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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-16 is/are pending. Claim(s) 6 and 14-16 is/are withdrawn.
Response to Arguments
Applicant’s arguments, filed 4/20/2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 2, 4-5, and 9-10 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 4/20/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive with respect to claim 11. The 35 USC 112(b) rejections of claim 11 has/have been withdrawn due to the Applicant’s amendments.
The 35 USC 112(b) rejection of claim 5 was not addressed and is therefore repeated below.
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive.
Applicant argues Burriesci fails to teach "the material is fixed to the proximal curve section from the inner surface of the stent frame, and fixed to the distal curve section from the outer surface of the stent frame" (Applicant's Response on 4/20/2026, herein "Response", page 6).
Applicant argues the prior art does not teach "a specific dual-sided attachment configuration: the material is attached at the proximal curve section from the inside, and at the distal curve section from the outside" (Response, page 6).
Burriesci teaches the prosthetic material is fixed to the proximal curve section from the inner surface of the stent frame (e.g. Figure 7h; Figures 7e-f, [0084], the skirt is attached to the frame and is from the inner side at least at the attachment location), and fixed to the distal curve section from the outer surface of the stent frame (e.g. Figure 7h, #23 is radially outward of the frame elements).
Annotated Figure 7h is added below to further clarify the locations of the material. SK13 and SK14 cover the entire proximal portion and is shown as connected to the radially inner surface (SK13/SK14 cris-cross lines over the frame) thereby meeting the requirement of “fixed to the proximal curve section from the inner surface.” In annotated Figure 7h lines showing the proximal and distal sections that mirror those in annotated Figure 7a(1) below in the prior art rejection section.
Annotated Figure 7h further shows that at least a portion of #23 is in the distal section and on the radially outer surface of the frame. Further, [0088] teaches the material provides “a seal around the entire circumference of the framework” and claims 14 and 16 indicate the “cuff” and the “skirt” are each “attached” to the framework. See also [0038], [0043], [0055], and [0087]. Thus, it is clear that the cited material on the distal portion is both on the outer surface and “fixed to” that outer surface.
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Annotated Figure 7h, Burriesci
Applicant argues the claimed configuration is not a mere design choice (Response, page 6).
The Examiner notes no rejection was/is made relying on design choice rationale. Thus, this argument is moot.
Applicant argues the connection of the material forms a pocket which can inflate in a balloon-like fashion and can coapt (Response, page 6).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a pocket that can inflate in a balloon-like fashion and coapt) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues the prior art is not fixed to the distal curve section in the specific manner claimed and disclosed by Applicant (Response, page 7).
The specific manner claimed is "fixed to the distal curve section from the outer surface of the stent frame" (claim 1). Beyond this language, there is no further manner or particular means of fixation claimed. Applicant's arguments are to language narrower than that present in the claims.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., any particular manner or means of fixation of the material to the proximal and distal curve sections beyond the claimed inner and outer surfaces) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 5 is 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 5 recites “preferably”. It is unclear if the limitation(s) following this language is required or not. For purposes of examination the Examiner considers this language to not be required by the claim.
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.
Claim(s) 1-5 and 7-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burriesci, et al (Burriesci) (US 2018/0161155 A1).
Regarding Claim 1, Burriesci teaches a prosthetic valve device for treatment of mitral valve insufficiency (e.g. abstract, Figures 6-7), the prosthetic valve device comprising
a main body having a lumen (e.g. Figure 7a, central lumen) and comprising a tubular flexible stent frame having an inner surface and an outer surface (e.g. Figure 7a, frame shown), and the main body further comprising a prosthetic material covering the stent frame at least partially (e.g. Figure 7h, SK13, SK14, #23), and wherein the lumen contains a valve structure (e.g. Figure 7b, LF1, LF2), wherein
the flexible stent frame consists of a plurality of wire-elements (e.g. Figure 7a; 2 instances of the portion in Figure 6b), each of the plurality of wire-elements being formed of a single wire (e.g. [0014]), the single wire having a first wire end portion (e.g. annotated Figure 6b(1) below, one of the noted ends) and a second wire end portion (e.g. annotated Figure 6b(1) below, the other of the noted ends), wherein each of the wire-elements has a proximal wire-element portion (e.g. annotated Figure 7a(1) below, above added solid lines, portions C1, C2, C3) and a distal wire-element portion (e.g. annotated Figure 7a(1) below, below the added dashed line, shown on the one part, but considered at this location on each element around the frame), wherein at the proximal wire-element portion an elongated loop-structure is provided (e.g. Figure 7a), the elongated loop-structure comprising a proximal curve section (e.g. Figure 7a) and a distal curve section (e.g. Figure 7a) and a medium section between the proximal and the distal curve section (e.g. annotated Figure 7a(1) below, remaining portions of the frame that are not the proximal or distal portions), wherein the prosthetic material covers the proximal wire-element portion (e.g. Figure 7h), and wherein the prosthetic material is fixed to the proximal curve section from the inner surface of the stent frame (e.g. Figure 7h; Figures 7e-f, [0084], the skirt is attached to the frame and is from the inner side at least at the attachment location), and fixed to the distal curve section from the outer surface of the stent frame (e.g. Figure 7h, #23 is radially outward of the frame elements).
