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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 05/11/2026. As directed by the amendment: claims 1 have been amended and claims 8 and 22-63 have been cancelled. Thus, claims 1-7, 9-21, and 64 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 05/11/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Sepetka et al (US 20080281350 A1), herein referenced to as “Sepetka” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “and a substantially flat portion at a proximal end, wherein the hub is not recessed relative to a plane defined by a proximal-most point of the permeable shell”.
The examiner agrees with the applicant that the prior art of record does not teach that the permeable shell is configured to assume a second restrained configuration comprising an open distal end and a substantially flat portion at a proximal end, wherein the hub is not recessed relative to a plane defined by a proximal-most point of the permeable shell.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sepetka in view of Villar et al (US 5935148 A).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 9-11, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al (US 20080281350 A1), herein referenced to as “Sepetka” in view of Villar et al (US 5935148 A), herein referenced to as “Villar”.
Claim 1
Sepetka discloses: A device implantable device (see Figs. 1A-1D, [0168]-[0169]) for treatment of a patient's cerebral aneurysm (see Figs. 1A-1D, [0168], seal the neck of an aneurysm), comprising: a permeable shell 45 (see Figs. 1A-1D, [0047], permeable to blood, and [0169]) made from a plurality of elongate filaments filaments (see [0144], braided with the matrix, hence the matrix is made of filaments that can be braided with radiopaque filaments), wherein each of the plurality of filaments filaments has a first end and a second end filaments have a first end and a second end, wherein the first end of each of the plurality of elongate filaments are gathered in a hub 30 (see Figs. 1A-1D, [0169], 45 is gathered around 30, as seen in Figs. 1A, C, and 1D, hence gathered in the hub, furthermore, the arms 40 are connected to 45, see [0127], and the arms are coupled to the hub, see [0089], hence at least a first end of each of the plurality of elongate filaments are gathered in a hub), wherein the permeable shell 45 has a first unrestrained preset configuration (see Fig. 1C, [0168] and [0172]) comprising a dome portion (see annotated Fig. 1C below) and a brim portion (see annotated Fig. 1C below), wherein the dome portion (see annotated Fig. 1C below) comprises an outer surface (see annotated Fig. 1C below), an inner surface (see annotated Fig. 1C below), and an inner cavity (see annotated Fig. 1C below) defined by the inner surface (see annotated Fig. 1C below), and wherein the hub 30 is located in the inner cavity (see annotated Fig. 1C below) in the first unrestrained preset configuration (Fig. 1C), and wherein the permeable shell 45 is configured to assume a second restrained configuration (see Fig. 1D, [0168]) when deployed in the patient's cerebral aneurysm aneurysm (see Fig. 1D), wherein the second restrained configuration (Fig. 1D) comprises an open distal end open distal end of 45 (see Fig. 1D) and a substantially flat portion (see annotated Fig. 1D below) at a proximal end the proximal end of the implant (see Fig. 1D).
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Sepetka does not explicitly disclose: wherein the hub is not recessed relative to a plane defined by a proximal-most point of the permeable shell.
However, Villar in a similar field of invention teaches a device 100/160 (see Figs. 1A-1B and 4) for treatment of a patient’s cerebral aneurysm (see Figs. 1A-1B and 4) with a permeable shell 104/168 (see Figs. 1A-1B and 4) with a hub 106/164 (see Figs. 1A-1B and 4) with a second restrained configuration (see Fig. 4). Villar further teaches: wherein in the second restrained configuration (see Fig. 4, as restrained by the aneurysm) the hub 164 is not recessed relative to a plane (see annotated Fig. 4 below, also col. 8, lines 21-24, 168 doesn’t have the detent, hence does not have a recessed joint/hub 164) defined by a proximal-most point (see annotated Fig. 4 below) of the permeable shell 168.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hub of Sepetka to incorporate the teachings of Villar and teach a device for treatment of a patient’s cerebral aneurysm with the hub is not recessed relative to a plane defined by a proximal-most point of the permeable shell. Motivation for such can be found in Villar as this hub is a electrolytically severable hub that is functionally flexible in their deployment, and allows for access to a core wire to be able to withdraw the device back into a delivery catheter is the device is somehow malplaced in the aneurysm (see col. 6, lines 3-7 and col. 8, lines 22-31, as can also be seen, in Fig. 4 the core wire 166 has easy access to 164 without any part of the permeable shell getting in the way).
