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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 6th, 2025, has been entered.
Response to Amendment
The claims filed on November 6th, 2025, have been entered. Claims 1, 8-10, 13-14, 16-18, 21-22, 24, 26, and 29-34 remain pending in the Application.
Response to Arguments
The rejection of claims 1, 8-10, 13-14, 16-18, 21, and 31-32 under 103 over Figulla et al. (Pub. No. 2012/0271337) has been withdrawn in light of Applicant’s amendment made November 6th, 2025; specifically, Figulla et al. does not disclose the disc having a greater diameter than the lobe.
Applicant’s arguments with respect to claim(s) 1, 8-10, 13-14, 16-18, 21, and 31-32 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.
Applicant's arguments filed November 6th, 2025, with respect to the rejection of claims 22, 24, 26, 29-30, and 33-34 under 103 over Glimsdale et al. (Pub. No. 2019/0274668) in view of Li et al. (Pub. No. 2023/0210537) have been fully considered but they are not persuasive.
Applicant argues that the modification of the first embodiment of Li et al. (FIGs. 6-7) cannot be modified in view of the second embodiment of Li et al. (FIGs. 1-2) because the buffer members cannot both extend along the edge of the disc and overlap along the edge of the disc, and because the modification would eliminate the proposed benefits of the first embodiment because the space-apart buffer members will no longer be overlapping to create less resistance. Examiner respectfully disagrees. First, the buffer members 114 can simultaneously extend along the edge of the disc (in both embodiments, 114 goes over the edge of 111) and overlap along the edge of the disc ([0040] states that 114 overlap while traversing the edge 113). Second, the modification does not eliminate the benefit of the first embodiment because the benefit described in [0043] is related to having the entire distal surface 112 be coated with film body 115, which is the central portion that the buffer members 114 extend off of to go over the edge and have their free ends overlap.
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, 8, 13-14, 16-18, 21, and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale et al. (Pub. No. 2019/0274668) in view of Bastin (Pub. No. 2011/0160753).
Regarding claim 1, Glimsdale et al. discloses a medical device (100; FIG. 9; [0082]) for treating a target site ([0046] 100 is placed at a target site to minimize blood flow), the medical device comprising: a proximal end (110) and a distal end (120), wherein the proximal end comprises a disc (180; [0082]) and the distal end comprises a lobe (185), the disc having a greater diameter than the lobe (FIG. 2: the diameter of 180 is greater than the diameter of 185), wherein the disc and lobe are connected by a connecting member (188) and the disc, lobe, and connecting member are formed from a same occlusive, braided shape memory material ([0083] 180, 185, and 188 are made from the same tubular structure, where in [0087] the tubular structure is disclosed as being made of braided nitinol strands that can occlude the blood flow), wherein, when the medical device is deployed at the target site, the lobe is configured to be positioned within a tissue cavity and engaged with tissue within the tissue cavity (FIG. 9: 185 is capable of being positioned in a tissue cavity and engaging with tissue), and the disc is configured to be positioned outside of the tissue cavity and engaged with tissue at an entrance to the tissue cavity (FIG. 9: 180 is capable of being positioned outside of the tissue cavity and engaging with the entrance tissue), and wherein the disc comprises a proximal surface (182; [0067]) and a distal surface (184) enclosing a first volume ([0067] 180 has a first expanded volume portion), wherein the lobe comprises a planar proximal surface (FIG. 9), a planar distal surface (FIG. 9), and a cylindrical side surface extending between and connecting the planar proximal surface and the planar distal surface of the lobe ([0085] 185 has a cylindrical shape, which will create a cylindrical side surface connecting the proximal and distal surfaces) to enclose a second volume greater than the first volume ([0067] 185 has a second expanded volume portion; FIG. 9: the volume of 185 is greater than the volume of 180); and a fabric patch (220), sutured to the braided shape memory material at a plurality of positions ([0082] 220 is sutured to a variety of locations around and within 180 and 185), the fabric patch configured to reduce or prevent leakage between the lobe and tissue even when a portion of the disc and a portion of the cylindrical side surface of the lobe are partially disengaged from the tissue ([0082] 220 occludes blood flow, which would prevent leakage through 100 even if 100 is not fully attached to tissue).
Glimsdale et al. does not explicitly disclose that the fabric patch extends across an entirety of the planar proximal surface of the lobe and at least a portion of the cylindrical side surface of the lobe, and that the plurality of positions are a plurality of varying axial positions and a plurality of different circumferential locations along the cylindrical side surface of the lobe. The fabric patch 220 of Glimsdale et al. is located within the first and second expanded volume portions 180 and 185.
Bastin teaches in the same field of endeavor of occluding devices (Abstract) and discloses a medical device (100; FIGs. 1-3; [0022]) comprising a disc (124), a lobe (126), and an exterior fabric patch (112), wherein the fabric patch extends across an entirety of the planar proximal surface of the lobe (FIG. 1: 112 covers the entirety of 124 and 126), the fabric patch is coupled to the proximal surface and the side surface of the lobe ([0055]), and may be sutured at a plurality of varying axial positions (FIG. 1: 180 travel up and down struts 120) and a plurality of circumferential locations ([0055] 180 can pass along multiple struts 120, which places them at a variety of locations around the circumference of 100) along the side surface of the lobe for the purpose of facilitating anchoring of the medical device to the vessel wall ([0044]) and of securing the covering to the frame ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the fabric patch of Glimsdale et al. (internal) for the fabric patch of Bastin (external) because both fabric patches are equivalent structures for improving the occlusion of the medical device, and the substitution of one for the other would have the predictable result of occluding the opening that the medical device is placed in.
Regarding claim 8, Glimsdale et al. as modified by Bastin further discloses the fabric patch has a circular configuration (Glimsdale et al. FIG. 9: the distal surface of 220 is a circle, and the substitution of the fabric patch from Bastin conforms to the shape of 220) and includes a first, circular portion (Glimsdale et al. FIG. 9: the distal surface of 220 is a circle, and the substitution of the fabric patch from Bastin conforms to the shape of 220) and a second, annular portion coupled to a peripheral edge of the first portion (Glimsdale et al. FIG. 9: the side surface of 220 is annular as part of a cylinder, and the substitution of the fabric patch from Bastin conforms to the shape of 220).
Regarding claim 13, Glimsdale et al. as modified by Bastin further discloses the fabric patch has a substantially circular configuration (Glimsdale et al. FIG. 9: the distal surface of 220 is a circle, and the substitution of the fabric patch from Bastin conforms to the shape of 220).
Regarding claim 14, Glimsdale et al. as modified by Bastin further discloses the fabric patch has a diameter greater than a diameter of the lobe (the substitution by Bastin places the fabric patch on the external surface of the lobe, which gives the fabric patch a greater diameter).
Regarding claim 16, Glimsdale et al. as modified by Bastin further discloses the braided shape memory material is nitinol (Glimsdale et al. [0087] the frame of 100 can be made of nitinol or other shape memory materials).
Regarding claim 17, Glimsdale et al. as modified by Bastin further discloses the fabric patch is formed from polyester (Glimsdale et al. [0016] the fabric patch can be made of polyester strands).
Regarding claim 18, Glimsdale et al. discloses a medical device (100; FIG. 9; [0082]) for treating a target site ([0046] 100 is placed at a target site to minimize blood flow), the medical device comprising: a proximal end (110) and a distal end (120), wherein the proximal end comprises a disc (180; [0082]) and the distal end comprises a lobe (185), the disc having a greater diameter than the lobe (FIG. 2: the diameter of 180 is greater than the diameter of 185), wherein the disc and lobe are connected by a connecting member (188) and the disc, lobe, and connecting member are formed from a same occlusive, braided shape memory material ([0083] 180, 185, and 188 are made from the same tubular structure, where in [0087] the tubular structure is disclosed as being made of braided nitinol strands that can occlude the blood flow), wherein, when the medical device is deployed at the target site, the lobe is configured to be positioned within a tissue cavity and engaged with tissue within the tissue cavity (FIG. 9: 185 is capable of being positioned in a tissue cavity and engaging with tissue), and the disc is configured to be positioned outside of the tissue cavity and engaged with tissue at an entrance to the tissue cavity (FIG. 9: 180 is capable of being positioned outside of the tissue cavity and engaging with the entrance tissue), and wherein the disc comprises a proximal surface (182; [0067]) and a distal surface (184) enclosing a first volume ([0067] 180 has a first expanded volume portion), wherein the lobe comprises a planar proximal surface (FIG. 9: 185 has a planar proximal surface), a planar distal surface (FIG. 9: 185 has a planar distal surface), and a cylindrical side surface extending between and connecting the planar proximal surface and the planar distal surface of the lobe (FIG. 9: 185 has a cylindrical side surface connecting the proximal and distal surfaces) to enclose a second volume greater than the first volume ([0067] 185 has a second expanded volume portion; FIG. 9: the volume of 185 is greater than the volume of 180); and a fabric patch (220), sutured to the braided shape memory material at a plurality of positions ([0082] 220 is sutured to a variety of locations around and within 180 and 185), the fabric patch configured to reduce or prevent leakage between the lobe and tissue even when a portion of the disc and a portion of the cylindrical side surface of the lobe are partially disengaged from the tissue ([0082] 220 occludes blood flow, which would prevent leakage through 100 even if 100 is not fully attached to tissue), and a delivery device ([0082] 100 is deployed by a delivery device) comprising: a delivery catheter ([0082] 100 can be delivered in a catheter); a delivery cable ([0059] 100 is coupled to a pusher wire) within the delivery catheter ([0059] the pusher wire, when attached to 100, will be within the delivery catheter) and translatable with respect to the delivery catheter ([0059] as 100 moves within the delivery catheter, the pusher wire attached to 100 will also move within the delivery catheter); and a coupling member (140) configured to couple the medical device to the delivery cable for facilitating at least one deployment of the medical device at the target site ([0059] 140 has threads to receive the pusher wire to help deploy 100).
Glimsdale et al. does not explicitly disclose that the fabric patch extends across an entirety of the planar proximal surface of the lobe and at least a portion of the cylindrical side surface of the lobe, and that the plurality of positions are a plurality of varying axial positions and a plurality of different circumferential locations along the cylindrical side surface of the lobe. The fabric patch 220 of Glimsdale et al. is located within the first and second expanded volume portions 180 and 185.
Bastin teaches in the same field of endeavor of occluding devices (Abstract) and discloses a medical device (100; FIGs. 1-3; [0022]) comprising a disc (124), a lobe (126), and an exterior fabric patch (112), wherein the fabric patch extends across an entirety of the planar proximal surface of the lobe (FIG. 1: 112 covers the entirety of 124 and 126), the fabric patch is coupled to the proximal surface and the side surface of the lobe ([0055]), and may be sutured at a plurality of varying axial positions (FIG. 1: 180 travel up and down struts 120) and a plurality of circumferential locations ([0055] 180 can pass along multiple struts 120, which places them at a variety of locations around the circumference of 100) along the side surface of the lobe for the purpose of facilitating anchoring of the medical device to the vessel wall ([0044]) and of securing the covering to the frame ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the fabric patch of Glimsdale et al. (internal) for the fabric patch of Bastin (external) because both fabric patches are equivalent structures for improving the occlusion of the medical device, and the substitution of one for the other would have the predictable result of occluding the opening that the medical device is placed in.
Regarding claim 21, Glimsdale et al. as modified by Bastin further discloses the fabric patch extends along an entire axial length of the cylindrical side surface of the lobe (Bastin FIG. 1: 112 covers the entirety of 124 and 126).
Regarding claim 31, Glimsdale et al. as modified by Bastin further discloses the fabric patch extends only over the lobe (Glimsdale et al. [0082] 220 can be positioned on just 185).
Regarding claim 32, Glimsdale et al. as modified by Bastin further discloses the fabric patch extends along only a portion of an axial length of the cylindrical side surface of the lobe (Glimsdale et al. [0082] 220 can be positioned on just portions of 100).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale et al. in view of Bastin, and in further view of Eidenschink et al. (Pub. No. 2024/0050080).
Regarding claim 9, Glimsdale et al. as modified by Bastin discloses the invention as claimed in claim 8, as discussed above. Glimsdale et al. does not disclose the second portion includes a flexible cylindrical rod having a diameter that corresponds to a depth of the disc, from about 0.5 to about 2.0 mm.
Eidenschink et al. teaches in the same field of endeavor of occlusion devices (Abstract) and discloses an occlusive device (100; FIG. 9A) comprising a frame (102) and a flexible cylindrical rod (104; [0054] 104 is flexible; FIGs. 5A-5B: 104 has a circular top and bottom with an annular side connecting them, making 104 a cylinder), where the flexible cylindrical rod has a diameter corresponding to a depth of the frame (FIG. 9A: the diameter of 104 is approximately equal to the depth of the frame portion 102 that 104 is located within; the depth of the frame is being considered as the distance between the two sides surfaces of the cylindrical portion of 102 that corresponds to the shape of 104) for the purpose of providing a more penetrable material than the frame ([0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective date of filing to have modified Glimsdale et al. to include a flexible cylindrical rod, as taught by Eidenschink et al., for the purpose of providing a more penetrable material than the frame.
