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 .
Claim Objections
Claim(s) 16 is/are objected to because of the following informalities:
Within claim 16, line 9: “the aortic” should be –the aorta--.
Within claim 16, line 11 (and claim 18, line 2): “the at least one guidewire” should be --the at least one of the plurality of guidewires-- (in order to maintain consistent claim terminology).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3, 11-20 is/are 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.
Within claim 3, lines 1-3: Applicant claims, “the first side-branch endoprosthesis, second side-branch endoprosthesis and third side-branch endoprosthesis are deployed through a femoral access site”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the scope of the claim is determined by the preamble (which is to the implantable device alone); however, the aforementioned claim requirement is claiming the method of use (as to how the implantable device is deployed). As such, if it unclear, whether Applicant is trying to claim the implantable device OR the method us implanting/ using the implantable device.
Claim 11 recites the limitation "the series of grooves" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Within claim 12, line 7: Applicant claims, “the side portal”; it is unclear, and therefore indefinite, if the single side portal (as required by claim 12, line 7) is a subset of OR includes all of the previously claimed “at least one side portal” (from claim 12, line 4) which is inclusive of two or more side portals. Claim(s) 13-15, which depend from claim 12, inherit all the problems associated with claim 12 (note: Appropriate correction will also be required within claim 13, line 2).
Within claim 16, lines 4-5: Applicant claims, “the first and second side-branch endoprostheses are configured to extend through the main endoprosthesis and the side portal”; it is unclear, and therefore indefinite, if the first and second side-branch endoprostheses actually extend through the main endoprosthesis and the side portal (as the claim is directed to a method of use and the actual extending can be part of a method) OR if the first and second side-branch endoprostheses are merely configured to extend through the main endoprosthesis and the side portal (as is currently claimed the first and second side-branch endoprostheses do not actually have to extend through the main endoprosthesis, they merely need to be CONFIGURED to/ CAPABLE of). Claim(s) 17-20, which depend from claim 16, inherit all the problems associated with claim 16.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Arbefeuille et al. (US 2013/0184806 A1) (as evidenced by SHIROKAZE et al. (US 2012/0226344 A1) for claim 9).
With respect to claim 1:
Arbefeuille et al. discloses an implantable device, as can be seen in figs. 1A-4B and 23A-23D, comprising:
a main endoprosthesis (aortic graft assembly 10) configured for implantation in a vessel, the main endoprosthesis (aortic graft assembly 10) including at least one side portal (wall aperture 20) (paragraph [0045]);
a first side-branch endoprosthesis (tubular branch component 254), as can be seen in figs. 23B-23C, configured to be deployed within the main endoprosthesis (aortic graft assembly 10) and direct flow through a first side-branch vessel (one of brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery) via the at least one side portal (wall aperture 20) (paragraphs [0072, 0079]);
a second side-branch endoprosthesis (second tubular branch component 260) configured to be deployed within the main endoprosthesis (aortic graft assembly 10) and direct flow through a second side-branch vessel (another of the brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery) via the at least one side portal (wall aperture 20) (paragraphs [0072, 0079]); and
wherein when not containing a side-branch endoprosthesis (tubular branch component 254 or 260) the at least one side portal (wall aperture 20) comprises a side channel (tunnel graft 28) without fluid separation (there is no fluid separation thru the wall aperture 20/ tunnel graft 28 when no tubular branches 254, 260 are positioned therein) (paragraphs [0046, 0072]).
With respect to claim 2:
Further comprising a third side-branch endoprosthesis configured to be deployed within the main endoprosthesis (aortic graft assembly 10) and direct flow through a third branch vessel (another of the brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery) via the at least one side portal (wall aperture 20) (the system maybe used to implant AT LEAST ONE tubular branch into the four arteries branching from the aortic arch; the aforementioned clause is inclusive, of all four, in which case - there must be four tubular branches (one for each of the four arteries).) (paragraph [0079]).
With respect to claim 3:
Wherein the first side-branch endoprosthesis, second side-branch endoprosthesis and third side-branch endoprosthesis (all the tubular branch components) are configured to be deployed through a femoral access site (transfemoral access) (paragraph [0044]).
With respect to claim 4:
Wherein the main endoprosthesis (aortic graft assembly 10) comprises a graft (wall 18) and a stent component (stents 34, 36) (paragraph [0045, 0047]).
With respect to claim 6:
Wherein the stent component (stents 34, 36) comprises nitinol (nitinol) (paragraph [0052]).
