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 .
Election/Restrictions
Applicant’s election without traverse of Species A of Sub-Species I and Species C of Sub-Species II (Claims 1, 3-15, & 17-21) in the reply filed on 12/31/2025 is acknowledged.
Claims 2, 16, 22, & 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected sub-species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025.
Claim Objections
Claims 10-13 are objected to because of the following informalities: claims 10-13 recite ‘the membrane’ which is believed to be the previously recited ‘cover’ - examiner suggests amending all instances of ‘the membrane’ to read --the cover-- to avoid confusion in the claims. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 2 - ‘intrasacular’ should be amended to read --intrasaccular--. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: paragraph [0104] - ‘intrasacular’ should be amended to read --intrasaccular--. .
Appropriate correction is required.
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, 3-6, 8-12, 14, 17, 18, 20, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ton et al. (WO 2018/129194 A1).
Regarding claim 1, Ton et al. disclose a device (Fig. 4A) for temporarily protecting a neck of an aneurysm of an intracranial blood vessel during an aneurysm treatment (paragraph [0009]), the device comprising: one or more wires forming a frame 10 (Fig. 4A; paragraph [0065]; NOTE: wires are not labeled in Fig. 4A but are clearly shown to form the frame 10), wherein the frame 10 has a collapsed configuration and an expanded configuration (sheath 104 is used to collapse by re-sheathing and expand by unsheathing - paragraph [0094]), wherein the frame 10 is configured to transition in use from the collapsed configuration to a deployed configuration that substantially conforms to a shape of an inside surface of the intracranial blood vessel in the vicinity of the aneurysm being treated (deployment discussed in paragraph [0094] - removal discussed in paragraph [0075])), and wherein the frame 10 is configured to transition back to the collapsed configuration and removed from the intracranial blood vessel after the aneurysm is treated (paragraph [0075]); and a cover 60 (not shown in Fig. 4A but discussed as an alternative to coating of the device - paragraphs [0084] & [0089]) disposed on at least a portion of the frame, the cover 60 comprising at least a first portion configured to be disposed against a neck of the aneurysm while the aneurysm is being treated, the first portion of the cover having pores formed therein defining a first porosity thereof (paragraphs [0084] & [0089]; cover 60 covers the majority of the frame 10 which is considered to include a portion that is capable of being disposed against a neck of the aneurysm).
Regarding claim 3, Ton et al. further disclose a retention wire 24 (Fig. 4A) disposed at a proximal end of the frame 10 of the at least one wire (Fig. 4A).
Regarding claim 4, Ton et al. further disclose wherein none of the one or more wires meet at a distal end of the frame 10 (distal end of frame is open - Fig. 4A), thereby providing an unobstructed distal end of the frame 10.
Regarding claim 5, Ton et al. further disclose wherein the frame 10 comprises a substantially circular flow exit opening 31 at the distal end of the frame 10 (paragraph [0065]).
Regarding claim 6, Ton et al. further disclose wherein the frame 10 comprises a beveled flow entrance opening at the proximal end 28 of the frame 10 (Figs. 4A-4B).
Regarding claim 8, Ton et al. further disclose wherein the frame 10 is configured to self-expand under a bias from the plurality of wires (paragraph [0094]).
Regarding claim 9, Ton et al. further disclose wherein the first porosity is configured to support hemostasis within the aneurysm by substantially blocking blood flow into the aneurysm through the first portion of the cover (paragraph [0089] discusses that the cover 60 ‘may be made porous preferentially towards its proximal and distal ends…which may advantageously allow blood flow through side branching blood vessels near the aneurysm’, thereby leaving the remaining portion that is near the aneurysm with no porosity which would meet the claim limitation ‘by substantially blocking blood flow into the aneurysm’).
Regarding claim 10, Ton et al. further disclose wherein the membrane/cover 60 is configured to retain any intra-aneurysmal clot within the aneurysm and, thereby, prevent displacement of the clot into the intracranial blood vessel while the aneurysm is being treated (paragraph [0089] discusses that the cover 60 ‘may be made porous preferentially towards its proximal and distal ends…which may advantageously allow blood flow through side branching blood vessels near the aneurysm’, thereby leaving the remaining portion that is near the aneurysm with no porosity which would meet the claim limitation ‘prevent displacement of the clot into the intracranial blood vessel’ by nature of the cover having no porosity which would not allow the clot to travel therethrough).
