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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/19/2025 has been entered.
Response to Arguments
The applicant argues in the response filed 08/19/2025 that the claim amendments would overcome the previous drawing objections and 112 rejections. The drawing objections and 112 rejections have been withdrawn.
The applicant argues prior art Akpinar in view of Wang/Meng and Adams/Liu/Amplatz would not be able to read on the amended claims with respect to the device comprising “a braided collapsible and expandable structure with a first disc and a second disc and a connecting neck in between the first disc and the second disc, a ridge disposed on a periphery of the first disc or the second disc…wherein the first disc is hub-less disc …and wherein the first disc incorporates a woven central section and the device comprises non-woven wires configured in or more stages, with each stage interspaced with one or more braids and braided together with the wires from the woven central section and earlier stages to form a remaining portion of the first disc and the second disc to from the device” with respect to the dual structured sept device having a woven central section on the first disc and a braided structure forming the reminding portion of the device.
It is to be noted that the claims are device claims and therefore the process by which the device is made is not given patentable weight. If the prior art reads on the structure of the claim (braided collapsible and expandable structure with first hub-less disc with a woven central section, connecting neck, second disc, thrombogenic material, and a ridge) the prior art will be able to read on the claims. Akpinar does disclose the structure of the device with respect to the braided collapsible expandable structure with a first hub-less disc, a connecting neck, disc, and thrombogenic material. Akpinar can read on a generic ridge based on the rounded periphery of the discs, or prior art Meng/Amplatz can teach the ridge. With respect to the braided device / woven central section, the claims (at least independent claim 1) does not positively claim the distinct different structures of the braid vs the weave. The applicant does argue the differences as highlighted in the table, where the “resulting geometry” is a flat, planar mesh with respect to the weaving, and a cylindrical or tubular braid with respect to the braiding. It is be noted that claim, as amended in the response filed 08/19/2025, does not positively claim the hub-less disc is flat. Teaching references Adams/Flament/Zhuang (as argued below) provides support for a woven structure can be made into a braided configuration, both a weave and a braid can be used together to form a device, and a pattern of wires can change to form a weave-like central section, that can be the (flat) central section of the hub-less first disc of Akpinar. Therefore, the “woven central section” can be disclosed by Akpinar since it does disclose the flat central section formed by known patterns of wires, and/or prior art Adams/Flament/Zhuang can teach/obviate/provide evidence that a woven central section can be used in a braided device. How the device is made is not given patentable weight since the inventive entity is a device claim and the structure as claimed is known. The examiner maintains the rejection Akpinar in view Meng/Amplatz, and Adams/Flament/Zhuang as made in the rejection below.
With respect to claim 4, the applicant argues the claim is a structural claim not a process claim and the plain weave or twill weave are structural geometries with distinct properties. The examiner acknowledges the positive recitation of a plain weave or twill weave. However claim 4 also does claim how the “wire is formed…in subsequent stages”. Therefore claim 4 is interpreted to have some limitation with respect to a product by process. With respect to the plain weave or a twill weave, the examiner maintains that Akpinar in view Meng/Amplatz, and Adams/Flament/Zhuang can read on the “woven central section” and prior art Hewitt teaches at least “a plain weave” in paragraph 127, which as the applicant states is a simple common type of weave”. Hewitt does teach the weave can allow for structural support while achieving desired pore size and flow resistance. Therefore it would have been known or obvious to use a simple plain weave. The rejections of claim as been made and maintained below.
The rejection(s) with respect to Akpinar in view of Amplatz/Meng and Adams/Flament/Zhuang (and Hewitt) have been made and maintained below.
Of note: the examiner suggests filing a DIV/CIP application directed to a method of making the device since it would seem the aspects of the device which are argued to be novel are with respect to how the device is formed.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2014/0194921 to Akpinar in view of U.S. Patent Publication 2007/0233186 to Meng, U.S. Patent Publication 2006/0247680 to Amplatz, U.S. Patent Publication 2009/0082803 to Adams, U.S. Patent 6,180,848 to Flament, and U.S. Patent Publication 2015/0374350 to Zhuang.