Claim 2
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the first unrestrained preset configuration (see Fig. 1C) has a hat shape (see Fig. 1C, 45 takes on a hat like shape).
Claim 3
The combination of Sepetka and Villar teaches: The device of claim 2, see 103 rejection above. Sepetka further discloses: wherein the hat shape (see Fig. 1C) further comprises a lip portion (see annotated Fig. 1C below).
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Claim 4
The combination of Sepetka and Villar teaches: The device of claim 3, see 103 rejection above. Sepetka further discloses: wherein the lip portion (see annotated Fig. 1C below claim 3) extends at an acute angle (see annotated Fig. 1C below claim 3) from the brim portion (see annotated Fig. 1C below claim 3).
Claim 5
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the first unrestrained preset configuration (see Fig. 1C) has an umbrella shape (see Fig. 1C, 45 takes on an umbrella shape).
Claim 6
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the hub 30 is located at a distal end distal end of the implant (see Fig. 1C, in this configuration the hub is at the distal end of the device) of the first unrestrained preset configuration (see Fig. 1C).
Claim 7
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the second restrained configuration (see Fig. 1D) has a bowl shape (see Fig. 1D, the implant/45 has a bowl shape in this configuration).
Claim 9
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the second restrained configuration (see Fig. 1D) has a tulip shape (see Fig. 1D, the implant/45 has a tulip shape in this configuration due to the “petals” at 41).
Claim 10
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the second restrained configuration (see Fig. 1D) has a cup shape (see Fig. 1D, the implant/45 has a cup shape in this configuration).
Claim 11
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the hub 30 is located at a proximal end the proximal end of the implant (see Fig. 1D, the hub 30 is at the proximal end of the device) of the second restrained configuration (see Fig. 1D).
Claim 15
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein a distal end the distal end of 45 (see Fig. 1C) of the permeable shell 45 in the first unrestrained preset configuration (see Fig. 1C) is inverted the distal end of 45 is inverted as it is facing proximally rather than distally (see Fig. 1C).
Claim 16
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein a distal end the distal end of 45 (see Fig. 1C) of the permeable shell 45 in the first unrestrained preset configuration (see Fig. 1C) has an outer convex surface (see [0018], Fig. 1C, which is the first orientation, is described as a convex orientation, hence has an outer convex surface).
Claim 17
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein a distal the distal end of 45 (see Fig. 1C) of the permeable shell 45 in the second restrained configuration (see Fig. 1D) has an inner concave surface the inner concave surface of 45 facing distally (see Fig. 1D).
Claim 18
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. Sepetka further discloses: wherein the plurality of elongate filaments filaments are arranged in a braided mesh (see [0144], braided with the matrix, hence the matrix is made of filaments that can be braided with radiopaque filaments, hence a braided mesh).
Claim 19
The combination of Sepetka and Villar teaches: The device of claim 18, see 103 rejection above. Sepetka further discloses: wherein the permeable shell 45 comprises a single layer of the braided mesh (see Figs. 1A-1D, [0144], there is a single layer of braided mesh).
Claim(s) 12-14 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka in view of Villar as applied to claims 1 and 18 above, and further in view of Pereira et al (US 20200367894 A1), herein referenced to as “Pereira”.
Claim 12
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. The combination of Sepetka and Villar does not explicitly teach: wherein the first end and the second end of each of the plurality of elongate filaments are gathered in the hub.
