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 action is in response to the claims filed as a preliminary amendment on 10/8/2024 - claims 1-20 were added.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as amended in the parent application (17/849,125), paragraph [0052] should recite ‘within a continuous mesh structure or network (i.e., the continuous mesh structure includes a plurality of strands that each extend continuously across all of the axial mesh carriages).’ in order to provide antecedent basis for this subject matter in the claims.
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.
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Claims 1, 5-14, & 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-14, 16, & 18-20 of U.S. Patent No. 12,076,022 B2 to Griffin. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 to Griffin discloses an occlusion device for implantation into a body lumen or aneurysm comprising: a continuous mesh structure, wherein the continuous mesh structure comprises a plurality of axial mesh carriages configured end to end, wherein the continuous mesh structure is compressible; and a plurality of markers encircling the continuous mesh structure at a plurality of pinch points in the continuous mesh structure, wherein each end of each axial mesh carriage is (i) at a respective pinch point of the plurality of pinch points in the continuous mesh structure and (ii) encircled by a respective marker of the plurality of markers, wherein the continuous mesh structure comprises a plurality of strands that each continuously extend across all of the plurality of axial mesh carriages, and wherein each axial mesh carriage has a width (y) and length (x) that is different from the length and width of adjacent carriages of the plurality of axial mesh carriages. Since application claim 1 is anticipated by claim 1 to Griffin, the claims are not patentably distinct.
Claim 5 to Griffin further discloses wherein the continuous mesh structure is configured to expand in a deployed shape and fill the body lumen or aneurysm, and wherein the deployed shape compresses an axial length (x) of each axial mesh carriage to about 5% to about 50% of an axial length of the axial mesh carriage in free air. Since application claim 5 is anticipated by claim 5 to Griffin, the claims are not patentably distinct.
Claim 6 to Griffin further discloses wherein each marker is radiopaque. Since application claim 6 is anticipated by claim 6 to Griffin, the claims are not patentably distinct.
Claim 7 to Griffin further discloses wherein at least one axial mesh carriage is an outer axial carriage which comprises at least one inner coaxial mesh carriage. Since application claim 7 is anticipated by claim 7 to Griffin, the claims are not patentably distinct.
Claim 8 to Griffin further discloses wherein the at least one inner coaxial mesh carriage comprises a different material than the outer axial carriage. Since application claim 8 is anticipated by claim 8 to Griffin, the claims are not patentably distinct.
Claim 9 to Griffin further discloses wherein the continuous mesh structure comprises a metal braid comprising nitinol or a nitinol alloy. Since application claim 9 is anticipated by claim 9 to Griffin, the claims are not patentably distinct.
Claim 10 to Griffin further discloses wherein each marker comprises a solid ring or a solid band. Since application claim 10 is anticipated by claim 10 to Griffin, the claims are not patentably distinct.
Claim 11 to Griffin further discloses wherein each marker is formed from a least one material selected from the group consisting of: gold, platinum and stainless steel. Since application claim 11 is anticipated by claim 11 to Griffin, the claims are not patentably distinct.
Claim 12 to Griffin further discloses wherein a width (y) of each axial mesh carriage in free air is between about 2 millimeters and about 50 millimeters. Since application claim 12 is anticipated by claim 12 to Griffin, the claims are not patentably distinct.
Claim 13 to Griffin discloses a system for delivering an occlusion device to a body lumen or aneurysm, comprising: an occlusion device comprising: a continuous mesh structure, wherein the continuous mesh structure comprises a plurality of axial mesh carriages configured end to end, wherein the continuous mesh structure is compressible; and a plurality of markers encircling the continuous mesh structure at a plurality of pinch points in the continuous mesh structure, wherein each end of each axial mesh carriage is (i) at a respective pinch point of the plurality of pinch points in the continuous mesh structure and (ii) encircled by a respective marker of the plurality of markers, wherein the continuous mesh structure comprises a plurality of strands that each continuously extend across all of the plurality of axial mesh carriages, and wherein each axial mesh carriage has a width (y) and length (x) that is different from the length and width of adjacent carriages of the plurality of axial mesh carriages; and a delivery system that is configured to deliver the occlusion device to the body lumen or aneurysm. Since application claim 13 is anticipated by claim 13 to Griffin, the claims are not patentably distinct.
