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 .
Status of Claims
This office action is responsive to the amendment filed on 09/19/2025. As directed by the amendment: claims 1, 7 and 14 have been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1, 3, 4, 7-11 and 14-25 are presently pending in this application, and currently examined in the Office Action.
Information Disclosure Statement
The information disclosure statement filed 11/10/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The Non-Patent Literature reference has been placed in the application file, but the information referred to therein has not been considered because it is entirely in Chinese and no translation has been provided.
Examiner’s Notes
It is to be noted that in device/apparatus claims, specifically claims 1, 3, 4, 7-11 and 21-25, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perkins et al. (US PG Pub. 2018/0153677), as previously disclosed, hereinafter Perkins.
Regarding claims 14, 18 and 20, Perkins discloses a distal aortic stent graft assembly deployment method comprising deploying a modular stent device (102) having a bypass gate and an artery leg (112&142) within an aorta such that the artery leg (112&142) is deployed on an outer curve of the aorta, illustrated in Figures 17-19; deploying a distal aortic stent graft assembly (122) within the bypass gate of the modular stent device (102) and an aorta, the distal aortic stent graft assembly (122) includes a main body and a coupling (132) extending radially from the main body, the main body has a proximal end (124) and a distal end (126), the proximal end (124) of the main body deployed within the bypass gate of the modular stent graft (102) such that the distal aortic stent graft assembly (122) is deployed distal the bypass gate of the modular stent device, wherein the distal end (126) of the main body of the distal aortic stent graft assembly (122) having a distal end diameter corresponding to an aortic diameter in a region in which the distal end of the main body of the distal aortic stent graft assembly is deployed; and aligning the coupling (132) with a blood vessel, specifically a left subclavian artery (LSA), while deploying the distal aortic graft assembly (122), illustrated in Figures 20-23 ([0062]; [0063], Lines 1-4 & [0064], Lines 4-12).
Regarding claim 15, Perkins discloses the distal aortic stent graft assembly deployment method of claim 14, wherein the distal end (126) of the main body of the distal aortic stent graft assembly (122) is distal the coupling (132) of the distal aortic stent graft assembly (122), illustrated in Figures 20-23.
Regarding claim 16, Perkins discloses the distal aortic stent graft assembly deployment method of claim 14, further comprising deploying a bridging stent graft (152) within the coupling (132), illustrated in Figures 21-23 ([0066]).
Regarding claim 17, Perkins discloses the distal aortic stent graft assembly deployment method of claim 16, wherein the bridging stent graft (152) is deployed via supra aortic access, illustrated in Figures 21-23 ([0066], Lines 1-18).
Regarding claim 19, Perkins discloses the distal aortic stent graft assembly deployment method of claim 14, wherein the distal aortic stent graft assembly (122) is deployed via femoral access, illustrated in Figures 19 and 20 ([0055], Lines 1-5).
Claim Rejections - 35 USC § 102/103
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.
Claims 7-11 and 25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Varga (US PG Pub. 2017/0340461), as previously disclosed.
Regarding claim 7, Varga discloses a modular stent device (100), illustrated in Figures 1 and 2, comprising a proximal aortic stent graft (200) including a main body having a proximal end and a distal end; a bypass gate (202) extending distally from the main body and defining a proximal end (BGPE) and a distal end (BGDE) defining a distal opening; and an artery leg (201) extending distally from the main body and defining proximal end (APE) and a distal end (ADE), defining a distal opening; a distal aortic stent graft (300/300D) including a main body having a proximal end (DPE), defining a proximal opening, and a distal end (DDE) defining a distal opening, the main body defining a peripheral opening and a coupling (3) extending radially from the main body and corresponding to the peripheral opening configured to align with a blood vessel and perfuse blood through the coupling when the coupling is in the deployed state, illustrated in Figures 1-4 ([0049]; [0050]; [0054] & [0055]), the proximal end (DPE) of the main body of the distal aortic stent graft deployed through, and within, the distal opening (BGDE) of the bypass gate (202) of the proximal aortic stent graft to perfuse blood through the main bodies of the proximal aortic stent graft (200) and the distal aortic stent graft (300/300D) in the deployed states; and a bridging stent graft (600) deployed through, and within, the distal opening (ADE) of the artery leg (201), the bridging stent graft (600) defining a proximal end (BPE) and a distal end (BDE), a proximal-most opening of the proximal end (BPE) of the bridging stent graft terminates distal a proximal-most opening of the proximal end (APE) of the artery leg (201) of the proximal aortic stent graft, and a proximal-most opening of the proximal end (DPE) of the main body of the distal aortic stent graft (300/300D) terminates distal the proximal-most opening of the proximal end (BPE) of the bridging stent graft (600), the bridging stent graft (600) continuously extends between the proximal end (BPE) and distal end (BDE) of the bridging stent graft (600), illustrated in Figures 1-4 and modified figure 2, below;
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it is to be noted that though the parameters of a proximal-most opening of the bridging stent graft terminating distal a proximal-most opening of the artery leg and a proximal-most opening of the main body of the distal aortic stent graft terminating distal the proximal-most opening of the bridging stent graft, are not specifically mentioned by Varga, they also aren’t specifically mentioned in the originally filed specification of the current application at hand (the originally filed specification is completely silent regarding such parameters); additionally, Varga discloses that “overlapping region allows for length adaptation of the modular system” ([0067]). Thus, it also would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to determine appropriate overlapping regions/lengths, including having a proximal-most opening of the proximal end of the bridging stent graft terminates distal a proximal-most opening of the proximal end of the artery leg, and a proximal-most opening of the proximal end of the main body of the distal aortic stent graft terminates distal the proximal-most opening of the proximal end of the bridging stent graft, in order to achieve an appropriate overall length for the modular stent device based on individual patient need.