However, Pereira in a similar field of invention teaches a device for treatment of a patient’s cerebral aneurysm 420 (see Fig. 1) with a hub 448 (see Fig. 1), and a plurality of elongate filaments 424 (see Fig. 1) with a first end 426 (see Fig. 1) and a second end 428 (see Fig. 1). Pereira further teaches: wherein the first end 426 and the second end 428 of each of the plurality of elongate filaments 424 are gathered in the hub 448 (see Fig. 1, [0029], the ends of the filaments that make up 424, have their ends gathered in the hub 448).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Pereira and teach a device for treatment of a patient’s cerebral aneurysm with the first end and the second end of each of the plurality of elongate filaments are gathered in a hub. Motivation for such can be found in Pereira as this allows access to the volume of the aneurysm to place additionally embolic devices (see [0027]), furthermore this creates a device without exposed edges that can potentially damage the aneurysm wall.
Claim 13
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. The combination of Sepetka and Villar does not explicitly teach: wherein each of the plurality of elongate filaments comprises a middle portion, and wherein the middle portion forms a loop at a distal end of the second restrained configuration.
However, Pereira in a similar field of invention teaches a device for treatment of a patient’s cerebral aneurysm 420 (see Fig. 1) in a second restrained configuration (see Fig. 1) with a hub 448 (see Fig. 1), and a plurality of elongate filaments 424 (see Fig. 1) with a first end 426 (see Fig. 1) and a second end 428 (see Fig. 1). Pereira further teaches: wherein each of the plurality of elongate filaments 424 comprises a middle portion 442 (see Fig. 1, [0029]), and wherein the middle portion 442 forms a loop 442 (see Fig. 1, [0029], forms an inversion fold/loop) at a distal end distal end of 420 (see Fig. 1) of the second restrained configuration (see Fig. 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Pereira and teach a device for treatment of a patient’s cerebral aneurysm with each of the plurality of elongate filaments comprises a middle portion, and wherein the middle portion forms a loop at a distal end of the second restrained configuration. Motivation for such can be found in Pereira as this allows access to the volume of the aneurysm to place additionally embolic devices (see [0027]), furthermore this creates a device without exposed edges that can potentially damage the aneurysm wall.
Claim 14
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. The combination of Sepetka and Villar does not explicitly teach: wherein each of the plurality of elongate filaments comprises a middle portion, and wherein the middle portion forms a loop at a proximal end of the first unrestrained preset configuration.
However, Pereira in a similar field of invention teaches a device for treatment of a patient’s cerebral aneurysm 420 (see Fig. 1) in a second restrained configuration (see Fig. 1) with a hub 448 (see Fig. 1), and a plurality of elongate filaments 424 (see Fig. 1) with a first end 426 (see Fig. 1) and a second end 428 (see Fig. 1). Pereira further teaches: wherein each of the plurality of elongate filaments 424 comprises a middle portion 442 (see Fig. 1, [0029]), and wherein the middle portion 442 forms a loop 442 (see Fig. 1, [0029], forms an inversion fold/loop).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Pereira and teach a device for treatment of a patient’s cerebral aneurysm with each of the plurality of elongate filaments comprises a middle portion, and wherein the middle portion forms a loop. Motivation for such can be found in Pereira as this allows access to the volume of the aneurysm to place additionally embolic devices (see [0027]), furthermore this creates a device without exposed edges that can potentially damage the aneurysm wall.
The combination of Sepetka and Pereira further teaches: the loop at a proximal end of the first unrestrained preset configuration (Sepetka is modified to have a loop of the filaments opposite from the ends where they are bundled in the hub, hence in the unrestrained present configuration (Fig. 1C), the loop would be at the proximal end of the device instead of the distal end when in the second restrained configuration (Fig. 1D)).
