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 Arguments
The amendments to the claims have overcome the previously presented 35 USC 102a1 rejections over Jayaraman and over White, Jr., and the 35 USC 103 rejections over Jayaraman in view of Lefebvre, Duncan, Buiser, White Jr. or Marks.
Applicant's arguments filed 5/15/2026 with respect to the amendments distinguishing the claimed invention from the prior art of Kobayashi have been fully considered but they are not persuasive. Applicant asserts that the radially-extending segments of the zigzag structure of Kobayashi (see fig. 2) do not meet the limitation of at least some of the radially-extending segments forming a set of chords configured to span an inner perimeter of the vessel wall that, when viewed transverse to a longitudinal axis of the vessel, are not coincident with one another. This is not found persuasive. Figure 7 shows the radially-extending segments forming a set of chords configured to span an inner perimeter of the vessel wall, noting that either end of a chord contacts (or nearly contacts, further noting that the device can be disposed in a smaller vessel) the perimeter of the vessel wall. Figure 7 shows the chords (each linear segment of zig-zag portion) when viewed transverse to a longitudinal axis of the vessel (patent ductus arteriosus D), noting the viewing direction of fig. 7 is transverse to a longitudinal axis of the vessel (i.e., the direction in which a person views the chords is perpendicular to the plane of the page and perpendicular to the longitudinal axis of the vessel). The chords, in this view, are clearly not coincident with each other.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 9, and 12-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kobayashi et al. (US 6,375,671). Regarding claims 1 and 14, Kobayashi discloses a vascular occlusion device (fig. 2) configurable between an unexpanded state (see fig. 6; when in catheter) and an expanded state (fig. 7), the vascular occlusion device comprising: a plurality of radially-extending segments (each linear segment of zigzag) and a plurality of bending portions (formed by bends in zigzag; fig. 2) that, in the expanded state, define angled bends formed at a vertex joining two or more substantially linear, radially-extending segments of the plurality of radially-extending segments (fig. 2). Each angled bend defines a contact point configured to anchor to a vessel wall (if placed into a vessel with a narrowing matching that of the occlusion device; similar to figs. 6, 7), when the vascular occlusion device moves from the unexpanded state (noting portion in catheter in fig. 6) to the expanded state (fig. 7), the plurality of angled bends are configured to expand such that the contact points contact the vessel wall (see figs. 6, 7), the contact points define a width of the vascular occlusion device (at least at that location) in a direction perpendicular to a length of the vascular occlusion device, and the width is configured to correspond to a diameter of a blood vessel (noting “configured to correspond to a diameter of a blood vessel is a recitation of intended use and the prior art must only be capable of being placed in a blood vessel having a diameter corresponding to the width of the occlusion device; see also fig. 7). At least some of the plurality of radially-extending segments substantially form between successive contact points a set of chords configured to span an inner perimeter of the vessel wall (noting either end of a radially-extending segment contacts the vessel wall as understood in view of fig. 7) that, when viewed transverse to a longitudinal axis of the vessel, are not coincident with one another (note: the view shown in fig. 7 is considered to show the radially-extending segments “when viewed transverse to a longitudinal axis of the vessel” since the viewing direction is perpendicular to the longitudinal axis of the vessel).
Further regarding claim 14, the device of Kobayashi is for occluding a vessel via contact with the vessel wall (see figs. 6,7; occluding patent ductus arteriosus). The plurality of radially-extending segments extends radially between successive contact points to occlude blood flow in the vessel (similar to fig. 7, at least by holding occlusion device within vessel).
Regarding claims 2 and 15, the vascular occlusion device comprises a single piece of shape memory material (1), and the vascular occlusion device self-transitions from the unexpanded state to the expanded state upon reaching a threshold temperature (col. 3, ll. 43-53; col. 5, ll. 8-29).
Regarding claims 3 and 16, the shape memory material comprises nitinol (col. 3, ll. 43-53)
Regarding claim 4, when the vascular occlusion device is in the unexpanded state, the vascular occlusion device comprises a wire or ribbon of the shape memory material (see fig. 5, noting Kobayashi discloses that the fixing member 1 is a made of a shape memory wire).
Regarding claim 9, when in the expanded state, two angled bends disposed at opposite ends of a linear segment of the plurality of radially-extending segments (noting zigzag shape) are configured to contact different radial positions of a wall of the blood vessel as understood in fig. 7 (see patent ductus arteriosus D in figs. 6 and 7).
Regarding claim 12, Kobayashi further discloses a coupler (13) extending from an end radially extending segment (note 13 is formed at end of segment that extends radially inward) of the vascular occlusion device (best shown in fig. 1), the coupler being configured to engage with a removal tool for removing the vascular occlusion device from the blood vessel. Note that “configured to engage with a removal tool is considered a recitation of intended use and the prior art coupler must only be capable of engaging with a removal tool in order to meet this limitation.
Regarding claim 13, the coupler can be considered a clamp hold as element (13) of Kobayashi is called a “holding portion” and is clearly capable of being held by a clamp.
