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 § 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) 1, 9, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. 2020/0352699.
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Noting figures 2, 11-13, Guo et al. discloses an aortic repair system for treating an aortic arch of a patient, the aortic repair system comprising: a base member (10), comprising: a main body (100) having a first end portion and a second end portion (this is interpreted to be the top/bottom of the tube or e.g. proximal and distal ends), wherein the main body defines a fluid conduit, and wherein the first end portion defines a first fluid opening;
a septum (see e.g. element 182) extending through the main body from the second end portion of the main body toward the first end portion of the main body, wherein the septum divides the fluid conduit into a primary lumen (see fig. 12-13 where 182 separates 1401 from 130) having a first cross-sectional area and a secondary lumen having a second cross-sectional area less than the first cross-sectional area (see figures 12-13 supa), and wherein the second end portion of the main body defines a second fluid opening for the primary lumen; and a leg (e.g. 600) extending form the second end portion of the main body, wherein the leg defines a leg lumen fluidly coupled to the secondary lumen, and wherein the leg has an end portion defining a third fluid opening for the secondary lumen;
a spanning member (500 see figure 10c) configured to be coupled to the second end portion of the main body, the spanning member (500) defining a spanning member lumen configured to be fluidly coupled to the primary lumen via the second fluid opening, wherein the spanning member includes a fenestration region ( window 550) sized and shaped to align with at least one branching vessel from the aortic arch, and wherein the fenestration region is configured to be pierced to form a fenestration in the spanning member to perfuse the at least one branching vessel (this is functional language see MPEP 2114). It is obvious to one having ordinary skill in the art to have the septum “extends through” the main body because Guo et al. states that the “septum” 182 “traverses” the structure (see [0083]).
Regarding claims 9-12, Guo et al. teaches that the spanning member 500 is a stent-graft which comprises struts/support frame (e.g. 110). However, does not specify that “..the stent structure includes a mobile stent portion configured to move independent from adjacent portions of the stent structure and independent from the graft material, and wherein the mobile stent portion at least partially defines the fenestration region.” This is functional language. As evidenced by Berra et al. 2007/0208410 a stent may be made of materials such as nitinol which is an expandable material capable of moving independently of the graft which is made of a material ([0039-0040). Thus, it would be obvious to modify the device of Guo et al. and utilize a metallic stent in conjunction with a polymer graft which is capable of moving independently of the stent in order to treat the vascular abnormality by the placement of stent-graft to bypass an abnormality, and to seal the abnormality off from access to any fluids passing through the vasculature at the location of the abnormality.
Regarding claims 16-17 Guo et al. discloses a branch perfusion member including a proximal region and a distal region, wherein the proximal region is configured to couple to the spanning member at the fenestration region, and wherein the distal region is configured to extend radially outward from the spanning member toward the at least one branching vessel (see fig. 19 below and branch 600 and [0105]
)
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Claim(s) 2-4, are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. 2020/0352699 in view of Chuter 2005/0010277.
Regarding claims 2 and 4, these limitations are considered to be functional language and describe the manner of implantation and do not recite additional structural features. See MPEP 2114. Nevertheless Guo et al. states that the device has an aortic arch [00987] and [0036] states that “…the device is particularly suitable for intraluminal treatment of Stanford A-type dissection or aortic arch aneurysm..” therefore it is obvious that the implant may be manipulated and positioned as claimed. Chuter teaches that stent grafts may be deployed such that The distal stent-graft branch
corresponds to the left subclavian artery, the middle stent-graft branch corresponds to the left carotid artery and the proximal stent-graft branch corresponds to the innominate (brachiocephalic) artery (see [0023]). It would be obvious to modify the device of Guo et al. and utilized the claim techniques in order to treat or repairing complex vasculature while minimizing risk and the recovery time of the patient.
Claim(s) 19-21, 28-32, 37-39, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. 2020/0352699 in view of Shalev 8945203.
Regarding claim 19-21 and described supra, Guo et al. discloses an aortic repair device which 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, and wherein the first fluid opening of the main body is fluidly coupled to the primary lumen to receive the first portion of the blood flow therethrough.
