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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7, 9 and 11-15 in the reply filed on August 29,20206 is acknowledged. Claims 23, 29, 31, 34-35, 43, and 45-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 15 is objected to because of the following informalities: a semicolon is missing at the end of line 4. Appropriate correction is required.
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.
Claim(s) 1-2, 5, 12-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al. (US 2021/0236688, which is cited in the Information Disclosure Statement, hereinafter “Wagner”).
Referring to claim 1, Wagner a method for producing a bioresorbable heart valve (“Accordingly, provided herein is a prosthetic heart valve device including a biocompatible and biodegradable metal frame…. and a biocompatible and biodegradable polymeric heart valve” para. [0007]) comprising:
forming valve leaflets on a first end of at least a portion of a mold coated with a first solution (para. [0144]: “The valve portion of the device described herein can be formed by any useful method, for example, by solvent casting in a mold, for example with particulate leaching to produce a porous structure, or by 3D printing or dry spinning methods, or by electrodeposition. In one aspect, the structure is cut from a polymeric mesh comprising synthetic and/or natural (e.g., ECM) polymer compositions. In one aspect, for illustrative purposes, a polymeric mesh is electrodeposited, e.g., electrospun onto a target, such as a mandrel”) comprising a polymeric material; and
attaching a frame to at least a portion of the coating (para. [0071]);
wherein the bioresorbable heart valve is configured to accommodate growth of a patient with the bioresorbable heart valve (paras. [0006] and [0183]).
Referring to claim 2, Wagner discloses the method of claim 1, wherein the bioresorbable heart valve is configured to accommodate growth of the patient being a fetus with the bioresorbable heart valve having been implanted in utero (in paragraph [0186] Wagner discloses the prosthetic valve is for congenital, thus, the device is capable of being implanted in utero).
Referring to claim 5, Wagner discloses the method of claim 1, wherein the polymeric material comprises a synthetic polymer selected from a group consisting of polyethers, polyamides, polyurethanes (paras. [0060] and [0140]), and polyesters.
Referring to claim 11, Wagner discloses a method for producing a resorbable heart valve (“Accordingly, provided herein is a prosthetic heart valve device including a biocompatible and biodegradable metal frame…. and a biocompatible and biodegradable polymeric heart valve” para. [0007]) comprising:
providing a first solution comprising a polymeric material comprising at least one biodegradable polymeric material (“The valve of the device can be formed of a biocompatible, biodegradable polymer” (para. [0121]) and “The valve portion of the device described herein can be formed by any useful method, for example, by solvent casting in a mold, for example with particulate leaching to produce a porous structure, or by 3D printing or dry spinning methods, or by electrodeposition. In one aspect, the structure is cut from a polymeric mesh comprising synthetic and/or natural (e.g., ECM) polymer compositions. In one aspect, for illustrative purposes, a polymeric mesh is electrodeposited, e.g., electrospun onto a target, such as a mandrel” (para. [0144]));
coating at least a portion of a mold with the first solution to form a coating; forming valve leaflets on a first end of the coating at (para. [0144]: “The valve portion of the device described herein can be formed by any useful method, for example, by solvent casting in a mold, for example with particulate leaching to produce a porous structure, or by 3D printing or dry spinning methods, or by electrodeposition. In one aspect, the structure is cut from a polymeric mesh comprising synthetic and/or natural (e.g., ECM) polymer compositions. In one aspect, for illustrative purposes, a polymeric mesh is electrodeposited, e.g., electrospun onto a target, such as a mandrel”);
placing a frame around at least a portion of the coating (Fig. 1A); and attaching the frame to the coating (para. [0121]: “The valve of the device can be formed of a biocompatible, biodegradable polymer, useful examples of which are provided in detail below. The valve includes an annular portion that can be attached to the frame portion by suitable methods, such as by suturing, annealing, or other known methods of attaching a polymer to a metal or metal alloy.”);
wherein coating the at least a portion of the mold with the first solution comprises: spray coating the at least a portion of the mold with the first solution; airbrushing the at least a portion of the mold with the first solution; or dip coating the at least a portion of the mold with the first solution (para. [0144]: “The valve portion of the device described herein can be formed by any useful method, for example, by solvent casting in a mold, for example with particulate leaching to produce a porous structure, or by 3D printing or dry spinning methods, or by electrodeposition. In one aspect, the structure is cut from a polymeric mesh comprising synthetic and/or natural (e.g., ECM) polymer compositions. In one aspect, for illustrative purposes, a polymeric mesh is electrodeposited, e.g., electrospun onto a target, such as a mandrel”).
Referring to claim 12, Wagner discloses the method of claim 11, wherein: the coating is a multi-layered coating; and coating the at least a portion of the mold with the first solution forms a first layer in the multi-layered coating (paras. [0147]-[0148]).
Referring to claim 13, Wagner discloses the method of claim 12 further comprising: coating the at least a portion of the first layer with a second solution to form a second layer of the multi-layer coating (paras. [0147]-[0148]).
