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 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 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 55, 56, 58 and 60-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roeder (US Pub No. 2013/0079870).
Regarding claim 55, Roeder discloses (Figure 21) a method for treating a subject (Paragraph 0098), comprising: providing an endovascular system that includes (a) a stent-graft (10) (Figure 1), which is configured to transition from a radially-compressed delivery state to a radially-expanded state (Paragraphs 0040 and 0091), and (b) an elongate delivery shaft assembly (curved inner cannula 2192 and curved outer sheath as disclosed in Paragraph 0098) (Figure 21), which has proximal and distal end portions, defines a central longitudinal axis, and includes an outer covering shaft (curved outer sheath as disclosed in Paragraph 0098) and an inner support shaft (curved inner cannula 2192), wherein when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, the distal end portion of the delivery shaft assembly is shaped so as to define a self-orienting portion (curved portion of the delivery shaft assembly as disclosed in Paragraph 0098) shaped so as to define at least one curved portion (Paragraph 0098); while the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, transvascularly introducing the delivery shaft assembly into a descending aorta of the subject (Paragraphs 0091-0092) and advancing the distal end portion of the delivery shaft assembly, including the curved portion, to an aortic arch, such that the self-orienting portion automatically rotationally orients itself in the aortic arch so that an outer curvature of the curved portion faces upstream toward an ascending aorta (Paragraph 0098) (Since Figure 21 only shows one branch on the stent-graft that is positioned and aligned with left subclavian artery, Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries which will result in the delivery shaft assembly to be positioned more towards the ascending aorta so that the branches of the stent-graft can align with the different arteries which will result in the outer curvature of the curved portion to face upstream toward the ascending aorta); and while the distal end portion of the delivery shaft assembly is positioned in the aortic arch, releasing the stent-graft from the delivery shaft assembly by proximally withdrawing the outer covering shaft while holding the inner support shaft in place (Paragraphs 0091-0092).
Regarding claim 56, wherein the stent-graft is shaped so as to define an inferior lateral opening (see annotated figure below), and wherein advancing the distal end portion of the delivery shaft assembly comprises advancing the distal end portion of the delivery shaft assembly to the aortic arch such that the self-orienting portion automatically rotationally orients itself such that the inferior lateral opening faces upstream toward the ascending aorta (see annotated figure below) (Paragraph 0098).
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Regarding claim 58, wherein the stent-graft is shaped so as to further define a superior lateral opening (Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries), and wherein advancing the distal end portion of the delivery shaft assembly comprises advancing the distal end portion of the delivery shaft assembly to the aortic arch such that the self-orienting portion automatically rotationally orients itself (Paragraph 0098) such that the superior lateral opening is rotationally aligned with a left common carotid artery (Paragraph 0075), and the inferior lateral opening faces upstream toward the ascending aorta (shown in the annotated figure above).
Regarding claim 60, further comprising: transvascularly advancing a guidewire of the endovascular system up the descending aorta and into a branch of the aortic arch (Paragraphs 0077-0078); and while the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, advancing the delivery shaft assembly over the guidewire until the stent-graft is partially disposed in the branch of the aortic arch, partially disposed in the aortic arch, and partially disposed in an upper part of the descending aorta (Figure 21) (Paragraphs 0077-0078).
Regarding claim 61, wherein transvascularly advancing the guidewire comprises transvascularly advancing the guidewire into a brachiocephalic artery (Paragraphs 0071 and 0077-0078), and wherein advancing the delivery shaft assembly over the guidewire comprises advancing the delivery shaft assembly over the guidewire until the stent-graft is partially disposed in the brachiocephalic artery, partially disposed in the aortic arch, and partially disposed in the upper part of the descending aorta (Paragraphs 0071 and 0077-0078).
Regarding claim 62, wherein transvascularly advancing the guidewire comprises: endovascularly introducing the guidewire into vasculature at a first vascular access site; advancing the guidewire through the vasculature; and extracting the guidewire from the vasculature and a body of the subject at a second vascular access site different from the first vascular access site, such that the guidewire extends between the first and the second vascular access sites through the vasculature (Paragraphs 0077-0078) (Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries which each artery or vascular access site will have the guidewire to pass through in order to insert the branch as shown in Figure 2).
