CTNF 18/265,368 CTNF 89442 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-25 AIA Applicant's election with traverse of Group I in the reply filed on 3/4/2026 is acknowledged. The traversal is on the ground(s) that Sun et al. in view of Cai et al is silent on treating skin conditions as claimed . This is not found persuasive because a new reference is found for claim rejections not applied to applicant’s argument . The requirement is still deemed proper and is therefore made FINAL. 08-05 AIA Claim s 28 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/4/2026 . Applicant’s response to species election requirement is shown as follow, reading on claims 1, 3, 29-33, 37, 42, and 44. PNG media_image1.png 258 604 media_image1.png Greyscale Claim Status Claims 1, 3, and 28-45 are pending. Claims 2 and 4-27 are cancelled. Claims 28 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Claims 34, 39-40, 43, and 45 are withdrawn as being directed to a non-elected species, the election having been made on 3/4/2026. Claims 1, 3, 29-33, 35-38, 42, and 44 have been examined. A prior art search found non-elected species of claims 35-36 and 38 are obvious variants of the elected species; thus, claims 35-36 and 38 are examined . Priority This application is a 371 of PCT/US21/61843 12/03/2021 PCT/US21/61843 has PRO 63/120,850 12/03/2020 Information Disclosure Statement The information disclosure statements (IDS) submitted on 6/5/2023, 12/22/2023, 10/28/2024, and 3/4/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. Sequence Listing The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421-2424. Specifically, the instant application does not comply with 37 C.F.R. l.82l(b)-(e). The instant claims and/or disclosure contain references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs" as prescribed (see, MPEP §§ 2421-2424). Specifically, the instant application discloses PNG media_image2.png 284 258 media_image2.png Greyscale sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs". At least the peptide sequences found in SPEC and claims 34-38 should have SEQ ID NOs. Given claim 34 as an example, the peptide sequence of (M o A) 155 -K 75 comprising 75 consecutive lysine residues fails to satisfy the requirement of SEQ ID NO for a peptide sequence comprising “at least 4 consecutive amino acids in length”. Appropriate correction is required. Specification The specification is objected to because of missing SEQ ID NOs for each polypeptide sequences comprising 4 or more consecutive amino acids in length. See the summary table above for the peptide sequences missing SEQ ID NOs. Claim Objections 07-29-01 AIA Claim s 35-36 and 38 are objected to because of the following informalities: The polypeptides of Substructure I and Substructure II require a SEQ ID NO . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1, 3, 31-32, 35-38, 42, and 44 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. 07-34-03 AIA The term " hydrophilic " in claim s 1 and 3 is a relative term which renders the claim indefinite. The term " hydrophilic " is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example: PNG media_image3.png 486 541 media_image3.png Greyscale • Serine has been identified in the prior art as both hydrophobic (see, e.g., US2014/0286865A1 (the ‘865 patent [0067], cited in IDS); see also US 5,670,483, cited in IDS, at claim 7, identifying serine as hydrophobic) and hydrophilic (see, e.g., Livingstone et al., Protein sequence alignments, CABIOS, vol. 9(6):745-756 (1993), cited in IDS); hereafter "Livingstone"; at p747, Figure 1); • Glutamine has been identified as hydrophobic (the ‘865 patent [0067]) and hydrophilic (Livingstone, p747, Fig 1, shown as follows); • Threonine has been identified as hydrophobic (Livingstone, p747, Fig 1) but also hydrophilic (Taylor In Biological Techniques Series, Genetic Databases, Academic Press, 1997, Pages 81-103 at p86, § 5.2.2.2); • Tyrosine has been identified as both hydrophobic (Livingstone at Fig 1) and hydrophilic (Taylor at p87 § 5.2.2.3). PNG media_image4.png 278 250 media_image4.png Greyscale These examples are not exhaustive. However, if tyrosine is deemed hydrophilic as taught by the prior art ( see, e.g., Taylor at 87 at§ 5.2.2.3), then all amino acids with a hydrophilicity value greater than tyrosine are presumably also hydrophilic, which would include amino acids such as cysteine and valine (see, e.g., US 4,554,101 (cited in IDS), the ‘101 patent at col 2 at lines 1-20, providing a table of comparative hydrophilicity values reproduced below): However, if lysine is considered hydrophobic as taught by the prior art (see, e.g., Livingstone at Figure 