DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 02/05/2026.
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 .
Claim Objections
The objection to claim(s) 7 and 14 in the previous Office Action for informalities is hereby withdrawn in view of Applicant’s Amendment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0173897 A1 to Raanani et al. (hereinafter “Rannani”) in view of US 2013/0190861 A1 to Chau et al. (hereinafter “Chau”) (both references previously of record).
Regarding claim 1, Raanani discloses (see abstract; Figs. 1-31; and [0097]-[0325]) an apparatus (as shown in Figs. 13A-17) for use with a prosthetic valve (see at least [0099]-[0101]) that is configured to be deployed within a native atrioventricular valve of a heart of a mammalian subject, the native atrioventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising: a valve frame (see Figs. 2A-B and [0191]), the valve frame comprising: a valve-frame body (135, see Figs. 13A-B) that is configured to support the prosthetic valve within the native atrioventricular valve (see [0183]); a first set of chord-recruiting arms (134) extending from the valve-frame body configured to curve around the valve-frame body circumferentially in a first circumferential direction (see Figs. 13A-17 and [0117], [0125]-[0128], [0149]-[0156], [0190]-[0196], [0208]-[0219], [0250]-[0267], [0296]-[0305]).
Raanani further discloses (claim 2) wherein the first set of chord-recruiting arms are configured to extend radially from the valve-frame body (see Figs. 13A-E); (claim 3) wherein the first set of chord-recruiting arms are configured to extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E); (claim 6) wherein the valve frame is configured such that rotating the valve frame in the first circumferential direction causes the first set of chord-recruiting arms to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame, by recruiting and deflecting at least a portion of the chords of the native atrioventricular valve (see [0100], [0182], [0190], [0194], [0258], [0267]); (claim 8) wherein the valve-frame body is configured to radially expand, such as to trap the leaflets of the native atrioventricular valve in a partially closed and twisted configuration, to thereby at least partially seal a space between the native atrioventricular valve and the prosthetic valve (see [0104], [0117], [0128])
Raanani fails to explicitly disclose, with respect to claim 1, a second set of chord-recruiting arms extending from the valve-frame body and configured to curve around the valve-frame body circumferentially in a second circumferential direction that is an opposite direction from the first circumferential direction. Chau discloses, in the same field of endeavor, a mitral valve prosthesis (see abstract) comprising chord-recruiting arms (see [0087] and [0181]-[0194]), wherein a first set of chord-recruiting arms curves around the frame in a first circumferential direction (see Figs. 84-87) and a second set of chord-recruiting arms curves around the frame in an opposite, second circumferential direction (see [0189]) for the purpose of allowing the device to be rotated in either direction to recruit the chordae (see Figs. 84-87 and [0189]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Raanani's device with the opposing chord-recruiting arms taught by Chau in order to allow the device to be rotated in either direction to recruit the chordae.
The combination of Raanani and Chau discloses the invention substantially as claimed as discussed above, and would further disclose, in combination (claim 4) wherein the second set of chord-recruiting arms are configured to extend radially from the valve-frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 5) wherein the second set of chord-recruiting arms are configured to extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 7) wherein the valve frame is configured such that rotating the valve frame in the first circumferential direction subsequent to the valve frame being rotated in the first direction causes cause the chords to become entangled between the first and second sets of chord-recruiting arms (see Figs. 13A-17 and [0117], [0125]-[0128], [0149]-[0156], [0190]-[0196], [0208]-[0219], [0250]-[0267], [0296]-[0305] of Raanani; and (claim 29) wherein the first and second sets of chord-recruiting arms are configured to be separately deployable (see Figs. 13A-E of Raanani and [0208], the arms are independently mounted for deployment, therefore in making the proposed combination, any of the arms which are configured in the opposing direction would also be independently mounted for deployment and thus separately deployable).