Regarding claim 11, Ton et al. further disclose wherein the membrane/cover 60 is configured to redirect coils introduced into the aneurysm away from the neck of the aneurysm to thereby facilitate effective filling of the aneurysm with the coils (paragraph [0089] discusses that the cover 60 ‘may be made porous preferentially towards its proximal and distal ends…which may advantageously allow blood flow through side branching blood vessels near the aneurysm’, thereby leaving the remaining portion that is near the aneurysm with no porosity which would meet the claim limitation ‘configured to redirect coils introduced into the aneurysm away from the neck of the aneurysm’ by nature of the cover having no porosity which would ultimately redirect any matter in the aneurysm that comes in contact with the cover - which is located at the neck- back into the aneurysm).
Regarding claim 12, Ton et al. further disclose wherein the membrane/cover 60 is configured to prevent coils introduced into the aneurysm from protruding into and/or tangling in the plurality of wires of the frame (paragraph [0089] discusses that the cover 60 ‘may be made porous preferentially towards its proximal and distal ends…which may advantageously allow blood flow through side branching blood vessels near the aneurysm’, thereby leaving the remaining portion that is near the aneurysm with no porosity which would meet the claim limitation ‘configured to prevent coils introduced into the aneurysm from protruding into and/or tangling in the plurality of wire of the frame’ by nature of the cover having no porosity which would not allow any portion of the coils within the aneurysm from crossing over/through the cover and into the frame)
Regarding claim 14, Ton et al. further disclose wherein the first porosity substantially blocks radiographic contrast agent injected into the intracranial blood vessel (paragraph [0089] discusses that the cover 60 ‘may be made porous preferentially towards its proximal and distal ends…which may advantageously allow blood flow through side branching blood vessels near the aneurysm’, thereby leaving the remaining portion that is near the aneurysm with no porosity which would meet the claim limitation ‘substantially blocks radiographic contrast agent’)
Regarding claim 17, Ton et al. further disclose wherein each of a proximal end and a distal end of the frame 10 is substantially open (Fig. 4A) such that the frame is configured to allow blood to flow freely longitudinally therethrough and directly feed tissues distal of the aneurysm while the frame is expanded.
Regarding claim 18, Ton et al. further disclose wherein the cover 60 comprises a polymer (paragraph [0015] - ‘sleeve’ is the cover 60).
Regarding claim 20, Ton et al. further disclose wherein a diameter of the frame 10 in an expanded configuration is less than 10 mm (paragraph [0060]).
Regarding claim 21, Ton et al. further disclose wherein a diameter of the frame in an expanded configuration is less than 5 mm (paragraph [0060]).
Claims 1, 3-13, 15, 17, 20, & 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choubey (US Pat. No. 10,893,869 B2).
Regarding claim 1, Choubey discloses a device 100 (Figs. 1A-1B) for temporarily protecting a neck of an aneurysm of an intracranial blood vessel during an aneurysm treatment (abstract), the device 100 comprising: one or more wires forming a frame 130 (Figs. 1A-1B), wherein the frame 130 has a collapsed configuration and an expanded configuration (column 6, lines 20-61), wherein the frame 130 is configured to transition in use from the collapsed configuration to a deployed configuration that substantially conforms to a shape of an inside surface of the intracranial blood vessel in the vicinity of the aneurysm being treated (column 2, lines 16-27), and wherein the frame 130 is configured to transition back to the collapsed configuration and removed from the intracranial blood vessel after the aneurysm is treated (if connection of the device 100 to the delivery wire is not disturbed (i.e. disconnected), the frame 130 would be capable of being retrieved back into the microcatheter it is delivered by - column 2, lines 10-15); and a cover 160 (Figs. 1A-1B - ‘flow-diverting mesh’; column 6, lines 20-25) disposed on at least a portion of the frame 130, the cover 160 comprising at least a first portion configured to be disposed against a neck of the aneurysm while the aneurysm is being treated, the first portion of the cover 160 having pores formed therein defining a first porosity thereof (column 9, lines 12-23).
Regarding claim 3, Choubey further discloses a retention wire (delivery wire - column 2, lines 10-15) disposed at a proximal end of the frame 130 of the at least one wire.
Regarding claim 4, Choubey further discloses wherein none of the one or more wires meet at a distal end of the frame 130 (Fig. 1B), thereby providing an unobstructed distal end of the frame.
