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 Amendment
This office action is responsive to the amendment filed on 04/16/2026. As directed by the amendment: claims 23 and 29 have been amended and claims 1-22, 25, and 31 have been cancelled. Thus, claims 23-24, 26-30, and 32-34 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 04/16/2026, with respect to the rejection of claim 16 under 35 U.S.C. 102(a)(1) as being anticipated by Heisel et al (US 20140257374 A1), herein referenced to as “Heisel” have been fully considered and are persuasive.
The applicant’s cancellation of claim 16 and depending claims overcome the rejection of claim 16.
The 102(a)(1) rejections have been withdrawn.
Applicant’s arguments, see pages 5-6, filed 04/16/2026, with respect to the rejection(s) of claim(s) 23 and 29 under 35 U.S.C. 103 as being unpatentable over Nguyen et al (US 20210129275 A1), herein referenced to as “Nguyen” in view of Heisel et al (US 20140257374 A1), herein referenced to as “Heisel” have been fully considered and are persuasive.
The applicant amended claim 23 to further recite “the first region having a length that is at least a third of a length of the inner layer”.
The applicant amended claim 29 to further recite “and the inner surface of the inner layer having a first region and a second region extending from the first region, wherein the first region extends proximally from the opening and is concave towards the inner surface of the outer layer, the first region having a length that is at least a third of a length of the inner layer, and wherein the second region is convex towards the inner surface of the outer layer”.
The examiner agrees that Nguyen in view of Heisel does not explicitly teach: “the first region having a length that is at least a third of a length of the inner layer”.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nguyen in view of Zaidat et al (US 20230355243 A1) and Heisel.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-24, 26-30, and 32-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 23, the limitation “the first region having a length that is at least a third of a length of the inner layer” fails to comply with the written description requirement. The applicant asserts that there is support for this amendment as seen in Fig. 4 and [0138] of the published application, provided below for sake of clarity by the examiner.
“[0138] A neck cover in accordance with any of the embodiments disclosed herein can comprise a membrane configured to prevent or limit flow through the membrane and into an aneurysm. FIGS. 19-20B depict examples of such neck covers 2400, 2500. The neck cover 2400 shown in FIG. 19 can be similar to any of the neck covers disclosed herein, except as detailed below. The neck cover 2400 may comprise a mesh 2402 having a proximal portion 2400a configured to be positioned over a neck of the aneurysm and a distal portion 2400b configured to be positioned within a cavity of an aneurysm. In some embodiments, the neck cover 2400 comprises a proximal coupler (not depicted in FIG. 19). The mesh may be biased towards a predetermined shape when the mesh is in an expanded, unconstrained state. For example, as shown in FIG. 19, the neck cover 2400 can be substantially bowl shaped. The mesh can comprise a wall surrounding an interior region and comprising a first portion, a second portion, and a third portion such that the first portion and the second portion each extend between the third portion and the proximal coupler. The second portion can define a cavity of the neck cover 2400, which can be configured to receive an embolic composition therethrough.”
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The examiner respectfully disagrees that there is adequate written description support for this claim limitation.
Specifically, [0138] does not make any reference does the proportional length of the first region 430 (see Fig. 4) in relation to the inner layer 410 (see Fig. 4), including being “at least a third of a length of the inner layer”. Additionally, [0138] makes no reference to Fig. 4. The paragraphs that do reference Fig. 4, [0112]-[0116], make no reference to the length either. Finally, the applicant’s Figure. 4 cannot be relied upon for this claim limitation as noted in [0054] of the published application, reproduced below.
“[0054] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.”
The figures in the published application are not necessarily drawn to scale, hence in light of the specification being silent of any comparative length, the applicant does not have written description support for the claim “the first region having a length that is at least a third of a length of the inner layer”.
Claims 24 and 26-28 are rejected as being dependent on claim 23.
In claim 29 the limitation, the limitation “the first region having a length that is at least a third of a length of the inner layer” fails to comply with the written description requirement, for the same reasons as with claim 23 above.
Claims 30 and 32-34 are rejected as being dependent on claim 29.
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) 23-24, 26-27, 29-30, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al (US 20210129275 A1), herein referenced to as “Nguyen” in view of Zaidat et al (US 20230355243 A1) and Heisel et al (US 20140257374 A1), herein referenced to as “Heisel”.
