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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 10/22/25 is acknowledged. Claims 1-21, 42-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 28 is objected to because of the following informalities: the recitation of “the septum extends from the first fluid opening at least partially toward the first fluid opening” is grammatically incorrect because the terms extends from and toward are meaning two different things which is not making sense. It is either at the first opening or its not. Did applicant mean second for the 2nd recitation of a fluid opening? 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.
Claims 24-39 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. In claim 34, the recitation of “permitting a plurality of stents within the secondary lumen to self-expand” is ambiguous because it is not evident if the plurality forms a single stent structure or are these plurality of stents distinct and separately located? In claim 37, the recitation of “when the portion of the spanning member is positioned within the secondary lumen” is not understood because the claim recited the spanning member was positioned in the primary lumen. Thus how can the spanning member be in both lumens when they were defined to separated by the septum as recited in claim 22? Regarding claim 38, it is not evident if the spanning member is included with the leg or not because it is recited to also be inserted into the second fluid opening, thus are these two features are positioned at the same time or not? The term “proximate” in claims 24,28,38,39 is a relative term which renders the claim indefinite. The term “proximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The exact location of the leg cannot be discerned from the phrases “proximate to the second fluid opening” or “proximate to the first fluid opening” as it is not evident if these locations are in a location adjacent or circumferential or at a close distance along a length, etc. as the term “proximate” provides no distance or implies no range whatsoever, thus it is vague.
Dependent claims are ambiguous for depending on indefinite preceding claims.
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) 22-33,36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Ehnes et al. (2020/0170778) in view of Pinchuk (5855598). Ehnes et al. show (Fig. 10A) a method of repairing a thoracic aorta, the method comprising: intravascularly delivering an aortic repair device to a target site in the thoracic aorta 11; positioning a main body 1001 of the aortic repair device such that an exterior surface of the main body sealingly contacts a wall of the thoracic aorta, a first fluid opening of the main body is positioned to receive blood flow from the thoracic aorta, and a second fluid opening of the main body is positioned to discharge a first portion of the blood flow into the thoracic aorta. Ehnes also show (Fig. 10A) positioning at least a portion of a leg 1011 of the aortic repair device within a branch vessel 14 branching from the thoracic aorta such that a third fluid opening of the leg is positioned within the branch vessel to discharge a second portion of the blood flow into the branch vessel. However, Ehnes et al. did not disclose the aortic repair device comprises a septum extending at least partially between the first fluid opening and the second fluid opening of the main body, the septum dividing the main body into a primary lumen and a secondary lumen. Pinchuk teaches (Figs. 31,32) an aortic repair device with a septum 126c extending at least partially between the first fluid opening and the second fluid opening of the main body. It would have been obvious to one of ordinary skill in the art to incorporate a septum extending at least partially between the first fluid opening and the second fluid opening of the main body as taught by Pinchuk in the repair device of Ehnes et al. such that use of septum or seam one is able to easily direct the branch structure. Thus per the modification the septum establishes the first fluid opening of the main body to be fluidly coupled to the primary lumen to receive the first portion of the blood flow therethrough. In addition passing a branch through a secondary lumen establishes that a third fluid opening is fluidly coupled to the secondary lumen to receive the second portion of the blood flow therethrough. With respect to claim 23, it can be seen (fig. 10A) that the main body 1001 has a length extending between the first fluid opening and the second fluid opening, and wherein positioning the main body of the aortic repair device includes positioning the main body to sealingly contact the wall of the thoracic aorta 13 along substantially the entire length of the main body. Regarding claims 24,38 Ehnes et al. show (Fig. 10A) the wall of the thoracic aorta is a wall of an ascending portion 13 of the thoracic aorta, wherein the leg extends from the main body proximate to the second fluid opening, and wherein the septum extends from the second fluid opening at least partially toward the first fluid opening. It can be construed the spanning member or a branch stent as taught by Pinchuk would be inserted in the second fluid opening and in the primary lumen since Ehnes shows multiple branches and Pinchuk teaches multiple branch stents or spanning members. With respect to claims 25,30 Ehnes et al. show (Fig. 10A) the branch vessel can be the brachiocephalic artery 20. With respect to claims 26,29 Ehnes et al. show (Fig. 10A) the branch vessel can be the left subclavian artery 14. With respect to claims 27,31 Ehnes et al. show (Fig. 10A) the branch vessel can be the left common carotid artery 15. Regarding claims 28,39 it can be seen also in Fig. 10A that the wall of the thoracic aorta is a wall of a descending portion 11 of the thoracic aorta for section 1000, wherein the leg extends 1013 from the main body proximate to the first fluid opening, and wherein the septum extends from the first fluid opening at least partially toward the first fluid opening per the teaching of Pinchuk. It can be construed the spanning member or a branch stent as taught by Pinchuk would be inserted in the first fluid opening and in the primary lumen since Ehnes shows multiple