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, 4-5, 6, and 21 have been amended, claims 11 and 14-15 have been cancelled, claims 22-23 have been added, and claims 13 and 20 remain withdrawn. Thus, claims 1-10, 12-13, and 16-23 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 02/26/2026, with respect to the drawing objections have been fully considered and are persuasive. The applicant’s cancellation of the claims that were not shown within the drawings overcome the drawing objection. The drawing objections have been withdrawn.
Applicant’s arguments, see page 8, filed 02/26/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments overcome the minor informalities in the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 8, filed 02/26/2026, with respect to the USC 112(b) 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 The USC 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 8-10, filed 02/26/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Marchand et al (US 20090275974 A1), herein referenced to as “Marchand” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite “and the first bundling portion is positionable inside the basket”. The examiner agrees that Marchand does not explicitly disclose the first bunding portion is positionable inside the basket.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Marchand and Marchand et al (US 20110152993 A1).
Applicant's arguments, see page 11, filed 02/26/2026, with respect to the rejection(s) of claim(s) 1 in regards to a combination of Marchand have been fully considered but they are not persuasive.
The applicant argues that one of ordinary skill in the art would not be motivated to modify Marchand to have “the first bundling portion is positionable inside the basket” because of disclosure of Marchand in [0113].
Specifically, “Conformability of a distal end portion may provide better device conformance to irregular shaped aneurysms or other vascular defects. A convex surface of the device may flex inward forming a concave surface to conform to curvature of a vascular site”. The applicant argues that positioned the distal hub inside the permeable shell would impair the conformability of the distal end portion. The examiner respectfully disagrees.
Specifically, having a distal hub within the basket would still result in a concave surface forming, even more so as the hub would be even more proximal than the current configuration shown in Marchand.
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) 1-10, 12, 16, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand et al (US 20090275974 A1), herein referenced to as “Marchand 974” in view of Marchand et al (US 20110152993 A1), herein referenced to as “Marchand 993”.
Claim 1
Marchand 974 discloses: An embolization device 10 (see Figs. 1-6, [0089]) for a bump in a lumen (see [0003], vascular defect/aneurysm, which are bumps in a lumen of the vasculature), comprising: an outer tube 61 (see Fig. 11, [0102]) having a distal end distal end of 61 (see Fig. 19) and a proximal end proximal end of 61 (see Fig. 17); a basket 10 (see Figs. 1-6, [0102]) comprising a plurality of wires 14 (see Figs. 1-10, [0102]), the plurality of wires 14 configured to form a mesh structure (see Fig. 4, [0102], mesh structure) having a meshed wall surface 40 (see Fig. 4, [0102]) in which the plurality of wires 14 intersect each other (see Fig. 4, the wires 14 intersect each other, having a woven structure, [0102]); and a basket pusher 110 (see Figs. 6, 11, and 23-26, [0114]) disposed on a proximal side 32 (see Figs. 1, 6, 11, and 23-26, [0101]) of the basket 10, wherein, the basket 10 is disposed in a lumen 120 (see Figs. 11 and 23-26, [0120]) of the outer tube 61 so that the basket 10 is expandable (see Figs. 23-26, [0061], self-expanding) when the basket 10 comes out of the outer tube 61, the basket 10 has a first bundling portion 66 (see Fig. 6, [0105]) and a second bundling portion 68 (see Fig. 6, [0105]), and distal ends 62 (see Fig. 6, [0102]) of the plurality of wires 14 are bundled and fixed (see Fig. 6, [0105]) at the first bundling portion 66 on a distal side 34 (see Figs. 1 and 6, [010]) of the basket 10 and proximal ends 60 (see Fig. 6, [102]) of the plurality of wires 14 are bundled and fixed at the second bundling portion 68 on the proximal side 32 of the basket 10 and the plurality of wires 14 are disposed inside the second bundling portion 68 (see Fig. 6, 60 are disposed within 68, and a long medical object can’t pass through 60 into the interior of 10, [0105], additionally 68 holds an epoxy or solder, which would not allow an elongate element to pass through it) so that no passage for inserting a medical long object in a direction from the proximal side 32 toward the distal side 34 of the basket 10 exists inside the second bundling portion 68.
Marchand 974 does not explicitly disclose: and the first bunding portion is positionable inside the basket.
