Detailed Action
The present office action is in response to the reply filed on 31 Oct 2025.
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
Claims 11-14 of the pending application have been examined on the merits. Claims 1-10 are withdrawn (see “Response to Applicant Election” below).
Priority
Applicants identify the instant application, Serial #: 17/990,976, filed 21 Nov 2022, as a Continuation of International Patent Application #: PCT/CN2022/091105, filed 06 May 2022, which claims foreign priority from Foreign Application #: CN2021105096975, filed 22 May 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 01 Mar 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election without traverse of Invention I, claims 11-14, in the reply filed on 31 Oct 2025 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 31 Oct 2025.
Claim Objections
Claim 14 is objected to because of the following informalities: "microbiota-derived plasmalogens is obtained" should be "microbiota-derived plasmalogens are obtained". Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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 13 contains a Markush grouping which does not have the proper coordinating conjunction. The claim contains the coordinating conjunction “and” instead of “or” which would properly limit the alternatives defined in the list. See MPEP § 2117(I). Applicant may overcome this rejection by adding the proper coordinating conjunction to each Markush group in need of one.
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.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2021/024871, hereinafter ‘871, in light of CICC 24632 (www.china-cicc.org, Bifidobacterium longum, CICC 24632, accessed 30 Jan 2026; cited for evidentiary purposes), hereinafter CICC.
The instant claims teach a drug comprising the following plasmalogens: choline plasmalogens, ethanolamine plasmalogens, serine plasmalogens, phosphatidylglycerol plasmalogens, and phosphatidic acid plasmalogens (claim 11). The claims further limit the plasmalogens to having dosages of 158.3 mg/g of the choline plasmalogens, 241.8 mg/g of the ethanolamine plasmalogens, 11.0 mg/g of the serine plasmalogens, 367.1 mg/g of the phosphatidylglycerol plasmalogens, and 181.0 mg/g of the phosphatidic acid plasmalogens (claim 12). The claims further limit the drug to being prepared as a capsule, a granule, a powder, or a liquid and include limitations that the plasmalogens are obtained by culturing the anaerobic microorganism in an MRS culture medium (claims 13 and 14). The examiner notes that in instant claim 11, the phrase, “for the treatment of colon cancer,” is construed as an intended use of the product and is of no significance to the claim construction. See MPEP § 2111.02(II).
‘871 teaches a plasmalogen-containing oral composition which comprises cells or a processed product of Bifidobacterium longum (pg. 1, Claims; pg. 2). ‘871 further teaches the cells can be of B. longum strain BB536 and that this strain was orally co-administered with antibiotics to mice (pg. 2; pg. 7). ‘871 teaches the form of the oral composition include tablets, capsules, powders, granules, and liquids (pg. 3). CICC, cited for evidence, teaches that B. longum BB536 is B. longum CICC 24632.
The instant application identifies B. longum CICC 24632 as having a plasmalogen composition of choline plasmalogens, ethanolamine plasmalogens, serine plasmalogens, phosphatidylglycerol plasmalogens, and phosphatidic acid plasmalogens. MPEP § 2112(II) states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” By claiming a plasmalogen-containing oral composition of B. longum cells or processed products thereof, ‘871 inherently teaches an oral composition of the plasmalogens claimed in the instant application and so anticipates the instant claims.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 over US 2021/0060096, hereinafter ‘096, further in view of Kim et al. (J Microbiol Biotechnol, 1995, 5:149-153), hereinafter Kim, Tian et al. (Biochem Biophys Res Commun, 2019, 516, 430-436), hereinafter Tian, in light of CICC.
‘096 teaches that administering B. longum ATCC BAA-999 improved depression scores for patients (paragraph [0005]). ‘096 further teaches that B. longum ATCC BAA-999 may be cultured according to any suitable method and the bacteria may be administered orally in the form of a drink (paragraphs [0059]-[0060]). ‘096 also teaches that B. longum ATCC BAA-999 has the trademarked name of BB536 (paragraph [0048]). However, ‘096 does not teach the specific mg/g values of the plasmalogens or culturing B. longum in MRS media.
Kim teaches that B. longum was grown in MRS media under anaerobic conditions and found good growth (pg. 149, column 2; pg. 151, column 1).
Tian teaches that Clostridium butyricum has neuroprotective effects on mood disorders and that preventive supplementation of C. butyricum in mice helped alleviate depression-like phenotypes in mice.
CICC, cited for evidence, teaches that B. longum BB536 is B. longum CICC 24632.
Based on the teachings of ‘096 and Kim, the artisan would have an expectation of success in growing B. longum in MRS media under anaerobic conditions. The artisan would find MRS media suitable for growing B. longum.
It would be prima facie obvious to one having ordinary skill in the art to combine the composition of B. longum with the composition of C. butyricum to create a third composition for the treatment of depression with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The instant application identifies that when combined, B. longum CICC 24632 and C. butyricum have a plasmalogen composition of choline plasmalogens (158.3 mg/g), ethanolamine plasmalogens (241.8 mg/g), serine plasmalogens (11.0 mg/g), phosphatidylglycerol plasmalogens (367.1 mg/g), and phosphatidic acid plasmalogens (181.0 mg/g). MPEP § 2112(II) states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” It is inherent that a combination of B. longum CICC 24632 and C. butyricum and so ‘096 and Tian make obvious the total compositions of the instantly claimed plasmalogens.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Valadez-Bustos et al. (Int J Mol Sci, 2019, 20:4275) is considered pertinent for teaches the oral administration of microencapsulated B. longum to treat a colorectal murine model. Fujino et al. (EBioMedicine, 2017, 17:199-205) is considered pertinent for teaching a composition of scallop-derived plasmalogens for the treatment of Alzheimer’s disease.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625