DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments filed 01/06/2026, with respect to the rejections of independent claim 1 under 35 U.S.C. § 112(a) and independent claim 16 under 35 U.S.C. § 102, have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration new grounds of rejection(s) is made.
Status of Claims
Claims 1-4, 6-13 and 15-20 are presently pending in this application, and currently examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the device comprising first and second elongated segments positioned longitudinally displaced such that first ends of the first and second elongated segments are longitudinally displaced from one another, and one of the first or second elongated segments includes a connector comprising a section of a biocompatible material extending beyond an end of the one of the first or second elongated segments, the connector having a connector length such that the connector is configured to be received within a corresponding primary lumen of the other of the first or second elongated segments (claim 1), the device comprising first and second elongated segments positioned longitudinally displaced such that first ends of the first and second elongated segments are longitudinally displaced from one another, and one of the first or second elongated segments includes a connector comprising a section of a biocompatible material extending beyond an end of the one of the first or second elongated segments, the connector having a connector length such that the connector is configured to be received within a corresponding primary lumen of the other of the first or second elongated segments; wherein the connector is configured to maintain at least a portion of an outer surface of one of the first or second elongated segments in proximity to an adjacent peripheral surface (claim 13), the device comprising first and second elongated segments positioned longitudinally displaced such that first ends of the first and second elongated segments are longitudinally displaced from one another, and one of the first or second elongated segments includes a connector comprising a section of a biocompatible material extending beyond an end of the one of the first or second elongated segments, the connector having a connector length such that the connector is configured to be received within a corresponding primary lumen of the other of the first or second elongated segments; wherein the connector is configured to maintain at least a portion of an outer surface of one of the first or second elongated segments in proximity to an adjacent peripheral surface, which comprises a surface at an end of one of the first or second elongated segments (claim 15), and the implantable endovascular system comprising first and second elongated segments implanted in a longitudinally displaced configuration from one another such that the first end of the first elongated segment is longitudinally offset from the first end of the second elongated segment, and the first and second elongated segments are connected with an articulating flange segment, coupled to one of the first or second elongated segments, configured to articulate by deforming with respect to one of the first or second elongated segments (claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Examiner’s Notes
It is to be noted that in device/apparatus claims 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 § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-13, 15, 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cragg et al. (US PG Pub. 2011/0130824), as previously disclosed, hereinafter Cragg, in view of Mead (US PG Pub. 2005/0177222) and Laguna (US PG Pub. 2005/0273162), as previously disclosed.
Regarding claims 1, 4, 6, 12, 13 and 15, Cragg discloses a device (1300), illustrated in Figures 1A, 1B and 13C, comprising a first elongated segment (102a & 1362a) having two opposing ends including a first end and a second end, the first elongated segment defining a first primary lumen (116) extending between the first end and the second end and comprising a first subsegment (102a) and a second subsegment (1362a), the first and second subsegments being separately insertable into a body lumen and joinable together during subsequent deployment in the body lumen; a second elongated segment (102b & 1362b) having two opposing ends including a first end and a second end, the second elongated segment defining a second primary lumen (116) extending between the first end and the second end and comprising a first subsegment (102a) and a second subsegment (1362b), the first and second subsegments being separately insertable into the body lumen and joinable together during subsequent deployment to form a seal in the body lumen, illustrated in Figures 13B and 13C ([0097]), a combined cross section of the first and second elongated segments (at portion 108) being substantially conformable to an intraluminal cross section of the body lumen/aortic neck (60), and the first and second elongated segments (102a & 102b) can be positioned and implanted in a longitudinally displaced configuration such that the first ends (118) of the first and second elongated segments are longitudinally displaced from one another and the respective second ends (1304) of the first and second elongated segments can be displaced from each other within the body lumen, illustrated in Figure 13C ([0039], Last 5 Lines & [0102]); and the first and second elongated segments having a side opening/fenestration (1038) in one of the first and/or second subsegments for access to left/right renal and/or iliac arteries, example illustrated in Figure 10B ([0093]); but does not specifically disclose a first branch segment inserted through the first side opening, having a first branch lumen in fluid communication with the first primary lumen, wherein the first branch segment is elastically deformable to provide an undeployed device diameter suitable for insertion into the body lumen, and a connector comprising a section of biocompatible material extending beyond an end of the first or second elongated segment, having a length configure to be received within the primary lumen of the other of the first or second elongated segment.