Claim 23
Nguyen discloses: An occlusive device 1000 (see Figs. 10A-10C, [0285]) for treating an aneurysm (see [0210]), the device 1000 comprising: a mesh 1000 (see Figs. 10A-10C, [0285]) configured to be implanted in an aneurysm (see [0210]) and comprising a proximal end portion the proximal end of 1000 that is coupled via a proximal coupler (see Figs. 10B-10C, [0285]), a distal end portion 1010 (see Figs. 10B-10C, [0285]), and a longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end (see Figs. 10B-10C) extending therebetween, the mesh 1000 defining an opening 1008 (see Figs. 10A-10C, [0286]) at the distal end portion 1010 and outer 1000a (see Figs. 10A-10C, [0285]) and inner layers 1000b (see Figs. 10A-10C, [0285]) that are continuous (see Figs. 10B-10C, 1000a and 1000b are continuous distally at 1010) with one another distally at the distal end portion 1010 of the mesh and proximally (see [0288], the first and second ends of 1000 are secured at proximal coupler to form a double layer) at the proximal end portion the proximal end of 1000 that is coupled via a proximal coupler of the mesh via a securing means proximal coupler (see [0285] and [0288], meets the 112(f) interpretation of a mechanical restraint, as a proximal coupler is a mechanical restraint); wherein the mesh 1000 is configured to transition between a collapsed state (see [0288], low profile state) for delivery to an aneurysm (see [0210]) through an elongated shaft delivery catheter (see [0288]) and an expanded, unconstrained state (see Figs. 10A-10C, [0285]) wherein, in the expanded, unconstrained state (see Figs. 10B-10C): an inner surface (see annotated Figs. 10B-C below) of the outer layer 1000a and an inner surface (see annotated Figs. 10B-C below) of the inner layer 1000b are separated by a radial distance (see annotated Figs. 10B-C below) such that the inner surfaces (see annotated Figs. 10B-C below) of the outer 1000a and inner layers 1000b enclose a cavity (see annotated Figs. 10B-C below), the inner surface (see annotated Figs. 10B-C below) of the inner layer 1000b having a first region (see annotated Figs. 10B-C below) and a second region (see annotated Figs. 10B-C below) extending from the first region (see annotated Figs. 10B-C below), wherein the first region (see annotated Figs. 10B-C below) extends proximally from the opening 1008 and is concave towards the inner surface (see annotated Figs. 10B-C below)of the outer layer 1000a, and wherein the second region (see annotated Figs. 10B-C below) is convex towards the inner surface (see annotated Figs. 10B-C below) of the outer layer 1000a.
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Nguyen does not explicitly disclose: the first region having a length that is at least a third of a length of the inner layer and a membrane positioned between the outer and inner layers.
However, Zaidat in a similar field of invention teaches an occlusive device 700 (see Figs. 29-30) for treating an aneurysm with a mesh single, continuous dual layer mesh (see Figs. 29-30, [0071]) with an inner layer 738 (see Figs. 29-30), an outer layer 712 (see Figs. 29-30), the inner layer 738 having a first region 711 (see Fig. 29-30) which the inner surface of is concave (see annotated Fig. 30 below) towards the inner surface of the outer layer 712 and is proximal of the opening 734 (see Fig. 30) and a second region extending from the first region 711 that is convex towards the inner surface of the outer layer 712. Zaidat further teaches: the first region 711 (see Figs. 29-30, [0071]-[0072]) having a length (see Figs. 29-30, [0072]) that is at least a third of a length (see [0072], the 711 can be between 30% and 150% of the length of 720, the lengths of 711 + 720 equal the total length of 738, so as 711 is 50% of length of 720, it would be 33% or 1/3 the length of 711 + 720, or otherwise known as the length of 738, for example if the length of 720 is 1, 50% of which is 0.5, 0.5 + 1 equals 1.5, and 0.5/1.5 is 1/3) of the inner layer 738.
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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 first region of Nguyen to incorporate the teachings of Zaidat and teach an occlusion device with the first region having a length that is at least a third of a length of the inner layer. Motivation for such can be found in Zaidat, as the specific comparative length of 711 to the device serves as an internal support to reduce the compressibility of the outer layer and maintain the shape of a globular contour, even throughout long-term implantation within an aneurysm (see [0074]).
The combination of Nguyen and Zaidat does not explicitly teach: and a membrane positioned between the outer and inner layers.
However, Heisel in a similar field of invention teaches a device 2 (see Figs. 1-2) for occluding a bodily lumen (see [0002]) with an expandable mesh 20 + 22 with at least two layers 20 + 22. Heisel further teaches: a membrane 24 (see Figs. 1-2, [0025] and [0035]) positioned between two 20 + 22 of the at least two mesh layers 20 + 22.
