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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive. Applicant argues on pages 7-8 that the teachings of Allen fail to disclose bristles which overlap “a majority” of the detachment element. Although FIG 24A of Allen is unclear regarding the terminating point of the bristles, Examiner further points to FIG 32 of Allen which clearly shown the bristles overlapping a majority of the detachment element. Further, Applicants arguments that Allen teaches away from this arrangement is not found to be persuasive because 1) the overlap is shown in FIG 32 and 2) Allen discloses that overall profile diameter can be reduced by partitioning half of the bristles to collapse in the proximal direction and half to collapse in the distal direction (Page 33 line 29-page 34 line 7). Therefore, modifying the device of Farnan to have bristles which overlap a majority of the detachment element would not destroy the intended function of the device because overall delivery profile can still remain reduced. Therefore, applicants’ argument is not found to be persuasive.
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, 11-15 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 2007/0123928) in view of Allen et al. (WO 2016/041961).
Regarding claims 1, 12, and 13, Farna discloses an embolisation system (10, FIG 1, [024-0030]) comprising: an embolisation device for promoting clot formation in a lumen (30, [0027, 0030, 0031]) comprising a stem (28); and a delivery element (14, FIG 1, [0024-0029, 0039]) connected to the stem of the embolisation device (FIG 2 shows that 24 of the delivery element is attached to stem 28) via a detachment element (32, [0027-0028]), wherein the detachment element is configured to break upon application of a predetermined amount of force ([0027]); wherein the detachment element comprises a first material ([0027] discloses that breakpoint 32 can include a length of material that is weaker in response to torsional forces than the rest of the elongate member), the stem and delivery element (which are parts of the ‘elongate member 24’) comprise second materials each different from the first material, and wherein the first material is less stiff than the second materials ([0027] discloses use of a different and weaker, which is interpreted as being less stiff, material for 32 than what is used for 24 and 28). Farna discloses the embolization device is a coil but further discloses in [0030] “Alternatively, the embolic element may be any other type of embolic element which may take on various forms and configurations”.
Farna is silent regarding a plurality of flexible bristles extending outwardly from the stem, the bristles having a collapsed delivery configuration and a deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the embolisation device in a lumen, in the collapsed delivery configuration, the bristles overlap a majority of the detachment element, and the device further comprising a flow restrictor, the flow restrictor having a collapsed delivery configuration and a deployed configuration, wherein in the collapsed delivery configuration, the membrane overlaps with the detachment element and wherein the flow restrictor is a membrane disposed on the stem.
However, Allen et al. teaches an embolization system comprising a delivery element (35, FIG 14, page 22 lines 20-26), a detachment element (threaded engagement between 30, 31 which is used to detach the embolization device or detachment mechanism 41 shown in the embodiment of FIG 21-22), and an embolization device having a stem (6, 8, 7) and a plurality of flexible bristles (4) extending outwardly from the stem (FIG 22), the bristles having a collapsed delivery configuration (FIG 24A) and a deployed configuration (FIG 24c) in which the bristles extend at least radially outwardly from the stem to anchor the embolisation device in a lumen (page 13 line 33). Allen et al. further teaches in the collapsed delivery configuration, the bristles overlap a majority of the detachment element (FIG 32 shows a collapsed delivery configuration wherein the set of proximal pointing bristles overlap and entire length of the detachment element, see structure at the end of the delivery wire. Although not numbered in FIG 32 specifically, FIG 30(a) shows the delivery wire, detachment mechanism, and bristle segments, which are understood to be the same as what is shown in FIG 32. Page 33 line 29-page 34 line 7 discloses that orienting half of the bristles to collapse proximally and half to collapse distally resolves the issue of an increased delivery profile. Examiner notes that the specification of the present invention does not define the bristles as overlapping “a majority” of the detachment element but that this state is shown in FIG 3. The teaching in the prior art similarity does not explicitly state the overlap to be “a majority” but it is clearly shown in FG 32. Therefore, the interpretation is understood to be consistent with the disclosure of the present invention), and the device further comprising a flow restrictor (flexible membrane 5, FIG 15c, page 15 lines 15-16), the flow restrictor having a collapsed delivery configuration (FIG 24a) and a deployed configuration (FIG 24c, page 15 line 31-page 16 line 2), wherein in the collapsed delivery configuration, the membrane overlaps with the detachment element (FIG 24a, page 23 lines 1-4 discloses a desire to minimize the overlap in order to maintain a reduced profiled but nonetheless disclose in lines 3-4 that the membrane overlaps the detachment mechanism) and wherein the flow restrictor is a membrane disposed on the stem (FIG 9a or 15c show membrane 5 is disposed on the stem).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the coil embolization device of Farna with the bristle embolization device taught by Allen, including the flow restrictor and the relative length of the plurality of bristles and flow restrictor relative to the position of the detachment element, for the purpose of substituting one commonly known embolization device for another and thereby achieving the predictable result of delivering a structure to the lumen which will promote clot formation therein.
