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 .
Status of Claims
Receipt of Arguments/Remarks filed on 3/18/2026 is acknowledged. Claims 11-14 and 16-28 are pending. Claims 11-12, 14, 16, 18, 21, and 25 were amended. Claim 15 was canceled. Claims 19-28 are withdrawn.
In response to the election of species requirement in the reply filed 11/10/2025, applicant elected Bifidobacterium longum in claim 11. In the non-final rejection dated 12/22/2025, the species election was expanded in view of the prior art search to include Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium breve,
Bifidobacterium bifidum, and Akkermansia muciniphila.
The species Ruminococcus gnavus and Bacteroides vulgatus were not elected or rejoined. Therefore, Ruminococcus gnavus and Bacteroides vulgatus remain withdrawn as being directed to unelected species.
Bifidobacterium longum was elected and is under consideration herein.
Withdrawn Objections/Rejections
The objections to claims 12, 14, and 16 are withdrawn.
The rejections of claims 11-14 and 17-18 under 35 U.S.C. § 112(b) are withdrawn.
New and modified rejections necessitated by amendment
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 16 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 16 depends on claim 11 and recites “a ratio of viable counts of microbial species within the intestinal probiotic”. However, as Ruminococcus gnavus and Bacteroides vulgatus are withdrawn from consideration as being directed to non-elected species, the intestinal probiotic of claim 11 only requires one microbial species, Bifidobacterium longum. Thus, the ratio of three microbial species, 1-3:1-3:1-3, is unclear.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-14 and 16-18 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 Bifidobacterium longum (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 1x108-5x108 CFU/mL, meaning that 1 mL of this probiotic has between 1x108-5x108 CFU. Thus, the ratio of 1 mL probiotic:5-20 g EA could also be expressed as 1x108-5x108 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 108, CFU/g (p. 25 para. 58). Thus, 1 g of the probiotic as taught by Kim may have at least 108 CFU. This means that Kim teaches a composition with a ratio of 108 CFU probiotic:5-20 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 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, i.e. 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”). Thus, Kim teaches a pharmaceutical composition wherein the 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 pharmaceutical composition. It is expected that any 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, including the intestinal bacteria in the pharmaceutical compositions, as discussed above.
Response to Arguments
Applicant previously elected Bifidobacterium longum as the species, and specifically the
"second intestinal probiotic" as the elected combination.
Applicant argues that the Examiner has already conducted a thorough search for Bifidobacterium longum in subclass A61K35/741, as evidenced by the citation of Kim. The newly presented claims are directed to the same bacterial species and fall squarely within the same classification. Therefore, the addition of Ruminococcus gnavus and Bacteroides vulgatus, both of which are well-known gut bacteria does not require the Examiner to venture into a new or unrelated art field. The prior art search already performed remains fully applicable and relevant to assessing these claims.
In response to this argument, it is noted that the cited prior art reference, Kim et al., does not teach Ruminococcus gnavus and Bacteroides vulgatus. These bacterial species were not among those rejoined in the non-final rejection dated 12/22/2025. Further, these newly presented claims are not directed to the same bacterial species. Ruminococcus gnavus and Bacteroides vulgatus are both distinct from Bifidobacterium longum and the addition of these species would require an expanded and updated prior art search. For this reason, the species Ruminococcus gnavus and Bacteroides vulgatus remain withdrawn, and Bifidobacterium longum is under examination herein.
Conclusion
Claims 11-14 and 16-18 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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