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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 03/08/2022. It is noted, however, that applicant has not filed a certified copy of the JP2022-034901 application as required by 37 CFR 1.55.
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.
Claim(s) 1-2, 5, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forber et al (US 5733294 A), herein referenced to as “Forber”.
Claim 1
Forber discloses: A medical device 20 + 40 (see Figs. 1-5E, col. 3, lines 15-20) comprising: an outer tube 40 (see Figs. 5A-5E, col. 4, lines 39-55) having a distal end 48 (see Figs. 5A-5E, col. 4, lines 55-60) and a proximal end the proximal end of 40 (see Figs. 5A-5E, a catheter which is a tube has a proximal end and a distal end as known in the art); a basket 20 (see Figs. 1-5E, col. 3, lines 15-20 and col. 4, lines 55-60) disposed in an inner cavity the lumen of 40 (see Figs. 5A-5E) of the outer tube 40 and having a plurality of wires 22 (see Figs. 1-5E, col. 3, lines 15-20) , the basket 20 being expandable (see Figs. 5A-5E, 20 expanding as it comes out of 40, col. 4, lines 39-54) when having come out of the outer tube 40; and a basket pusher 42 (see Figs. 5A-5E, col. 4, lines 39-54) disposed on a proximal side 42 is placed proximally in relation to 20 (see Figs. 5A-5E) with respect to the basket 20, wherein the basket 20 includes a first bundling portion 23 (see Figs. 1, 4, and 5A, col. 3, lines 15-20) at which the plurality of wires 22 are bundled and fixed at a distal portion distal portion of 20 (see Figs. 1, 4, and 5A) of the basket 20, and a second bundling portion 27 (see Figs. 1, 4, and 5A, col. 3, lines 15-20) at which the plurality of wires 22 are bundled and fixed at a proximal portion proximal portion of 20 (see Figs. 1, 4, and 5A) of the basket 20, the basket 20 is configured so that in a state (see Fig. 5A, col. 4, lines 41-44) where the basket 20 is accommodated in the outer tube 40, the first bundling portion 23 has a first end (see annotated Fig. 5A below) being an end portion on a far side (see annotated Fig. 5A below) with respect to the second bundling portion 27 and a second end (see annotated Fig. 5A below) being an end portion on a near side (see annotated Fig. 5A below) with respect to the second bundling portion 27, and the basket 20 is configured so that in a state (see Figs. 5C-5E, col. 5, lines 16-47) where an entirety of the basket 20 has come out of the outer tube 40 and no external force (see Figs. 1 and 5C-5E, col. 5, lines 16-47) is applied to the basket 20, the second end (see annotated Fig. 1 below) is positioned on a distal side (see annotated Fig. 1 below) with respect to the first end (see annotated Fig. 1 below).
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Claim 2
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the basket 20 is configured so that in the state (see Fig. 5A) where the basket 20 is accommodated in the outer tube 40, the first bundling portion 23 is positioned outside the basket (see Fig. 5A, 23 is positioned outside of the basket), and in the state (see Fig. 1) where the entirety of the basket 20 has come out of the outer tube 40 and no external force is applied to the basket 20, the first bundling portion 23 is positioned inside the basket 20 (see Fig. 1, 23 is inside the basket 20).
Claim 5
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the plurality of wires 22 of the basket 20 include a first wire group (see annotated Fig. 1 below) and a second wire group (see annotated Fig. 1 below), and the basket 20 is configured so that in the state (see Fig. 1) where the entirety of the basket 20 has come out of the outer tube 40 and no external force is applied to the basket 20, a radius (see annotated Fig. 1 below) of a bent portion (see annotated Fig. 1 below) of the wire of the first wire group (see annotated Fig. 1 below) on the distal side (see annotated Fig. 1 below) with respect to the second end (see annotated Fig. 1 below) of the first bundling portion 23 is smaller than a radius (see annotated Fig. 1 below) of a bent portion of the wire of the second wire group (see annotated Fig. 1 below) on the distal side (see annotated Fig. 1 below) with respect to the second end (see annotated Fig. 1 below) of the first bundling portion 23.
