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
This office action is responsive to the amendment filed on 01/02/2026. As directed by the amendment: claim 2 has been amended and claim 3 has been cancelled. Thus, claims 1, 2, and 4-18 are presently pending in this application with claims 16-18 withdrawn.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 01/02/2026, with respect to the rejection of claim 2 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 2 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 01/02/2025 have been fully considered but they are not persuasive.
Applicant argues that the proposed modification of Allen to use the membrane support of Hetts would likely render Allen unsatisfactory for its intended purpose, which is to completely occlude a bodily lumen” (remarks pg. 8). Applicant goes onto explain that the membrane 800 is Allen is a flow restrictor that is impermeable to blood flow and that the membrane and membrane support of Hetts is designed to allow blood to pass through. The Office respectfully disagrees. Allen is cited as disclosing a membrane (800 in fig. 191 and 830 in fig. 200) which is equated to the claimed flow restrictor, and a membrane support 831 (see claim 1 below and [0657] of Allen), which is equated to the claimed membrane support. Fig. 200 of Allen clearly shows that the membrane support has large spaces therein and does not itself perform the occlusion (that is performed by the membrane). Additionally, these spaces would allow blood flow therethrough. Allen is modified by Hetts to have the membrane support have a self-expanding mesh extending at least radially outwardly from the stem, the self-expanding mesh further comprising a tubular section extending longitudinally along the stem, wherein the tubular section is configured to contact the bodily lumen in the expanded deployed configuration. The fact that the membrane support of Hetts allows blood flow therethrough is consistent with that of Allen’s membrane support. The membrane of Allen is not modified by thus retains its occlusion properties. Therefore, The Office maintains that it would be obvious to modify Allen with Hetts to achieve the claimed invention and such a modification does not render Allen unsatisfactory for its intended purpose.
Applicant further argues that “the structures of Allen and Hetts are at substantial odds with one another such that one of skill in the art would not look to Hetts for modification of an embolization device as Hetts is non-analogous art” (remarks pg. 9). The Office respectfully disagrees. Applicant admits on the remarks pg. 9 that “[i]n order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention”. In other words both Allen and Hetts need to be analogous to the claimed invention but need not be analogous to one another. Both Allen and Hetts are in the same field of endeavor as they are used for (Allen [see abstract])/ in (Hetts [see [0030] and [0086]]) embolization procedures. Therefore, The Office maintains that it would be obvious to one of ordinary skill in the art to modify Allen with Hetts.
Applicant further argues “Hetts is directed to filtering apparatuses which maintains blood flow, Hetts specifically teaches away from any combination with an occluding film as such would necessarily prevent Hetts from performing its filtering function. Accordingly, one of skill would find no teaching, suggestion, or motivation to combine Hetts with an embolization structure” (remarks pg. 9). The Office respectfully disagrees. Hetts is not being modified in any way, shape or form. Instead, Allen is being modified by Hetts as explained above. As such applicant’s argument that it would not be obvious to modify Hetts is moot.
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.
Claims 1-2 and 4-6, 8-10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. (US 20160166257 A1) in view of Hetts et al. (US 20150305850 A1).
Regarding claim 1 Allen discloses (fig. 191-192 and 200) an embolisation device for promoting clot formation in a bodily lumen (see [0016]), comprising a stem (see annotated fig, 191 below) and a plurality of flexible bristles extending outwardly from the stem (see annotated fig. 191 below and [0674]), the bristles having a contracted delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the device in the lumen (see [0071], [0651], and fig. 192), wherein the embolisation device further comprises:
a flow restrictor (membrane: 800 in fig. 191 and 830 in fig. 200) configured to restrict flow through the bodily lumen, the flow restrictor comprising:
a membrane support 831 having a contracted delivery configuration and an expanded deployed configuration (see [0657]); and
an occluding mesh membrane 830 mounted on the membrane support 831 (see [0657] and [0658]), wherein the occlusion rate of the occluding mesh membrane is greater than that of the membrane support (the legs of the membrane support are spaced far apart and the membrane is a flow restrictor; see fig. 200);
wherein the flow restrictor is attached to the stem at a first longitudinal end, the flow restrictor further comprising an open second longitudinal end (see fig. 191 and 200), and
wherein the occluding mesh membrane is configured to restrict flow through the lumen when the device is deployed and the membrane support is in the expanded deployed configuration (see [0657]).
