Office Action Predictor
Last updated: April 15, 2026
Application No. 18/229,592

USE OF INTESTINAL PROBIOTIC IN PREPARATION OF MEDICAMENT THAT PROMOTES METABOLISM OF ELLAGIC ACID INTO UROLITHIN A, PHARMACEUTICAL COMPOSITION AND USE THEREOF

Non-Final OA §102§112
Filed
Aug 02, 2023
Examiner
EIX, EMILY FAY
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Zhejiang University
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
84%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
10 granted / 21 resolved
-12.4% vs TC avg
Strong +37% interview lift
Without
With
+36.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
59 currently pending
Career history
80
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
37.1%
-2.9% vs TC avg
§102
18.3%
-21.7% vs TC avg
§112
24.0%
-16.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 resolved cases

Office Action

§102 §112
DETAILED ACTION 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. Election/Restrictions Applicant’s election without traverse of claims 11-18, as well as the species election of Bifidobacterium longium in claim 11 and the second intestinal probiotic formed by Bifidobacterium breve, Bifidobacterium bifidum, and Bifidobacterium longium in claim 15, in the reply filed on 11/10/2025 is acknowledged. Claim s 19-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 11/10/2025. In view of the prior art search , the species election is expanded to include Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus rhamnosus , Bifidobacterium breve, Bifidobacterium bifidum, and Akkermansia muciniphila in claim 11 . Priority This application claims priority to CN2023105790477 ( 5/19/2023 ) as reflected in the filing receipt issued on 8/17/2023 . The certified cop y of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Claim Objections Claims 12 , 14 , and 16 are objected to because of the following informalities: claims 12 and 14 recite “ clony -forming units”. This should be “colony-forming units”. Claim 16 recites “six intestinal probiotic ”. This should be “sixth”. 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 appl icant regards as his invention. Claim s 11-18 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. Claims 11 and 15 recite “ Bifidobacterium longium ”. There does not appear to be a bacterium by this name. The specification recites B if idobacterium longum (see specification para. 8). It appears that this is likely a typographical error and for purposes of examination this bacterium is being treated as B if idobacterium longum . However, a s this is an elected species from among the probiotics in claim s 11 and 15 , it is requested that applicant clarify the bacterium being referred to in claims 11 and 15. Claim s 16 and 18 recite the limitations "the first intestinal probiotic ”, “ the second intestinal probiotic ” , etc. There is insufficient antecedent basis for th ese limitation s in the claim s . Claim s 16 and 18 depend on claim 11. Claim 11 does not recite a first, second, third , etc. probiotic. It appears that these limitations in claim s 16 and 18 are meant to refer to the combinations recited in claim 15. However, it is not clear what “the first intestinal probiotic” etc. is referring to , given the dependency of claim s 16 and 18 on claim 11. Claims 12-14 and 1 7 are included in the rejection because they depend on a rejected claim and do not clarify the issue. 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 1 1 -1 8 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kim et al., WO 2019/212997 . Regarding claim 11, Kim teaches a pharmaceutical composition (p. 61 para. 131-132) comprising a first component including ellagic acid and a second component comprising one or more probiotic species (p. 1 para. 5-6). Kim teaches that the probiotic may be one or more species including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus rhamnosus , Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, and Akkermansia muciniphila (pp. 1-2 para. 5-6). The limitation “for increasing urolithin A content” is an intended use of the claimed composition, and any composition having this same structure is capable of performing the intended use. Further, Kim expressly teaches that the composition is used to produce urolithin A (p. 34 para. 80). Regarding claim 12, the instantly claimed composition comprises a probiotic at a concentration of 1x10 8 -5x10 8 CFU/mL, meaning that 1 mL of this probiotic has between 1x10 8 -5x10 8 CFU. Thus, the ratio of 1 mL probiotic :5-20 g EA could also be expressed as 1x10 8 -5x10 8 CFU probiotic :5-20 g EA . Kim teaches that the ratio of the weight of the first component (EA) to the weight of viable probiotic species in the second component is at about 1:1 to 25:1 (p. 26 para. 59 ). Therefore, Kim