DEAILTED 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 Arguments
Applicants’ arguments, see pages 5-6, filed 07/07/2026, with respect to the rejections of claims 1-21 under USC 102/103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 USC 103 in view of Levi et al. 20190046314 A1, herein referred to as Levi, in view of Li Y et al. Carbon Nanotubes Enhanced Fluorinated Polyurethane Macroporous Membranes for Waterproof and Breathable Application (furnished with action), herein referred to as Li., in addition to other references, see details below in action.
Claim Objections
Claims 1-20 objected to because of the following informalities: Typographical error in claim limitation “one or more fluorinated end-groups at at least one end of the backbone.”. Appropriate correction is required. Examiner suggests deleting one of the repeated word “at”.
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.
Claim(s) 1 and 19-21 are rejected under 35 U.S.C. 103 being unpatentable over Levi et al. 20190046314 A1, herein referred to as Levi, in view of Li Y et al. Carbon Nanotubes Enhanced Fluorinated Polyurethane Macroporous Membranes for Waterproof and Breathable Application (furnished with action), herein referred to as Li.
Regarding claim 1, Levi teaches an apparatus ([0045]), comprising an implant (Fig 1, prosthetic valve 10) for implantation at a heart valve of a subject ([0020]), the implant comprising: a frame (Fig 1, frame 12); and a textile mounted on the frame (Fig 2, skirt 30 [0069] teaches a fabric formed from weaves or knitting); wherein the textile comprising fibers formed from a mixture ([0081] Levi teaches forming a laminate, considered a mixture) of: a polymer ([0081] Levi teaches a polymer fiber).
Levi does not explicitly disclose; and an additive molecule that comprises: a polyurethane backbone, and one or more fluorinated end-groups at least one end of the backbone.
Li discloses a similar polymer fiber (see pg 13539 [0003]). Li teaches an additive molecule that comprises: a polyurethane backbone, and one or more fluorinated end-groups at least one end of the backbone (see pg 13539 [0003] and [0005] Li teaches terminal fluorinated polyurethane (FPU); and see Figure produced from Supplemental Materials of Li, furnished in office action, below, showing two fluorinated end groups on a polyurethane backbone).
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Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the textile of Levi to incorporate an additive molecule that comprises: a polyurethane backbone, and one or more fluorinated end-groups at least one end of the backbone, as taught and suggested by Li in order to impart mechanical performance to a fiber (Li pg 13539 [0003]).
Regarding claim 19, the combination of Levi, and Li discloses the invention substantially as claimed and as discussed above with respect to claim 1. Levi teaches wherein: the heart valve (Levi Fig 1, valve 10) has a first leaflet and an opposing leaflet (Levi Fig 1, leaflet 12, oppose each other as claimed), a heart chamber being upstream of the heart valve (Levi [0004], the frame is defined at least in part by a flexible wire (Levi Fig 1, 12 frame, [0143] cables used), and the implant comprises: an interface; and a flexible coaptation portion (Levi Fig 1, strut 32), coupled to the interface (Levi Fig 1), and comprising: a loop of the flexible wire (Figure 1, hole for strut is a loop), the loop defining an aperture therethrough (Levi Fig 1); and the textile, coupled to the wire and covering at least part of the aperture (Levi Fig 1); and an anchor (Levi Fig, outflow end 16), configured to anchor the interface to a site in the heart such that the coaptation portion extends over the first leaflet toward the opposing leaflet in a manner in which (Levi [0064]), during ventricular systole of the heart (Levi Abstract, part of natural heart function and would function as claimed), the first leaflet and the opposing leaflet coapt against the coaptation portion (Levi [0064]).
Regarding claim 20, the combination of Li and Levi discloses the invention substantially as claimed and as discussed above with respect to claim 19. Levi teaches wherein the coaptation portion has an open part in which the aperture is not covered by the textile (Levi Fig 1).
Regarding claim 21, the combination of Levi and Li discloses the invention substantially as claimed and as discussed above with respect to claim 19. Levi teaches further comprising a delivery system comprising: a shaft (Levi (Fig 21, elongate shaft 404), configured to, via engagement with the interface, transluminally position the interface is at the site (Levi [0108]), and an anchor driver, configured to anchor the interface to the site by driving the anchor into the tissue ([0108] Levi teaches actuator driving delivery and anchoring at annulus).
Claim(s) 2-10, and 13-14 are rejected under 35 U.S.C. 103 being unpatentable over Levi and Li, in view Scholz et al. WO 2010111491 A1, herein referred to as Scholz.
Regarding claim 2, Levi and Li do not explicitly disclose wherein the textile comprises an air texturized yarn that includes the fibers.
However, in the same field of endeavor, Scholz discloses a similar textile. Scholz teaches a textile (pg 3, teaches fibrous articles, corresponds to the claimed ‘textile’), the textile comprising fibers formed from a mixture of: a polymer (pg 5, Para [0003]). Scholz teaches wherein the textile comprises an air texturized yarn that includes the fibers (Pg 2, para 3, polyester is air texturized).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the textile of the combination as made of Levi and Li to incorporate wherein the textile comprises an air texturized yarn that includes the fibers, as suggested and taught by Scholz in order to impart hydrophobicity (Scholz pg 2)
Regarding claim 3, Scholz discloses wherein the textile comprises a core-spun yarn that includes the fibers (Pg 2, para [0003] and pg 27, polyester is core-spin).
