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 claims filed on December 11th, 2025, have been entered. Claims 2-10 and 14-19 remain pending in the Application. Claims 11-13 were canceled by the Applicant. Claims 14-19 were added by the Applicant. The claim amendments overcome the previous claim objections and 112(b) rejection.
Response to Arguments
The rejection of claims 2-10 under 103 over Dubrul et al. (Pub. No. 2016/0022293) has been withdrawn in light of Applicant’s amendment made February 24th, 2026; specifically, Dubrul et al. does not teach the inner tube portion has a braid angle of 75 degrees or less.
Applicant’s arguments with respect to claim(s) 2-10 and 14-19 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. It is noted that Applicant argues that the newly added claim limitation is not taught by Dubrul et al.; however, as discussed below, the newly added reference Taylor et al. (Pub. No. 2008/0154296) teaches said limitation.
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.
Claim 4 is 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 4 recites the limitation "an outer portion of the porous tube" in line 2. Claim 2, upon which claim 4 depends, already introduced an outer tube portion, and the claims are unclear on if these are the same outer tube portion or different outer tube portions. For the purposes of examination, the outer tube portions will be considered the same.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-6, 8-9, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubrul et al. (Pub. No. 2016/0022293) in view of Taylor et al. (Pub. No. 2008/0154296).
Regarding claim 2, Dubrul et al. discloses an apparatus (190; FIGs. 29-34; [0128]) comprising:
an outer elongate member (192);
an inner elongate member (196) slidably disposed within the outer elongate member (FIG. 29: 196 is slidably contained within 192); and
a porous tube (200) comprising a braided material ([0128] 200 is a braided sleeve; FIG. 29), wherein the porous tube extends from a distal end of the inner elongate member ([0128] second end 204 of 200 is secured to distal tip 198 of 196) and is inverted over itself (FIGs. 29-32: 200 is inverted over itself at 206, where the portion extending distally from 192 meets the portion extending distally from 196), wherein the porous tube includes an inner tube portion (FIG. 29: the portion extending distally from 196) and an outer tube portion (FIG. 29: the portion extending distally from 192), further wherein the porous tube has a column strength that resists collapsing ([0128] 200 is strong enough to prevent collapsing, as 190 is used to seal a hollow body structure) and is configured to invert and roll over itself and extend, unsupported, (FIGs. 29-31: 200 inverts and rolls over itself, as shown by the positions of 202 and 204 shown moving relative to each other as 200 expands from 194 and 198) and wherein a portion of the porous tube is constrained to prevent radial expansion (FIGs. 29-32: part of 200, connected by 204, does not expand because 192 and 196 prevent expansion).
Dubrul et al. does not explicitly disclose the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment.
However, Dubrul et al. discloses a second embodiment ([0102] and FIGs. 16-18A) that discloses an inner elongate member (82) and a porous tube (66), where the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment ([0102] the user creates a suction force in the inner tube 82 using a vacuum syringe, which comes out of the funnel 66 to draw in the occlusion 40 for removal) for the purpose of drawing the occlusion into the porous tube for extraction ([0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner elongate member of the first embodiment of Dubrul et al. so that the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment, as taught by the second embodiment of Dubrul et al., for the purpose of drawing the occlusion into the porous tube for extraction.
Dubrul et al. does not disclose the inner tube portion has a braid angle of 75 degrees or less and the outer tube portion has a braid angle of between 80 and 170 degrees.
Taylor et al. discloses that a braided sheath can be configured with layers having different braid angles, as a higher braid angle section imparts greater flexibility and a lower braid angle section imparts less flexibility ([0038]). While Taylor et al. does not give explicit angles to define what a high braid angle and a low braid angle would be, it would have been obvious to one of ordinary skill in the art before the effective filing date that an angle less than 75 degrees would be considered a low angle because that angle would be clearly acute while an angle over 90 degrees would be considered a high angle because that angle would be obtuse.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner tube portion of Dubrul et al. to have a braid angle of 75 degrees or less and the outer tube portion to have a braid angle of at least 90 degrees, as taught by Taylor et al., for the purpose of having a flexible outer layer that can respond to outward forces while maintaining a relatively rigid inner layer that aids in manipulating the porous tube through vasculature.
Regarding claim 3, Dubrul et al. further discloses the porous tube comprising a braided material ([0128] 200 is a braided sleeve).