1), then all amino acids with a hydrophilicity value less than lysine are presumably also hydrophobic, which would include amino acids such as serine, asparagine, and glutamine (the '101 patent at col 2 at lines 1-20). Accordingly, hydrophilicity is a relative term, and any amino acid is therefore more or else less hydrophilic than another amino acid arbitrarily selected by an artisan. Accordingly, the use of a relative term in the absence of any definition renders the metes and bounds of the claim scope indefinite. Therefore, the scope of claims 1 and 3 are rejected as indefinite and claims 31-32, 35-38, 42, and 44 are further rejected as depending on claim 1. The broader scope of a non-ionic amino acid and narrower scope of glycine and alanine co-exist in the base claim. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 3 recite the broad recitation X and/or Y 1 as a non-ionic amino acid, and the claims also recite X and/or Y 1 as the amino acid of glycine or alanine which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 31-32, 35-38, 42, and 44 are further rejected as depending on claim 1. The symbol “ M o ” is not defined in claim 1 rendering the dependent claims 31-32 and 35-38 indefinite and lack of antecedent basis for this limitation in the claims. For prior art search purposes, the symbol is interpreted as methionine sulfoxide (see claim 29). Claim Rejections - 35 USC§ 112(a), Written Description 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claims 1, 3, 31-32, 35-38, 42, and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 3 are representative of the pending claim scope. The term "hydrophilic" is reasonably inferred to be a relative term (see, e.g., discussion above under 35 USC § 112(b ), incorporated herein) and a functional limitation that is intended to exclude an unknown set of structures of amino acids based upon an unknown hydrophilicity value that Applicant has necessarily relied upon, but not explicitly disclosed on record. However, such information is required to reasonably distinguish what structures satisfy the functional characterization of "hydrophilic" amino acids. In the absence of any definition or hydrophilicity value, the structures included and excluded by the functional limitation requiring "hydrophilic" amino acids is unknown and undescribed on record. The specification disclosed hydrophilic polypeptide/copolypeptide segment consists of residues selected from lysine, glutamate, aspartate, arginine, ornithine, homoarginine, a residue of Formula I, a residue of Formula II, a residue of Formula III, a residue of Formula IV, a residue of Formula V, a residue of Formula VI, and combinations thereof in one example (p13, line 10-15). The disclosed example failed to define the functional limitation "a hydrophilic amino acid" for the entire genus of "a hydrophilic amino acid" as claimed. This is problematic because the claims appear to cover all known amino acids, which includes over 500 naturally occurring amino acids (See Abstract of Wagner et al. Angew. Chem. Int. Ed. Engl., vol. 22:816-828 (1983)), thousands of non-natural amino acids, β-amino acids, γ-amino acids, post-translationally modified amino acids, branched amino acids, etc. Accordingly, it is unclear based on the instant description what amino acids were contemplated by the Inventor(s) as "hydrophilic". This is a substantial issue because the prior art provides conflicting information with respect to even the basic twenty amino acids, much less the thousands of additional amino acids potentially encompassed by the pending claims. For example: • Serine has been identified in the prior art as both hydrophobic (see, e.g., US2014/0286865A1 (the ‘865 patent [0067]); see also US 5,670,483 at claim 7, identifying serine as hydrophobic) and hydrophilic (see, e.g., Livingstone et al., Protein sequence alignments, CABIOS, vol. 9(6):745-756 (1993); hereafter "Livingstone"; at p747, Figure 1); • Glutamine has been identified as hydrophobic (the ‘865 patent [0067]) and hydrophilic (Livingstone, p747, Fig 1, shown as follows); • Threonine has been identified as hydrophobic (Livingstone, p747, Fig 1 shown as follows) but also hydrophilic (Taylor In Biological Techniques Series, Genetic Databases, Academic Press, 1997, Pages 81-103 at p86, § 5.2.2.2); • Tyrosine has been identified as both hydrophobic (Livingstone at Fig 1) and hydrophilic (Taylor at p87 § 5.2.2.3). • US 4,554,101, Hydrophilicity Value of common 20 amino acids (col 2 at lines 1-20). However, many more natural or non-natural “hydrophilic” amino acids were neither disclosed in US 4,554,101 nor disclosed in the instant specification. Because no "precise definition" by structure, formula, or exact chemical name was provided in the instant specification and the cited prior art references provide conflicting guidance regarding whether some amino acids are "hydrophilic" or not, one of ordinary skill in the art would not recognize applicant possesses the full scope of this invention. Thus, claims 1, 3, 31-32, 35-38, 42, and 44 are rejected under 35 U.S.C. 112(a). Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1, 3, 29-33, 35-38, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Deming et al. (WO 2019/067676 A1, cited in IDS) in view of Dominguez Valdes-Hevia et al. (US 10,391,050 B2) and Owczarczyk-Saczonek et al. (Stem Cells Int. 2017:2017: 4740709) . PNG media_image5.png 624 550 media_image5.png Greyscale Claim 1 is directed to a method of treating fine lines or superficial wrinkles in the skin of a subject, comprising administering a composition comprising a polypeptide hydrogel comprising substructure I and substructure II. PNG media_image6.png 312 392 media_image6.png Greyscale Deming et al. teach polyion complex polypeptide hydrogels useful as a drug or cell delivery systems, scaffolds for tissue repair or as 3D printable media (Abstract). Deming et al. teach polyion complex polypeptide comprising Substructure 1 and Substructure 2 defined as follows (p2, line 1-22), reading on the polypeptide hydrogel in claim 1. Deming et al. show the polypeptide made by the process of mixing substructure I and substructure II together shown as follows (Fig 1), reading on substructure I of Xm-C 1p as (methionine sulfoxide 0.88 -Ala 0.12 ) 155 Kx and structure II of Y 1n -A 1q as (methionine sulfoxide 0.88 -Ala 0.12 ) 155 Ex. Deming et al. teach the repeating units of p and q are between 20 and 200 (p4, line 17-18), reading on Deming’s repeating unit of Kx and Ex as K 20-200 and E 20-200 . Deming et al. teach the use of polyion complex polypeptide hydrogels as a drug or cell delivery systems, scaffolds for tissue repair or as 3D printable media (Abstract). Deming et al. do not specify the use of polypeptide hydrogels to treat a skin condition. Dominguez Valdes-Hevia et al. teach dermatological, cosmetic or cosmeceutical compositions intended for skin treatment (Title). Dominguez Valdes-Hevia et al. teach the outermost organ of skin is subjected to significant deterioration and aggression, which leads to premature ageing of the skin. Dominguez Valdes-Hevia et al. teach skin premature ageing as a result of internal or endogenous factors, such as those related to an unbalanced nutrition in terms of vitamins, iatrogenic factors such as radiotherapy, the intake of drugs such as nonsteroidal anti-inflammatory agents, immunosuppressants, etc., or the presence in the body of very reactive toxins such as those ingested by drug addicts, alcoholics, etc. Deterioration of the skin appears in the form of wrinkles, spots, laxity, benign neoplasms, etc (col 1, line 23-39). Dominguez Valdes-Hevia et al. teach administration of a hydrogel comprising proteins and other active ingredients to active epidermal stem cell (col 2, line 22-27; claim 1). Furthermore, Owczarczyk-Saczonek et al. teach “The Use of Adipose-Derived Stem Cells in Selected Skin Diseases” (Title). Owczarczyk-Saczonek et al. teach ADSCs are used in aesthetic dermatology for skin rejuvenation, to correct wrinkles, to correct facial lipoatrophy (p3, col 1, para 2). Owczarczyk-Saczonek et al. teach that Adipose-Derived Stem Cells (ADSCs) are even necessary for the activation of epidermal stem cells in the skin (p2, col 1, para 2). Owczarczyk-Saczonek et al. teach subcutaneous ADSCs demonstrated greater proliferation and differentiation capacity (p2, col 2, para 4). Owczarczyk-Saczonek et al. further suggest the use of an injectable protein-containing hydrogel to deliver cells (e.g., ADSCs) for wound healing and other tissue regeneration applications (p8, col 1, last para). Owczarczyk-Saczonek et al. further show the treated disease and application method in Table 1 (p5-7), including diabetic foot ulcer (a skin wound). Because (a) Deming et al. teach the use of polyion complex polypeptide hydrogels as drug or cell delivery systems and/or scaffolds for tissue repair (Abstract) and the rapid self-healing ability of polyion complex polypeptide hydrogels would allow for delivery of it via injection through small bore needles (p9, line 15-17), (b) Dominguez Valdes-Hevia et al. teach the use of a hydrogel composition comprising bioactive compounds, proteins, and other active ingredients to active epidermal stem cell (col 2, line 22-27; claim 1) to treat a skin aging condition such