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
In response to the amendment filed on 6/25/2026, no claims have been cancelled, and Claims 1-10 are pending.
Amendments to claim 6 to remedy USC 112(b) issues has been acknowledged and the rejection has been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140350523 Dehdashtian et al. (hereinafter Dehdashtian) in view of US 20130253573 Agnew.
Regarding claim 1, Dehdashtian discloses an endovascular variable aortic occlusion device configured to modulate anterograde blood flow (abstract, paragraph 6-7), comprising:
a longitudinal body (801, Fig. 14a) having a distal end (804) and a proximal end (802);
a wire basket (812) having proximally extending supporting wires (816) coupled to the distal end of the longitudinal body (as seen in Fig. 14a) and comprising a memory-shape material (paragraph 156, 168, the wire basket 812 (similar to the wire basket 612 of Fig. 8a) can be made of Nitinol which is a memory-shape material), the wire basket and the supporting wires configured to be deployed from a contracted state to an expanded state such that the wire basket engages an inner wall of a patient artery (abstract, paragraph 6-7);
an occlusion barrier (830) comprising a cup-like body (paragraph 169, Fig. 14b, occlusion barrier 830 has a cylindrical portion 830b and a conical portion 830a forming a cup-like body) having a first opening extended therethrough (Fig. 14a, 14c, paragraph 170, occlusion barrier 830 has a first opening at a distal portion of the cylindrical portion 830b that goes through to the proximal portion of the conical portion 830a to allow blood to flow in direction 829 in Fig. 14c and out of openings 832), the cup-like body configured to surround at least a portion of an exterior surface of the wire basket with another portion of the exterior surface of the wire basket not being surrounded by the occlusion barrier (as seen in Fig. 14a-c), wherein the supporting wires extend proximally from the occlusion barrier and are not surrounded by the occlusion barrier (paragraph 169, Fig. 14a, 14c, the conical portion 830a of the occlusion barrier 840 ends at an edge 831 and the supporting wires 816 are not covered past the edge 831 to create openings 832).
Dehdashtian discloses that the device is delivered into a lumen of an aorta (abstract, paragraph 6-8), but is silent on a sheath configured to receive the longitudinal body and move in sliding relation thereto, a collapsed form of the wire basket being fully contained in the sheath during delivery of the device into the lumen of the aorta,
wherein, when the wire basket and the supporting wires are expanded, sliding the sheath distally toward the occlusion barrier restricts a flow of blood through the supporting wires and past the occlusion barrier, stops the flow of blood through the supporting wires and past the occlusion barrier, or both.
However, Agnew teaches a vascular treatment device (abstract, paragraph 2) comprising a sheath (90, Fig. 11-12) that receives Nitinol supporting wires (22, Fig. 1, 3, paragraph 39) of an expandable wire basket (20, Fig. 1, paragraph 39, 49, 61), wherein the sheath (90) slides over the wire basket (20) to collapse and fully contain it within the sheath during delivery into a vessel (Fig. 11-12, paragraph 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dehdashtian with the teachings of Agnew to control the flow of blood through the occlusion barrier and supporting wires as the combination of the sheath (90) of Agnew and the sliding translation of the sheath over the wire basket (20) to constrict or allow radial expansion as taught by Agnew would achieve the same effect when combined with the wire basket (812) and supporting wires (816) of Dehdashtian since it is also made of Nitinol, and the combination would be capable of having a sheath configured to receive the longitudinal body and move in sliding relation thereto, a collapsed form of the wire basket being fully contained in the sheath during delivery of the device into the lumen of the aorta, wherein, when the wire basket and the supporting wires are expanded, sliding the sheath distally toward the occlusion barrier restricts a flow of blood through the supporting wires and past the occlusion barrier, stops the flow of blood through the supporting wires and past the occlusion barrier, or both, because the sheath (90) of Agnew would surround the supporting wires (816) of Dehdashtian and the distal translation of the sheath would constrict the supporting wires and make the openings (832) of Dehdashtian smaller as the sheath is slid distally, therefore restricting and/or stopping the flow of blood through the opening.