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 Nguyen to incorporate the teachings of Heisel and teach a device for treating an aneurysm with a membrane positioned between two of the at least two mesh layers. Motivation for such can be found in Heisel as this membrane can provide an immediate and a long-term benefit, immediately it provides an occlusive benefit, for long-term occlusion it provides cell seeding and tissue growth such that device stability and closure is facilitated (see [0037]).
Claim 24
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 23, see 103 rejection above. Nguyen further discloses: wherein the mesh 1000 comprises a plurality of braided filaments 1002 (see Figs. 10A-10C, [0288]).
Claim 26
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 is fluid impermeable (see [0037], occlusive, hence prevents the passing of fluid).
Claim 27
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 has a plurality of perforations (see [0037], semi-nonporous, meaning will have some pores).
Claim 29
Nguyen discloses: An occlusive device 1000 (see Figs. 10A-10C, [0285]) for treating an aneurysm (see [0210]), the device 1000 comprising: a mesh 1000 (see Figs. 10A-10C, [0285]) configured to be implanted in an aneurysm (see [0210]) and having a proximal end portion the proximal end of 1000 that is coupled via a proximal coupler (see Figs. 10B-10C, [0285]), a distal end portion 1010 (see Figs. 10B-10C, [0285]), and a longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end (see Figs. 10B-10C) extending therebetween, the mesh 1000 further comprising an opening 1008 (see Figs. 10A-10C, [0286]) at the distal end portion 1010 and outer 1000a (see Figs. 10A-10C, [0285]) and inner layers 1000b (see Figs. 10A-10C, [0285]) that meet distally at the distal end portion 1010 of the mesh 1000 and proximally (see [0288], the first and second ends of 1000 are secured at proximal coupler to form a double layer) at the proximal end portion the proximal end of 1000 that is coupled via a proximal coupler of the mesh 1000 via a securing means proximal coupler (see [0285] and [0288], meets the 112(f) interpretation of a mechanical restraint, as a proximal coupler is a mechanical restraint), wherein the mesh 1000 comprises a collapsed state (see [0288], low profile state) for delivery through an elongated shaft delivery catheter (see [0288]) to the aneurysm and an expanded, unconstrained state (see Figs. 10A-10C, [0285]), and wherein, in the expanded, unconstrained state (see Figs. 10A-10C, [0285]): an inner surface (see annotated Figs. 10B-10C below) of the outer layer 1000a and an inner surface (see annotated Figs. 10B-10C below) of the inner layer 1000b are separated by a radial distance (see annotated Figs. 10B-10C below) such that the inner surfaces (see annotated Figs. 10B-10C below) of the outer 1000a and inner layers 1000b enclose a first cavity (see annotated Figs. 10B-10C below), and the outer layer 1000a defines a diameter (see annotated Figs. 10B-10C below) that increases then decreases along the longitudinal axis the longitudinal axis of 1000 that extends from the proximal end of the device to the distal end of the mesh 1000 between the proximal the proximal end of 1000 that is coupled via a proximal coupler and distal end portions 1010, and the inner surface (see annotated Figs. 10B-C below) of the inner layer 1000b having a first region (see annotated Figs. 10B-C below) and a second region (see annotated Figs. 10B-C below) extending from the first region (see annotated Figs. 10B-C below), wherein the first region (see annotated Figs. 10B-C below) extends proximally from the opening 1008 and is concave towards the inner surface (see annotated Figs. 10B-C below)of the outer layer 1000a, and wherein the second region (see annotated Figs. 10B-C below) is convex towards the inner surface (see annotated Figs. 10B-C below) of the outer layer 1000a.
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Nguyen does not explicitly disclose: the first region having a length that is at least a third of a length of the inner layer and a membrane positioned between the outer and inner layers.
However, Zaidat in a similar field of invention teaches an occlusive device 700 (see Figs. 29-30) for treating an aneurysm with a mesh single, continuous dual layer mesh (see Figs. 29-30, [0071]) with an inner layer 738 (see Figs. 29-30), an outer layer 712 (see Figs. 29-30), the inner layer 738 having a first region 711 (see Fig. 29-30) which the inner surface of is concave (see annotated Fig. 30 below) towards the inner surface of the outer layer 712 and is proximal of the opening 734 (see Fig. 30) and a second region extending from the first region 711 that is convex towards the inner surface of the outer layer 712. Zaidat further teaches: the first region 711 (see Figs. 29-30, [0071]-[0072]) having a length (see Figs. 29-30, [0072]) that is at least a third of a length (see [0072], the 711 can be between 30% and 150% of the length of 720, the lengths of 711 + 720 equal the total length of 738, so as 711 is 50% of length of 720, it would be 33% or 1/3 the length of 711 + 720, or otherwise known as the length of 738, for example if the length of 720 is 1, 50% of which is 0.5, 0.5 + 1 equals 1.5, and 0.5/1.5 is 1/3) of the inner layer 738.
