DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 06/10/2026 have been entered. Claims 1-7, 9-10, and 12-21 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 06/10/2026, with respect to the rejection(s) of claim(s) 1 and 14 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Allen (US 2016/0166257) in view of Kurz (US 6,296,622).
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
Claim 1 recites in line 7, “the detachment element” prior to recitation of “a detachment element” in line 10-11. The sue of “the” and “s” should be swapped such that the first instance of the limitation is referred to as “a detachment element” and the second instance is “the detachment element”.
In li8 of claim 14, “plurality of flexible bristles” should be changed to “plurality of bristles” in order to maintain consistent terminology throughout the claim.
Appropriate correction is required.
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.
Claim(s) 1-7, 9, 10, and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 2016/0166257) in view of Kurz et al. (US 6,296,622).
Regarding claims 1, 9-10 and 16, Allen discloses an embolisation system (FIG 209-246, [0677]) comprising: an embolisation device for promoting clot formation in a lumen (1501, wherein the vessel is shown in FIG 217, [0676] discloses the formation of clot) comprising a stem (1530, FIG 222) and a plurality of flexible bristles (1504) extending outwardly from the stem (FIG 222), wherein the plurality of flexible bristles are mounted to the stem (FIG 209, 217(a), 222), the bristles having a collapsed delivery configuration (FIG 211) and a deployed configuration in which the bristles extend at least radially outwardly from the stem (FIG 223(b)) to anchor the embolization device in a lumen ([0690]), wherein in the collapsed delivery configuration, the bristles overlap a majority of the detachment element ([0721] discloses the bristles and membrane “minimally overlap the detachment mechanism”. Although described as being minimal, the bristles are still taught to overlap a detachment mechanism); and a delivery element (1535, FIG 222, [0719]) connected to the stem of the embolisation device (FIG 222) via a detachment element (1531). Allen further teaches the stem is made of a second material comprising nitinol (Table 1 indicates a “more preferable” stem wire material is nitinol).
Allen teaches the detachment element is a hypotube connector (FIG 222, [0717-0720]) which threadedly connects the delivery element to the stem of the embolization device and therefore fails to teach the detachment element is configured to break upon application of a predetermined amount of force, wherein the detachment element comprises a first material, the stem and delivery element comprise second materials each different from the first material, and wherein the first material is less stiff than the second materials.
However, Kurz teaches an alternative technique for releasable connecting a delivery element (32’’, FIG 21) to a stem (42’’’) of an embolization device (“endoluminal therapeutic device”) using a detachment element (36’’’) in the form of a tubular collar (FIG 21-22) which is configured to break upon application of a predetermined amount of force (Break occurs at scoring 41, col 15 lines 20-45).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the detachment element of Allen with that taught by Kurz, such that instead of being a threaded engagement collar, the detachment element is instead a collar having a narrowed segment of material and a scoring in order to encourage breaking at a specific point, for the purpose of substituting a mechanism commonly known in the art for providing a releasable connection between a delivery element and an embolization device.
The device as modified is silent regarding the detachment element comprising a first material including cobalt-chrome and the delivery element comprise a second material including nitinol.
However, Allen teaches that nitinol and cobalt-chrome are disclosed as appropriate biocompatible materials to select for various components of the device (table 1) and further discloses the detachment element is a hypotube ([0717, 0719]) which is commonly known in the art to be formed of a biocompatible metal.
Therefore, it would have been obvious to one of ordinary skill in the art to select cobalt-chrome as a material for the detachment element and nitinol as a material for the delivery element, since both materials are commonly known in the art to be biocompatible and have satisfactory properties for forming elements of a embolization system. The selection of these materials would achieve the predictable result of allowing the delivery element to be sufficiently pushable but flexible, as desired for a delivery wire and would allow the detachment element to have sufficient structure to connect the delivery wire and stem, which still being breakable upon application of a predetermined amount of force. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2-3, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the detachment element is a shearable element configured to break upon a predetermined shear of the delivery element relative to the stem (Due to the scored region, the detachment element is understood to be a shearable element at least configured to break upon application of a shearing force) and the shearable element is configured to break upon a predetermined rotation of the delivery element relative to the stem (The scored hypotube is at least configured to break upon rotation of the delivery element relative to the stem).
Regarding claims 4-5, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the detachment element comprises a necked portion (FIG 21-22 of Kurz show a region of narrowed material at the breakpoint 41, which is interpreted as forming a necked portion), wherein the cross-sectional area of the necked portion is 50% or less of the cross sectional area of the delivery element (FIG 21-22 shows the collar has a narrowed thickness thereby forming a reduced cross section. The cross section of the delivery element is significantly larger than the detachment element, therefore the necked portion is at least 50% or less of the area).
Regarding claims 6-7, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the detachment element comprises a weakening structure (FIG 21-22 of Kurz show a region of narrowed material at the line of scoring 41, which is interpreted as forming a weakening structure), wherein the cross-sectional area of the weakening structure is 50% or less of the cross sectional area of the delivery element (FIG 21-22 shows the collar has a narrowed thickness thereby forming a reduced cross section. The cross section of the delivery element is significantly larger than the detachment element, therefore the weakening structure is at least 50% or less of the area).
Regarding claims 12-13, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1. Allen further discloses a flow restrictor (1505, [0684]), the flow restrictor having a collapsed delivery configuration (Shown collapsed in FIG 220(a)) and a deployed configuration (Shown deployed in FIG 217(b), 220(c), 223(b)), wherein in the collapsed delivery configuration, the membrane overlaps with the detachment element ([0721] discloses the bristles and membrane “minimally overlap the detachment mechanism”. Although described as being minimal, the membrane is still taught to overlap a detachment mechanism).
Regarding claims 14 and 17, Allen discloses a method of manufacturing an embolisation system (FIG 209-246, [0677]) including an embolisation device for promoting clot formation in a lumen (1501, wherein the vessel is shown in FIG 217, [0676] discloses the formation of clot), comprising providing a stem (1530, FIG 222; it is understood that in order to arrive at the disclosed device, a stem has been ‘provided’); providing a delivery element (1535, FIG 222, [0719];it is understood that in order to arrive at the disclosed device, a delivery element has been ‘provided’); providing a detachment element (1531_ between the stem and the delivery element (FIG 222); and attaching a plurality of bristles (1504) to the stem (FIG 209), extending outwardly from the stem (FIG 209), wherein the plurality of flexible bristles are mounted to the stem (FIG 209, 217(a), 222), the bristles having a collapsed delivery configuration (FIG 211) and a deployed configuration in which the bristles extend at least radially outwardly from the stem (FIG 223(b)) to anchor the embolization device in a lumen ([0690]), wherein in the collapsed delivery configuration, the bristles overlap a majority of the detachment element ([0721] discloses the bristles and membrane “minimally overlap the detachment mechanism”. Although described as being minimal, the bristles are still taught to overlap a detachment mechanism). Allen further teaches the stem is made of a second material comprising nitinol (Table 1 indicates a “more preferable” stem wire material is nitinol).
Allen teaches the detachment element is a hypotube connector (FIG 222, [0717-0720]) which threadedly connects the delivery element to the stem of the embolization device and therefore fails to teach the detachment element is configured to break upon application of a predetermined amount of force, wherein the detachment element comprises a first material, the stem and delivery element comprise second materials each different from the first material, and wherein the first material is less stiff than the second materials.
However, Kurz teaches an alternative technique for releasable connecting a delivery element (32’’, FIG 21) to a stem (42’’’) of an embolization device (“endoluminal therapeutic device”) using a detachment element (36’’’) in the form of a tubular collar (FIG 21-22) which is configured to break upon application of a predetermined amount of force (Break occurs at scoring 41, col 15 lines 20-45).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the detachment element of Allen with that taught by Kurz, such that instead of being a threaded engagement collar, the detachment element is instead a collar having a narrowed segment of material and a scoring in order to encourage breaking at a specific point, for the purpose of substituting a mechanism commonly known in the art for providing a releasable connection between a delivery element and an embolization device.
The device as modified is silent regarding the detachment element comprising a first material including cobalt-chrome and the delivery element comprise a second material including nitinol.
However, Allen teaches that nitinol and cobalt-chrome are disclosed as appropriate biocompatible materials to select for various components of the device (table 1) and further discloses the detachment element is a hypotube ([0717, 0719]) which is commonly known in the art to be formed of a biocompatible metal.
Therefore, it would have been obvious to one of ordinary skill in the art to select cobalt-chrome as a material for the detachment element and nitinol as a material for the delivery element, since both materials are commonly known in the art to be biocompatible and have satisfactory properties for forming elements of a embolization system. The selection of these materials would achieve the predictable result of allowing the delivery element to be sufficiently pushable but flexible, as desired for a delivery wire and would allow the detachment element to have sufficient structure to connect the delivery wire and stem, which still being breakable upon application of a predetermined amount of force. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 15, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 14. The device as modified further discloses the detachment element comprises a necked portion (FIG 21-22 of Kurz show a region of narrowed material at the breakpoint 41, which is interpreted as forming a necked portion),
Regarding claim 18-19, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1 and 14. Allen further discloses in the collapsed delivery configuration, the bristles inhibit premature detachment of the embolisation device (The bristles covering the detachment element in the delivery configuration aids in “inhibiting” premature detachment).
Regarding claim 20-21, Allan/Kurz disclose the invention substantially as claimed, as set forth above for claim 1 and 14. Allen further discloses the embolisation device has a uniform profile where the bristles overlap the detachment element (FIG 220(a) of Allen, the bristles are constrained within the delivery sheath and therefore their profile is defined by the inner diameter of the sheath, which is interpreted as being uniform).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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