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 02/26/2026. As directed by the amendment: claims 1-14 have been amended, claims 15-18 have been cancelled and claims 19 have been added. Thus, claims 1-14 and 19 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 5, filed 02/26/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 5, filed 02/26/2026, with respect to the USC 112b rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity within the claims. The USC 112b rejections have been withdrawn.
Applicant’s arguments, see pages 5-6, filed 02/26/2026, with respect to the rejection(s) of claim(s) 1-14 under 35 U.S.C. 103 as being unpatentable over Rhee et al (US 20170079662 A1), herein referenced to as “Rhee” in view of Kresslein et al (US 20180161185 A1), herein referenced to as “Kresslein” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “wherein the first portion of the electrospun cover comprises pores characterized by a product of median pore size times fractional porosity of 5 to 20”. The examiner agrees that the combination of Rhee in view of Kresslein does not explicitly disclose the amended claim language.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rhee in view of Kresslein and Gorochow (US 20220031443 A1).
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.
Claim(s) 1-14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhee et al (US 20170079662 A1), herein referenced to as “Rhee” in view of Kresslein et al (US 20180161185 A1), herein referenced to as “Kresslein” and Gorochow (US 20220031443 A1), herein referenced to as “Gorochow”.
Claim 1
Rhee discloses: An intrasaccular flow diverter 350 (see Figs. 1 and 6, [0098]) for treating an aneurysm 40 (see Fig. 1, [0075]) of an intracranial blood vessel (see [0002], patient’s vasculature, [0004] cerebral aneurysms), the intrasaccular flow diverter 350 comprising: one or more wires the wires that form 356 (see Fig. 6, [0098]) forming a frame 356 (see Fig. 6, [0098]), wherein the frame 356 has a collapsed configuration reduced profile (see [0101]) and an expanded configuration (see Fig. 6 and Fig. 10 as an example of deploying a device to an aneurysm), wherein the frame 356 is configured to transition in use from the collapsed configuration (see [0101]) to a deployed configuration (see Fig. 6, when the device expands inside an aneurysm is the deployed configuration); a cover 354 + 352 (see Fig. 6, [0098]) disposed on at least a portion (see [0098]-[0099]) of the frame 356, the cover 354 + 352 comprising: a first portion 352 (see Fig. 6, [0098]-[0099]) configured to be disposed against a neck 352 is positioned toward the neck of the aneurysm being on the proximal portion of the frame of the aneurysm, the first portion 352 of the cover having pores (see Fig. 6, [0098], has mesh porosity) formed therein defining a first porosity the porosity of 352 thereof; and a second portion 354 (see Fig. 6, [0098]-[0099]) having a second porosity the porosity of 354 to blood flow greater than the first porosity (see Fig. 6, the porosity of 354 is greater than 352, as it has larger holes than 352, see also [0120], high porosity is shown larger sized pores vs smaller sized pores), the second portion 354 configured to be disposed within the sac of aneurysm distal to the neck of the aneurysm (see Fig. 6, 354 is distal to 352, which sits at the neck of the aneurysm, hence 354 is disposed within the sac of the aneurysm); wherein the first portion 352 of the cover 352 has a median pore size between 20 and 30 microns (see [0122], between 1 micron to about 400 micron, hence between 20 and 30 microns).
Rhee does not explicitly disclose: the deployed configuration substantially conforms to a shape of an inside surface of a sac of the aneurysm and the cover is electrospun; wherein the first portion of the electrospun cover comprises pores characterized by a product of median pore size times fractional porosity of 5 to 20.
However, Kresslein in a similar field of invention teaches an intrasaccular flow diverter (see Fig. 13A) with a frame 101 (see Fig. 13A) and a cover 102 (see Fig. 13A) with a deployed configuration (see Fig. 13A). Kresslein further teaches: the deployed configuration (see Fig. 13A, [0121]) substantially conforms (see [0121], conform to a body and neck portion of an aneurysm) to a shape of an inside surface of a sac of the aneurysm (see [0121]) and the cover is electrospun (see [0099], polymeric electrospun 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 the frame of Rhee to incorporate the teachings of Kresslein and teach an intrasaccular flow diverter with the deployed configuration substantially conforms to a shape of an inside surface of a sac of the aneurysm. Motivation for such can be found in Kresslein as a device that more readily conforms to an aneurysm can provide more complete occlusions or sealing of aneurysm (see [0123]).