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.
Claim(s) 6, 8, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Lefebvre (US 4,990,156). Kobayashi discloses the invention substantially as stated above except for the angled bends comprising an increased coefficient of friction as compared to the plurality of radially extending segments, or the angled bends having a surface roughness that is greater than that of the plurality of radially extending segments.
Lefebvre discloses another self-expanding vascular implant that includes a portion (12) meant to contact the vessel wall to anchor the implant at a location within the vessel. The portion (12) meant to contact the vessel wall includes a surface roughness (caused by “rough portions” 13) greater than that of other sections of the device not meant to contact the wall in order to better anchor the implant to the vessel wall (col. 5, ll. 18-22; noting other sections are free of “rough portions” 13). As understood in view of the surface roughness enhancing anchoring of portion (12) to the wall, the roughness results in an increased coefficient of friction at portion (12) as compared to the other sections of the device that do not have the surface roughness. According to Lefebvre, the rough portions procure for the implant a very good stability in position and will avoid long-term migration of the implant (col. 5, ll. 17-22). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kobayashi in view of Lefebvre to provide the angled bends, which are meant to contact the vessel wall to anchor the device in place according to Kobayashi, with increased surface roughness resulting in increased coefficient of friction as compared to the radially extending segments in order to procure for the implant very good stability and to prevent migration of the implant.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Lefebvre as applied to claims 6 and 17 above and further in view of Duncan (US 2013/0184658). Kobayashi in view of Lefebvre disclose the invention substantially as stated above including a greater surface roughness (and therefore coefficient of friction as it is meant to better anchor the implant to the wall) on the angled bends in order to facilitate better anchoring of the device. Kobayashi in view of Lefebvre do not expressly disclose using a layer of polymeric material on the angled bends.
Duncan discloses another occlusion device and further discloses that a coating including granules of polymeric material are known in the art and can be used to impart a textured surface to impart increased frictional properties to prevent movement of the device ([0122]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Kobayashi in view of Lefebvre to provide the surface roughness on the angled bends via a layer of polymeric material in the form of a coating with granules of polymeric material as taught by Duncan in view of Duncan’s teaching that such coatings are known in the art as an alternative means of providing increased surface roughness and coefficient of friction on a portion of a vascular implant, the results are predictable, and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Buiser et al. (US 2007/0142859). Kobayashi discloses the invention substantially as stated above except for a hydrogel coating disposed on at least the angled bends.
Buiser discloses another vascular occlusion device comprising a coil (20) having a collapsed, linear configuration (fig. 1b, 2c) and an expanded configuration (figs. 2d, 2e). Buiser discloses a hydrogel (20; [0076]-[0077]) over the entire length of the occlusion device that enhances the deliverability of the coil and can be used to deliver one or more therapeutic agents to a target site ([0066]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kobayashi in view of Buiser to include a hydrogel coating over the entire length of the occlusion device, which includes the angled bends, in order to enhance deliverability of the coil and allow delivery of therapeutic agents to a target site.
Claim(s) 5, 11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of White, Jr. et al. (US 9,301,764). Regarding claims 11 and 21, Kobayashi discloses the invention substantially as stated above except for thrombogenic fibers extending from at least one of the plurality of radially extending segments and/or the angled bends.
White, Jr. discloses another vascular occlusion device configurable between an unexpanded shape and an expanded shape. White discloses providing thrombogenic fibers along the entire length of the vascular occlusion device in order to help occlude fluid flow through the lumen of the blood vessel (see fig. 2b, 6a-6c; col. 4, ll. 50-55). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kobayashi to include thrombogenic fibers along the entire length of the vascular occlusion device (which includes the radially-extending segments and angled bends) in view of White for the predictable result of encouraging quicker occlusion of fluid flow through the vessel lumen, thereby closing a vascular defect more quickly.
Regarding claim 5, Kobayashi discloses the invention substantially as stated above, but does not expressly state that in the expanded state, one or more radially-extending segments of the plurality of radially-extending segments are configured to extend radially through a geometric center of the vascular occlusion device.
White discloses another vascular occlusion device that includes radially-extending segments that span the perimeter of the vessel, and further discloses that one or more of the radially extending segments are configured to extend radially through a geometric center of the vascular occlusion device. See the examiner-annotated figures below. Thus, such a configuration is known in the art.
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Additionally, the application as filed does not disclose a problem solved, purpose served, or advantage gained by such placement. Furthermore, it appears that the device of Kobayashi would work equally well with radially extending segments that do not pass through the geometric center of the vascular occlusion device or radially extending segments that include at least one segment that passes through the geometric center of the vascular occlusion device. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kobayashi to position the radially-extending segments such that one or more of them extend radially through a geometric center of the vascular occlusion device since such placement of the radially extending segments is known as suitable in the art of occlusive devices according to White and such a modification appears to be a mere design choice that leads to the predictable result of providing radially extending segments that span the perimeter of the vessel to provide contact points to anchor the device in place and does not change the function of the occlusion device.
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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KSH 7/8/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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