DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 07/17/25.
The examiner acknowledges the amendments to the claims.
Claims 1, 3-14 are pending in this application.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 5, “the waist” should read as --the waist portion--.
In lines 9-10, “the waist” should read as --the waist portion--.
In line 14, “the waist” should read as --the waist portion--.
In line 17, “the waist” should read as --the waist portion--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10, line 1 recites “the first disk”. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be read as --the proximal disk--.
Claim 12 recites “at least one of the proximal and distal disks comprises a short arm extending in a first direction from the hub, and a long arm extending in a second direction from the hub”. It is unclear if “a short arm” is referring to “a first short arm” previously recited in Claim 1, line 14 (upon which Claim 12 depends), and if “a long arm” is referring to “a second extended arm” as previously recited in Claim 1, line 17. For examination purposes, “a short arm” will be read as --the first short arm--, and “a long arm” will be read as --the second extended arm--. Furthermore, in Claim 13 (dependent on Claim 12) “the short arm” will be read as --the first short arm--, and “the long arm” will be read as --the second extended arm--.
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 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freudenthal (U.S. Pub. No. 2006/0224183), cited in IDS filed 04/09/25.
Regarding claim 1, Freudenthal discloses an asymmetric occlusion device 1 (Figures 3-3a; [0073]-[0076]) for occluding an opening in a body tissue, comprising:
a. a waist portion 40 having a distal end extending to a proximal end;
b. a pair of asymmetric occluder disks, comprising:
i. an asymmetric distal disk 30 attached to a distal portion of the waist, the asymmetric distal disk being asymmetric in a radial direction relative a longitudinal axis of the occlusion device (extending through through-opening 50), the asymmetric distal disk comprises a rim (outer circumferential surface) and shape memory material (claim 66, [0032], [0104]), and
ii. an asymmetric proximal disk 20 attached to a proximal portion of the waist, the asymmetric proximal disk being asymmetric in a radial direction relative a longitudinal axis of the occlusion device (extending through through-opening 50), the asymmetric proximal occluder disk comprises a rim (outer circumferential surface) and shape memory material (claim 66, [0032], [0104]);
wherein each asymmetric disk comprises:
a) a first short arm (extending to 23, 33) having a portion extending from the waist to the rim with a first length as measured perpendicularly relative the longitudinal axis of the occlusion device, and
b) a second extended arm (extending to 21, 31) having a portion extending from the waist to the rim with a second length as measured perpendicularly relative the longitudinal axis of the occlusion device,
wherein a length of the second extended arm, as measured perpendicularly from a hub area (central area of through-opening 50) of the asymmetric occluder disk, exceeds a length of the first short arm, as measured perpendicularly from the hub area of the asymmetric occluder disk, wherein the first length is longer than the second length;
c. a channel 50 extending through the waist portion and the pair of asymmetric disks.
Regarding claim 4, Freudenthal discloses the waist portion 40 has a width that is smaller than a width of the proximal disk 20 and the distal disk 30 (Figure 3a).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal (U.S. Pub. No. 2006/0224183) in view of Cully et al., hereinafter “Cully” (U.S. Pub. No. 2006/0136043), cited in IDS filed 04/09/25.
Regarding claim 3, Freudenthal discloses the claimed invention, as discussed above, except for the proximal disk, the distal disk and the waist portion are formed from a braiding of wires, as Fredenthal teaches an interwoven single wire (see abstract).
Cully teaches an occlusion device formed of multiple braided wires ([0044], [0047]) instead of one wire.
It would have been obvious to one of ordinary skill before the effective filing date to modify the occlusion device of Freudenthal such that the proximal disk, the distal disk and the waist portion are formed from a braiding of wires, as taught by Cully, as a known alternative to a single wire (Id.) and since doing so would be substitution of one known braid for another, which would yield predictable results, namely occlusion of defective openings in the body. See MPEP 2143.
Claims 5, 7-8, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal (U.S. Pub. No. 2006/0224183) in view of Cully (U.S. Pub. No. 2006/0136043) and Amplatz et al., hereinafter “Amplatz” (U.S. Patent No. 6,468,303), cited in IDS filed 04/09/25.