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 cover of Rhee to incorporate the teachings of Kresslein and teach an intrasaccular flow diverter with the cover being electrospun. Motivation for such can be found in Kresslein as an electrospun polymeric mesh provide biocompatibility and biomimicry that can accelerate the rate of cell adhesion and endothelialization to close off the aneurysm from the parent artery (see [0109]).
The combination of Rhee and Kresslein does not explicitly teach: wherein the first portion of the electrospun cover comprises pores characterized by a product of median pore size times fractional porosity of 5 to 20.
However, Gorochow in a similar field of invention teaches a saccular flow diverter 100 (see Fig. 3F, with the top portion of 202 being within inside the sac) with a first portion 202 (see Fig. 3F) of the cover 202 (see Fig. 3F). Gorochow further teaches: a porosity of the first portion is between 0.3 and 0.6 (see [0009], 50% to 70%, which has a porosity between 0.3 to 0.6, or 30% to 60%).
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 Rhee and Kresslein to incorporate the teachings of Gorochow and teach an intrasaccular flow diverter with the porosity of the first portion is between 0.3 and 0.6. Motivation for such can be found in Gorochow as this porosity has been clinically proven to be dense enough to treat the aneurysm (see [0009]) and furthermore keeps to a lower porosity in order to easily position the implant into the treatment site (see [0038]).
The combination of Rhee, Kresslein, and Gorochow further teaches: wherein the first portion of the electrospun cover (352 of Rhee, the first portion, modified by Kresslein to be electrospun, has median pore size of 20 to 30 microns) comprises pores characterized by a product of median pore size times fractional porosity (Rhee as modified by Gorochow has a porosity between 0.3 to 0.6, for example, Gorochow teaches 0.5) of 5 to 20 (this results in a product of median pore size of 25 times a fractional porosity of 0.5, which equals 12.5, which is between 5 to 20).
Claim 2
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the frame 101 comprises each of the one or more wires the one or more wires that form the frame 356 wound in a substantially helical shape (see Fig. 6, each wire, wounds in a helical shape from a proximal end to a distal end of the wires, in the same way as described in applicant’s figures, see Fig. 4A of the applicant’s patent application publication).
Claim 3
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: a plurality of helical loops the helical loops that form the one or more wires that form the frame 356 (see Fig. 6) have successively increasing and then decreasing diameters to, thereby, form a substantially spherical structure (see Fig. 6, 356 forms a substantially spherical structure).
Claim 4
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the plurality of wires is one of 8 wires, 12 wires (see [0101], 12 or fewer wires, 8 is included in less than 12 or 36 or more wires) and 16 wires (will not be examined due to being an optional claim limitation).
Claim 5
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the one or more wires are configured to self-expand under a bias from the one or more wires (see [0101], expansion characteristics).
Claim 6
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the intrasaccular flow diverter 350 is configured to be disposed, in a collapsed form, within a microcatheter (see [01010], reduced profile to be delivered through lower-sized catheters) that is configured to be threaded through the blood vessel to a location within the aneurysm (see Figs. 10-11).
Claim 7
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee does not explicitly disclose: wherein the first porosity is less than 0.05.
As noted in Rhee it is necessary the porosity of the mesh can increase surface area to encourage endothelization (see [0113]). This correlates to the first porosity and as such wherein the first porosity is less than 0.05 is considered to be a result effective variable since that the porosity directly impacts the surface area to encourage endothelization. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rhee by causing the first porosity be less than 0.05 as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 8
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee does not explicitly disclose: wherein the second porosity is greater than 0.05.
As noted in Rhee it is necessary for a higher porosity section of a composite porosity meshes to support the aneurysm wall to aid in healing and thrombogenesis (see [0121]). This correlates to the second porosity that is in the sac of the aneurysm and as such the second porosity is greater than 0.05 is considered to be a result effective variable since that the second porosity affects the ability of the second portion of the cover in supporting the aneurysm wall. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rhee by causing the second porosity is greater than 0.05 as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 9
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee does not explicitly disclose: wherein each of the plurality of wires has a diameter of one of approximately 0.0003 inches, approximately 0.0005 inches, 0.0007 inches and 0.001 inches.