Glimsdale et al. as modified by Eidenschink et al. is silent regarding the diameter of the flexible cylindrical rod being about 0.5 to about 2.0 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the flexible cylindrical rod 0.5-2.0 mm in diameter because 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 present case, the flexible cylindrical rod would not operate differently with the claimed lengths, as the flexible cylindrical rod would still be sized based on the depth of the disc, which is selected based on the size of the opening being occluded. Furthermore, Applicant places no criticality on the claimed dimensions, indicating simply that one embodiment can have the claimed dimensions in [0035] of the present Specification.
Regarding claim 10, Glimsdale et al. as modified by Bastin and Eidenschink et al. further discloses the flexible cylindrical rod is formed from a fabric material ([0053] 104 can be a woven, knitted, or braided material), and wherein the fabric or yarn material includes polyester ([0053] 104 can be formed from polyester).
Claim(s) 22, 24, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale et al. in view of Li et al. (Pub. No. 2023/0210537).
Regarding claim 22, Glimsdale et al. discloses a medical device (100; [0046]; FIGs. 2-9) for treating a target site, the medical device comprising:
a disc (180; [0055]; FIG. 7) at a proximal end of the medical device (FIG. 7), the disc comprising a planar proximal surface (FIG. 7), a planar distal surface (FIG. 7), and a side surface collectively enclosing a first volume (FIG. 7);
a lobe (185; [0055]; FIG. 7) at a distal end of the medical device (FIG. 7), the lobe having a cylindrical shape (FIG. 7) and comprising a proximal surface (FIG. 7), a distal surface (FIG. 7), and a cylindrical side surface collectively enclosing a second volume greater than the first volume (FIG. 7);
a connecting member (188; [0070]; FIG. 7) connecting the disc and the lobe, wherein the disc, lobe, and connecting member are formed from a same occlusive, braided shape memory material ([0087] 100 is made of braided strands made of nitinol); and
a fabric patch (220; [0082]; FIG. 9).
Glimsdale et al. does not disclose the fabric patch has a star configuration including a plurality of extensions extending radially outward from a central portion to respective free ends; the central portion is coupled to the planar proximal portion of the disc and extends across an entirety of the planar proximal surface of the disc; the plurality of extensions extend axially along the side surface of the disc such that the fabric patch extends along an entire axial length of the disc; and the plurality of extensions are coupled to the planar distal surface in an overlapping configuration in which the free ends of the plurality of extensions at least partially overlap one another. The fabric patch 220 of Glimsdale et al. is located within the first and second expanded volume portions 180 and 185.
Li et al. teaches in the same field of endeavor of occluding devices (Abstract), and discloses an occluding device (100) comprising a disc (110) and an exterior cover (114, 115), where the cover is coupled to the proximal surface of the disc ([0043] 115 is on 111; FIG. 7) and the cover is coupled to the distal surface of the disc ([0043] 114 is on 113 and at least a portion of 112; FIG. 7), and extends entirely across the planar proximal surface of the disc (FIG. 7) and along an entire axial length of the side surface of the disc (FIG. 7) where the cover has a star configuration (FIG. 6) including a plurality of extensions (114) extending radially outward from a central portion (115) the central portion is coupled to the proximal portion of the disc ([0043] 115 is coupled to 111; FIG. 7) and the plurality of extensions extend around an edge of the disc (Li et al. 114; FIGs. 6-7) and are coupled to the distal surface of the disc ([0043] 114 is coupled to 112; FIG. 7), and the plurality of extensions are coupled to the planar distal surface (FIG. 7: 114 are coupled to 113) for the purpose of reducing the damage of friction on the disc and improving the sealing effect of the disc ([0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the fabric patch of Glimsdale et al. (internal) for the fabric patch of Li et al. (external) because both fabric patches are equivalent structures for improving the occlusion of the medical device, and the substitution of one for the other would have the predictable result of occluding the opening that the medical device is placed in. The fabric patch of Li et al. would also have the advantage of reducing the damage of friction on the disc and improving the sealing effect of the disc.
The embodiment of FIGs. 6-7 does not explicitly disclose that the plurality of extensions are in an overlapping configuration in which the free ends of the plurality of extensions at least partially overlap one another.