Regarding claim 5, Freudenthal discloses the claimed invention, as discussed above, except for a hub joining ends of wires of the braiding, the hub protruding from an exterior surface of at least one of the proximal or distal disks.
Cully teaches an occlusion device formed of multiple braided wires ([0044], [0047]) instead of one wire.
It would have been obvious to one of ordinary skill before the effective filing date to modify the occlusion device of Freudenthal such that the proximal disk, the distal disk and the waist portion are formed from a braiding of wires, as taught by Cully, as a known alternative to a single wire (Id.) and since doing so would be substitution of one known braid for another, which would yield predictable results, namely occlusion of defective openings in the body. See MPEP 2143.
Furthermore, Amplatz teaches in Figures 1-3, a hub 24 protruding from an exterior surface of at least one of proximal or distal disks 12, 14.
It would have been obvious to one of ordinary skill before the effective filing date to modify Freudenthal as modified with a hub as claimed, as taught by Amplatz, in order to inhibit unraveling of the wires and to allow coupling with a delivery device (Amplatz; col. 5, lines 20-25).
Regarding claim 7, Freudenthal as modified teaches the hub 24 is off-center of the waist portion 16 (Amplatz, Figures 1-3).
Regarding claim 8, Freudenthal as modified teaches the braids of at least one of the proximal and distal disks 12, 14 radiating in a first direction extending further from the hub 24 along the disk than braids radiating in a second direction along the disk opposite the first direction (Amplatz, Figures 1-3).
Regarding claim 12, Freudenthal as modified teaches at least one of the proximal and distal disks comprises a short arm (the first short arm, to the right side of 24 in Figures 2-3 of Amplatz) extending in a first direction from the hub 24, and a long arm (the second extended arm, to the left side of 24 in Figures 2-3) extending in a second direction from the hub, wherein the first direction is different from the second direction.
Regarding claim 13, Freudenthal as modified teaches the claimed invention, as discussed above, except for the short arm (first short arm) being thicker than the long arm (the second extended arm). However, Freudenthal teaches the occluder device material thickness can be different from portion to portion ([0024], [0032]) wherein the larger thickness yields different (greater) stiffness to adapt to a specific application to have a secure hold inside the body. Also, in other embodiments ([0082]-[0084], Figures 7-7c) teach thicker occluder portions 20.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have the short arm be thicker than the long arm,
in order to adjust and change the stability of the occluder in a targeted manner to a specific application at the shorter side, such that the thicker area has a firmer and secure hold in the body (Freudenthal; [0022], [0024]).
Regarding claim 14, Freudenthal as modified teaches the claimed invention, as discussed above, except for the width of the waist portion is from 1 to 4 mm larger in size than the opening in which the occlusion device is to be positioned so as to provide a stopper-like plug to the opening. However, Amplatz teaches in col. 10, lines 26-30 that a skilled artisan would understand that the occluder would be optimally sized in proportion to a patient’s target site or defect. Furthermore, one of ordinary skill in the art
would understand that depending on the patient, the waist portion could be optimally sized to be larger than the defect to be properly seated within the defect and to prevent undesirable displacement. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the waist portion in Freudenthal as modified to be from 1 to 4 mm larger in size than the defect in which the septal defect occluder is to be positioned so as to provide a stopper-like plug to the defect, for the purpose of preventing undesirable displacement from the defect, and 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 is rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal (U.S. Pub. No. 2006/0224183) in view of Cully (U.S. Pub. No. 2006/0136043) and Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Amplatz et al., hereinafter “Amplatz ‘738” (U.S. Patent No. 5,944,738), cited in IDS filed 04/09/25.
Regarding claim 9, Freudenthal as modified teaches the claimed invention, as discussed above, except for the proximal disk being larger than the distal disk.
In the same field of art, namely septal occluders, Amplatz '738 teaches a first
disk may be larger than a second disk (col. 10, lines 49-52).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Freudenthal as modified to have the proximal disk being larger than the distal disk, as taught by Amplatz '738, in order to adjust to differently sized openings in the septal wall (Id.).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal (U.S. Pub. No. 2006/0224183) in view of Cully (U.S. Pub. No. 2006/0136043) and Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Neuss (U.S. Pub. No. 2011/0054519), cited in IDS filed 04/09/25.
