DETAILED ACTION
Claims 1-4, 7, 9-12, 14-15, 17, 19, 21, 23-25, 28-29, 31-33, 35, 37, 39-41, and 43-44 are cancelled.
New claims 47 and 48 are added.
Claims 5-6, 8, 13, 16, 18, 20, 22, 26-27, 30, 34, 36, 38, 42, and 45-48 are pending.
Claims 26-27, 30, 34, 36, 38, 42, and 45-46 are withdrawn.
Claims 5-6, 8, 13, 16, 18, 20, 22, and 47-48 are being examined.
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 .
Priority
This application is a 371 of PCT/IL2020/050286 filed 03/11/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
(previous objection, withdrawn) The abstract of the disclosure was previously objected to because of a grammatical error. Applicants have filed a corrected abstract on 08/19/2025 thereby overcoming the previous objection.
Claim Objections
(previous objection, withdrawn) Claim 5 objected to because of the following informalities: The term “MaSp” is enclosed in parentheses and it is unclear if this is intended to be a limitation of the claim. Appropriate correction is required.
(previous objection, withdrawn) Claim 6 is objected to because of the following informalities: Claim 6 recites, “wherein said bound is via an amino acid of said MaSp-based fiber”. For the sake of clarity, the examiner suggests that claim 6 should instead recite, “The composition of claim 5, wherein the first polymer is covalently bound to an amino acid of said MaSp-based fiber”. Appropriate correction is required.
(previous objection, withdrawn) Claim 13 is objected to because of the following informalities: Claim 13 appears to be missing a comma in line 3. Additionally, it is unclear if the terms enclosed in parentheses are intended to be limitations of the claim. Appropriate correction is required.
(previous objection, withdrawn) Claim 20 is objected to because of the following informalities: The second to last line of claim 20 contains extra space characters in the recitation of “set forth in SEQ ID NO: 3”. Additionally, it is unclear if the amino acid sequence in the last line of claim 20 is intended to be a limitation of the claim, as it is enclosed in parentheses. Furthermore, the numbers and “Z” contained within the recited amino acid sequence of SEQ ID NO: 1 appear to be incorrectly written as regular characters, when they should be written as subscripts. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(previous rejection, withdrawn) Claims 5-6, 8-9, 12-13, 16, 18, 20, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Applicants have amended claim 5 in order to overcome this previous rejection. Accordingly, the previous rejection is withdrawn.
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.
(previous rejection, maintained; withdrawn regarding cancelled claim 12; new rejection regarding new claims 47-48) Claims 5, 9, 13, 16, 18, 20, 22, and 47-48 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ittah, US 20190040110 A1 (See form PTO-892 Notice of References Cited).
Regarding instant claims 5 and 18, Ittah teaches a composition comprising a mixture of proteins and at least one polymer, wherein said mixture of proteins comprises “m” types of proteins of differing molecular weight, wherein each protein in said mixture comprises, “n” repeats of a repetitive region of a major ampullate spidroin (MaSp) protein, or a functional homolog, variant, derivative or fragment thereof, wherein m and n are, independently, an integer between 2 and 70 (Ittah, claim 1). Ittah further teaches that the mixture of proteins and the polymer are covalently cross-linked to on another (Ittah, [279]). Ittah also teaches that the fiber is characterized by a porous structure (Ittah, [203]). The above teachings anticipate instant claims 5 and 18.
Regarding instant claim 12, Ittah teaches, “The composite of claim 1, wherein a total concentration of said proteins ranges from about 0.1 weight percent to about 10 weight percent of the total weight of said composite” (Ittah, claim 9).
