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 .
Election/Restrictions
Applicant’s election without traverse of Species A1 and B1 in the reply filed on 2/19/2026 is acknowledged.
Claim(s) 12, 14-26 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/19/2026. (PLEASE NOTE: In the response dated 2/19/2026 Applicant withdrew claim(s) 12, 15, 19-20, 22-26 as being directed to non-elected species; Examiner has further withdrawn claim(s) 14, 16-18, 21 as being drawn to non-elected species A2 (due to “the plurality of protrusions extending around and outward from a first surface of the sealing member” as required by claim 14 which is a feature of species A2 (see Figs. 8A-8C and Applicant’s specification [0434]) NOT elected species A1).
Claim Objections
Claim(s) 13 is/are objected to because of the following informalities:
Within claim 13, line 3: “at one of the inter-ridge gaps” is an incomplete clause (and may not have been intended to be separated form the previous claim clause).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 9, 13 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the surface of the first layer" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 13, which depend from claim 9, inherit all the problems associated with claim 9.
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.
Claim(s) 1-3, 7-11 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Braido et al. (US 2011/0098802 A1) (as evidenced by LEE et al. (US 2019/0209304 A1) for claim 3).
With respect to claim 1:
Braido et al. discloses a prosthetic heart valve, as can be seen in fig. 7, comprising:
a frame (stent) comprising a plurality of intersecting struts (cell struts 204) (paragraph [0065]), wherein the frame (stent) is movable between a radially compressed state (radially collapsed condition) and a radially expanded state (radially expanded state) (paragraph [0065]);
a leaflet assembly (prosthetic valve leaflets 271) mounted within the frame (stent) (paragraphs [0006, 0008, 0066]); and
a sealing member (cuff 200) coupled to an outer surface (exterior of annulus section 200) of the frame (stent) (paragraph [0065]), wherein the sealing member (cuff 200 made up of sub and supra-annular portions 80, 90) extends from an inflow edge toward an opposing outflow edge (as can be seen in figs. 5-6), wherein the sealing member (cuff 200) comprises a first layer (an inner one of the more than one layers of pericardium/ fabric making the cuff 200) and a second layer (an outer one of the more than one layers of pericardium/ fabric making the cuff 200) coating the first layer (an inner one of the more than one layers of pericardium/ fabric making the cuff 200) (paragraphs [0058, 0065]), wherein a nonfibrous outer surface (an outermost one of the more than one layers of pericardium/ non- woven fabric making the cuff 200) of the sealing member (cuff 200) is formed of a material inherently shaped (configured to assume a shape with) to define a plurality of elevated portions with peaks (ridge regions 205 of pleats) and a plurality of non-elevated portions (valley regions 203 of pleats) (paragraph [0065]) (Please note: Applicant has defined “nonfibrous” as devoid of yarns/ strands and is to be understood and being a non-woven and non-braided layer (see Applicant’s specification paragraph [0305]); as such, the outermost layer of the multilayered pericardium or the outermost layer of the multilayered non-woven fabrics making up the cuff 200 (paragraph [0058]), as disclosed by Braido et al., are “nonfibrous” as currently claimed), and
wherein said first and second layers (layers of the more than one layers of pericardium/ fabric making the cuff 200) are disposed externally to the outer surface (exterior of annulus section 200) of the frame (stent) (paragraph [0065]).
With respect to claim 2:
Wherein the elevated portions (ridge regions 205 of pleats) are configured to deform (are capable of deforming) when an external pressure exceeding a predefined threshold is applied thereto in a direction configured to press them against the frame (stent) (thus creating “sealing”) (paragraphs [0008, 0065]), and to revert to a relaxed state (where the pleats are not deformed by the vessel) thereof when the external pressure is no longer applied thereto, and wherein a distance to the peaks (ridge regions 205 of pleats) from the frame (stent) is greater than a distance to the non-elevated portions (valley regions of pleats) from the frame (stent) in the relaxed state (where the pleats are not deformed by the vessel), as can be seen in fig. 7.