as skin wrinkles (col 1, line 23-39), and (c) Owczarczyk-Saczonek et al. teach Adipose-Derived Stem Cells (ADSCs) are used in aesthetic dermatology for skin rejuvenation, to correct wrinkles, to correct facial lipoatrophy (p3, col 1, para 2). and further teach that Adipose-Derived Stem Cells (ADSCs) are even necessary for the activation of epidermal stem cells in the skin (p2, col 1, para 2), one of ordinary skill in the art would have found it obvious to inject Deming’s polyion complex polypeptide hydrogel as a carrier or scaffold comprising ADSCs and growth factor/bioactive compounds to treat a skin condition, including correction of wrinkles or facial lipoatrophy as suggested by Dominguez Valdes-Hevia et al. (p3, col 1, para 2) for skin rejuvenation, reading on claims 1 and 3. One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Deming et al. and (ii) Dominguez Valdes-Hevia et al. in view of Owczarczyk-Saczonek et al. because (a) Deming et al. teach the use of polyion complex polypeptide hydrogels as a drug or cell delivery systems and/or scaffolds for tissue repair (Abstract) and the rapid self-healing ability of polyion complex polypeptide hydrogels would allow for delivery of it via injection through small bore needles (p9, line 15-17), (b) Dominguez Valdes-Hevia et al. teach the use of a hydrogel composition comprising bioactive compounds, proteins, and other active ingredients to active epidermal stem cell (col 2, line 22-27; claim 1) to treat a skin aging condition such as skin wrinkles (col 1, line 23-39), and (c) Owczarczyk-Saczonek et al. teach Adipose-Derived Stem Cells (ADSCs) are used in aesthetic dermatology for skin rejuvenation, to correct wrinkles, to correct facial lipoatrophy (p3, col 1, para 2). and further teach that Adipose-Derived Stem Cells (ADSCs) are even necessary for the activation of epidermal stem cells in the skin (p2, col 1, para 2). The combination would have reasonable expectation of success because all references teach the use of hydrogel as a therapeutic or PNG media_image7.png 172 392 media_image7.png Greyscale cosmetic drug (including cells) carrier. With respect to claims 29-30 and 33, Deming et al. show (i) X and Y is an amino acid residue 88 mol% methionine sulfoxide (M o ) and 12 mol% alanine, (ii) C 1 is lysine, and (iii) A1 is glutamic acid shown above (Fig 1). PNG media_image8.png 262 438 media_image8.png Greyscale With respect to claims 31-32 and 35-38, Deming et al. teach K and E lengths in the hydrogel of (M o A) 155 Kx and (M o A) 155 Ex are result effective variable for viscoelastic property of storage modulus and loss modulus (p8, para 1; Table 2 as follows) that can be routinely optimized in the range of 20 and 200 (p4, line 17-18; claims 28-29). See MPEP 2144.05(II). With respect to claim 42, Owczarczyk-Saczonek et al. teach subcutaneous ADSCs demonstrated greater proliferation and differentiation capacity (p2, col 2, para 4); thus, one of ordinary skill in the art would subcutaneous injection of a hydrogel comprising Owczarczyk-Saczonek’s ADSCs or even epidermal stem cell directly as suggested by Dominguez Valdes-Hevia et al. (col 2, line 22-27; claim 1) to treat a skin condition such as skin wrinkles as suggested by Dominguez Valdes-Hevia et al. (col 1, line 23-39) or skin lesion of diabetic food ulcer as suggested by Owczarczyk-Saczonek et al. (p6, Table 2). With respect to claim 44, Dominguez Valdes-Hevia et al. suggest the active compound in a hydrogel composition (claim 1) can be administered topically (col 4, Example 1). Owczarczyk-Saczonek et al. teach surface application (not injection) of a composition comprising ADSCs to treat skin burns (p6, Table 2). Furthermore, if administration by injection, the hydrogel size that does not obstruct arteries (arterial occlusion) after injection is a result effective variable that can be optimize among m (100-600), n (100-600), p (20-200), and q (20-200) taught by Deming et al. (p2, line 1-22). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I) . Double Patenting 08-33 AIA 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. 