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Annotated Figure 6b(1), Burriesci
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Annotated Figure 7a(1), Burriesci
Regarding Claim 2, there is a tube-element (e.g. Figure 7a, labeled in Figure 1, each connection like S3 shown; Figures 11a-b show the details of the tube-elements), the tube-element comprising at least one lumen extending through the tube-element (e.g. Figures 11a-b), the lumen being designed for accommodating the first and the second wire end portions (e.g. Figures 11a-b, Figure 6b the wire fits through these elements).
Regarding Claim 3, the plurality of wire-elements consists of three or more wire elements (e.g. annotated Figure 6b(2) below; here each side is considered to have two wire-“elements”; each wire-element remains of a single wire; in the interpretation there are four wire-elements).
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Annotated Figure 6a(2), Burriesci
Regarding Claim 4, the loop-structure is an open or a closed loop structure (e.g. Figure 7a; the Examiner notes the claimed options cover all possible options for this feature of the loop).
Regarding Claim 5, the first and the second wire end portions of the wires are being held together (e.g. Figure 7a, all parts of the frame are held together at the tube-elements in the distal section; [0073]), adjacent and distal to the distal curve section, at least over a certain distance (e.g. annotated Figure 7a(1) above, the solid arrows show examples of distal curve sections).
Regarding Claim 7, the proximal curve section comprises two layers of the wire (e.g. annotated Figure 7a(1) above, at the solid lines where there are two wires), and the distal curve section comprises one layer of the wire (e.g. annotated Figure 7a(1) above, where there is a single wire, there is one layer of wire).
Regarding Claim 8, crimp-elements are provided connecting the wire-elements with one another (e.g. Figure 7a, labeled in Figure 1, each connection like S3 shown; Figures 11a-b show the details of the tube-elements).
Regarding Claim 9, there is a tube-element (e.g. Figure 7a, labeled in Figure 1, each connection like S3 shown; Figures 11a-b show the details of the tube-elements), the tube-element comprising at least one lumen extending through the tube-element (e.g. Figures 11a-b, [0073]), the lumen being designed for accommodating the first and the second wire end portions (e.g. Figures 11a-b, [0073]), and wherein the tube-element has multiple lumens extending through the tube-element (e.g. Figures 11a-b, [0073]), such, that each of the first and the second wire end portions of the single wires or in pairs is guided through a single lumen of the multiple lumens of the tube-element (e.g. Figures 11a-b, [0073]).
Regarding Claim 10, there is a tube-element (e.g. Figure 7a, labeled in Figure 1, each connection like S3 shown; Figures 11a-b show the details of the tube-elements), the tube-element comprising at least one lumen extending through the tube-element (e.g. Figures 11a-b, [0073]), the lumen being designed for accommodating the first and the second wire end portions (e.g. Figures 11a-b, [0073]), and wherein the tube-element comprises at least three or six lumens (e.g. Figures 11a-b, [0073]).
Regarding Claim 11, the wire-elements consist of a shape-memory alloy (e.g. [0065], nitinol).
Regarding Claim 12, the prosthetic material is fixed only to the proximal curve section and the distal curve section (e.g. annotated Figure 7a(2) below, here the proximal curve portion is above the solid line, the distal curve portion is below the dashed line; the prosthetic material attachment is shown in e.g. Figure 7i and is not at elements “S”; therefore, this interpretation meets the claim requirements) .
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Annotated Figure 7a(2), Burriesci
Regarding Claim 13, the elongated loop-structure has a substantially oval form (e.g. Figures 7a, 6a).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 5/16/2026
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