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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/3/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 6/17/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant's arguments, see page 10, alleging that Ivancev’s wall 52 is not a circumferential flange with superior and inferior openings and is not a single crown-shaped collar have been fully considered but they are not persuasive. Firstly, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “superior and inferior openings” and “a single crown-shaped collar”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Secondly, Ivancev expressly depicts a single large aperture defined by wall 52 having two side arm opening disposed therein (as shown in annotated Fig. 3 below). For at least these reasons, Applicant’s arguments are not persuasive.
PNG
media_image1.png
321
667
media_image1.png
Greyscale
Applicant's arguments, see page 10, alleging that Ivancev’s wall 52 is not mounted on a single aperture formed on the upper face of the arcuate central part of the main tubular endoprosthesis have been fully considered but they are not persuasive. Ivancev expressly depicts such a structural configuration, as shown in annotated Fig. 3 above. No “floor” is disposed within the aperture defined by wall 52, as undulating stent portions (without the use of ghost lines, as used for other covered components) are depicted with solid lines through the single large aperture defined by wall 52. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see page 10, alleging that Ivancev’s wall 52 is not configured to be housed at the base of the patient’s supra-aortic trunks have been fully considered but they are not persuasive. Ivancev expressly depicts (see exemplary Fig. 4) its upper guide wall 52 (and side arms disposed therein) positioned at the base of the patient’s supra-aortic trunks ([0026]; [0038]-[0039]). The disclosure of Ivansev appears to directly read on the intended use/functional language statement of claim 15. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see page 10, alleging that Ivancev fails to expressly disclose a second stent meshing around a flange and/or a first stent meshing projecting onto or attached to the flange have been fully considered and they are persuasive. It is the Examiner’s position, as set forth in the previous office action, that Ivancev failed to expressly disclose such features and a secondary reference to Marmur was used in making 103 rejections for those features. Applicant is direct toward the 103 rejections of the previous office action that are maintained herein. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see page 11, alleging that Ivancev cannot serve as a primary reference without impermissible hindsight have been fully considered but they are not persuasive. It is the Examiner’s position that impermissible hindsight arguments are conventionally used to argue that a secondary reference fails to provide proper motivation to be combined with a primary reference. Applicant appears to be somehow attempting to argue impermissible hindsight against a primary reference. Applicant’s argument are both vague and unclear. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 11-12, alleging that it would not be obvious to combine Marmur with Ivancev to modify the wall of Ivancev with the stent structure of Marmur have been fully considered but they are not persuasive. It is the Examiner’s position that Ivancev discloses a stent graft having an upper protrusion for placement at the base of a patient’s supra-aortic trunks, and Marmur teaches (see exemplary Fig. 6B) a similar stent graft for placement in the aortic arch ([0003]; [0006]; [0088]) having specific stent configurations on an upper protrusion for beneficially preventing fatigue-resistance of the upper protrusion and further still providing for an enhanced collapsible lower profile due to the non-overlapping specific stent structure of the upper protrusion (see Abstract; [0007]; [0080]). Therefore, Ivancev and Marmur both comprise highly similar aortic arch stent graft structures wherein Marmur further teaches specific lateral stent configurations for enhancing fatigue-resisatnce and further providing a lower profile for delivery. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 12-13, alleging that it would not be obvious to combine Perkins with Ivancev and Marmur have been fully considered any they are partially persuasive. It is the Examiner’s position (concerning claim 16), that the sinusoidal or zigzag circumvolutions taught by Perkins are not compatible/combinable with the stent structures of Marmur used in rejection for claim 15. Therefore the prior art rejection of claim 16 has been withdrawn. However, the subject matter of claims 22 and 24 (stent zones devoid of fabric and/or radiopaque markers) are well-known structural configurations as taught by Perkins. The prior art rejections of claims 22 and 24 are maintained. For at least these reasons, Applicant’s arguments are partially persuasive (i.e., persuasive as to claim 16, but not claims 22 and 24).
