermost periphery of the frame (see Fig. 4).
Regarding claim 10, Nir et al. further teaches wherein the suture holes are radially outward of an inner surface of the stent structure (see [0014] disclosing the frame struts can have passages (holes) along their length such that attachment sutures positioned within them remain inward of the outermost surface of the frame periphery).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein the suture holes are radially outward of an inner surface of the stent structure, as further taught by Nir et al. Doing so would provide a means to configure a stent structure such that the suture holes are radially outward of an inner surface of the stent structure, in order to recess attachment sutures inward of the frame’s outermost periphery (see [0014]).
Regarding claim 11, Levi et al. further teaches wherein the outer skirt sutures are radially outward of the inner surface (see Fig. 1 illustrating the outer skirt (18) and outer skirt sutures (70) positioned on the exterior, radially outward of the frame and its inner surface (12)).
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 provided Nir et al.’s modified implantable prosthetic valve assembly with suture holes, wherein the outer skirt sutures are radially outward of the inner surface, as further taught by Levi et al. Doing so would provide a means to attach an outer skirt to a stent structure such that the outer skirt sutures are radially outward of the inner surface, in order to secure the outer skirt onto the exterior of the frame while maintaining the attachment sutures inward of the outermost periphery to reduce delivery friction (see Fig. 1).
Regarding claim 12, Nir et al. further teaches wherein by locating the outer skirt sutures within the suture holes (see [0014] disclosing attachment sutures disposed through passages (holes) of the outermost surface of the frame periphery (e.g., outer skirt)), contact between the outer skirt sutures and the prosthetic valve is prevented (see [0072] disclosing the inward offsetting of the sutures (17) minimizes contact or interaction between the sutures and the valve delivery).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein by locating the outer skirt sutures within the suture holes, contact between the outer skirt sutures and the prosthetic valve is prevented, as further taught by Nir et al. Doing so would provide a means to locate the outer skirt sutures within the suture holes, in order to prevent contact between the outer skirt sutures and the prosthetic valve (see [0072]).
Regarding claim 15, Nir et al. further teaches wherein the suture holes are larger than the outer skirt sutures (see [0014] disclosing struts having passages (holes) for the sutures to pass through, thereby requiring the passages to be sized (e.g., large) and configured to receive and pass sutures through the strut body).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein the suture holes are larger than the outer skirt sutures, as further taught by Nir et al. Doing so would provide a means to configure the suture passages (holes) to be larger than the outer skirt sutures, in order to allow the outer skirt sutures to pass through and be retained within the strut holes while remaining recessed inward of the frame’s outermost periphery (see [0014]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 2019/0053897) in view of Peterson et al. (US 2003/0109922).
Levi et al. discloses a valve prosthesis comprising: a prosthetic valve comprising valve leaflets and a valve inflow cylinder proximal of the valve leaflets (see [0044] disclosing a prosthetic valve (10) comprising a valvular structure (14) with valve leaflets (40) configured to allow blood flow in a direction from an outlet end (50) to the inlet end (48), to which the valvular structure effectively functions as a valve inflow cylinder), the valve leaflets including curved cusps where the valve leaflets meet the valve inflow cylinder (see [0046] disclosing each leaflet (40) has a curved cusp edge (52) giving the inlet edge of the valvular structure a curved scalloped shape), the tacking stitching being located adjacent and proximal to the curved cusps and following the curve of the curved cusps (see [0091] disclosing the cusp edges (52) of the leaflets (40) are sutured (stitched) to the fabric layer (88) of the inner skirt (16) along a suture line that tracks the curvature of the scalloped inflow edge of the leaflet structure).
Levi et al. fails to disclose a stent structure comprising suture apertures extending radially through the stent structure; and tacking stitching tacking the prosthetic valve to the stent structure, the tacking stitching being located within the suture apertures.
Peterson et al. also discloses a prosthetic heart valve and a sewing cuff (see [0013]). Peterson et al. teaches a stent structure comprising suture apertures extending radially through the stent structure (see [0032] disclosing a stent (16) with a circumferential base (22) comprising a plurality of apertures or holes (24) spaced circumferentially around the base, thereby allowing the apertures around the base to extend radially to provide access points for a needle to draw a suture through the apertures); and tacking stitching tacking the prosthetic valve to the stent structure (see [0030] disclosing a sewing ring circumscribing the valve body and is attached to the valve body by pins or sutures through the apertures in the stent and elastic material), the tacking stitching being located within the suture apertures (see [0030] disclosing a sewing ring circumscribing the valve body and is attached to the valve body by pins or sutures through the apertures in the stent and elastic material).
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 provided Levi et al.’s implantable prosthetic valve, with a stent structure comprising suture apertures extending radially through the stent structure; and tacking stitching tacking the prosthetic valve to the stent structure, the tacking stitching being located within the suture apertures, as further taught by Peterson et al. Doing so would provide a means for securing a prosthetic valve to a stent structure via stitching located within radial apertures, in order to improve valve durability by eliminating the need to puncture or pierce the elastic material of the valve during construction and attachment (see [0030]).
Claims 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 2019/0053897) in view of Peterson et al. (US 2003/0109922) as applied to claim 16 above, and further in view of Nir et al. (US 2021/0369452).
Regarding claims 17, and 18 Levi et al. in view of Peterson et al., fails to disclose wherein the stent structure comprises a node having a suture aperture of the suture apertures therein, and wherein the stent structure comprises a strut having a suture aperture of the suture apertures therein.
Nir et al. also discloses an implantable prosthetic device comprising a frame and a plurality of struts and/or nodes (see [0014]). Nir et al. teaches wherein the stent structure (see [0010] disclosing a frame or stent structure) comprises a node having a suture aperture of the suture apertures therein (see [0014] disclosing a plurality of struts and/or nodes with passages (e.g., holes or apertures) along their length which retention sutures are disposed); and wherein the stent structure (see [0010] disclosing a frame or stent structure) comprises a strut having a suture aperture of the suture apertures therein (see [0014] disclosing a plurality of struts and/or nodes with passages (e.g., holes or apertures) along their length which retention sutures are disposed).
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 provided Levi et al.’s modified implantable prosthetic valve, wherein the stent structure comprises a node having a suture aperture of the suture apertures therein, and wherein the stent structure comprises a strut having a suture aperture of the suture apertures therein, as further taught by Nir et al. Doing so would provide a means to configure a stent structure comprising a node having a suture aperture, in order to dispose retention sutures through passages in the structural nodes of the frame for securing valve components (see [0014]).
Conclusion
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/STEFAN BRADLEY CAMPBELL/ Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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