However, Marchand 993 in a similar field of invention teaches an embolization device 290 (see Figs. 50-5A) with a first bundling portion 306 (see Figs. 50-50A) and a basket 292 (see Figs. 50-50A). Marchand 993 further teaches: and the first bunding portion 306 is positionable (see Figs. 50-50A, [0237], 306 is positioned below the distal surface 296) inside the basket 292.
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 Marchand 974 to incorporate the teachings of Marchand 993 and teach an embolization device with the first bunding portion is positionable inside the basket. Motivation for such can be found in Marchand 993 as this creates an inverted structure (see [0020]) that provides a high surface area internal flow baffle to slow blood flow in side-wall aneurysms (see [0024]).
Claim 2
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the plurality of wires 14 are not fixed to each other at an intersection point (applicant defines this as allowing each wire to move when an external force is applied to the basket, applicant’s PGPUB [0074], see [0108] of Marchand, the ends of the filaments 14 are fixed to one another, and not the intersections of the filaments 14, thus allowing each wire to move when an external force is applied to the basket) of the meshed wall surface 40.
Claim 3
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the basket is configured so that a position of intersection point of the plurality of the wires of the meshed wall surface is shifted by an external force and a shape of an opening of the meshed wall surface is changed.
The language, "wherein the basket is configured so that a position of intersection point of the plurality of the wires of the meshed wall surface is shifted by an external force and a shape of an opening of the meshed wall surface is changed," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Marchand meets the structural limitations of the claim, and is capable of the wires shifting when an external force is applied (see Figs. 1 and 11) which changes the pore sizes of the meshed wall surface 40, furthermore, as the wires are made of a shape-memory metal (see [0106]), nitinol, known for its elasticity, the wires when met with a targeted precise force can also shift, changing adjacent pore sizes.
Claim 4
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein, in a state (see Fig. 4) where no external force is applied to the basket 10 and the basket is fully expanded (see Fig. 4), the basket viewed in a direction perpendicular to a longitudinal direction 46 (see Fig. 4, [0102]) of the outer tube 61 has an opening the pores 40 (see Fig. 4) of the meshed wall surface 40, in which an angle (see annotated Fig. 4 below) formed on the distal side 34 between a straight line (see annotated Fig. 4 below) passing through the first bundling portion 66 and the second bundling portion 68 and at least one wire of the plurality of wires 14 at a midpoint (see annotated Fig. 4 below) between the first bundling portion 66 and the second bundling portion 68 is equal to or larger than 30 degrees and smaller than 90 degrees (see annotated Fig. 4 below).
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Claim 5
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein, in a state (see Fig. 4) where no external force is applied to the basket 10 and the basket 10 is fully expanded (see Fig. 4), the basket 10 viewed in the direction perpendicular to a longitudinal direction 46 (see Fig. 4, [0102]) of the outer tube 61 has an opening the pores of 40 (see Fig. 4) of the meshed wall surface 40, in which an angle (see annotated Fig. 4 below, [0115], diamond shape) formed in an axial direction (see annotated Fig. 4 below) at the intersection point of the wires 14 is not smaller than 60 degrees and not larger than 160 degrees (see annotated Fig. 4 below).
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Claim 6
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the basket 10 is deformable (see Figs. 1, 3, and 11, [0106], super-elastic material) and is slidable inside a tube microcatheter (see [0140]) having an inner diameter of 0.021 inches or smaller (see [0140], inner lumen diameter of about 0.020 inches to 0.022 inches, which is less than 0.021 inches and includes 0.021 inches).
Claim 7
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: further comprising a detachable connection member 72 (see Figs. 6 and 11-15, [0105]) disposed between the basket 10 and the basket pusher 110 (see Figs. 11-15, and [0105], 72 is between 10 and 110).
Claim 8
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 7, see 103 rejection above. Marchand 974 further discloses: further comprising a heater 124 (see Figs. 11-15, [0118]) for heating the detachable connection member 72, wherein the detachable connection member 72 comprises a material (see [0114], [0118], and [0119], tether material) having a property of melting (see [0114] and [0119], severable, melting point) due to heat generated (see [0119], heats) by the heater 124.