However, Guo et al. does not specify the method of implantation the device as claimed e.g.
“the main body sealingly contacts a wall of the thoracic aorta”; positioning at least a portion of a leg of the aortic repair device within a first branch vessel branching from the thoracic aorta such that a third fluid opening of the leg is positioned within the first branch vessel to discharge a second portion of the blood flow into the first branch vessel, wherein the third fluid opening is fluidly coupled to the secondary lumen to receive the second portion of the blood flow therethrough; and positioning at least a portion of a spanning member of the aortic repair device within a portion of the primary lumen of the main body, wherein the spanning member includes a fenestration region configured to align with a second branch vessel branching from the thoracic aorta, and wherein the fenestration region is configured to be pierced to form a fenestration in the spanning member to perfuse the second branch vessel.
Shalev teaches a multi component stent graft system for implantation into thoracic arch of a patient (see figure 2) and teaches contacting a wall of the thoracic aorta; positioning at least a portion of a leg of the aortic repair device within a first branch vessel branching from the thoracic aorta such that a third fluid opening of the leg is positioned within the first branch vessel to discharge a second portion of the blood flow into the first branch vessel, wherein the third fluid opening is fluidly coupled to the secondary lumen to receive the second portion of the blood flow therethrough; and positioning at least a portion of a spanning member of the aortic repair device within a portion of the primary lumen of the main body, wherein the spanning member includes a fenestration region configured to align with a second branch vessel branching from the thoracic aorta, and wherein the fenestration region is configured to be pierced to form a fenestration in the spanning member to perfuse the second branch vessel (see figures 3e-3H and 6b-6h below; see paragraphs 37:50-67; 38:1-67; 39-40:).
Regarding claim 20 Guo et al. teaches forming a fenestration through the fenestration region; and positioning a branch perfusion member to (i) receive fluid from within the spanning member via the fenestration and (ii) discharge the received fluid into the second branch vessel (see fig. 20 and elements 600)
Regarding claim 21 see fig. 19 and window 550 (interpreted as the fenestration) and the branches positioned through 550.
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Guo et al. and utilize the methods as claimed in order to provide a multi-component stent graft capable of assuming radially expandable states and forming a blood impervious seal within the surrounding tissue upon full deployment.
Regarding claims 28-32 While Guo et al. does specifically state that “the main body 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 contact the wall of the thoracic aorta along substantially the entire length of the main body they do not state “that the main body sealingly contacts”.
Shalev teaches that stent grafts with branches that extend through a fenestration may deployed to sealingly contact the surrounding vessel (see abstract and see 2:25-38 which also disclose placement in the thoracic aorta). Shalev further teaches that the system is configured to be deployed in the thoracic aorta and in one or more of the branches of the aortic arch (the brachiocephalic artery, the left common carotid artery, and/or the left subclavian artery). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Guo et al. implant the main body to sealing contact the wall of the thoracic aorta in order to prevent blood flow from contacting outside of the flow path of the implant.
Regarding claims 37-39, Guo et al. discloses that a stent structure is paired with the spanning device (see e.g. figure element 110, 132 “support frame” and [00064] which is made of nickel-titanium) however the branches 600 are not supported the stent. Shalev et al. teaches that the branching members are stented as illustrated in figures 3E-3L. It is obvious that the spanning member has a stented support and it further would have been obvious to modify and provide an expandable stented structure to the secondary lumen in order to create further structure and support to the branched vessel.
Regarding claim 44-45, while Guo et al. does disclose that the implant may be positioning in the thoracic aortic dissection (see [0082]) Guo et al. does not specifically state that the implants main body is placed in an aortic aneurysm. Shalev teaches that stent grafts may be placed in patients suffering from a thoracic aortic aneurysm of an aortic arch (see 14:38-42). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Guo et al. and position the main body adjacent to an aortic aneurysm because Guo et al. states that the implant if for repair of the thoracic aorta (see e.g. [0082]).
Allowable Subject Matter
Claims 5-8, 13-15, 18, 22-27, 40-43 are 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.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 November 14, 2025