With respect to claim 3:
Wherein the nonfibrous outer surface (an outermost one of the more than one layers of pericardium/ non- woven fabric making the cuff 200) (paragraph [0058]) is a smooth surface (porcine pericardium is considered to have a smooth surface as evidenced by LEE et al. paragraph [0087]).
With respect to claim 4:
Wherein the sealing member (cuff 200) comprises a third layer, wherein the second layer and the third layer collectively form a coating which covers the first layer (Please note: the sealing member (cuff 200) can be made from a plurality of layers (paragraph [0058]); in which case the radially inner most and radially outer most are considered to the third layer and second layer respectively and an intermediate layer therebetween OR polymer placed between the other layers are considered the first layer (paragraphs [0058, 0068])).
With respect to claim 7:
Wherein the elevated portions (ridge regions 205 of pleats) of the sealing member (cuff 200) comprise a plurality of ridges (ridge regions 205 of pleats) (paragraph [0065]), wherein the plurality of ridges (ridge regions 205 of pleats) are spaced apart from each other along a first surface (outer most surface of cuff 200) of the sealing member (cuff 200), as can be seen in fig. 7, wherein the second layer (an outermost one of the more than one layers of pericardium/ fabric making the cuff 200) forms the first surface (outer most surface of cuff 200) of the sealing member (cuff 200), wherein each one of the plurality of ridges (ridge regions 205 of pleats) extends outward from the outer surface (exterior of annulus section 200) of the frame (stent) (paragraph [0065]), wherein the sealing member (cuff 200) comprises a plurality of inner channels (space between each ridge region 205 of pleats and the exterior of annulus section 200), wherein each channel (space between each ridge region 205 of pleats and the exterior of annulus section 200) is formed at a second surface (inner most surface of the cuff 200) of the sealing member (cuff 200), and wherein each one of the plurality of channels (space between each ridge region 205 of pleats and the exterior of annulus section 200) is facing inward (toward the stent), as can be seen in fig. 7.
With respect to claim 8:
Wherein the number of channels (space between each ridge region 205 of pleats and the exterior of annulus section 200) is identical to the number of ridges (ridge regions 205 of pleats), wherein each one of the plurality of channels (space between each ridge region 205 of pleats and the exterior of annulus section 200) is formed by a respective one of the plurality of ridges (ridge regions 205 of pleats) at an opposing surface of the sealing member (cuff 200), as can be seen in fig. 7.
With respect to claim 9:
Wherein the non-elevated portions (valley regions 203 of pleats) of the sealing member (cuff 200) comprise a plurality of inter-ridge gaps (spaces over the valley regions 203) formed over the first surface (outer most surface of cuff 200) of the sealing member (cuff 200) between each two adjacent ridges (ridge regions 205 of pleats) of the sealing member (cuff 200), as can be seen in fig. 7.
With respect to claim 10:
Wherein the plurality of ridges (ridge regions 205 of pleats) follow parallel path-lines (generally in the circumferential direction) extending along the first surface (outer most surface of cuff 200) of the sealing member (cuff 200) (paragraph [0065]), and wherein the plurality of ridges (ridge regions 205 of pleats) are compressible (made of tissue/ fabric which is unsupported and thus is compressible) (paragraph [0058]).
With respect to claim 11:
Wherein the plurality of ridges (ridge regions 205 of pleats) follow parallel path-lines (generally in the circumferential direction) extending substantially in parallel to at least one of the inflow edge or the outflow edge (generally in the circumferential direction) (paragraph [0065]).
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US 2011/0098802 A1) in view of Stevenson et al. (US 2019/0307924 A1).
With respect to claims 5-6:
Braido et al. discloses the invention substantially as claimed, as discussed above. However, Braido et al. does not disclose the first layer to comprise at least one tear resistant polyethylene terephthalate (PET) fabric (as required by claim 5); nor the second layer to be made of biocompatible thermoplastic polyurethan (TPU) (as required by claim 6).