As to claim 1, Akpinar discloses an implantable atrial septal defect occlusion device (paragraph 13) with woven central section on left atrial flange, the said device comprising: a braided collapsible and expandable structure (paragraph 35) with a first disc and a second disc (103,104, figure 3a-c, 4, 7a-d paragraph 38) and a connecting region (106) in between the first disc and the second disc (figure 3a,c,7a-d), wherein each of the first disc and the right disc define a respective periphery (figure 3a-c, 4, 7a-d), and a ridge (paragraph 41,42 the peripheral edges can read on a generical ridge based on the curvature and shape of the edges) disposed on the periphery of at least one of the first disc or the second disc, wherein the first disc is a hub-less disc (figure 3a,c, 3a-c, 4, 7a-d, only one hub can be used, wherever the hub is located, the other disc can be the “first hub-less disc” paragraph 60, 62) and is configured for the left atrial side whereas the second disc is configured for the right atrial side (figure 3a,c, paragraph 33, 34, 37, 39, the first and second discs can be configured for the left/right atrial sides respectively since the devices is used for cardiac occlusion and the hub can be on either of the discs, see interpretation below), and wherein the first disc and the second disc include a thrombogenic material (paragraph 37, the wires are made from nickel-titanium which is the same as the disclosed invention material, therefore can be thrombogenic) and the first disc incorporates a woven central section (figure 3a-c, 4, 7a-d, paragraph 34, 37, the central section of hub-less disc will have a mesh formed from the wires, which can read on the woven central section) and the device comprises non-woven wires configured in one or more stages, with each stage interspaced with one or more braids and braided together with the wires from the woven center and earlier stages to form a remaining portion of the first disc and the second disc to form the device (the limitation is interpreted to be product-by-process, therefore not novel / given patentable weight, see interpretation below).
If it would not be known that the rounded edges of Akpinar can read the ridge, Meng teaches a similar device (occlusion device, abstract) having a ridge (812, figure 8a, the bulbous profile can define/read on a ridge, paragraph 49) disposed on a periphery of a disc for the purpose of aiding on securing the device in place and preventing unwanted damage to the tissue. Amplatz also teaches a similar device (occlusion device, abstract), having a ridge (32, figure 2, paragraph 35) disposed on a periphery of a disc for the purpose of assisting in retaining the device in place. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the device of Akpinar to have a ridge as taught by Meng or Amplatz disposed on a periphery of at least one of the first disc or the second disc in order for aiding on securing/retaining the device in place and preventing unwanted damage to the tissue.
Akpinar does disclose the device can be formed by a structural formation of threads which can be a single continuous fabric or braiding (paragraph 35, 37). Akpinar discloses one disc can be hub-less, therefore will have a continuous section formed from the wires. Adams teaches a similar device where strands are woven into a braided fabric (paragraph 46) in order to form the desired expanded preset configuration. Flament teaches a similar device where a sheet can comprise a combination of woven and braided materials (col. 2 ll. 58-65). Zhuang teaches a similar device where a central section of a device is formed from pattern change in the strands (figure 3,4, 11, paragraph 63) to form a central interlocking structure. It would seem that Zhuang does teach that strands from a braiding overlap to form a woven central section. Therefore, the prior art renders obvious a braided device with a woven central section by either combining braiding and weaving, using weaving to form a braided device, and/or using different wire formations which can result in a weave-like central section. If it would not be known that the hub-less braided central section of Akpinar can read on a woven central section, Adams teaches that braiding materials can be formed from a woven strands and Flament teaches a device can comprise both braiding and weaving. Zhuang teaches a central section can be formed from a change in the strand pattern to form a central locking section. It would have been obvious to one of ordinary skill in the art before the effective filing date for the device of Akpinar have a woven central section on a first disc of a braided device in order for using a desired wire pattern to form a preset expanded configuration.
