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. DETAILED ACTION Applicant’s preliminary amendment filed on 4/21/2023 is entered. Claims 1-22 are cancelled and claim s 23-36 are new. C laims 23-36 are pending and examin ed. Priority Acknowledgment is made of Applicant’s claim for priority to the filing date of KR10-2017-0013632 filed 1/31/2017 and PCT/KR2018/001359 filed 1/31/2018 , as well as Applicant’s claim to the domestic benefit of US application no. 16/481,643 filed 7/29/2019 . Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 in the parent application no. 16/481,643 . T he effective filing date is 1/31/2017. Information Disclosure Statement The information disclosure statement (IDS) submitted on 21 April 2023 and 26 March 2024 are being considered by the examiner. Claim Objections Claims 23-25 and 30-32 are objected to because of the following informalities: The claim term “ Lactobacillus plantarum IM76 KCCM11962P” should differentiate the strain name “IM76” from the deposit number “KCCM11962P”. It is suggested to amend the phrase to “ Lactobacillus plantarum strain IM76 deposited under accession number KCCM11962P”. Appropriate correction is required. 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. Fill in the claim numbers Claim s … rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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. It is apparent that biological material Lactobacillus plantarum IM76 KCCM11962P is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material Lactobacillus plantarum IM76 KCCM11962P . The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the Lactobacillus plantarum IM76 KCCM11962P that is considered necessary to make and use the invention is both known and readily available to the public. It is noted that Applicants have deposited Lactobacillus plantarum IM76 KCCM11962P under the terms of the Budapest Treaty (specification pgs. 62-63) , but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection. If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent , would satisfy the deposit requirement made herein. Claim s 25 and 32 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 specification lacks sufficient written description for the full genus of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 KCCM11962P . The broadest reasonable interpretation of these products and extracts includes any compound that is present in a culture of Lactobacillus plantarum IM76 KCCM11962P, which includes ubiquitous compounds such as water, sugars, and minerals. MPEP §2163.02 states “[a] n applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. ” The specification discloses that a “culture product” is a product obtained by culturing lactic acid bacteria in a known medium (specification pg. 10 para. 3). The specification also discloses a “crushed product” is a lactic acid bacteria which is crushed by means of enzymatic treatment, homogenization, or ultrasonic treatment, and an “extract” is a product obtained by carrying out an extraction of the lactic acid bacteria with a known extraction solvent (specification pg. 10 para. 2). However, the specification does not describe what specific compounds, components or structures , in the culture product, crushed product, or an extract thereof, produce the desired effect of treating allergy, autoimmune, or inflammatory diseases. The specification does not disclose a structure-function relationship which would lead one of ordinary skill in the art to readily identify the critical structures required to treat allergy, autoimmune, or inflammatory diseases. Examples 1-7 in the specification disclose different experiments showing the efficacy of the Lactobacillus plantarum IM76 strain in treat ment , but these examples only utilized the Lactobacillus plantarum IM76 strain cells (i.e. whole cell body thereof) , and does not administer nor describe any culture product, crushed product, or extract of the Lactobacillus plantarum IM76 strain. Example s 10 and 11 in the specification disclose theoretical compositional preparations which may contain the Lactobacillus plantarum IM76 strain, but the examples do not further describe the content of the culture products, crushed products, and extracts of Lactobacillus plantarum IM76 KCCM11962P that is functional in treating allergy, autoimmune, or inflammatory diseases. The instant disclosure lacks any guidance that directs one of ordinary skill in the art to what specific compounds, components, or structures of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 strain produce the desired effect of treating allergy, autoimmune, or inflammatory diseases, and the disclosure lacks sufficient written description of the entire scope of claimed culture products, crushed products, and extracts of Lactobacillus plantarum IM76 strain . The prior art discloses the species Lactobacillus plantarum is suitable to treat different allergy, autoimmune, or inflammatory diseases. Kim et al. (US 11,202,811 B2, published 21 December 2021, effectively filed 15 September 2015) teaches the use of a pharmaceutical or food composition comprising Lactobacillus plantarum strain LC5 to treat allergic, autoimmune, and inflammatory diseases (Kim col 13 ln. 22, col. 14 ln. 27, col. 12 lns. 7-17, and col. 29 ln. 35). Cook et al. (US 9,956,282 B2, published 01 May 2018, effectively filed 16 December 2013) teaches Lactobacillus plantarum pharmaceutical and food compositions (Cook col. 13 lns. 11 and 22, col. 25 ln. 34, col. 26 ln. 16) for treating autoimmune, inflammatory, and allergic diseases (Cook col. 18 lns. 3-15). The prior art lacks any guidance that directs one of ordinary skill in the art to what specific compounds, components, or structures of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 strain produce the desired effect of treating allergy, autoimmune, or inflammatory diseases, and the prior art lacks any sufficient description of the entire scope of claimed culture products, crushed products, and extracts of Lactobacillus plantarum IM76 strain . Lac king sufficient prior art knowledge of the structure-function relationship for the genus of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 KCCM11962P , the specification does not provide sufficient description of the genus of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 KCCM11962P such that one of ordinary skill in the art would be able to reasonably predict the species o f the entire genus. Thus, one of ordinary skill in the art would