Claim 14 to Griffin further discloses wherein the delivery system is a microcatheter, catheter, guide wire or pusher wire. Since application claim 14 is anticipated by claim 14 to Griffin, the claims are not patentably distinct.
Claim 16 to Griffin further discloses wherein the continuous mesh structure is configured to expand in a deployed shape and fill the body lumen or aneurysm, and wherein the deployed shape compresses an axial length (x) of each axial mesh carriage to about 5% to about 50% of an axial length of the axial mesh carriage in free air. Since application claim 17 is anticipated by claim 16 to Griffin, the claims are not patentably distinct.
Claim 18 to Griffin further discloses wherein at least one axial mesh carriage is an outer axial carriage which comprises at least one inner coaxial mesh carriage. Since application claim 18 is anticipated by claim 18 to Griffin, the claims are not patentably distinct.
Claim 19 to Griffin further discloses wherein the at least one inner coaxial mesh carriage comprises a different material than the outer axial carriage. Since application claim 19 is anticipated by claim 19 to Griffin, the claims are not patentably distinct.
Claim 20 to Griffin further discloses wherein the continuous mesh structure comprises a metal braid comprising nitinol or a nitinol alloy. Since application claim 20 is anticipated by claim 20 to Griffin, the claims are not patentably distinct.
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, 6, 10, 11, 13, & 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sepetka et al. (US Pub. No. 2006/0116713 A1).
Regarding claim 1, Sepetka et al. disclose an occlusion device 12 (Figs. 4 & 10 - Fig. 10 showing the generic delivery system) for implantation into a body lumen or aneurysm comprising: a continuous mesh structure 14 (Fig. 4 - paragraphs [0245]-[0247]), wherein the continuous mesh structure 14 comprises a plurality of axial mesh carriages (created by the mesh structure 14 being crimped by radiopaque markers 16 at either end -Fig. 4) configured end to end, wherein the continuous mesh structure 14 is compressible (mesh structure 14 is a ‘reticulated biodurable elastomeric matrix’ which is described in paragraph [0232] as ‘a preferred reticulated elastomeric matrix is an optionally compressible, lightweight material, designed for its ability to expand preferably in conformal fashion within the aneurysm without expanding too much’); and a plurality of markers 16 (Fig. 4; paragraph [0245]) encircling the continuous mesh structure 14 at a plurality of pinch points in the continuous mesh structure 14, wherein each end of each axial mesh carriage is (i) at a respective pinch point of the plurality of pinch points in the continuous mesh structure (‘crimped’ points - paragraph [0245]) and (ii) encircled by a respective marker 16 of the plurality of markers (paragraph [0245]; Fig. 4), and wherein the continuous mesh structure 14 comprises a plurality of strands that each continuously extend across all of the plurality of axial mesh carriages (the mesh structure 14 is a continuous matrix from end to end of the implant 12, also associated with the mesh structure 14 is a structural component 20 which is described as extending through the entire length of the implant 12 and be incorporated into the matrix 14, the structural component 20 can comprise of twisted or braided rope, wire, or cable which is considered to read on a plurality of strands (since multiple strands would be required to ‘twist’ or ‘braid’) - paragraphs [0246]-[0247]).
Regarding claim 6, Sepetka et al. further disclose wherein each marker 16 is radiopaque (paragraph [0245]).
Regarding claim 10, Sepetka et al. further disclose wherein each marker 16 comprises a solid ring (discussed throughout as platinum bands or other marker bands which reads on a solid ring; i.e. paragraph [0249]).
Regarding claim 11, Sepetka et al. further disclose wherein each marker 16 is formed from a least one material selected from the group consisting of: gold, platinum and stainless steel (discussed throughout as platinum marker bands; i.e. paragraph [0249]).