As noted in Rhee it is necessary for to control the porosity of the device to either support the aneurysm wall (see [0121]) or to encourage endothelization (see [0113]). This correlates to the diameter of the filaments/wire that form the frame and/or mesh as it is a component within the porosity and total surface area of the device (see [0085]) and as such wherein each of the plurality of wires has a diameter of one of approximately 0.0003 inches, approximately 0.0005 inches, 0.0007 inches and 0.001 inches is considered to be a result effective variable since that the diameter of the wires affects the calculation of porosity and surface area (see [0085]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rhee by causing wherein each of the plurality of wires has a diameter of one of approximately 0.0003 inches, approximately 0.0005 inches, 0.0007 inches and 0.001 inches as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 10
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee does not explicitly disclose: configured to have a minimum outside diameter of one of approximately 0.002 inches, approximately 0.003 inches, approximately 0.004 inches, and approximately 0.006 inches when the substantially spherical structure is fully collapsed.
As noted in Rhee it is necessary for a section of the implantable device to be positioned at the neck of the aneurysm so the aneurysm can be occluded (see [0116]). This correlates to the outside diameter of the device, including the minimum outside diameter of the proximal end of the sphere, as the minimum diameter effects the maximum diameter for a sphere and as such minimum outside diameter of one of approximately 0.002 inches, approximately 0.003 inches, approximately 0.004 inches, and approximately 0.006 inches when the substantially spherical structure is fully collapsed is considered to be a result effective variable since that diameter of the spherical device in the collapsed and expanded forms affects whether it will seat properly in the neck of the aneurysm. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rhee by causing the intrasaccular device to be configured to have a minimum outside diameter of one of approximately 0.002 inches, approximately 0.003 inches, approximately 0.004 inches, and approximately 0.006 inches when the substantially spherical structure is fully collapsed as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 11
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee does not explicitly disclose: wherein the intrasaccular flow diverter is configured to have a maximum outside diameter of approximately 0.18 inches when the substantially spherical structure is fully expanded.
As noted in Rhee it is necessary for a section of the implantable device to be positioned at the neck of the aneurysm so the aneurysm can be occluded (see [0116]). This correlates to the maximum outside diameter of the device, wherein the intrasaccular flow diverter is configured to have a maximum outside diameter of approximately 0.18 inches when the substantially spherical structure is fully expanded is considered to be a result effective variable since that diameter of the spherical device in the collapsed and expanded forms affects whether it will seat properly in the neck of the aneurysm. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rhee by causing wherein the intrasaccular flow diverter is configured to have a maximum outside diameter of approximately 0.18 inches when the substantially spherical structure is fully expanded as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 12
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein a substantial majority of an aggregate porosity (see [0101], the mesh component, 352 + 354, primarily provides the desired porosity profile of the device) of the intrasaccular flow diverter 350, at the first and second portions 352 + 354 of the membrane (see 112b rejection above, interpreted as “the cover, 352 + 354), is derived from the first and second porosities the porosities of 352 + 354 (see Fig. 6) of the membrane (see 112b rejection above, interpreted as “the cover, 352 + 354) at the respective first and second portions (see [0101]).
Claim 13
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein each of the one or more wires the one or more wires that make up 356 comprises a super-elastic nitinol (see [0076], nitinol, it is known in the field of art that nitinol is super-elastic due to its shape-memory properties).
Claim 14
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the membrane 352 + 354 (see 112b rejection above, interpreted as “the cover, 352 + 354) comprises a polymer (see [0076], the mesh component can comprise PLGA, which is a polymer, which is a material that can be electrospun, see [0096] of Kresslein).
Claim 19
The combination of Rhee, Kresslein, and Gorochow teaches: The intrasaccular flow diverter of claim 1, see 103 rejection above. Rhee further discloses: wherein the median pore size is between 20 and 30 microns (see [0122], between 1 micron to about 400 micron, hence between 20 and 30 microns).
Gorochow further teaches: the porosity is between 0.3 and 0.6 (see [0009], 50% to 70%, which has a porosity between 0.3 to 0.6, or 30% to 60%).
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771