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 A in the reply filed on 3/30/2026 is acknowledged.
Claim(s) 14-22 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 3/30/2026.
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) 1-13 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.
Within claim 1, lines 2-5: Applicant claims, “a valve body having […], and an inner surface facing a flow channel, and a skirt including a first level forming at least a portion at the outer surface of the valve body and configured to be thromboresistant and a second level forming at least a portion of the outer surface of the valve body”; it is unclear, and therefore indefinite, if the valve body includes OR is a separate structure from the skirt. Specifically, the “and an inner surface facing a flow channel” grammatically would be the last item of the valve body (due to the “and” before an inner surface, as “and” is only supposed to be used in the before the last item in a list separated by commas); however, “and a skirt” is not broken out into a new paragraph nor is it separated by a semicolon (like the valve leaflets are within claim 1, line 7) suggesting it is to be part of the valve body. Additionally, the “first level forming at least a portion AT the outer surface of the valve body” suggests the first level (which is a substructure of the skirt) is not part of the valve body (due to the “at”); however, the “a second level forming at least a portion OF the outer surface of the valve body” suggests the second level (which is a substructure of the skirt is part of the valve body (due to the “of”). Claim(s) 2-13, which depend from claim 1, inherit all the problems associated with claim 1. (Additionally, please note: appropriate correction maybe required within claim 6, line 2 for the “about” based on whether the skirt is part of or a separate structure form the valve body.)
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, 4-11 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Braido (US 2015/0073545 A1).
With respect to claim 1:
Braido discloses an implantable prosthetic valve (valve 200), as can be seen in figs. 4A-4B (paragraph [0058]), comprising:
a valve body (stent 202 and cuff 206) having a proximal end (distal end 232), a distal end (proximal end 230), an outer surface, and an inner surface facing a flow channel (central passage in which leaflets 208 are positioned), and a skirt (cuff 206) including a first level (distal cuff 252) forming at least a portion of the outer surface of the valve body (is on the abluminal surface) and configured to be thromboresistant (is made from UHMWPE which is disclosed by Applicant to be a thromboresistant material see Applicant’s specifications paragraph [0080]) and a second level (proximal cuff 250) forming at least a portion of the outer surface of the valve body (is on the abluminal surface) and configured to allow tissue ingrowth with the second level (paragraphs [0058, 0065, 0072-0075, 0077]); and
a plurality of prosthetic valve leaflets (leaflets 208) positioned within the flow channel (central passage in which leaflets 208 are positioned) and extending inward from the inner surface of the valve body (stent 202 and cuff 206) (paragraph [0074]).
With respect to claim 4:
Wherein the second level (proximal cuff 250) is positioned adjacent to the first level (distal cuff 252) in an axial direction, as can be seen in figs. 4A-4B.
With respect to claim 5:
Wherein the second level (proximal cuff 250) is coupled to the first level (distal cuff 252) by bonding or stitching (suturing along boundary line 254) (paragraph [0079]).
With respect to claim 6:
Wherein the first level (distal cuff 252) and the second level (proximal cuff 250) both extend circumferentially about the valve body (stent 202 and leaflets 208), as can be seen in figs. 4A-4B.
With respect to claim 7:
Wherein the valve body (stent 202 and cuff 206) includes a frame (stent 202), and the first level (distal cuff 252) and the second level (proximal cuff 250) are both positioned radially outward (on the abluminal surface thereof) of the frame (stent 202) (paragraph [0073]).
With respect to claim 8:
Wherein the first level (distal cuff 252) and the second level (proximal cuff 250) are both coupled to the frame (stent 202) by bonding or stitching (the suturing along boundary line 254 connects the cuffs 252, 250 not only to each other but also the stent 202) (paragraph [0079]).
With respect to claim 9:
Wherein a ratio of relative axial extent along the valve body (stent 202 and cuff 206) of the first level (distal cuff 252) to the second level (proximal cuff 250) is 1:1 or greater (D4:D2 = 1.5:1) (paragraphs [0076, 0078]).
With respect to claim 10:
Wherein the first level (distal cuff 252) comprises a first material (material of distal cuff 252) and the second level (proximal cuff 250) comprises a second material (material of proximal cuff 250) that is different than the first material (material of distal cuff 252) (paragraphs [0074-0075, 0077]).
With respect to claim 11:
Wherein the first material (material of distal cuff 252) includes at least one or more of a polytetrafluoroethylene, an ultra-high molecular weight polyethylene, or a coated thermoplastic polyurethane (UHMWPE) (paragraphs [0073, 0077]).
Claim(s) 1-8, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Schwartz et al. (US 2019/0192296 A1).
