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 .
Response to Arguments
Applicant’s arguments, see Pg 4-5, filed 8/25/2025, with respect to the rejection(s) of claim(s) 1 and 3-9 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendment.
The Applicant’s request that the double patenting rejections be held in abeyance is noted. They have been modified in view of amendment and maintained herein.
Claim Status
Claims 1 and 3-9 are pending under examination. Claims 2 and 10-18 are cancelled. Claims 1 and 8 are currently amended. Claims 3-7 were previously presented.
Priority
The instant application is the 371 national stage entry of PCT/US20/25414, filed 3/27/2020, which claims priority to the provisional application 62/824,601, filed 3/27/2019. The priority date of 3/27/2019 is acknowledged.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Claim 1 - The claim includes amino acid sequences with 4 or more specifically defined and enumerated residues, which require SEQ ID NO’s. However, no SEQ ID NO’s are listed in the claim. See MPEP 2422 and 37 C.F.R. 1.821.
Claim 8 - The claim includes several ranges, which ultimately amount to 5 kDa to about 144 kDa. For readability and clarity, amend the claim such that the range recited is simply 5kDa to about 144kDa.
Appropriate correction is required.
Claim Interpretation
As cited in the previous Office Action, a leather substrate as recited in claim 1 is being interpreted as including both natural and synthetic leather, per the instant specification (Pg 133, lines 24-30).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 5-9 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Scheibel et al. (WO 2006/008163 A2, published 1/26/2006).
Scheibel et al. teaches recombinant spider silk proteins, nucleic acids thereof, expression systems, and use of the proteins in biotechnology and/or medicine or other industrial fields (Pg 1, first paragraph). One such application includes coating for textile and leather products to confer stability and durability to the coated product. The silk proteins in particular show applicability for coating leather products, since in this case, tanning and its negative effects for environment can be avoided or reduced (Pg 19, final paragraph). Scheibel teaches the peptide GSSAAAAAAAASGPGGYGPENQGPSGPGGYGPGGP (SEQ ID NO: 5, also referred to as C16; Pg 43, first paragraph), which corresponds to the instant SEQ ID NO: 29 as recited in claim 1. Table 1 demonstrates that C16 has a molecular mass (kDa) of 47.7 (Pg 43, first paragraph; Pg 47, Table 1). Thus, claims 1 and 8 are anticipated.
Polydispersity is defined as the ratio of the weight average molecular weight to the number average molecular weight and is equal to one when all the molecules have the same weight, as evidenced by Molecular weight (University of Cambridge, accessed 10/23/2025). As Scheibel teaches that C16 is a purified protein with a molecular mass of 47.7kDa (Table 1; “Protein purification” Pg 27-28), it must have a polydispersity of 1. Thus, claims 3 and 9 are also anticipated.
Scheibel teaches several species of spiders from which silk proteins and fragments can be derived from (Pg 7, second to last paragraph – Pg 8, top). Thus, claim 5 is anticipated.
Scheibel further teaches that in generating silk, a mixture of silk from spiders and B. mori (silkworm) can be made (Pg 17, 4th full paragraph). Thus, claim 6 is anticipated.
Scheibel further teaches that a recombinant spider silk protein may not only comprise protein sequences from one species but may also contain sequences derived from different spider species, such as one or more synthetic repetitive spider silk protein sequences from one species and one or more authentic non-repetitive spider silk protein sequences from another. It is also possible to design a recombinant spider silk protein, which contains more than one type of repetitive sequence, wherein the different types are derived from different species (Pg 9, first paragraph). Thus, claim 7 is anticipated.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. (US 2016/0222579 A1; published 8/4/2016) in view of Borkner et al., 2016 (Borkner CB, Wohlrab S, Möller E, Lang G, Scheibel T. Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.).
Altman discloses an article having a coating, wherein the coating comprises silk-based proteins or fragments thereof having a weight average molecular weight range of about 5 kDa to about 144 kDa (claim 1 and [0426]). Altman disclose the silk proteins or fragments include recombinant silk proteins and fragments thereof (claims 4-6). Altman teaches that an article, such as action sportswear/apparel, can be partially made from a silk coated textile and partially made from an uncoated textile that combines an uncoated inert synthetic material with a silk coated inert synthetic material. Examples of insert synthetic materials include polyester, polyamide, polyethylene, polypropylene, polyurethane, LYRCA and mixtures thereof among others ([0006]), which reads on synthetic leather (instant specification, Pg 133, lines 24-30).