In response to applicant's argument (see pages 13-14) that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a flange specifically shaped to conform to the anatomical footprint of the suprs-aortic trunk origins” … “to match the asymmetric, noncircular, three vessel anatomical base of the TSA” … “flange specifically designed to conform simultaneously to the anatomical base of the three supra-aortic trunks”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is the Examiner’s suggestion that such functional language, if included within the claims, may help in properly distinguishing the prior art of record from the present invention.
Claim Rejections - 35 USC § 103
Claim(s) 15, 17-21, 23 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Ivancev et al. (US 2012/0197383) in view of Marmur et al. (US 2017/0273809).
Ivancev discloses (see embodiment of Fig. 3, and an exemplary deployment in Fig. 4) a stent graft with guide arrangement comprising the following claim limitations:
(claim 15) A fenestrated endoprosthesis (1, as show in Fig. 3) of the thoracic aorta ([0005]; see Fig. 4) comprising a first stent meshing (11), a main tubular endoprosthesis made of fabric (3), said main tubular endoprosthesis (3) being integral with said first stent meshing (11) (as shown in Fig. 3; [0027]), and having an arcuate central part (7) configured to be (i.e., capable of) housed in the aortic arch of a patient ([0005]; see Fig. 4), said arcuate central part (7) extending between a first end (5) configured to be (i.e., capable of) housed in a portion of the ascending aorta (60, Fig. 4) and a second end (9) configured to be (i.e., capable of) housed in a portion of the descending aorta (64, Fig. 4), wherein the fenestrated endoprosthesis (1) of the thoracic aorta further includes a flange (50, Fig. 3) also made of fabric ([0030]; graft fabric material disclosed) and associated with a second stent meshing (54, Fig. 3), said flange (50) provided with a base (i.e., at connection between flange wall 50 and tubular body 3), said base of the flange (50) being fitted over an aperture (i.e., wall 52 of flange 50 defines an aperture therein through the tubular body 3, as shown in Fig. 3) made on the upper face of the arcuate central part (7) of the main tubular endoprosthesis (3) (as shown in Fig. 3), said base (i.e., at connection between flange wall 50 and tubular body 3) of the flange (50) being attached to the main tubular endoprosthesis (3) at the aperture (as shown in annotated Fig. 3 below), said flange (50) being configured to be (i.e., capable of) housed at the base of the patient's supra-aortic trunks (as shown in exemplary Fig. 4), said flange (50) facing all the supra-aortic trunks and not engaging in any of the supra-aortic trunks (as shown in exemplary Fig. 4);
PNG
media_image1.png
321
667
media_image1.png
Greyscale
(claim 18) wherein the second stent meshing (54) further includes an elliptical mesh or a mesh defining the contour of a hyperbolic paraboloid surface (as shown in Fig. 3; [0036]), at the base of the flange (50), so as to maintain the aperture made on the upper face of the arcuate central part (7) of the main tubular endoprosthesis (3) (as expressly shown in Fig. 3);
(claim 19) wherein the first stent meshing (11) mainly consists of a plurality of disjointed meshes (as shown in Fig. 3; [0027]), each extending over the entire circumference of the main tubular endoprosthesis (3) in substantially sinusoidal or zigzag circumvolutions (as shown in Fig. 3), the radial force of said meshing making it possible to press the main tubular endoprosthesis (3) against the aortic wall and thus reduce the risk of endoleaks, and reinforce the anchoring of the endoprosthesis (1) (as shown in Figs. 3-4; [0027]; first stent portions are expressly self-expanding providing a radially outward expansion force);
(claim 23) wherein the stent meshings (11/54) are made of a shape memory alloy ([0018]; Nitinol expressly disclosed), and the fabric (3) covering the stent meshings (11/54) is selected from the list defined by braided polyesters, braided Dacron, or PTFE ([0002]; woven Dacron, polyester, and/or PTFE expressly disclosed); and
(claim 29) wherein the stent meshings (11/54) are made of a Nickel-Titanium alloy ([0018]; Nitinol expressly disclosed), and the fabric (3) covering the stent meshings (11/54) is selected from the list defined by braided polyesters, braided Dacron, or PTFE ([0002]; woven Dacron, polyester, and/or PTFE expressly disclosed).