The Office notes that fig. 200 shows an alternate embodiment of the membrane 800 in fig. 191-192, but the rest of the device is the same.
PNG
media_image1.png
310
1085
media_image1.png
Greyscale
Allen is silent regarding the membrane support comprising a self-expanding mesh extending at least radially outwardly from the stem, the self-expanding mesh further comprising a tubular section extending longitudinally along the stem, wherein the tubular section is configured to contact the bodily lumen in the expanded deployed configuration.
However Hetts, in the same filed of endeavor, teaches (fig. 1-2B) of a flow restrictor comprising a membrane support (frame) a comprising a self-expanding mesh (see [0047]) extending at least radially outwardly from a stem (see fig. 2A and [0047]) and a membrane 104; wherein the self-expanding mesh is attached to the stem at a first longitudinal end (see fig. 2A), the self-expanding mesh further comprising a tubular section extending longitudinally along the stem (see fig. 2A), wherein the tubular section is configured to contact the bodily lumen in the expanded deployed configuration (see fig. 2A and [0051]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Allen to have the membrane support comprising a self-expanding mesh extending at least radially outwardly from the stem, the self-expanding mesh further comprising a tubular section extending longitudinally along the stem, wherein the tubular section is configured to contact the bodily lumen in the expanded deployed configuration as taught by Hetts, for the purpose of having a support that can be constrained for delivery and expanded to the full size of the vessel to maximize effectiveness (see [0042]-[0043]) and be able to separate the frame and the membrane to exchange them (see [0035]).
Regarding claim 2, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen is further silent regarding the occluding mesh membrane is a metallic mesh membrane.
However Hetts further teaches a mesh membrane 104 is a metallic mesh membrane (see [0049]).
Therefore, the substitution of one known material (metallic mesh as taught in Hetts) for another (polymer/Dacron mesh as taught in Allen) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Hetts teaches that a metallic mesh is a suitable alternative material to a polymer mesh to form an occluding membrane out of and the substitution of the metallic mesh as taught in Hetts would have yielded predictable results, namely, a mesh that can occlude. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 4, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen is further silent regarding the occluding mesh membrane is mounted radially outside of the self-expanding mesh.
However Hetts further teaches (fig. 1-2B) the occluding mesh membrane 104 is mounted radially outside of the self-expanding mesh (see [0048]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Allen to have the occluding mesh membrane is mounted radially outside of the self-expanding mesh as taught by Hetts, as Hetts teaches this is a suitable alternative mounting configuration (see Hetts [0048]) and so that the occluding mesh being able to contact tissue to provide a secure engagement to tissue.
Regarding claim 5, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen as modified further teaches the occluding mesh membrane (104 of Hetts) comprises a first network of wires having a first average diameter (see Hetts [0049], a metallic mesh has wires with diameters), and the self- expanding mesh (of Hetts) comprises a second network of wires having a second average diameter (see fig. 2B of Hetts).
Allen as modified is silent regarding the second average diameter is greater than the first average diameter.
Therefore, it would have been obvious to one of ordinary skill in the art, at before the effective filing date of the claimed invention, to try having the second average diameter is greater than the first average diameter since it has been held “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions (in this case having a diameter smaller than, equal to and larger than), a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 6, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen as modified further teaches the occluding mesh membrane comprises a plurality of pores (openings in mesh, see [0658] of Allen, [0049] and fig. 2B of Hetts), the number of pores per unit area of the occluding mesh membrane is greater than the number of pores per unit area of the self- expanding mesh (of Hetts) (see fig. 2B of Hetts and fig. 200 of Allen both of which show the number of pores per unit are in the occluding mesh being more than in the membrane support).