Altman does not explicitly teach specific silk protein or fragment sequences.
Borkner teaches that catheters (article) made out of synthetic materials such as polyurethane (synthetic leather) can be coated in recombinant spider silk to increase its biocompatibility (Pg 767, Introduction, first and second paragraph). Borkner specifically teaches coating catheters with the spider silk peptides GSSAAAAAAAASGPGGYGPENQGPSGPGGYGPGGP (eADF4(c16)) or GSSAAAAAAAASGPGGYGPKNQGPSGPGGYGPGGP (eADFR(k16)), which correspond to the instant SEQ ID NO: 29 and 40, respectively.
Thus, regarding claim 1, Altman teaches a synthetic leather article having a silk-coating, wherein the silk has a weight average molecular weight of about 5-144kDa. Borkner teaches coating synthetic leather with eADF4(c16) or eADFR(k16) spider silk sequence to increase its biocompatibility. Therefore, it would be prima facie obvious to coat the synthetic leather of Altman with the peptides taught by Borkner in order to increase the biocompatibility of articles worn on the body. One skilled in the art would have a reasonable expectation of success as Borkner already established that implanting such articles into the body did not cause biocompatibility issues; thus, by extension, one would expect that wearing such articles would similarly not cause issues.
Regarding claims 3 and 4, Altman discloses that the polydispersity of the recombinant silk-based proteins or fragments thereof is between 1.5 and 3 (claim 8).
Regarding claims 5 and 6, Altman discloses that the protein or fragments thereof comprise recombinant spider silk proteins or silkworm silk proteins or fragments thereof (claims 4-6).
Regarding claim 7, Altman discloses that the silk proteins or fragments thereof comprise a copolymer (claim 7).
Regarding claim 8, Altman discloses that silk proteins or fragments thereof have an average weight average molecular weight range selected from about 5kDa to about 144 kDa (claim 8).
Regarding claim 9, Altman discloses that the polydispersity is between about 1.5 and about 3 (claim 8).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-9, 11, and 28-30 of U.S. Patent No. 10,287,728 (US ‘728). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘728 recites an article comprising a fiber or yarn having a coating, wherein the coating comprises biocompatible silk fibroin based proteins or fragments thereof having an average weight average molecular weight ranging from about 5 kDa to about 80 kDa, wherein the biocompatible silk fibroin based proteins or fragments thereof comprise a polydispersity ranging from about 1 to about 5.0, and wherein the proteins or protein fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in an aqueous solution for at least 10 days. “Fibroin” includes silkworm fibroin and insect or spider silk protein (Col. 29, lines 15-16). Claim 31 also recites an article comprising a fiber or yarn having a coating, wherein the coating comprises biocompatible silk fibroin-based proteins or fragments thereof having an average weight average molecular weight ranging from about 5 kDa to about 10 kDa, wherein the biocompatible silk fibroin-based proteins or fragments thereof comprise a polydispersity ranging from about 1 to about 5.0.
Dependent claims include the article is a fabric (claim 2), the silk fibroin is recombinant (claim 4), the silk fibroin-based proteins or fragments comprise silk and a copolymer (claim 7), the silk fibroin-based proteins or fragments have an average weight molecular weight from about 6 to about 80kDa (claim 8), the fiber or yarn is synthetic (synthetic leather; claims 9 and 11), the polydispersity is about 1.5 to about 3.0 (claims 28-30).
Claims 1 and 3-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-11 of U.S. Patent No. 12,385,181 B2 (US ‘181; formerly copending Application No. 17/938,594). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘181 recites an article comprising leather having a coating, wherein the coating comprises silk fibroin fragments having an average weight average molecular weight selected from between about 5 kDa and about 144 kDa, wherein the silk fibroin fragments have a polydispersity of between 1 and about 5.0, and wherein the silk fibroin fragments, prior to coating the leather, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days. “Fibroin” includes both silkworm fibroin and spider silk protein (Col. 95, lines 58-67).
Dependent claims further include the silk average weight average molecular weight ranges (claim 2), the silk is recombinant (claim 4), the silk is from spider or silkworm (claims 5 and 6), the coating comprises a copolymer (claim 7), the leather is natural, tanned, or synthetic leather (claims 8, 9, 10, and 11).