Ivancev, as applied above, discloses a stent graft with guide arrangement comprising all the limitations of the claim except for the flange being substantially frustoconical in shape, wherein the second stent meshing mainly consists of a plurality of disjointed meshes radially offset from one another, extending over the entire circumference of the flange in substantially sinusoidal or zigzag circumvolutions, the radial force of said meshing making it possible to press the flange against the wall of the base of the supra-aortic trunks and thus reduce the risk of endoleaks, wherein the first stent meshing includes at least one mesh attached to the second stent meshing, so as to prevent plications of the main tubular endoprosthesis, wherein the first stent meshing includes at least one mesh attached to the mesh of the base of the flange, so as to prevent plications of the main tubular endoprosthesis, wherein the first meshing projects onto the flange, wherein the second meshing projects onto the main tubular endoprosthesis, and wherein a Nitinol reinforcement extends along the convex face of the arcuate central part of the main tubular endoprosthesis, and preferably over the entire length of said main tubular endoprosthesis.
However, Marmur teaches (see Figs. 4A-4B and 5B) a similar endovascular stent graft with a fatigue-resistant lateral tube comprising a flange (50) being substantially frustoconical in shape (as shown in Figs. 4A and 5B), wherein the second stent meshing (70/84) mainly consists of a plurality of disjointed meshes radially offset from one another, extending over the entire circumference of the flange in substantially sinusoidal or zigzag circumvolutions, the radial force of said meshing making it possible to press the flange against the wall of the base of the supra-aortic trunks and thus reduce the risk of endoleaks (as shown in Figs. 4A and 5B; see Abstract; [0016]; [0056]-[0057]; [0089]; two meshings 70/84 expressly depicted radially offset from each other about the circumference of the flange with sinusoidal portions 84 and composed from self-expanding material such as Nitinol), wherein the first stent meshing (88) includes at least one mesh attached to the second stent meshing (70/84), so as to prevent plications of the main tubular endoprosthesis (as shown in Figs. 4A and 5B, at junction 60), wherein the first stent meshing (88) includes at least one mesh attached to the mesh of the base (at 60) of the flange (50), so as to prevent plications of the main tubular endoprosthesis (as shown in Figs. 4A and 5B, at junction 60), wherein the first meshing (88) projects onto the flange (50) (as shown in Figs. 4A and 5B, overlap at junction 60), wherein the second meshing (70/84) projects onto the main tubular endoprosthesis (40) (as shown in Figs. 4A and 5B, overlap at junction 60), and wherein a Nitinol reinforcement (86, Fig. 4A) extends along the convex face (i.e., upper branch lumen side) of the arcuate central part (7) of the main tubular endoprosthesis (40) (as shown in Figs. 4A and 5B; [0062]-[0063]; Nitinol structural struts 86 expressly reinforce the proximal end 54 of the lateral tube 50) in order to beneficially increase fatigue-resistance of the lateral tube member of a fenestrated stent graft within an aortic arch and further allow for a lower profile in the compressed configuration due to strut linking members not overlapping (see Abstract; [0007]; [0080]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Ivancev to have the flange being substantially frustoconical in shape, wherein the second stent meshing mainly consists of a plurality of disjointed meshes radially offset from one another, extending over the entire circumference of the flange in substantially sinusoidal or zigzag circumvolutions, the radial force of said meshing making it possible to press the flange against the wall of the base of the supra-aortic trunks and thus reduce the risk of endoleaks, wherein the first stent meshing includes at least one mesh attached to the second stent meshing, so as to prevent plications of the main tubular endoprosthesis, wherein the first stent meshing includes at least one mesh attached to the mesh of the base of the flange, so as to prevent plications of the main tubular endoprosthesis, wherein the first meshing projects onto the flange, wherein the second meshing projects onto the main tubular endoprosthesis, and wherein a Nitinol reinforcement extends along the convex face of the arcuate central part of the main tubular endoprosthesis, and preferably over the entire length of said main tubular endoprosthesis in order to beneficially increase fatigue-resistance of the lateral tube member of a fenestrated stent graft within an aortic arch and further allow for a lower profile in the compressed configuration due to strut linking members not overlapping, as taught by Marmur.
