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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 17-20 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/17/2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/17/2026.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan, et al (Kaplan) (WO 2018/156613 A1).
Regarding Claim 1, Kaplan teaches an airway support device (e.g. abstract) comprising:
a first longitudinal strip (e.g. annotated Figure 1A(1) below, one of the labeled/boxed longitudinal strips) for attachment to a first region of cartilage (e.g. abstract, the stent is designed for use at the trachea, thus the stent is able to be placed as claimed; the cartilage where the first strip is located is considered the first region of cartilage);
a second longitudinal strip (e.g. annotated Figure 1A(1) below, the other of the labeled/boxed longitudinal strips) for attachment to a second region of cartilage (e.g. abstract, the stent is designed for use at the trachea, thus the stent is able to be placed as claimed; the cartilage where the second strip is located is considered the second region of cartilage); and
lateral strips extending from the first longitudinal strip to the second longitudinal strip (e.g. annotated Figure 1A(1) below), the airway support device forming windows between the first longitudinal strip and the second longitudinal strip and between adjacent pairs of the lateral strips (e.g. Figure 1A, openings #130).
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Annotated Figure 1A(1), Kaplan
Regarding Claim 2, the first longitudinal strip, the second longitudinal strip, and the lateral strips are formed from a continuous mesh (e.g. Figures 1E, 1F; the openings of the device form an overall mesh structure).
Regarding Claim 4, there are suture markers along the first longitudinal strip and the second longitudinal strip (e.g. [0159], when mixed in with the silk material, the markers are at all elements including the longitudinal strips), the suture markers indicating a target location for a suture (they indicate the suture location because they indicate where the device is and thus where the suture should be located to be placed in the device).
Regarding Claim 3, there is a third longitudinal strip between the first longitudinal strip and the second longitudinal strip and intersecting the lateral strips (e.g. annotated Figure 1A(2)). The Examiner notes the claim 1 remains met by this alternative interpretation of Kaplan with differences seen in the annotated Figure 1A(2) below.
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Annotated Figure 1A(2), Kaplan
Claim(s) 1-6, 10, 11-12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wijay (US 5,741,293 A).
Regarding Claim 1, Wijay teaches an airway support device (e.g. Figures 9, 11-12, abstract; stent) comprising:
a first longitudinal strip (e.g. Figures 11-12, one #20) for attachment to a first region of cartilage (the stent is able to be placed as claimed; the cartilage where the first strip is located is considered the first region of cartilage);
a second longitudinal strip (e.g. Figures 11-12, the other #20) for attachment to a second region of cartilage (the stent is able to be placed as claimed; the cartilage where the second strip is located is considered the second region of cartilage); and
lateral strips extending from the first longitudinal strip to the second longitudinal strip (e.g. Figures 11-12, #s 10), the airway support device forming windows between the first longitudinal strip and the second longitudinal strip and between adjacent pairs of the lateral strips (e.g. Figures 11-12; annotated Figure 12(1) below, arrows indicate example windows).
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Annotated Figure 12(1), Wijay
Regarding Claim 2, the first longitudinal strip, the second longitudinal strip, and the lateral strips are formed from a continuous mesh (e.g. Figures 11-12; each device is has openings between vertical and horizontal elements forming the mesh).
Regarding Claim 3, there is a third longitudinal strip between the first longitudinal strip and the second longitudinal strip (e.g. Figure 12, #24 between the first and second strips; annotated Figure 12(2) below) and intersecting the lateral strips (e.g. Figure 12, where #24 is connected to each lateral adjacent strips).
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Annotated Figure 12(2), Wijay
Regarding Claim 4, there are suture markers along the first longitudinal strip and the second longitudinal strip (e.g. Figures 11-12, openings #s22), the suture markers indicating a target location for a suture (they are openings through which a suture can be placed and thus indicate a target location for a suture).