Regarding claim 2, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1. Farna further discloses the detachment element is a shearable element configured to break upon a predetermined shear of the delivery element relative to the stem (32 is shearable and configured to break upon reaching a threshold torque between 24 and 28, [0027]).
Regarding claim 3, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 2. Farna further discloses the shearable element is configured to break upon a predetermined rotation of the delivery element relative to the stem ([0027] discloses the predetermined force is a rotational force).
Regarding claim 4, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1. Farna further discloses the detachment element comprises a necked portion (Fig 2 shows the narrowed diameter at 32 which is interpreted as forming a necked portion).
Regarding claim 5, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 4. Farna further discloses the cross-sectional area of the necked portion is a reduced cross-sectional area relative to the delivery element (FIG 2, [0027] discloses 32 is a notch formed by a full circumferential indent).
Farna is silent specifically regarding amount of reduction, particularly the necked portion being 50% or less of the cross-sectional area of the delivery element.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the cross sectional area to be 50% or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Farna would not operate differently with the claimed cross-sectional area of the detachment element and since the detachment element is meant to be made of a reduced amount of material in order to break prior to breaking of the delivery element, the device would function appropriately having the claimed size. Further, applicant places no criticality on the range claimed, indicating simply that the area “may” be within the claimed ranges (specification [0009]).
Regarding claim 6, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1. Farna further discloses detachment element comprises a weakening structure ([0027]; 32 is disclosed as a weakened portion of a reduced diameter), and, optionally, wherein the weakening structure is a fracture.
Regarding claim 7, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 6. Farna further discloses the cross-sectional area of the weakening structure is a reduced cross-sectional area relative to the delivery element (FIG 2, [0027] discloses 32 is a notch formed by a full circumferential indent).
Farna is silent specifically regarding amount of reduction, particularly the weakening structure being 50% or less of the cross-sectional area of the delivery element.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the cross sectional area to be 50% or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Farna would not operate differently with the claimed cross-sectional area of the detachment element and since the detachment element is meant to be made of a reduced amount of material in order to break prior to breaking of the delivery element, the device would function appropriately having the claimed size. Further, applicant places no criticality on the range claimed, indicating simply that the area “may” be within the claimed ranges (specification [0009]).
Regarding claim 14-15, Farna discloses a method of manufacturing an embolisation system (10, FIG 1, [0024-0030]) including an embolisation device for promoting clot formation in a lumen (30, [0027, 0030, 0031]) comprising: providing a stem (28, it is understood that in order to arrive at the disclosed device, a stem has been ‘provided’); providing a delivery element (14, FIG 1, [0024-0029, 0039]; it is understood that in order to arrive at the disclosed device, a delivery element has been ‘provided’); providing a detachment element (32, [0027-0028]) between the stem and the delivery element (FIG 1-2; it is understood that in order to arrive at the disclosed device, a detachment element has been ‘provided’), the detachment element configured to break upon application of a predetermined amount of force ([0027]); wherein the detachment element comprises a first material ([0027] discloses that breakpoint 32 can include a length of material that is weaker in response to torsional forces than the rest of the elongate member), the stem and delivery element (which are parts of the ‘elongate member 24’) comprise second materials each different from the first material, and wherein the first material is less stiff than the second materials ([0027] discloses use of a different and weaker, which is interpreted as being less stiff, material for 32 than what is used for 24 and 28), wherein the detachment mechanism comprises a necked portion (Fig 2 shows the narrowed diameter at 32 which is interpreted as forming a necked portion) and/or a weakened structure ([0027]; 32 is disclosed as a weakened portion of a reduced diameter). Farna discloses the embolization device is a coil but further discloses in [0030] “Alternatively, the embolic element may be any other type of embolic element which may take on various forms and configurations”.
