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 The preliminary amendment dated 6 September 2023, in which claim 3 has been amended, and claim 4 has been added, is acknowledged. Claims 1- 4 are pending in the instant application. Claims 1- 4 are being examined herewith. Priority The instant application is a National Stage entry of International Application No. PCT/JP2022/007228, filed on 22 February 2022 , which claims priority from Japan Patent Application No. 2021-040578 , filed on 12 March 2021. A certified copy of the priority document, in Japanese , was submitted on 6 September 2023. Information Disclosure Statement The information disclosure statement (IDS) submitted on 6 September 2023 is acknowledged and considered. 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- 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. C laim 1 recite s a composition comprising plasmalogen, which is a natural product. Claim 2 depends on claim 1 and recites that the plasmalogen is extracted from an animal tissue. Claims 3 and 4 recite that the plasmalogen is an ethanolamine type plasmalogen, which is a natural product. C laims 1-4 also recite intended use. This judicial exception is not integrated into a practical application because the claims do not include any elements other than natural products. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only recite plasmalogen, or an ethanolamine type of plasmalogen, which occur in nature. Although claim 2 and dependent claim 4 recite a plasmalogen extracted from an animal tissue, there is no indication that extracting the plasmalogen from an animal tissue changes the structure, function, or other properties of the natural products in any marked way. There is no showing that the plasmalogens extracted from an animal tissue does or has any markedly different characteristics compared to the closest naturally occurring counterparts. There are no additional elements present in the claims and the claims do not qualify as eligible subject matter. Claiming a combination of plasmalogen and an additional component, together with a demonstration that the claimed combination does something markedly different than the component in nature; or a limitation requiring the product/preparation to no longer be just a natural product or a mixture of natural products may provide a path toward patent eligibility, such as, for example, a preparation in the form of tablets, granules, creams, ointments, gels, etc. 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. Claim interpretation: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror , 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02. In this case, the body of claims 1-4 fully and intrinsically set forth all the limitations of the claimed invention, namely a composition comprising plasmalogen; the preamble “for ameliorating inflammation of periodontal tissue” only states the intended use of the composition. Thus, the preamble is not given any patentable weight. "[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). It is well settled that “intended use” of a composition or product, e.g., “for use as a medicament”, will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161 Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ifuku et al. (US 2012/0283223, cited in PTO-892). Ifuku teaches (Abstract, Figure 1, claims 4-6) a composition (cerebral nerve cell neogenesis agent) comprising an ethanolamine plasmalogen, as in instant claims 3, 4, extracted from a biological tissue, namely an avian tissue, as in instant claims 2, 4. As such, a composition of instant claims 1-4 is anticipated by Ifuku . Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Forgeot et al. (US5,759,585 of 2 June 1998, cited in PTO-892). Forgeot teaches (column 3, lines 25-43) that mammalian brain and spinal cord are the best sources of phospholipidet h ers in the form of plasmalogens. Forgeot teaches (column 3, lines 25 -43, including Table) a composition comprising plasmalogens, as in instant claim 1, wherein the composition comprises phosphatidylethanolamine 30% to 40% , of which 2/3 are in plasmalogen form. Thus, Forgeot teaches a composition comprising plasmalogen ethanolamine, as in instant claims 1, 3. Forgeot teaches (column 4, Example I) a composition comprising phospholipids rich in ether lipids (plasmalogen) extracted from mammalians or fishes brains or spinal cord and optionally from hens eggs, which is a composition comprising plasmalogen extracted from animal tissue, as in instant claim 2, which is ethanolamine type plasmalogen (column 3, line 35, line 54), as in instant claim 4. As such, a composition of instant claims 1-4 is anticipated by Forgeot . Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Di Martino et al. (EP 0638083, published 12 March 1997, cited in PTO-892). Di Martino teaches (page 6, lines 29-33; also lines 34-38) a composition comprising plasmalogen ethanolamine (line 32, line 37), as in instant claims 1, 3, where the preparation/phospholipid mixture of the invention (containing plasmalogen ethanolamine) is made by extraction (Example I) from bovine brains, thus plasmalogen extracted from animal tissue, as in instant claims 2, 4. Di Martino teaches (Example 7, page 13-14) a composition comprising plasmalogen ethanolamine, as in instant claims 1, 3, wherein the plasmalogen-ethanolamine is contained in the phospholipids extracted from cortical grey matter , thus is plasmalogen extracted from animal tissue, as in instant claims 2, 4. As such, a composition of instant claims 1-4 is anticipated by Di Martino. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hossain et al. (Biochemical and Biophysical Research Communications 2018, 496 (4), 1033-1039, cited in IDS). Hossain teaches (page 1034, left column, first paragraph) a composition comprising plasmalogen ethanolamine, as in instant claims 1, 3, suspended in drinking water, where the plasmalogen ethanolamine is extracted from chicken breast meat, thus plasmalogen extracted from animal tissue, as in instant claims 2, 4. As such, a composition of instant claims 1-4 is anticipated by Hossain. 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. Claims 1- 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 5 of U.S. Patent 8,822,437 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of U.S. Patent 8,822,437 anticipate or render obvious the instant claims. Claims 1-5 of U.S. Patent 8,822,437 recite a composition comprising plasmalogen, wherein not less than 90% mass of the plasmalogen is an ethanolamine plasmalogen and a choline plasmalogen; claim 3 discloses that the plasmalogen is extracted from a biological tissue, and claim 4 recites that the plasmalogen is extracted from an avian tissue. Thus, a composition containing ethanolamine plasmalogen, as in instant claims 1, 3, wherein the plasmalogen is extracted from an animal tissue, as in instant claims 2, 4, is anticipated by claims 1-5 of U.S. Patent 8,822,437 . Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-22 of U.S. Patent application 17/921,501 (cited in PTO-892 , notice of allowance sent ). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 7-22 of U.S. Patent application 17/921,501 anticipate or render obvious the instant claims. Claims 7-22 of U.S. Patent application 17/921,501 recite a composition comprising plasmalogen (claims 7, 9, 11, 22) , wherein the plasmalogen is an ethanolamine plasmalogen (claims 13-21) ; clai ms 8, 10, 12 disclose that the plasmalogen is extracted from a n animal tissue. Thus, a composition containing ethanolamine plasmalogen, as in instant claims 1, 3, wherein the plasmalogen is extracted from an animal tissue, as in instant claims 2, 4, is anticipated or rendered obvious by claims 7-22 of U.S. Patent application 17/921,501 . Claims 1- 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4 of co-pending U.S. Patent application 18/010,587 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 3, 4 of co-pending U.S. Patent application 18/010,587 anticipate or render obvious the instant claims. Claims 3, 4 of co-pending U.S. Patent application 18/010,587 recite a composition comprising plasmalogen (claim 3 ), wherein the plasmalogen is extracted from an animal tissue (claim 4), as in instant claims 1-2. Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 7, 11-13 of co-pending U.S. Patent application 18/010, 604 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 7, 11-13 of co-pending U.S. Patent application 18/010, 604 anticipate or render obvious the instant claims. Claims 7, 11-13 of co-pending U.S. Patent application 18/010,604 recite a composition comprising plasmalogen (claim s 7, 12 ), wherein the plasmalogen is extracted from an animal tissue (claim s 11, 13 ), as in instant claims 1-2. Claims 1 , 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of co-pending U.S. Patent application 18/ 685,412 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-11 of co-pending U.S. Patent application 18/685,412 anticipate or render obvious the instant claims. Claims 1-11 of co-pending U.S. Patent application 18/685,412 are drawn to a compound of formula (I) or to a composition comprising said compound, , wherein X is, for example, O; R1 is an unsaturated aliphatic hydrocarbon group containing one double bond (claim 4), wherein the double bond of R1 is present between the carbon at position 1 and the carbon at position 2, when the carbon bonded to the carbon bonded to X is defined as the carbon at position 1 (claim 5) ; and R3 is, for example, ethanolamine. The genus of compounds of formula (I) encompasses plasmalogen (alpha unsaturated ether at sn-1) ethanolamine, as in instant claims 1, 3. As such, there is considerable overlap between the genus of compounds of formula (I) in c laims 1-11 of co-pending U.S. Patent application 18/ 685,412 , and plasmalogen ethanolamine of instant claims 1, 3 . Conclusion Claims 1- 4 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT IRINA NEAGU whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5908 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8-5 . 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, JEFFREY S. LUNDGREN can be reached on (571) 272-5541. 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. /IRINA NEAGU/ Primary Examiner, Art Unit 1629