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 with respect to claim(s) 1-12, 14-16, 19-20 have been considered but are moot because the new ground of rejection over Dickinson et al. US 2008/0194939 in view of Fogarty et al. US 6123722 in view of Campbell et al. US 5800522. Claims 24-26 have been newly added.
Applicant argues the prior art fails to disclose wherein the stent graft covers one or more collateral vessels of the second vessel. Applicant argues Fogarty avoids covering the branch vessels to maintain blood flow.
However, Examiner notes Fogarty is being used only to teach overlapping first and second stent grafts, not the placement of the first and second stent graft. Dickinson et al. discloses the placement between and extending along the first and second vessels. Additionally, Campbell et al. teaches a tube or any other intraluminal graft for lining vessels (column 1, lines 34-35) modifying a vessel to make the valves incompetent by using a valvulotome procedure to cut the valves (column 9 line 41-67), 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 opposite to the normal flow (column 9 line 41-67), deploying a graft in the vessel such that the graft covers one or more collateral vessels (column 7, lines 16-22; liner or graft may be used to provide an anastomosis between conduits 30, 32 and may also be used to occlude side vessels 39, figures 5, 8C), the length of the segment may be optimized to address valves and/or tributaries or collateral vessels as desired (column 9, lines 41-67). Therefore, in combination the amendment fails to overcome the prior art.
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 vessel or 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 covers one or more collateral vessels of 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 § 112
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 discloses “the stent graft comprising a covering or a graft” on lines 1-2. This language is indefinite as it is unclear whether the claimed “covering or graft” refers to the graft or covering already disclosed as part of the stent graft or instead requires an additional covering or graft separate from that already associated with the stent graft.
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) 1-5, 8, 10-12, 14, 15, 16, 19, 20, and 24-26 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 Campbell et al. US 5800522.
Regarding claims 1-5, 8, 15, 16 and 20 and 24-26, 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).
Dickinson et al. 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 comprises a covering or a graft such that the second stent is configured to cover one or more collateral vessels of the second vessel to reduce blood flow diversion through the one or more collateral vessels, wherein the second stent graft has a parameter different than the first stent graft, and wherein the parameter comprises at least one of a braid angle, a filament diameter, a filament material, a cut pattern, a weave pattern, a radial force, or a porosity.
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), wherein the second stent graft has a parameter different than the first stent graft, and wherein the parameter comprises at least one of a braid angle, a filament diameter, a filament material, a cut pattern, a weave pattern, a radial force, or a porosity (column 19, line 55- column 20, line 11; frame may comprise a plurality of independent ring frame material or thickness to be varied to impose different spring forces to provide various radial stiffness of the frame or liner to provide the desired radial stiffness to provide sealing as necessary).
Campbell et al. teaches a tube or any other intraluminal graft or covering for lining vessels (column 1, lines 34-35) modifying a vessel to make the valves incompetent by using a valvulotome procedure to cut the valves (column 9 line 41-67), 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 opposite to the normal flow (column 9 line 41-67), deploying a graft in the vessel such that the graft covers one or more collateral vessels (column 7, lines 16-22; liner or graft may be used to provide an anastomosis between conduits 30, 32 and may also be used to occlude side vessels 39, figures 5, 8C), the length of the segment may be optimized to address valves and/or tributaries or collateral vessels as desired to reduce blood flow diversion through the one or more collateral vessels (column 9, lines 41-67, figures 5, 8C).
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, and the first stent graft comprising a different parameter than the second stent graft, 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 providing different material or thicknesses to provide the desired radial stiffness to provide sealing as necessary, and making the valves in the second vessel incompetent and covering one or more collateral vessels, 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 and optimizing the length to cover valves or collateral vessels as desired for a procedure.
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 (column 3, lines 28-36, proximal and distal portion overlap to provide a custom fit tailored to the individual patient), the first stent graft and second stent graft share at least one deployment parameter (delivered within same vessel with catheter 30, column 11, lines 37-44) 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 deployed within a vessel, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
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) 6 and 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 Campbell et al. US 5800522 as discussed above, and further in view of Nobles et al. US 5284478.
Regarding claims 6 and 7, Dickinson et al. in combination discloses the method of making the valves in the second vessel incompetent (Campbell et al. teaches a tube or any other intraluminal graft for lining vessels, column 1, lines 34-35, modifying a vessel to make the valves incompetent by using a valvulotome procedure to cut the valves, column 9 line 41-67) essentially as claimed as discussed above, but fails to disclose deploying a reverse valvulotome to cut the valves, the reverse valvulotome comprises one ore more blades, 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 Campbell et al. US 5800522 as discussed above, 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
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