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Claim 12
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the first bundling portion 23 and the second bundling portion 27 include a radiopaque material (see col. 3, lines 15-30, radiopaque).
Claim 13
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein each wire 22 of the basket 20 includes a superelastic alloy (see col. 3, lines 15-30, nitinol which is a superelastic alloy as known in the art).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forber in view of Chou et al (US 20180242978 A1), herein referenced to as “Chou”.
Claim 3 and Claim 4
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the plurality of wires 22 of the basket 20 include a first wire group (see annotated Fig. 1 below), a second wire group (see annotated Fig. 1 below), and a third group (see annotated Fig. 1 below).
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Forber does not explicitly disclose: and a length of the wire of the first wire group is shorter than a length of the wire of the second wire group; a length of the wire of the third wire group is longer than the length of the wire of the first wire group and shorter than the length of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group.
However, Chou in a similar field of invention teaches a medical device 102 (see Fig. 2B) with a plurality of wires 202 (see Fig. 2B) with a basket pusher 104 (see Fig. 2B), first wire group (see annotated Fig. 2B below) and a second wire group (see annotated Fig. 2B below), and a third wire group (see annotated Fig. 2B below). Chou further teaches: and a length (see annotated Fig. 2B below) of the wire of the first wire group (see annotated Fig. 2B below) is shorter than a length (see annotated Fig. 2B below) of the wire of the second wire group (see annotated Fig. 2B below) a length of the wire of the third wire group (see annotated Fig. 2B below) is longer than the length of the wire of the first wire group (see annotated Fig. 2B below) and shorter than the length of the wire of the second wire group (see annotated Fig. 2B below), and in a cross-section perpendicular to an extending direction of the basket pusher 104, a distance (see annotated Fig. 2B below) between the first wire group (see annotated Fig. 2B below) and the second wire group (see annotated Fig. 2B below) is longer than a distance between the first wire group (see annotated Fig. 2B below) and the third wire group (see annotated Fig. 2B 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 Forbes to incorporate the teachings of Chou and teach a medical device with a length of the wire of the first wire group is shorter than a length of the wire of the second wire group; a length of the wire of the third wire group is longer than the length of the wire of the first wire group and shorter than the length of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group. Motivation for such can be found in Chou as this allows the device to exert enough radial strength in the expanded configuration to grip the anchoring anatomy and resist a proximal pull (see [0098]).
Claim(s) 6-9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forber in view of Calabria et al (US 20090227976 A1), herein referenced to as “Calabria”.
Claim 6 and Claim 7
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the plurality of wires 22 of the basket 20 include a first wire group (see annotated Fig. 1 below), a second wire group (see annotated Fig. 1 below), and a third group (see annotated Fig. 1 below).
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Forber does not explicitly disclose: a rigidity of the wire of the first wire group is lower than a rigidity of the wire of the second wire group; a rigidity of the wire of the third wire group is higher than the rigidity of the wire of the first wire group and lower than the rigidity of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group.
