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 Amendment filed 06/11/24 has been entered. Claims 1, 7, 9-13, and 15-16 have been amended, claims 2-6, 8, 14, and 17-25 have been cancelled, and new claims 26-33 have been entered. Claims 1, 7, 9-13, 15-16, and 26-33 are addressed in the following office action.
Claim Rejections - 35 USC § 102
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, 26-28, and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aguilar et al. (EP 2,713,909).
Regarding claim 1, an invention relating to intraluminal devices, Aguilar discloses (Figs. 12A-B) an intraluminal device comprising: an elongated structure (400) formed of a plurality of wires (402 & 403), the elongated structure comprising: a clot capturing area comprising a plurality of strands [i.e. elements defined by twisted wires (402 & 403; Par. 0098)] spaced circumferentially about the elongated structure (Fig. 12A; Par. 0098), the plurality of strands being configured to cooperate with each other to form a plurality of clot entry openings [i.e. openings between intersecting strands in the clot capturing area], each strand of the plurality of strands comprising a set of two or more wires of the plurality of wires, and the plurality of strands being intertwined [i.e. interlock or interweaving] with each other to create a plurality of loosely coupled junctions (405), wherein each junction of the plurality of loosely coupled junctions includes a weaving of a first strand and a second strand (see annotated figure below) such that a first wire (402) of the first strand is situated between two wires of the second strand and a second wire (403) of the second strand is situated between two wires of the first strand, and wherein the plurality of strands within the clot capturing area includes a twist of wires before and after each junction of the plurality of loosely coupled junctions (see annotated figure below) [Note, figure 12B exemplifies the twisted wires in the clot capturing area (Par. 0098), therefore the twisted wires are expected to be before and after each of the plurality of junctions].
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Regarding claim 26, Aguilar discloses the intraluminal device of claim 1. Aguilar discloses further comprising at least one grouping of woven wires (see annotated figure below) [Note, the twisted or spiraling elements interlocking crossing elements at intersections/interweaving is interpreted as the woven wires] longitudinally located adjacent to the clot capturing area, wherein the at least one grouping of woven wires is configured such that when an opening force [i.e. radial expansive force] is exerted on the elongated structure, the at least one grouping of woven wires provides structural support to hold open first interstices [i.e. openings between intersecting strands in the intermediate portion but outside the clot capturing area] between the plurality of strands, and wherein in response to the opening force, second interstices [i.e. openings between intersecting strands in the at least one grouping of woven wires] are formed between wires in the at least one grouping of woven wires, the first interstices between the strands being larger than the second interstices between the wires (Fig. 12A; Par. 0098).
Regarding claim 27, Aguilar discloses the intraluminal device of claim 26. Aguilar further discloses (Fig. 12A) wherein the at least one grouping of woven wires forms at least one of a distal filter (414; Par. 0097-0098).
Regarding claim 28, Aguilar discloses the intraluminal device of claim 26. Aguilar further discloses (Fig. 12A) wherein the at least one grouping of woven wires forms at least one of a distal scaffold (414; Par. 0097-0098).
Regarding claim 31, Aguilar discloses the intraluminal device of claim 1. Aguilar further discloses wherein the plurality of wires includes at least 8 wires (Par. 0088).
Regarding claim 32, Aguilar discloses the intraluminal device of claim 31. Aguilar further discloses wherein each wire of the plurality of wires has a diameter of about 60 to 85 microns (Par. 0088).
Regarding claim 33, Aguilar discloses the intraluminal device of claim 1. Aguilar further discloses wherein the elongated structure is configured to transition between a collapsed position for delivery to a treatment site and an expanded position in response to an opening force exerted thereon (Par. 0098).
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.
Claims 7, 9, 11-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sudin et al. (US 2014/0343663) in view of Aguilar et al. (EP 2,713,909).
Regarding claim 7, an invention relating to intraluminal devices, Sudin discloses (Fig. 1) an intraluminal device including an elongated structure (100) formed of a plurality of wires (102; Par. 0033 & 0044), the intraluminal device comprising: a first region (3) wherein the plurality of wires are twisted to form a shaft (3; Par. 0057); a second region (see annotated figure below), adjacent to the first region, wherein the plurality of wires are woven to form a scaffold (Abstract); a third region (see annotated figure below), adjacent to the second region, wherein the plurality of wires are separated into a plurality of strands [i.e. filaments arranged in staked configuration] spaced circumferentially about the elongated structure (Par. 0039 & 0053-0055), the plurality of strands being configured to cooperate with each other to form a clot capture structure (Par. 0031), each strand of the plurality of strands comprising a set of two or more wires (1102) of the plurality of wires (Par. 0055); and a fourth region (see annotated figure below) wherein the plurality of wires are braided to form a dense filter configured to catch a blood clot [Note, Merriam-Webster defines a filter as "a porous article or mass through which a gas or liquid is passed to separate out matter in suspension", and the distal region of the elongate structure is a braided filament mesh through which blood is passed and can separate out obstructions that are larger than the pores. Hence, the fourth region is interpreted as comprising a dense filter configured to catch a blood clot] (Par 0070).
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However, Sudin fails to disclose the plurality of strands being intertwined with each other to create a plurality of loosely coupled junctions, wherein each junction of the plurality of loosely coupled junctions includes a weaving of a first strand and a second strand such that a first wire of the first strand is situated between two wires of the second strand and a second wire of the second strand is situated between two wires of the first strand, and wherein the plurality of strands within the clot capturing area includes a twist of wires before and after each junction of the plurality of loosely coupled junctions.