branches and Pinchuk teaches multiple branch stents or spanning members. With respect to claim 40, Ehnes et al. did not disclose treatment of an aneurysm. However, Pinchuk teaches (col. 3, lines 31-34) the use of the endoluminal graft to be used in placement adjacent an aneurysm. It would have been obvious to one of ordinary skill in the art to position the aortic repair device adjacent an aneurysm as taught by Pinchuk in the method of treatment within an aorta by Ehnes et al. such that upon evaluation of a patient having an aneurysm, the surgeon can utilize the repair device and still supply blood to other vessels. Regarding claim 41, Ehnes et al. disclose (paragraph 127) that the positioning of the main body of the aortic repair device can be placed in a position to be adjacent an aortic dissection. With respect to claims 32, 36 it is noted that Ehnes discloses (paragraph 145) there can be branch stents. However, Ehnes did not explicitly disclose expanding stent structure in the secondary lumen. Pinchuk teaches (Fig. 29) that branch stents 115 are expanded within secondary lumens, col. 12, lines 39-42. It would have been obvious to one of ordinary skill in the art to utilize an anchor stent for the leg as taught by Pinchuk in the secondary lumen for the aortic repair device of Ehnes in the method of deploying the apparatus in aorta. Thus, in passing the branch stents in the secondary lumen via the teaching of Pinchuk these stents maintain a cross-section of the secondary lumen. With respect to claim 33, Ehnes discloses (paragraph 148) that the secondary lumen has branches which are tubular and thus per the modification with Pinchuk the stent structure is to be tubular. See also the tubular openings of the secondary lumens shown in fig. 30 of Pinchuk. With respect to claim 37 as best understood and note to Applicant that claims are given their broadest reasonable interpretation. In this instance it is not evident to the scope of the claim whether the spanning member remains in the primary lumen or secondary lumen or can have a portion extend from a primary or secondary lumen into a branch. Thus, it would have been obvious to one of ordinary skill in the art to use spanning members or in other known terminology in the art a stent or branch as taught by Pinchuk, see Fig. 29 showing spanning members or branch stents that are placed within a primary and secondary lumen. Note to Applicant the claims are broad and define no boundaries to these two lumens other than being separated by the septum recited in claim 22, which per the teaching of Pinchuk two lumens are created via the septum or in other terms known in the art a seam. Thus it could be construed that the multiple branches as seen by Ehnes and per the teaching of Pinchuk that a branch member can include a stent member or as considered by Applicant as spanning member would be passed in multiple lumens to deliver to the branches, thus the primary and secondary lumens can have a spanning member pass into the lumen and into a side branch.
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Ehnes et al. (2020/0170778) in view of Pinchuk (5855598) as applied to claim 32 above, and further in view of McDonald et al. (6090136). Ehnes et al. in view of Pinchuk is explained supra. However, Ehnes et al. as modified by Pinchuk did not disclose the stent structure permitting a plurality of stents within the secondary lumen to self-expand. McDonald et al. teach (Fig. 8) a plurality of stents 130 are delivered to a curved vessel such as use in the aorta, col. 8, lines 34-45. It would have been obvious to one of ordinary skill in the art to provide a plurality of stents within the secondary lumen to self-expand as taught by McDonald et al. in the method of treating an aorta by Ehnes as modified with Pinchuk such that it provides greater flexibility for positioning, see McDonald et al. col. 17, lines 51-64.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Ehnes et al. (2020/0170778) in view of Pinchuk (5855598) and McDonald et al. (6090136) as applied to claim 34 above, and further in view of Park (2007/0156229). Ehnes et al. in view of Pinchuk and McDonald et al. is explained supra. However, Ehnes et al. as modified by Pinchuk and McDonald et al. did not disclose the stent structure of the stents are generally D-shape. Park teaches (Figs. 1A, 1C) stents 10 for use in bifurcated or stent grafts having secondary lumens, paragraph 9. It would have been obvious to select stents with a D-shape as taught by Park in the method of treating an aorta by Ehnes et al. as modified with Pinchuk and McDonald et al. such that it provides greater stability in use due to the semicircular construction, see Park paragraph 24.
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 22-34,36-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19,28-40,42,44,45 of copending Application No. 18/202853 (reference application-PGPUB 20230380953). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims of current application are merely broader than claims of app. ‘853. Claim 22 has the same limitations of claim 19 of app. ‘853 and is broader for lacking additional recitations of claim 19. Narrower claims anticipate the broader, see In re Goodman. With respect to claim 23, see claim 28 of copending application ‘853. Regarding claim 24, see claim 29 of copending application ‘853. With respect to claims 25-27, see claims 30-32 respectively of copending application ‘853. Regarding claim 28, see claim 33 of copending application ‘853. With respect to claims 29-31, see claims 34-36 respectively of copending application ‘853. Regarding claim 32, see claim 37 of copending application ‘853. Regarding claim 33, see claim 38 of copending application ‘853. Regarding claims 34,36 see claim 39 of copending application ‘853 and also it is inherent that an expanded stent structure maintains a lumen. With respect to claim 37, see claims 19 and 37 of copending application ‘853.Regarding claim 38, see claim 40 of copending application ‘853. With respect to claim 39, see claim 42 of copending application ‘853. Regarding claim 40, see claim 44 of copending application ‘853. With respect to claim 41, see claim 45 of copending application ‘853.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799