However, Calabria in a similar field of invention teaches a medical device 200 (see Fig. 2) with a pusher 204 (see Fig. 2), a plurality of wires 202 + 802 + 806 + 808 (see Figs. 2 and 8) with a first wire group 802 (see Fig. 8), a second wire group 806 (see Fig. 8) and a third wire group 808 (see Fig. 8). Calabria further teaches: a rigidity (see Fig. 8, [0065], the diameter, hence the surface area of 802 is the smallest so it has the lowest rigidity and rigidity is directly proportional to surface area which is proportional to the diameter of a circle) of the wire of the first wire group 802 is lower than a rigidity (see Fig. 8, [0065], the diameter, hence the surface area of 806 is the largest so it has higher rigidity than 802 and 808) of the wire of the second wire group 806; a rigidity (see Fig. 8, [0065], the diameter, hence the surface area of 808 is intermediate to 802 and 806, hence it has a rigidity higher than 802 but lower than 806) of the wire of the third wire group 808 is higher than the rigidity of the wire of the first wire group 802 and lower than the rigidity of the wire of the second wire group 806, and in a cross-section (see Fig. 8, shows a cross-section perpendicular to a direction to the pusher 204) perpendicular to an extending direction of the basket pusher 204, a distance between the first wire group (see Fig. 8, the distance between 802 and 806 is greater than the distance between 802 and 808) and the second wire group 806 is longer than a distance between the first wire group 802 and the third wire group 808.
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 Forber to incorporate the teachings of Calabria and teach a medical device with a rigidity of the wire of the first wire group is lower than a rigidity of the wire of the second wire group; a rigidity of the wire of the third wire group is higher than the rigidity of the wire of the first wire group and lower than the rigidity of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group. Motivation for such can be found in Calabria as differing mechanical biases allow for the overall device to have differing structure overtime for biocompatible implantation (see [0061]).
Claim 8 and Claim 9
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber further discloses: wherein the plurality of wires 22 of the basket 20 include a first wire group (see annotated Fig. 1 below), a second wire group (see annotated Fig. 1 below), and a third group (see annotated Fig. 1 below).
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Forber does not explicitly disclose: and an outer diameter of the wire of the first wire group is smaller than an outer diameter of the wire of the second wire group; an outer diameter of the wire of the third wire group is larger than the outer diameter of the wire of the first wire group and smaller than the outer diameter of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group.
However, Calabria in a similar field of invention teaches a medical device 200 (see Fig. 2) with a pusher 204 (see Fig. 2), a plurality of wires 202 + 802 + 806 + 808 (see Figs. 2 and 8) with a first wire group 802 (see Fig. 8), a second wire group 806 (see Fig. 8) and a third wire group 808 (see Fig. 8). Calabria further teaches: and an outer diameter the diameter of 802 (see Fig. 8, [0065], smallest diameter) of the wire of the first wire group 802 is smaller than an outer diameter the diameter of 806 (see Fig. 8, [0065], largest diameter of 802, 806, and 808) of the wire of the second wire group 806; an outer diameter the diameter of 808 (see Fig. 8, [0065], diameter larger than 802 but smaller than 806) of the wire of the third wire group 808 is larger than the outer diameter the diameter of 802 of the wire of the first wire group 802 and smaller than the outer diameter the diameter of 806 of the wire of the second wire group 806, and in a cross-section (see Fig. 8, shows a cross-section perpendicular to a direction to the pusher 204) perpendicular to an extending direction of the basket pusher 204, a distance between the first wire group (see Fig. 8, the distance between 802 and 806 is greater than the distance between 802 and 808) and the second wire group 806 is longer than a distance between the first wire group 802 and the third wire group 808.
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 Forber to incorporate the teachings of Calabria and teach a medical device with an outer diameter of the wire of the first wire group is smaller than an outer diameter of the wire of the second wire group; an outer diameter of the wire of the third wire group is larger than the outer diameter of the wire of the first wire group and smaller than the outer diameter of the wire of the second wire group, and in a cross-section perpendicular to an extending direction of the basket pusher, a distance between the first wire group and the second wire group is longer than a distance between the first wire group and the third wire group. Motivation for such can be found in Calabria as differing mechanical biases allow for the overall device to have differing structure overtime for biocompatible implantation (see [0061]).
Claim 14
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber does not explicitly disclose: wherein each wire of the basket includes a radiopaque material.