Regarding claim 5, Choubey further discloses wherein the frame 130 comprises a substantially circular flow exit opening at the distal end of the frame (the expanded state of the frame is intended to expand to fit within the vasculature, which is cylindrical, providing that the open distal end would be ‘substantially circular’ by nature of the cylinder’s form).
Regarding claim 6, Choubey further discloses wherein the frame 130 comprises a beveled flow entrance opening at the proximal end of the frame 130 (Fig. 1B shows the offset connection point of the bundled frame wires which connect to the delivery wire - this offset configuration provides for a beveled proximal opening).
Regarding claim 7, Choubey further discloses wherein the one or more wires is 12 or fewer wires (seen in Figs. 1A & 1B).
Regarding claim 8, Choubey further discloses wherein the frame 130 is configured to self-expand under a bias from the plurality of wires (column 7, lines 15-19).
Regarding claim 9, Choubey further discloses wherein the first porosity is configured to support hemostasis within the aneurysm by substantially blocking blood flow into the aneurysm through the first portion of the cover 160 (column 9, lines 24-32).
Regarding claim 10, Choubey further discloses wherein the membrane is configured to retain any intra-aneurysmal clot within the aneurysm and, thereby, prevent displacement of the clot into the intracranial blood vessel while the aneurysm is being treated 160 (column 9, lines 24-32 - since the porosity is small enough to divert blood flow, then it is considered capable of preventing a clot from being displaced therethrough).
Regarding claim 11, Choubey further discloses wherein the membrane is configured to redirect coils introduced into the aneurysm away from the neck of the aneurysm to thereby facilitate effective filling of the aneurysm with the coils 160 (column 9, lines 24-32 - since the porosity is small enough to divert blood flow, then it is considered capable of preventing a coil from being displaced therethrough, which would end up redirecting the coil back into the aneurysm away from the neck where the cover is located)
Regarding claim 12, Choubey further discloses wherein the membrane is configured to prevent coils introduced into the aneurysm from protruding into and/or tangling in the plurality of wires of the frame 160 (column 9, lines 24-32)
Regarding claim 13, Choubey further discloses wherein the first porosity allows fluid to flow out of the aneurysm through the first portion of the membrane as intrasaccular volume is displaced by coils introduced into the aneurysm and systemic blood pressure keeps the aneurysm inflated while the coils are introduced into the aneurysm (it is considered that any fluid having a molecule size less than that of blood/blood cells would be able to pass through the cover 160 since it is disclosed that the cover 160 will have a pore size to interfere with blood flow into an aneurysm or across the device - column 9, line 24-32).
Regarding claim 15, Choubey et al. further disclose wherein: the first porosity is 10% or less (column 9, lines 12-23 - 10% or less falls in the range of 5-95%); and a pore size associated with the first porosity is less than approximately 20 microns (column 9, lines 12-23 - 20 microns falls in the range of 2 microns to 35 microns).
Regarding claim 17, Choubey et al. further disclose wherein each of a proximal end and a distal end of the frame 130 is substantially open (Figs. 1A-1B) such that the frame 130 is configured to allow blood to flow freely longitudinally therethrough and directly feed tissues distal of the aneurysm while the frame is expanded.
Regarding claim 20, Choubey et al. further disclose wherein a diameter of the frame 130 in an expanded configuration is less than 10 mm (column 15, lines 40-42).
Regarding claim 21, Choubey et al. further disclose wherein a diameter of the frame in an expanded configuration is less than 5 mm (column 15, lines 40-42).
Claim Rejections - 35 USC § 103
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 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 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ton et al. (WO 2018/129194 A1) in view of Jones et al. (US Pub. No. 2021/0052360 A1).
Regarding claim 19, Ton et al. further disclose that the cover 60 may be applied to the frame 10 by dip-coating, by wrapping the cover around the device, and/or any other suitable means in paragraph [0089]. However, Ton et al. fail to explicitly disclose wherein the cover is electrospun onto the frame.
Jones et al. teaches the use of electrospinning a membrane onto a metal frame in an embolic protection device (paragraphs [0091]-[0092]). It is considered that by the teachings and suggestions of Jones et al., electrospinning would fall under the ‘other suitable means’ category of Ton et al.’s cover application method. Therefore, it is considered that one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize electrospinning as another suitable means in the art to apply the cover to the frame in Ton et al.’s device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 January 23, 2026