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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 first region of Nguyen to incorporate the teachings of Zaidat and teach an occlusion device with the first region having a length that is at least a third of a length of the inner layer. Motivation for such can be found in Zaidat, as the specific comparative length of 711 to the device serves as an internal support to reduce the compressibility of the outer layer and maintain the shape of a globular contour, even throughout long-term implantation within an aneurysm (see [0074]).
The combination of Nguyen and Zaidat does not explicitly teach: and a membrane positioned between the outer and inner layers.
However, Heisel in a similar field of invention teaches a device 2 (see Figs. 1-2) for occluding a bodily lumen (see [0002]) with an expandable mesh 20 + 22 with at least two layers 20 + 22. Heisel further teaches: a membrane 24 (see Figs. 1-2, [0025] and [0035]) positioned between two 20 + 22 of the at least two mesh layers 20 + 22.
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 Nguyen to incorporate the teachings of Heisel and teach a device for treating an aneurysm with a membrane positioned between two of the at least two mesh layers. Motivation for such can be found in Heisel as this membrane can provide an immediate and a long-term benefit, immediately it provides an occlusive benefit, for long-term occlusion it provides cell seeding and tissue growth such that device stability and closure is facilitated (see [0037]).
Claim 30
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 29, see 103 rejection above. Nguyen further discloses: wherein the mesh 1000 comprises a plurality of braided filaments 1002 (see Figs. 10A-10C, [0288]).
Claim 32
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 is fluid impermeable (see [0037], occlusive, hence prevents the passing of fluid).
Claim 33
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 has a plurality of perforations (see [0037], semi-nonporous, meaning will have some pores).
Claim(s) 28 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Zaidat and Heisel as applied to claim 23 and claim 29 above, and further in view of Warner et al (US 20190336132 A1), herein referenced to as “Warner”.
Claim 28
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 23, see 103 rejection above. Heisel further teaches: wherein the membrane 24 comprises a polymer (see [0037], polyester, which is a polymer).
The combination of Nguyen, Zaidat, and Heisel does not explicitly teach: wherein the membrane comprises a fluoropolymer.
However, Warner in a similar field of invention teaches a device (see Fig. 23) for treating an aneurysm (see [0002] and [0028]) with mesh 300 + 320 (see Fig. 23, [0077]) with two layers 300 + 320 and membrane 310 (see Fig. 23, [0077]) positioned between (see [0077], sandwiched between) the two layers 300 + 320. Warner further teaches: wherein the membrane 320 comprises a fluoropolymer (see [0080], ePTFE, which is a fluoropolymer).
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 Nguyen and Heisel to incorporate the teachings of Warner and have a device for treating an aneurysm with the membrane comprising a fluoropolymer. This is due to fluoropolymer being used for membranes is common in the art (see [0080]), thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 34
The combination of Nguyen, Zaidat, and Heisel teaches: The device of claim 29, see 103 rejection above. Heisel further teaches: wherein the membrane 24 comprises a polymer (see [0037], polyester, which is a polymer).
The combination of Nguyen, Zaidat, and Heisel does not explicitly teach: wherein the membrane comprises a fluoropolymer.
However, Warner in a similar field of invention teaches a device (see Fig. 23) for treating an aneurysm (see [0002] and [0028]) with mesh 300 + 320 (see Fig. 23, [0077]) with two layers 300 + 320 and membrane 310 (see Fig. 23, [0077]) positioned between (see [0077], sandwiched between) the two layers 300 + 320. Warner further teaches: wherein the membrane 320 comprises a fluoropolymer (see [0080], ePTFE, which is a fluoropolymer).
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 Nguyen and Heisel to incorporate the teachings of Warner and have a device for treating an aneurysm with the membrane comprising a fluoropolymer. This is due to fluoropolymer being used for membranes is common in the art (see [0080]), thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ottma (US 20130296912 A1) teaches an occlusion device with a double layer with a first region 115 that’s concave to the inner surface of the outer layer 114 (see Fig. 1)
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights