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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 27, 2026 has been entered.
Priority
This application is a 371 of PCT/US2020/036510 06/06/2020, which claims benefit of 62/858,048 06/06/2019.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/858,048, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application does not have support for "modulating collagen expression in a subject in need thereof"; "an effective amount"; "between about 14 kDa and about 30 kDa"; or "a pharmaceutically acceptable carrier", required in claim 1; “an elixir”, “a jelly”, “a slurry”, or “a suppository”, required in claim 22; and "about 101% - about 200%", required in claim 45.
Therefore, claims 1-2, 4, 9-10, 12, 20, 22, 26, 30, 33-35, 38, 43-45 and 47 are determined to have a priority date of June 06, 2020.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 08/05/2025 and 04/27/2026 have been considered.
Claim Status
The claim set and Applicant’s remarks filed April 27, 2026 have been entered.
Claims 3, 5-8, 11, 13-19, 21, 23-25, 27-29, 31-32, 36-37, 39-42, 46 and 48-64 are canceled.
Thus, claims 1-2, 4, 9-10, 12, 20, 22, 26, 30, 33-35, 38, 43-45 and 47 as amended are examined on the merits herein.
Claim Interpretation
The claim interpretation of claim 21 as discussed on pp. 3-4 of the final rejection mailed May 29, 2025 is withdrawn in view of the incorporation of claim 21 into claim 1 and Applicant’s subsequent canceling of claim 21 as discussed in the Claim Status section above.
However, claim 1, lines 13-16, are drawn to “a pharmaceutically acceptable carrier comprising one or more of”.
In addition, claims 33-34 are drawn to “wherein a portion of the pharmaceutically acceptable carrier is modified with a cross-linking agent”.
Because the claim language recites “comprising” when referring to the pharmaceutically acceptable carrier within the composition of claim 1, said pharmaceutically acceptable carrier is construed to mean any pharmaceutically acceptable carrier within the composition can be cross-linked.
Additionally, the Examiner did not find anything within the specification that would limit said pharmaceutically acceptable carrier that is cross-linked to the specifically recited ones in claim 1, lines 13-16.
Therefore, this would appear to be the broadest reasonable interpretation; and thus, if the prior art teaches any pharmaceutically acceptable carrier present within the recited composition is cross-linked, then the prior art will read on the limitation “wherein a portion of the pharmaceutically acceptable carrier is modified with a cross-linking agent” as discussed above and recited in claims 33-34.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the final office action on May 29, 2025:
(I) The objection to claims 12, 21, 38 and 64 is withdrawn in view of the amendments to claims 12 and 28 and the cancelation of claims 21 and 64.
Additionally, the Examiner particular notes the claim status identifier for claim 12 is currently “previously presented”, however the Examiner interprets the identifier should be “currently amended” as the superfluous hyphen in the phrase “solution-for” which appeared in claim 12, line 3 of the claim set filed March 28, 2025, is now depicted as “solution for” in claim 12, line 3 of the claim set filed April 27, 2026 and therefore has resolved the objection to claim 12 as discussed above.
(II) The rejection of claims 1-2, 4, 9-10, 12, 20-22, 26, 30, 32-35, 38, 43-45, 47, 51-52 and 64 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of the amendments to claims 1 and 47; and the cancelation of claims as discussed in the Claim Status section above.
(III) The rejection of claims 1-2, 4, 9-10, 12, 20-22, 26, 30, 32, 43 and 47 under 35 U.S.C. 102(a)(1) as being anticipated by Altman et al. (US-20180008522-A1); and
(IV) The rejection of claims 1-2, 4, 9-10, 12, 20-22, 26, 30, 32-35, 38, 43-45, 47 and 64 under 35 U.S.C. 102(a)(1) as being anticipated by Altman et al. (WO-2019005848-A1) are both withdrawn in view of the amendment to claim 1 and the cancelation of claims as discussed in the Claim Status section above.
(V) The rejection of claims 51-52 under 35 U.S.C. 103; and
(VI) The provisional rejection of claims 51-52 on the ground of nonstatutory double patenting as being unpatentable U.S. Patent No. 11,660,372 are withdrawn in view of Applicant canceling claims 51-52 as discussed in the Claim Status section above.
(VII) The provisional rejection of claims 1, 4, 20, 22, 30, 35, 43-45 and 47 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/306,965 has been modified in view of the ‘965 application being issued as US. Patent No. 12,611,484.