Claim 9
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 7, see 103 rejection above. Marchand 974 further discloses: wherein in a cross-section (see Fig. 6, the cross section shown) perpendicular to the longitudinal direction 46 of the outer tube 61, the detachable connection member 72 is disposed inside the second bundling portion 68, and the wires 14 are disposed outside the connection member 72 (see Fig. 6, the ends 68 of the wires, are not inside 72, but are outside of it).
Claim 10
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein, in a state (see Fig. 4) where no external force (see Fig. 4) is applied to the basket 10 and the basket 10 is fully expanded (see Fig. 4), the first bundling portion 66 is located on the proximal side (see Fig. 4, 66 is proximal compared to the distal end of 10) with respect to a distal end 34 (see Fig. 4, the distal end of the mesh 40 is the distal end of 10) of the basket 10.
Claim 12
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein, in a state (see Fig. 4) where no external force (see Fig. 4) is applied to the basket 10 and the basket is fully expanded (see Fig. 4), the second bundling portion 68 is located on the distal side (see Fig. 4, 68 is distal compared to the proximal end of 10) with respect to a proximal end 32 of the basket 10.
Claim 16
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein at least one of the first bundling portion 66 and the second bundling portion 68 is bundled by a bundling member hubs (see Figs. 4 and 6, [0105] and [0108], hubs bundle the bundling portions, meets the 112(f) interpretation of a ring-shaped member as the hubs have ring-like shapes).
Claim 21
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the plurality of wires 14 are not fixed to each other at an intersection point (applicant defines this as allowing each wire to move when an external force is applied to the basket, applicant’s PGPUB [0074], see [0108] of Marchand, the ends of the filaments 14 are fixed to one another, and not the intersections of the filaments 14, thus allowing each wire to move when an external force is applied to the basket) of the meshed wall surface 40, the basket is configured so that a position of an intersection point of the plurality of the wires of the meshed wall surface is shifted by an external force and a shape of an opening of the meshed wall surface is changed, wherein, in a state (see Fig. 4) where no external force is applied to the basket 10 and the basket is fully expanded (see Fig. 4), the basket viewed in a direction perpendicular to a longitudinal direction 46 (see Fig. 4, [0102]) of the outer tube 61 has an opening the pores 40 (see Fig. 4) of the meshed wall surface 40, in which an angle (see 1st annotated Fig. 4 below) formed on the distal side 34 between a straight line (see 1st annotated Fig. 4 below) passing through the first bundling portion 66 and the second bundling portion 68 and at least one wire of the plurality of wires 14 at a midpoint (see 1st annotated Fig. 4 below) between the first bundling portion 66 and the second bundling portion 68 is equal to or larger than 30 degrees and smaller than 90 degrees (see annotated Fig. 4 below), and in a state (see Fig. 4) where no external force is applied to the basket 10 and the basket 10 is fully expanded (see Fig. 4), the basket 10 viewed in the direction perpendicular to the longitudinal direction 46 (see Fig. 4, [0102]) of the outer tube 61 has an opening the pores of 40 (see Fig. 4) of the meshed wall surface 40, in which an angle (see 2nd annotated Fig. 4 below, [0115], diamond shape) formed in an axial direction (see 2nd annotated Fig. 4 below) at the intersection point of the wires 14 is not smaller than 60 degrees and not larger than 160 degrees (see annotated Fig. 4 below).
The language, "wherein the basket is configured so that a position of intersection point of the plurality of the wires of the meshed wall surface is shifted by an external force and a shape of an opening of the meshed wall surface is changed," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Marchand meets the structural limitations of the claim, and is capable of the wires shifting when an external force is applied (see Figs. 1 and 11) which changes the pore sizes of the meshed wall surface 40, furthermore, as the wires are made of a shape-memory metal (see [0106]), nitinol, known for its elasticity, the wires when met with a targeted precise force can also shift, changing adjacent pore sizes.