Regarding claims 8 and 9, Varga discloses the modular stent device of claim 7, and though it is not specifically disclosed that the proximal end of the main body of the distal aortic stent graft has a frustoconical shape having a second circumference and a first circumference, longitudinally closer to the coupling and greater than the second circumference, and the distal end of the main body of the distal aortic stent graft has a third circumference greater than the second circumference, this/these parameter(s) is/are deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the proximal end of the main body of the distal aortic stent graft, including having a frustoconical shape, such that a first circumference, longitudinally closer to the coupling, is greater than a second circumference, and a third circumference of the distal end is greater than the second circumference; since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Furthermore, it is to be noted that neither the claims, nor the originally filed specification gave no reason/benefit for, or criticality to, the parameter(s) of the proximal end of the main body of the distal aortic stent graft has a frustoconical shape having a second circumference and a first circumference, longitudinally closer to the coupling and greater than the second circumference, and the distal end of the main body of the distal aortic stent graft has a third circumference greater than the second circumference, as opposed to the distal aortic stent graft having any other shape/form.
Regarding claims 10 and 11, Varga discloses the modular stent device of claim 7, wherein the coupling (3) has a frustoconical shape including a base and a top, wherein a circumference of the base is greater than a circumference of the top, illustrated in Figure 7.
Regarding claim 25, Varga discloses the modular stent device of claim 7, wherein the main body of the distal aortic stent graft (300) includes two or more circumferential stents completely proximal the coupling (3) and completely inward the proximal end of the main body, illustrated in Figure 10B.
Claims 1, 3, 4 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US PG Pub. 2013/0274861), as previously disclosed, in view of Bruszewski et al. (US PG Pub. 2012/0271401), as previously disclosed, hereinafter Bruszewski.
Regarding claims 1, 3 and 4, Kelly discloses a modular stent device comprising a proximal aortic stent graft (400) including a main body (405) having a proximal end (407) and a distal end (406); a bypass gate (which forms lumen 415) extending distally from the main body and defining a proximal end and a distal end, the distal end defining a distal opening; and an artery leg (which forms lumen 410) defining a proximal end and a distal end, the proximal end of the artery leg extending distally from the distal end of the main body (405), illustrated in Figures 4A and 4B ([0016]; [0024]; [0025] & [0141]); and a distal aortic stent graft (DAS) including a main body having a proximal end and a distal end, the proximal end defining a proximal opening, and the distal end defining a distal opening, the proximal end of the main body of the distal aortic stent graft (DAS) deployed through the distal opening of the bypass gate and within the distal end of the bypass gate (via lumen 415) to perfuse blood through the main bodies of the proximal aortic stent graft (400) and the distal aortic stent graft (DAS) when the main bodies of the proximal aortic stent graft and the distal aortic stent graft are in deployed states, illustrated in Figure 6 and modified figure 6, below;
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and though it does not specifically disclose a proximal-most opening of the proximal end of the main body of the distal aortic stent graft (DAS) terminates distal a proximal-most opening of the proximal end of the bypass gate of the proximal aortic stent graft, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine the appropriate location/placement of the main body of the distal aortic stent graft within the bypass gate of the proximal aortic stent graft, including having its proximal-most opening of its proximal end terminate distal the proximal-most opening of the proximal end of the bypass gate, in order to create a tight fit to allow blood to perfuse through the main bodies (it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for or criticality to the parameter of the proximal-most opening of the proximal end of the main body of the distal aortic stent graft terminating distal the proximal-most opening of the proximal end of the bypass gate, as opposed to terminating at any other location/having any other placement; in fact, this parameter wasn’t even mentioned in the originally filed specification, thereby iterating the parameter being a mere matter of normal design choice and not involving a novel, inventive step); but Kelly does not specifically disclose the distal aortic stent graft having the structural features as claimed.