Regarding claim 9, Raanani discloses (see abstract; Figs. 1-31; and [0097]-[0325]) a method (see at least [0243]) for use with a prosthetic valve that is configured to be deployed within a native atrioventricular valve of a heart of a mammalian subject (see [0243]-[0245]), the native atrioventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles, the method comprising: placing a valve frame (see Figs. 2A-B and [0191]) within the subject's heart (see [0246]-[0251]), the valve frame including a valve- frame body (135, see Figs. 13A-B) that is configured to support the prosthetic valve within the native atrioventricular valve (see [0183]), and a first set of chord-recruiting arms (134) that are configured to extend from the valve-frame body (see Figs. 13A-17 and [0117], [0125]-[0128], [0149]-[0156], [0190]-[0196], [0208]-[0219], [0250]-[0267], [0296]-[0305]); deploying the first set of chord-recruiting arms, such that the first set of chord- recruiting arms become deployed among chords of the native atrioventricular valve, and the first set of chord-recruiting arms curve around the valve-frame body circumferentially in a first circumferential direction (see [0253]-[0267]); rotating at least a portion of the valve frame, in the first circumferential direction, such as to cause the first set of chord-recruiting arms to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame, by recruiting and deflecting at least a portion of the chords of the native atrioventricular valve (see [0100], [0182], [0190], [0194], [0258], [0267]).
Raanani fails to explicitly disclose, with respect to claim 9, a second set of chord-recruiting arms, deploying the second set of chord-recruiting arms, such that the second set of chord- recruiting arms become deployed among chords of the native atrioventricular valve, and the second set of chord-recruiting arms curve around the valve-frame body circumferentially in a second circumferential direction that is an opposite direction from the first circumferential direction; and rotating at least a portion of the valve frame, in the second circumferential direction, such as to cause the chords to become entangled between the first and second sets of chord- recruiting arms. Chau discloses, in the same field of endeavor, a mitral valve prosthesis and method of use (see abstract) comprising chord-recruiting arms (see [0087] and [0181]-[0194]), wherein a first set of chord-recruiting arms curves around the frame in a first circumferential direction (see Figs. 84-87) and a second set of chord-recruiting arms curves around the frame in an opposite, second circumferential direction (see [0189]) for the purpose of allowing the device to be rotated in either direction to recruit the chordae (see Figs. 84-87 and [0189]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Raanani's device with the opposing chord-recruiting arms taught by Chau in order to allow the device to be rotated in either direction to recruit the chordae. The resulting device in the combination method would allow the user to deploying the second set of chord-recruiting arms, such that the second set of chord- recruiting arms become deployed among chords of the native atrioventricular valve, and the second set of chord-recruiting arms curve around the valve-frame body circumferentially in a second circumferential direction that is an opposite direction from the first circumferential direction (opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); and rotating at least a portion of the valve frame, in the second circumferential direction, such as to cause the chords to become entangled between the first and second sets of chord- recruiting arms (see [0214]-[0219, Figs. 31G-H, and [0262]-[0265] of Raanani, rotation in the second direction prevents the chords from detangling with the arms).
