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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2021/049432 filed 09/08/2021, which claims the benefit of the priority of US Provisional application 63/075,638 filed 09/08/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 04/15/2026 has been considered by the examiner.
Claim Status
Claims 1-7, 9, 13-22, 25, 34-39 are pending. Claims 8, 10-12, 23-24, 26-33 are canceled. Claims 38-39 are new. Claims 21-22 , 25, and 34 are withdrawn from consideration. Claims 1, 7, and 17 are amended. Claims 1-7, 9, 13-20 and 35-39 are being examined on the merits in this office action.
Claim Objections - Withdrawn
The objection of claim 17 is withdrawn in view of the claim amendments.
Claim Rejections - Withdrawn
The rejection of claims 1-6, 9, 13-20, and 35-37 under 35 U.S.C. 101 is withdrawn in view of the claim amendments.
The rejection of claims 1-7, 9, 13-20 and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Montanari et al. (WO2008080443A2 – hereinafter “Montanari”) in view of Lintner et al. (US20040132667A1 – hereinafter “Lintner”) and Blum et al. (Exp. Dermatol. 2014 Jul; 23(7): 457-63) is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 103 - New
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-7, 9, 13-20 and 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over Montanari et al. (WO2008080443A2 – hereinafter “Montanari”) in view of Lintner et al. (US20040132667A1 – hereinafter “Lintner”), and Wiechers et al. (Cosmetics and Toiletries- published 2013- Formulating at pH 4-5: How Lower pH Benefits the Skin and Formulations | Cosmetics & Toiletries) and Blum et al. (Exp. Dermatol. 2014 Jul; 23(7): 457-63).
Claim Interpretation
“deconstructed matrisome” is defined in the instant invention as one or more peptides (i.e., matrikines) and that matrikines are derived from tissue-specific extracellular matrix [0072-0073]. Examiner notes that a composition comprising matrikines or a composition comprising peptides derived from tissue-specific extracellular matrix would thus read on the claimed invention.
Montanari teaches a cosmetic composition comprising matrikines, wherein said matrikine is a peptide of Glycyl-Histidyl- Lysine or Glycyl-Glutaminyl-Prolyl-Arginine or a mixture thereof and a cosmetically acceptable carrier (claims 1-2), and that matrikines are peptide fragments formed by the proteolysis of the extracellular matrix and are cараble of regulating the cellular activity (Page 9, line 1-20). Montanari teaches that the matrikines promote the cellular proliferation of keratinocytes and fibroblasts and are consequently effective in the reconstruction of the extracellular dermal matrix (Page 10 , line 1-4) and that the composition for stimulating the cellular reproduction of the connective tissue and relative production of collagen fiber suitable for restoring the damaged tissue (Page 8, line 12-15).
Montanari does not teach the % weight of the peptides of 0.1 to 15% and does not teach all the peptide fragments recited in dependent claim 16.
Lintner teaches a topical composition comprising between about 0.00001% and about 0.5% w/w of at least one rigin-based tetrapeptide and about 0.00001% and about 1.0% w/w of at least one GHK-tripeptide (claim 1) and further comprising dermatologically acceptable carrier (claim 11). Lintner teaches the composition with a pH of about 6 [0303, 0312, 0036]. Examiner is interpreting this teaching to mean that the pH includes a pH of slightly below 6 and would thus read on the claim. Additionally, it is known in the art to formulate cosmetic composition at pH slightly below the pH 6 as taught by Wiecher. Wiecher teaches that the pH of the skin is 5.5 and that growth of microorganisms such as Staphylococcus aureaus slows down at pH of 5.5 (Page 5, 3rd paragraph, line 1-5). Wiechers recommends formulating cosmetic compositions at a pH of 5 and teaches that the formulations were more stable with enhanced permeability to the skin and that preservation of the composition was obtained with composition with low pH (Page 6-7).
Blum teaches matrikines which are biologically active fragments of the extracellular matrix and that numerous extracellular proteins and glycosaminoglycans (GAGs) undergo limited enzymatic cleavage resulting in the release of fragments exerting biological activities (Abstract), that the fragments regulate a number of physiopathological processes including angiogenesis, cancer, fibrosis, inflammation, neurodegenerative diseases and wound healing (Abstract). Blum teaches the matrikines released from human extracellular proteins such as collagen, fibronectin, laminins (See Table 1), growth factors, endostatin, EGF, tenascin (Page 460, right col., 2nd and 3rd paragraph). Blum teaches that the fragments with kDa including 85 kDa for aggrecan core protein fragments, 240 kDa for Collagen XIII α1 chain, or 85 kDa for Perlecan (See Table 1). Blum teaches compositions 20 µg/ml of peptide fragments and other compositions having 0.2% peptide fragments and teaches that composition for topical administration( See Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Montanari and Lintner and include the matrikine peptides in the amounts taught by Lintner since Lintner teaches the same peptides taught by Montanari and teaches the composition has the benefit in tissue regeneration [0011, 0326-0327]. Further, it would have been obvious to modify the composition of Montanari to include the fragments of Blum since Blum teaches that the fragments have been successful for wound healing and skin repair (Abstract; page 457, left col. Last paragraph; page 460, left col., 1st paragraph). Additionally, it would have been obvious to modify the teachings of Montanari and formulate the composition at a slightly acidic pH such as below 6, since Litner teaches a composition of about 6 and Wiechers teaches that cosmetic composition should be at around 5 since the pH of skin is around 5.5 and a slightly acidic composition enhances penetration of the composition to the skin. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the matrikine peptides in the amounts taught by Lintner and Blum, since Lintner the composition has the benefit in tissue regeneration [0011, 0326-0327]. Additionally, one of ordinary skill in the art would have had a reasonable expectation of successfully combining the cited prior art teachings, because the cited references hail from the same field of endeavor, i.e. compositions comprising matrikine peptides. The disclosures render obvious claim 1.