(VIII) The rejection of claims 1-2, 4, 9-10, 12, 20-22, 26, 30, 32-35, 38, 43-45, 47 and 64 on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,660,372 is withdrawn in view of Applicant’s amendment to claim 1.
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.
Claims 1-2, 4, 9-10, 12, 20, 22, 26, 30, 33-35, 38, 43-45 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. ("hereafter referred to as Altman-1", Published 03 January 2019, Filed 26 June 2018, WO-2019005848-A1, IDS filed 09/27/2024) in view of Altman et al. ("hereafter referred to as Altman-2", Published 03 November 2016, WO-2016176633-A1, IDS filed 09/27/2024).
Regarding claims 1-2, 4, 9-10, 12, 20, 22, 26, 30, 33-35, 38, 43-45 and 47, Altman-1 teaches a method of treating a condition in a subject in need thereof, the method includes administering to the subject a therapeutically effective amount of a biocompatible tissue filler including silk protein fragments (SPF) (e.g. the silk fibroin fragments, required in claim 1, lines 4-5) having a polydispersity of between about 1.5 to about 3.0 (e.g. the polydispersity, required in claim 1, line 13 and claim 4) and a polysaccharide, see pg. 16, lines 10-13.
Altman-1 teaches the skin condition is selected from and including skin dehydration or a wrinkle (e.g. reversing dry skin or reversing wrinkles, required in claim 47), see pg. 16, lines 14-17.
Altman-1 teaches the polysaccharide is hyaluronic acid (HA) and the tissue filler may be prepared from silk and hyaluronic acid, see pg. 12, lines 24-28.
Altman-1 teaches the composition includes cross-linked HA-HA, see pg. 58, lines 3-4; and wherein the HA is cross-linked into a matrix where the HA matrix encapsulates one or more SPF, see pg. 58, lines 7-9.
Altman-1 teaches matrix polymers may be cross-linked using PEG-based crosslinking agents and divinyl sulfones (e.g. the cross-linking agent, required in claim 33), see pg. 130, lines 8-11; and teaches non-limiting examples of HA cross-linking agents include 1,4-butanediol diglycidyl ether (BDDE) and 1,2-bis(2,3-epoxypropoxy)ethylene (EGDGE) (e.g. the cross-linking agent, required in claim 34), see pg. 130, lines 11-13.
Altman-1 exemplifies adding hyaluronic acid or its salt form at a concentration of about 0.5% to about 10% to the aqueous solution of pure silk fibroin-based protein fragments (e.g. the hyaluronic acid percentage, required in claim 26), see pg. 113, lines 1-3.
Altman-1 teaches the biocompatible tissue filler includes silk protein fragments (SPF) having an average weight average molecular weight ranging from about 6 kDa to about 17 kDa, from about 17 kDa to about 39 kDa, or from about 39 kDa to about 80 kDa, see pg. 17, lines 8-13. The Examiner notes the teachings of Altman-1 above encompass an average weight average molecular weight of SPF from about 6 kDa to about 80 kDa and therefore encompasses the claimed average weight average molecular weight of silk fibroin protein fragments recited in claim 1, lines 5-11.
Altman-1 teaches administration of a tissue filler disclosed herein increases new collagen deposition, see pg. 118, lines 18-20; and the molecular weight of SPFs used in the preparation of tissue fillers described herein may be adjusted to provide a mild inflammatory response at a selected tissue in order to trigger the deposition or formation of collagen through the tissue proliferation and maturation responses that follow the initial inflammatory response, see pg. 188, lines 8-12; and may be tuned because the SPF solutions used herein have narrow rather than broad polydispersities, see pg. 188, lines 17-18.
Altman-1 teaches administration of the tissue filler disclosed herein increases new collagen deposition or formation by at most 200% (e.g. the collagen expression, required in claim 45), see pg. 189, lines 25 – pg. 190, line 11.
The Examiner notes the teachings of Altman-1 in the preceding two paragraphs correspond to the limitation of a method of stimulating or modulating collagen expression, required in claim 1, line 1; and increasing collagen expression required in claim 44.
Altman-1 teaches the composition of the invention comprises a carrier phase and wherein said composition can be a monophasic or multiphasic composition; and where the carrier is advantageously a physiologically-acceptable carrier, see pg. 56, lines 1-5.