The combination of Raanani and Chau discloses the invention substantially as claimed as discussed above, and would further disclose, in combination (all references to Raanani unless expressly cited to Chau) further discloses (claim 10) wherein the valve-frame body is configured to radially expand, such as to trap the leaflets of the native atrioventricular valve in a partially closed and twisted configuration, to thereby at least partially seal a space between the native atrioventricular valve and the prosthetic valve (see [0104], [0117], [0128]); (claim 11) wherein deploying the first set of chord- recruiting arms such that the first set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the first set of chord- recruiting arms such that the first set of chord-recruiting arms extend radially from the valve- frame body (see Figs. 13A-E); (claim 12) wherein deploying the first set of chord- recruiting arms such that the first set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the first set of chord- recruiting arms such that the first set of chord-recruiting arms extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E); (claim 13) wherein deploying the second set of chord- recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the second set of chord- recruiting arms such that the second set of chord-recruiting arms extend radially from the valve-frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 14) wherein deploying the first set of chord- recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the second set of chord- recruiting arms such that the second set of chord-recruiting arms extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 15) wherein deploying the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve subsequent to rotating the portion of the valve frame in the first circumferential direction (see [0252]-[0260]); (claim 16) wherein deploying the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve comprises deploying the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve prior to rotating the portion of the valve frame in the first circumferential direction (see [0252]-[0260]); (claim 17) wherein rotating at least the portion of the valve frame in the second circumferential direction comprises rotating the portion of the valve frame in the second circumferential direction through an angle that is less than an angle through which the portion of the valve frame is rotated during the rotation of the portion of the valve frame in the first circumferential direction (see [0214]-[0219]); (claim 18) wherein rotating at least the portion of the valve frame in the second circumferential direction comprises rotating the portion of the valve frame in the second circumferential direction through an angle that is equal to an angle through which the portion of the valve frame is rotated during the rotation of the portion of the valve frame in the first circumferential direction (see [0214]-[0219]).
Regarding claim 19, Raanani discloses (see abstract; Figs. 1-31; and [0097]-[0325]) an apparatus (as shown in Figs. 13A-17) for use with a prosthetic valve (see at least [0099]-[0101]) that is configured to be deployed within a native atrioventricular valve of a heart of a mammalian subject, the native atrioventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising: a valve frame (see Figs. 2A-B and [0191]), the valve frame comprising: a valve-frame body (135, see Figs. 13A-B) that is configured to support the prosthetic valve within the native atrioventricular valve (see [0183]); a first set of chord-recruiting arms (134) extending from the valve-frame body configured to curve around the valve-frame body circumferentially in a first circumferential direction (see Figs. 13A-17 and [0117], [0125]-[0128], [0149]-[0156], [0190]-[0196], [0208]-[0219], [0250]-[0267], [0296]-[0305]); and a delivery device (50) configured to: deliver the valve frame to the native atrioventricular valve (see [0243]-[0251]); deploy the first set of chord-recruiting arms, such that the first set of chord- recruiting arms become deployed among chords of the native atrioventricular valve (see [0252]-[0267]), and the first set of chord-recruiting arms curve around the valve-frame body circumferentially in a first circumferential direction (see Figs. 13A-17); rotate at least a portion of the valve frame, in the first circumferential direction, such as to cause the first set of chord-recruiting arms to (a) pull the native atrioventricular valve radially inward toward the valve frame, and (b) twist the native atrioventricular valve around the valve frame, by recruiting and deflecting at least a portion of the chords of the native atrioventricular valve (see [0100], [0182], [0190], [0194], [0258], [0267]).
Raanani fails to explicitly disclose, with respect to claim 19, a second set of chord-recruiting arms, deploying the second set of chord-recruiting arms, such that the second set of chord- recruiting arms become deployed among chords of the native atrioventricular valve, and the second set of chord-recruiting arms curve around the valve-frame body circumferentially in a second circumferential direction that is an opposite direction from the first circumferential direction; and rotating at least a portion of the valve frame, in the second circumferential direction, such as to cause the chords to become entangled between the first and second sets of chord- recruiting arms. Chau discloses, in the same field of endeavor, a mitral valve prosthesis (see abstract) comprising chord-recruiting arms (see [0087] and [0181]-[0194]), wherein a first set of chord-recruiting arms curves around the frame in a first circumferential direction (see Figs. 84-87) and a second set of chord-recruiting arms curves around the frame in an opposite, second circumferential direction (see [0189]) for the purpose of allowing the device to be rotated in either direction to recruit the chordae (see Figs. 84-87 and [0189]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Raanani's device with the opposing chord-recruiting arms taught by Chau in order to allow the device to be rotated in either direction to recruit the chordae. The resulting device would allow the user to deploying the second set of chord-recruiting arms, such that the second set of chord- recruiting arms become deployed among chords of the native atrioventricular valve, and the second set of chord-recruiting arms curve around the valve-frame body circumferentially in a second circumferential direction that is an opposite direction from the first circumferential direction (opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); and rotating at least a portion of the valve frame, in the second circumferential direction, such as to cause the chords to become entangled between the first and second sets of chord- recruiting arms (see [0214]-[0219], Figs. 31G-H, and [0262]-[0265] of Raanani, rotation in the second direction prevents the chords from detangling with the arms).