Regarding instant claims 9, 13, and 16, Ittah teaches that the at least one polymer a synthetic polymer, a thermoplastic polymer, a thermoset an epoxy, a polyester a polyamide, a polyol, a polyurethane, polyethylene, Nylon, a polyacrylate, a polycarbonate, polylactic acid (PLA) or a copolymer thereof a silicon, a liquid crystal polymer, a maleic anhydride grafted polypropylene, polycaprolactone (PCL), rubber, cellulose, or any combination thereof, optionally wherein at least one polymer is a non MaSp protein derived polymer (Ittah, claim 4). Additionally, regarding instant claim 16, cellulose is well known in the art to be biodegradable. Further, the instant specifications state that PCL, PLA, polycarbonate, and polyurethane are examples of biodegradable polymers (Specifications filed 09/11/2022, [78]). Although Ittah does not state that the above polymers are biodegradable, MPEP section 2112(II) states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference”. Thus, the above teachings anticipate claims 9, 13, and 16.
Regarding instant claim 20, Ittah teaches disclose the following; “The composite of claim 1, wherein each of said proteins comprise, independently, an amino acid sequence as set forth in SEQ ID NO: 1:
(X1)ZX2GPGGYGPX3X4X5GPX6GX7GGX8GPGGPGX9X10,
wherein X1 is, independently, at each instance A or G wherein at least 50% of (X1)Z is A, Z is an integer between 5 to 30; X2 is S or G; X3 is G or E; X4 is G, S or N; X5 is Q or Y; X6 is G or S; X7 is P or R; X8 is Y or Q; X9 is G or S; and X10 is S or G” (Ittah, claim 5). Additionally, Ittah teaches; “The composite of claim 1, wherein said repetitive region comprises the amino acid sequence as set forth in SEQ ID NO: 3 (AAAAAAAASGPGGYGPGSQGPSGPGGYGPGGPGSS)” (Ittah, claim 6. The above teachings of Ittah anticipate instant claim 20.
Regarding instant claim 22, Ittah teaches “The composite of claim 1, wherein said mixture of proteins is characterized by one or more properties selected from the group consisting of:
(a) each repeat has a molecular weight in the range of 2 kDa to 3.5 kDa;
(b) the ratio of ‘n’ to ‘m’ is in the range of 1.5:1 to 1:1.5;
(c) in the form of a fiber, optionally a fiber characterized by a porosity of at least 30%” (Ittah, claim 2). Thus, Ittah teaches that the MaSp-based composition of claim 1 is a fiber, and has a porosity of at least 30%. Therefore, Ittah anticipates instant claim 22.
Regarding new claims 47-48, Ittah teaches enriching a polylactic acid (PLA) sample with 2% w/w (percent of total weight) of SS (spider silk) (Ittah, [399], [430]).
As shown above, Ittah anticipates instant claims 5, 8, 13, 16, 18, 20, and 22. Accordingly, claims 5, 8, 13, 16, 18, 20, 22, and 47-48 are rejected. Claims 9 and 12 were previously rejected as being anticipated by Ittah, but have since been cancelled by applicants. Ergo, the previous rejection of claims 9 and 12 is moot, and accordingly withdrawn.
(previous rejection, maintained; withdrawn regarding cancelled claim 9) Claims 5, 6, 8, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Leimer, US 10253213 B2 (See form PTO-892 Notice of References Cited).
Leimer teaches a method of coating a polymer material with a recombinant spider silk polypeptide (Leimer, claim 6). Leimer teaches that the polymer material may be a polyester, nylon, polyurethane, polyethylene, silicone, or polypropylene (Leimer, column 25, ln 48-59). Leimer teaches that the spider silk polypeptide coating is covalently linked to the polymer via at least one of a cysteine residue, and lysine residue (Leimer, claim 7). Leimer further teaches that the spider silk polypeptide is comprised of MaSp1 and MaSp2 motifs or repetitive subunits, thus making it a MaSp based fiber (Leimer, column 6, ln 5-18). Regarding claim 9, Leimer teaches applying multiple coatings of polymer, and spider silk polypeptide which are covalently bound in a similar fashion to a cysteine or lysine residue as described above (Leimer, column 32, ln 22-59). The different coatings of polymers taught by Leimer in this case would be the first and second polymers of instant claim 13. Additionally, regarding the porous limitation of claim 5, Leimer teaches that the ampullate spidroin protein have some degree of porosity (Leimer, column 5, ln 58-64).
Regarding new claim 47, Leimer teaches that the polypropylene covalently bonded to the recombinant MaSp-based fiber coating is part of a larger fabric, yarn, or fiber (Leimer, claim 5). Leimer teaches that the coated product has improved haptic and optical properties, which is interpreted to read upon the enriched polymeric material of claim 47.
As shown above, Leimer anticipates claims 5, 6, 8, and 13. Accordingly, claims 5, 6, 8, 9, and 13 are rejected. Claim 9 was previously rejected but has since been cancelled by applicants. Therefore, the previous rejection of claim 9 is moot and is accordingly withdrawn.
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.
(previous rejection, maintained) Claims 5, 6, 8, 12, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 17/972,020 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the reference recites, “A derivatized porous major ampullate spidroin protein (MaSp)-based fiber, wherein: said derivatized porous MaSp-based fiber is characterized by a BET surface area of at least 10 m2/g; said derivatized porous MaSp-based fiber comprises a functional moiety covalently bound to a tyrosine of the porous MaSp-based fiber; said functional moiety comprises any one of: amino, carboxy, nitro, sulfonate, carbonyl, ester, anhydride, carbonate ester, carbamate, cyano, hydroxy, a polymer, or any combination thereof”. Regarding instant claim 6, the reference application states that in some embodiments, the polymer is a graft copolymer (US 17/972,020, [104]). Regarding claim 8, as shown above, the polymer is covalently bound to the MaSp-based fiber through a tyrosine residue. Additionally, regarding instant claim 12, the reference teaches that the MaSp-based fiber is present in the composition at a concentration of 0.1% to 25%, 0.1% to 20%, 0.1% to 15%, 0.5% to 30%, 1% to 30%, 5% to 30%, or 10% to 30%, by total weight, including any range therebetween (US 17/972,020, [208]). Thus, claim 1 of the reference reads on instant claims 5-6, 8, and 12.
Claim 11 of the reference recites, “The derivatized porous MaSp-based fiber of claim 1, wherein said MaSp-based fiber is characterized by a degradation temperature (Td) between 280° C. and 350° C. as determined by differential scanning calorimetry (DSC), and by a glass transition temperature (Tg) between 200° C. and 250° C., as determined by DSC: optionally wherein said MaSp-based fiber comprises a repetitive region comprising an amino acid sequence set forth in Formula 10: (X1)zX2GPGGYGPX3X4X5GPX6GX7GGX8GPGGPGX9X10; wherein X1 is, independently, at each instance A or G, Z is an integer between 5 to 30, X2 is S or G: X3 is G or E; X4 is G, S or N: X5 is Q or Y: X6 is G or S; X7 is P or R; X8 is Y or Q; X9 is G or S; and X10 is S or G”. Thus, claim 11 of the reference application anticipates instant claims 18 and 20.
For the reasons above, instant claims 5, 6, 8, 12, 18, and 20 are rejected. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(previous rejection, maintained) Claims 5 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 10 of copending Application No. 18/014,547 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of the reference recites, “ A composition comprising a porous major ampullate spidroin protein (MaSp)-based fiber wherein said fiber is characterized by a BET surface area of at least 100 m.sup.2/g, and a residual amount of an organic solvent”.
Claim 9 of the reference recites, “The composition of claim 1, further comprising a thermoplastic polymer selected from polyester, a polyamide, a polyol, a polyurethane, polyethylene, Nylon, polyolefine, a polyacrylate, a polycarbonate, polylactic acid (PLA) or a copolymer thereof, polycaprolactone (PCL), rubber, cellulose, or any combination thereof”.
Claim 10 of the reference recites, “The composition of claim 9, wherein a weight per weight (w/w) ratio of said MaSp-based fiber to said polymer is between 0.01:1 and 1:1”.
Regarding instant claim 13, the ratio of the reference application is recited inversely to the ratio of instant claim 13. The reference recites MaSp fiber weight/polymer weight. Instant claim 13 recites polymer weight/MaSp fiber weight. Therefore, the ratio of instant claim 13 is identical to the ratio in claim 10 of the reference application.