Regarding claim 63, wherein transvascularly introducing the delivery shaft assembly into the descending aorta comprises: transvascularly introducing the delivery shaft assembly into the descending aorta while the self-orienting portion is at least partially constrained to a straight configuration; and once the delivery shaft assembly approaches the aortic arch, allowing the self-orienting portion to assume a precurved shape and thus automatically rotationally orient itself in the aortic arch so that the outer curvature of the curved portion faces upstream toward the ascending aorta (Figure 21) (Paragraph 0098).
Regarding claim 64, wherein advancing the distal end portion of the delivery shaft assembly and releasing the stent-graft comprises advancing the distal end portion of the delivery shaft assembly to the aortic arch and releasing the stent-graft from the delivery shaft assembly such that (a) a proximal portion of the stent-graft, including a proximal end thereof, is positioned in an upper part of the descending aorta, (b) a middle portion of the stent- graft is positioned in the aortic arch, and (c) a distal portion of the stent-graft, including a distal end thereof, is positioned in a branch of the aortic arch (Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries which will result in the delivery shaft assembly to be positioned more towards the ascending aorta so that the branches of the stent-graft can align with the different arteries resulting in the stent-graft to achieve the configuration as recited in the claim above).
Regarding claim 65, wherein advancing the distal end portion of the delivery shaft assembly and releasing the stent-graft comprises advancing the distal end portion of the delivery shaft assembly to the aortic arch and releasing the stent-graft from the delivery shaft assembly such that (a) the proximal portion of the stent-graft, including the proximal end thereof, is positioned in the upper part of the descending aorta, (b) the middle portion of the stent-graft is positioned in the aortic arch, and (c) the distal portion of the stent-graft, including the distal end thereof, is positioned in a brachiocephalic artery (Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries which will result in the delivery shaft assembly to be positioned more towards the ascending aorta so that the branches of the stent-graft can align with the different arteries resulting in the stent-graft to achieve the configuration as recited in the claim above).
Regarding claim 66, wherein the elongate delivery shaft assembly further includes a distal tip (2294) (Figures 21 and 22).
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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.
Claims 67 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Roeder (US Pub No. 2013/0079870) as applied to claim 1 above.
Regarding claims 67 and 68, Roeder discloses the invention above except for wherein providing the endovascular system includes providing the endovascular system in which, when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, a smallest radius of curvature of the curved portion, measured at the central longitudinal axis, is between 2.5 and 12 cm specifically 4 and 10cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Roeder to have the endovascular system in which, when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, to have a smallest radius of curvature of the curved portion, measured at the central longitudinal axis, to be between 2.5 and 12 cm specifically 4 and 10cm since the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Claims 55, 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev (US Pub No. 20160030209) in view of Roeder (US Pub No. 2013/0079870).
Regarding claim 55, Shalev discloses a stent-graft (Figure 8), which is configured to transition from a radially-compressed delivery state to a radially-expanded state (Paragraphs 0243 and 0247).
Shalev fails to disclose an elongate delivery shaft assembly, which has proximal and distal end portions, defines a central longitudinal axis, and includes an outer covering shaft and an inner support shaft, wherein when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, the distal end portion of the delivery shaft assembly is shaped so as to define a self-orienting portion shaped so as to define at least one curved portion; while the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, transvascularly introducing the delivery shaft assembly into a descending aorta of the subject and advancing the distal end portion of the delivery shaft assembly, including the curved portion, to an aortic arch, such that the self-orienting portion automatically rotationally orients itself in the aortic arch so that an outer curvature of the curved portion faces upstream toward an ascending aorta; and while the distal end portion of the delivery shaft assembly is positioned in the aortic arch, releasing the stent-graft from the delivery shaft assembly by proximally withdrawing the outer covering shaft while holding the inner support shaft in place.
