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
The claims filed 02/13/2026 has been entered. Claims 1-2, 21, and 26-27 and 29-31 remain pending in the application, claims 3-20, 22, 23-25, and 28 are cancelled, and claims 32-37 are added. Applicant’s arguments have not overcome the prior art rejection previously set forth in the Non-Final Office Action mailed 11/14/2025.
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 that Griffin fails to disclose or suggest “wherein, when the mesh is in the expanded state, the first and second portions are spaced apart from one another by a distance, and wherein the distance increases as the first and second portions extend radially outwardly.” The Office respectfully disagrees. As Applicant has not specifically pointed out how Griffin does not disclose such limitation, the Office provides support for such limitation in figures 3A-4C, and paragraphs 55 and 59 when discussing the width/diameter of the mesh 14 in the non-deployed and deployed state. Paragraph 55 discloses “In the deployed shape, the 14 body having a folded back 24 dual layer is deeper when compared to a non-deployed 24 dual layer occlusion device accounting for a change in width of approximately 15% which translates to an increase in the diameter (x) of the device when pressure is applied at the 16 marker,” and thus the distance between the first portion and the second portion increases when the mesh is in the globular expanded state due to the expanded width/diameter. Additionally, the distance between the first portion and the second portion increases as the portions extend radially outward is shown in figure 4C when the coupler 16 is moving from the left side of the device to the right. The distance between the first portion and second portion is closer at the coupler 16 than it is at the ridge (see annotated figure 4C below). Therefore, the rejection is maintained.
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 21, 26, 29-34 and 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin (US PGPub 2015/0313605).
With regards to claim 1, Griffin discloses (Figures 3A-4C) a device 14 for treating an aneurysm 10 (paragraph 49), the device 14 comprising:
a mesh 14 (paragraph 49) having an expanded, unconstrained state (figure 3B), the mesh 14 formed of a plurality of braided filaments (paragraphs 68-70), each of the filaments having a first end and a second end (see annotated figure 3B below), wherein the mesh 14 has a proximal portion configured to be positioned over a neck 22 of the aneurysm 10 (figure 3B) and a distal portion (see annotated figure 3B below);
a single coupler 16, wherein the first and second ends are secured relative to one another at the coupler 16 (see annotated figure 3B below); and
wherein the mesh 14 is formed of a wall comprising a first portion (outside of the mesh), a second portion (inside of the mesh), and a ridge (top surface between the inner and outer mesh portions; see annotated figure 3B below), and wherein:
the first portion extends between the coupler 16 and the ridge, the first portion comprising a first region extending proximally from the ridge and a second region extending distally and radially inwardly from the first region towards the coupler (see annotated figure 3B below), and
the second portion extends proximally and radially inwardly from the ridge to the coupler 16 (see annotated figure 3B below), and
wherein the mesh 14 includes a first cavity (space where element 20 points to in figure 3B) at the distal portion and a second cavity (space where coupler 16 resides, see annotated figure 3B below) at the proximal portion, the first cavity defined by the second portion of the mesh 14 and a distal side of the coupler 16 (see annotated figure 3B below), and wherein all or a portion of the coupler 16 is positioned within the second cavity (see annotated figure 3B below), and
wherein the ridge defines an opening at the distal portion of the mesh 14 that is continuous with the first cavity (see annotated figure 3B below);
wherein, when the mesh 14 is in the expanded state (figures 3B and 4C), the first and second portions are spaced apart from one another by a distance, and wherein the distance increases as the first and second portions extend radially outwardly (see annotated figure 4C below – mesh 14 has a radially constrained elongate state configured for delivery in figure 4A, and an expanded state with the mesh having a globular and longitudinally shortened configuration in figure 4C; paragraphs 59 and 55 – “In the deployed shape, the 14 body having a folded back 24 dual layer is deeper when compared to a non-deployed 24 dual layer occlusion device accounting for a change in width of approximately 15% which translates to an increase in the diameter (x) of the device when pressure is applied at the 16 marker” - thus the distance between the first portion and the second portion increases when the mesh is in the globular expanded state due to the expanded width/diameter; the distance between the first portion and the second portion increases as the portions extend radially outward is shown in figure 4C when the coupler 16 is moving from the left side of the device to the right; the distance between the first portion and second portion is closer at the coupler 16 than it is at the ridge).
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With regards to claim 2, Griffin discloses wherein the mesh has a double-layer delivery configuration (paragraph 40; figure 4A).
With regards to claim 30, Griffin discloses wherein the coupler 16 is disposed closer to the proximal portion of the mesh 14 than the distal portion (see annotated figure 3B above).
With regards to claim 32, Griffin discloses wherein the mesh 14 comprises a superelastic material (paragraph 74).