Claim(s) 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ivancev in view of Marmur as applied to claim 15 above, and further in view of Perkins et al. (US 2018/0153677).
Ivancev in view of Marmur, as applied above, discloses a stent graft with guide arrangement comprising all the limitations of the claim except for wherein at least one of the ends of the main tubular endoprosthesis is an apparent meshing zone devoid of fabric; and the fenestrated endoprosthesis comprises radiopaque markers.
Regarding claim 22, Perkins teaches a similar prosthetic assembly wherein at least one of the ends (110A, Fig. 4) of the main tubular endoprosthesis (108, Fig. 4) is an apparent meshing zone devoid of fabric (as shown in Fig. 4; [0038]; open-web configuration depicted and disclosed) or having fabric ([0038]; closed-web configuration expressly disclosed and shown at 110B in Fig. 4). Accordingly, Perkins teaches that it is known that an endoprosthesis end devoid of fabric and an endoprosthesis end including fabric are elements that are functional equivalents for providing an endoprosthesis free end enhanced for anchoring and/or sealing the endoprosthesis to the vascular wall ([0038]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the meshing zone devoid of fabric taught by Perkins for the meshing zone having fabric of Ivancev because both elements were known equivalents for providing an endoprosthesis free end enhanced for anchoring and/or sealing the endoprosthesis to the vascular wall within the endoprosthetic art. The substitution would have resulted in the predictable results of providing an endoprosthesis free end enhanced for anchoring and/or sealing the endoprosthesis to the vascular wall to the device of Ivancev in view of Marmur.
Regarding claim 24, Perkins teaches a similar fenestrated endoprosthesis (102) comprising radiopaque markers ([0056]; radiopaque markers expressly disclosed) in order to beneficially provide for device visualization to verify device positioning during delivery and deployment ([0056]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the endoprosthesis of Ivancev in view of Marmur to have radiopaque markers in order to beneficially provide for device visualization to verify device positioning during delivery and deployment, as taught by Perkins.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ivancev in view of Marmur as applied to claim 15 above, and further in view of Sun et al. (US 2013/0218257).
Ivancev in view of Marmur, as applied above, discloses a stent graft with guide arrangement comprising all the limitations of the claim except for the fenestrated endoprosthesis comprising radiopaque markers disposed at the ends of the main tubular endoprosthesis and at the free end of the flange.
However, Sun teaches a similar aortic stent graft comprising a fenestrated endoprosthesis comprising radiopaque markers disposed at the ends of the main tubular endoprosthesis ([0085]; radiopaque markers at the ends of the overall stent graft expressly taught) and at the free end of the flange ([0060]; [0088]; radiopaque markers at the terminal/free end of flange 140 expressly taught) in order to beneficially assist a physician in locating the stent structures and aligning them with the desired vasculature during delivery and deployment at the treatment site ([0060]; [0085]; [0088]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Ivancev in view of Marmur to have the fenestrated endoprosthesis comprise radiopaque markers disposed at the ends of the main tubular endoprosthesis and at the free end of the flange in order to beneficially assist a physician in locating the stent structures and aligning them with the desired vasculature during delivery and deployment at the treatment site, as taught by Sun.
Allowable Subject Matter
Claims 16 and 31 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
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights