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 1-8, 10-15, 29 and 30 in the reply filed on 07/25/25 is acknowledged.
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.
Claims 1-8, 10-15, 29 and 30 is/are rejected under 35 U.S.C. 103 as being obvious over USPUB 20190144957 A1 issued to Purcell et al. in view of USPUB 2008/0103287 A1 issued to Chino et al.
Regarding Claim 1, where Applicant seeks that a thermoplastic collagen elastomer composite material comprising collagen that has been reacted with a reactive thermoplastic elastomer comprising a functional group, wherein the reactive thermoplastic is a natural rubber derived product; Applicant is directed to the teachings of Purcell who discloses a thermoplastic collagen elastomer composite material comprising a reactive collagen and a thermoplastic elastomer [Abstract].
At ¶ 0007, the instant reference teaches that the biofabricated material may comprise recombinant bovine collagen.
At ¶ 0033, the instant reference, teaches that their collagen or collagen-like protein may be chemically modified to promote chemical! and/or physical crosslinking between the collagen fibrils. Chemical crosslinking may be possible because reactive groups such as lysine, glutamic acid, and hydroxyl groups on the collagen molecule project from collagen’s rod-like fibril structure.
At ¶ 0039, the instant reference teaches that resins may be added to modify the stretchability, strength, rigidity, abrasion resistance or softness of the material. Suitable resins include but are not limited to elastomers, acrylic copolymers, polyurethane, and the like. Suitable elastomers include but are not limited to styrene, isoprene, butadiene copolymers such as elastomers, or acrylic resins. Resins may be used at from about 5% to 200%, or from about 50% to 150%, or from 75% to 125% (based on the weight of collagen). The amount of resin may be varied across the material to provide zonal properties in the final product.
At ¶ 0023, the instant reference discloses that a crosslinked network of collagen, sometimes called a hydrogel, may be formed as the collagen is fibrillated, or it may form a network after fibrillation. Once formed, the fibrillated collagen network may be further stabilized by incorporating molecules with di-, tri-, or multifunctional reactive groups that include chromium, amines, carboxylic acids, sulfates, sulfites, sulfonates, aldehydes, hydrazides, sulfhydryls, diazarines, aryl-, azides, acrylates, epoxides, or phenol.
Purcell et al teach what is set forth but do not explicitly teach that the collagen has been reacted with a reactive thermoplastic elastomer comprising a functional group.
This is remedied by the teachings of Chino et al.
Chino et al. are from the same art of endeavor as their invention relates to thermoplastic elastomers as well.
Chino et al. teaches a thermoplastic elastomer comprising a functional group [abstract] The thermoplastic elastomer comprises an elastomeric polymer having epoxide, hydroxy group, and a nitrogen-containing heterocycle and is bonded to the backbone of the elastomeric polymer.
At ¶0002, Chino et al teach that their invention relates to a thermoplastic elastomer and a thermoplastic elastomer composition, and more specifically, to a thermoplastic elastomer which has a characteristic nature that it can be repetitively and reproducibly undergo crosslinking and de-crosslinking by temperature change (hereinafter sometimes referred to as “recyclability”), and a thermoplastic elastomer composition containing such thermoplastic elastomer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined these references and incorporate the reactive thermoplastic elastomer comprising a functional group as the thermoplastic elastomer of Purcell et al. [¶ 0039 Purcell] by routine experimentation to provide crosslinkable elastomers crosslinked with the crosslinkable collagen of Purcell et al [¶ 0033 Purcell et al] and optimize the fabrication of the material Chino et al [¶ 0002 Chino et al].
Regarding Claim 2, where Applicant seeks that the composite material of claim 1, wherein the functional group is selected from the group consisting of a maleic anhydride, an epoxide, a silane, or a glycidyl group; Applicant is directed Purcell et al modified by Chino et al., where Chino et al at ¶ 0123 for the maleic anhydride, ¶ 0013 for the epoxide, ¶ 0121 for the silane and ¶ 0013-0015 for teachings of the functional groups.
Regarding Claim 3, where Applicant seeks that a thermoplastic collagen elastomer composite material comprising:(a) collagen and/or collagen-like protein having at least one first reactive functional group;(b) at least one thermoplastic elastomer having at least one second reactive functional group; wherein the collagen and/or collagen-like protein and the at least one immiscible reactive thermoplastic elastomer are covalently bound together through reaction of the first and second reactive functional groups and wherein the at least one immiscible reactive thermoplastic elastomer is a natural rubber derived product; Purell et al teach a thermoplastic collagen elastomer composite material [abstract], but does not teach the at least one thermoplastic elastomer having at least one second reactive functional group, wherein the collagen and/or collagen-like protein and the at least one immiscible reactive thermoplastic elastomer are covalently bound together through reaction of the first and second reactive functional groups.
Chino et al teaches a thermoplastic elastomer comprising a second reactive functional group, wherein the elastomers are crosslinkable [Chino abstract, ¶0002]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the inventio to have combined these references and incorporate the reactive thermoplastic elastomer comprising a functional group as the thermoplastic elastomer of Purcell et al by routine experimentation to provide crosslinkable elastomers crosslinked with the crosslinkable collagen of Purcell et al [¶ 0033], wherein the collagen and/or collagen-like protein and the at least one immiscible reactive thermoplastic elastomer are covalently bound together through reaction of the first and second reactive functional groups [Purcell et al ¶ 0033-0035].
Regarding Claim 4, where Applicant seeks that the composite material of claim 3, wherein the collagen is recombinant collagen; Applicant is directed to Purcell et al at ¶ 0007, where the instant reference teaches that in a preferred embodiment, the biofabricated material may comprise recombinant bovine collagen.