Claim 20
The combination of Sepetka and Villar teaches: The device of claim 18, see 103 rejection above. The combination of Sepetka and Villar does not explicitly disclose: wherein the permeable shell comprises a double layer of the braided mesh.
However, Pereira in a similar field of invention teaches a device for treatment of a patient’s cerebral aneurysm 420 (see Fig. 1) in a second restrained configuration (see Fig. 1) with a hub 448 (see Fig. 1), and a permeable shell 424 (see Fig. 1) with a braided mesh (see [0042], braised tubes). Pereira further teaches: wherein the permeable shell 424 comprises a double layer (see Fig. 1, [0029], has an inner layer, 444 and an outer layer 430, hence a double layer) of the braided mesh.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Pereira and teach a device for treatment of a patient’s cerebral aneurysm with the permeable shell comprises a double layer of the braided mesh. Motivation for such can be found in Pereira as this allows access to the volume of the aneurysm to place additionally embolic devices (see [0027]), furthermore this creates a device without exposed edges that can potentially damage the aneurysm wall.
Claim 21
The combination of Sepetka and Villar teaches: The device of claim 18, see 103 rejection above. The combination of Sepetka and Villar does not explicitly disclose: wherein the permeable shell comprises multiple layers of the braided mesh.
However, Pereira in a similar field of invention teaches a device for treatment of a patient’s cerebral aneurysm 420 (see Fig. 1) in a second restrained configuration (see Fig. 1) with a hub 448 (see Fig. 1), and a permeable shell 424 (see Fig. 1) with a braided mesh (see [0042], braised tubes). Pereira further teaches: wherein the permeable shell 424 comprises multiple layers (see Fig. 1, [0029], has an inner layer, 444 and an outer layer 430, hence has two layers, which is multiple layers) of the braided mesh.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Pereira and teach a device for treatment of a patient’s cerebral aneurysm with the permeable shell comprises multiple layers of the braided mesh. Motivation for such can be found in Pereira as this allows access to the volume of the aneurysm to place additionally embolic devices (see [0027]), furthermore this creates a device without exposed edges that can potentially damage the aneurysm wall.
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka in view of Villar as applied to claim 1 above, and further in view of Mu et al (US 20240268832 A1), herein referenced to as “Mu”.
Claim 64
The combination of Sepetka and Villar teaches: The device of claim 1, see 103 rejection above. The combination of Sepetka and Villar does not explicitly teach: wherein a distal end of the hub is located in the inner cavity in the first unrestrained preset configuration.
However, Mu in a similar field of invention teaches a device 1 (see Figs. 1-5) for treatment of a patient’s cerebral aneurysm (see Fig. 5) with a hub 2 (see Figs. 1-5) and a permeable shell 1 (see Figs. 1-5, [0031], metal wires) made from a plurality of elongate filaments ([0031], metal wires), wherein each of the plurality of filaments has a first gathered in the hub 2 (see [0032], bound into the developing mark) with a first unrestrained preset configuration (Fig. 4) with an inner cavity (see annotated Fig. 4 below) and a second unrestrained configuration (see Fig. 5). Mu further teaches: wherein a distal end (see annotated Fig. 4 below) of the hub 2 is located in the inner cavity (see annotated Fig. 4 below) in the first unrestrained preset configuration (see Fig. 4).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sepetka to incorporate the teachings of Mu and teach a device for treatment of a patient’s cerebral aneurysm with a distal end of the hub is located in the inner cavity in the first unrestrained preset configuration. Motivation for such can be found in Mu as this predisposes the hub to remain within neck of the aneurysm and prevent it from protruding out to the vascular lumen and inducing an embolism (see [0040]-[0041]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cox et al (US 20110022149 A1) teaches a device for aneurysm (see Fig. 33) with a flattened proximal end and a hub that is proximal of the proximal-most point of the permeable shell
Amplatz et al (US 20060247680 A1) teaches an occlusion device with a hub that proximal to a flattened proximal portion of the permeable shell
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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