For the reasons above, claims 5 and 13 are rejected.
Response to Arguments
Applicant's arguments filed 08/19/2025 have been fully considered and are acknowledged below.
Applicants argue the previous objections to claims 6, 13, and 20 on the grounds that the claims have been amended to overcome the previous objections. The Examiner agrees with these arguments, and the previous objections to claims 6, 13, and 20 are withdrawn as shown above.
Applicants argue the previous rejection of claims 5-6, 8-9, 12, 13, 16, 18, and 20 under 35 U.S.C 112(b) on the grounds that these claims have been amended to overcome the previous rejection. The Examiner finds this argument persuasive, and the previous rejection is withdrawn as shown above.
Applicants argue the previous rejection of claims 5, 9, 12, 13, 16, 18, 20, and 22 under 35 U.S.C 102 as being anticipated by Ittah. Applicants’ arguments are on the grounds that Ittah is silent regarding a copolymer as instantly claimed. Applicants further argue that Ittah plainly recites a mixture of MaSp and a polymer, and recites crosslinked proteins (i.e. proteins bound to each other via covalent bonds) and not a copolymer as instantly claimed. However, these arguments are not found persuasive. Ittah teaches that their composite material comprising a MaSp protein and at least one polymer that is not a MaSp protein (Ittah, claims 1 and 4). Furthermore, Ittah states that in some embodiments the polymer material is a copolymer (Ittah, [24], [241]). Additionally, Ittah teaches that a plurality of the disclosed proteins (MaSp based proteins) and/or the disclosed fiber derived from the mixture of proteins are covalently cross-linked to one another (Ittah, [279]). Ittah states that in some embodiments, a linker functionalizes the fibers with other functional groups functional groups for further attachment or creating covalent bonds with the matrices of polymers tested (Ittah, [288]). And finally, in one example, Ittah discloses coating a polymer substrate surface with covalently bonded Spidersilk (Ittah, [493]). For these reasons, applicants arguments are not found persuasive. Accordingly, the previous rejection of claims 5, 9, 12, 13, 16, 18, 20, and 22 under 35 U.S.C 102 is maintained as shown above.
Applicants argue the previous rejection of claims 5, 6, 8, 9, and 13 under 35 U.S.C 102 as being anticipated by Leimer. Applicants’ arguments are on the grounds that Leimer does not teach a copolymer as instantly claimed. Applicants argue that “a copolymer refers to a polymeric chain having two or more chemically distinct repeating units” (Remarks filed 08/19/2025, pg. 10). Additionally, the definition of “copolymer” disclosed in the instant specifications is noted below: The instant specifications define the term “copolymer” as “a polymer that is made up of more than one type of monomeric units and hence is composed of heterogenic backbone units. The heterogenic backbone units can differ from one another by the pendant groups thereof” (specifications filed 09/11/2022, [75]). As shown, this definition does not limit the scope of “copolymer” to any particular type of copolymer, and the specifications further discloses “In some embodiments, the copolymer is a graft copolymer” (specifications filed 09/11/2022 [91]). Applicants’ arguments are not found persuasive because Leimer teaches that the spider silk MaSp fiber is covalently linked to a polypropylene material (Leimer, claims 1, 6). Leimer further discloses that the spider silk protein component comprises repetitive units, and it is well known in the art that polypropylene contains repeating units of propylene. Therefore, the composition taught by Leimer is interpreted to read upon the claimed invention because it teaches a polymer material comprising two non-identical repetitive units that are covalently bonded to one another. Accordingly, the previous rejection of claims 5, 6, 8, 9, and 13 is maintained as shown above.
Applicants acknowledge the previous double patenting rejections over the copending application No. 17/972,020 and copending application No. 18/014,547 and state their intent to filed a terminal disclaimer should there be patentable subject matter. Applicants request that this provisional rejection be placed in abeyance until such time as there are allowable claims in the present application.
Conclusion
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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/BENJAMIN HALL EASTON/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652