Claims 1, 3-6, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. US12,371,848 B2 (US’ 848; formerly copending Application No. 17/884,341). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘848 recites an article comprising a fabric having a coating, the coating comprising silk fibroin fragments having a weight average molecular weight selected from between about 5 kDa to about 144 kDa, wherein the silk fibroin fragments have a polydispersity of between about 1.5 and about 3.0, wherein the silk fibroin fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days, and wherein the article exhibits an accumulative one-way moisture transport index greater than 40%. “Fibroin” includes both silkworm fibroin and spider silk protein (Col. 29, lines 15-16).
Dependent claims include the silk is recombinant (claim 2) and the fabric comprises polyester, nylon, polyester-polyurethane copolymer, or combinations thereof (synthetic leather; claim 5).
Claims 1, 3-5, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 37, 38, 44, and 46-48 of copending Application No. 16/651,648 (‘648 reference application; claim listing filed 1/10/25). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 34 of copending Application No. ‘648 recites an article comprising a fabric leather having a coating, wherein the coating comprises low molecular weight recombinant spider silk-based proteins or fragments thereof having an average weight average molecular weight selected from about 5kDa to 20 kDa and medium molecular weight recombinant spider silk-based proteins or fragments thereof having an average weight average molecular weight range of greater than 20 kDa to 55 kDa, wherein the w/w ratio between low molecular weight recombinant spider silk-based proteins or fragments thereof and medium molecular weight recombinant spider silk-based proteins or fragments thereof is about 80:20, about 79:21, about 78:22, about 77:23, about 76:24, about 75:25, about 74:26, about 73:27, about 72:28, about 71:29, about 70:30, about 30:70, about 29:71, about 28:72, about 27:73, about 26:74, about 25:75, about 24:76, about 23:77, about 22:78, about 21:79, or about 20:80.
Dependent claims include the silk’s average weight molecular weight and polydispersity (claims 37, 38 and 44) and the leather is natural, synthetic, or tanned (claims 46-48).
Claims 1, 3-5, and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 10, 30-32, 35-37, and 44 of U.S. Patent No. 11,453,975 B2 (US ‘975). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘975 recites an article comprising a fiber or yarn having a coating, wherein the coating comprises silk based proteins or fragments thereof having an average weight average molecular weight selected from about 5 to about 144 kDa, wherein the silk based proteins or fragments thereof have a polydispersity of between about 1.5 and about 3.0, and wherein the silk based proteins or protein fragments thereof, prior to coating the fiber or yarn, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days. Claim 30 additionally recites an article comprising: a synthetic fiber or yam; and a coating comprising silk based proteins or fragments thereof having an average weight average molecular weight selected from about 5 kDa to about 144 kDa and a polydispersity ranging from 1 to about 5.0, wherein the article is a fabric, and wherein the silk based proteins or protein fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days.
Dependent claims include the silk proteins or fragments are recombinant (claims 4 and 41), the coating comprises a copolymer (claim 7), the fiber or yarn is synthetic fiber or yarn (synthetic leather; claims 10, 31, 32, 35-37), and the molecular weight and polydispersity (claim 44).
Claims 1, 3-6, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12-13, and 16 of U.S. Patent No. 11,970,815 B2 (US ‘815). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘815 recites a single or multilayered material comprising a plurality of fibers, filaments, powders, particles, or yarns, and a silk derived protein, wherein the silk derived protein comprises silk fibroin proteins or fragments thereof having an average weight average molecular weight selected from between about 1 kDa and about 80 kDa, and a polydispersity between 1 and about 5. “Fibroin” is defined to include spider silk protein and silkworm fibroin (Col. 40, lines 24-27).
Claim 14 further recites a spun yarn comprising a plurality of fibers and a silk derived protein or fragments thereof, wherein a portion of the silk derived protein or fragments thereof are coated onto the plurality of fibers, wherein the plurality of fibers are natural fibers, synthetic fibers, or a combination thereof, and the silk derived protein or fragments thereof includes silk fibroin proteins or fragments thereof having an average weight average molecular weight in a range selected from between about 1 kDa and about 144 kDa, and a polydispersity between 1 and about 5.
Dependent claims include the leather is synthetic (claim 2-4 and 16) and further comprising a coating of silk (claims 12 and 13).
Claims 1, 3-6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 12 of copending Application No. 17/260,336 (‘336 reference application; claim listing filed 2/19/2025) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘336 recites an article comprising a leather substrate and a coating comprising a coating material, the coating material comprising: i) silk fibroin proteins or fragments thereof having an average weight average molecular weight selected from between about 20 kDa and about 55kDa and a polydispersity between 1 and about 5; ii) a plasticizer; and iii) a polysaccharide selected from starch, cellulose, gum Arabic, guar gum, xanthan gum, alginate, pectin, chitin, chitosan, carrageenan, inulin, and gellan gum; wherein the coating material has an elongation at break at 18.9% and 85.3%. “Fibroin” is defined to include spider silk protein and silkworm fibroin (Pg 116, lines 23-24).
