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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/4/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 2/4/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant's arguments, see page 5, with respect to the deficiencies of the prior art of record in view of the present amendments to independent claim 69 have been fully considered but they are not persuasive. It is the Examiner’s position that Seguin expressly discloses delivering first and second anchors to the valve annulus and cinching first and second sutures, as set forth below. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant’s arguments, see pages 5-6, with respect to the deficiencies of the prior art of record in view of the present amendments to independent claims 78 and 85 have been fully considered and are persuasive. The previous prior art rejections of claims 78-88 have been withdrawn.
Claim Rejections - 35 USC § 102
Claim(s) 69, 71 and 73-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seguin (FR 3027212).
Seguin discloses (see Figs. 1-8) a method implanting a mitral valve implant comprising the following claim limitations:
(claim 69) A method of delivering and anchoring a transvalvular band (1) to a valve annulus (102) of a valve (100) (see Fig. 3-8), the method comprising positioning a delivery catheter (51) to deliver a first tissue anchor (e.g., “left” anchor 55 in Figs. 7-8) and a second tissue anchor (e.g., “right” anchor 55 in Figs. 7-8) to the valve annulus (102) (as shown in Fig. 3); delivering the first tissue anchor (“left” 55) to the valve annulus (102) (as shown in Figs. 4-5), wherein the first tissue anchor (55) comprises a first suture (e.g., “left” suture 56 in Figs. 7-8) (as shown in Figs. 4-7); delivering the second tissue anchor (“right” 55) to the valve annulus (102) (as shown in Figs. 4-5), wherein the first tissue anchor (55) comprises a first suture (e.g., “right” suture 56) (as shown in Figs. 5-7); cinching the first suture (“left” 56) and second suture (“right” 56) (as expressly shown in Figs. 7-8; [0014]); delivering the transvalvular band (1) to the valve annulus (102) (as shown in Figs. 5-8), wherein the transvalvular band (1) moves along the first suture (56) toward the first tissue anchor (55) (as shown in Figs. 6-8), wherein the transvalvular band (1) comprises a first aperture (e.g., “left” hole 11, Figs. 1-2) to receive the first suture (56) (as shown in Figs. 5-7); and moving a first locking clip (e.g., “left” washer/clip 57) along the first suture (56), wherein the first locking clip (57) secures the transvalvular band (1) to the valve annulus (102) (as shown in Figs. 7-8; [0014]; washers 57 slid down suture 56 and clipped/secured into place);
(claim 71) further comprising delivering the first tissue anchor (“left” anchor 55) and the second tissue anchor (“right” anchor 55) sequentially (i.e., first anchor delivered in Figs. 3-5, and second anchor delivered after in Figs. 5-7);
(claim 73) wherein the transvalvular band (1) moves along the second suture (“right” suture 56) toward the second tissue anchor (“right” anchor 55) (as shown in Figs. 6-8), and wherein the transvalvular band (1) comprises a second aperture (“right” hole 11) to receive the second suture (56) (as shown in Figs. 1-2);
(claim 74) further comprising moving a second locking clip (e.g., “right” washer/clip 57) along the second suture (56), wherein the second locking clip (57) secures the transvalvular band (1) to the valve annulus (102) (as shown in Fig. 7-8);
(claim 75) further comprising delivering the first locking clip (i.e., “left” clip/washer 57) and the second locking (i.e., “right” clip/washer 57) clip sequentially (as shown in Figs. 4-8; [0014]; sequential anchor and washer/clip delivery disclosed);
(claim 76) wherein the transvalvular band (1) comprises two apertures (as shown in Figs. 1-2; “left” and “right” holes 11); and
(claim 77) wherein the transvalvular band (1) treats mitral valve prolapse and mitral regurgitation (as shown in Figs. 3-8; [0001]; [0008]; treating for regurgitation expressly disclosed).
Claim Rejections - 35 USC § 103
Claim(s) 72 is rejected under 35 U.S.C. 103 as being unpatentable over Seguin as applied to claim 69 above, and further in view of Rowe et al. (US 2013/0331930).
Seguin, as applied above, discloses a method implanting a mitral valve implant comprising all the limitations of the claim except for the first tissue anchor and the second tissue anchor being delivered simultaneously.
However, Rowe teaches (see exemplary embodiments of Figs. 1-4 and 14-16) a similar method of implanting an implant (4, Figs. 1-4) at a heart annulus comprising first tissue anchor and second tissue anchor (e.g., at least two anchors 10, as shown in Fig. 2) being delivered simultaneously ([0051]; [0080]-[0081]; [0093]). Accordingly, Rowe teaches that it is known that sequential anchor delivery and simultaneous anchor delivery are steps that are functional equivalents for providing multiple anchors into an annulus for securing a cardiac implant. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the simultaneous anchor delivery step taught by Rowe for the sequential anchor delivery step of Seguin because both elements were known equivalents for providing multiple anchors into an annulus for securing a cardiac implant within the heart repair arts. The substitution would have resulted in the predictable results of providing multiple anchors into an annulus for securing a cardiac implant to the method of Seguin.
Allowable Subject Matter
Claims 78-88 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a method of delivering and anchoring a transvalvular band to a valve annulus of a valve as claimed that includes, in combination with the claim(s) as a whole, delivering a first tissue anchor having a first suture attached thereto to a first valve location, delivering a second tissue anchor having a second suture attached thereto to a second valve location, and cinching the first valve location to the second valve location on the valve annulus together with the first suture and the second suture. The closest prior art of record appears to be Seguin (FR 3027212) disclosing a similar transvalvular method, but failing to disclose the step of using first and second sutures (attached to respective anchors) to cinch first and second locations of the valve annulus together during the transvalvular band implantation process.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771