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 06/03/2026 have been fully considered but they are not persuasive. The objection of claim 1 has been maintained as line 5 was not fully corrected as indicated.
Applicant’s arguments, filed 06/03/2026, with respect to the rejection(s) of claim(s) 1-6 under 35 USC 103 have been fully considered and are persuasive. Applicant’s argument that Fish in view of Gabbay and Ozaki fails to disclose a venous valve comprising a monocusp shape having an apex that is formed upon folding a sheet comprising a top section having the shape resembling a belly curve on a bottom rectangular section is persuasive. Therefore, the rejection has been withdrawn.
Claim Objections
The limitation “the bottom” in line 5 should be changed “the bottom rectangular section” for consistency in terminology.
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.
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Claims 1-4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 14 of U.S. Patent No. 12,575,932 in view of Gabbay US Patent No. 4,759,758 and Fish et al US Patent No. 9,737,400 B2.
Regarding claim 1 of the present case, Claim 1 of ‘932 recites a replacement venous valve (Col. 28, line 43) comprising biological tissue (Col. 28, line 45) cut to have a top section and a bottom rectangular section (Col. 28, lines 46-48), wherein the top section defines the shape of a cusp having a belly curve (Col. 28, lines 48-50); an apex (Col. 28, line 52) formed by folding the top section onto the bottom to form an apex of a monocusp leaflet (Col. 28, lines 51-52); a monocusp leaflet formed by attaching the top folded section onto the bottom rectangular section (Col. 28, lines 53-54), and Claim 14 of ‘932 recites a frame coupled to the monocusp leaflet (Col. 29, lines 21-22). Claims 1 and 14 of ‘932 fails to the biological tissue is subjected to a fixation treatment and the monocusp shape providing a spatial buffer between the monocusp leaflet and a valve wall of the replacement valve when the replacement valve is in the open position, and facilitating closing of the replacement valve when adequate flow pressure gradient is created.
Gabbay also discloses a replacement venous valve (Col. 4, lines 41-43). Gabbay teaches a biological tissue (8) subjected to a fixation treatment (Col 3, lines 41-44). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the replacement venous valve recited in ‘932 comprising a biological tissue subjected to a fixation treatment, as taught by Gabbay, in order to prevent the tissue from being rejected (Col. 3, lines 39-44).
Further, Fish also discloses a replacement venous valve (Col. 6, lines 13-20, “implantation in a vascular system”). Fish teaches the commonly understood function of a replacement valve leaflet that opens and closes (Col. 1, lines 28-46), which meets the limitation “the leaflet providing a spatial buffer between the monocusp and the valve wall of the replacement valve when the replacement valve is in the open position and facilitating closing of the replacement valve when adequate flow pressure gradient is created.” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the replacement venous valve recited in claim 1 of ‘932 comprising a monocusp shape that provides a spatial buffer between the monocusp leaflet and a valve wall of the replacement valve when the replacement valve is in the open position, and facilitating closing of the replacement valve when adequate flow pressure gradient is created, as taught by Fish, in order to maintain the native opening and closing function of the replacement venous valve (Col. 1, lines 28-46).
Regarding claim 2 of the present case, claim 1 of ‘932 discloses the monocusp leaflet (Col. 28, line 54), but fails to disclose wherein the monocusp leaflet is disposed towards one end of the frame. Fish further teaches wherein the monocusp leaflet (Fig. 1E, leaflet structure 130) is disposed towards one end of the frame (Col. 15, lines 62-67, Fig. 1G, seam 132, frame members 141). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the replacement venous valve recited in claim 1 of ‘932 wherein the monocusp leaflet is disposed towards one end of the frame, as further taught by Fish, in order for axial alignment of the valve (Col. 15, lines 62-67, Col. 16, lines 1-5).
Regarding claim 3 of the present case, claim 1 of ‘932 discloses the inflow skirt (Col. 29, lines 1-2), but fails to disclose wherein an inflow skirt is attached to the valve wall to minimize disruption of flow and thrombosis. Gabbay further teaches wherein an inflow skirt (sewing ring 12) is attached to the valve wall to minimize disruption of flow and thrombosis (Col 3, lines 3-12 and 55-68, Figs. 4, 5, 8-10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the replacement venous valve recited in claim 1 of ‘932 wherein an inflow skirt is attached to the valve wall to minimize disruption of flow and thrombosis, as further taught by Gabbay, in order to reduce thrombogenic and infection sites (Col. 3, lines 55-68).