With respect to claim 7:
Wherein at least one of the first side-branch endoprosthesis, second side-branch endoprosthesis, and third side-branch endoprosthesis (the all the tubular branch components include stent rings, as can be seen in figs. 23B) is self-expanding (the stent rings of the tubular branch components are made from self-expanding nitinol) (paragraph [0052]).
With respect to claim 9:
Wherein the side channel (tunnel graft 28) includes a series of grooves (folds) (the main endoprosthesis (aortic graft assembly 10) including the side channel (tunnel graft 28) is delivered in a compressed configuration; at which point the main endoprosthesis (aortic graft assembly 10) and the side channel (tunnel graft 28) will have grooves (folds), as evidenced by paragraph [0066] of SHIROKAZE et al.).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille et al. (US 2013/0184806 A1) in view of Ouellette et al. (US 8062345 B2).
With respect to claim 5:
Arbefeuille et al. discloses the invention substantially as claimed, as discussed above. However, Arbefeuille et al. is silent concerning the material making up the graft (wall 18) of the main endoprosthesis (aortic graft assembly 10) (specifically being expanded polytetrafluoroethylene).
Ouellette et al. teaches a main endoprosthesis comprising a graft (graft sleeve 10) and a nitinol stent component (stent 20), where the graft (graft sleeve 10) is made from ePTFE (column 14, lines 53-67).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the graft (wall 18) of the main endoprosthesis (aortic graft assembly 10), as disclosed by Arbefeuille et al., from the same material (specifically, ePTFE) as the graft (graft sleeve 10), as taught by Ouellette et al., as the two structures are used for the same purposes (as a vascular graft supported by self-expanding stents) and as such would be made from obviously interchangeable materials.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille et al. (US 2013/0184806 A1) in view of Roeder et al. (US 2018/0303641 A1).
With respect to claim 8:
Arbefeuille et al. discloses the invention substantially as claimed, as discussed above. However, Arbefeuille et al. least one of the first, second, or third side-branch endoprostheses (tubular branch components) is balloon-expandable.
Roeder et al. teaches a main endoprosthesis with at least one side portal and a side branch endoprosthesis (branch prosthesis 550), as can be seen in fig. 22 (paragraphs [0080]). Both the main endoprosthesis and the side branch endoprosthesis (branch prosthesis 550) maybe balloon expandable or self-expanding (deployed by any known method) (paragraphs [0029, 0080]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the first, second, or third side-branch endoprostheses (tubular branch components), as disclosed by Arbefeuille et al., balloon expandable, as taught by Roeder et al., as Roeder et al. teaches that the mode/ method of deployment of a side branch endoprosthesis (branch prosthesis 550) not important/ relevant to the functioning of a side branch endoprosthesis (branch prosthesis 550).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille et al. (US 2013/0184806 A1) in view of Dake et al. (US 2013/0211506 A1).
With respect to claim 16:
Arbefeuille et al. discloses the invention substantially as claimed. Specifically, Arbefeuille et al. discloses a method of deploying an implantable device, as can be seen in figs. 1A-4B and 23A-23D, the implantable device comprising a main endoprosthesis (aortic graft assembly 10), a first side-branch endoprosthesis (tubular branch component 254), as can be seen in figs. 23B-23C, and a second side-branch endoprosthesis (second tubular branch component 260) (paragraphs [0072, 0079]), the main endoprosthesis (aortic graft assembly 10) comprising a side portal (wall aperture 20) (paragraph [0045]), wherein the first and second side-branch endoprostheses (tubular branch components) are configured to extend through the main endoprosthesis (aortic graft assembly 10) and the side portal (wall aperture 20) (paragraphs [0072, 0079]), the method comprising:
accessing an aorta (aorta) (paragraphs [0008, 0072]);
cannulating a main aortic lumen (aorta) of the aorta (aorta) with at least one guidewire (guidewire 320) (paragraphs [0076-0077]);
advancing the main endoprosthesis (aortic graft assembly 10) over the at least one guidewire (guidewire 320) within the aorta (aorta) (paragraphs [0076-0077]);
deploying the main endoprosthesis (aortic graft assembly 10) (paragraphs [0076-0077]);
advancing the first and second side-branch endoprostheses (tubular branch component 254), as can be seen in figs. 23B-23C, within the at least two side vessels (brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery) (paragraphs [0076-0077]); and
deploying the first and second side-branch endoprostheses (tubular branch components), as can be seen in figs. 23B-23C (paragraphs [0076-0077]).
