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 .
Claim Status
Claims 1-11 are pending under examination.
Priority
The instant application is the 371 national stage entry of PCT/KR2022/014392, filed 9/27/2022, which claims priority to KR10-2021-0129258, filed 9/29/2021. The priority date of 9/29/2021 is acknowledged although it is noted that no translation has been made of record.
Information Disclosure Statement
The information disclosure statement filed on 3/29/2024 is under consideration; any strikethrough is owed to lack of a translation in the file wrapper.
The information disclosure statement filed on 1/29/2025 and 4/2/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Drawings
The drawings are objected to because Figures 1A, 1B, 1C, 2, 3A, 3B, 3C, 4A, 4B, 5A, 5C, 6B, 7A, 7B, 7C are illegible; for instance, see Figure 1A, below:
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specifically, the file size must be listed in bytes rather than kilobtyes.
Claim Interpretation
Claim 1 recites a peptide comprising an amino acid sequence of SEQ ID NO: 1. The limitation “an amino acid” is being interpreted as a peptide comprising or consisting of the entirety of the sequence of SEQ ID NO: 1 or any fragment thereof, as is supported by instant [0042].
Claims 2, 4, 7, and 8 each recite functional characteristics of the peptide comprising an amino acid sequence of SEQ ID NO: 1 rather than structural limitations. As such, the claim is being interpreted based upon the structural limitation (a peptide… comprising an amino acid sequence SEQ ID NO: 1), where the functional limitation is a property endowed by the structure.
Claim 3 recites the limitation “A composition for skin aging inhibition or skin regeneration”; claim 9 recites, “A cosmetic composition for skin aging inhibition or skin regeneration”; and claim 11 recites “A pharmaceutical composition for preventing or treating photoaging” (emphasis added). These limitations are being interpreted as intended uses.
Claim Rejections - 35 USC § 112
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.
First rejection – written description
Claims 2-11 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.
The claims are drawn to a peptide, as well as compositions thereof, comprising an amino acid sequence of SEQ ID NO: 1, wherein an amino acid of SEQ ID NO: 1 is being interpreted as comprising or consisting of the full-length sequence of SEQ ID NO: 1 or any smaller fragment derived therefrom, as is consistent with the instant specification [0042] (also see Claim Interpretation section above). Thus, effectively, the claims are drawn to a genus of peptides consisting of fragments as small as dipeptides that can be found within or derived from SEQ ID NO: 1 as well as larger fragments and peptides comprising SEQ ID NO: 1.
The claims are further drawn to the functionality of said peptides, wherein the peptides should impart or cause skin aging inhibition activity or skin regeneration activity (claims 2 and 3); improve resistance to damage to cells caused by aging or external stimulus (claims 4-6); increase expression or secretion of collagen, fibronectin, elastin, or hyaluronic acid and increase expression of SIRT1 or AQP3 (claim 7); inhibit production of ROS, increase the expression of collagen, fibronectin, or elastin decreased by UV rays, and inhibit expression of MMP-1 increased by UV rays (claim 8); and prevent or reduce skin wrinkles, improve skin elasticity, strengthen skin barrier, prevent pigmentation, or ameliorate skin photoaging (claims 10 and 11). However, the core structure or the residue(s) of SEQ ID NO: 1 that mediate these functionalities is unknown and untested in the instant application. Without any additional positional information (i.e., where certain residues should be preserved), it would be extremely difficult for one skilled in the art to be able to derive an amino acid sequence from SEQ ID NO: 1 that would retain said functionalities.
Kelly et al. (US 20060058228, published 3/16/2006) discuss a phage display screen to identify peptides that distinguish between well-differentiated (HCT116) and poorly-differentiated (HT29) colon cancer cell lines. Analysis of the selected library resulted in the identification of a nine amino acid, disulfide-constrained peptide having a three amino acid (arg-pro-met, “RPM”) motif that specifically binds HT29 cells ([0032]). Substituting each of RPM with alanine significantly limited or abolished the ability of the peptide to compete with wild type RPM in a binding assay, indicating that these three residues alone accounted for the ability to bind to HT29 cells ([0034]). In contrast to this example, it is unknown which residues of SEQ ID NO: 1 must be preserved to retain the skin aging inhibition or skin regeneration activity functionalities described. Thus, one skilled in the art cannot extrapolate an amino acid sequence of SEQ ID NO: 1 that would similarly result in the same functional outcomes.
