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 Arguments
Applicant's arguments filed 12/2/25 have been fully considered but they are not persuasive. Applicant argues that the amendment to claim 1 changes the scope to be different than patent 11883291 and not be obvious to be rejected under double patenting. The examiner disagrees because the teaching of McLean still applies to address the amended feature to interconnected struts for the frame and the new feature added to claim 1, is actually a feature cited in patent claim 1 of US ‘291 that includes a clip. It is noted while the claim language may differ in terms it must be noted that patent ‘291 does recite an arm in defining the clip and also another feature called a free end in the patent claim that one might consider analogous to the claimed root portion. Thus it is believed the claim is still obvious under double patenting.
Regarding the rejection over Naor, the argument was that the prior art device did not include a clip configured to engage the second native leaflet, with the clip having an arm portion and a root portion the examiner disagrees. Applicant is reminded that claims are given their broadest reasonable interpretation and in this instance the examiner refers Applicant to fig. 8D of Naor it is noted that coupled or extending from the coaptation member is an arm member and also a root portion at the bottom.
Applicant’s arguments, see page 1 of remarks (pg 11 of response), filed 12/2/25, with respect to the rejection(s) of claim(s) 1,7,8,10-12 under 35 U.S.C. 102 over McLean 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 Therefore, the rejection has been withdrawn.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 Spence to address the new limitation of the clip feature.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,11 of U.S. Patent No. 11,883,291 in view of McLean et al. (2019/0201191). US patent '291 claims 1+11 recite a valve repair device configured to coapt with leaflets and is including a coaptation member with an inner portion and outer portion configured to engage first and second leaflets. US '291 also recites the valve device includes an atrial fixation member and a connection portion with the coaptation member. However, US '291 did not recite the valve repair device include struts interconnected at least partially about a flow axis of the cardiac valve. McLean et al. teach (Figs. 2A,B) a valve repair device having an atrial-fixation member 102 that is formed with a plurality of interconnected struts extending around and about a flow axis of the cardiac valve. It would have been obvious to one of ordinary skill in the art to utilize a frame including a plurality of interconnected struts for an atrial fixation member that provides a circumferential U-like shape about a flow axis of the cardiac valve as taught by McLean et al. in the prosthetic valve device of US '291 in order to provide stability about the circumference and flexible framework. With respect to the clip member recited and having an arm portion and a root portion, it is noted that claim 1 of US ‘291 recites a clip mechanism including an articulatable arm member and a base portion along with a free end portion unaffixed that could be equated to a “root portion” since roots are known to have free ends.
Claim Rejections - 35 USC § 102
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. 102(a)(1) as being anticipated by Naor (2016/0074164). Fig. 8D shows 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. Regarding the limitation, “a clip member coupled to the coaptation member and configured to secure the second native leaflet, wherein the clip member has an arm portion and a root portion” see Fig. 8D shows a clip member having an arm portion 853 and a root portion 852. 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 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) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Naor (2016/0074164) in view of Naor (WO 2010/106438). Naor 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 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 Khairkhahan et al. (2020/0205966). Naor 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 such that it effectively integrates and remains stably connected in the site of placement.
Claim(s) 1,7,8,10-12 are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (2019/0201191) in view of Spence (2005/0070999). McLean et al. show (Fig. 2A) a valve repair device 100 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 114. Fig. 2B shows the coaptation member 114 with an inner portion 116 having a coaptation surface configured to coapt with the first native leaflet during systole and an outer portion 118 configured to displace at least a portion of the second native leaflet. Figs. 2A,B also show an atrial-fixation member 102 comprising a plurality of interconnected struts 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, McLean et al. did not disclose a clip member coupled to the coaptation member and configured to secure the second native leaflet, wherein the clip member has an arm portion and a root portion. Spence teaches (Fig. 16) a valve repair device with a coaptation member 250 having a clip member coupled to the coaptation member and configured to secure the second native leaflet, wherein the clip member has an arm portion 258 and a root portion 260. It would have been obvious to one of ordinary skill in the art to utilize a clip member as taught by Spence using an arm portion and root portion to provide the clip member coupled to the coaptation member of McLean et al. such that it provides the ability to grip a leaflet in the desired area and not interfere with its function, paragraph 71 of Spence. With respect to claim 7, Fig. 4A shows the coaptation member 314 includes a secondary brim portion configured to press against cardiac tissue above the second native leaflet proximate to the native valve annulus. Regarding claim 8, it can also be seen (Fig. 4A) shows the secondary brim portion comprises a plurality of interconnected struts 318 covered with a biocompatible material 322. Regarding claim 10, Figs. 8A,B show the 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. show (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, 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.
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 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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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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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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