Altman-1 exemplifies the biocompatible filler as a biocompatible hydrogel tissue filler (e.g. the gel, required in claim 22), see pg. 24, lines 21-26.
Altman teaches the composition includes a liquid phase, for example water and or an aqueous solution, (e.g. the aqueous phase, required in claim 30), see pg. 55, lines 26-27.
Altman-1 teaches in preparing an aqueous solution of pure silk fibroin-based protein fragments, see pg. 113, lines 13-15; the aqueous solution of pure silk fibroin-based protein fragments may comprise lithium bromide residuals of less than 300 ppm, see pg. 113, lines 28-30; and may comprise sodium carbonate residuals of less than 100 ppm, see pg. 113, line 31 – pg. 114, line 1; and exemplifies silk protein fragment solutions of lithium bromide at 90.85 ppm, and sodium carbonate at 32.12 ppm, see FIG 3, Sample ID A. Altman-1 teaches the silk solutions may be used to generate the tissue filler, see pg. 68, lines 25-26.
The Examiner notes the teachings of Altman-1 in the preceding paragraph correspond to the teachings of the concentrations of lithium bromide and/or sodium carbonate as recited and required in claim 2.
Altman-1 teaches the percent SPF content, by weight, in the tissue fillers described herein is about 5% (e.g. the silk fibroin fragment percentage, required in claim 9), see pg. 70, lines 12-13.
Altman-1 teaches the biocompatible tissue filler including silk protein fragments (SPF), wherein the SPF are substantially devoid of sericin, see pg. 15, line 1-3; wherein in an embodiment, silk fibroin and SPF that are substantially devoid of sericin refers to silk fibroin and SPF having a sericin content between about 0.01% (w/w) and about 0.1% (w/w) (e.g. the composition comprising sericin, required in claim 10), see pg. 59, lines 27-29.
Altman-1 teaches SPF solution compositions of the present disclosure have shelf stability, i.e., they will not slowly or spontaneously gel (e.g. do not spontaneously or gradually gelate, required in claim 12, line 2) when stored in an aqueous solution and there, without apparent aggregation of fragments and/or increase in molecular weight over time, from 10 days to 3 years depending on storage conditions, percent silk, and number of shipments and shipment conditions, see pg. 73, lines 26-30.
Altman-1 teaches the color of the solution can be controlled with for example LiBr, see pg. 111, line 11.
Thus, the Examiner reasonably interprets when the solution contains LiBr the silk fibroin fragments contained in the solution do not visibly change in color as required in claim 12, line 2.
Altman-1 teaches the tissue filler may be administered without limitation via a catheter (e.g. parenteral) and topically, see pg. 196, lines 1-6; and wherein the tissue is injectable, see pg. 196, line 8 (e.g. the formulated composition, required in claim 20 and claim 35).
Altman-1 teaches the tissue filler is administered to a region of the patient by injection wherein the region may be in the subdermal tissue, cutaneous tissues or subcutaneous tissues (e.g. the composition is formulated for administration, required in claim 38), see pg. 196, lines 25-30.
Although, Altman-1 does not teach the biocompatible tissue filler comprises sesame oil, corn oil, cottonseed oil or peanut oil as recited in claim 1, lines 13-16.
However, in the same field of endeavor of compositions to address wrinkles of the skin, Altman-2 teaches silk protein fragment compositions and moisturizers wherein the silk moisturizer can be used to address fine lines and wrinkles of the skin, see paragraph [0005].
Altman-2 teaches compositions in the form of a liquid, a semisolid, or a solid; including gels. Additionally, Altman-2 teaches it is understood to be within the scope of the composition that any of the foregoing compositions may be prepared with elements of other compositions such as, without limitation, silk, hyaluronic acid and one or more emollients as described herein. See paragraph [00201].
Altman-2 teaches the composition includes one or more emollients, and exemplifies said emollients that may be included in said composition are sesame oil, corn oil, cottonseed oil or peanut oil (e.g. the pharmaceutically acceptable carrier component, required in claim 1, lines 13-16), see paragraph [0154].