Roeder, in the same field of endeavor, teaches (Figure 21) a method for treating a subject (Paragraph 0098), comprising: providing an endovascular system that includes (a) a stent-graft (10) (Figure 1), which is configured to transition from a radially-compressed delivery state to a radially-expanded state (Paragraphs 0040 and 0091), and (b) an elongate delivery shaft assembly (curved inner cannula 2192 and curved outer sheath as disclosed in Paragraph 0098) (Figure 21), which has proximal and distal end portions, defines a central longitudinal axis, and includes an outer covering shaft (curved outer sheath as disclosed in Paragraph 0098) and an inner support shaft (curved inner cannula 2192), wherein when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, the distal end portion of the delivery shaft assembly is shaped so as to define a self-orienting portion (curved portion of the delivery shaft assembly as disclosed in Paragraph 0098) shaped so as to define at least one curved portion (Paragraph 0098); while the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, transvascularly introducing the delivery shaft assembly into a descending aorta of the subject (Paragraphs 0091-0092) and advancing the distal end portion of the delivery shaft assembly, including the curved portion, to an aortic arch, such that the self-orienting portion automatically rotationally orients itself in the aortic arch so that an outer curvature of the curved portion faces upstream toward an ascending aorta (Paragraph 0098) (Since Figure 21 only shows one branch on the stent-graft that is positioned and aligned with left subclavian artery, Paragraph 0075 discloses that the stent-graft can include multiple branches to align with the left subclavian, left common carotid, and inanimate arteries which will result in the delivery shaft assembly to be positioned more towards the ascending aorta so that the branches of the stent-graft can align with the different arteries which will result in the outer curvature of the curved portion to face upstream toward the ascending aorta); and while the distal end portion of the delivery shaft assembly is positioned in the aortic arch, releasing the stent-graft from the delivery shaft assembly by proximally withdrawing the outer covering shaft while holding the inner support shaft in place (Paragraphs 0091-0092).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shalev to have included an elongate delivery shaft assembly, which has proximal and distal end portions, defines a central longitudinal axis, and includes an outer covering shaft and an inner support shaft, wherein when the delivery shaft assembly is unconstrained and the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, radially between the outer covering shaft and the inner support shaft, the distal end portion of the delivery shaft assembly is shaped so as to define a self-orienting portion shaped so as to define at least one curved portion; while the stent-graft is removably constrained in the radially-compressed delivery state in the delivery shaft assembly, transvascularly introducing the delivery shaft assembly into a descending aorta of the subject and advancing the distal end portion of the delivery shaft assembly, including the curved portion, to an aortic arch, such that the self-orienting portion automatically rotationally orients itself in the aortic arch so that an outer curvature of the curved portion faces upstream toward an ascending aorta; and while the distal end portion of the delivery shaft assembly is positioned in the aortic arch, releasing the stent-graft from the delivery shaft assembly by proximally withdrawing the outer covering shaft while holding the inner support shaft in place as taught by Roeder, in order to provide a delivery device that automatically orients and aligns the stent-graft circumferentially with the branch vessels of the aortic arch (Roeder, Paragraph 0098).
Regarding claim 56, Shalev modified by Roeder further discloses wherein the stent-graft is shaped so as to define an inferior lateral opening (Shalev, 34) (Figures 2A-2B), and wherein advancing the distal end portion of the delivery shaft assembly comprises advancing the distal end portion of the delivery shaft assembly to the aortic arch such that the self-orienting portion automatically rotationally orients itself such that the inferior lateral opening faces upstream toward the ascending aorta (Shalev, Figure 8).
Regarding claim 57, Shalev modified by Roeder further discloses wherein the stent-graft is a first stent-graft (Shalev, 24), and wherein the method further comprises deploying a second endovascular stent-graft (Shalev, 26) up the descending aorta, through a proximal portion of the first stent-graft, partially out of the inferior lateral opening so as to form a blood-tight seal with the inferior lateral opening, and into the ascending aorta (Shalev, Figure 8) (Paragraphs 0288-0295).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 55, 56 and 58-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-11 of U.S. Patent No. 11,389,313. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
18/940,152
55, 59
56
58
59
60
61
62
63
64
65
66
67
68
Claims
Patent 11,389,313
1
9
9
1
2
3
4
9
7
8
1
10
11
Allowable Subject Matter
Claim 59 is 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 and also, if they overcome the double patenting rejection set forth in this Office Action.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose the self-orienting portion is shaped so as to further define (i) at least a proximal curved portion disposed more proximal than the distal curved portion, and (ii) at least one point of inflection on the central longitudinal axis longitudinally between the proximal and the distal curved portions (claim 59).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (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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/MAJID JAMIALAHMADI/ Primary Examiner, Art Unit 3771