Regarding claims 10-11, Freudenthal as modified teaches the claimed invention, as discussed above, except for at least one of the proximal disk and the distal disk has an ovoid shape, and at least one of the proximal disk and the distal disk includes a radiopaque marker.
In the same field of art, namely occluders, Neuss teaches first and second disks
5, 6 (Figure 5) wherein they are ovoid in shape ([0048] and [0062])
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify at least one of the proximal disk and the distal disk of Freudenthal as modified to have an ovoid shape, as taught by Neuss, in order to conform to defects with an oval cross-section (Neuss; [0028]) and in order to protect the adjacent structure (Neuss; [0062]).
Neuss further teaches in [0151] having radiopaque markers on disk 5.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to provide a radiopaque marker to at least one of the proximal disk and the distal disk, as taught by Neuss, in order to simplify disk positioning with X-ray control (Id.).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, 7-8, 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No. 12,303,117 in view of Amplatz (U.S. Patent No. 6,468,303). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that the application elements can be found in claims 8-9 of the patent, and therefore the patent claims encompass the application claims, except for the proximal and distal disks comprising shape memory material. Amplatz teaches an occlusion device including shape memory material (see abstract, col. 6, lines 19-35). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with shape memory material, as taught by Amplatz, in order to achieve desired elastic properties and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,303,117 in view of Amplatz (U.S. Patent No. 6,468,303). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that the application elements can be found in claim 3, except for features that are merely obvious. Amplatz teaches in Figures 1-3 an asymmetric occlusion device including a length of a second extended arm, as measured perpendicularly from a hub area 24 of an asymmetric occluder disk (and to the rim, or outer circumferential surface to the left side of 24 in Figures 2-3) exceeds a length of a first short arm (and to the rim, or opposite circumferential surface to the right side of 24 in Figures 2-3), as measured perpendicularly from the hub area, wherein the first length is longer than the second length, and a channel 18 extending through the waist portion and a pair of asymmetric disks 12, 14. It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Amplatz, in order to position a hub that inhibits unraveling of the wires and allows coupling with a delivery device (Amplatz; col. 5, lines 20-25).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,303,117 in view of Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Amplatz ‘738 (U.S. Patent No. 5,944,738). The patent claim and Amplatz teach the claimed invention, except for features that are merely obvious. In the same field of art, namely occluders, Amplatz '738 teaches a first disk may be larger than a second disk (col. 10, lines 49-52). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patent claims as modified to have the proximal disk being larger than the distal disk, as taught by Amplatz '738, in order to adjust to differently sized openings in the septal wall (Id.).
Claims 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,303,117 in view of Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Neuss (U.S. Pub. No. 2011/0054519). The patent claim and Amplatz teach the claimed invention, except for features that are merely obvious. In the same field of art, namely occluders, Neuss teaches first and second disks 5, 6 (Figure 5) wherein they are ovoid in shape ([0048] and [0062]) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one of the proximal disk and the distal to have an ovoid shape, as taught by Neuss, in order to conform to defects with an oval cross-section (Neuss; [0028]) and in order to protect the adjacent structure (Neuss; [0062]). Neuss further teaches in [0151] having radiopaque markers on disk 5. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a radiopaque marker to at least one of the proximal disk and the distal disk, as taught by Neuss, in order to simplify disk positioning with X-ray control (Id.).
Claims 1, 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,197,660 in view of Freudenthal (U.S. Pub. No. 2006/0224183). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a bar occlusion device with a waist portion, asymmetric proximal and distal disks (both disks have off-center hub in patent claims). However, the application claims lack features that are merely obvious. Freudenthal teaches proximal and distal disks 20, 30 each including a) a first short arm (near 23, 33) having a portion extending from the waist 40 to the rim with a first length as measured perpendicularly relative the longitudinal axis of the occlusion device, and b) a second extended arm (near 21, 31) having a portion extending from the waist to the rim with a second length as measured perpendicularly relative the longitudinal axis of the occlusion device, wherein a length of the second extended arm, as measured perpendicularly from a hub area (central area of through-opening 50) of the asymmetric occluder disk, exceeds a length of the first short arm, as measured perpendicularly from the hub area of the asymmetric occluder disk, wherein the first length is longer than the second length; c. a channel 50 extending through the waist portion and the pair of asymmetric disks, and a waist portion 40 has a width that is smaller than a width of the proximal disk 20 and the distal disk 30 (Figure 3a), and the disks made of shape memory material (claim 66, [0032], [0104]). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim with the above features, as taught by Freudenthal, in order to implant the device firmly and safely even with a lack of space on one side ([0021] of Freudenthal).