Regarding claim 2, the combination of Dehdashtian and Agnew teaches the limitations of claim 1, and Dehdashtian further discloses further comprising both a guidewire (paragraph 103, 115, 124) and a delivery sheath (806, Fig. 14a-c).
Regarding claim 3, the combination of Dehdashtian and Agnew teaches the limitations of claim 1, and Dehdashtian further discloses wherein the memory-shape material is a metal alloy, a polymer, or a combination thereof (paragraph 156, the wire basket 812 (similar to the wire basket 612 of Fig. 8a) can be made of Nitinol which is a metal alloy). Furthermore, Agnew teaches wherein the wire basket (20) is made of Nitinol (paragraph 14-15, 39, 41, 46, 61).
Regarding claim 4, the combination of Dehdashtian and Agnew teaches the limitations of claim 1, and Dehdashtian further discloses wherein the occlusion barrier is a membrane (paragraph 169, occlusion barrier 830 is a flexible liner).
Regarding claim 5, the combination of Dehdashtian and Agnew teaches the limitations of claim 4, and Dehdashtian further discloses wherein the membrane comprises a polymer or a polyester (paragraph 158, 169, the occlusion barrier 830 is similar to liner 630 of Fig. 8a which is made of a polymer).
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dehdashtian in view of Agnew and further in view of US 20140371781 A1 Morgan.
Regarding claim 6, Dehdashtian discloses an endovascular variable aortic occlusion device configured to modulate anterograde blood flow (abstract, paragraph 6-7), comprising:
a longitudinal body (801, Fig. 14a) having a distal end (804) and a proximal end (802);
a wire basket (812) having a proximally extending wire throat (as seen in Fig. 14a-c, struts 816 form a proximally extending conical wire throat) coupled to the distal end of the longitudinal body (as seen in Fig. 14a) and comprising a memory-shape material (paragraph 156, 168, the wire basket 812 (similar to the wire basket 612 of Fig. 8a) can be made of Nitinol which is a memory-shape material), the wire basket and the wire throat configured to be deployed from a contracted state to an expanded state such that the wire basket engages an inner wall of a patient artery (abstract, paragraph 6-7);
an occlusion barrier (830) comprising a cup-like body (paragraph 169, Fig. 14b, occlusion barrier 830 has a cylindrical portion 830b and a conical portion 830a forming a cup-like body) with a proximally extending barrier neck (conical portion 830a) having a first opening extended therethrough (Fig. 14a, 14c, paragraph 170, occlusion barrier 830 has a first opening at a distal portion of the cylindrical portion 830b that goes through to the proximal portion of the conical portion 830a to allow blood to flow in direction 829 in Fig. 14c and out of openings 832), the cup-like body configured to surround at least a portion of an exterior surface of the wire basket with another portion of the exterior surface of the wire basket not being surrounded by the occlusion barrier (as seen in Fig. 14a-c) and the barrier neck configured to surround at least a portion of the wire throat such that another portion of the wire throat extends proximally from the occlusion barrier and is not surrounded by the occlusion barrier (paragraph 169, Fig. 14a, 14c, the conical portion 830a of the occlusion barrier 840 ends at an edge 831 and the struts 816 are not covered past the edge 831 to create openings 832).
Dehdashtian discloses that the device is delivered into a lumen of an aorta (abstract, paragraph 6-8), but is silent on a sheath configured to receive the longitudinal body and move in sliding relation thereto, a collapsed form of the wire basket being fully contained in the sheath during delivery of the device into the lumen of the aorta,
wherein, when the wire basket and the supporting wires are expanded, sliding the sheath distally toward the occlusion barrier restricts a flow of blood through the supporting wires and past the occlusion barrier, stops the flow of blood through the supporting wires and past the occlusion barrier, or both; and
a longitudinal balloon configured to be received by the wire basket and the wire throat,
wherein inflating the longitudinal balloon restricts a flow of blood through the wire throat and past the occlusion barrier, stops the flow of blood through the wire throat and past the occlusion barrier, or both.