08-36 AIA Claim s 1, 3, 29-33, 35-38, 42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-2 of U.S. Patent No. 12,226,546 B2 (the ‘546 patent, cited in IDS) in view of Deming et al. (WO 2019/067676 A1, cited in IDS), Dominguez Valdes-Hevia et al. (US 10,391,050 B2) and Owczarczyk-Saczonek et al. (Stem Cells Int. 2017:2017: 4740709) . Claims 1-2 of the ‘546 patent disclosed a hydrogel composition comprising substructure I and substructure II identical to the hydrogel of instant claim 1. Claims 1-2 of the ‘546 patent do not disclosed administration of the hydrogel in a composition to treat a skin condition. The relevancy of Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. as applied to claims 1, 3, 29-33, 35-38, 42, and 44 described above not repeated here. Because Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. teach beneficial use of the hydrogel disclosed by claims 1-2 of the ‘546 patent as a carrier to deliver stem cells and bioactive compounds to treat a skin condition, one of ordinary skill in the art would have found it obvious to combine (i) claims 1-2 of the ‘546 patent and (ii) Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. Thus, claims 1-2 of the ‘546 patent in view of Deming et al., Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. are obvious to the instant claims 1, 3, 29-33, 35-38, 42, and 44 . 08-37 AIA Claim s 1, 3, 29-33, 35-38, 42, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-2 and 8 of copending Application No. PCT/US18/53050 (the ‘050 application) in view of Deming et al., Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. Claim 1 of the ‘050 application disclosed a hydrogel composition comprising substructure I and substructure II identical to the hydrogel of instant claim 1. Claim 1 of the ‘050 application disclosed Claim 2 of the ‘050 application disclosed the amino acid X as methionine sulfoxide. Claim 8 of the ‘050 application disclosed the amino acid X as methionine sulfoxide. Claims 1-2 and 8 of the ‘050 application do not disclosed administration of the hydrogel in a composition to treat a skin condition. The relevancy of Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. as applied to claims 1, 3, 29-33, 35-38, 42, and 44 described above not repeated here. Because Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. teach beneficial use of the hydrogel disclosed by claims 1-2 and 8 of the ‘050 application as a carrier to deliver stem cells and bioactive compounds to treat a skin condition, one of ordinary skill in the art would have found it obvious to combine (i) 1-2 and 8 of the ‘050 application and (ii) Deming et al. in view of Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. Thus, claims 1-2 and 8 of the ‘050 application in view of Deming et al., Dominguez Valdes-Hevia et al. and Owczarczyk-Saczonek et al. are obvious to the instant claims 1, 3, 29-33, 35-38, 42, and 44 . This is a provisional nonstatutory double patenting rejection. 08-35 AIA Claim s 1, 3, 29-33, and 35-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 28-33, and 35-38 of copending Application No. PCT/US21/61843 (the ‘843 application) . Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘843 application is obvious to the instant application. Claim 1 of the ‘843 application disclosed a method treating fine lines or superficial wrinkles in the skin of a subject as follows: PNG media_image9.png 84 678 media_image9.png Greyscale Claim 28 of the ‘843 application disclosed the polypeptide hydrogel identical to the polypeptide hydrogel in the instant claim 1. Thus, claims 1 and 28 of the ‘843 application are obvious to the instant claims 1 and 3. Claims 29-30 of the ‘843 application are obvious to the instant claims 29-30. Claims 31-33 of the ‘843 application are obvious to the instant claims 31-33 respectively Claims 35-38 of the ‘843 application are obvious to the instant claims 35-38 respectively This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /J.L/Examiner, Art Unit 1658 25-May-2026 /Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658 Application/Control Number: 18/265,368 Page 2 Art Unit: 1658 Application/Control Number: 18/265,368 Page 3 Art Unit: 1658 Application/Control Number: 18/265,368 Page 4 Art Unit: 1658 Application/Control Number: 18/265,368 Page 5 Art Unit: 1658 Application/Control Number: 18/265,368 Page 6 Art Unit: 1658 Application/Control Number: 18/265,368 Page 7 Art Unit: 1658 Application/Control Number: 18/265,368 Page 8 Art Unit: 1658 Application/Control Number: 18/265,368 Page 9 Art Unit: 1658 Application/Control Number: 18/265,368 Page 10 Art Unit: 1658 Application/Control Number: 18/265,368 Page 11 Art Unit: 1658 Application/Control Number: 18/265,368 Page 12 Art Unit: 1658 Application/Control Number: 18/265,368 Page 13 Art Unit: 1658 Application/Control Number: 18/265,368 Page 14 Art Unit: 1658 Application/Control Number: 18/265,368 Page 15 Art Unit: 1658 Application/Control Number: 18/265,368 Page 16 Art Unit: 1658 Application/Control Number: 18/265,368 Page 17 Art Unit: 1658 Application/Control Number: 18/265,368 Page 19 Art Unit: 1658 Application/Control Number: 18/265,368 Page 20 Art Unit: 1658
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