With respect to the limitation “wherein administering the composition decreases expression of one or more metalloproteinases (MMP) in the subject”, required in claim 43, the Examiner is reasonably interpreting this limitation as a physical consequence of administering the composition as taught by the method of claim 1. Since the combined teachings of Altman-1 and Altman-2 correspond to the method of claim 1 by administering the composition as recited within claim 1, the physical consequence is achieved by the method taught by the combination of Altman-1 and Altman-2.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the emollients as taught by Altman-2 above within the carrier phase of the biocompatible tissue filler as taught by Altman-1 above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to and would have had a reasonable expectation of success for including the emollients as taught by Altman-2 above as physiologically acceptable carriers in the composition and method as taught by Altman-1 above, because both Altman-1 and Altman-2 are drawn to methods of reducing wrinkles of the skin using a composition comprising silk protein fragments as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
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.
(I) Claims 1-2, 4, 9, 12, 20, 30, 35, 43-45 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 9-11, 14, 16-17 and 23-25 of copending Application No. 18/702,304 (Applicant: Evolved by Nature, Inc., claim set filed 11/04/2024) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward stimulating or modulating collagen expression in a subject.
Reference claim 1 recites a method of treatment or prevention of a disorder, disease or condition alleviated by i) stimulating or modulating collagen expression in a subject in need thereof by administering to the subject a composition comprising silk fibroin fragments having an average weight average molecular weight selected from between about 14 kDa and 30 kDa or between about 39 kDa and about 54 kDa; and having a polydispersity between 1 and about 5.
Reference claim 15 recites the composition further comprises a pharmaceutically acceptable carrier; and as evidenced by the specification of ‘304, the pharmaceutically acceptable carrier comprising one or more of sesame oil, corn oil, cottonseed oil, peanut oil, mannitol or dextrose (see pg. 3, lines 7-10).
Reference claims 2, 4, 9, 10-11, 14, 16-17 and 23-25 correspond to instant claims 2, 4, 9, 12, 20 and 35, 30 and 47, respectively.
With respect to limitations (a) decreases expression of one or more metalloproteinases (MMP) in the subject, required in instant claim 43; (b) wherein stimulating or modulating collagen expression comprises increasing collagen expression, required in instant claim 44; and (c) wherein collagen expression is increased after administration of the composition by an amount recited in the Markush group, required in instant claim 45; are all interpreted to be an intended result of administering the composition comprising the silk fibroin fragments, and since reference claim 1 recites administering the composition comprising silk fibroin fragments as a method of stimulating or modulating collagen expression in a subject, the claimed limitations recited in instant claims 43-45 are achieved.
Thus, the combination of reference claims 1-2, 4, 9-11, 14, 16-17 and 23-25 make obvious instant claims 1-2, 4, 9, 12, 20, 30, 35, 43-45 and 47.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II) Claims 1, 4, 20, 22, 30, 35, 38, 43-45 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87, 89, 95, 98 and 101-102 of copending Application No. 16/626,081 (Applicant: Evolved by Nature, Inc., amended claim set filed 06/05/2026) in view of Altman et al. (Published 03 November 2016, WO-2016176633-A1, IDS filed 09/27/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward stimulating or modulating collagen expression in a subject.
Reference claim 87 recites a method of treating a condition in an subject in need thereof, comprising administering to the subject a therapeutically effective amount of a biocompatible tissue filler comprising hyaluronic acid (HA), an anesthetic agent, and silk proteins fragments (SPF) comprising fibroin wherein the SPF have an average weight average molecular weight ranging from about 1 kDa to about 250 kDa;
wherein a portion of the HA and a portion of SPF are crosslinked by one or more linker moieties; comprising one or more of an alkane or alkyl chain, an ether group, and a secondary alcohol, wherein the linker moieties are covalently attached to the modified or crosslinked HA or SPF; wherein the one or more linker moieties comprise a polyethylene glycol chain.
Reference claim 95 recites wherein administration of the tissue filler to the subject results in increases in collagen production compared to the collagen production induced by a control tissue filler comprising hyaluronic acid and lidocaine, wherein the control tissue filler does not include silk protein fragments (SPF).
Reference claim 101 recites wherein the SPF have a polydispersity of between about 1.5 and about 3.0.
Reference claim 98 recites wherein the tissue is delivered to soft tissues selected from and including subcutaneous tissues; and reference claim 102 recites wherein the tissue filler is injectable.
Reference claims 89 and 101 correspond to instant claim 47; and instant claims 22 and 30, respectively.