Consequently, it is unknown whether all variants encompassed within “an amino acid sequence of SEQ ID NO: 1” would retain the structural, chemical, and/or physical properties required to facilitate skin aging inhibition or skin regeneration activity. Therefore, the instant specification does not provide adequate written description to possess the broad genus described above since the specification does not disclose a correlation between the necessary structure of the sequence and the claimed function to be maintained.
Second rejection – scope of enablement
Claims 10 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating photoaging, does not reasonably provide enablement for the prevention of photoaging. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
1) Nature of the invention, 5) breadth of the claims, and 7) the presence or absence of
working examples: The claims are drawn to a composition for preventing or treating photoaging, wherein the composition comprises SEQ ID NO: 1. The instant specification defines “prevention” as any action that inhibits or delays the occurrences, spread, and recurrence of photoaging by the peptide of the present invention or a composition containing the same (see instant [0088]). Prevention, as claimed, reads on administering a composition comprising SEQ ID NO: 1 to any individual with or without photoaging, as prevention does not require a subject in need to have photoaging. Thus, at its broadest interpretation, prevention reads on a composition to be used before photoaging has started.
The instant specification teaches that the peptide SEQ ID NO: 1 can reduce or treat several molecular signs of aging in in vitro cell cultures, including increasing the expression of ECM components by upregulating transcripts of collagen, fibronectin, and elastin; decreases in ROS generated upon UV exposure; increased inhibition of MMP-1; and increasing expression of genes that contribute to skin barrier function (Experimental Examples 2-1 through 2-4, corresponding to Figures 4A-7C). However, pretreatment of cells with a composition comprising SEQ ID NO: 1 for an hour prior to exposure to UV radiation still resulted in molecular photoaging, particularly in HaCaT cell assays. In other words, pretreatment with SEQ ID NO: 1 cannot prevent molecular photoaging, it can only reduce some of the damage.
2) State of the prior art and 4) predictability or unpredictability of the art: The state of the art at the time of filing recognized several molecular components to photoaging. Poon et al. teaches that UV radiation can generate reactive oxygen species (ROS), which leads to activation of several downstream signaling pathways that cause DNA damage and degradation of procollagen, the precursor to collagen that constitutes most of the skin’s structural integrity (see Pg 66, “Mechanisms of Photoaging” left and right columns of Poon et al., (2015), Mechanisms and treatments of photoaging. Photodermatol. Photoimmunol. Photomed., 31: 65-74.). More specifically, increased ROS leads to DNA damage, and MMP expression increases to degrade procollagen (Figure 1).
Per Poon, photoprevention is a key primary preventative strategy in photoaging. Good protective measures include a combination of wearing sun protective clothing, appropriate sunscreen application, and sun avoidance during peak UV hours (Pg 69, left column, “Photoprotection,” first paragraph). Poon also discusses some treatment options for photoaging, including topical retinoids and 5-fluorocuracil cream as well as certain cosmeceuticals (Pg 69, left column, “Topical retinoids” – Pg 71, right column, “Ginseng”), but no therapeutics for the prevention of photoaging.
Based on the information provided in the instant specification as well as the teachings of the prior art, one skilled in the art would reasonably predict that a pharmaceutical composition comprising SEQ ID NO: 1 would not prevent photoaging.
3) The relative skill of those in the art: The relative skill of those in the art is high.
6) The amount of direction or guidance presented: At the time of filing, neither the prior
art nor the instant specification offered any examples wherein a therapeutic substance is administered as a means to prevent photoaging.
8) The quantity of experimentation necessary: As there are no working examples in
either the instant specification nor the prior art, reasonable guidance with respect to preventing photoaging by administering a pharmaceutical composition comprising SEQ ID NO: 1 was limited. Consequently, one skilled in the art would be burdened with undue experimentation to determine the parameters and conditions necessary to effectively prevent photoaging.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for the prevention of photoaging.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to a peptide, which is a composition of matter.
