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 .
Status of the Claims
Claims 1-12 are examined herein.
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.
Claims 1-12 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, 6, and 11 recite a composition for diagnosing skin aging, a kit for diagnosing skin aging, and a method for screening a composition for improving skin aging.
The specification discloses that mRNA levels for ORIJ2, ORIJ4, OR1L3, OR1Q1, OR2AG2, OR2C1 and OR52N4 biomarkers expressed in Hs68 cell line increase with the number of the cell culture passages (Fig. 7). Applicant discloses other biomarkers known in the art of skin aging with similar trend: beta-galactosidase and p16 (Figs 2-3 and pg. 23-24). Based on this similarity, Applicant treats ORIJ2, ORIJ4, OR1L3, OR1Q1, OR2AG2, OR2C1 and OR52N4 biomarkers as biomarkers of skin aging (Example 2. Culturing of dermal fibroblasts and construction of aging model).
The specification does not disclose direct evidence supporting the olfactory receptors as biomarkers of skin aging. The aging phenomena recited in claim 2: fine wrinkles, hyperpigmentation, loss of skin elasticity and moisture deficiency do not have data support in the specification as related to the olfactory receptor biomarkers. Predicting the degree of skin aging recited in claim 3 also lacks data support in the specification.
Prior art teaching ORIJ2, ORIJ4, OR1L3, OR1Q1, OR2AG2, OR2C1 and OR52N4 biomarkers is very limited. Specifically, the prior art is silent on these biomarkers being biomarkers of skin aging. Therefore, the specification is required to provide more evidence linking the biomarkers to skin aging than that presented in Fig. 7 which is based only on one time point experiment (young vs old cell cultures).
The art of biomarkers is highly unpredictable. Therefore, without evidence showing correlation of the biomarkers with skin aging at multiple age points, one of ordinary skill in the art cannot reasonably expect ORIJ2, ORIJ4, OR1L3, OR1Q1, OR2AG2, OR2C1 and OR52N4 to be biomarkers of skin aging.
The specification fails to disclose evidence for diagnosing skin aging, predicting the degree of skin aging or improving skin aging. As such, claims 2 and 3 lack support in the specification related to specific aging phenomena and predicting the degree of skin aging. Claims 6-7 lack support in the specification for use in diagnosing skin aging.
Additionally, a correlation between a biomarker and skin aging usually mean that the level of the biomarker changes with skin aging. The reverse conclusion is not necessarily true. Changes in a biomarker level in response to a candidate substance are not necessarily related to skin aging. For example, Fig. 7 discloses increase of mRNA levels of the olfactory receptor biomarkers. A candidate substance added to Hs68 culture could decrease overall level of mRNA transcription leading to a false conclusion that this candidate substance improves skin aging. The specification fails to disclose a mechanism leading to skin aging when mRNA levels of the olfactory receptor biomarkers change in response to external factors. The prior art is silent on any such mechanism.
As such, claims 11-12 lack data support that the claimed biomarker levels can be used for screening compositions for improving skin aging.
The teachings of the instant specification are insufficient to establish possession of evidence for using the claimed biomarkers for diagnosing skin aging, predicting the degree of skin aging or improving skin aging.
Additionally, claim 1 recites a composition comprising an agent.
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc) (MPEP §2163.03.V).
“[T]he disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." (MPEP § 2163.II.A).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.") (MPEP § 2163).
In the instant case, claim 1 is directed to any composition and any agent for measuring the expression level of the claimed biomarkers.
The specification discloses only primers for RT-PCR (Table 2) as agents used to measure mRNA levels. No data for compositions relying on a DNA chip, an ELISA, a protein chip, a rapid kit or an MRM (multiple reaction monitoring) is disclosed. The reported changes in mRNA levels do not necessarily cause changes in protein levels and they certainly cannot change DNA levels to be detected by DNA chips. No antibodies or aptamers are disclosed (claim 5).
The teachings of the instant specification are insufficient to establish possession of the breadth of agents for measuring the expression level or protein level of the claimed biomarkers. Therefore, claims 1-12 are rejected under 35 U.S.C. 112(a).
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 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.
Claims 1 and 4-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duroux et al. (IDS; Molecules. 2020 Oct 16;25(20):4743).
Regarding claims 1 and 4-9, Duroux teaches “A Rose Extract Protects the Skin against Stress Mediators: A Potential Role of Olfactory Receptors” (Title). Specifically, the reference teaches identification of a new olfactory receptor OR2AG2 in skin (Abstract). OR2AG2 mRNA was detected using RT-PCR (pg. 2, last par.) meeting the limitations of claim 4 reciting the agent for measuring the expression of the gene is a primer that specifically binds to the nucleic acid molecule of the gene, claims 6-7 reciting the kit is an RT-PCR (reverse polymerase chain reaction) kit, and claim 8 reciting a method comprising a step of measuring the expression level of OR2AG2.
Additionally, the reference teaches detection of OR2AG2 protein using staining with anti-OR2AG2 primary antibodies (pg. 11, par. 2) meeting the limitation of claim 5 reciting the agent for measuring the amount of expression of the protein is an antibody.
Regarding claim 9, Duroux teaches biological samples of microdissected human skin and NHEKs cells isolated from human skin epidermis (pg. 10, section 4.3, par. 2-3) meeting the limitation of claim 9 reciting the biological sample comprises skin tissues or skin tissue-derived cells.
Subject Matter Free of the Prior Art
Claims 2-3 and 10-12 are free of the prior art.
The prior art neither teaches nor suggests:
a composition for diagnosing skin aging, comprising an agent selected from group consisting of OR1J2, OR1J4, OR1L3, OR1Q1, OR2AG2, OR2C1 and OR52N4, wherein the skin aging comprises one or more aging phenomena selected from a group consisting of fine wrinkles, hyperpigmentation, loss of skin elasticity and moisture deficiency; and wherein the composition is a composition for predicting the degree of skin aging;
a method of claim 10, wherein the skin tissue-derived cells are dermal fibroblasts;
a method for screening a composition for improving skin aging (claims 11-12).
The closest prior art:
Duroux et al. (IDS; Molecules. 2020 Oct 16;25(20):4743) fail to teach specific skin conditions, dermal fibroblasts, and the screening method;
Son et al. (IDS; Int J Mol Sci. 2021 Aug 27;22(17):9273) teach dermal fibroblasts, but fail to teach agents OR1J2, OR1J4, OR1L3, OR1Q1, OR2AG2, OR2C1 or OR52N4, and the screening method;
Mur et al. (Journal of Investigative Dermatology, 142S72; Sept. 2022) teach OR2AT4 but fail to teach specific skin conditions, dermal fibroblasts, and the screening method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