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Claim 22
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the embolization device 10 comprises: the outer tube 61 having the distal end distal end of 61 and the proximal end proximal end of 61; the basket 10 disposed in the lumen 120 of the outer tube 61, the basket 10 comprising the plurality of wires 14, the plurality of wires 14 being configured to form the mesh structure (see Fig. 4, [0102], mesh structure) having the meshed wall surface 40 in which the plurality of wires 14 intersect (see Fig. 4, the wires 14 intersect each other, having a woven structure, [0102]); and the basket pusher 110 disposed on the proximal side 32 of the basket 10, the basket 10 being expandable (see Figs. 23-26, [0061], self-expanding) when the basket 10 comes out of the outer tube 61, the basket 10 having the first bundling portion 66 and the second bundling portion 68, distal ends distal ends of 14 of the plurality of wires 14 being bundled and fixed at the first bundling portion 66 on the distal side 34 of the basket 10, and proximal ends proximal ends of 14 of the plurality of wires 14 being bundled and fixed at the second bundling portion 68 on the proximal side 32 of the basket 10.
Marchand 993 in a similar field of invention teaches an embolization device 430 (see Figs. 63-64) with a basket 430 with a meshed wall surface 432 (see Figs. 63-64). Marchand 993 further teaches: A method of placing a medical long object 436 (see Figs. 63-64, [0258], coils) in an in-vivo lumen (see Fig. 64, in-vivo lumen of 160), comprising: and introducing the medical long object 436 into an interior 434 (see Fig. 64, [0258]) of the basket 430 through an opening a pore of 430 (see Figs. 63-64, [0257]-[0258]) of the meshed wall surface 432 of the basket 430.
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 Marchand 974 to incorporate the teachings of Marchand 993 and teach the embolization device used with a method of placing a medical long object in an in-vivo lumen comprising: and introducing the medical long object into an interior of the basket through an opening of the meshed wall surface of the basket. Motivation for such can be found in Marchand as this allows for filling of the embolization device with coils to treat larger aneurysms without needing to use a larger catheter to reach the aneurysm (see [0258]).
Claim 23
The combination of Marchand 974 and Marchand 993 teaches: The method according to claim 22, see 103 rejection above. Marchand 993 further teaches: wherein the opening of the meshed wall surface through which the medical long object 436 (see [0258], coils) is introduced is selected from a plurality of mesh openings the pores of 432 (see Figs. 63-64) of the meshed wall surface 432 according to a condition of a lesion site or a procedure (see [0258], the condition is that the aneurysm is a larger aneurysm, the procedure is filling a larger aneurysm, and it is chosen to use an opening of the plurality of mesh openings to fill the device to pack the aneurysm).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand 974 and Marchand 993 as applied to claim 1 above, and further in view of Sepetka et al (US 20060116713 A1), herein referenced to as “Sepetka”.
Claim 17
The combination of Marchand 974 and Marchand 993 teaches: The embolization device according to claim 1, see 103 rejection above. Marchand 974 further discloses: wherein the wires 14 include a first wire 48 (see Fig. 10, [0102]) and a second wire 50 (see Fig. 10, [0102]).
The combination of Marchand 974 and Marchand 993 does not explicitly teach: and a material forming the first wire is different from a material forming the second wire.
However, Sepetka in a similar field of invention teaches an embolization device 30 (see Figs. 6-7) with wires 34 + 36 (see Figs. 6-7) with a first wire 34 and a second wire 36. Sepetka further teaches: and a material forming the first wire 34 is different from a material forming the second wire 36 (see [0253], the filament 34, can have different materials, and the filament 36 can have different materials).
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 Marchand to incorporate the teachings of Sepetka and have an embolization device with a material forming the first wire is different from a material forming the second wire. This is due to using different materials for the filaments/wires of an embolization device (see [0253]) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 18
The combination of Marchand 974, Marchand 993, and Sepetka teaches: The embolization device according to claim 17, see 103 rejection above. Sepetka further teaches: wherein at least one of the first wire 34 and the second wire 36 has a configuration having a core portion platinum wire core (see [0253], which has radiopacity) containing an X-ray impermeable material (see [0253], platinum wire core) and an outer layer portion (see [0326], nitinol, is an example of a filament, and platinum can be embedded into a nitinol outer layer portion) containing a Ni-Ti alloy (see [0326]).
Claim 19
The combination of Marchand 974, Marchand 993, and Sepetka teaches: The embolization device according to claim 17, see 103 rejection above. Sepetka further teaches: wherein the second wire 36 is composed of a structure (see [0253], twisted double platinum wires, or combinations of other materials) obtained by twisting together a plurality of wire materials (see [0253]).
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.
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.
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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