Regarding Claim 5, where Applicant seeks that the composite material of claim 4, wherein the molecular weight of the collagen and/or collagen-like protein is about 10 kDa to about 1000 kDa; Neither Purcell or Chino teaches the molecular weight of the collagen or collagen like protein. It would have been obvious to one of ordinary skill in the art to use a collagen in the molecular weight of the collagen is about 10 kDa to about 1000 kDa by routine experimentation to optimize molecular weight of forming the composite material based on the end use of the final product.
Regarding Claim 6, where Applicant seeks that the composite material of Claim 3, wherein the first reactive functional group is an amino group, a hydroxyl group, or a carboxylic acid group; Applicant is directed to ¶ 0013 and 0033 of Purcell et al.
.
Regarding Claim 7, where Applicant seeks that the composite material of Claim 3, wherein the second reactive functional group is a maleic anhydride, an epoxy group, a silane, or a glycidyl group; Applicant is directed Purcell et al modified by Chino et al., where Chino et al at ¶ 0123 for the maleic anhydride, ¶ 0013 for the epoxide, ¶ 0121 for the silane and ¶ 0013-0015 for teachings of the functional groups.
Regarding Claim 8, where Applicant seeks that the composite material of claim 3, wherein the thermoplastic elastomer has an elastic modulus of about 1 MPa to about 20 MPa; Applicant is directed to ¶ 0050-0053 of Purcell et al.
Regarding Claim 10, where Applicant seeks that the composite material of Claim 3, wherein at least one immiscible reactive thermoplastic elastomer is selected from the group consisting of an epoxidized natural rubber and a methyl methacrylate grafted natural rubber; Applicant is directed to ¶ 0125 and 0212 of Chino et al.
Regarding Claim 11, where Applicant seeks that the composite material of claim 3, wherein the at least one immiscible reactive thermoplastic elastomer is an epoxidized natural rubber; Applicant is directed to ¶ 0125 and 0212 of Chino et al.
Regarding Claim 12, where Applicant seeks that the composite material of claim 3, further comprising an immiscible unreactive thermoplastic elastomer; Applicant is directed ¶ 0179 of Chino et al.
Regarding Claim 13, where Applicant seeks that the composite material of claim 12, wherein the immiscible unreactive thermoplastic elastomer is selected from the group consisting of a polyurethane block copolymer, a copolyether ester block copolymer, a polyamide block copolymer, a polyether block copolymer, an ethylene vinyl acetate, and a block copolymer having the general formula A-B-A′ or A-B’; Applicant is directed to ¶ 0151 of Chino et al.
Regarding Claim 14, where Applicant seeks that the composite material of claim 12, wherein the immiscible unreactive thermoplastic elastomer is selected from the group consisting of polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene, polystyrene-block-poly(ethylene-propylene)-block-styrene block copolymer, polyisoprene, polystyrene-block-polyisoprene-block-polystyrene, polybutadiene, polystyrene-block-polybutadiene-block-polystyrene, styrene-ethylene-butylene-styrene, poly(ethylene-co-vinyl acetate), ethylene-propylene rubber, natural rubber, and poly(ethylene-co-ethyl acrylate); Purell et al teach a thermoplastic collagen elastomer composite material [abstract], but does not teach the at least one thermoplastic elastomer having at least one second reactive functional group, wherein the collagen and/or collagen-like protein and the at least one immiscible reactive thermoplastic elastomer are covalently bound together through reaction of the first and second reactive functional groups.
Chino et al teaches a thermoplastic elastomer comprising a second reactive functional group, wherein the elastomers are crosslinkable [Chino abstract, ¶0002]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the inventio to have combined these references and incorporate the reactive thermoplastic elastomer comprising a functional group as the thermoplastic elastomer of Purcell et al by routine experimentation to provide crosslinkable elastomers crosslinked with the crosslinkable collagen of Purcell et al [¶ 0033], wherein the collagen and/or collagen-like protein and the at least one immiscible reactive thermoplastic elastomer are covalently bound together through reaction of the first and second reactive functional groups [Purcell et al ¶ 0033-00350035].Regarding Claim 15, where Applicant seeks that the composite material of claim 8, wherein the composite material is a film; Applicant is directed to ¶ 0040
Regarding Claim 29, where Applicant seeks an article comprising the composite material of claim 3; Applicant is directed to ¶ 0003 and 0048 of Purcell et al. and ¶ 0207 of Chino et al.
Regarding Claim 30, where Applicant seeks that the article of claim 29, wherein the article is selected from the group consisting of footwear, garments, gloves, furniture, vehicle upholstery, overcoats, coats, jackets, shirts, trousers, pants, shorts, swimwear, undergarments, uniforms, emblems, letters, costumes, ties, skirts, dresses, blouses, leggings, mittens, shoes, shoe components, dress shoes, athletic shoes, running shoes, casual shoes, fashion shoes, boots, buttons, sandals, hats, masks, headgear, headbands, head wraps, belts, jewelry, gloves, umbrellas, walking sticks, wallets, mobile phones, wearable computer coverings, purses, backpacks, suitcases, handbags, folios, folders, boxes, hunting gear, recreational gear, book bindings, book covers, picture frames, artwork, furnishings, wall coverings, ceiling coverings, flooring, automobile products, boat products, and aircraft products; Applicant is directed to ¶ 0003 and 0048 of Purcell et al. and ¶ 0207 of Chino et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please review references cited on the PTO-892.
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/Arti Singh-Pandey/
Primary Patent Examiner
Art Unit 1759
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