Regarding Claim 5, there is a third longitudinal strip (e.g. annotated Figure 12(3) below);
multiple first bronchial lateral strips (e.g. annotated Figure 12(3) below), each of the first bronchial lateral strips extending between the first longitudinal strip and the third longitudinal strip (e.g. annotated Figure 12(3) below);
a fourth longitudinal strip (e.g. annotated Figure 12(3) below); and
multiple second bronchial lateral strips (e.g. annotated Figure 12(3) below), each of the second bronchial lateral strips extending between the second longitudinal strip and the fourth longitudinal strip (e.g. annotated Figure 12(3) below).
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Annotated Figure 12(3), Wijay
Regarding Claim 6, the third longitudinal strip is connected to the fourth longitudinal strip (e.g. annotated Figure 12(4) below).
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Annotated Figure 12(4), Wijay
Regarding Claim 10, there are reinforcement members (e.g. annotated Figure 12(5) below), each of the reinforcement members extending from the first longitudinal strip to the second longitudinal strip along a corresponding one of the lateral strips (e.g. annotated Figure 12(5) below.
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Annotated Figure 12(5), Wijay
Regarding Claim 11, Wijay teaches an airway support device (discussed supra for claim 1) comprising:
a mesh (discussed supra for claim 2) forming:
a first longitudinal strip for attachment to a first region of cartilage (discussed supra for claim 1);
a second longitudinal strip for attachment to a second region of cartilage (discussed supra for claim 1);
lateral strips extending from the first longitudinal strip to the second longitudinal strip (discussed supra for claim 1); and
reinforcement members interwoven with the mesh (discussed supra for claim 10; the reinforcement members are interwoven because they are interlinked, <https://www.oed.com/dictionary/interweave_v?tab=meaning_and_use#128532>), the reinforcement members being less stretchable than the mesh (the reinforcement members are solid bars and thus less flexible than the mesh which has large openings).
Regarding Claim 12, the reinforcement members extend along an outer periphery of the mesh (e.g. Figure 9; the reinforcements for part of the radially outer surface and thus are along an outer periphery of the mesh).
Regarding Claim 15, each of the reinforcement members extending from the first longitudinal strip to the second longitudinal strip along a corresponding one of the lateral strips (e.g. annotated Figure 12(5) above).
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.
Claims 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan, et al (Kaplan) (WO 2018/156613 A1) as discussed supra, alone.
Regarding Claim 7, Kaplan teaches the embodiment of Figures 1A-F (device #100) is made of a sheet/film of silk fibrin (e.g. [0289], [0343] and that the sheet of silk fibrin has reinforcement fibers (e.g. [0032], additives are included in the silk material; [0035]-[0036]; [0198], [0299], additives include fibers; [0355] sheet/film with fibers).
However, Kaplan does not indicate if the fibers are part of the sheet described in [0343]. Therefore, discloses the invention substantially as claimed but fails to teach there are reinforcement members, each of the reinforcement members surrounding a corresponding one of the windows.
Each cited embodiment is concerned with the same field of endeavor as the claimed invention, namely tracheal stent meshes with longitudinal and lateral elements.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Figures 1A-1F such that the material is that with fibers as taught by Kaplan in order “to provide stability and/or to reinforce provided silk fibroin based tracheal stents” (e.g. Kaplan, [0032]).
Regarding Claim 8, the first longitudinal strip, the second longitudinal strip, and the lateral strips are formed from a mesh (discussed supra for claim 2); and the reinforcement members are interwoven with the mesh (e.g. Kaplan, [0197], the fibers are within the material and thus woven throughout it; as broadly claimed, there is no particular pattern of the fibers, thus this broad interpretation of woven throughout applies).