The combination of Raanani and Chau discloses the invention substantially as claimed as discussed above, and would further disclose, in combination (all references to Raanani unless expressly cited to Chau) further discloses (claim 20) wherein the valve-frame body is configured to radially expand, such as to trap the leaflets of the native atrioventricular valve in a partially closed and twisted configuration, to thereby at least partially seal a space between the native atrioventricular valve and the prosthetic valve (see [0104], [0117], [0128]); (claim 21) wherein t the first set of chord-recruiting arms extend radially from the valve- frame body (see Figs. 13A-E); (claim 22) wherein the first set of chord- recruiting arms such that the first set of chord-recruiting arms extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E); (claim 23) wherein the second set of chord-recruiting arms extend radially from the valve-frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 24) wherein the second set of chord-recruiting arms extend axially from a ventricular end of the valve-frame body to an atrial end of the valve frame body (see Figs. 13A-E of Raanani, opposing direction arms as suggested by Chau would have the same structure as the arms in Raanani but extend in a circumferentially opposite direction); (claim 25) wherein the delivery device is configured to deploy the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve, subsequent to rotating the portion of the valve frame in the first circumferential direction (see [0252]-[0260]); (claim 26) wherein the delivery device is configured to deploy the second set of chord-recruiting arms such that the second set of chord-recruiting arms become deployed among chords of the native atrioventricular valve, prior to rotating the portion of the valve frame in the first circumferential direction (see [0252]-[0260]); (claim 27) wherein the delivery device is configured to rotate at least the portion of the valve frame in the second circumferential direction through an angle that is less than an angle through which the portion of the valve frame is rotated during the rotation of the portion of the valve frame in the first circumferential direction (see [0214]-[0219]); and (claim 28) wherein the delivery device is configured to rotate at least the portion of the valve frame in the second circumferential direction through an angle that is equal to an angle through which the portion of the valve frame is rotated during the rotation of the portion of the valve frame in the first circumferential direction (see [0214]-[0219]).
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive.
Applicant alleges that it would not be obvious to modify Raanani with Chau because Chau’s anchors are configured to avoid entanglement with or damage to the native chordae, whereas Raanani engages the chords. This is not persuasive because Chau’s Figs . 85/87 clearly shows the anchors 4004/5004 engaging the chords 16, similar to Rannani, in order to secure the valve in place without causing damage to the chordae, and thus the disclosure are “compatible” and therefore a person of ordinary skill would look to Chau in combination with Raanani. Applicant alleges that Chau’s Fig. 37 shows only a single anchor and therefore fails to meet the claim language of two distinct arms with curvature in opposite directions. This is not persuasive because Fig. 87 shows two distinct arms with curvature in opposite directions. Further, Fig. 37 shows the side view of an embodiment of the anchor, and therefore the side view would only show one arm. Reference to Fig. 38 clearly shows that there are two arms on the valve on opposing sides – therefore the argument that Chau only teaches a single anchor and not two anchors is not persuasive. Applicant alleges that the combination of references does not teach rotating the anchor twice, in opposing directions. This is not persuasive because Raanani teaches at [0214]-[0219], Figs. 31G-H, and [0262]-[0265] that there is two separate rotations 98 and 99 in opposing directions in order to fully engage the chordae. Accordingly, Applicant’s arguments are not persuasive and the claims stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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