However, Arbefeuille et al. does not disclose the method of deploying the implantable device comprising extending a plurality of guidewires (as opposed to a singular guidewire) into the aorta and at least two side vessels (brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery) branching from the aorta (aorta).
Dake et al. teaches a method of deploying an implantable device where the implantable device comprises a main endoprosthesis and first, second, and third side branch endoprostheses (branch members 200a, 200b, 200c), as can be seen in figs. 9 (paragraphs [0032, 0034-0036]). During the delivery thereof into the aorta and side vessels a plurality of guidewires (first, second, and third branch guidewires) are used such that one (branch) guide wire extends through the aorta, a portion of the main endoprosthesis, and each of the side vessels (paragraphs [0032, 0034-0036]). Each of the (branch) guide wires (branch guidewires) is used to deliver (and properly position) the side branch endoprostheses (branch members 200a, 200b, 200c) with the main endoprosthesis and the respective side vessels.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the plurality of guidewires (first, second, and third branch guidewires) and method of use thereof, as taught by Dake et al., during the delivery of the side-branch endoprostheses (tubular branch components), as disclosed by Arbefeuille et al., in order to aid with the delivery thereof and ensure the proper positioning thereof in the side vessels (brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery).
With respect to claim 17:
Wherein three side vessels (another of the brachiocephalic artery, left subclavian artery left common carotid artery, or right common carotid artery), as disclosed by Arbefeuille et al., branch from the aorta and advancing the first and second side-branch endoprostheses (tubular branch components) includes advancing a third side-branch endoprosthesis (the system maybe used to implant AT LEAST ONE tubular branch into the four arteries branching from the aortic arch; the aforementioned clause is inclusive, of all four, in which case - there must be four tubular branches (one for each of the four arteries).) (paragraph [0079]).
With respect to claim 18:
Wherein advancing the main endoprosthesis (aortic graft assembly 10) over the at least one guidewire (guidewire 320), as disclosed by Arbefeuille et al., includes advancing the main endoprosthesis (aortic graft assembly 10) in an undeployed configuration, as can be seen in figs. 24A-24B (paragraph [0076]).
With respect to claim 19:
Wherein the main endoprosthesis (aortic graft assembly 10) comprises a stent component (stents 34, 36) that is self-expanding (nitinol) and deploying the main endoprosthesis (aortic graft assembly 10) includes self-expansion (removing constraining elements therefrom) of the stent component (stents 34, 36) (paragraphs [0052, 0079]).
With respect to claim 7:
Wherein at least one of the first side-branch endoprosthesis, second side-branch endoprosthesis, and third side-branch endoprosthesis (the all the tubular branch components include stent rings, as can be seen in figs. 23B) is self-expanding (the stent rings of the tubular branch components are made from self-expanding nitinol) (paragraph [0052]).
With respect to claim 20:
Wherein the at least first and second side-branch endoprostheses (tubular branch components) each comprise a stent component (the all the tubular branch components include stent rings, as can be seen in figs. 23B) that is self-expanding (the stent rings of the tubular branch components are made from self-expanding nitinol) and deploying the first and second side-branch endoprostheses (tubular branch components) includes self-expansion (due to being made of self-expanding material) of the first and second side-branch endoprostheses (tubular branch components) (paragraphs [0052, 0079-0080]).
Allowable Subject Matter
Claim(s) 10 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 12-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim(s) 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 10:
An implantable device (as required by claims 1 and 9) wherein the number of grooves and side-branch endoprosthesis are the same, and the grooves aid in sealing with the side branch endoprostheses.
With respect to claim 11:
An implantable device (as required by claims 1 and 9) wherein the grooves are a part of a side portal adaptor.
With respect to claim 12:
An implantable device comprising:
a main endoprosthesis (for implantation into a main vessel), the main endoprosthesis having a side portal communicating with a side channel;
a side portal adaptor configured for attachment within the side portal and extending through the side channel, the side portal adaptor comprising a series of grooves; and
at least one side-branch endoprosthesis extending through the side portal, the at least one side-branch endoprosthesis being received by at least one groove of the series of grooves.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Abefeuille et al. (US 2018/0206972 A1) discloses an implantable device comprising a main endoprosthesis, at least one side branch endoprosthesis, and an adaptor; however, the adaptor does not include the grooves (as required by claim 9 nor 12) nor is it configured to be implanted within a side portal and side channel (as required by claim 12).
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/REBECCA S PRESTON/Examiner, Art Unit 3774