Dependent claims include the silk’s polydispersity (claims 2 and 6) and coating the leather (claim 12).
Copending Application No. ‘336 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into copending Application No. ‘336, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of copending Application No. ‘336.
Claims 1, 3-6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, 13-15, and 18 of copending Application No. 17/604,161 (‘161 reference application; claim listing filed 10/15/2021) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘161 recites an article comprising a coated substrate, wherein the coating comprises silk fibroin or silk fibroin fragments and a chemical modifier or a physical modifier. “Fibroin” includes silkworm fibroin and spider silk protein (Pg 22, second paragraph). Claim 18 further recites a method of coating a substrate with a coating comprising silk fibroin or silk fibroin fragments and a chemical modifier or a physical modifier, the method comprising applying to the substrate at least one composition comprising silk fibroin or silk fibroin fragments with an average weight average molecular weight from about 1 kDa to about 144 kDa, and a polydispersity between 1 and about 5.0.
Dependent claims include the silk fibroin or fragments average weight molecular weight (claims 8 and 9) and polydispersity (claim 10), and the type of substrate (synthetic leather; claims 13-15).
Copending Application No. ‘161 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into copending Application No. ‘161 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of copending Application No. ‘161.
Claims 1, 3-6, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, and 9 of U.S. Patent 12,129,596 (US ‘596) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘596 recites a silk fibroin coated article comprising a flexible material substrate comprising a plurality of fibers, and a coating comprising low molecular weight silk fibroin protein fragments and medium molecular weight silk fibroin protein fragments, wherein a portion of the fibers are coated with silk fibroin protein fragments. “Fibroin” includes spider silkworm fibroin and spider silk protein (Col. 45, lines 53-57).
Dependent claims include the silk’s average weight molecular weight and polydispersity (claim 2 and 3) and the type of flexible material substrate (synthetic leather; claims 6, 7, and 9).
US ‘596 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into US ‘596 thereby arriving at the instant invention One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of US ‘596.
Claims 1, 3-6 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 24, and 51 of copending Application No. 17/793,342 (‘342 reference application; claim listing filed 6/14/2023) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Claim 19 of copending Application No. ‘342 recites a method of method of treating a leather substrate with a silk formulation, the method comprising applying on a surface of the leather a silk formulation comprising silk fibroin proteins or fragments thereof having an average weight average molecular weight selected from between about 1 kDa and about 144 kDa, and a polydispersity ranging from 1 to about 5. “Fibroin” includes silkworm fibroin and spider silk protein (Pg 59, second paragraph).
Dependent claims include coating the silk onto the leather substrate (claim 24) and the leather article produced by the method (claim 51).
Copending Application No. ‘342 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into copending Application No. ‘342 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of copending Application No. ‘342
Claims 1 and 3-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 9 of U.S. Patent No. 12,227,897 B2 (US ‘897; formerly copending Application No. 18/179,869). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘897 recites an article comprising a fabric having a coating, the coating comprising silk fibroin protein fragments having a weight average molecular weight selected from about 140 kDa to about 200 kDa, and a polydispersity between 1 and about 5, wherein the silk fibroin protein fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days. “Fibroin” includes silkworm fibroin and spider silk protein (Col. 29, lines 27-28).
Dependent claims include the silk fibroin is recombinant (claim 3), the coating comprises a copolymer (claim 6), the fabric comprises polyester, nylon, polyester-polyurethan copolymer, or combinations thereof (synthetic leather; claim 9).
Claims 1, 3-5, and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-9 and 11 of copending Application No. 18/999,739 (‘739 reference application; claim set filed 12/23/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 recites an article comprising a fiber or yarn having a coating, wherein the coating comprises silk-based proteins or fragments thereof having a weight average molecular weight range of about 5kDa to about 144kDa.
Dependent claims include the article is a fabric (claim 2), the silk-based proteins or fragments are recombinant (claim 4), the silk-based proteins or fragments comprise silk and a copolymer (claim 7), the silk has an average weight molecular weight range and polydispersity (claim 8), the fiber or yarn is synthetic fiber or yarn (synthetic leather; claims 9 and 11).