Claims 5, 7-8, 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,197,660 in view of Freudenthal (U.S. Pub. No. 2006/0224183), as applied to claim 4 above, and further in view of Amplatz (U.S. Patent No. 6,468,303). The patent claim and Freudenthal teach the claimed invention, as discussed above, except for features that are merely obvious.
Amplatz teaches in Figures 1-3, a hub 24 protruding from an exterior surface of at least one of proximal or distal disks 12, 14, the hub 24 is off-center of the waist portion 16, the braids of at least one of the proximal and distal disks 12, 14 radiating in a first direction extending further from the hub 24 along the disk than braids radiating in a second direction along the disk opposite the first direction, at least one of the proximal and distal disks comprises a short arm (the first short arm, to the right side of 24 in Figures 2-3 of Amplatz) extending in a first direction from the hub 24, and a long arm (the second extended arm, to the left side of 24 in Figures 2-3) extending in a second direction from the hub, wherein the first direction is different from the second direction.
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claim and Freudenthal with the above features, as taught by Amplatz, in order to inhibit unraveling of the wires and to allow coupling with a delivery device (Amplatz; col. 5, lines 20-25).
Regarding claim 13, patent claim and Freudenthal teach the claimed invention, as discussed above, except for the short arm (first short arm) being thicker than the long arm (the second extended arm). However, Freudenthal teaches the occluder device material thickness can be different from portion to portion ([0024], [0032]) wherein the larger thickness yields different (greater) stiffness to adapt to a specific application to have a secure hold inside the body. Also, in other embodiments ([0082]-[0084], Figures 7-7c) teach thicker occluder portions 20. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the short arm be thicker than the long arm, in order to adjust and change the stability of the occluder in a targeted manner to a specific application at the shorter side, such that the thicker area has a firmer and secure hold in the body (Freudenthal; [0022], [0024]).
Regarding claim 14, patent claim and Freudenthal teach the claimed invention, as discussed above, except for the width of the waist portion is from 1 to 4 mm larger in size than the opening in which the occlusion device is to be positioned so as to provide a stopper-like plug to the opening. However, Amplatz teaches in col. 10, lines 26-30 that a skilled artisan would understand that the occlude would be optimally sized in proportion to a patient’s target site or defect. Furthermore, one of ordinary skill in the art
would understand that depending on the patient, the waist portion could be optimally sized to be larger than the defect to be properly seated within the defect and to prevent undesirable displacement. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the waist portion to be from 1 to 4 mm larger in size than the defect in which the septal defect occluder is to be positioned so as to provide a stopper-like plug to the defect, for the purpose of preventing undesirable displacement from the defect, and 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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,197,660 in view of Freudenthal (U.S. Pub. No. 2006/0224183) and Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Amplatz ‘738 (U.S. Patent No. 5,944,738). The patent claim and Freudenthal, Amplatz teach the claimed invention, except for features that are merely obvious. In the same field of art, namely occluders, Amplatz '738 teaches a first disk may be larger than a second disk (col. 10, lines 49-52). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal disk to be larger than the distal disk, as taught by Amplatz '738, in order to adjust to differently sized openings in the septal wall (Id.).
Claims 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,197,660 in view of Freudenthal (U.S. Pub. No. 2006/0224183) and Amplatz (U.S. Patent No. 6,468,303), as applied to claim 5 above, and further in view of Neuss (U.S. Pub. No. 2011/0054519). The patent claim and Freudenthal, Amplatz teach the claimed invention, except for features that are merely obvious. In the same field of art, namely occluders, Neuss teaches first and second disks 5, 6 (Figure 5) wherein they are ovoid in shape ([0048] and [0062]) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one of the proximal disk and the distal to have an ovoid shape, as taught by Neuss, in order to conform to defects with an oval cross-section (Neuss; [0028]) and in order to protect the adjacent structure (Neuss; [0062]). Neuss further teaches in [0151] having radiopaque markers on disk 5. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a radiopaque marker to at least one of the proximal disk and the distal disk, as taught by Neuss, in order to simplify disk positioning with X-ray control (Id.).