However, Calabria in a similar field of invention teaches a medical device 200 (see Fig. 2) with a pusher 204 (see Fig. 2), a plurality of wires 202 + 802 + 806 + 808 (see Figs. 2 and 8) with a first wire group 802 (see Fig. 8), a second wire group 806 (see Fig. 8) and a third wire group 808 (see Fig. 8). Calabria further teaches: wherein each wire 202 + 802 + 806 + 808 of the basket includes a radiopaque material (see [0041], radiopaque fibers).
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 Forber to incorporate the teachings of Calabria and have each wire of the basket of a medical device with a radiopaque material. This is due to using radiopaque material for wires in occlusive medical devices (see [0041] of Calabria) are 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(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forber in view of Vu et al (US 20210282789 A1), herein referenced to as “Vu”.
Claim 10
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber does not explicitly disclose: wherein the basket is configured so that in the state where the basket is accommodated in the outer tube, the second bundling portion has one end being an end portion on a near side with respect to the first bundling portion and another end being an end portion on a far side with respect to the first bundling portion, and in the state where the entirety of the basket has come out of the outer tube and no external force is applied to the basket, the one end is positioned on the distal side with respect to the other end.
However, Vu in a similar field of invention teaches a medical device 10 (see Figs. 6 and 11) with a basket 40 (see Figs. 6 and 11) with a second bundling portion 66 (see Figs. 6 and 11), a first bundling portion 68 (see Figs. 6 and 11), and an outer tube 61 (see Fig. 11). Vu further teaches: wherein the basket 40 is configured so that in the state (see Fig. 11, [0029] and [0064]) where the basket 40 is accommodated in the outer tube 61, the second bundling portion 68 has one end (see annotated Fig. 11 below) being an end portion on a near side (see annotated Fig. 11 below) with respect to the first bundling portion 66 and another end (see annotated Fig. 11 below) being an end portion on a far side (see annotated Fig. 11 below) with respect to the first bundling portion 66, and in the state (see Fig. 6, [0024] and [0074]) where the entirety of the basket 40 has come out of the outer tube 61 and no external force is applied to the basket 40, the one end (see annotated Fig. 6 below) is positioned on the distal side (see annotated Fig. 6 below) with respect to the other end (see annotated Fig. 6 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 Forber to incorporate the teachings of Vu and teach a medical device with the basket is configured so that in the state where the basket is accommodated in the outer tube, the second bundling portion has one end being an end portion on a near side with respect to the first bundling portion and another end being an end portion on a far side with respect to the first bundling portion, and in the state where the entirety of the basket has come out of the outer tube and no external force is applied to the basket, the one end is positioned on the distal side with respect to the other end. Motivation for such can be found in Vu as this creates a sinusoid-like or multiple curve shape may provide a concavity in the proximal end that may reduce an obstruction of flow in a parent vessel adjacent a vascular defect (see [0074]).
Claim 11
Forber discloses: The medical device according to claim 1, see 102 rejection above. Forber does not explicitly disclose: comprising a connection member on the proximal side with respect to the basket and on the distal side with respect to the basket pusher.
However, Vu in a similar field of invention teaches a medical device 10 (see Figs. 6 and 11) with an outer tube 61 (see Fig. 11), a basket pusher 72 (see Figs. 6 and 11), a basket 40 (see Figs. 6 and 11) with a second bundling portion 66 (see Figs. 6 and 11) and a first bundling portion 68 (see Figs. 6 and 11). Vu further teaches: comprising a connection member 92 (see Fig. 6, [0076]) on the proximal side the proximal side of 40 (see Fig. 6) with respect to the basket 40 and on the distal side distal side of 72 (see Fig. 6, [0076]) with respect to the basket pusher 72.
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 Forber to incorporate the teachings of Vu and teach a medical device with a connection member on the proximal side with respect to the basket and on the distal side with respect to the basket pusher. Motivation for such can be found in Vu as this creates a releasable tether for the device that can be actuated by the user when proper positioning of the implant has been confirmed with controllable manner(see [0070] and [0076]).
Conclusion
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