Regarding claim 4, Dubrul et al. further discloses the porous tube is configured so that pulling the inner elongate member proximally compresses an outer portion of the porous tube into a configuration in which a column strength of the outer tube portion resists collapsing ([0128] 200 is strong enough to prevent collapsing, as 190 is used to seal a hollow body structure; FIGs. 30-31 show 196 is pulled proximally to cause 192 to spread out).
Dubrul et al. does not explicitly disclose the column strength of the porous tube resists collapsing up to 500 g of compression. However, the present Specification discloses in [0111] that the column strength is based on making the porous tube out of a braided material with an outer braid angle of between 80 and 170 degrees and an inner braid angle of less than 80 degrees. As discussed above in claim 3, Dubrul et al. has these properties for 196. Therefore, it would have been obvious to one of ordinary skill in the art that the porous tube of Dubrul et al. can be configured so that pulling the inner elongate member proximally compresses an outer portion of the porous tube into a configuration in which the column strength of the porous tube resists collapsing up to 500 g of compression because the column strength is based on properties which Dubrul et al. is disclosed as having. Furthermore, it would have been obvious to modify the column strength to be within the disclosed range 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 modified porous tube of Dubrul et al. would not operate differently with the claimed column strength, and since both the prior art and the present invention are directed towards extracting objects from within a body, the porous tube would function appropriately with the claimed column strength. Additionally, Applicant places no criticality on the dimensions claimed, indicating the column strength may be configured to resist collapsing up to at least 300 g, 400 g, 500 g, 600 g, 700 g, etc. (Present Application [0074]).
Regarding claim 5, Dubrul et al. further discloses the porous tube is formed of between 24-48 filaments ([0158] the braid is made of 18-144 yarns).
Regarding claim 6, Dubrul et al. further discloses the porous tube is formed of a plurality of filaments ([0128] 200 is a braided sleeve made of a plurality of filaments), each having a diameter of greater than 0.003 inches ([0118] the filaments have diameters in the range of 0.0001 to 0.005 inches).
Regarding claim 8, Dubrul et al. as modified further discloses the inner elongate member comprises an inner lumen configured to pass suction through the porous tube ([0102] the user creates a suction force in the inner tube using a vacuum syringe, which comes out of the funnel to draw in the occlusions for removal; the inner lumen of 196 is capable of receiving the suction force).
Regarding claim 9, Dubrul et al. as modified further discloses a vacuum source coupled to the inner elongate member and configured to apply a vacuum therethrough ([0102] the user creates a suction force in the inner tube using a vacuum syringe, which comes out of the funnel to draw in the occlusions for removal).
Regarding claim 14, Dubrul et al. as modified further discloses the outer tube member is constrained over a portion of its length to prevent radial expansion ([0121] the outer tube member can be constrained by an over sheath to keep the system in the contracted state until ready to expand).
Regarding claim 15, Dubrul et al. as modified further discloses the inner tube portion is expanded to a diameter that is 50% or less of a diameter of the outer tube portion ([0185] the expansion can be a tenfold increase at the portion of the porous tube which expands; while the proximal portion of the inner tube portion will barely expand, the distal portion of the outer tube portion will undergo the full expansion, resulting in the proximal portion of the inner tube portion being less than 50% the diameter of the distal portion of the outer tube portion).
Regarding claim 16, Dubrul et al. as modified further discloses the porous tube has a length that is greater than 10 cm ([0183-184] the working length of the device is 10-500 cm).
Claim(s) 7, 10, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubrul et al. in view of Taylor et al., and in further view of Ganesan et al. (Pub. No. 2013/0184742).
Regarding claim 7, Dubrul et al. modified discloses the invention as claimed in claim 1, as discussed above. Dubrul et al. is silent regarding the porous tube has a porosity of 60% or greater.
Ganesan et al. teaches in the same field of endeavor of thrombectomy devices (Abstract), and discloses a porous tube (102; FIG. 2A), where the porous tube has a porosity of at least 75% ([0130] at least 75% of the blood flow will not be interrupted by the distal filter device and in additional embodiments at least 85% of the blood will not be interrupted) for the purpose of capturing emboli while allowing other blood components to pass through uninterrupted ([0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the porous tube of Dubrul et al. to have a porosity of 60% or greater as taught by Ganesan et al., for the purpose of capturing emboli while allowing other blood components to pass through uninterrupted.
