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 29th, 2025, have been entered. Claims 1-14 remain pending in the Application. The claim amendments overcome the previous claim objection and 112(b) rejection.
Response to Arguments
Applicant's arguments filed December 29th, 2025, have been fully considered but they are not persuasive.
Applicant argues that Guterman et al. (Pub. No. 2006/0064151) does not disclose the newly added claim limitation “the knot being a localized hub region in which a plurality of the yarns are mechanically connected together thereby forming a zone of denser density relative to the surrounding woven structure” because the marker bands 24, 24a, 24b, and 24c are not interconnections of yarns. Examiner respectfully disagrees. While Applicant is correct that marker band 24 is not a knot under the newly established description from the new claim limitation, the examiner is not relying on the marker band for the claimed “knot”. Rather, the portion of the fibers that are positioned within the marker (where the woven fibers are densest, as shown in FIG. 1, due to the constriction of the fibers together by the smaller diameter of the marker band compared to the rest of the device) are considered the claimed knot, noting that “knot” is defined in the claim as a localized hub region in which a plurality of yarns are mechanically connected together thereby forming a zone of a denser density relative to the surrounding woven structure”). Since the woven fibers have interconnections from the points where the fibers are woven together, the fibers under 24 satisfy the new claim limitation.
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guterman et al. (Pub. No. 2006/0064151) in view of Lam et al. (Pub. No. 2017/0079820).
Regarding claim 1, Guterman et al. discloses an intra-aneurysm device (10; [0046]; FIG. 1) for treating an aneurysm affecting an artery ([0046] 10 treats aneurysms 12 affecting cranial vasculature 16), comprising:
a woven structure ([0046] 10 is a cylindrical stent woven of fibers), with meshes made of a plurality of filaments ([0046] 10 is made up of woven fibers in meshes, as shown in FIG. 1), the structure comprising a proximal portion (FIG. 1: the portion proximal to 32), an intermediate portion (32), and a head (38) intended to be inserted into the aneurysm (FIG. 1: 38 is inserted into 12), the intermediate portion comprising a knot ([0049] the fibers woven together under 24), the knot being a localized hub region in which a plurality of the yarns are mechanically connected together thereby forming a zone of a denser density relative to the surrounding woven structure ([0049] the fibers woven together under 24 are in the narrow waist region 32, where the yarns are the densest and have interconnections from the weave of the fibers; FIG. 1), the knot being connected to the head and preserving the structural integrity of the head and to the proximal portion (FIG. 1: the fibers under 24 are connected to 38 and holds the woven fibers in place), the proximal portion being placed in the artery affected by the aneurysm and anchoring the intra-aneurysm device in the artery affected by the aneurysm (FIG. 1: the proximal portion to 32 is placed within 16 and anchors 10), and
the head being capable of significantly reducing a blood flow in the aneurysm ([0050] blood flow to 12 is blocked by 38), said head being dome-shaped ([0050] and FIG. 1: 38 is dome-shaped), the head is formed from yarn ends (FIG. 1: 38 is formed by the ends of the woven fibers).
Guterman et al. is silent regarding at least some of the yarn heads are mechanically connected to one another.
Lam et al. teaches in the same field of endeavor of aneurysm treatment devices ([0002]), and discloses device (110) comprising a mesh of wires which are joined together in pairs at the ends of the device (FIG. 8) and permanently connected by welding ([0034]) for the purpose of avoiding traumatizing the vessel ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the yarn heads of Guterman et al. to be mechanically connected to one another, as taught by Lam et al., for the purpose of avoiding traumatizing the vessel.
Regarding claim 2, Guterman et al. as modified by Lam et al. further discloses the yarn ends are mechanically connected in pairs (Lam et al. [0033] the wire ends are joined at least in pairs).
Regarding claim 3, Guterman et al. further discloses the meshes of the woven structure are denser at a proximal end of said head than at a distal end of said head (FIG. 1: the woven fibers that are bound together at 24 spread apart in a distal direction to the distal periphery of 38, making the meshes formed by the woven fibers denser at the proximal end of 38 than the distal end of 38).
Regarding claim 4, Guterman et al. further discloses the head has a substantially semi-spherical geometry facing outwards (FIG. 1: 38 is a dome facing distally into 12), a distal end of said head having a substantially circular cross-section of diameter (FIG. 1: the distal periphery of 38 is a circle), and the knot having a substantially circular cross-section with a diameter smaller than the diameter of the head (FIG. 1: 32 has a smaller diameter than the distal periphery of 38).
Regarding claim 5, Guterman et al. further discloses the number the plurality of yarns is between 4 and 250 (FIG. 1: 10 is made up of between 4 and 250 fibers shown crossing over each other in the proximal section).
Regarding claim 6, Guterman et al. further discloses the plurality of yarns have a diameter between 10 and 500 micrometers ([0046] the diameter of 10 ranges from 0.010-0.050 inches, or 254-1270 microns, which puts the diameter of the fibers within the claimed range).
Regarding claim 7, Guterman et al. as modified by Lam et al. further discloses the plurality of yarns overlap at intersection zones (Guterman et al. FIG. 1: the fibers intersect at 24), the plurality of yarns being mechanically connected at said intersection zones (Lam et al. FIG. 8: the yarns overlap when welded together).
Regarding claim 8, Guterman et al. as modified by Lam et al. further discloses at least some of the yarn ends are mechanically connected to one another through a connecting portion made of a part of a first yarn and a part of a second yarn (Lam et al. [0034] the filament ends are joined together by mechanical connection in a way in which the connection provides an additional portion, by welding to create a similar shape to an alternative embodiment bulb 112 shown in FIG. 8).
Regarding claim 9, Guterman et al. further discloses the plurality of yarns are made of biocompatible material ([0046] the fibers are made of nitinol, which is a biocompatible material according to the present Spec Page 5, lines 10-11).
Regarding claim 10, Guterman et al. further discloses at least one yarn of the plurality of yarns is radiopaque ([0047] the marker bands 24 can be radiopaque, and incorporated into the fibers).
Regarding claim 11, Guterman et al. further discloses the proximal portion is for positioning the device (FIG. 1: the proximal portion to 32 is placed within 16 and anchors 10), and said knot in the intermediate portion connects the proximal portion to the head (FIG. 1: 32 connects 38 and the proximal portion).
Regarding claim 12, Guterman et al. further discloses the meshes of the woven structure at the knot are denser than the meshes of the woven structure at a proximal end of the head (FIG. 1: the woven fibers that are bound together at 24 spread apart in a distal direction to the distal periphery of 38, making the meshes formed by the woven fibers denser at 32 than the distal end of 38).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guterman et al. in view of Lam et al., and in further view of Wallace et al. (Pub. No. 2019/0374228).
Regarding claim 13, Guterman et al. as modified by Lam et al. discloses the invention as claimed in claim 1, as discussed above. Guterman et al. does not disclose that said knot is formed by a crimping ring connecting the yarn ends to each other, though Guterman et al. does disclose that the knot can be formed by a ring (24).
Wallace et al. teaches in the same field of endeavor of vasco-occlusive devices for treating aneurysms (Abstract), and discloses an intra-aneurysm device (FIGs. 17A-17C) comprising a woven structure ([0187] and FIG. 17A: the device has a woven configuration) with a knot formed by a crimping ring (1721; [0188]; FIGs. 17A-17C) connecting yarn ends to each other (Fig. 17A: 1721 connects the yarn ends) for the purpose of better securing the yarn ends in place for delivery and deployment.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the knot of Guterman et al. to have a crimping ring, Wallace et al., for the purpose of better securing the yarn ends in place for delivery and deployment.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guterman et al. in view of Lam et al., and in further view of Losordo et al. (Pub. No. 2014/0121752).
Regarding claim 14, Guterman et al. as modified by Lam et al. discloses the invention as claimed in claim 1, as discussed above. Guterman et al. does not disclose said knot is formed by welding yarn ends to one another.
Losordo et al. teaches in the same field of endeavor of aneurysm treatment devices ([0003]), and discloses a device (50) comprising a plurality of yarns ([0068] 50 comprises a plurality of struts) and a knot (55), where the knot is formed by welding the ends of the yarns to one another ([0115] the filaments can be welded together, including in junctions 55 of 54), for the purpose of securing the different yarns and sections to each other ([0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the knot of Guterman et al. to be formed by welding the ends of the yarns together, as taught by Losordo et al. for the purpose of securing the different yarns and sections to each other.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771