Farna is silent regarding a plurality of flexible bristles extending outwardly from the stem, the bristles having a collapsed delivery configuration and a deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the embolisation device in a lumen, wherein in the collapsed delivery configuration the bristles overlap a majority of the detachment element.
However, Allen et al. teaches an embolization system comprising a delivery element (35, FIG 14, page 22 lines 20-26), a detachment element (threaded engagement between 30 31 which is used to detach the embolization device or detachment mechanism 41 shown in the embodiment of FIG 21-22), and an embolization device having a stem (6, 8, 7) and a plurality of flexible bristles (4) extending outwardly from the stem (FIG 22), the bristles having a collapsed delivery configuration (FIG 24A) and a deployed configuration (FIG 24c) in which the bristles extend at least radially outwardly from the stem to anchor the embolisation device in a lumen (page 13 line 33). Allen et al. further teaches in the collapsed delivery configuration, the bristles overlap a majority of the detachment element (FIG 32 shows a collapsed delivery configuration wherein the set of proximal pointing bristles overlap and entire length of the detachment element, see structure at the end of the delivery wire. Although not numbered in FIG 32 specifically, FIG 30(a) shows the delivery wire, detachment mechanism, and bristle segments, which are understood to be the same as what is shown in FIG 32. Page 33 line 29-page 34 line 7 discloses that orienting half of the bristles to collapse proximally and half to collapse distally resolves the issue of an increased delivery profile. Examiner notes that the specification of the present invention does not define the bristles as overlapping “a majority” of the detachment element but that this state is shown in FIG 3. The teaching in the prior art similarity does not explicitly state the overlap to be “a majority” but it is clearly shown in FG 32. Therefore, the interpretation is understood to be consistent with the disclosure of the present invention).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the coil embolization device of Farna with the bristle embolization device taught by Allen, including the relative length of the plurality of bristles relative to the position of the detachment element, for the purpose of substituting one commonly known embolization device for another and thereby achieving the predictable result of delivering a structure to the lumen which will promote clot formation therein.
Regarding claim 18-19, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1 and 14. The device as modified by 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, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1 and 14. The device as modified by Allen further discloses the embolisation device has a uniform profile where the bristles overlap the detachment element (FIG 32 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).
Claim(s) 9-10 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 2007/0123928) in view of Allen et al. (WO 2016/041961), further in view of Wallace (US 2014/0277099).
Regarding claims 9-10, Farna/Allen disclose the invention substantially as claimed, as set forth above for claim 1. Farna further discloses the second material is comprised of a metallic material which has the desired tensile and flex properties ([0028]) and that the first material can be a material which is weaker ([0027]).
Farna is silent regarding specific materials, particularly that the first material is selected from one of Nylon, PTFE, or Cobalt-chrome and that the second material is selected from one of nitinol or Cobalt-chrome.
However, Wallace teaches an embolization system wherein any or all elements of the embolic devices described above and/or other devices or apparatuses described herein can be made from, for example nickel titanium alloys (e.g., Nitinol) or cobalt-chrome alloys ([0186]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select the first material to be cobalt chrome and the second material to be nitinol, for the purpose of utilizing commonly known materials in the art for forming an embolization device, as taught by Wallace, which achieving the desired tensile strength characteristics taught by Farna. It is commonly known in the art that cobalt chrome has a lower tensile strength and hardness than nitinol, therefore satisfying the requirements of the claim and being obvious material to select in view of Farna.
Conclusion
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