teaches a w/w ratio of probiotic to EA that is between 1:1 and 1:25 , which encompasses 1 g probiotic :5-20 g EA . Kim further teaches that the probiotic species is at least 100 million, or 10 8 , CFU/g ( p. 25 para. 58 ). Thus, 1 g of the probiotic as taught by Kim may have at least 10 8 CFU. This means that Kim teaches a composition with a ratio of 10 8 CFU probiotic :5-2 0 g EA . This is the same ratio of probiotic : EA and probiotic concentration as instantly claimed. Regarding claim 13, Kim teaches that EA has a structure according to formula 1 (see structure on p. 16). Regarding claim 14, as discussed above, Kim teaches a pharmaceutical composition having the structure according to formula 1 as required by claim 13 . Kim additionally teaches the claimed ratios and concentrations as discussed regarding claim 12. Regarding claim 15, the elected combination is the second intestinal probiotic, formed by Bifidobacterium breve, Bifidobacterium bifidum and Bifidobacterium longum . Kim teaches a composition comprising one or more bacteria, including Bifidobacterium breve, Bifidobacterium bifidum , and Bifidobacterium longum (p. 21 para. 53). Therefore, Kim teaches a probiotic composition comprising all three of these strains. Regarding claim 16, Kim teaches various concentrations at which that the one or more probiotic species may be present in the probiotic composition (pp. 24-25 para. 58). If there is more than one probiotic in the composition , such as a composition comprising Bifidobacterium breve, Bifidobacterium bifidum and Bifidobacterium longum , these may all be present at the same concentration /viable count , which would be a 1:1:1 ratio. Regarding claim 17 , the limitation “ promotes metabolism of EA into urolithin A ” is a functional limitation of the intestinal probiotic. It is expected that any composition having the claimed structure is capable of performing this function. Further, Kim teaches urolithins, including urolithin A, are produced from ellagic acid metabolism by the gut microbiota (intestinal probiotics) used in the composition (p. 9 para. 26; p. 34 para. 80). Regarding claim 18, the “population metabotype ” refers to the patient population that the pharmaceutical composition is being administered to. The claims are directed to a pharmaceutical composition comprising probiotic bacterial strains and ellagic acid. Kim teaches the pharmaceutical composition of claim 11, as discussed above. Kim teaches that the pharmaceutical composition may be formulated in various compositions for therapeutic administration, i.e. prepared as a medicament (p. 61 “Pharmaceutical Compositions”). Kim additionally teaches the elected species of claim 15, the second intestinal probiotic formed by Bifidobacterium breve, Bifidobacterium bifidum and Bifidobacterium longum as discussed above. Thus, Kim teaches a pharmaceutical composition wherein the second intestinal probiotic is prepared into a medicament. The pharmaceutical composition is capable of being administered to any patient, including patients from metabotype O and B populations. The limitation “ that promotes metabolism of EA into urolithin A in a metabotype B /O population ” is a functional limitation of the p harmaceutical composition . It is expected that a ny composition having the claimed structure is capable of performing this function . As Kim teaches the same pharmaceutical compositions/medicament as the instant claims, these compositions would be capable of performing the claimed function of promoting metabolism of EA into urolithin A in a metabotype B or metabotype O population. Further, Kim teaches that urolithin A is produced from ellagic acid metabolism by gut bacteria, such as the intestinal bacteria included in the pharmaceutical compositions, as discussed above. Conclusion Claims 11-18 are rejected. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT EMILY F EIX whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0808 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8am-5pm ET . 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 Sharmila Landau can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-0614 . 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. /EMILY F EIX/ Examiner, Art Unit 1653 /SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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Prosecution Timeline

Aug 02, 2023
Application Filed
Dec 15, 2025
Non-Final Rejection — §102, §112
Mar 18, 2026
Response Filed

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
48%
Grant Probability
84%
With Interview (+36.7%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 21 resolved cases by this examiner. Grant probability derived from career allow rate.

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