Regarding claim 4, Scholz discloses wherein the textile comprises a yarn that is formed from (i) the fibers formed from the mixture (Pg 7, para [0003]), and (ii) other fibers that are not formed from the mixture (Pg 2, para [0003]).
Regarding claim 5, Li discloses wherein the mixture included the additive molecule at 1-5 percent by mass (Li pg 13539 [0005]).
Regarding claim 6, Li discloses wherein the textile is an electrospun textile (Pg 13559 Fabrication of the Membrane).
Regarding claim 7, Scholz discloses wherein the textile is a woven textile (pg 1, para [0001]).
Regarding claim 8, Scholz discloses wherein the textile is a knitted textile (pg 1, para [0001]).
Regarding claim 9, Scholz discloses wherein the textile is a nonwoven textile (pg 1, para [0001]).
Regarding claim 10, Levi and Li do not disclose wherein the wherein the fibers are formed by extrusion of a melt of the mixture
Scholz teaches wherein the fibers are formed by extrusion of a melt of the mixture (pg 7, para [0002]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the textile of Levi and Li to incorporate wherein the fibers are formed by extrusion of a melt of the mixture, as taught and suggested by Scholz in order to allow a good mixing process (Scholz pg 7).
Regarding claim 13, Levi discloses wherein the textile is a fabric with which at least part of the frame is dressed (Fig 1).
Regarding claim 14, Levi discloses wherein the textile is a suture that is stitched onto at least part of the frame (Fig 1, stitching can be seen).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Levi in view Li, and further in view of Mullick et al. US 9751972 B2, herein referred to as Mullick.
Regarding claim 11, Levi and Li do not disclose wherein the fibers are formed by spinning of a melt of the mixture.
However, in the same field of endeavor, Mullick discloses a similar fiber. Mullick teaches wherein the fibers are formed by extrusion of a melt of the mixture (Col 12, lines 37-50; teaches mixture being melt-spun to form fibers).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the textile of Levi and Li to incorporate discloses wherein the fibers are formed by spinning of a melt of the mixture, as taught and suggested by Mullick in order to allow the formation of fibers into a nonwoven fabric with some level of repellency (Mullick Col 12, lines 37-5 and Col 7, lines 38- Col 8, lines 4).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Levi in view Li, and further in view of Palasis et al. US 20100291182 A1, herein referred to as Palasis.
Regarding claim 12, Levi and Li do not disclose wherein the additive molecule is configured to promote a thin layer of endothelium to form a smooth benign surface on the textile while preventing overthickening of the layer on the textile.
However, in the same field of endeavor, Palasis discloses a similar fiber and additive molecule [0392]. Palasis teaches the additive molecule is configured to promote a thin layer of endothelium to form a smooth benign surface on the textile while preventing overthickening of the layer on the textile (In paragraph [0392], the instant application recites the additive molecule being “a polyphosphazene molecule” or “a combination of two or more molecules”. Palasis also teaches adding polyphosphazenes to the formation of a polyurethane fiber, therefore, the additive molecule polyphosphazenes is fully capable of configuring the fiber to promote the formation of a thin layer of endothelium as claimed).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the additive molecules of the combination Levi, Li to also include polyphosphazenes to incorporate wherein the additive molecule is configured to promote a thin layer of endothelium to form a smooth benign surface on the textile while preventing overthickening of the layer on the textile, as taught and suggested by Scholz to increase biocompatibility (Palasis [0028]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Levi in view Li, and further in view of Carpentier et al. US 3656185 A, herein referred to as Carpentier
Regarding claim 15, the combination of Levi, Li, and Scholz does not disclose the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose explicitly wherein the implant is an annuloplasty structure.
Carpentier teaches wherein the implant is an annuloplasty structure (Fig 1, ring 1; [0002]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Carpentier to incorporate wherein the implant is an annuloplasty structure as taught and suggested by Carpentier in order to allow the implant to be compatible with an annuloplasty procedure [0002].
Claim(s) 16-18 are rejected under 35 U.S.C. 103 being unpatentable over over Levi in view Li, and further in view of Klausmann et al. US 20220151763 A1, herein referred to as Klausmann.
Regarding claim 16, the combination of Levi and Li, do not disclose wherein the implant is a prosthetic valve, the frame is a stent frame that is dressed with the textile.
However, in the same field of endeavor, Klausmann discloses a similar implant with a textile ([0007] of background).
Klausmann teaches wherein the implant is a prosthetic valve (Fig 1, stent frame 13), the frame is a stent frame that is dressed with the textile ([0003] of description).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the frame of Levi to incorporate disclose wherein the implant is a prosthetic valve, the frame is a stent frame that is dressed with the textile, taught and suggested but Klausmann in order shield lesions in the implant area (Klausmann [0040]).
Regarding claim 17, the combination as made of Levi, Li, and Klausmann, specifically Klausmann teaches wherein the stent frame (Fig 1, stent frame 13) is dressed with the textile ([0005]) in a manner that directs blood flow through the prosthetic valve ([0003]).
Since Klausman teaches wherein the stent frame is dressed with the textile in a manner that directs blood flow through the prosthetic valve, which would be incorporated in the frame when the modification is made.
Regarding claim 18, the combination of Levi, Li and Klausmann, discloses the invention substantially as claimed and as discussed above with respect to claim 17. Levi teaches wherein the stent frame is dressed with the textile in a manner that inhibits paravalvular leakage between the prosthetic valve and the heart valve ([0004] Levi teaches stopping mitral regurgitation with implant).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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