Detailed Action
The present office action is in response to the reply filed on 10 Jun 2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
Status
Claims 11 and 13-20 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 10 Jun 2026. Acknowledgement is made of the cancellation of claims 1-10 and 12.
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.
Response to Applicant Arguments
Acknowledgement is made of the remarks filed 10 Jun 2026.
Examiner thanks applicant for correcting the record regarding WO 2021/024872 which was misidentified as WO 2021/024871 in the office action mailed 12 Feb 2026. The record has been corrected below.
The objection to claim 14 is rendered moot following applicant amendments.
The rejection of claim 13 under 35 U.S.C. § 112(b) is rendered moot following applicant amendments.
The rejection of claims 11 and 13 under 35 U.S.C. § 102(a)(1) over WO 2021/024872 is rendered moot following applicant amendments.
Regarding the rejection of claims 11-14 under 35 U.S.C. § 103 over US 2021/0060096, hereinafter ‘096, Kim et al. (J Microbiol Biotechnol, 1995, 5:149-153; provided in the office action mailed 12 Feb 2026), hereinafter Kim, Tian et al. (Biochem Biophys Res Commun, 2019, 516, 430-436; provided in the office action mailed 12 Feb 2026), hereinafter Tian, and CICC 24632 (www.china-cicc.org, Bifidobacterium longum, CICC 24632, accessed 30 Jan 2026; provided in the office action mailed 12 Feb 2026), hereinafter CICC; applicant arguments filed 10 Jun 2026 have been fully considered but are not persuasive. Claims 16-17 and 19-20 have been included in the rejection below and the rejection has been amended to reflect the new grounds of rejection. This is necessitated by applicant amendment.
Applicant argues on pg. 11 of the remarks that the cited reference does not provide evidence that discloses or suggests a drug formulation comprising specific microbiota derived plasmalogens comprising 158.3 mg/g of choline plasmalogen, 241.8 mg/g of ethanolamine plasmalogen, 11.0 mg/g of serine plasmalogen, 367.1 mg/g of phosphatidylglycerol plasmalogen, and 181.0 mg/g of phosphatidic acid plasmalogen.
This is not persuasive. By teaching all the elements of the claims, ‘096, Kim, Tian, and CICC teach the inherent properties of the drug of the instant claims. Because ‘096, Kim, Tian, and CICC do not teach purification of the plasmalogen component, the claims directed to plasmalogens of greater than 90% purity are not rejected by the prior art.
In light of the discussion above, the rejection of claims 11, 13-14, 16-17, and 19-20 under 35 U.S.C. § 103, as obvious over ‘096, Kim, Tian, and CICC is amended for the reasons of record and restated below
Claim Objections
Claims 15 and 18 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening 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, 13-14, 16-17, and 19-20 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]). ‘096 further teaches administering the composition in an amount that provides a therapeutically effective dose of the B. longum ATCC BAA-999 (paragraph [0080]). 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 have the claimed composition of plasmalogens and so ‘096 and Tian make obvious the total mass of the instantly claimed plasmalogens.
Conclusion
No claim is allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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