Regarding claim 10, Dubrul et al. discloses an apparatus (190; FIGs. 29-34; [0128]) comprising:
an outer elongate member (192);
an inner elongate member (196) slidably disposed within the outer elongate member (FIG. 29: 196 is slidably contained within 192);
a porous tube (200) comprising a braided material ([0128] 200 is a braided sleeve; FIG. 29), and the porous tube extends from a distal end of the inner elongate member ([0128] second end 204 of 200 is secured to distal tip 198 of 196) and is inverted over itself (FIGs. 29-32: 200 is inverted over itself at 206, where the portion extending distally from 192 meets the portion extending distally from 196), wherein the porous tube includes an inner tube portion (FIG. 29: the portion extending distally from 196) and an outer tube portion (FIG. 29: the portion extending distally from 192), further wherein the porous tube is configured to resist collapsing ([0128] 200 is strong enough to prevent collapsing, as 190 is used to seal a hollow body structure) and is configured to invert and roll over itself and extend, unsupported, from the distal end of the outer elongate member as the inner elongate member is driven distally (FIGs. 30-31: 200 inverts and rolls over itself, as shown by the positions of 202 and 204 shown moving relative to each other as 200 expands from 194 and 198, and 196, caused by 196 moving distally relative to 192), and wherein a portion of the porous tube is constrained to prevent radial expansion (FIGs. 29-32: part of 200, connected by 204, does not expand because 192 and 196 prevent expansion).
Dubrul et al. does not explicitly disclose the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment.
However, Dubrul et al. discloses a second embodiment ([0102] and FIGs. 16-18A) that discloses an inner elongate member (82) and a porous tube (66), where the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment ([0102] the user creates a suction force in the inner tube 82 using a vacuum syringe, which comes out of the funnel 66 to draw in the occlusion 40 for removal) for the purpose of drawing the occlusion into the porous tube for extraction ([0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner elongate member of the first embodiment of Dubrul et al. so that the inner elongate member is configured to couple to a source of vacuum to apply aspiration through the inner elongate member and the porous tube in this first embodiment, as taught by the second embodiment of Dubrul et al., for the purpose of drawing the occlusion into the porous tube for extraction.
Dubrul et al. modified fails to disclose wherein the porous tube is more than 75% porous.
Ganesan et al. teaches in the same field of endeavor of thrombectomy devices (Abstract), and discloses a porous tube (102; FIG. 2A), where the porous tube has a porosity of at least 75% ([0130] at least 75% of the blood flow will not be interrupted by the distal filter device and in additional embodiments at least 85% of the blood will not be interrupted) for the purpose of capturing emboli while allowing other blood components to pass through uninterrupted ([0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the porous tube of Dubrul et al. modified to have a porosity of more than 75%, as taught by Ganesan et al., for the purpose of capturing emboli while allowing other blood components to pass through uninterrupted.
Dubrul et al. does not disclose the inner tube portion has a braid angle of 75 degrees or less and the outer tube portion has a braid angle of between 80 and 170 degrees.
Taylor et al. discloses that a braided sheath can be configured with a variety of different braid angles, as a higher braid angle section imparts greater flexibility and a lower braid angle section imparts less flexibility ([0038]). While Taylor et al. does not give explicit angles to define what a high braid angle and a low braid angle would be, it would have been obvious to one of ordinary skill in the art before the effective filing date that an angle less than 45 degrees would be considered a low angle because that angle would be clearly acute while an angle over 90 degrees would be considered a high angle because that angle would be obtuse.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner tube portion of Dubrul et al. to have a braid angle of 75 degrees or less and the outer tube portion to have a braid angle of at least 90 degrees, as taught by Taylor et al., for the purpose of having a flexible outer layer that can respond to outward forces while maintaining a relatively rigid inner layer that aids in manipulating the porous tube through vasculature.
Regarding claim 17, Dubrul et al. as modified further discloses the outer tube member is constrained over a portion of its length to prevent radial expansion ([0121] the outer tube member can be constrained by an over sheath to keep the system in the contracted state until ready to expand).
Regarding claim 18, Dubrul et al. as modified further discloses the inner tube portion is expanded to a diameter that is 50% or less of a diameter of the outer tube portion ([0185] the expansion can be a tenfold increase at the portion of the porous tube which expands; while the proximal portion of the inner tube portion will barely expand, the distal portion of the outer tube portion will undergo the full expansion, resulting in the proximal portion of the inner tube portion being less than 50% the diameter of the distal portion of the outer tube portion).
Regarding claim 19, Dubrul et al. as modified further discloses the porous tube has a length that is greater than 10 cm ([0183-184] the working length of the device is 10-500 cm).
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.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771