With regards to claim 33, Griffin discloses wherein the mesh 14 comprises a shape memory material (paragraph 74).
With regards to claim 34, Griffin discloses wherein the first cavity has a different shape than the second cavity (figure 3B – first cavity at the distal portion of the mesh 14 is wider than the second cavity at the proximal portion of the mesh 14).
With regards to claim 21, Griffin discloses (Figures 3A-4C) a device 14 for treating an aneurysm 10 (paragraph 49), the device 14 comprising:
a mesh 14 (paragraph 49) having an expanded, unconstrained state (figure 3B), the mesh 14 formed of a plurality of braided filaments (paragraphs 68-70), each of the filaments having a first end and a second end (see annotated figure 3B below), wherein the mesh 14 has a proximal portion configured to be positioned over a neck 22 of the aneurysm 10 (figure 3B), a distal portion opposite the proximal portion along a longitudinal dimension of the mesh 14 (figure 3B), and an intermediate portion between the proximal and the distal portions along the longitudinal dimension, wherein the mesh 14 is formed of a wall comprising a first portion (outside of mesh), a second portion (inside of mesh), and a ridge (top surface between the inner and outer mesh portions; see annotated figure 3B below);
a single coupler 16 at the intermediate portion, wherein the first and second ends are secured relative to one another at the coupler 16 (see annotated figure 3B below),
wherein:
the second portion of the wall of the mesh 14 extends proximally and radially inwardly from the ridge to the coupler 16 and the second portion and a distal side of the coupler 16 define a first cavity (see annotated figure 3B below; space where element 20 points to in figure 3B),
the first portion comprises a first region extending proximally from the ridge and a second region extending distally and radially inwardly from the first region towards the coupler 16 (see annotated figure 3B below) wherein the second region of the first portion defines a second cavity (space where coupler 16 resides, see annotated figure 3B below) and the coupler 16 is positioned within the second cavity (see annotated figure 3B below), and
wherein the ridge defines an opening at the distal portion of the mesh 14 that is continuous with the first cavity (see annotated figure 3B below);
wherein, when the mesh 14 is in the expanded state (figures 3B and 4C), the first and second portions are spaced apart from one another by a distance, and wherein the distance increases as the first and second portions extend radially outwardly (see annotated figure 4C below – mesh 14 has a radially constrained elongate state configured for delivery in figure 4A, and an expanded state with the mesh having a globular and longitudinally shortened configuration in figure 4C; paragraphs 59 and 55 – “In the deployed shape, the 14 body having a folded back 24 dual layer is deeper when compared to a non-deployed 24 dual layer occlusion device accounting for a change in width of approximately 15% which translates to an increase in the diameter (x) of the device when pressure is applied at the 16 marker” - thus the distance between the first portion and the second portion increases when the mesh is in the globular expanded state due to the expanded width/diameter; the distance between the first portion and the second portion increases as the portions extend radially outward is shown in figure 4C when the coupler 16 is moving from the left side of the device to the right; the distance between the first portion and second portion is closer at the coupler 16 than it is at the ridge).
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With regards to claim 26, Griffin discloses wherein the first cavity has a different shape than the second cavity (figure 3B – first cavity at the distal portion of the mesh 14 is wider than the second cavity at the proximal portion of the mesh 14).
With regards to claim 29, Griffin discloses wherein the mesh has a double-layer delivery configuration (paragraph 40; figure 4A).
With regards to claim 31, Griffin discloses wherein the coupler 16 is disposed closer to the proximal portion of the mesh 14 than the distal portion (see annotated figure 3B above).
With regards to claim 36, Griffin discloses wherein the mesh 14 comprises a superelastic material (paragraph 74).
With regards to claim 37, Griffin discloses wherein the mesh 14 comprises a shape memory material (paragraph 74).
Claims 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Marchand et al. (US PGPub 2011/0152993), hereinafter known as “Marchand.”
With regards to claims 27 and 35, Griffin discloses the device as claimed in claims 21 and 1, respectively. Griffin does not explicitly show wherein the first portion comprises a third region extending proximally from the second region to the coupler.
However, in a similar field of endeavor of aneurysm treatment devices, Marchand teaches (Figures 50-50A) wherein the first portion comprises a third region extending proximally from the second region to the coupler 304 (see annotated figure 50A below).
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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 device of Griffin to include wherein the first portion comprises a third region extending proximally from the second region to the coupler as taught by Marchand for the purpose of further providing conformability to the device so that it can adapt to the shape and size of the aneurysm neck (paragraph 207 of Marchand).
The combination would result in the filaments of Griffin to have a similar third region of the first portion as depicted in annotated figure 50A of Marchand above that would extend from the second region to the coupler 16 of Griffin.
Conclusion
THIS ACTION IS MADE FINAL. 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/30/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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