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) 1-20 is/are pending.
Response to Arguments
Applicant’s arguments, filed 12/5/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims has/have been withdrawn due to the Applicant’s amendments and arguments.
Applicant's arguments with respect to the prior art filed 12/5/2026 have been fully considered but they are not persuasive.
Applicant argues claim 1 requires three distinct lock states: (1) manually disengaged state, (2) passively disengaged state, and (3) engaged state and that Goldfarb does not teach all three of these states (Applicant's Response on 12/5/2025, herein "Response", pages 6-7).
The three states are met as follows.
(1) manually disengaged while upward force is being applied to the locking mechanism (e.g. [0075]-[0076]).
(2) passively disengaged after being manually disengaged and attached to the interventional tool (e.g. [0077]) (no additional force is added during this state).
(3) engaged state while locked (e.g. [0075]-[0076]).
Therefore, Applicant's arguments are not persuasive.
With respect to new claim 16, Applicant argues the prior art does not teach locking and unlocking the lock without manual actuation of the lock (Response, page 7).
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., locking and unlocking the lock without manual actuation of the lock) 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).
Instead claim 16 states "the lock automatically transitions to the engaged state without manual actuation of the lock". The claimed limitation is met as described below in the prior art rejection section.
With respect to the locking threshold value, as broadly claimed, the value can be any value and set at any step of the method. Therefore, Examiner's interpretation that this threshold is the angle where the claimed transition relative to the angle occurs meets the broad claim language.
Applicant’s arguments with respect to claim 19 and its dependents are moot.
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) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldfarb, et al (Goldfarb) (US 2006/0020275 A1).
Regarding Claim 1, Goldfarb teaches a method for implanting a mitral valve clip (e.g. abstract, [0020], Figure 1) comprising:
introducing the mitral valve clip (e.g. Figure 1, #14) into a left atrium of a heart using a delivery system (e.g. [0022] mitral valve’s atrial side, which is the left atrium; [0065], interventional tool), the clip including two arms at an angle relative to one another (e.g. Figure 1, #s 16/18) and a lock (e.g. Figure 1, #106; [0066]; Figures 5-7) that prevents widening of the angle (e.g. [0075]-[0076], when locked changing of the angle is prevented; [0079]) when the angle is below a locking threshold value (the locking threshold value is the angle at which the device locks and when locked at angles below this angle), wherein the lock is in a passively disengaged state when the angle is above the locking threshold value (e.g. [0075]-[0076], [0079], when unlocked and the angle is above the threshold);
manually disengaging the lock and expanding the angle to a leaflet capture starting angle while the lock is manually disengaged (e.g. [0075]-[0076], [0078]-[0079]);
returning the lock to the passively disengaged state after the angle is expanded to the leaflet capture starting angle (e.g. [0077], [0084]);
capturing leaflets of a mitral valve by manipulating the clip to trap the leaflets while the lock remains in the passively disengaged state ([0075]-[0076], [0078]-[0079]), and
closing the clip to a final closure angle by narrowing the angle while the leaflets are trapped against the arms (e.g. [0084], arms approach each other and thus the angle narrows), wherein the lock transitions to an engaged state when the angle falls below the locking threshold value (when in the locked configuration and at the noted angle, this limitation is met).
Regarding Claim 2, the leaflet capture starting angle is about 90 degrees (e.g. Figure 1 is “about” 90 degrees between the arms; although Applicant’s Specification defines “about”, it does not provide numeric bounds (e.g. Applicant’s Specification, [0033]), thus the angle shown is “about” 90 degrees).
Regarding Claim 3, the locking threshold value is about 60 degrees (e.g. [0094]).
Regarding Claim 4, the locking threshold value is about 45 degrees (e.g. [0094]).
Regarding Claim 5, the locking threshold value is between about 30 degrees to about 60 degrees (e.g. [0094]).
Regarding Claim 6, the step of manually disengaging the lock is performed by applying tension to a harness line of the delivery system that extends to the lock (e.g. [0075]-[0076], [0078]-[0079]).
Regarding Claim 7, the step of returning the lock to the passively disengaged state is performed by releasing the tension on the harness line (e.g. [0075]-[0076], [0078]-[0079]).
Regarding Claim 8, the clip is introduced into the left atrium with the angle at a smallest possible value (e.g. [0022], where the angle used is considered the smallest possible, since it is the only angle shown to be possible; “smallest possible” is indefinite and provides no value or bounds for this angle).
Regarding Claim 9, there is a step of puncturing a hole in a wall of the left atrium, wherein the clip is introduced through the hole (e.g. [0022], in order for the device to be able to be passed through into the left atrium from the atrial side and via the heart wall, a hole must be made in the atrial wall).
Regarding Claim 10, the step of manipulating the clip to trap the leaflets includes manipulating anchors of the clip to trap each leaflet against a respective anchor and a respective arm (e.g. Figure 1, barbs on side #16; trapping as discussed supra for claim 1; [0075]-[0076], [0078]-[0079]).
Regarding Claim 11, the step of manipulating the anchors of the clips includes applying tension to one or more anchor lines of the delivery system (e.g. [0070]-[0072]).
Regarding Claim 12, the final closure angle is between about 10 degrees and about 30 degrees (e.g. [0094], 15 and 30 degrees).
Regarding Claim 13, there is a step of releasing the clip from the delivery system; and withdrawing the delivery system (e.g. [0077], [0084]).
Regarding Claim 14, the lock remains in the engaged state with the angle remaining at the final closure angle after the clip is released from the delivery system (e.g. [0077], [0084]).
Regarding Claim 15, there is a step of making a second attempt to capture the leaflets, wherein the step of making the second attempt includes the step of manually disengaging the lock and expanding the angle up to the leaflet capture starting angle between the arms while the lock is manually disengaged (e.g. [0077], [0084]).
Regarding Claim 16, a method for implanting a valve repair clip (e.g. abstract, [0020], Figure 1), the method comprising:
introducing the valve repair clip (e.g. Figure 1, #14) into a heart using a delivery system (e.g. [0022] mitral valve’s atrial side, which is the left atrium; [0065], interventional tool), the clip including two arms at an angle relative to one another (e.g. Figure 1, #s 16/18) and a lock (e.g. Figure 1, #106; [0066]; Figures 5-7) having an engaged state and a passively disengaged state ((1) manually disengaged while upward force is being applied to the locking mechanism (e.g. [0075]-[0076]), (2) passively disengaged after being manually disengaged and attached to the interventional tool (e.g. [0077]) (no additional force is added during this state), and (3) engaged state while locked (e.g. [0075]-[0076]), wherein the lock is in the engaged state when the angle is at or below a locking threshold value (e.g. [0075]-[0076], [0079], the angle where the lock becomes engaged is when it becomes engaged and thus is part of the engaged state),
expanding the angle between the arms to a leaflet capture starting angle that is above the locking threshold value such that the lock is in the passively disengaged state (e.g. e.g. [0021], [0075]-[0076]);
capturing leaflets of a heart valve by manipulating the clip to trap the leaflets against the arms while the lock remains in the passively disengaged state (e.g. [0075]-[0076], [0078]-[0079]);
closing the clip to a closure angle by narrowing the angle while the leaflets are trapped against the arms (e.g. [0084], arms approach each other and thus the angle narrows), wherein the lock remains in the passively disengaged state during the closing until the angle falls below the locking threshold value (e.g. [0075]-[0076], [0079], when unlocked and the angle is above the threshold), at which point the lock automatically transitions to the engaged state without manual actuation of the lock (e.g. [0075]-[0076], when the held tension used to manually narrow the angle is released the lock automatically returns to the engaged state).
Regarding Claim 17, in the engaged state the lock prevents widening of the angle between the arms (e.g. [0075]-[0076], when finally locked changing of the angle is prevented; [0079]), and wherein in the passively disengaged state the lock does not prevent widening or narrowing of the angle between the arms (e.g. [0075]-[0076], [0078]-[0079]).
Regarding Claim 18, the engaged state exists across a range of angles below the locking threshold value, and wherein the closure angle is within the range (e.g. [0075]-[0076], [0078]-[0079]; there are multiple angles that can be set as the threshold value).
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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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 3/12/2026