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 .
Response to Arguments
Applicant’s arguments, see page 3 of remarks (pg 8 of response), filed 4/13/26, with respect to the rejection(s) of claim(s) 22-33,36-41 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teaching of Perkins to address the newly added limitation of the “leg being integral with or permanently coupled to the main body” which illustrates or discloses the feature.
Regarding Applicant’s request to reconsider the rejections of claims 24-39 for being indefinite, while not in total agreement with the arguments or finding the limitations to be very narrow claim language, the examiner withdraws these rejections. It is noted that these limitations are being considered very broad.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 22-33,36-41,73,74 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (2020/0306064) in view of Pinchuk (5855598). Perkins et al. show (Fig. 8) a method of repairing a thoracic aorta, the method comprising: intravascularly delivering an aortic repair device to a target site in the thoracic aorta 302; positioning a main body 102A 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. Perkins et al. also show (Fig. 8) positioning at least a portion of a leg 106A of the aortic repair device within a branch vessel LCC 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. It is also noted that Perkins shows (Fig. 8) the leg 106A being integral with the main body 102A. However, Perkins 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 Perkins et al. such that use of septum or seam one is able to easily direct the flow into branch structure. Thus per the modification the septum establishes the second 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. 8) that the main body 102A 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 302 along substantially the entire length of the main body. Regarding claims 24,38 Perkins et al. show (Fig. 8) the wall of the thoracic aorta is a wall of an ascending portion 302 of the thoracic aorta (paragraph 76), 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 Perkins shows multiple branches and Pinchuk teaches multiple branch stents or spanning members. With respect to claims 25,30 Perkins et al. show (Fig. 9) a branch vessel can be the brachiocephalic artery BCA with main body and integral branch is coupled with another main body and integral branch along the thoracic aorta. With respect to claims 26,29 Perkins et al. show (Fig. 10) a branch vessel that additionally can be accessed is the left subclavian artery LSA. With respect to claims 27,31 Perkins et al. show (Fig. 8) the branch vessel can be the left common carotid artery LCC. Regarding claims 28,39 it can be seen also in Fig. 8 that the wall of the thoracic aorta is a wall of a descending portion 302 of the thoracic aorta , wherein the leg extends 106A 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 Perkins shows multiple branches and Pinchuk teaches multiple branch stents or spanning members. With respect to claim 40, Perkins et al. did disclose (paragraph 75) 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 Perkins 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, Perkins et al. disclose (paragraph 75) 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 Perkins illustrates (Fig. 10) there can be branch stents 106B. However, Perkins 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 a branch stent to be expanded in a second lumen of a main body as taught by Pinchuk in the secondary lumen for the aortic repair device of Perkins in the method of deploying the apparatus in a thoracic 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 and also of note it is common knowledge in the art they are delivered compressed to easily pass through lumens of vessel to then deploy and be expanded. With respect to claim 33, Perkins shows (Fig. 10) 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 Perkins 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. With respect to claim 73, it can be seen (Fig. 9) that Perkins et al. disclose positioning a second main body 102 of the aortic repair device such that an exterior surface of the second main body sealingly contacts a wall of a descending portion of the thoracic aorta; positioning at least a portion of a second leg 106 of the aortic repair device within a second branch vessel branching BCA from the thoracic aorta, the second leg integral with or permanently coupled to the second main body. Fig. 11 of Perkins show positioning a spanning member 100B of the aortic repair device to span between the main body and the second main body, wherein: the second main body includes a fourth fluid opening positioned to receive blood flow from the spanning member and a fifth fluid opening positioned to discharge blood flow into the descending portion of the thoracic aorta; and the second leg includes a sixth fluid opening positioned within the second branch vessel to discharge blood flow into the branch vessel. With respect to claim 74, per the modification with Pinchuk it can be construed that the second main body can be modified to include a second septum extending at least partially between the fourth fluid opening and the fifth fluid opening of the second main body, the septum dividing the second main body into a second main body primary lumen and a second main body secondary lumen, wherein the spanning member is disposed within the primary lumen of the main body and the second main body primary lumen of the second main body.
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (2020/0306064) in view of Pinchuk (5855598) as applied to claim 32 above, and further in view of McDonald et al. (6090136). Perkins et al. in view of Pinchuk is explained supra. However, Perkins 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 Perkins et al. 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 Perkins et al. (2020/0306064) in view of Pinchuk (5855598) and McDonald et al. (6090136) as applied to claim 34 above, and further in view of Park (2007/0156229). Perkins et al. in view of Pinchuk and McDonald et al. is explained supra. However, Perkins 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 Perkins 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.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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