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
The instant application claims priority to 371 National Stage Application PCT/KR2022/014390, filed September 27th, 2022, and foreign application KR10-2021-0129257, filed September 29th, 2021. under 35 U.S.C. 119(a)-(d). The priority date of September 29th, 2021 is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims Status
The claims listing filed on March 29th, 2024 is pending. Claims 1-11 are being examined on the merits.
Claim Interpretation
The indefinite article “an” prior to “amino acids sequence of SEQ ID NO: 1” causes the broadest reasonable interpretation of claim 1 to include peptides comprising full-length SEQ ID NO:1 and peptides comprising fragments of SEQ ID NO: 1. The following 102 rejection is based on this. To overcome this, the applicant may change the “an” to “the.”
Claim Rejections - 35 USC § 112
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. While the applicant does have support the peptide consisting of SEQ ID NO: 1 reduced in practice, they do not have support all peptides comprising the sequence of SEQ ID NO: 1 and peptides comprising an amino acid sequence of SEQ ID NO: 1.
Claim 2 recites “comprising an amino acid sequence of SEQ ID NO: 1.” with “skin aging inhibition activity or skin regeneration activity” However, the specification does not support that the inventors possess the complete recited genus and that the complete genus has for skin aging or skin regeneration activity.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus [MPEP 2163 ii)].
The broadest reasonable interpretation of the claim includes long sequences comprising SEQ ID NO: 1 and peptides comprising fragments of SEQ ID NO: 1 (see claim interpretation) with skin aging or skin regeneration activity. Only those sequences meeting the structural and functional requirements of the genus are encompassed by the claim. Therefore, the claim encompasses all of the sequences meeting the structural requirements that also have skin aging inhibition activity or skin regeneration activity.
The inventors provide support by demonstrating that the expression of collagen, fibronectin and elastin genes in NIH3T3 cells and skin barrier genes in HaCaT cells increased when treated with a peptide containing SEQ ID NO: 1 [00105-00116]. The inventors also showed reactive oxygen species and collal and fibronectin expression levels were restored by a peptide consisting of SEQ ID NO: 1 after being decreased by UV irradiation [00120-00130]. However, only the sequence of SEQ ID NO:1 is revealed and the SEQ ID NO: 1 reduced to practice by the applicant is not representative of the entire genus of peptides comprising the sequence of SEQ ID NO: 1 and peptides comprising an amino acid sequence of SEQ ID NO: 1 claimed. Nor, would one of ordinary skill in the art be able to attest to the complete genus’s ability to inhibit skin aging and regenerate skin. There is a high level of unpredictability and complexity associated with how the primary amino acid sequence of a peptide influences its 3-dimensional structure and thereafter its functional capabilities. Thus, while the applicant has support for the specific peptide consisting of SEQ ID NO: 1 reduced to practice, they do not have support for the complete genus of variants of comprising the sequence of SEQ ID NO: 1 and peptides comprising an amino acid sequence of SEQ ID NO: 1.
Claims 3-19 do not further limit the sequence of a peptide comprising an amino acid sequence of SEQ ID NO: 1 are therefore not supported by the written description requirement.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN113398004A; published 2021-09-17).
The following rejection is based on the claim interpretation due to the indefinite article “an” (see claim interpretation).
Li et al. provide a salamander peptide-hyaluronic acid mixture that has the technical effects of improving the survival rate of human skin fibroblasts, increasing the content of collagen in the skin and increasing the water content of the stratum corneum of the skin [Summary of the Invention pgh 1]. Of these peptides, salamander active peptide B or SEQ ID NO: 2 comprises of DSS, an amino acid sequence of instant SEQ ID NO: 1 [pg 7 pgh 8 line 6]. Thus, Li et al. anticipates a peptide comprising an amino acid sequence of SEQ ID NO: 1.
Regarding claim 2, Li et al. tested the effect of the salamander peptide group in a skin aging model caused by D-galactose [pg 8]. The collagen content of the giant salamander peptide group was 66±8.7%, compared to the model group of 53.6±4.4%, indicating that Li et al.’s peptides have skin aging inhibition activity.
Regarding claim 3, Li et al. provide a salamander peptide-hyaluronic acid mixture that has the technical effects of improving the survival rate of human skin fibroblasts, increasing the content of collagen in the skin and increasing the water content of the stratum corneum of the skin [Summary of the Invention pgh 1]. Of these peptides, salamander active peptide B or SEQ ID NO: 2 comprises of DSS, an amino acid sequence of instant SEQ ID NO: 1 [pg 7 pgh 8 line 6]. Thus, Li et al. anticipates a composition for skin aging inhibition or skin regeneration activity.