The claim limitation “the device comprises non-woven wires configured in one or more stages, with each stage interspaced with one or more braids and braided together with the wires from the woven center and earlier stages to form a remaining portion of the first disc and the second disc to form the device” is product by process based on the key words “earlier stages to form the device”, “to form a remaining portion…”. Akpinar (as modified by Meng/Amplatz and Adams/Flament/Zhuang) discloses the structure of a braided collapsible and expandable structure with first and second discs, the connecting neck, a ridge, and a woven central section. Therefore the end product is disclosed and known. The process by which it is made is not given patentable weight. The known braiding of several threads, as disclosed in paragraph 34, 36, 37, in the art would therefore be able to read on the claim of record. Since Akpinar does disclose the device can be formed by braiding (and the woven central sections based on the teachings of Adams/Flament/Zhuang) and discloses the structure of the claimed device, Akpinar can read on the claim limitations with Adams/Flament/Zhuang providing evidence or it can be obvious to one of ordinary skill in the art before the effective filing date to have the device of Akpinar be woven as taught by Adams/Flament/Zhuang order for using a known similar technique to make a braided device.
As to claim 5, with the device of Akpinar and Meng/Amplatz, and Adams/Flament/Zhuang above, Akpinar discloses a distal end where wire ends meet are combined together in a hub incorporating a release mechanism (paragraph 60-62).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0194921 to Akpinar in view of U.S. Patent Publication 2007/0233186 to Meng, U.S. Patent Publication 2006/0247680 to Amplatz, U.S. Patent Publication 2009/0082803 to Adams, U.S. Patent 6,180,848 to Flament, and U.S. Patent Publication 2015/0374350 to Zhuang as applied to claims 1, 5 above, and further in view of U.S. Patent Publication 2014/0358178 to Hewitt.
As to claim 4, Akpinar as modified by Meng/Amplatz and Adams/Flament/Zhuang discloses the device above where a wire mesh is formed with a weave mat on the top and the wires introduced in subsequent stages all getting braided together (paragraph 32, the limitation is considered product-by-process) but is silent about the woven central weave is a plain weave or a twill wave. The claim is product by process. A comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentable of the product. Whether a product is patentable depends on whether it is known in the art or it is obvious and is not governed whether the process by which it is made is patentable. Akpinar does disclose the braid and wire mesh. Therefore, Akpinar can read on the disclosed limitations with Adams/ Flament / Zhuang providing further teaching/evidence.
Hewitt teaches a similar device (device for occluding, abstract) having a woven structure being a plain weave (paragraph 127, 157 ) for the purpose of using a known weave type that can facilitate fixation, fibrosis, thrombosis, or to obtain desired mechanical characteristics. It would have been obvious for the central section of the device of Akpinar as modified by Meng/Amplatz, Adams/Flament/Zhuang have a central plain weave as taught by Hewitt in order for using a known weave type that can facilitate fixation, fibrosis, thrombosis, or to obtain desired mechanical characteristics.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2007/0265656 to Amplatz (as cited document A in the 892 filed 12/02/2024), U.S. Patent Publication 2009/0099647 to Glimsdale (as cited document C in the 892 filed 12/02/2024), U.S. Patent Publication 2013/0178886 to Liu (as cited document A in the 892 filed 04/26/2023), U.S. Patent Publication 2014/0012303 to Heipl, U.S. Patent Publication 2014/0257360 to Keillor (as cited document E in 892 filed 10/06/2023), U.S. Patent Publication 2015/0297240 to Divino (as cited document E in the 892 filed 12/02/224), and U.S. Patent Publication 2019/0209180 to Kealey (as cited document F in 892 filed 10/06/2023) all disclose similar devices capable of rendering obvious, and/or providing evidence on the claims of record specifically the braiding/woven central section.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771