Claims 1, 3-5, 7-12, 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 13, 16, 20, 28, 32 of U.S. Patent No. 10,064,612 in view of Amplatz (U.S. Patent No. 6,468,303). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that they both recite a waist portion, a pair of asymmetric occluder disks, a first short arm, a second extended arm, a hub. However, the application claims lack features that are merely obvious. Amplatz teaches in Figures 1-3 a channel 18 extending through a waist portion 16 and a pair of asymmetric disks 12, 14, the disks and waist portion being formed from a braiding of wires (col. 2, lines 20-39), an off-center hub 24 joining ends of wires of braiding and protruding from an exterior surface of the proximal and distal disks (col. 5, lines 20-25). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Amplatz, in order to act as a shunt (see abstract of Amplatz) and inhibit unraveling of the wires and to allow coupling with a delivery device (Amplatz; col. 5, lines 20-25).
Regarding claim 14, patent claim and Amplatz teach the claimed invention, except for the width of the waist portion is from 1 to 4 mm larger in size than the opening in which the occlusion device is to be positioned so as to provide a stopper-like plug to the opening. However, Amplatz teaches in col. 10, lines 26-30 that a skilled artisan would understand that the occlude would be optimally sized in proportion to a patient’s target site or defect. Furthermore, one of ordinary skill in the art would understand that depending on the patient, the waist portion could be optimally sized to be larger than the defect to be properly seated within the defect and to prevent undesirable displacement. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the waist portion to be from 1 to 4 mm larger in size than the defect in which the septal defect occluder is to be positioned so as to provide a stopper-like plug to the defect, for the purpose of preventing undesirable displacement from the defect, and 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 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 13, 16, 20, 28, 32 of U.S. Patent No. 10,064,612 in view of Amplatz (U.S. Patent No. 6,468,303), as applied to claim 12 above, and further in view of Freudenthal (U.S. Pub. No. 2006/0224183). Regarding claim 13, patent claim and Amplatz teach the claimed invention, as discussed above, except for the short arm (first short arm) being thicker than the long arm (the second extended arm). Freudenthal teaches the occluder device material thickness can be different from portion to portion ([0024], [0032]) wherein the larger thickness yields different (greater) stiffness to adapt to a specific application to have a secure hold inside the body. Also, in other embodiments ([0082]-[0084], Figures 7-7c) teach thicker occluder portions 20.It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the short arm be thicker than the long arm, in order to adjust and change the stability of the occluder in a targeted manner to a specific application at the shorter side, such that the thicker area has a firmer and secure hold in the body (Freudenthal; [0022], [0024]).
Allowable Subject Matter
Claim 6 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if a Terminal Disclaimer is filed to overcome the double patenting rejection set forth in this office action.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious an asymmetric occlusion device including, inter alia, a waist portion, a pair of asymmetric occluder disks comprising an asymmetric distal disk attached to a distal portion of the waist, an asymmetric proximal disk attached to a proximal portion of the waist, each asymmetric disk comprises a first short arm having a portion extending from the waist portion to a rim with a first length as measured perpendicularly relative to a longitudinal axis of the occlusion device, and a second extended arm having a portion from the waist portion to a rim with a second length as measured perpendicularly relative to the longitudinal axis, wherein a length of the second extended arm, as measured perpendicularly from a hub area of the asymmetric occluder disk, exceeds a length of the first short arm, as measured perpendicularly from the hub area of the asymmetric occluder disk, wherein the first length is longer than the second length, and a channel extending through the waist portion and the pair of asymmetric disks, a hub joining ends of wires of the braiding, the hub protruding from an exterior surface of at least one of the proximal or distal disks, and wherein the hub is defined by an extension located on the proximal disk, the channel extending through the extension, as recited in claim 6.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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