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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 18, 2025 has been entered.
Response to Amendment
This office action is in response to the request for continued examination filed December 18, 2025. Claim(s) 1 are amended. Claim(s) 4-8 and 24-94 stand canceled. Claim(s) 3, 11-12, 15-16, and 18-19 stand withdrawn. Claims 95-97 are newly added. Claim(s) 1-2, 9-10, 13-14, 17, 20-23, and 95-97 are pending and addressed below.
Response to Arguments
Applicant’s amendment to the claims have overcome each and every 35 USC § 112(b) rejection previously set forth in the Final Office Action dated September 19, 2025.
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. Applicant argues that the reference of Griffin (U.S. Pub. No. 2019/0053810) does not teach the third layer as a single layer because “bolus” 30 is a double layer that is folded over, citing see also Griffin, para. 0042 ("In another embodiment, the mesh density of the inner 30 bolus is a double layer of mesh and is greater (or higher) than the mesh density of its 20 body's outer double layer of mesh." (emphasis added)). However, the “bolus” 30 is considered the second plurality of elongate filaments that are woven together, which is made up of two single layers (an inner and outer layer) which form the double layer. It is noted, the claim does not require the second plurality of elongate filaments that forms the third layer be a single layer. The outer layer of the bolus 30 (i.e., third layer) can be considered a single layer while the inner layer of the bolus 30 can be considered a separate single layer. Therefore, the arguments are unpersuasive.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 9-10, 21-23, and 95-96 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halden et. al. (U.S. Pub. No. 2013/0211495) hereinafter, “Halden.”
Regarding Claim 1, Halden teaches a device for treatment of a patient's cerebral aneurysm (Fig. 14), comprising:
a permeable shell (90; Fig. 14) comprising first (12; Fig. 14), second (12; Fig. 14), and third layers (92; Fig. 14), a proximal end (see annotated Fig. 14 below), a distal end (see annotated Fig. 14 below), wherein the permeable shell (90) has radially constrained elongated state configured for delivery (e.g., Fig. 1B) within a catheter lumen (2; Fig. 1B) and an expanded state (Fig. 14) with a longitudinally shortened configuration relative to the radially constrained state.
wherein the first and second layers (12/14) are formed from a first plurality of elongate filaments (12 & 14 in combination; Fig. 14) that are woven together to form a mesh (pp. [0102]), wherein each of the first plurality of elongate filaments (12 & 14) have a first end (see annotated Fig. 14 below), a second end (see annotated Fig. 14 below), and a middle portion (16; Fig. 14), wherein the first and second ends of each of the first plurality of elongate filaments (12 & 14) are gathered at the proximal end (see annotated Fig. 14 below) of the permeable shell (90) in a hub (30; Fig. 14), and wherein the middle portion (16) is associated with the distal end (see annotated Fig. 14 below) of the permeable shell (90), wherein each of the first and second layers (12/14) has an inner side and an outer side (see annotated Fig. 14 below) and
wherein the third layer (92) is formed from a second plurality of elongate filaments that are woven together to form a mesh (pp. [0102]), wherein the third layer (92) is located between the first and second layers (12/14), wherein the first layer (12) is an outermost layer of the device (see annotated Fig. 14 below) and the second layer (14) is an innermost layer of the device (see annotated Fig. 14 below), and
wherein the third layer (92) is a single layer having an inner side and an outer side (see annotated Fig. 14 below), wherein the outer side of the third layer (92) is adjacent the inner side of the first layer (12) and the inner side of the third layer (92) is adjacent the outer side of the second layer (14), and wherein a first end of each of the second plurality of elongate filaments are gathered at the proximal end (see annotated Fig. 14 below) of the permeable shell (90).
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Regarding claim 2, Halden further teaches the mesh formed by the first plurality of elongate filaments is inverted in the middle portion (pp. [0101]) to form the first and second layers (12/14).
Regarding claim 9, Halden further teaches the third layer (92) is a stasis layer (“contribute to implant density” pp. [0100]).
Regarding claim 10, Halden further teaches the first and second layers (12/14) are structural layers (pp. [0102]).
Regarding claim 21, Halden further teaches a marker band (32; Fig. 8) located at the proximal end of the permeable shell (90).