Referring to claim 15, Wagner discloses the method of claim 11, wherein at least one of: attaching the frame to the coating comprises suturing the frame to the coating (“The scaffold-based PCUU valve was mounted on the Mg stent using 5-0 polypropylene sutures distributed at six locations as illustrated (FIG. 1).” (para. [0171])); attaching the frame to the coating comprises coating at least a portion of the frame with a third solution different than the first solution the frame is configured as an expandable and contractable stent; the frame is configured as expandable and contractable stents (paras. [0022]-[0023]); the frame comprises a material selected from a group consisting of plastics, metals (paras. [0010]-[0011]), and carbon; the frame comprises a metal selected from a group consisting of zinc, iron, aluminum, magnesium, nickel, silver, titanium, and alloys thereof (para. [0125]); or the frame comprises a bioresorbable material (para. [0125]).
Claim Rejections - 35 USC § 103
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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. in view of Edelman et al. (US 2015/0182332, which is cited in the Information Disclosure Statement, hereinafter “Edelman”).
Referring to claim 4, Wagner discloses the method of claim 1 and “The valve portion of the device described herein can be formed by any useful method” (para. [0144]). Wagner fails to disclose the method further comprising at least one of: dip coating at least a portion of the mold with the first solution; spray coating at least a portion of the mold with the first solution; or airbrushing at least a portion of the mold with the first solution.
Referring again to claim 4, however, in the same field of endeavor, which is a method of making a prosthetic valve, Edelman discloses the valve portion of the prosthetic valve can be made with air spray coating a first and/or a second polymeric materials on a portion of a mold, dip coating a first and/or a second polymeric materials on a portion of a mold or vacuum forming (Figs. 12A-15C, paras. [0031]-[0040]). Edelman disclose air spray coating provide the advantage of controlling the thickness of one or more locations along the mold (para. [0033]). It view of Edelman’s teaching, it would have been obvious to use the air spray coating process as suggested by Edelman to made the polymeric heart valve of Wagner.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. in view of Edelman et al. (US 2015/0182332, hereinafter “Edelman”) and further in view of Corbett et al. (US 2022/0313425, hereinafter “Corbett”).
Referring to claim 3, Wagner discloses the method of claim 1 and “The valve portion of the device described herein can be formed by any useful method” (para. [0144]). Wagner fails to disclose further comprising: (1) airbrushing the at least a portion of the mold with the first solution and (2) wherein the valve leaflets comprise one or more commissures having a thickness greater than an average thickness of the valve leaflets.
Referring again to claim 3, as to (1), however, in the same field of endeavor, which is a method of making a prosthetic valve, Edelman discloses the valve portion of the prosthetic valve can be made with air spray coating a first and/or a second polymeric materials on a portion of a mold, dip coating a first and/or a second polymeric materials on a portion of a mold or vacuum forming (Figs. 12A-15C, paras. [0031]-[0040]). Edelman disclose air spray coating provide the advantage of controlling the thickness of one or more locations along the mold (para. [0033]). It view of Edelman’s teaching, it would have been obvious to use the air spray coating process as suggested by Edelman to made the polymeric heart valve of Wagner.
Referring still to claim 3, as to (2), however, in the same field of endeavor, which is a prosthetic valve, Corbett discloses valve leaflets 130 comprise one or more commissures 450 (Figs. 2 (the commissure located at the region at reference numeral 2 and 4 ) and 6E (the commissure located at lead lines 450)) having a thickness greater than an average thickness of the valve leaflets (claim 42). In view of Corbett’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made the leaflets of Wagner to have the thickness at the commissures more than average thickness of the leaflets to provide low forward flow pressure loss and prevent low fluid velocities in the commissures between the leaflets and in the sinus lobes distal to each leaflet (Corbett: para. [0040]).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. in view of Feinberg et al. (US 2021/0031455, hereinafter “Feinberg”).
Referring to claims 7 and 9, Wagner discloses the method of claims 5 and 1, respectively, wherein the polymeric material further comprises a naturally derived polymer such as ECM (para. [0144]: “Further, solutions comprising other polymers, ECM materials (e.g., ECM gel, or solubilized ECM)” Examiner notes that ECM is known as extra-cellular matric). Wagner discloses the invention substantially as claimed except for disclosing the naturally derived polymer material, ECM, is selected from a group consisting of a polypeptides, proteins, polysaccharides, glycoproteins and glycosaminoglycan.
Referring again to claims 7 and 9, however, in the same field of endeavor, which is a prosthetic heart valve, Feinberg discloses valve component can be made from ECM material such as polysaccharides, glycoproteins (para. [0035]). In view of Feinberg’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have used polysaccharides or glycoproteins as the ECM material since Feinberg has been proven these materials can be used in making prosthetic valve.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. in view of Corbett et al. (US 2022/0313425, hereinafter “Corbett”).
Referring to claim 14, Wagner discloses the method of claim 11, but fails to discloses wherein the valve leaflets comprise one or more commissures having a thickness greater than an average thickness of the valve leaflets.
Referring again to claim 14, however, in the same field of endeavor, which is a prosthetic valve, Corbett discloses valve leaflets 130 comprise one or more commissures 450 (Figs. 2 (the commissure located at the region at reference numeral 2 and 4 ) and 6E (the commissure located at lead lines 450)) having a thickness greater than an average thickness of the valve leaflets (claim 42). In view of Corbett’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made the leaflets of Wagner to have the thickness at the commissures more than average thickness of the leaflets to provide low forward flow pressure loss and prevent low fluid velocities in the commissures between the leaflets and in the sinus lobes distal to each leaflet (Corbett: para. [0040]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
