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 Claim(s) 6 and 14-16 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I and Species 1-1 in the reply filed on 9/17/2025 is acknowledged.
Claims 6 and 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/17/2025.
Claim Objections
Claims 2, 4-5, and 9-10 are objected to because of the following informalities:
Claims 2, 5, and 9-10 each recites “the first and second”, which should be “the first and the second.
Claim 4 recites “or closed-loop structure”, which should be “or a closed-loop structure”.
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.
Claims 5 and 11 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.
Claims 5 and 11 each 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 11 requires the trade name “Nitinol”. MPEP 2173.05(u) states “If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.” Therefore, this language is indefinite.
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 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 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 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 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 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 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).
Relevant Prior Art
US 2001/0039450 A1 to Pavcnik, et al teaches a heart valve having a wire frame with a covering (e.g. Figures 18, 26-28).
US 2011/0112621 A1 to Case, et al teaches a heart valve having a wire frame with a covering (e.g. Figures 3-4).
US 2015/0112433 A1 to Schweich, et al teaches a heart valve repair device having a wire frame with a covering (e.g. Figures 16-19).
US 4,106,129 to Carpentier, et al teaches a heart valve having a wire frame with a covering (e.g. Figures 1-2, 6-8).
Conclusion
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, Jerrah Edwards can be reached on (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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 10/15/2025