Regarding claim 2, Lintner teaches a topical composition comprising between about 0.00001% and about 0.5% w/w of at least one rigin-based tetrapeptide and about 0.00001% and about 1.0% w/w of at least one GHK-tripeptide (claim 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Montanari and Lintner and include the matrikine peptides in the amounts taught by Lintner since Lintner teaches the same peptides taught by Montanari and teaches the composition has the benefit in tissue regeneration [0011, 0326-0327].
Regarding claims 3-4, Montanari teaches that the composition is applied on the skin on stretch marks and that the composition is massaged until complete absorption (Page 28, line 12-19), that the effect is on the epidermis and dermis (Page 5, line 1-10). Further, Blum teaches a composition comprising syndecan binding sequence KKLRIKSKE of the LG4 domain of laminin a3, used for epidermal repair and which induces keratinocyte adhesion and promotes keratinocyte migration (Page 460, left col. 1st paragraph).
Regarding claims 5-6, Blum teaches that the fragments with kDa including 85 kDa for aggrecan core protein fragments, 240 kDa for Collagen XIII α1 chain, or 85 kDa for Perlecan (See Table 1). Examiner notes that the amounts are all less than 250 or 500 da. It would have been obvious to modify the composition of Montanari to include the fragments of Blum since Blum teaches that the fragments have been successful for wound healing and skin repair (Abstract; page 457, left col. Last paragraph; page 460, left col., 1st paragraph).
Regarding claim 7, Lintner teaches the composition with a pH of about 6 [0303, 0312, 0036]. It would have been obvious to modify the composition of Montanari to a pH taught by Lintner since Lintner teaches the same composition taught by Montanari and teaches the composition has the benefit in tissue regeneration [0011, 0326-0327].
Regarding claims 9 and 13, Montanari teaches that the peptides are derived from collagen I (Page 10, line 5-6). Further, Blum teaches peptide fragments from collagens, glycosaminoglycans, proteoglycans, laminins, cytokines, chemokines, fragments of ECM regulators (MMPs, a disintegrin and metalloproteinases, ADAMs, cross-linking enzymes) and ECM-affiliated proteins (e.g. mucins, galectins, semaphorins) (Abstract; Page 457, right col.,1st and 2nd paragraph; Page 459, left col., 1st paragraph). It would have been obvious to modify Montanari to include the fragments taught by Blum since Blum suggests drugs that comprise other bioactive fragments to improve efficacy (Page 461, left col., 4th paragraph).
Regarding claims 14-15, Montanari teaches that the peptide fragments have an effect in production of elastin and collagen (Page 22, line 14-15). Further, Lintner teaches the peptide fragments have a concentration of 500ppm [0052], which is equivalent to 500 µg/ml. Further, Blum teaches compositions 20 µg/ml of peptide fragments and other compositions having 0.2% peptide fragments and teaches that composition for topical administration( See Table 2). It would have been obvious to combine the teachings of the cited references and have the peptide fragments in the concentrations taught by Lintner since both reference teach composition comprising the same peptides.
Regarding claims 16-20, Montanari teaches that the peptides are derived from the alpha 2 chain of collagen I and that the peptide fragments have shown an increase in the synthesis of collagen and glycosaminoglycans (Page 10, line 5-10). Further, Blum teaches fragments comprise heparan sulphate proteoglycan and growth factor receptors (Page 460, right col.,2nd paragraph), Collagen VI α3 chain, Tenascin-C, ECM regulators (MMPs, a disintegrin and metalloproteinases, ADAMs, cross-linking enzymes) and ECM-affiliated proteins (e.g. mucins, galectins, semaphorins), Bone Morphogenetic Protein-1, BMP-1, laminin, hyaluronan binding complex (Table 1; Table 2; Page 457, right col.,1st and 2nd paragraph; Page 459, left col., 1st paragraph, Page 459, left col., last paragraph). It would have been obvious to modify Montanari to include the fragments taught by Blum since Blum suggests drugs that comprise other bioactive fragments to improve efficacy (Page 461, left col., 4th paragraph).