However, Mead teaches a device, in the same field of endeavor, comprising a connector (52) comprising a section of biocompatible material extending beyond an end of a first elongated segment/stent-graft, and having a length such that the connector (52) is configure to be received within the primary lumen of a second elongated segment/stent-graft, illustrated in Figure 2A; the connector retains the first and second elongated segments/stent-grafts within a minimum distance of each other (Mead: [0007] & [0035], Lines 1-5). Furthermore, Laguna teaches a device, in the same field of endeavor, comprising at least one elongated segment (104/204), having a side opening/fenestration (204), and an elastically deformable first branch segment (106), having an undeployed device diameter suitable for insertion into a body lumen, wherein the first branch segment (106) is inserted through the first side opening/fenestration (204), and has a first branch lumen in fluid communication with a lumen of the elongated segment (104/204), illustrated in Figures 1-3 (Laguna: [0043] – [0045]); the first branch segment reduces the chance of blockage/stenosis in a side branch artery due to redistribution/movement of plaque (Laguna: [0010] & [0135], Last 5 Lines).
In view of the teachings of Mead and Laguna, it would have been obvious to one having ordinary skill in the art at the time of the invention for the device of Cragg to further include a connector comprising a section of biocompatible material extending beyond an end of the first or second elongated segment, having a length configure to be received within the primary lumen of the other of the first or second elongated segment, such that at least a portion of an outer surface of the first or second elongated segment is maintained adjacent a peripheral surface at an end of the first or second elongated segment such that fluid flow into an area between the outer surface and the adjacent peripheral surface is reduced, in order to connect and retain the first and second elongated segments within a minimum distance of each other, as taught by Mead (it is to be noted that Cragg teaches the first and second elongated segments being deployed side-by-side and connected/sealed such that an outer surface of the first/second elongated segment is maintained adjacent a peripheral surface at an end of the first/second elongated segment thereby reducing/preventing fluid flow into an area between the outer surface and the adjacent peripheral surface; and Mead teaches the use of a connector to connect/retain two elongated segments/stent-grafts together within a minimum distance of each other). And it would further would have been obvious to one having ordinary skill in the art at the time of the invention for the device of Cragg to also include an elastically deformable first branch segment, inserted through the first side opening/fenestration in the first and/or second subsegments of the first elongated segment, and having a first branch lumen in fluid communication with the first primary lumen, in order to access left/right renal and/or iliac arteries, while reducing the chance of blockage/stenosis in the renal or iliac arteries due to redistribution/movement of plaque, as taught by Laguna and Cragg.
Regarding claim 2, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Cragg further teaches a separate cross section (of portion 1362) of at least one of the first and/or second elongated segment substantially conforms to another elongated segment in the body lumen (56), illustrated in Figure 13C.
Regarding claim 3, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Laguna further teaches an anchoring structure (112) defines the first branch segment (106), wherein the anchoring structure (112) is configured to anchor the device within the body lumen (110), illustrated in Figure 1.
Regarding claims 7-10, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Cragg further teaches a plurality/second, third, fourth side openings/fenestrations (1038) in the first and/or second subsegments of the first and/or second elongated segments for access to left/right renal and/or iliac arteries (Cragg: [0093]), and Laguna further teaches a plurality/second, third, fourth branch segments, having lumen in fluid communication with the primary lumen, attached to side openings/fenestrations; the branch segments reducing the chance of blockage/stenosis in side branch arteries due to redistribution/movement of plaque (Laguna: [0010]; [0033]; [0034]; [0043] & [0135], Last 5 Lines). Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention for the device of Cragg in view of Mead and Laguna to include second, third and fourth branch segments, having second, third and fourth branch lumen, respectively, in fluid communication with the first or second primary lumen, attached to the second, third and fourth side openings/fenestrations in the first and/or second subsegments of the first and/or second elongated segments, for access to left/right renal and/or iliac arteries while reducing the chance of blockage/stenosis in the renal and iliac arteries due to redistribution/movement of plaque, as taught by Cragg and Laguna.
Regarding claim 11, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Cragg further teaches the device comprises ePTFE (Cragg: [0066]).
Regarding claim 19, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Cragg further teaches the first and second elongated segments have different cross-sectional shapes from one another/are asymmetrical (Cragg: [0035], Lines 11-20).
Regarding claim 20, Cragg in view of Mead and Laguna disclose the device of claim 1, wherein Laguna further teaches the first branch segment (106) is permanently integrated with the first/second subsegments (Laguna: [0109] – to clarify, it is stated first branch segment is secured, i.e. by bonding, soldering, suturing, adhesives etc., to the main member; thus teaching permanent integration).
Claims 16-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cragg in view of Mead and Laguna.