Regarding claim 4 of the present case, claim 1 of ‘932 recites wherein the monocusp leaflet is folded from one continuous biological tissue (Col. 28, line 47) without suturing to form the apex of the monocusp leaflet (Col. 28, lines 51-52).
Regarding claim 6 of the present case, claim 1 of ‘932 discloses the monocusp leaflet (Col. 28, line 54), but fails to disclose wherein the valve wall is attached to the monocusp leaflet. Fish further teaches wherein the valve wall is attached to the monocusp leaflet (Col. 15, lines 62-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the replacement venous valve recited in claim 1 of ‘932 wherein the valve wall is attached to the monocusp leaflet, as further taught by Fish, in order for axial alignment of the valve (Col. 15, lines 62-67, Col. 16, lines 1-5).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 14 of U.S. Patent No. 12,575,932 in view of Gabbay US Patent No. 4,759,758, Fish et al US Patent No. 9,737,400 B2, and further in view of Ozaki (Foreign Patent No. JP2009077838A).
Regarding claim 5 of the present application, claim 1 of ‘932 recites wherein the monocusp leaflet has a belly curve (Col. 28, lines 48-50), but fails to disclose at least one of a coaptation angle of about 20 degrees to 80 degrees, a free margin angle between commissure points of about 90 degrees to 270 degrees, a monocusp leaflet total height of about 6 mm to 11 mm, a coaptation height ratio of about 0.5-1, a commissure-to- commissure (CC)/flat width of about 12 mm - 20 mm, a coaptation gap of about 0 to 3 mm, and a free margin distance of about 14 mm - 27 mm.
Ozaki also discloses a replacement valve (Fig. 10, prosthetic valve 82, Fig. 11, valve cusp) comprising biological tissue (Paragraph [0008] of attached translation). Ozaki teaches the monocusp has a free margin angle between commissure points of about 90 degrees to 270 degrees ([0010] of the attached translation, Fig 11, central angle of commissure portions K is 120 degrees, which falls within the claimed range as interpreted). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the replacement venous valve recited in claim 1 of ‘932 to provide at least one of a coaptation angle of about 20 degrees to 80 degrees, a free margin angle between commissure points of about 90 degrees to 270 degrees, a monocusp leaflet total height of about 6 mm to 11 mm a coaptation height ratio of about 0.5-1, a commissure-to-commissure (CC)/flat width of about 12 mm - 20 mm, a coaptation gap of about 0 to 3 mm, and a free margin distance of about 14 mm - 27 mm, specifically, a free margin angle between commissure points of about 90 degrees to 270 degrees, as taught by Ozaki, in order to model the shape of a native valve cusp ([0010] of the attached translation).
Allowable Subject Matter
Claims 1-6 would be allowable if a terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) is timely filed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art are:
Fish et. Al: US Patent No. 9,737,400 B2
Gabbay: US Patent No. 4,759,758
Regarding claim 1, Fish discloses a replacement venous (Col. 6, lines 13-20, “implantation in a vascular system”) valve (Figs. 1A-1G, template 100) comprising: a frame coupled (Fig. 1G, frame members 141) to the monocusp leaflet (Col. 15, lines 62-67, Fig. 1G, seam 132).
Fish describes the commonly understood function of a replacement valve leaflet that opens and closes (column 1, lines 28-46), which meets the limitation “the leaflet providing a spatial buffer between the monocusp and the valve wall of the replacement valve when the replacement valve is in the open position and facilitating closing of the replacement valve when adequate flow pressure gradient is created.”
Fish fails to disclose a biological tissue (Col. 6, lines 20-23) subjected to a fixation treatment. Gabbay also discloses a replacement venous valve (Col. 4, lines 41-43), comprising biological tissue (Col 3, lines 5-7 and 61-68, pericardial tissue 8). Gabbay teaches a biological tissue (8) subjected to a fixation treatment (Col 3, lines 41-44).
However, Fish and Gabbay fail to disclose or suggest a biological tissue cut to have a top section and a bottom rectangular section, wherein the top section defines the shape of a cusp having a belly curve; an apex formed by folding the top section onto the bottom rectangular section to form an apex of a monocusp shape of a leaflet, and a monocusp leaflet formed by attaching the top folded section onto the bottom rectangular section.
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.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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