However, Agnew teaches a vascular treatment device (abstract, paragraph 2) comprising a sheath (90, Fig. 11-12) that receives Nitinol supporting wires (22, Fig. 1, 3, paragraph 39) of an expandable wire basket (20, Fig. 1, paragraph 39, 49, 61), wherein the sheath (90) slides over the wire basket (20) to collapse and fully contain it within the sheath during delivery into a vessel (Fig. 11-12, paragraph 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dehdashtian with the teachings of Agnew to control the flow of blood through the occlusion barrier and supporting wires as the combination of the sheath (90) of Agnew and the sliding translation of the sheath over the wire basket (20) to constrict or allow radial expansion as taught by Agnew would achieve the same effect when combined with the wire basket (812) and supporting wires (816) of Dehdashtian since it is also made of Nitinol, and the combination would be capable of having a sheath configured to receive the longitudinal body and move in sliding relation thereto, a collapsed form of the wire basket being fully contained in the sheath during delivery of the device into the lumen of the aorta, wherein, when the wire basket and the supporting wires are expanded, sliding the sheath distally toward the occlusion barrier restricts a flow of blood through the supporting wires and past the occlusion barrier, stops the flow of blood through the supporting wires and past the occlusion barrier, or both, because the sheath (90) of Agnew would surround the supporting wires (816) of Dehdashtian and the distal translation of the sheath would constrict the supporting wires and make the openings (832) of Dehdashtian smaller as the sheath is slid distally, therefore restricting and/or stopping the flow of blood through the opening.
Furthermore, Morgan teaches an embolic filter device (Fig. 30a) comprising a longitudinal balloon (1020, Fig. 30a) that is received in a wire basket (1002) and a wire throat (wire basket 1002 converges into a conical shape which constitutes the wire throat as seen in Fig. 30a), wherein inflating the balloon restricts blood flow in a blood vessel (1001) and deflating the balloon allows for aspiration of thrombus through a lumen of a catheter (1008) (paragraph 132).
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 modification of Dehdashtian with Agnew with the teachings of Morgan to control the flow of blood through the occlusion barrier and the wire throat as combining the balloon (1020) of Morgan into the wire basket (812) and wire throat (struts 816 form a proximally extending conical wire throat) of Dehdashtian and inflating the balloon would restrict blood flow through the wire throat and past the occlusion barrier, stops the flow of blood through the wire throat and past the occlusion barrier, or both, because when the balloon is expanded, it takes up space in the blood vessel to occlude it and restrict blood flow past the occlusion barrier (830) and the wire throat and out of the openings (832) of Dehdashtian.
Regarding claim 7, the combination of Dehdashtian, Agnew and Morgan teaches the limitations of claim 6, and Dehdashtian further discloses further comprising both a guidewire (paragraph 103, 115, 124) and a delivery sheath (806, Fig. 14a-c). Furthermore, Morgan teaches further comprising both a guidewire (paragraph 48, 61, 95) and a delivery sheath (1008, Fig. 30a).
Regarding claim 8, the combination of Dehdashtian, Agnew and Morgan teaches the limitations of claim 6, and Dehdashtian further discloses wherein the memory-shape material is a metal alloy, a polymer, or a combination thereof (paragraph 156, the wire basket 812 (similar to the wire basket 612 of Fig. 8a) can be made of Nitinol which is a metal alloy). Furthermore, Agnew teaches wherein the wire basket (20) is made of Nitinol (paragraph 14-15, 39, 41, 46, 61).
Regarding claim 9, the combination of Dehdashtian, Agnew and Morgan teaches the limitations of claim 6, and Dehdashtian further discloses wherein the occlusion barrier is a membrane (paragraph 169, occlusion barrier 830 is a flexible liner).
Regarding claim 10, the combination of Dehdashtian, Agnew and Morgan teaches the limitations of claim 8, and Dehdashtian further discloses wherein the membrane comprises a polymer or a polyester (paragraph 158, 169, the occlusion barrier 830 is similar to liner 630 of Fig. 8a which is made of a polymer).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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