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 .
The amendment and response filed on August 26, 2026, are received.
Claims 1-15 were previously canceled by Applicant.
New claim 30 is added.
Claims 16-30 are pending in this application, claims 18, 22, 25 and 27-30 are withdrawn from further consideration, and claims 16, 17, 19-21, 23 and 26 are being examined to the extent they read on the elected species.
Restriction/Election:
Applicants’ election without traverse of, Group I, claims 16-26, in the reply filed on 08/26/2026 is acknowledged. The election of the species “Faecalibacterium prausnitzii and Anaerostipes caccae” (as the two species of bacterial strains) and “non-alcoholic fatty liver disease (NAFLD)” (as the species of disease) in the same reply is also acknowledged.
Examiner Note:
The inclusion of claims 1-15 in Group I in the restriction requirement mailed on 07/07/2026, was an inadvertent typo. Group I includes claims 16-26, since claims 1-15 were previously canceled.
Claims 18, 22, 25 and 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II) and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
Objection(s):
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See page 6 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejection - 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 24 and 26 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.
Regarding claim 24, the phrase "preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Suggestion to obviate the rejection: delete the phrase.
Regarding claim 26, the phrase "preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Suggestion to obviate the rejection: delete the phrase.
Claim Rejection - 35 USC § 103
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.
Claims 16, 17, 19-21, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sokol et al. (US 2019/0282638 A1) and Guohong-Liu et al. (Annals of Hepatology, Volume 18, Issue 6, 2019, Pages 796-803).
Regarding claim 16, Soko et al. teach a method for treating, delaying, ameliorating, preventing or curing a disease or condition of the liver or a symptom thereof, the method comprising administrating to a subject in need thereof a composition comprising two or more bacterial strains of at least two of the following genera: Faecalibacterium, Butyricicocccus, Roseburia, Akkermansia, Lactiplantibacillus and Anaerostipes (administering probiotics comprising Faecalibacterium, Faecalibacterium prausnitzii, Anaerostipes, and Anaerostipes caccae treating non-alcoholic fatty liver disease) (See for example, p. 1 paragraphs [0010], [0012] and [0015] and p. 5 paragraph [0077]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the teachings of Soko et al. with a reasonable expectation of success in providing the claimed method for treating, delaying, ameliorating, preventing or curing a disease or condition of the liver or a symptom thereof.
Regarding claim 17, Soko et al. teach the composition comprises two or more bacterial strains of at least two of the following species: Faecalibacterium prausnitzii (the elected species), Butyricicocccus pullicaecorum, Roseburia inulinivorans, Akkermansia muciniphila, Lactiplantibacillus plantarum and Anaerostipes caccae (the elected species) (Faecalibacterium prausnitzii and Anaerostipes caccae) (See for example, p. 1 paragraph [0015] and p. 5 paragraph [0077]).
Regarding claim 19, Soko et al. teach the composition further comprises at least one additional bacterial strain capable of producing propionate or a propionate precursor (bacteria probiotics propionic acid bacterium, Bacteroides, Eubacterium, etc.) (See for example. p. 5 paragraph [0074]).
Regarding claim 20, Soko et al. teach the composition further comprises at least two additional bacterial strains capable of producing propionate or a propionate precursor (bacteria probiotics propionic acid bacterium, Bacteroides, Eubacterium, etc.) (See for example. p. 5 paragraph [0074]).
Regarding claim 21, Soko et al. teach the composition further comprises three additional bacterial strains capable of producing propionate or a propionate precursor (bacteria probiotics propionic acid bacterium, Bacteroides, Eubacterium, etc.) (See for example. p. 5 paragraph [0074]).
Regarding claim 24, Soko et al. teach the method is a method for treating, delaying, ameliorating, preventing or curing non-alcoholic fatty liver disease (NAFLD) (the elected species), liver fibrosis, liver cirrhosis and/or a liver neoplasm, the liver neoplasm preferably being hepatocellular carcinoma (HCC), or a symptom thereof (non-alcoholic fatty liver disease) (See for example. p. 1 paragraph [0012]).
Regarding claim 26, Soko et al. teach the method is for delaying or preventing disease progression of NAFL (the elected species), preferably delaying progression of NAFL to NASH, NASH to liver fibrosis, liver fibrosis to liver cirrhosis and/or liver cirrhosis to HCC (non-alcoholic fatty liver disease) (See for example. p. 1 paragraph [0012]).
Sokol et al. do not teach the composition further comprises:- Phocaeicola vulgatus; -Veillonella parvula or Veillonella atypica; and- Blautia obeum, Blautia wexlerae, or Blautia luti (Claim 23).
However, regarding claim 23, before the effective filing date of the invention Guohong-Liu et al. teach healthy individuals have increased Veillonella parvula bacteria in their stool compared to stools of individuals with a liver disease (liver cirrhosis) (See for example, p. 801, Table 3, right-hand column last “objects” and “bacteria” showing increased Veillonella parvula in human healthy controls, and p. 801 right-hand column last paragraph –Continued on p. 802 left-hand column).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to further add Veillonella parvula in the composition being administered in the method according to Soko et al. with as reasonable expectation of success in providing the claimed method for treating, delaying, ameliorating, preventing or curing a disease or condition of the liver or a symptom thereof. The claimed method would have been obvious because Soko et al. teach a method for treating, delaying, ameliorating, preventing or curing a disease or condition of the liver or a symptom thereof, the method comprising administrating to a subject in need thereof a composition comprising two or more bacterial strains of at least two of the following genera: Faecalibacterium, Butyricicocccus, Roseburia, Akkermansia, Lactiplantibacillus and Anaerostipes, and because Guohong-Liu et al. teach healthy individuals have increased Veillonella parvula bacteria in their stool compared to individuals compared to stools of individuals with a liver disease.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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