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 11/24/25, with respect to the rejection(s) of claim(s) 1-12, 14-16, 19 and 20 under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 Dickinson et al. US 2008/0194939 in view of Fogarty et al. US 6123722 in view of Mehigan US 5171316, as discussed below.
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, 2, 4-11, 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9, 11, and 15 of U.S. Patent No. 9,545,263. Although the claims at issue are not identical, they are not patentably distinct from each other because overlap in scope for the claims indicated below.
Claims of 18656574
Rejected over Claims of U.S. 9,545,263
Overlapping Scope
1, 8, 15
1 and/or 11
The method comprising: forming a fistula, deploying a first stent graft (prosthesis) at least partially in a fistula between the first vessel and the second vessel such that the first stent graft diverts the blood from the first vessel to the second vessel; deploying a second stent graft in the second vessel such that the second stent graft lines the second vessel, wherein the first stent graft is separate from the second stent graft, wherein a proximal segment of the second stent graft longitudinally overlaps a distal segment of the first stent graft, and wherein after deploying the first stent graft and the second stent graft, the second stent graft is fluidly connected to the first stent graft for receiving the diverted blood; and making valves in the second vessel incompetent.
2
2
wherein deploying the second stent graft comprises placing the second stent graft through the first stent graft after deploying the first stent graft.
4
4
wherein the proximal segment of the second stent graft is radially outward of the distal segment of the first stent graft.
5
5
wherein the proximal segment of the second stent graft is radially inward of the distal segment of the first stent graft.
6
1
wherein making the valves in the second vessel incompetent comprises deploying a reverse valvulotome to cut the valves.
7
6
wherein the reverse valvulotome comprises one or more blades, and wherein deploying the reverse valvulotome to cut the valves comprises: advancing the reverse valvulotome distally in the second vessel in a direction opposite a native fluid flow of the second vessel; and while advancing the reverse valvulotome distally in the second vessel, cutting the valves with the blades.
9
7
wherein rendering the valves in the second vessel incompetent comprises at least one of inflating a balloon and expanding a temporary stent.
10, 11
15
wherein the second vessel comprises proximal tibial vein, and wherein positioning the second stent graft comprises lining an entire length of the proximal tibial vein with the second stent graft.
14
9
wherein the second stent graft comprises a first portion configured to anchor in an artery, a second portion configured to anchor in and line a length of a vein, and a third portion longitudinally between the first portion and the second portion.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-6, 8, 10-12, 14, 15, 16 and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. US 2008/0194939 in view of Fogarty et al. US 6123722 in view of Mehigan US 5171316.
Regarding claims 1-6, 8, 15, 16 and 20-23, Dickinson et al. discloses method of diverting blood from a first vessel to a second vessel, the method comprising: deploying a first stent graft at least partially in a fistula between the first vessel and the second vessel such that the first stent graft diverts the blood from the first vessel to the second vessel (figure 7, paragraph 0041); but fails to disclose deploying a second stent graft in the second vessel such that the second stent graft lines the second vessel, wherein the first stent graft is separate from the second stent graft, wherein a proximal segment of the second stent graft longitudinally overlaps a distal segment of the first stent graft, and wherein after deploying the first stent graft and the second stent graft, the second stent graft is fluidly connected to the first stent graft for receiving the diverted blood; and making valves in the second vessel incompetent, wherein deploying the second stent graft further comprises deploying the second stent graft such that the second stent covers one or more collateral vessels of the second vessel.
Fogarty et al. teaches deploying a second prosthesis in the second vessel wherein the first prosthesis separate from the second prosthesis (stent grafts being a first and second modules or prosthesis, for example, 62, 64 and 66, figure 5C) wherein a proximal segment of the second stent graft longitudinally overlaps a distal segment of the first stent graft (column 3, lines 20-25, overlapping ends of each module or stent graft), and wherein after deploying the first stent graft and the second stent graft, the second stent graft is fluidly connected to the first stent graft for receiving the diverted blood (column 3, lines 60-65, prosthesis within fistula or blood vessels), establishing a fluid connection between the first stent graft and the second stent graft such that the second stent graft is configured to receive the diverted blood (configured when placed between the first and second vessels), wherein deploying the second stent graft comprises placing the second stent graft through the first stent graft after deploying the first stent graft (for example, portions 64 deployed within or overlapping portion 62, figure 5C) or wherein deploying the first stent graft comprises placing the first stent graft through the second stent graft after deploying the second stent graft (column 11, lines 28-36, proximal and distal portion overlap to provide a custom fit tailored to the individual patient, configured to overlap or lock with either first or second prosthesis or stent, figure 5C shows the center portion 64 overlapping on the exterior or interior of the end portions 62 and 66 radially inward or outward by assembling modules as required for the desired length), wherein the proximal segment of the second stent graft is radially outward of the distal segment of the first stent graft, (figure 5C, proximal segment 66 is configured to be radially outward of 62, as it flares outward), wherein the proximal segment of the second stent graft is radially inward of the distal segment of the first stent graft (interface ends are interchangeable comprising inner and outer mating pairs for coupling together modules, column 10, lines 49-61; Examiner notes it would have been obvious to construct the modules and mating the ends on either an outward or inward configuration as desired to form the shape and length of the prosthesis), wherein the second stent graft is cylindrical or frustoconical (figure 5C), and further comprising: deploying a third stent graft configured to appose a sidewall of an artery (modules may be selectively combined to provide the prosthesis having the desired length, figure 5C shows three portions 62, 64 and 66), wherein the length of the second stent graft is greater than the length of the third stent graft plus the length of the first stent graft, wherein the third stent graft is cylindrical (column 11, lines 28-36, proximal and distal portion overlap to provide a custom fit tailored to the individual patient, configured to overlap or lock with either first or second prosthesis or stent), wherein deploying the second stent graft further comprises deploying the second stent graft such that the second stent covers one or more collateral vessels of the second vessel (second stent graft or most distal module may be placed as desired to custom fit the patient, in combination will be placed over the incompetent valves of the second vessel).