Regarding Claim 9, the reinforcement members are thicker than the mesh (e.g. [0211] incorporates US 2011/0046686, which discloses fibers of 3 mm length in its [0116]; [0014] of Kaplan discloses the thickness of the device is 1 mm to 5 mm and [0287] discloses a single layer’s thickness is on the nanometer and micron scales, with a range to 1 nm to 1000 microns (1 mm); thus, all layer thicknesses are less than 3 mm. The thickness in the direction of the fiber that is 3 mm is greater than the layer thickness of the Kaplan device, thereby meeting the claimed requirement).
Regarding Claim 10, there are reinforcement members (discussed supra for claim 7; here, the reinforcement members are those fibers located between the first and second longitudinal strips and at the lateral strips), each of the reinforcement members extending from the first longitudinal strip to the second longitudinal strip along a corresponding one of the lateral strips (discussed supra for the preceding limitation).
Regarding Claim 11, Kaplan teaches an airway support device (discussed supra for claim 1) comprising:
a mesh (discussed supra for claim 2) forming:
a first longitudinal strip (discussed supra for claim 1) for attachment to a first region of cartilage (discussed supra for claim 1);
a second longitudinal strip (discussed supra for claim 1) for attachment to a second region of cartilage (discussed supra for claim 1);
lateral strips extending from the first longitudinal strip to the second longitudinal strip (discussed supra for claim 1); and
reinforcement members interwoven with the mesh (discussed supra for claims 7-8), the reinforcement members being less stretchable than the mesh (e.g. Kaplan, [0032], the fibers are the reinforcement element and thus are stiffer and thus less stretchable that the material they are within).
Regarding Claim 12, the reinforcement members extend along an outer periphery of the mesh (discussed supra for claim 10).
Regarding Claim 13, the reinforcement members each surround a corresponding window formed by the mesh (discussed supra for claim 10).
Regarding Claim 14, the reinforcement members are thicker than the mesh (discussed supra for claim 9).
Regarding Claim 15, each of the reinforcement members extending from the first longitudinal strip to the second longitudinal strip along a corresponding one of the lateral strips (discussed supra for claim 10).
Regarding Claim 16, the reinforcement members are of a material that is different than a material of the mesh (as broadly claimed, the fibers are of a different material because they are a separate element within the material of the sheet/film; thus, they are different material elements).
Claims 9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan, et al (Kaplan) (WO 2018/156613 A1)(provided by Applicant with the 4/14/2023 IDS) as discussed supra in view of Kaplan-2 (US 2011/0046686 A1).
Regarding Claims 9 and 14, if not considered included in the incorporated material from US 2011/0046686, then Kaplan discloses the invention substantially as claimed but fails to teach the reinforcement members are thicker than the mesh.
Kaplan-2 teaches fibers of 3 mm length in its (e.g. [0116]).
Kaplan and Kaplan-2 are concerned with the same field of endeavor as the claimed invention, namely reinforcements for implant materials.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kaplan by incorporating the fibers as taught by Kaplan-2 as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of fibers that add reinforcement to the material they are held within (e.g. Kaplan, [0032]).
[0014] of Kaplan discloses the thickness of the device is 1 mm to 5 mm and [0287] discloses a single layer’s thickness is on the nanometer and micron scales, with a range to 1 nm to 1000 microns (1 mm). Thus, all layer thicknesses are less than 3 mm. The thickness in the direction of the fiber that is 3 mm is greater than the layer thickness of the Kaplan device, thereby meeting the claimed requirement.
Relevant Prior Art
US 5,549,662 to Fordenbacher teaches a stent having longitudinal and lateral strips and windows therebetween (e.g. Figure 1).
US 7,763,065 B2 to Schmid, et al teaches a stent having longitudinal and lateral strips and windows therebetween forming a mesh (e.g. Figures 1-2).
WO 2017/206483 to Fu teaches a stent having longitudinal and lateral strips (e.g. Figure 1).
US 6,623,521 B1 to Steinke, et al teaches a stent having longitudinal and lateral strips and windows therebetween forming a mesh (e.g. Figures 1A-C, 4C, 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/29/2026
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