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
2. Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on March 23, 2023 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
3. 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.
4. Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oba et al. (hereafter Oba) 2018/0055629. MPEP 2114 states:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
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Noting fig. 18 Oba discloses the apparatus of a prosthetic mitral valve for implantation at a native mitral valve of a heart having a left atrium and a left ventricle, the native mitral valve having a native mitral valve annulus and native mitral valve leaflets, wherein the native mitral valve annulus has an atrium side that faces the left atrium of the heart and a ventricle side that faces the left ventricle of the heart, the prosthetic mitral valve system See MPEP 2114 supra) comprising:
an expandable valve stent (frame 820) having an inflow end (this is the lower end) through which blood from the left atrium enters the prosthetic mitral valve and an outflow end (this is considered the upper side) out of which blood exits the prosthetic mitral valve to flow into the left ventricle;
one or more atrial clamp jaws projecting radially outwards from the valve stent (824; 842a-b); one or more ventricular clamp jaws projecting radially outwards from the valve stent (854); and a plurality of prosthetic leaflets (see [0456] and 870) coupled to the valve stent at commissure attachment features of the valve stent (as seen for example in view of fig. 5);
wherein when the prosthetic mitral valve is deployed at the site of the native mitral valve, the ventricular clamp jaws are deployed on the ventricle side of the native mitral valve annulus and atrial clamp jaws are deployed on the atrial side of the native mitral valve annulus such that the atrial clamp jaws and ventricular clamp jaws are sufficiently resiliently biased with respect to each other to grip the native mitral valve leaflets and the native mitral valve annulus between them (this is functional language see MPEP 2114. Oba is capable of performing the functions as claimed. See [0441]).
5. Regarding claim 2, see [0445];
6. Regarding claim 3, the intended use recitation language “where the valve stent has a deployed configuration and a shape set configuration such that at least a portion of the ventricular clamp jaws is more distal to the outflow end in said shape set configuration than in the deployed configuration” carries no weight in the absence of any distinguishing structure. Oba discloses the structure as claimed and is thus capable of performing the functions.
7. Regarding claims 4-5, see [0442] which discloses “…The tips or ends of the anchors 842a-b, 854 can advantageously provide atraumatic surfaces..”
Regarding claim 6 limitation of “a fabric covered the atrial clamp jaws” (see [0442] “…cover and/or cushion, the tips or ends 856 of the anchors 842a-b, 854…”
8. Claim(s) 12-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Agian et al. (hereafter Again) 2022/0015896.
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Agian discloses a prosthetic mitral valve for implantation at a native mitral valve of a heart having a left atrium and a left ventricle, the native mitral valve having a native mitral valve annulus and native mitral valve leaflets, wherein the native mitral valve annulus has an atrium side that faces the left atrium of the heart and a ventricle side that faces the left ventricle of the heart (functional language. See MPEP 2114 supra), the prosthetic mitral valve system comprising:
an expandable atrial valve stent (see fig. 5A) having an inflow end (bottom) and an outside diameter; one or more atrial clamp jaws (61) projecting radially outwards from the expandable atrial valve stent;
an expandable ventricular valve stent (see fig. 4A-4B) having an outflow end and an inside diameter that is greater than the outside diameter of the expandable atrial valve stent (Figs. 1B-1C); one or more ventricular clamp jaws (52) projecting radially outwards from the valve stent; and a plurality of prosthetic leaflets (23) coupled to the expandable atrial valve stent at commissure attachment features of the expandable atrial valve stent (Fig. 23), wherein the expandable atrial valve stent is inserted into the expandable ventricular valve stent and the expandable atrial valve stent and the expandable ventricular valve stent are connected to each other such that the one or more atrial clamp jaws and the one or more ventricular clamp jaws are resiliently biased towards each to form a spring like clamp (Fig. 5B).
9. Regarding claim 13, see [0203];
10. Regarding claim 14, this is considered to be functional language, nevertheless Again et al. utilizes the materials as claimed and is capable of performing the functions. See MPEP 2114.
Claim Rejections - 35 USC § 103
11. 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.
12. Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Oba et al. (hereafter Oba) 2018/0055629.
Oba has been disclosed supra, however does not specifically state that the fabric covers one side of the atrial clamp jaws. It would have been obvious to one having ordinary skill in the art to utilize the fabric to cover one side of the atrial clamp jaws because Oba already discloses the use of using a cover or cushion in order to prevent unnecessary or undesired trauma to tissue.
Allowable Subject Matter
13. Claims 8-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
14. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art has been disclosed supa, however the prior art fails to teach or disclose “a first removeable suture loop having free ends, wherein the first removeable suture loop is connected to a first one of the atrial clamp jaws; further comprising: second and third removeable suture loops having free ends, wherein the second removeable suture loop is connected to a second one of the atrial clamp jaw and the third removeable suture loop is connected to a third one of the atrial clamp jaws; a circumferential suture that is connected to the atrial clamp jaws along the circumference of the prosthetic mitral valve; or further comprising: one or more removeable suture loops that are looped through the circumferential suture, each of the removeable suture loops having two free ends.”.
Conclusion
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 April 13, 2026
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