Mehigan teaches a method for placing a graft within a vessel to provide a bypass vessel (column 1, lines 9-17), modifying a vessel to make the valves incompetent by using a valvulotome procedure to cut the valves, and lining the vessel with a graft being secured against the vessel wall over valves that have been cut by a valvulotome for cutting the valve so they can no longer prevent flow in the directions oppostite to the normal flow (column 1, lines 17-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dickinson et al. with the at least one stent may be deployed across the valves comprising deploying a second stent graft in the second vessel such that the second stent graft lines the second vessel, wherein the first stent graft is separate from the second stent graft, wherein a proximal segment of the second stent graft longitudinally overlaps a distal segment of the first stent graft, and wherein after deploying the first stent graft and the second stent graft, the second stent graft is fluidly connected to the first stent graft for receiving the diverted blood, establishing a fluid connection between the first stent graft and the second stent graft such that the second stent graft is configured to receive the diverted blood, wherein deploying the second stent graft comprises placing the second stent graft through the first stent graft after deploying the first stent graft, wherein deploying the first stent graft comprises placing the first stent graft through the second stent graft after deploying the second stent graft, wherein the proximal segment of the second stent graft is radially outward of the distal segment of the first stent graft, wherein the proximal segment of the second stent graft is radially inward of the distal segment of the first stent graft, wherein the second stent graft is cylindrical or frustoconical, and further comprising: deploying a third stent graft configured to appose a sidewall of an artery, the third stent graft comprising a circumferential cell structure along a length of the third stent graft, wherein the length of the second stent graft is greater than the length of the third stent graft plus the length of the first stent graft, wherein the third stent graft is cylindrical, as taught by Fogarty et al. to provide a stent graft which is customizable to the length of the vessels as necessary for the patient while maintaining a fluid connection between the first and second vessels, and making the valves in the second vessel incompetent, as taught by Campbell and known in the art to modify a vessel by cutting and making the valves incompetent in a vessel for receiving a stent graft or prosthesis therethrough.
Regarding claims 10, 11, 12 and 19, Dickinson et al. in combination discloses a method essentially as claimed as discussed above, but fail to explicitly disclose wherein positioning the second stent graft comprises lining an entire length of the second vessel or the proximal tibial vein with the second stent graft, wherein the second stent graft has a length between 2 cm and 30 cm, wherein the first stent graft and the second stent graft share at least one deployment parameter, or wherein a length of the second stent graft is greater than a length of the first stent graft.
Fogarty et al. teaches customizing the length of the prosthesis such that the second stent graft comprising (lines 28-36, proximal and distal portion overlap to provide a custom fit tailored to the individual patient), wherein a length of the second stent graft is greater than a length of the first stent graft (for example, portions 64 and 66 is greater than portion 62, figure 5C; column 3, lines 24-31; axial lengths of the stent grafts or modules may be varied to provide a custom fit for the patient).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to lining an entire length of the second vessel or the proximal tibial vein, or having a second stent graft having a length between 2cm and 30 cm column 11, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 14, Dickinson in combination discloses the stent graft between first and second passages are between an artery and a vein (0045, veins and arteries run parallel such as first and second body cavities 30, 32, figure 1), wherein the second stent graft comprises a first portion configured to anchor in an artery, a second portion configured to anchor in and line a length of a vein, and a third portion longitudinally between the first portion and the second portion (figure 7, shown along stent 26 between passages 30 to 32).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. US 2008/0194939 in view of Fogarty et al. US 6123722 in view of Mehigan US 5171316, and further in view of Nobles et al. US 5284478.
Regarding claim 7, Dickinson et al. in combination discloses the method essentially as claimed as discussed above, the valvulotome comprising one or move blades (cutting edge 14, figure 1), but fails to disclose wherein deploying a reverse valvulotome to cut the valves comprises: advancing the reverse valvulotome distally in the second vessel in a direction opposite a native fluid flow of the second vessel; and while advancing the reverse valvulotome distally in the second vessel, cutting the valves with the blades.
Nobles et al. teaches a valvulotome having a blade for cutting venous valves releasably engaged with a catheter, the catheter being pushed through a vein, as devices may be occasionally difficult to pull through a vein (column 2, lines 13-20).
Therefore, it would have been obvious to modify Dickinson et al. in combination with a reverse valvulotome to cut the valves comprises: advancing the reverse valvulotome distally in the second vessel in a direction opposite a native fluid flow of the second vessel; and while advancing the reverse valvulotome distally in the second vessel, cutting the valves with the blades, as taught by Nobles et al. to provide a valvulome that may be cut the valves while being pushed distally when pulling proximally may prove difficult.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickinson et al. US 2008/0194939 in view of Fogarty et al. US 6123722 in view of Mehigan US 5171316 and further in view of Segalowitz US 5092872.
Regarding claim 9, Dickinson et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose wherein rendering the valves in the second vessel incompetent comprises at least one of inflating a balloon and expanding a temporary stent.
Segalowitz teaches a valvulotome catheter for cutting vein valves to render the valves incompetent, rendering the valves incompetent comprising at least one of inflating a balloon and expanding a temporary stent (abstract, column 4, lines 12-26; catheter tip is positioned and fixed in the position by inflating a balloon).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dickinson et al. with rendering the valves in the second vessel incompetent comprises at least one of inflating a balloon, as taught by Segalowitz, to allow for proper positioning and fixing of a position of the catheter comprising the blade elements to cut where desired rendering the valves incompetent.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771