Regarding claim 35, Montanari teaches a cosmetic composition comprising matrikines, wherein said matrikine is a peptide of Glycyl-Histidyl- Lysine or Glycyl-Glutaminyl-Prolyl-Arginine or a mixture thereof and a cosmetically acceptable carrier (claims 1-2), and that matrikines are peptide fragments formed by the proteolysis of the extracellular matrix and are cараble of regulating the cellular activity (Page 9, line 1-20). Further, Blum teaches that proteins of the core matrisome, GAGs, ECM regulators and ECM-affiliated proteins are sources of bioactive fragments (Figure S1), that collagens and proteoglycans, elastin and laminins are major sources of the bioactive peptides and that matricellular proteins, e.g. secreted protein acidic and rich in cysteine (SPARC), osteopontin are additional sources of bioactive fragments (Page 459, 2nd paragraph). It would have been obvious to modify Montanari to include the fragments taught by Blum since Blum suggests drugs that comprise other bioactive fragments to improve efficacy (Page 461, left col., 4th paragraph). Montanari further teaches that the matrikines promote the cellular proliferation of keratinocytes and fibroblasts and are consequently effective in the reconstruction of the extracellular dermal matrix (Page 10 , line 1-4) and that the composition for stimulating the cellular reproduction of the connective tissue and relative production of collagen fiber suitable for restoring the damaged tissue (Page 8, line 12-15).
Regarding claim 36, the instant composition is rendered obvious by the teachings of Montanari, Lintner and Blum. Examiner notes that Blum teaches the instant peptide fragments and compositions comprising the fragments. Blum teaches the fragments for use in treating scarring (Page 460, left col., last paragraph; Table 2, Page 461, left col., 4th paragraph). It would have been obvious to combine the teachings of the cited references and use the composition to treat scarring. Examiner further notes the limitations of claim 36 recite an intended use and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art composition contains the same active ingredient and is in the same form as the claimed composition, and as a result, is capable of performing the claimed intended use (see MPEP § 2112.01).
Regarding claim 37, Montanari teaches that the peptides are derived from the alpha 2 chain of collagen I and that the peptide fragments have shown an increase in the synthesis of collagen and glycosaminoglycans (Page 10, line 5-10). Further, Blum teaches fragments comprise heparan sulphate proteoglycan and growth factor receptors (Page 460, right col.,2nd paragraph), Collagen VI α3 chain, Tenascin-C, ECM regulators (MMPs, a disintegrin and metalloproteinases, ADAMs, cross-linking enzymes) and ECM-affiliated proteins (e.g. mucins, galectins, semaphorins), Bone Morphogenetic Protein-1, BMP-1, laminin, hyaluronan binding complex (Table 1; Table 2; Page 457, right col.,1st and 2nd paragraph; Page 459, left col., 1st paragraph, Page 459, left col., last paragraph). It would have been obvious to modify Montanari to include the fragments taught by Blum since Blum suggests drugs that comprise other bioactive fragments to improve efficacy (Page 461, left col., 4th paragraph).
Regarding claims 38-39, Montanari renders obvious the instant composition. Montanari does not teach the pH. However, Litner teaches the instant composition and teaches a topical composition comprising between about 0.00001% and about 0.5% w/w of at least one rigin-based tetrapeptide and about 0.00001% and about 1.0% w/w of at least one GHK-tripeptide (claim 1) and further comprising dermatologically acceptable carrier (claim 11). Lintner teaches the composition with a pH of about 6 [0303, 0312, 0036]. Examiner is interpreting this teaching to mean that the pH includes a pH of slightly below 6 and would thus read on the claim. Additionally, it is known in the art to formulate cosmetic composition at pH slightly below the pH 6 as taught by Wiecher. Wiecher teaches that the pH of the skin is 5.5 and that growth of microorganisms such as Staphylococcus aureaus slows down at pH of 5.5 (Page 5, 3rd paragraph, line 1-5). Wiechers recommends formulating cosmetic compositions at a pH of 5 and teaches that the formulations were more stable with enhanced permeability to the skin and that preservation of the composition was obtained with composition with low pH (Page 6-7). It would have been obvious to modify the teachings of Montanari and formulate the composition at a slightly acidic pH such as below 6, since Litner teaches a composition of about 6 and Wiechers teaches that cosmetic composition should be at around 5 since the pH of skin is around 5.5 and a slightly acidic composition enhances penetration of the composition to the skin. Examiner further adds that the limitations of claims 38-39 recite an expected result of the claimed composition. MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the composition and is given little patentable weight.
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 04/15/2026, with respect to the rejection(s) of claim(s) 1-7, 9, 13-20 and 35-37 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 Wiecher et al.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 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, Lianko G. Garyu can be reached at (571)270-7367. 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.
/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
Prosecution Insights