Regarding claims 16 and 18, Cragg discloses an implantable endovascular system (1300), illustrated in Figure 13C, comprising a first elongated segment (102a & 1362a) having a first end and a second end opposite the first end, the first elongated segment defining a first primary lumen (116) extending between the first and second ends, and the first elongated segment comprising a first subsegment (102a) and a second subsegment (1362a), the first and second subsegments of the first elongated segment being separately insertable into a body lumen and joinable together during subsequent deployment in the body lumen, illustrated in Figures 13B and 13C; and a second elongated segment (102b & 1362b) having a first end and a second end opposite the first end, the second elongated segment defining a second primary lumen (116) extending between the first and second ends, and the second elongated segment comprising a first subsegment (102b) and a second subsegment (1362b), the first and second subsegments of the second elongated segment being separately insertable into the body lumen, illustrated in Figures 1A, 1B, 13B and 13C ([0097]), wherein the first and second elongated segments are implantable laterally adjacent with one another such that cross sections of the first and second elongated segments (at portion 108) are configured to be positioned adjacent to one another to form a combined cross-section that is substantially conformable to an intraluminal cross section of the body lumen/aortic neck (60), wherein the second subsegments (1362a & 1362b) of the first and second elongated segments are each configured to be positioned independently relative to each other; wherein the first and second elongate segments are implantable in a longitudinally displaced configuration from one another such that the first ends (118) of the first and second elongated segments are longitudinally offset from one another, illustrated in Figure 13C ([0039], Last 5 Lines & [0102]); and the first and second elongated segments are connected together subsequent to deployment in the body lumen, illustrated in Figure 1B ([0034], Lines 5-7; [0036], Lines 1-3 & [0040]); but doesn’t specifically teach the first and second elongated segments are connected with an articulating flange segment configured to articulate by deforming with respect to one of the first or second elongated segment.
However, Laguna teaches an implantable endovascular system, in the same field of endeavor, wherein a first elongated segment (104) and a second elongated segment (106) are connected with an articulating flange segment (304) coupled to the second elongated segment (106) configured to articulate by deforming with respect to the second elongated segment (106), illustrated in Figures 1-3 ([0050] & [0106]).
In view of the teachings of Laguna, it would have been obvious, and well within the capability of one having ordinary skill in the art at the time of the invention to determine an appropriate way to connect the first and second elongated segments, of the implantable endovascular system of Cragg, including with an articulating flange segment coupled to one of the first or second elongated segments configured to articulate by deforming with respect to one of the first or second elongated segment, as taught by Laguna; since both references teach art equivalent means for connecting two elongated segments of an implantable endovascular system. Furthermore, it is to be noted that neither the claims, nor the originally field specification, gave any reason/benefit for, or criticality to the parameter of the first and second elongated segments being connected with an articulating flange, as opposed to being connected in any other way/form.
Regarding claim 17, Cragg in view of Laguna disclose the system of claim 16, wherein Cragg further teaches a first side opening/fenestration (1038) in one of the first and/or second subsegments of the first elongated segment for access to left/right renal and/or iliac arteries (Cragg:[0093]); and Laguna teaches at least one elongated segment (104) and a first branch segment (106) engaged to a side opening/fenestration (204) in the at least one elongated segment (104), the first branch segment (106) having a branch lumen in fluid communication with a primary lumen of the elongated segment (104), illustrated in Figures 1-3 (Laguna: [0043] – [0045]); the first branch segment reduces the chance of blockage/stenosis in a side branch artery due to redistribution/movement of plaque (Laguna: [0010] & [0135], Last 5 Lines). Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention to further include a first branch segment, having a first branch lumen in fluid communication with the first primary lumen, engaged to the first side opening/fenestration in the first and/or second subsegments of the first elongated segment, in order to access left/right renal and/or iliac arteries while reducing the chance of blockage/stenosis in the side branch artery due to redistribution/movement of plaque, as taught by Cragg and Laguna.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 10,987,234, hereinafter ‘234 in view of Cragg. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a device comprising first and second elongated segments, each having first and second opposing ends with first and second primary lumen, respectively, extending therebetween; wherein a combined cross section of the first and second elongated segments are substantially conformable to an intraluminal cross section of the body lumen; wherein the first and second elongated segments can be positioned and implanted in a longitudinally displaced configuration such that the first end of the first elongated segment is longitudinally displaced from the first end of the second elongated segment; a first branch segment engaged to a first side opening in one of the first and second subsegments of the first elongated segment, the first branch segment having a first branch lumen in fluid communication with the first primary lumen; and wherein one of the first or second elongated segments includes a connector comprising a section of a covering material extending beyond an end of the one of the first elongated segment and the second elongated segment, the connector configured to be received within a corresponding primary lumen of the other of the first or second elongated segment, the corresponding primary lumen being one of the first or second primary lumen; but '234 does not specifically disclose the first and second elongated segments each comprising first and second subsegments, the first and second subsegments being separately insertable and joinable together in the body lumen. However, Cragg teaches a device, in the same field of endeavor, which comprises first and second elongated segments (102a/b & 1362a/b) each comprising a first subsegment (108) and a second subsegment (1362a/b), the first and second subsegments being separately insertable and joinable together in the body lumen, illustrated in Figure 13B and 13C, in order to form a modular device which can reach branched portions/arteries ({0097]). Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention for each of the first and second elongated segments, of the device of 234, to further comprise first and second subsegments which are separately insertable and joinable together in the body lumen, in order to from a modular device which can reach branched portions/arteries, as taught by Cragg.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 03/24/2026