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 .
Response to Amendment
In response to the amendment filed on 2/27/2026, claims 8, 10, 14-16, 21, 23-25, 27-344 are canceled, claims 1-7, 9, 11-13, 17-20, 22, 26 and newly added claims 345-352 are pending.
Response to Arguments
Applicant's arguments filed 2/27/2026 with respect to the prior art rejection of claim 1 have been fully considered but they are not persuasive. Applicant argues Subramanian et al does not disclose the amended limitation of the patch is a surrogate coaptation surface that moves toward and coapts with the second leaflet during ventricular systole. In contrast, the patch of Subramanian et al is intended to promote coaptation between the native leaflets while remaining stationary itself. The Examiner does not disagree with how the patch of Subramanian et al is used. However, Applicant is reminded claim 1 is directed to an apparatus claim and not a method of use, and thus the device should structurally distinguish over the prior art. If the prior art is capable of being used in a manner that can perform the claimed function, then the claim is considered unpatentable over the prior art. In the instance of Subramanian et al, the patch (500) itself can be anchored on only one side in a way where it is attached to an edge of a single leaflet, to augment the leaflet, rather than across both leaflets. Such an anchoring on one leaflet, similar to Applicant’s patch, would perform the claimed function. Therefore, claim 1 as amended does not distinguish over Subramanian et al and thus the rejection is maintained.
Claim Objections
Claims 19, 345 and 347 objected to because of the following informalities:
In claim 19, “the at least one frame” should recite - - the frame - - to remain consistent with the frame that was introduced in claim 1.
In claims 345 and 347, “the leaflet” should recite - - the leaflets - - or a specific one of the first leaflet or second leaflet to remain consistent with the claim terminology as there was two leaflets introduced in the claim.
Appropriate correction is required.
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, 9 and 348 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Subramanian et al (US 2018/0214270).
Subramanian et al discloses the following limitations:
Claim 1. An apparatus (Figs. 57-65, 71) for use with a valve (mitral valve) disposed between an atrium and a ventricle of a heart of a subject, the valve having a first leaflet (anterior leaflet) and a second leaflet (posterior leaflet), and the apparatus comprising an implant (500) that comprises:
a leaflet-augmentation patch (500) comprising:
a flexible sheet (514) ([0258], [0262], i.e. an encapsulation made of silicone thereby forms a flexible sheet as seen in Figs. 57A-57D), and
a frame (516) that supports the flexible sheet and defines a spring ([0258], [0260], [0263]; the frame is made from a super elastic material, Nitinol, and is therefore a spring structure in itself);
a patch anchor (retainer 612 which includes pledget 652) ([0280], [0283]; Figs. 61D, 61E); and
a cord (654), coupling the patch anchor to the patch in a manner in which anchoring the patch anchor to the first leaflet positions the patch to be a surrogate coaptation surface that moves towards, and coapts with, the second leaflet during ventricular systole (Figs. 58, 61D, 61E, 71; [0285], [0286]; the cord is capable of performing the claimed function as the patch can be anchored to only the first leaflet on one side of the patch, such that the patch can be in a position that will function as a surrogate coaptation surface with the second leaflet during ventricular systole), the spring being configured to tension the cord ([0288], the cord is intended to be cinched and thus the spring nature of Nitinol in the frame will assist in holding the cord in tension and thereby encompasses the claimed language).
Claim 5. The apparatus according to claim 1, wherein the spring lies substantially flat with respect to the patch (Figs. 57A-57D, the spring lies within the same plane as the patch the entire time and therefore lies substantially flat with respect to the flexible sheet.
Claim 9. The apparatus according to claim 1, wherein the patch anchor (612) is configured to be driven through the leaflet while disposed within a hollow needle (628) (Fig. 61D; [0285]).
Claim 348. An apparatus (Figs. 57-65, 71) for use with a valve (mitral valve) disposed between an atrium and a ventricle of a heart of a subject, the valve having a first leaflet (anterior leaflet) and a second leaflet (posterior leaflet), and the apparatus comprising an implant (500) that comprises:
a leaflet-augmentation patch (500) comprising:
a flexible sheet (514) ([0258], [0262], i.e. an encapsulation made of silicone thereby forms a flexible sheet as seen in Figs. 57A-57D), and
a frame (516) that supports the flexible sheet and defines a spring ([0258], [0260], [0263]; the frame is made from a super elastic material, Nitinol, and is therefore a spring structure in itself);
a patch anchor (retainer 612 which includes pledget 652) ([0280], [0283]; Figs. 61D, 61E); and
a cord (654), coupling the patch anchor to the patch in a manner in which anchoring the patch anchor to the first leaflet positions the patch to coapt with the second leaflet during ventricular systole (Figs. 58, 61D, 61E, 71; [0285], [0286]; the cord is capable of performing the claimed function as the patch can be anchored to only the first leaflet on one side of the patch, such that the patch can be in a position that will coapt with the second leaflet during ventricular systole), the spring being configured to tension the cord ([0288], the cord is intended to be cinched and thus the spring nature of Nitinol in the frame will assist in holding the cord in tension and thereby encompasses the claimed language), the spring being configured to pull the patch anchor toward the patch by pulling on the cord (since the spring is formed of a super elastic material, it can be bent during anchoring such that it is no longer in its resting state. The material property (stored memory) of the super elastic material will bias it to return to its resting configuration, thus pulling the patch anchor towards the patch via the cord).
Allowable Subject Matter
Claims 2-4, 6, 7, 13, 17-20, 22, 26, 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 and written to obviate the claim objections above.
Claims 11, 12, 345-347, 349, 350, 352 would be allowable if rewritten to obviate the claim objections above.
Claim 351 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Subramanian et al, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed apparatus comprising, inter alia, the structures of claims 2-4, 6, 7, 13, 17, 26, 345 and 351; or the properties of the spring as claimed in claim 347. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
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 KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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