Although, ‘081 does not recite the biocompatible filler comprises sesame oil, required in instant claim 1, lines 13-14.
However, in the same field of endeavor of compositions to address wrinkles of the skin, Altman teaches silk protein fragment compositions and moisturizers wherein the silk moisturizer can be used to address fine lines and wrinkles of the skin, see paragraph [0005].
Altman teaches compositions in the form of a liquid, a semisolid, or a solid. Additionally, Altman teaches it is understood to be within the scope of the composition that any of the foregoing compositions may be prepared with elements of other compositions such as, without limitation, silk, hyaluronic acid and one or more emollients as described herein. See paragraph [00201].
Altman teaches the composition includes one or more emollients, and exemplifies said emollients that may be included in said composition include sesame oil (e.g. the pharmaceutically acceptable carrier component, required in instant claim 1, lines 13-14), see paragraph [0154].
With respect to limitations (a) decreases expression of one or more metalloproteinases (MMP) in the subject, required in instant claim 43; (b) wherein stimulating or modulating collagen expression comprises increasing collagen expression, required in instant claim 44; and (c) wherein collagen expression is increased over a base level by an amount recited in the Markush group, required in instant claim 45; are all interpreted to be an intended result of administering the composition comprising the silk fibroin fragments, and since reference claim 1 recites administering the composition comprising silk fibroin fragments the claimed limitations recited in instant claims 43-45 are achieved.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the emollients as taught by Altman above into the composition and method as recited by ‘081 above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to and would have had a reasonable expectation of success for including the emollients as taught by Altman above into the composition and method as recited by ‘081 above, because both Altman and ‘081 are drawn to methods of reducing wrinkles of the skin with a composition comprising silk protein fragments as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘081 and the teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
(III) Claims 1, 4, 20, 22, 30, 35, 43-45 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 10-11 and 18-19 of U.S. Patent No. 12,611,484 (Applicant: Evolved by Nature, Inc., PTO-892) in view of Altman et al. (Published 03 November 2016, WO-2016176633-A1, IDS filed 09/27/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward stimulating or modulating collagen expression in a subject.
Reference claim 18 recites a method of treating a skin condition in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a tissue filler of claim 1.
Reference claim 1 recites a biocompatible tissue filler comprising hyaluronic acid (HA) and silk fibroin protein fragments (SPF), wherein said SPF has an average weight average molecular weight selected from about 1 kDa to about 250 kDa and a polydispersity of between 1 and about 5.0, wherein a portion of the HA or SPF is modified or crosslinked by one or more linker moieties comprising one or more of an alkane or alkyl chain, an ether group, and a secondary alcohol.
Reference claim 10 recites wherein the SPF has an average weight average molecular weight selected from and including from about 6 kDa to about 17 kDa; 17 kDa to about 39 kDa; or from about 39 kDa to about 80 kDa.
Reference claim 11 recites wherein the silk fibroin protein fragments (SPF) have a polydispersity of between about 1.5 and about 3.0.
Reference claim 7 recites wherein the tissue filler is a gel or a hydrogel; reference claim 8 recites wherein the tissue filler is injectable.
Reference claim 19 corresponds to instant claim 47.
Although, ‘484 does not recite the biocompatible filler comprises sesame oil, required in claim 1, lines 13-14.
However, in the same field of endeavor of compositions to address wrinkles of the skin, Altman teaches as set forth above.
With respect to limitations (a) alleviated by stimulating or modulating collagen expression, required in instant claim 1; (b) decreases expression of one or more metalloproteinases (MMP) in the subject, required in instant claim 43; (c) wherein stimulating or modulating collagen expression comprises increasing collagen expression, required in instant claim 44; and (d) wherein collagen expression is increased over a base level by an amount recited in the Markush group, required in instant claim 45; are all interpreted to be an intended result of administering the composition comprising the silk fibroin fragments, and since reference claim 19 recites administering the composition comprising silk fibroin fragments as recited within reference claim 1, the claimed limitations as recited within instant claims 1 and 43-45 are achieved.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the emollients as taught by Altman above into the compositions and methods recited by ‘484 above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to and would have had a reasonable expectation of success for including the emollients as taught by Altman above into the composition and method recited by ‘484 above, because both Altman and ‘484 are drawn to methods of reducing wrinkles of the skin with a composition comprising silk protein fragments as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘484 and the teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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