CTNF 18/031,349 CTNF 83913 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. Claims 1-8 are pending in the application. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I, claims 1-3 in the reply filed on August 18, 2025 is acknowledged. 08-06 AIA Claim s 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 18, 2025 . Priority This application is a National Stage Entry for PCT/KR2021/014055 filed October 12, 2021, which claims benefit to Republic of Korea Foreign Application No. 10-2020-0131716 Filed October 13, 2020. Information Disclosure Statement Receipt of Information Disclosure Statement filed April 12, 2023 is acknowledged. Sequence Listing The sequence listing submitted April 12, 2023 has been accepted. Claim Rejections - 35 USC § 112 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. Claims 1-3 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention because the specification does not provide evidence that the claimed biological material are (1) known and readily available to the public; (2) reproducible from the written description. The claims are directed to at least one strain selected from the group consisting of a Lactobacillus plantarum subsp. shebah-202 (accession number: KCTC14087BP) strain, a Lactobacillus fermentum subsp. shebah-101 (accession number: KCTC14086BP) strain, and a Lactobacillus paraplantarum subsp. shebah-401 (accession number: KCTC14088BP) strain, which are skin-derived Lactobacillus sp. strains, a culture thereof, a lysate thereof or an extract thereof. The specification indicates that strains were deposited with the Korean Collection for Type Cultures (KCTC) on December 20, 2019 under the above stated accession numbers. There is no indication that the deposit was made under the Budapest Treaty. Under the Budapest Treaty, there is a requirement that the deposit be tested for viability before it is accepted. Thus, a mere statement by an applicant, an authorized representative of applicant or the assignee that the deposit has been accepted under the Budapest Treaty would satisfy 37 CFR 1.807. However, Applicant has not provided evidence that the Deposit has been "made and accepted” under the Budapest Treaty. The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b), that all restrictions on the accessibility be irrevocably removed by the by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990). Applicant has not provided clear evidence that the Deposit has been "made and accepted" under the Budapest Treaty. Thus, the subject matter was not described in the specification in such a way to enable one skilled in the art to make and use the invention without undue experimentation. If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit of the Lactobacillus plantarum subsp. shebah-202 (accession number: KCTC14087BP) strain, the Lactobacillus fermentum subsp. shebah-101 (accession number: KCTC14086BP) strain, and the Lactobacillus paraplantarum subsp. shebah-401 (accession number: KCTC14088BP) strain has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposit complies with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request: (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application: (c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit. 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 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. Claim 1 recites a Lactobacillus plantarum subsp. shebah-202 (accession number: KCTC14087BP) strain, a Lactobacillus fermentum subsp. shebah-101 (accession number: KCTC14086BP) strain, and a Lactobacillus paraplantarum subsp. shebah-401 (accession number: KCTC14088BP) strain. The use of parentheses renders the claims indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. It is recommended that the bacterium be identified as “a Lactobacillus plantarum subsp. shebah-202 strain, deposited as accession number: KCTC14087BP, a Lactobacillus fermentum subsp. shebah-101 strain, deposited as accession number: KCTC14086BP, and a Lactobacillus paraplantarum subsp. shebah-401 strain, deposited as accession number: KCTC14088BP”. Claims 2 and 3 are dependent from claim 1 and are thus, also rejected. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a Lactobacillus plantarum subsp. shebah-202 (accession number: KCTC14087BP) strain, a Lactobacillus fermentum subsp. shebah-101 (accession number: KCTC14086BP) strain, and a Lactobacillus paraplantarum subsp. shebah-401 (accession number: KCTC14088BP) strain as an antioxidant, anti-inflammatory or whitening functional cosmetic composition. Claim 2 is directed to the intended use of the Lactobacillus stains claimed. This judicial exception is not integrated into a practical application because the Lactobacillus plantarum subsp. shebah-202 strain, a Lactobacillus fermentum subsp. shebah-101 strain, and a Lactobacillus paraplantarum subsp. shebah-401 strain are natural products. Review of the original disclosure indicates that the Lactobacillus plantarum subsp. shebah-202 (accession number: KCTC14087BP) strain, Lactobacillus fermentum subsp. shebah-101 (accession number: KCTC14086BP) strain, and Lactobacillus paraplantarum subsp. shebah-401 (accession number: KCTC14088BP) strain were deposited on December 20, 2019 at the Korean Collection for Type Cultures (KCTC) under the above stated accession numbers. See page 38, paragraphs [00141]-[00152]- page 39, paragraph [00154]. The original specification indicates that under the consent of 30 subjects living in Chuncheon, Korea, skin surface microorganisms on both facial cheeks, foreheads, and palms were swabbed at constant temperature and humidity. Each seabed sample was streaked on a solid agar palate until single colonies appeared. Next, 50 individual single colonies were collected and then streaked and subcultured on de Man, Rofosa and Sharpe (MSR) agar plates to increase the growth activities of the strains. The single colonies cultured were isolated, and the 16s RNA sequences of the isolated strains were analyzed. See page 25-26, paragraph [0074]. This leads to the conclusion that the composition, as claimed, comes from nature. In addition, it is known in the art that other strains of Lactobacillus exist in nature. This is evidenced by the Lee Publication (Lee et al., J. Microbiol. Biotechnol., 2015). Lee et al. disclose Lactobacillus plantarum HY7714 improves skin hydration and has anti-photoaging effects (Abstract). Lee et al. teach HY7714 was isolated from breast milk of healthy women (page 2161, col. 1, Materials and Methods, Dietary Supplements paragraph 1). This is further evidenced by the Klayraung Publication (Klayraung et al., Brazilian Journal of Microbiology, 2009). Klayraung et al. disclose that miang is a kind of traditional fermented tea leaves, widely consumed in northern Thailand as a snack. It contains several kinds of Lactobacilli spp. The study isolated strains of Lactobacillus fermentum from miang and investigate their antibacterial and antioxidant activities (Abstract). Klayraung et al. disclose samples of miang were collected from local markets in Chiang Mia area, Thailand. Appropriately diluted samples with saline solution were plated onto MSR agar and incubated under anaerobic condition. Based on the phenotypic characteristics isolates of lactobacilli were collected (page 758, col. 2, Materials and Method, Isolation of Lactobacillus strains, paragraph 1). The antioxidant activity of L. fermentum FTL2311 and L. fermentum FTL10BR was investigate (page 760, col. 1, Determination of antioxidant activity of L. fermentum ). Klayraung et al. disclose twenty four strains of Lactobacillus sp. were isolated from miang (page 760, col. 2, Results and Discussions). Regarding instant claim 2, Klayraung et al. disclose that the antioxidant activity of L. fermentum strains was determined by FRAP and ABTS methods with respect to reducing power and free radical scavenging activity and were expressed as EC and TEAC values, respectively. Results shown in Figure 2 indicated that the strains of L. fermentum FTL2311 and L. fermentum FTL10BR possessed antioxidant activity of both mechanisms but at different levels (763, col. 1, Antioxidant activity of L. fermentum ). Providing further evidence, the Cha Publication (Cha et al., Anaerobe, Cha et al., 2020) discloses Cutibacterium acnes is the main bacterium targeted for the prevention and medical treatment of acne vulgaris. Lactic acid bacteria (LAB) are a group of microorganisms classified by their ability to produce lactic acid through fermentation. Although the activities of LAB have been studied, their potential anti-acne effects are not well known. Here, Lactobacillus paraplantarum THG-T10, which has antibacterial activity against C. acnes , was isolated from traditional Kimchi in Republic of Korea (Abstract). Cha et al. disclose kimchi is the most famous Korean traditional food made with pepper, garlic, ginger, and fermented fish sauce as seasoning in cabbage. Cha et al. disclose that LAB were isolated from Kimchi in Republic of Korea. To isolate Lactobacillus spp., a 1-ml sample was diluted and spread onto Bromocresol purple agar (page 2, col. 1, 2. Material and method, 2.1 Isolation and identification of lactic acid bacteria). Regarding the intended use of claim 2, Cha et al. disclose anti-inflammatory activity was evaluated by a nitric oxide (NO) assay; only Lactobacillus paraplantarum THG-T10 and ascorbic acid reduced LPS-induced NO production in RAW 264.7 cells in a dose-dependent manner (Abstract). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because based on these teachings Lactobacillus plantarum , Lactobacillus fermentum , and Lactobacillus paraplantarum exist in nature. In the absence of evidence that Applicants manipulated or modified a natural strains of Lactobacillus plantarum , Lactobacillus fermentum , and Lactobacillus paraplantarum to produce non-natural strains of the Lactobacillus , and in view of the fact that other Lactobacillus strains exist in nature as evidenced by the Lee Publication, the Klayraung Publication and the Cha Publication, the claimed composition is not considered markedly different from naturally occurring Lactobacillus plantarum , Lactobacillus fermentum , and Lactobacillus paraplantarum strains that exist in nature. Being found naturally in breast milk, miang (tea leaves), and Kimchi would provide the same properties of an antioxidant, anti-inflammatory, or whitening functional cosmetic composition, which is routine and adds nothing more than a mere field of use. In addition, the Lactobacillus strains found in nature provide the same intended purposes of inhibition of reactive oxygen species and inhibition of nitric oxide production. Therefore, the claimed invention is not considered to be patent eligible subject matter. 