Regarding claim 8, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen further discloses (fig. 191-192 and 200) a tubular connector receiving the stem and the membrane support to attach the membrane support to the stem (see annotated fig. 200 below and fig. 191).
PNG
media_image2.png
421
511
media_image2.png
Greyscale
Regarding claim 9, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 8. Allen further discloses (fig. 191-192 and 200) the occluding mesh membrane 830 is attached to the stem by the tubular connector (see fig. 200).
Regarding claim 10, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 8. Allen (fig. 191-192 and 200) does not expressly disclose the tubular connector is a crimping connector.
However Allen teaches in a variant embodiment of a tubular connector that is a crimping connector (see [0077]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Allen (fig. 200) to have the tubular connector is a crimping connector as taught by Allen ([0077]), for the purpose of being able to securely attach the flow restrictor to the stem (see Allen [0077]).
Regarding claim 14, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen further discloses (fig. 191-192 and 200) the embolisation device comprises a bristle segment and the flow restrictor is located longitudinally within the bristle segment or directly adjacent the bristle segment (see [0654]).
Regarding claim 15, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 14. Allen further discloses (fig. 191-192 and 200) the embolisation device is configured to be delivered from a delivery catheter to the bodily lumen in a distal direction, the bristle segment is a proximal bristle segment and the embolisation device further comprises a distal bristle segment spaced apart in the distal direction from the proximal bristle segment (see [0650] and fig. 191).
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Hatts as applied to claim 1 above, and further in view of Van Tassel et al. (US 20030120337 A1).
Regarding claim 7, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen further discloses (fig. 191-192 and 200) the occluding mesh membrane 830 comprises a plurality of pores (opening in mesh, see [0658]).
Allen as modified is silent regarding the pores having a lateral extent of less than 200pm.
However Van Tassel, in the same filed of endeavor, teaches () of an occluding mesh membrane 40 having a plurality of pores, where the pores having a lateral extent of less than 200pm (see [0062]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Allen as modified to have the pores having a lateral extent of less than 200pmas taught by Van Tassel, for the purpose of sufficiently occluding while promoting the growth of cells (see Van Tassel [0062]).
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Hatts as applied to claim 1 above, and further in view of Van der Burg et al. (US 20030220667 A1).
Regarding claim 11, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen as modified is silent regarding the occluding mesh membrane is attached to the membrane support by adhesive or welding.
However Van der Burg, in the same filed of endeavor, teaches (fig. 1) an occluding mesh membrane 15 is attached to a membrane support 14 by adhesive or welding (see [0079]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Allen as modified to have the occluding mesh membrane is attached to the membrane support by adhesive or welding as taught by Van der Burg, for the purpose of having a secure connection of the mesh to the membrane support (see Van der Burg [0079]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Hatts as applied to claim 1 above, and further in view of Miloslavski et al. (US 20090306702 A1).
Regarding claim 12, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Allen as modified is silent regarding the flow restrictor is spaced apart from the plurality of bristles such that in the expanded deployed configuration the flow restrictor is free from contact with any bristles.
However Miloslavski, in the same field of endeavor, teaches (fig. 16) an embolization device comprising a flow restrictor 3 and a plurality of bristles 6, wherein the flow restrictor 6 is spaced apart from the plurality of bristles 6 such that in the expanded deployed configuration the flow restrictor is free from contact with any bristles 6 (see fig. 16 and [0131]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Allen as modified to have the flow restrictor is spaced apart from the plurality of bristles such that in the expanded deployed configuration the flow restrictor is free from contact with any bristles as taught by Miloslavski, for the purpose of the bristles being able to fragment thrombus and the flow restrictor being able to catch the fragmented thrombus (see Miloslavski [0131]).
Regarding claim 13, Allen as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Allen further discloses (fig. 191-192 and 200) the embolisation device is configured to be delivered from a delivery catheter to the bodily lumen in a distal direction, and comprises a bristle segment positioned distally from the flow restrictor (see [0650]).
Conclusion
THIS ACTION IS MADE FINAL. 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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771