Regarding claim 22, Halden further teaches the distal end of the permeable shell (90) does not include a distal hub (see Fig. 14).
Regarding claim 23, Halden further teaches the distal end of the permeable shell (90) comprises an opening (see Fig. 14) in communication with an inner cavity of the permeable shell (90).
Regarding claim 95, Halden further teaches the inner side of the second layer (14) forms an inner surface of the inner cavity (see Fig. 14).
Regarding claim 96, Halden further teaches the expanded state of the permeable shell (90) has a substantially globular shape (see Fig. 14).
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) 1-2, 9-10, 13-14, 21-23, 95, and 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et. al. (U.S. Pub. No. 2019/0053810) in view of Marchand et. al. (U.S. Pub. No. 2011/0152993) hereinafter, “Marchand.”
Regarding Claim 1, Griffin teaches a device for treatment of a patient's cerebral aneurysm (Fig. 1), comprising:
a permeable shell (20 and 30 in combination; Fig. 1) comprising first (20; see annotated Fig. 1 below), second (20; see annotated Fig. 1 below), and third layers (30, e.g., the outermost layer; see annotated Fig. 1 below), a proximal end (see annotated Fig. 1 below), a distal end (see annotated Fig. 1 below), wherein the permeable shell (20, 30) has a delivery state (pp. [0010]) within a catheter lumen (pp. [0029]) and an expanded state with (pp. [0010]).
wherein the first and second layers (20) are formed from a first plurality of elongate filaments (pp. [0036]) that are woven together to form a mesh (pp. [0036]), wherein each of the first plurality of elongate filaments have a first end (see annotated Fig. 1 below), a second end (see annotated Fig. 1 below), and a middle portion (see annotated Fig. 1 below), wherein the first and second ends of each of the first plurality of elongate filaments are gathered at the proximal end (see annotated Fig. 1 below) of the permeable shell (20, 30) in a hub (40; Fig. 1), and wherein the middle portion is associated with the distal end (see annotated Fig. 1 below) of the permeable shell (20, 30), wherein each of the first and second layers (20) has an inner side and an outer side (see annotated Fig. 1 below) and
wherein the third layer (30) is formed from a second plurality of elongate filaments that are woven together to form a mesh (pp. [0036], it is noted, the second plurality of elongate filaments is folded over similar to the first plurality of elongate filaments in which the dual layer is formed with two single layers), wherein the third layer (30) is located between the first and second layers (20), wherein the first layer (20) is an outermost layer of the device (see annotated Fig. 1 below) and the second layer (20) is an innermost layer of the device (see annotated Fig. 1 below), and
wherein the third layer (30) is a single layer having an inner side and an outer side (it is noted, the second plurality of elongate filaments is folded over forming a dual layer similar to the first second plurality of elongate filaments, however, each layer when considered independently is a single layer), wherein the outer side of the third layer (30) is adjacent the inner side of the first layer (20, see annotated Fig. 1 below) and the inner side of the third layer (30) is adjacent the outer side of the second layer (20; it is noted, “adjacent” is given its broadest reasonable interpretation to mean “not distant” or “nearby.” The inner side of the third layer is considered adjacent to the outer side of the second layer because the layers are in close proximity), and wherein a first end of each of the second plurality of elongate filaments are gathered at the proximal end (see annotated Fig. 1 below) of the permeable shell (20, 30).
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However, Griffin does not explicitly disclose the delivery state is a radially constrained elongated state, wherein expanded state is longitudinally shortened relative to the radially constrained state. Griffin does teach the permeable shell has a self-expanding nitinol body (pp. [0044]) with a first delivery shape and a second expandable deployed shape (pp. [0010]).
Marchand teaches it is known in the art for curved self-expanding permeable mesh shells to have radially constrained elongated states configured for delivery within a microcatheter and longitudinally shortened expanded configurations relative to the radially constrained state (pp. [0018]).
Marchand is considered to be analogous to the claimed invention because it is in the same field of occlusive devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the permeable shell of Griffin to incorporate the teachings of Marchand by providing the delivery state is a radially constrained elongated state, wherein expanded state is longitudinally shortened relative to the radially constrained state. Elongating the permeable mesh in the radially constrained shape relative to the expanded shape would radially decrease its dimension to fit into the smallest catheter possible.