However, Bruszewski discloses a distal aortic stent graft (100), in the same field of endeavor, including a main body (102) having a proximal end (106) and a distal end (108), the main body (102) defining a peripheral opening, the proximal end defining a proximal opening, and the distal end defining a distal opening, and a coupling (120) extending radially from the main body (102) and corresponding to the peripheral opening, wherein the coupling (120) has a frustoconical shape, including a base (124) and a top (126), such that a circumference of the base (124) is greater than a circumference of the top (126), and wherein the coupling is configured to align with a blood vessel and perfuse blood through the coupling when the coupling is in the deployed state , illustrated in Figures 1 and 2 ([0032] & [0033]).
In view of the teachings of Bruszewski, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the main body, of the distal aortic stent graft of the modular stent device of Kelly, to have a peripheral opening, and a coupling extending radially from the main body and corresponding to the peripheral opening, wherein the coupling has a frustoconical shape, including a base and a top, such that a circumference of the base is greater than a circumference of the top, and the coupling is configured to align with a blood vessel and perfuse blood through the coupling when the coupling is in the deployed state, as taught by Bruszewski, in order to create an effective modular stent device based on patient need.
Regarding claims 21 and 24, Kelly in view of Bruszewski disclose the modular stent device of claim 1, wherein Bruszewski further teaches the main body (102) of the distal aortic stent graft (100) includes two circumferential stents (104/112) completely proximal the coupling (120) and completely inward the proximal end of the main body, illustrated in Figure 2 (to clarify, the proximal end of the main body is considered to be the proximal most end of the proximal most stent that creates the stent graft).
Regarding claims 22 and 23, Kelly in view of Bruszewski disclose the modular stent device of claim 1, wherein Bruszewski further teaches the coupling (120) includes a base portion (124) having a base portion stent (702), and a top portion (126) having a top portion stent (622), illustrated in Figure 7 (Bruszewski: [0039] & [0040]).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 14-16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 10, 11 and 13 of U.S. Patent No. 10,702,369; claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 5 of U.S. Patent No. 11,116,650; claims 1, 14-16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7 and 12 of U.S. Patent No. 11,534,285; and claims 1, 3, 4, 14-16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 and 18 of U.S. Patent No. 11,751,988. Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims disclose a modular stent graft device/prosthetic assembly and/or a deployment method of said modular stent graft device/prosthetic assembly comprising a proximal aortic stent graft including a main body having proximal and distal ends; a bypass gate extending distally from the main body and defining proximal and distal ends, wherein the distal end defines a distal opening; and an artery leg extending distally from the main body and defining proximal and distal ends; and a distal aortic stent graft including a main body having a proximal end, defining a proximal opening, a distal end, defining a distal opening and defining a peripheral opening; the proximal end of the distal aortic stent graft deployed through, and within, the distal opening, and end, of the bypass gate to perfuse blood through the main bodies of the proximal and distal aortic stent grafts; and a coupling extending radially from the main body and corresponding to the peripheral opening, the coupling is configured to align with a blood vessel and perfuse blood through the coupling when the coupling is in the deployed state; and though the claims of the above mentioned U.S. Patent Nos. do not specifically disclose a proximal-most opening of the proximal end of the main body of the distal aortic stent graft terminates distal a proximal-most opening of the proximal end of the bypass gate of the proximal aortic stent graft and/or the distal end of the main body of the distal aortic stent graft assembly having a diameter corresponding to an aortic diameter in which it is deployed, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate sizes and/or overlapping regions/lengths, such that a proximal-most opening of the main body of the distal aortic stent graft terminates distal a proximal-most opening of the bypass gate and/or the distal end of the main body of the distal aortic stent graft assembly having a diameter corresponding to an aortic diameter in which it is deployed, since doing so amounts to a mere change in size/shape/form which is generally recognized as being within the level of ordinary skill in the art.
Response to Arguments
Applicant’s arguments with respect to independent claims 1 and 14 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Perkins and Kelly, in addition to the prior art of Bruszewski; rejecting independent claim 1, and those claims that depend from it, as being unpatentable over Kelly in view of Bruszewski, and rejecting independent claim 14, and those claims that depend from it, as being unpatentable over Perkins.
Applicant's arguments filed 09/19/2025, regarding independent claim 7, have been fully considered but they are not persuasive. Applicant argues the prior art of Varga does not teach the newly added parameter of the bridging stent graft continuously extending between its distal and proximal ends; Examiner respectfully disagrees with Applicant’s assertion. In response to the newly added parameter, the device of Varga has been interpreted in a different way such that leg (201), of the proximal aortic stent graft (200), is the artery leg (201) and the stent graft (600) is the bridging stent graft (600); the bridging stent graft (600) being deployed through, and within, the distal opening (ADE) of the artery leg (201), and the bridging stent graft (600) continuously extending between its proximal end (BPE) and distal end (BDE), as illustrated in Figure 2 and modified figure 2, above. Therefore, the rejection of independent claim 7 as being unpatentable over the prior art of Varga is deemed to be proper, since all the structural limitations set forth in the claim are taught; thus, the rejection stands.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774