Regarding 2a), the peptide claimed is a product of nature. The claims are drawn to a peptide, as well as compositions thereof, comprising an amino acid sequence of SEQ ID NO: 1, wherein an amino acid of SEQ ID NO: 1 is being interpreted as comprising or consisting of the full-length sequence of SEQ ID NO: 1 or any smaller fragment derived therefrom, as is consistent with the instant specification [0042] (also see Claim Interpretation section above). The fragment CACCLHNCNECQ reads on platelet-derived growth factor C from many different species/organisms, such as:
UniProt ID H9FBJ5_MACMU
UniProt ID A0A1A6GNB1_NEOLE
UniProt ID A0A7J8BUN5_ROUAE
UniProt ID A0A8J6AM58_GALPY
Others not listed here
Regarding 2b), there is nothing significantly more recited in the claims that would distinguish the fragment claimed from the above described naturally-occurring peptides; in particular, claims 2, 4, 7, and 8 merely recite properties of an amino acid sequence of SEQ ID NO: 1 endowed by their structure, and claims 3, 9, and 11 recite intended uses for a composition comprising an amino acid sequence of SEQ ID NO: 1. As such, the claims do not contain elements added to the judicial exception to render the claims significantly more than the exception.
In sum, the claims are drawn to patent ineligible subject matter and are rejected here.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Du et al. (Effects of autologous platelet-rich plasma injections on facial skin rejuvenation. Exp Ther Med. 2020 Apr;19(4):3024-3030.), as evidenced by Fang et al. (Fang et al. PDGF C Is A Selective α Platelet-Derived Growth Factor Receptor Agonist That Is Highly Expressed in Platelet α Granules and Vascular Smooth Muscle. Arteriosclerosis, Thrombosis, and Vascular Biology. 2004. 787-792.) and Frade et al. (Prolonged viability of human organotypic skin explant in culture method (hOSEC). An Bras Dermatol. 2015 May-Jun;90(3):347-50.).
Regarding claim 1, Du teaches autologous serum platelet-rich plasma (PRP) has been used to rejuvenate wrinkled and aged skin for years. As evidenced by Fang, PDGF-C is highly expressed in platelets (Pg 790, “PDGF C mRNA and its protein is highly expressed in platelets,” Figure 4). Thus, the fragment CACCLHNCNECQ, derived from SEQ ID NO: 1, which reads on PDGF-C as described above, is highly expressed in PRP.
Regarding claims 2 and 4, Du describes how the PRP injections decrease pigmentation, increase the density of collagen, and improve skin pores, wrinkles, and spots (skin aging inhibition activity/skin regeneration activity; Figures 1-3; Table 1; Pg 3026, right column, first paragraph – Pg 3027, left column, first paragraph).
Regarding claim 3, 9, and 11, Du describes treating participants in of the study with PRP
injections over the course of one month, which reads on a composition comprising a fragment of the instant SEQ ID NO: 1 (Abstract; Pg 3026, left column, “Changes in skin biophysical parameters and skin appearance”, first paragraph).
Regarding claim 5, Du teaches PRP can protect hOSEC (organotypic human skin model) from UV damage (Pg 3027, left column, “PRP protects skin against photoaging caused by UV light” – Pg 3028, left column, first paragraph; Figure 4).
Regarding claim 6, as evidenced by Frade, hOSEC comprises both keratinocytes and dermal fibroblasts in addition to other types of normal skin cells (Pg 350, “Discussion,” second paragraph).
Regarding claim 7, as stated above, Du teaches PRP increases the expression and density of collagen (Figures 1-3; Table 1; Pg 3026, right column, first paragraph – Pg 3027, left column, first paragraph). Du further teaches PRP inhibits UV-induced skin photoaging by restoring the expression of fibrillin and tropoeleastin (elastin; Pg 3028, left column, “PRP inhibits UVB-induced MMP-1 and tyrosinase upregulation to protect skin against photoaging”; Figure 5).
Regarding claim 8, as stated above, Du teaches PRP inhibits UV-induced skin photoaging by restoring the expression of fibrillin and tropoelastin (elastin) inhibiting UV-induced MMP-1 to protect against photoaging (Pg 3028-3029, left column, “PRP inhibits UVB-induced MMP-1 and tyrosinase upregulation to protect skin against photoaging”; Figure 5).
Regarding claim 10, as stated above, Du teaches PRP results in the reduction of skin wrinkles and amelioration of skin photoaging (Figures 1-3; Table 1; Pg 3026, right column, first paragraph – Pg 3027, left column, first paragraph). Du also teaches that PRP induced the expression of fibrillin and tropoelastin, which have been reported to improve skin elasticity (Pg 3029, left column, “Discussion,” third paragraph).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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