In the same field of endeavor, which is intraluminal devices, Aguilar discloses (Figs. 12A-B) a plurality of strands [i.e. twisted wires (402 & 403)] being intertwined with each other to create a plurality of loosely coupled junctions (405), wherein each junction of the plurality of loosely coupled junctions includes a weaving of a first strand and a second strand such that a first wire of the first strand is situated between two wires of the second strand and a second wire of the second strand is situated between two wires of the first strand, and wherein the plurality of strands within a clot capturing area [i.e. portion of element 400 that capture debris, thrombus, foreign body, etc] includes a twist of wires before and after each junction of the plurality of loosely coupled junctions (see annotated figure below) [Note, figure 12B exemplifies the twisted wires in the clot capturing area (Par. 0098), therefore the twisted wires are expected to be before and after each of the plurality of junctions].
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sudin to have the plurality of strands being intertwined with each other to create a plurality of loosely coupled junctions, wherein each junction of the plurality of loosely coupled junctions includes a weaving of a first strand and a second strand such that a first wire of the first strand is situated between two wires of the second strand and a second wire of the second strand is situated between two wires of the first strand, and wherein the plurality of strands within the clot capturing area includes a twist of wires before and after each junction of the plurality of loosely coupled junctions. Doing so would create additional surface area to increase the ability of the device to capture debris, thrombus, foreign body, etc (Par. 0098), as taught by Aguilar.
Regarding claim 9, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 7. Sudin further discloses wherein the elongated structure is configured such that when the opening force is applied, first interstices are formed between wires in the second region and second interstices are formed between wires in the third region, such that the second interstices are larger than the first interstices (Fig. 1; Par. 0060 & 0065).
Regarding claim 11, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 7. Sudin further discloses (Fig. 1) further comprising a fifth region (112-2), adjacent to the fourth region, and wherein the plurality of wires in the fifth region are twisted [i.e. coiled] to form an additional shaft (112-2; Par. 0046).
Regarding claim 12, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 7. Sudin further discloses wherein the plurality of wires includes at least 8 wires (Par. 0054-0055).
Regarding claim 13, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 12. Sudin further discloses wherein each wire of the plurality of wires has a diameter of about 60 to 80 microns (Par. 0057).
Regarding claim 15, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 7. Sudin further discloses wherein the elongated structure is configured such that the opening force is applied via axial movement of the first region (Par. 0034 & 0040).
Regarding claim 16, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 7. Sudin discloses further comprising an additional second region of scaffold between the third region and the fourth region (see annotate figure below).
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Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sudin et al. (US 2014/0343663) in view of Aguilar et al. (EP 2,713,909) as applied to claim 9 above, or, in the alternative, under 35 U.S.C. 103 as obvious over Greenhalgh (US 6,364,895).
Regarding claim 10, Sudin, as modified by Aguilar, discloses the intraluminal device of claim 9. Sudin further discloses wherein the elongated structure is configured such that when the opening force is applied, third interstices are formed between wires in the fourth region, such that the third interstices are smaller than both the first interstices and the second interstices (Par. 0060 & 0067-0068).
In the alternative and the analogous art of intraluminal devices, Greenhalgh teaches (Fig. 1) wherein an elongated structure (10) is configured such that when the opening force is applied (Col. 4, lines 52-57), third interstices [i.e. openings] are formed between wires (24) in a fourth region, such that the third interstices are smaller than both first interstices and second interstices [i.e. openings formed between wires (22)] (see annotated figure below & Col. 5, lines 15-25 & Col. 7, lines 36-44)
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sudin, in view of Aguilar, to have wherein the elongated structure is configured such that when the opening force is applied, third interstices are formed between wires in the fourth region, such that the third interstices are smaller than both the first interstices and the second interstices. Doing so would prevent embolism during vascular procedure (Col. 1, lines 15-30), as taught by Greenhalgh.
Claim 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Aguilar et al. (EP 2,713,909) as applied to claim 1 above, and further in view of Sudin et al. (US 2014/0343663).
Regarding claim 29, Aguilar discloses the intraluminal device of claim 1. Aguilar fails to disclose further comprising a proximal shaft, wherein the proximal shaft is formed by twisting or coiling the plurality of wires.
In the same field of endeavor, which is intraluminal devices, Sudin teaches (Fig. 9) a proximal shaft (902-3), wherein the proximal shaft is formed by twisting or coiling the plurality of wires and an endpiece (912; Par. 0051).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aguilar to have a proximal shaft, wherein the proximal shaft is formed by twisting or coiling the plurality of wires. Doing so would maintain the coil in shaft region while the mesh in the filament mesh expands or contracts under control of an elongated control member (Par. 0051), as taught by Sudin.
Regarding claim 30, Aguilar discloses the intraluminal device of claim 1. Aguilar fails to disclose further comprising a shaft, wherein the shaft is formed by twisting or coiling the plurality of wires.
In the same field of endeavor, which is intraluminal devices, Sudin teaches (Fig. 9) a shaft (902-3), wherein the shaft is formed by twisting or coiling the plurality of wires and an endpiece (912; Par. 0051).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aguilar to have a shaft, wherein the shaft is formed by twisting or coiling the plurality of wires. Doing so would maintain the coil in shaft region while the mesh in the filament mesh expands or contracts under control of an elongated control member (Par. 0051), as taught by Sudin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, 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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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 January 11, 2026