07-06 AIA 15-10-15 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. Claim Rejections - 35 USC § 102/Claim Rejections - 35 USC § 103 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 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. 07-27-aia AIA Claim s 1-3 are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lim et al. (KR 102263454 B1, English Translation) . Regarding claim 1, Lim et al. disclose novel lactic acid bacteria derived from skin with skin barrier strengthening and anti-wrinkle activity and uses thereof, and more specifically, to Lactobacillus plantarum subsp. shebah-202 (Accession number: KCTC14087BP) strain, Lactobacillus fermentum subsp. shebah-101 (Accession number: KCTC14086BP) strain or Lactobacillus paraplatanum subsp. shebah-401 (Accession number: KCTC14088BP) strain, which is novel lactic acid bacteria isolated and identified from human skin, and to a cosmetic composition for strengthening the skin barrier and an anti-wrinkle cosmetic composition (page 1, Abstract). Lim et al. disclose while the present inventors were studying to identify new lactic acid bacteria that can be raw materials for the production of functional cosmetics having skin barrier improvement and anti-wrinkle activity containing lactic acid bacteria (page 3, Description of Embodiments, paragraph 2, Translation). Lim et al. disclose elastase is one of the representative enzymes involved in skin aging, and this enzyme is an enzyme that decomposes elastin, which acts as a spring in the tissue. Excessive production of elastase decomposes elastin excessively, weakening the bond between collagens, creating skin wrinkles and reducing skin elasticity. This is because the action of elastase becomes very active with age, causing some elastin fibers to disappear or aggregation phenomenon to occur, and collagen fibers to decrease. Therefore, by inhibiting the activity of elastase, it is possible to suppress the wrinkle formation of the skin (page 3, Description of Embodiments, paragraph 6, Translation). Regarding claim 3, Lim et al. disclose the cosmetic composition may be prepared in the form of a nourishing lotion, a nourishing cream, a massage cream, an essence, a cleansing cream, a cleansing foam, or a powder (page 5, paragraph 1, Translation). Lim et al. do not specifically disclose the composition has abilities to inhibit reactive oxygen species production, inhibit nitric oxide (NO) production, inhibit tyrosinase activity, inhibit melanin production and synthesize collagen. However, it would have been obvious to one of ordinary skill in the art that these abilities are the intended purpose of the Lactobacillus strains claimed. Lim et al. disclose the same composition comprising Lactobacillus plantarum subsp. shebah-202 (Accession number: KCTC14087BP) strain, Lactobacillus fermentum subsp. shebah-101 (Accession number: KCTC14086BP) strain or Lactobacillus paraplatanum subsp. shebah-401 (Accession number: KCTC14088BP) strain. Therefore, the properties possessed by the composition of the instant application would be possessed by the prior art. Where the claimed and prior art product(s) are identical or substantially identical, the burden of proof is on applicant to establish that the prior art product(s) do not necessarily or inherently possess the characteristics of the instantly claimed product(s), see In re Best, 195 USPQ 430. In addition, 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. Lim et al. meet all the limitations of the claims and thereby anticipate and are obvious over the claims. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANDRIAE M HOLT/Examiner, Art Unit 1614 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614 Application/Control Number: 18/031,349 Page 2 Art Unit: 1614 Application/Control Number: 18/031,349 Page 3 Art Unit: 1614 Application/Control Number: 18/031,349 Page 4 Art Unit: 1614 Application/Control Number: 18/031,349 Page 5 Art Unit: 1614 Application/Control Number: 18/031,349 Page 6 Art Unit: 1614 Application/Control Number: 18/031,349 Page 7 Art Unit: 1614 Application/Control Number: 18/031,349 Page 8 Art Unit: 1614 Application/Control Number: 18/031,349 Page 9 Art Unit: 1614 Application/Control Number: 18/031,349 Page 10 Art Unit: 1614 Application/Control Number: 18/031,349 Page 11 Art Unit: 1614 Application/Control Number: 18/031,349 Page 12 Art Unit: 1614 Application/Control Number: 18/031,349 Page 13 Art Unit: 1614