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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on December 30, 2025 has been entered.
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.
Claims 52-54, 56-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 10500048 in view of Khairkhahan et al (US 20130023985). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10500048 recites a coaptation assist device comprising a anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory (claim 9) structure comprising a hub and a plurality of struts (claim 1), wherein the coaptation assist device comprises a proximal end greater than a distal end, wherein the coaptation assist device tapers along a first lateral edge and a second lateral edge toward the distal end (claim 1), wherein the hub is placed on a proximal side of the coaptation assist device and coupled to the biocompatible membrane; and a helical tissue anchor, wherein the hub is configured to receive the helical tissue anchor, wherein the helical tissue anchor is configured to be rotated relative to the hub, wherein the helical tissue anchor is configured to secure the coaptation assist device to an annulus of a mitral valve (claim 1). Khairkhahan teaches an anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory structure (500, nitinol, paragraph 0100) comprising a hub (762)and a plurality of struts (830), wherein the coaptation assist body comprises a biocompatible membrane (covering 850, paragraph 0100, 0114) coupled to the shape memory structure in order to maintain a shape of the coaptation assist body. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further include a biocompatible membrane coupled to the shape memory structure in the device of Patent 10500048 claim 9 order to maintain of a shape of the coaptation assist body.
Claims 61- are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 10500048 in view of Khairkhahan et al (US 20130023985). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10500048 recites a coaptation assist device comprising a anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory (claim 9) structure comprising a hub and a plurality of struts (claim 1), wherein the coaptation assist device comprises a proximal end greater than a distal end, wherein the coaptation assist device tapers along a first lateral edge and a second lateral edge toward the distal end (claim 1), wherein the hub is placed on a proximal side of the coaptation assist device and coupled to the biocompatible membrane; and a helical tissue anchor, wherein the hub is configured to receive the helical tissue anchor, wherein the helical tissue anchor is configured to be rotated relative to the hub, wherein the helical tissue anchor is configured to secure the coaptation assist device to an annulus of a mitral valve (claim 1). Khairkhahan teaches an anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory structure (500, nitinol, paragraph 0100) comprising a hub (762)and a plurality of struts (830), wherein the coaptation assist body comprises a biocompatible membrane (covering 850, paragraph 0100, 0114) coupled to the shape memory structure in order to maintain a shape of the coaptation assist body. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further include a biocompatible membrane coupled to the shape memory structure in the device of Patent 10500048 claim 9 order to maintain of a shape of the coaptation assist body.
Claims 52-54, 56-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 21 of U.S. Patent No. 10500048 in view of Khairkhahan et al (US 20130023985). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10500048 recites a coaptation assist device comprising a anchoring system comprising: a coaptation assist device (claim 1), wherein the coaptation assist device comprises an arcuate, peripheral superior edge, a first lateral edge, a second lateral edge, an inferior edge, wherein the arcuate peripheral superior edge is greater than the inferior edge (claims 8, 21), wherein the coaptation assist device comprises a hub and a plurality of struts extending from the hub, wherein the hub is positioned closer to the arcuate, peripheral superior edge than the inferior edge (claim 1, positioned proximally from which the plurality of struts extend); and a helical tissue anchor, wherein the hub is configured to receive the helical tissue anchor, wherein the helical tissue anchor is configured to be rotated relative to the hub, wherein the helical tissue anchor is configured to secure the coaptation assist device to an annulus of a mitral valve (claim 1). Khairkhahan teaches an anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory structure (500, nitinol, paragraph 0100) comprising a hub (762)and a plurality of struts (830), wherein the coaptation assist body comprises a biocompatible membrane (covering 850, paragraph 0100, 0114) with a plurality of struts comprising a first zone that is generally oriented substantially parallel to the longitudinal axis of a substantially perpendicular to the longitudinal axis of the coaptation assist body (see image in previous office action) coupled to the shape memory structure in order to maintain a shape of the coaptation assist body. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further include a plurality of struts comprising a first zone that is generally oriented substantially parallel to the longitudinal axis of a substantially perpendicular to the longitudinal axis of the coaptation assist body with a biocompatible membrane coupled to the shape memory structure in the device of Patent 10500048 claims 8 and 21 in order to maintain of a shape of the coaptation assist body.
Claims 66-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 10500048 in view of Khairkhahan et al (US 20130023985). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10500048 recites a coaptation assist device comprising a anchoring system comprising: a coaptation assist device (claim 1), wherein the coaptation assist device comprises a hub and a plurality of struts extending from the hub, wherein at least one strut of the plurality of struts comprises a first zone that is generally oriented downward and a second zone, wherein the second zone has a greater dimension transverse to the longitudinal axis of the coaptation assist body than the first zone (claim 1), wherein the hub directly from the second zone (claim 1, positioned proximally from which the plurality of struts extend); and a helical tissue anchor, wherein the hub is configured to receive the helical tissue anchor, wherein the helical tissue anchor is configured to be rotated relative to the hub, wherein the helical tissue anchor is configured to secure the coaptation assist device to an annulus of a mitral valve (claim 1). Khairkhahan teaches an anchoring system comprising: a coaptation assist device, wherein the coaptation assist device comprises a shape memory structure (500, nitinol, paragraph 0100) comprising a hub (762)and a plurality of struts (830), wherein the coaptation assist body comprises a biocompatible membrane (covering 850, paragraph 0100, 0114) with a plurality of struts comprising a first zone that is generally oriented substantially parallel to the longitudinal axis of a substantially perpendicular to the longitudinal axis of the coaptation assist body (see image in previous office action) coupled to the shape memory structure in order to maintain a shape of the coaptation assist body. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further include a plurality of struts comprising a first zone that is generally oriented substantially parallel to the longitudinal axis of a substantially perpendicular to the longitudinal axis of the coaptation assist body with a biocompatible membrane coupled to the shape memory structure in the device of Patent 10500048 claims 8 and 21 in order to maintain of a shape of the coaptation assist body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771
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