conclude that Applicant was not in possession of the entire genus of culture products, crushed products, and extracts of Lactobacillus plantarum IM76 KCCM11962P as claimed. Claim Rejections - 35 USC § 102 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 23-28 and 30-35 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Kim et al. (US 11,202,811 B2, published 21 December 2021, effectively filed 15 September 2015 ) . Regarding claims 23 , 25, 30 , and 32 , Kim teaches the use of a pharmaceutical or food composition comprising Lactobacillus plantarum strain LC5 to treat allergic, autoimmune, and inflammatory diseases (Kim col 13 ln. 22, col. 14 ln. 27, col. 12 lns. 7-17, and col. 29 ln. 35). Regarding claims 24 and 31 , Kim teaches the Lactobacillus plantarum strain LC5 has a 16s rDNA sequence SEQ ID NO: 4 (Kim col. 10 lns. 60-63), which is 100% identical to the instant SEQ ID NO: 2 (see sequence search results 6/25/2025 in IFW). Therefore, the prior art Lactobacillus plantarum strain LC5 is the same as the claimed strain IM76 and anticipates the claimed invention . Regarding claims 26 and 33 , Kim teaches the administered composition treats atopy, asthma, and atopic dermatitis (Kim col. 12 ln. 55 and col. 46 lns. 54-60) Regarding claims 27 and 34 , Kim teaches the administered composition treats Crohn’s disease, rheumatoid arthritis, inflammatory bowel disease (Kim col. 12 lns. 52-67). Regarding claims 28 and 35 , Kim teaches the administered composition treats arthritis, gastritis, colitis, allergies, and dermatitis (Kim col. 12 lns. 52-67). Claim Rejections - 35 USC § 103 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. Claims 29 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim s 23-28 and 30-35 above, and further in view of Strozzi et al. ( US 20100092440 A1 , published 15 April 2010) . Kim does not teach that the composition further comprises a prebiotic that is chitosan, inulin, or citrus pectin . Strozzi teaches a composition comprising Lactobacillus plantarum can comprise the prebiotic fibers inulin, chitosan, and pectin (Strozzi claims 9, 11, and 12). Strozzi also teaches that prebiotics are used as carbon and/or energy sources for probiotic species, such as Lactobacillus plantarum (Strozzi [0057]). I t would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have added prebiotic compounds inulin, chitosan, and pectin as taught by Strozzi into the composition comprising Lactobacillus plantarum LC5, and administering that composition to treat allergic, autoimmune, and inflammatory diseases as taught by Kim. One of ordinary skill in the art would have been motivated to do so because Strozzi teaches that prebiotic fibers such as inulin, chitosan, and pectin are used as carbon and/or energy sources for probiotic species, such as Lactobacillus plantarum . Thus, one of ordinary skill in the art would recognize that adding the prebiotics to the probiotic composition of Kim would provide the necessary carbon and energy sources to allow the Lactobacillus plantarum LC5 to thrive in the subject. One of ordinary skill in the art would have had reasonable expectations of success because Strozzi teaches that the prebiotics inulin, chitosan, and pectin are added to a composition comprising Lactobacillus plantarum , and result it in the intended effect. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . C laim s 23-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 4-10 and 14-20 of U.S. Patent No. 11,660,321 . Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the conflicting claims . Regarding the instant claims 23 and 30 , patent claim 4 recites a method for treating allergic, autoimmune, or inflammatory diseases comprising administering a pharmaceutical composition which comprises Lactobacillus plantarum IM76 strain , and conflicting claim 14 recites a method for treating allergic, autoimmune, or inflammatory diseases comprising administering a food composition which comprises Lactobacillus plantarum IM76 strain . Regarding the instant claims 24 and 31 , patent claims 5 and 15 recite that Lactobacillus plantarum IM76 KCCM11962P comprises a 16S rDNA sequence of SEQ ID NO: 2. Regarding the instant claims 25 and 32 , patent claims 6 and 16 recite that the Lactobacillus plantarum IM76 KCCM11962P is a live cell body thereof, a dead cell body thereof, a culture product thereof, a crushed product thereof or an extract thereof. Regarding the instant claims 26 and 33 , patent claims 7 and 17 recite that the allergic diseases are at least one selected from the group consisting of rhinitis, atopy, asthma, atopic dermatitis, allergic conjunctivitis, allergic otitis media, hives and anaphylactic shock. Regarding the instant claims 27 and 34 , patent claims 8 and 18 recite that the autoimmune diseases are at least one selected from the group consisting of Crohn's disease, rheumatoid arthritis, Hashimoto's thyroiditis, pernicious anemia, Addison's disease, type 1 diabetes, lupus, chronic fatigue syndrome, fibromyalgia syndrome, hypothyroidism and hyperthyroidism, scleroderma, Behcet's disease, inflammatory bowel disease, multiple sclerosis, myasthenia gravis, Meniere's syndrome, Guillain-Barre syndrome, Sjogren's syndrome, leukoplakia, endometriosis, psoriasis, leukoplakia, systemic scleroderma, asthma and ulcerative colitis. Regarding the instant claims 28 and 35 , patent claims 9 and 19 recite that the inflammatory diseases are at least one selected from the group consisting of arthritis, gout, hepatitis, obesity, corneitis, gastritis, enteritis, nephritis, diabetes, tuberculosis, bronchitis, pleurisy, peritonitis, spondylitis, pancreatitis, inflammatory pain, urethritis, cystitis, vaginitis, arteriosclerosis, septicemia, burn, dermatitis, periodontitis, gingivitis and colitis. Regarding the instant claims 29 and 36 , patent claims 10 and 20 recite that the composition s further comprise at least one prebiotic selected from the group consisting of chitosan, inulin and citrus pectin. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ALEXANDER M DURYEE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9377 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9:00 am - 5:00 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, FILLIN "SPE Name?" \* MERGEFORMAT Louise Humphrey can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571)-272-5543 . 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. /LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657 /Alexander M Duryee/ Examiner, Art Unit 1657