Regarding claims 4-6, Li et al. explore the preventive and repairing effects of salamander peptide-hyaluronic acid mixture on human fibroblast injury induced by ultraviolet (UVB) irradiation [pg 9 pgh 1]. They found that after adding the salamander peptide-hyaluronic acid mixture, the survival rate of fibroblasts after UVB irradiation improved [pg 9 pgh 10]. Therefore, Li et al. anticipates a composition that improves the resistance to fibroblast cells to ultraviolet rays.
Regarding claim 7, Li et al. tested the effect of the giant salamander peptide-hyaluronic acid mixture group in a skin aging model caused by D-galactose [pg 8]. The collagen content of giant salamander peptide-hyaluronic acid mixture group was 79.8±4.7% compared to the model group of 53.6±4.4%, indicating that Li et al.’s composition comprising giant salamander peptides as the active ingredient increase the secretion of collagen.
Regarding claim 8, Li et al. tested the effect of the giant salamander peptide-hyaluronic acid mixture group in a skin aging model caused by D-galactose [pg 8]. The collagen content of giant salamander peptide-hyaluronic acid mixture group was 79.8±4.7% compared to the model group of 53.6±4.4%, indicating that Li et al.’s composition comprising giant salamander peptides as the active ingredient increase the secretion of collagen. Li et al. also explored the preventive and repairing effects of salamander peptide-hyaluronic acid mixture on human fibroblast injury induced by ultraviolet (UVB) irradiation [pg 9 pgh 1]. They found that after adding the salamander peptide-hyaluronic acid mixture, the survival rate of fibroblasts after UVB irradiation improved [pg 9 pgh 10]. Therefore, Li et al. anticipates a composition that protects cells from ultraviolet rays by increasing the expression of collagen.
Regarding claim 9, Li et al. tested the effect of the giant salamander peptide-hyaluronic acid mixture group in a skin aging model caused by D-galactose [pg 8]. The collagen content of giant salamander peptide-hyaluronic acid mixture group was 79.8±4.7% compared to the model group of 53.6±4.4%, indicating that Li et al.’s composition comprising giant salamander peptides as the active ingredient is used ion a composition for skin aging inhibition.
Regarding claim 10, Li et al state that the salamander peptide-hyaluronic acid mixture provided by the invention can effectively promote the synthesis of collagen in the dermis tissue, improve the activity of human skin fibroblasts under the condition of ultraviolet irradiation, and increase the content of moisture and oil in the skin, thereby achieving the technical effect of anti-wrinkle [pg 6 pgh 5]. Therefore, Li et al. anticipates the composition for preventing wrinkles.
Regarding claim 11, Li et al state that the salamander peptide-hyaluronic acid mixture provided by the invention can effectively promote the synthesis of collagen in the dermis tissue, improve the activity of human skin fibroblasts under the condition of ultraviolet irradiation, and increase the content of moisture and oil in the skin, thereby achieving the technical effect of anti-wrinkle [pg 6 pgh 5]. Therefore, Li et al. anticipates the composition for treating photoaging due to ultraviolet irradiation.
Conclusion
Claims 2-11 are rejected under 35 U.S.C. 112(a). Claims 1-11 are rejected under 35 U.S.C. 102.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: A peptide consisting of the amino acid sequence of SEQ ID NO: 1 is allowable.
The closest prior art is A0A4Z1FBL6. A0A4Z1FBL6 is the DH domain-containing protein in the Botrytis paeoniae organism, strain Bp0003. Instant SEQ ID NO: 1 has an 86.7% query match with residues 228 to 239 of A0A4Z1FBL6, with a mismatch at two residues. However, there exists no motivation to use a DH domain-containing protein or Botrytis paeoniae for skin regeneration or skin aging inhibition, nor is the region of the amino acid sequence in which the residues of SEQ ID NO: 1 are known for any significant activity.
There are no other publications or prior art that would suggest to one of ordinary skill in the art that SEQ ID NO: 1 has skin aging inhibition or skin regeneration activity. Thus, the peptide consisting of SEQ ID NO: 1 supported by the specification is allowable over the prior art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko 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.
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/SACHI JAUHARI/Examiner, Art Unit 1654
/CHRISTINA M MARCHETTI BRADLEY/Primary Examiner, Art Unit 1654
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