Stevenson et al. teaches a vascular prosthesis (16), as can be seen in fig. 7, comprising a frame (support 18) and a sealing member (conduit 10) coupled thereto (paragraphs [0458]). The sealing member (conduit 10) comprises a first layer (wall 10f defining a porous inner surface 10a) and a second layer (sealant 14) coating (radially outside of) the first layer (paragraphs [0382, 0397, 0409]). The sealing member (conduit 10) has a nonfibrous outer surface (the outer surface is defined by the layer created by the sealant 14 which is itself non-woven/ non-braided and does not contain fibers but surrounds the fibers of the layer therebelow) and is formed of a material inherently shaped to define a plurality of elevated portions (crimps 10g) with peaks and plurality of non-elevated portion, as can be seen in fig. 7 (paragraph [0458]). The first layer to comprises at least one tear resistant polyethylene terephthalate (PET) fabric (paragraphs [0376]), and the second layer (sealant 14) to be made of biocompatible thermoplastic polyurethan (TPU) (paragraph [0397]). The aforementioned vascular prosthesis (16) is highly flexible (paragraphs [0417, 0419]) and maybe used within a damaged portion of the vessel as a bypass graft (paragraphs [00465-0466]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the materials of the sealing member (conduit 10), as taught by Stevenson et al., to make the sealing member (cuff 200), as disclosed by Braido et al., as the two structures are used for similar purposes (to create wrinkled grafted supported by stent structures used within damaged portions of the vasculature) and as such should be made from the same/ interchangeable materials. In making the aforementioned combination, the sealing member (cuff 200), as disclosed by Braido et al., would feature a first (luminal) layer of tear resistant polyethylene terephthalate (PET) fabric, as taught by Stevenson et al., and a second (abluminal) layer comprising biocompatible thermoplastic polyurethan (TPU) which would define a nonfibrous outer surface thereof, as taught by Stevenson et al..
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US 2011/0098802 A1).
With respect to claim 13:
Braido et al. discloses the invention substantially as claimed, as discussed above. However, Braido et al. is silent regarding the thickness differential between: the total layer thickness measured between the first surface (outer most surface of cuff 200) and the second surface (inner most surface of the cuff 200) of the sealing member (cuff 200) at one of the inter-ridge gaps (spaces over the valley regions 203) (i.e. the thickness of the cuff 200 at the bottom of the valley regions 203), and the sealing member thickness (cuff 200) measured by the height (depth/ peak) of the ridges (ridge regions 205 of pleats) of the sealing member (cuff 200) (i.e. the radial distance between the inner most surface of the cuff 200 within the valley regions 203 and the outer most surface of cuff 200 at the peak of the ridge regions 205); specifically, the sealing member thickness (i.e. the radial distance between the inner most surface of the cuff 200 within the valley regions 203 and the outer most surface of cuff 200 at the peak of the ridge regions 205) is greater by at least 1000% than the total layer thickness (i.e. the thickness of the cuff 200 at the bottom of the valley regions 203). However, Braido et al. discloses the sealing member (cuff 200) having a pleated structure (thus creating the claimed differing thicknesses) (paragraphs [0008, 0065-0066]) and the pleats both allowing the frame (stent) of the prosthetic heart valve to elongate in the radially collapsed configuration and creating a sealing structure with the native tissue when the prosthetic heart valve in is the radially expanded configuration (paragraphs [0008, 0065]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the depth of the pleats (i.e. the radial distance between the inner most surface of the cuff 200 within the valley regions 203 and the outer most surface of cuff 200 at the peak of the ridge regions 205) such that the peats have a depth of 1000% in comparison to the thickness (i.e. the thickness of the cuff 200 at the bottom of the valley regions 203) of the sealing member (cuff 200) since these are result effective variables that contribute both to the amount the prosthetic heart valve can elongate in the radially collapsed configuration (which also determines the smallest diameter the prosthetic heart valve can be collapsed to) and amount of space that can be sealed between the frame (stent) and the vessel it is implanted therein and it has been held that where the general conditions of a claim are disclosed in the prior art discovering the optimum or workable ranges involves only routine skill in the art and modifying the depth of the pleats (i.e. the radial distance between the inner most surface of the cuff 200 within the valley regions 203 and the outer most surface of cuff 200 at the peak of the ridge regions 205), as taught and suggested by Braido et al., would allow for a smaller radially collapsed configuration and would allow for sealing between the frame (stent) and the vessel when there are greater irregularities in the shape of the vessel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774