With respect to claim 1:
Schwartz et al. discloses an implantable prosthetic valve (prosthetic heart valve 100), as can be seen in figs. 5-12 (paragraph [0114]), comprising:
a valve body (frame 102 and covering 112) having a proximal end (outflow end 108), a distal end (inflow end 106), an outer surface, and an inner surface facing a flow channel (central passage in which leaflets 110 are positioned) (paragraphs [0114-0015]), and a skirt (covering 112) including a first level (only backing layer 114 of inflow protective portion 120) forming at least a portion of the outer surface of the valve body (frame 102 and covering 112) and configured to be thromboresistant (configured to minimally impact flow thru the valve and to reduce the risk of thrombosis) (paragraph [0117]) and a second level (only cushion layer 116 of main cushioning portion 136) forming at least a portion of the outer surface of the valve body (frame 102 and covering 112) and configured to allow tissue ingrowth with the second level (main cushioning portion 136) (paragraphs [0115, 0122-0124]); and
a plurality of prosthetic valve leaflets (leaflets 110) positioned within the flow channel (central passage in which leaflets 110 are positioned) and extending inward from the inner surface of the valve body (frame 102 and covering 112) (paragraph [0114]).
With respect to claim 2:
Wherein the distal end (inflow end 106) is an inflow end of the valve body (frame 102 and covering 112), and the first level (only backing layer 114 of inflow protective portion 120) is adjacent to the distal end (inflow end 106) (paragraphs [0114, 0117]).
With respect to claim 3:
Wherein the proximal end (outflow end 108) is an outflow end of the valve body (frame 102 and covering 112), and the second level (only cushion layer 116 of main cushioning portion 136) is positioned between the first level (only backing layer 114 of inflow protective portion 120) and the proximal end (outflow end 108), as can be seen in fig. 8.
With respect to claim 4:
Wherein the second level (only cushion layer 116 of main cushioning portion 136) is positioned adjacent to the first level (only backing layer 114 of inflow protective portion 120) in an axial direction, as can be seen in fig. 8.
With respect to claim 5:
Wherein the second level (only cushion layer 116 of main cushioning portion 136) is coupled to the first level (only backing layer 114 of inflow protective portion 120) by bonding or stitching (paragraph [0128]).
With respect to claim 6:
Wherein the first level (only backing layer 114 of inflow protective portion 120) and the second level (only cushion layer 116 of main cushioning portion 136) both extend circumferentially about the valve body (frame 102 and covering 112), as can be seen in figs. 5 and 8.
With respect to claim 7:
Wherein the valve body (frame 102 and covering 112) includes a frame (frame 102), and the first level (only backing layer 114 of inflow protective portion 120) and the second level (only cushion layer 116 of main cushioning portion 136) are both positioned radially outward of the frame (frame 102) (paragraphs [0115-0016]).
With respect to claim 8:
Wherein the first level (only backing layer 114 of inflow protective portion 120) and the second level (only cushion layer 116 of main cushioning portion 136) are both coupled (directly or indirectly) to the frame (frame 102) by bonding or stitching (paragraph [0129]).
With respect to claim 10:
Wherein the first level (only backing layer 114 of inflow protective portion 120) comprises a first material (material of backing layer 114, such as PTFE) and the second level (only cushion layer 116 of main cushioning portion 136) comprises a second material (material of cushion layer 116) that is different than the first material (material of backing layer 114, such as PTFE) (paragraphs [0121-0122]).
With respect to claim 11:
Wherein the first material (material of backing layer 114, such as PTFE) includes at least one or more of a polytetrafluoroethylene, an ultra-high molecular weight polyethylene, or a coated thermoplastic polyurethane (paragraph [0121]).
With respect to claim 12:
Wherein the second level (only cushion layer 116 of main cushioning portion 136) includes textured yarns extending radially outward (pile 158 strands) (paragraphs [0122-0123]), and the first level (only backing layer 114 of inflow protective portion 120) includes a smooth texture configured to inhibit tissue growth (material of backing layer 114 maybe PTFE which is disclosed by Applicant to be a thromboresistant material see Applicant’s specifications paragraph [0079] and is not disclosed to be textured or porous and as such is considered to be a “smooth texture”) (paragraph [0121]).
With respect to claim 13:
Wherein the valve body (frame 102 and covering 112) is configured to be (is capable of being) implanted to a native heart valve (aortic valve) (paragraph [0114]), and the second level (only cushion layer 116 of main cushioning portion 136) is configured to allow (is capable of allowing) tissue ingrowth with native leaflets of the native heart valve (aortic valve) (paragraphs [0122-0125]), and the first level (only backing layer 114 of inflow protective portion 120) is configured to be positioned (is capable of being positioned) within an annulus of the native heart valve (aortic valve) (paragraph [0119]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
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