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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's AF submission filed on 3/6/26 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 3/6/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,883,291 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see pages 1,2 of remarks (pgs 11,12 of response), filed 3/6/26, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 over Naor and 35 U.S.C. 103 over McLean in view of Spence have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dixon et al. (2021/0145571) to address the new limitation and combine with Naor.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,3-5,7,9 are rejected under 35 U.S.C. 103 as being unpatentable over Naor (2016/0074164) in view of Dixon et al. (2021/0145571). Naor shows (Fig. 8D) a valve repair device 831 for repairing a cardiac valve including a first native leaflet and a second native leaflet opposite the first native leaflet, the valve repair device comprising: a coaptation member 850 comprising (a) an inner portion having a coaptation surface configured to coapt with the first native leaflet during systole and (b) an outer portion configured to displace at least a portion of the second native leaflet; and an atrial-fixation member comprising a plurality of interconnected struts 832 extending at least partially about a flow axis of the cardiac valve, wherein the atrial-fixation member extends upward from the coaptation member relative to the flow axis, wherein the interconnected struts define a brim portion and a pair of connection portions, wherein the connection portions are coupled to the coaptation member, and wherein the brim portion is configured to press against cardiac tissue above the first native leaflet proximate to a native valve annulus of the cardiac valve. However, Naor did not disclose a clip member coupled to the outer portion of the coaptation member, wherein the clip member has an arm portion and a root portion and wherein the arm portion is movable relative to the outer portion of the coaptation member for securing the second native leaflet therebetween. Dixon et al. teach (Figs. 334,335) a clip member 6300 that has an arm portion 6350 and a root portion 6352 and wherein the arm portion is movable relative (paragraph 649) to the outer portion of the coaptation member (see Fig. 336) for securing the second native leaflet therebetween. Dixon et al. further teach (paragraph 651) that the clip member can be coupled to a coaptation member. It would have been obvious to one of ordinary skill in the art to utilize a clip member having an arm portion and a root portion and wherein the arm portion is movable relative to the outer portion of the coaptation member for securing the second native leaflet therebetween as taught by Dixon et al. with the coaptation member of Naor such that it assures the surgeon/cardiologist that the leaflet has been secured with the coaptation member at the correct location, see Dixon paragraphs 653, 654. Regarding claim 3, it can be seen (Fig. 8D) the brim portion is positioned above the coaptation surface along the flow axis. Regarding claim 4, it can also be seen (Fig. 8D) the atrial-fixation member has a medial portion between the connection portions and the brim portion, and wherein a superior portion of the atrial- fixation member tapers downward relative to the flow axis from the medial portion to the brim portion. Regarding claim 5, Fig. 8D shows the brim portion includes a plurality of cleats 848 extending upward and then down relative to the flow axis. Regarding claim 7, it can be seen (Fig. 8E) the coaptation member includes a secondary brim portion configured to press against cardiac tissue above the second native leaflet 835 proximate to the native valve annulus. With respect to claim 9, Naor also shows (Fig. 7A) the secondary brim portion 708 curves in a direction away from the brim portion of the atrial-fixation member back toward the brim portion of the atrial-fixation member.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Naor (2016/0074164) in view of Dixon et al. (2021/0145571) as applied to claim 1 above, and further in view of Naor (WO 2010/106438). Naor as modified by Dixon et al. is explained supra. It is also noted (paragraphs 269,270) Naor '164 discloses maintaining the coaptation member rotationally stable during implantation of the valve repair device at the cardiac valve is critical. However, Naor did not disclose the brim portion includes two or more connectors configured to be coupled to a delivery system to stabilize the coaptation member. Naor (WO '438) teaches (Fig. 4a) that a delivery system (page 14, 1ˢᵗ paragraph) is coupled with a connector configured to assist in stabilizing during delivery. It would have been obvious to one of ordinary skill in the art to utilize a brim portion including two or more connectors configured to be coupled to a delivery system to stabilize the coaptation member as taught by Naor (WO '438) in the valve device of Naor '164 as modified with Dixon et al. such that it prevents an improper positioning of the prosthetic device and eliminates leakage.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Naor (2016/0074164) in view of Dixon et al. (2021/0145571) as applied to claim 7 above, and further in view of Khairkhahan et al. (2020/0205966). Naor as modified by Dixon et al. is explained supra. It is also noted (Fig. 8D) there are a plurality of interconnected struts in the secondary brim portion of the coaptation member. However, Naor did not disclose the coaptation struts covered with a biocompatible material. Khairkhahan et al. show a coaptation member and Figs. 3G1,2 illustrate to cover (paragraph 73) the coaptation member with a biocompatible material 170. It would have been obvious to one of ordinary skill in the art to cover the frame or struts of a coaptation member as taught by Khairkhahan et al. on the valve repair device of Naor as modified with Dixon et al. such that it effectively integrates and remains stably connected in the site of placement.
Claim(s) 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Naor (2016/0074164) in view of Dixon et al. (2021/0145571) as applied to claims 1,7 above, and further in view of McLean et al. (2019/0201191). Naor as modified by Dixon et al. is explained supra. However, Naor in view of Dixon did not disclose any of the coaptation member having a plurality of interconnected struts defining the secondary brim portion and a hollow interior volume within the coaptation member, and wherein the struts are covered with a biocompatible material or two or more cleats extending from the secondary brim portion downward relative to the flow axis or the coaptation member includes (a) a first side portion between the inner portion and the outer portion and (b) a second side portion, opposite the first side portion, between the inner portion and the outer portion, wherein a first one of the connection portions is coupled proximate to the first side portion of the coaptation member, and wherein a second one of the connection portions is coupled proximate to the second side portion of the coaptation member. Regarding claim 10, McLean teaches (Figs. 8A,B) a coaptation member 804 comprises a plurality of interconnected struts 808 defining the secondary brim portion and a hollow interior volume within the coaptation member, and wherein the struts are covered with a biocompatible material, paragraph 39. Regarding claim 11, McLean et al. also teach (Figs. 2A,B,4A,B) cleats 112,312 respectively and extend from the secondary brim portion along with being capable of extending downward (paragraph 66) relative to the flow axis. With respect to claim 12, McLean et al. also teach (Fig. 2C) shows the coaptation member includes (a) a first side portion between the inner portion and the outer portion and (b) a second side portion, opposite the first side portion, between the inner portion and the outer portion, wherein a first one of the connection portions is coupled proximate to the first side portion of the coaptation member, and wherein a second one of the connection portions is coupled proximate to the second side portion of the coaptation member. It would have been obvious to one of ordinary skill in the art to utilize a biocompatible material covering the struts as taught by McLean with the coaptation member of Naor as modified with Dixon such that it is biocompatible and accepted within the patient with no biological rejection. Further it would have been obvious to one of ordinary skill in the art to utilize cleats to extend from the secondary brim portion along with being capable of extending downward as taught by McLean with the coaptation member of Naor as modified by Dixon such that it properly engages the anatomy and is stabilized at the site. Further it would have been obvious to one of ordinary skill in the art to provide a coaptation member with a first side portion between the inner portion and the outer portion and (b) a second side portion, opposite the first side portion, between the inner portion and the outer portion, wherein a first one of the connection portions is coupled proximate to the first side portion of the coaptation member, and wherein a second one of the connection portions is coupled proximate to the second side portion of the coaptation member as taught by McLean to modify the coaptation member of Naor in view of Dixon such that it can be effective in being positioned adjacent the native valve and properly seated to conform to the anatomy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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