However, Li et al. further discloses in [0035] that the embodiment of FIGs. 1-2 includes a plurality of extensions 114 which are distributed along the edge 113, where [0040] states that the 114 may overlap while arranged around the edge 113 to provide a better buffer effect and reduce the damage done by the disc to the internal tissues ([0040]). In this distribution, 114 are arranged in an overlapping configuration in which 114 overlap each other to form a circle (FIG. 2), and the free ends of 114 would at least partially overlap (the ends are shown best in FIG. 6, but would be modified to overlap going around the entire edge 113).
It would have been obvious to one of ordinary skill in the art before the effective filing date that the first embodiment of FIGs. 6-7 of Li et al. could have the free ends of 114 overlap, as taught by the second embodiment of FIGs. 1-2, for the purpose of providing a better buffer effect and reducing the damage done by the disc to the internal tissues.
Regarding claim 24, Glimsdale et al. as modified by Li et al. further discloses the central portion of the fabric patch has a diameter approximately equal to a diameter of the disc (Li et al. FIG. 6 illustrates 115 covers 111, making the diameter of 115 approximately equal to the diameter of 110).
Regarding claim 26, Glimsdale et al. as modified by Li et al. further discloses the fabric patch is coupled to the disc by sutures (Li et al. [0043] 114 and 115 are attached by suturing).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale et al. in view of Li et al., and further in view of Eidenschink et al.
Regarding claims 29-30, Glimsdale et al. as modified by Li et al. discloses the invention as claimed in claim 22, as discussed above. Glimsdale et al. does not disclose the second portion includes a flexible cylindrical rod positioned against an interior of the side surface of the disc, and having a diameter that corresponds to a depth of the disc from about 0.5 to about 2.0 mm.
Eidenschink et al. teaches in the same field of endeavor of occlusion devices (Abstract) and discloses an occlusive device (100; FIG. 9A) comprising a frame (102) and a flexible cylindrical rod (104; [0054] 104 is flexible; FIGs. 5A-5B: 104 has a circular top and bottom with an annular side connecting them, making 104 a cylinder), where the flexible cylindrical rod has a diameter corresponding to a depth of the frame (FIG. 9A: the diameter of 104 is approximately equal to the depth of the frame portion 102 that 104 is located within; the depth of the frame is being considered as the distance between the two sides surfaces of the cylindrical portion of 102 that corresponds to the shape of 104) for the purpose of providing a more penetrable material than the frame ([0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective date of filing to have modified Glimsdale et al. to include a flexible cylindrical rod, as taught by Eidenschink et al., for the purpose of providing a more penetrable material than the frame.
Glimsdale et al. as modified by Eidenschink et al. is silent regarding the diameter of the flexible cylindrical rod being about 0.5 to about 2.0 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the flexible cylindrical rod 0.5-2.0 mm in diameter because 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 present case, the flexible cylindrical rod would not operate differently with the claimed lengths, as the flexible cylindrical rod would still be sized based on the depth of the disc, which is selected based on the size of the opening being occluded. Furthermore, Applicant places no criticality on the claimed dimensions, indicating simply that one embodiment can have the claimed dimensions in [0035] of the present Specification.
Claim(s) 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale et al. in view of Li et al., and in further view of Bastin.
Regarding claim 33, Glimsdale et al. as modified by Li et al. discloses the invention as claimed in claim 26, as discussed above. Neither Glimsdale et al. nor Li et al. explicitly disclose the fabric patch is coupled to the disc by sutures positioned along the proximal surface and the distal surface of the disc.
Bastin teaches in the same field of endeavor of occluding devices (Abstract) and discloses a device (100; [0022]; FIGs. 1-3) comprising a disc (124), a lobe (126), and a fabric patch (112), where the fabric patch is coupled to the proximal surface ([0055]) and the distal surface ([0055]) of the disc and may be sutured ([0055] 112 is sutured by 180 to 110) for the purpose of securing the covering to the frame ([0055]).
Therefore, it would have been obvious to one of ordinary skill in the before the effective date of filing to have modified Glimsdale et al. to suture the fabric patch to the braided shape memory material at the proximal and distal surfaces of the disc, as taught by Bastin, for the purpose of securing the fabric patch to the braided shape memory material.
Regarding claim 34, Glimsdale et al. as modified by Bastin further discloses the fabric patch is coupled to the disc by sutures positioned along the side surface of the disc (Bastin [0055] 112 is sutured by 180 to 110; FIG. 1).
Conclusion
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
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771