Regarding claim 13, Sepetka et al. disclose a system (Figs. 4 & 10 - Fig. 10 showing the generic delivery system) for delivering an occlusion device to a body lumen or aneurysm, comprising: an occlusion device 12 (Fig. 4) comprising: a continuous mesh structure 14 (Fig. 4 - paragraphs [0245]-[0247]), wherein the continuous mesh structure 14 comprises a plurality of axial mesh carriages 12 (Fig. 4) configured end to end, wherein the continuous mesh structure 14 is compressible (mesh structure 14 is a ‘reticulated biodurable elastomeric matrix’ which is described in paragraph [0232] as ‘a preferred reticulated elastomeric matrix is an optionally compressible, lightweight material, designed for its ability to expand preferably in conformal fashion within the aneurysm without expanding too much’); and a plurality of markers 16 (Fig. 4; paragraph [0245]) encircling the continuous mesh structure 14 at a plurality of pinch points in the continuous mesh structure (Fig. 4; paragraph [0245]), wherein each end of each axial mesh carriage 12 is (i) at a respective pinch point of the plurality of pinch points in the continuous mesh structure 14 ( (‘crimped’ points - Fig. 4; paragraph [0245]) and (ii) encircled by a respective marker of the plurality of markers 16 (Fig. 4; paragraph [0245]), and wherein the continuous mesh structure 14 comprises a plurality of strands that each continuously extend across all of the plurality of axial mesh carriages 12 (the mesh structure 14 is a continuous matrix from end to end of the implant 12, also associated with the mesh structure 14 is a structural component 20 which is described as extending through the entire length of the implant 12 and be incorporated into the matrix 14, the structural component 20 can comprise of twisted or braided rope, wire, or cable which is considered to read on a plurality of strands (since multiple strands would be required to ‘twist’ or ‘braid’) - paragraphs [0246]-[0247]); and a delivery system (shown in Fig. 10; paragraph [0249] - advancement through a tortuous catheter or microcatheter) that is configured to deliver the occlusion device 12 to the body lumen or aneurysm.
Regarding claim 14, Sepetka et al. further disclose wherein the delivery system is a microcatheter, catheter, guide wire or pusher wire (shown in Fig. 10; paragraph [0249] - advancement through a tortuous catheter or microcatheter; pusher members also disclosed in further embodiments - paragraph [0249] discusses ‘pushing during delivery or deployment’ as well).
Claim Rejections - 35 USC § 103
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 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 9, 12, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka et al. (US Pub. No. 2006/0116713 A1).
Regarding claims 9 & 20, Sepetka et al. further discloses wherein the continuous mesh 14 comprises a metal braid (the mesh structure 14 is a continuous matrix from end to end of the implant 12, also associated with the mesh structure 14 is a structural component 20 which is described as extending through the entire length of the implant 12 and be incorporated into the matrix 14, the structural component 20 can comprise of a twist or braid of platinum wire and polymeric fiber or filament, or twisted or braided double platinum wires or combinations thereof - paragraphs [0246]-[0247]). Sepetka et al. does not explicitly disclose in these paragraphs that the metal braid incorporates nitinol; however, later on in Sepetka et al.’s disclosure it is further disclosed that exemplary filaments associated with the implant include platinum or nitinol (paragraph [0326]). Such a statement suggests that platinum and nitinol are interchangeable/equivalent materials suitable for use as filaments throughout the embodiments. Therefore, it is considered that one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute nitinol for the platinum associated with the braid of structural component 20, as suggested by Sepetka et al.’s disclosure with respect to their interchangeability as exemplary filaments.
Regarding claim 12, Sepetka et al. further discloses wherein the cross-section of the implant could be from about 0.25mm to about 10mm. This range partially overlaps with the claimed range (about 2mm to about 50mm). However, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art," a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Allowable Subject Matter
Claims 2-4, 15, & 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. *Claims 5, 7, 8, 16, 18, & 19 are rejected under Double Patenting above. Reasons for allowability over the prior art with respect to these claims is found below. However, in order to proceed with allowance of these claims, the Double Patenting rejection of these claims must be properly overcome.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 2 & 15, the prior art fails to further disclose, teach, or suggest wherein each axial mesh carriage of the plurality of axial mesh carriages is configured to be compressed along the dimension of the length (x) such that the width (y) of the axial mesh carriage expands by up to about a factor of two relative to the width (y) of the axial mesh carriage when the axial mesh carriage is in free air; regarding claims 5 & 17, the prior art fails to further disclose, teach, or suggest wherein the deployed shape compresses an axial length (x) of each axial mesh carriage to about 5% to about 50% of an axial length of the axial mesh carriage in free air; regarding claims 7 & 18, the prior art fails to further disclose, teach, or suggest wherein at least one axial mesh carriage is an outer axial carriage which comprises at least one inner coaxial mesh carriage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Examiner has cited WO 2010/030485 A1 as pertinent prior art - see Figure 9 & 10 showing an implant comprising a continuous mesh having two carriages and a pinch point encircled with a band therebetween.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 December 10, 2025