Claims 1, 3-6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 24 of copending Application No. 18/550,922 (‘922 reference application; claim listing filed 6/24/2024) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘922 recites an article comprising a fabric and a coating, wherein the coating comprises a surfactant and/or emulsifier system, and silk fibroin fragments having an average weight average molecular weight selected from between about 1 kDa and about 144 kDa, and a polydispersity ranging from 1 to about 5. “Fibroin” includes both silkworm fibroin and spider silk protein ([0057]). Claim 25 also recites a method of making a silk fibroin coated fabric. Dependent claims include the type of fabric (claim 6).
Copending Application No. ‘922 does not teach that the silk fragments are recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into Copending Application No. ‘922 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of Copending Application No. ‘922.
Claims 1, 3-6, and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-66 of copending Application No. 18/605,448 (‘448 reference application; claim listing filed 11/20/24) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘448 recites an article comprising a single or multilayered material comprising a leather substrate, and a silk derived protein, the article comprising a layer of material having a thickness between about 0.01 mm and about 10 mm, wherein the leather substrate comprises one or more of bonded leather, faux leather, natural leather, synthetic leather, leather waste, recycled leather, fibrillated leather, or grounded leather.
Dependent claims include the silk derived protein comprises the silk’s average weight molecular weight and polydispersity (claim 60) and a coating comprising silk (claims 56 and 61). “Fibroin” includes both silkworm fibroin and spider silk protein (Pg 35, second paragraph).
Copending Application No. ‘448 does not teach that the silk derived protein is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into copending Application No. ‘448 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of copending Application No. ‘448.
Claims 1, 3-6, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,320,060 B2 (US ‘060; formerly copending Application No. 18/753,686) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘060 recites a silk fibroin coated article comprising a leather substrate and a coating comprising low molecular weight silk fibroin protein fragments and medium molecular weight silk fibroin protein fragments. “Fibroin” includes both silkworm fibroin and spider silk protein (Col. 116, lines 5-6).
Dependent claims include the silk’s average weight molecular weight and polydispersity (claims 2-5) and the type of leather (claims 6-8).
US ‘060 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into US ‘060 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of US ‘060.
Claims 1, 3-5, and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, and 10 of U.S. Patent No. 11,649,585 (US ‘585). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘585 recites an article comprising a fiber or yarn having a coating,
wherein the article is a fabric, wherein the coating comprises silk-based proteins or fragments thereof having a weight average molecular weight range of about 5 kDa to about 144 kDa,
wherein the proteins or protein fragments, prior to coating the fabric, do not spontaneously or gradually gelate and do not visibly change in color or turbidity when in a solution for at least 10 days, and wherein the article exhibits an overall moisture management capability selected from the group consisting of greater than 0.05.
Dependent claims include the silk is recombinant (claim 3), the coating comprises a copolymer (claim 6), the silk’s average weight molecular weight and polydispersity (claim 7), and the fiber or yarn is synthetic (synthetic leather; claim 10).
Claims 1, 3-6 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15-19, 31-37, 45, 48-50, 58, and 60 of U.S. Patent No. 11,512,425 (US ‘425) in view of Borkner et al., 2016 (Surface Modification of Polymeric Biomaterials Using Recombinant Spider Silk Proteins. ACS Biomater Sci Eng. 2017 May 8;3(5):767-775. Epub 2016 Aug 24.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Claims 1, 17, and 33-35, and 48 of US ‘425 recites a method of coating a material with silk fibroin to provide a silk fibroin coated material, the method comprising: (a) preparing a silk fibroin solution comprising silk fibroin fragments having an average weight average molecular weight selected from about 5 to about 144 kDa at less than about 1% by volume (v/v), wherein the silk fibroin fragments have a polydispersity ranging from 1 to about 5.0. “Fibroin” includes both silkworm fibroin and spider silk protein (Col. 95, lines 58-67).
Dependent claims include the silk fibroin fragments with a certain average weight molecular weight (claims 2, 3, 18, 19, 36, 37, 49, 50), the type of material (synthetic leather; claim 15, 31, 45, 58), and a silk coated material (claim 16, 32, 60).
US ‘425 does not teach that the silk fibroin is recombinant.
Borkner teaches coating polyurethane catheters (synthetic leather article) in recombinant spider silk to improve their biocompatibility (Pg 767, Introduction, paragraphs 1 and 2).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Borkner into US ‘425 thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Borkner established a way to improve the biocompatibility of such products. Thus, the claims are obvious in light of the teachings of US ‘425.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658