Regarding claim 2, Griffin further teaches the mesh formed by the first plurality of elongate filaments is inverted in the middle portion (see annotated Fig. 1 above) to form the first and second layers (20).
Regarding claim 9, Griffin further teaches the third layer (30) is a stasis layer (“bolus” 30 “further reduces blood flow,” pp. [0038]).
Regarding claim 10, Griffin further teaches the first and second layers (30) are structural layers (the first and second layers are the layers that contact the aneurysm wall and hold the implant within the aneurysm, therefore, they are considered structural layers, see also pp. [0038] discussing the device anchoring itself within the LAA).
Regarding claim 13, Griffin teaches each of the first plurality of filaments (20) has a diameter between about 0.001" to about 0.004" (pp. [0065]).
Regarding claim 14, Griffin teaches the filaments of the meshes can be formed of varying diameter (pp. [0059]), but does not explicitly disclose each of the second plurality of filaments has a diameter between about 0.00025" to about 0.00075".
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Griffin to have each of the second plurality of filaments have a diameter between about 0.00025" to about 0.00075" 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 invention of Griffin operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Griffin. Further, applicant places no criticality on the dimensions claimed, indicating simply that diameters may be about 0.00025" - about 0.00075," depending on implant size (emphasis added)(paragraph [00135] of applicant’s specification).
Regarding claim 21, Griffin further teaches a marker band (the “hub” 40 is taught being a marker band, pp. [0045]; Fig. 1) located at the proximal end of the permeable shell (20, 30).
Regarding claim 22, Griffin further teaches the distal end of the permeable shell (20, 30) does not include a distal hub (see Fig. 1).
Regarding claim 23, Griffin further teaches the distal end of the permeable shell (20, 30) comprises an opening (see annotated Fig. 1 above) in communication with an inner cavity of the permeable shell (20, 30).
Regarding claim 95, Griffin further teaches the inner side of the second layer (20) forms an inner surface of the inner cavity (see Fig. 14).
Regarding claim 97, Griffin further teaches the expanded state of the permeable shell (20, 30) has a substantially barrel shape (see Fig. 1).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Marchand, and further in view of Amplatz et. al. (U.S. Pub. No. 2006/0241690), hereinafter, “Amplatz.”
Regarding claim 17, Griffin does not explicitly disclose an average diameter of the first plurality of filaments is larger than an average diameter of the second plurality of filaments.
Amplatz teaches a permeable shell (Fig. 7) with an outer layer (110; Fig. 7), middle layer (112; Fig. 7), and inner layer (114; Fig. 7), wherein an average diameter of the filaments of the outer layer is larger than an average diameter of the filaments of the inner layers (pp. [0069]).
Amplatz is considered to be analogous to the claimed invention because it is in the same field of occludes for vascular defects. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filaments diameters of Griffin to incorporate the teachings of Amplatz by providing the average diameter of the first plurality of filaments (i.e., the outermost layer) is larger than an average diameter of the second plurality of filaments (i.e., the inner most layer). Doing so would increase the strength of the outer layer of the permeable which would allow the implant to maintain its shape while contacting and pressing against a vessel wall.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Marchand, and further in view of Cam et. al. (U.S. Pub. No. 2012/0290067), hereinafter, “Cam.”
Regarding claim 20, Griffin does not explicitly disclose the second plurality of filaments has a larger number of filaments than the first plurality of filaments. Griffin does teach the second plurality of filaments has a higher density than the first plurality of filaments (pp. [0042]), but is silent as to how the greater density is achieved.
Cam teaches a known method of increasing filament density of a permeable shell by increasing the number of filaments (pp. [0048]).
Cam is considered to be analogous to the claimed invention because it is in the same field of occludes for vascular defects. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the permeable shell of Griffin to incorporate the teachings of Cam by providing the second plurality of filaments with a larger number of filaments than the first plurality of filaments. Doing so would increase the density of the second plurality of filaments relative to the first plurality of filaments as desired by Griffin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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