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 .
Claims 1-5, 7-8 and 12-29 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements filed 1/2/2025, 2/28/25, 6/13/25 and 6/27/25 have been considered and initialed copies are enclosed.
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.
Claims 7, 15 and 27 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 7 and 15 refer to tables in the specification.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience. "Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
The microbial strains in table 5 and the metabolites in tables 1-4 can be listed in the claims. Appropriate correction is requested.
Please clarify the scope of claim 27. Is the ten microbial strains in claim 27 different from the ten or more microbial strains in claim 1.
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) 1-5, 7, 15-18, 20, and 22-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paramsothy, Sudarshan et al. Gastroenterology, Volume 156, Issue 5, 1440 - 1454.e2
Claims 1-5: Paramsothy et al disclose a method comprising: determining a level of one or more metabolites (short-chain fatty acid biosynthesis, secondary bile acids, biotin, heme, dehydrolithocolate, lysine, heme) in a fecal sample from a human, wherein the subject has received a human fecal microbiota transplant comprising ten or more microbial strains: “Patients in remission after FMT had enrichment of Eubacterium hallii and Roseburia inulivorans compared with patients who did not achieve remission after FMT and had increased levels of short-chain fatty acid biosynthesis and secondary bile acids”. See p. 1440 column 2 under results, p. 1442 graph A showing the number of microbial strains in the fecal sample and under metabolomics p. 1443. Paramsothy et al disclose 228 metabolites were identified to differentiate (P < .05, Q < 0.15) between positive and negative primary outcomes at week 8 FMT. See p. 1447 column 1 last paragraph to column 2.
Claim 7: Paramsothy et al disclose the ten or more microbial strains are selected from table 4. See p. 1442 graph A showing the microbial strains in the fecal sample.
Claim 15: the one or more metabolites include lysine set forth in table 4. See figure 2 p. 1445.
Claim 16: disclose the one or more of the metabolites are associated with ulcerative colitis such as increased level of heme and lipopolysaccharide biosynthesis. See p. 1440 under results disclosing metabolites in patients who did not achieve remission after treat with the fecal microbiome transplant.
Claim 17: the human is suffering from ulcerative colitis.
Claim 18 and 20: the sample is fecal sample which comprises bacterial cell.
Claim 21: Paramsothy et al disclose quantifying the level of one or more metabolites in the fecal sample. See p. 1454.e2 under metabolite quantification.
Claim 22: Paramsothy et al disclose the method further comprises administering to the subject the composition comprising ten or more microbial strains i.e. “where applicable, a further 8 weeks of open-label treatment”. See p. 1441 under trial sample collection and p. 1443 column 1 lines 1-2.
Claims 23-25: Paramsothy et al disclose comparing the level of one or more metabolites in the sample from the subject to a reference value i.e. placebo which is a control reference value or a wherein the reference level is a level of one or more metabolites in a control sample from the subject, wherein the controls sample was obtained from the subject prior to the subject receiving the ten or more microbial strains i.e. baseline fecal sample prior to FMT. See p. 1443 under metabolomics.
Claim 26-27: the method of Paramsothy et al is a method of modulating the one or more metabolites in the subject, and the method characterizes the ability of the ten or more microbial strains to modulate one or more metabolites in the subject.
Claim 28: the method involves characterizing the metabolome of the subject. See p. 1443 under metabolomics.
Claim 29: the method of Paramsothy et al is a method of treating ulcerative colitis. See title and what you need to know on p. 1440-1441. See whole reference in its entirety.
Claim(s) 1, 2, 13, 14, 16, 17, 18, 19, 20, 21, 23-24, 26, 28 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Temesvari et al. Pediatr Res 34, 182–186 (1993).
Claims 1, 2, 13-14, 16, 17: Temesvari et al disclose a method comprising determining the level of metabolic acidosis HCO3-1 and PaCO2 in blood sample from piglets, wherein the piglets have received E. coli 0111.B4 lipopolysaccharide, wherein the metabolites are associated with the experimental neonatal meningitis in the piglets. See title, abstract, p, 183 column 2 first paragraph under results “cardiovascular and blood chemistry parameters”.
Claim 18-20: Temesvari et al disclose the sample is blood which comprise blood cells.
Claim 21: Temesvari et al disclose quantifying the level of HCO3-1 mM x L-1 and PaCO2 in blood sample from piglets in the blood from the piglet. See p, 183 column 2 first paragraph under results “cardiovascular and blood chemistry parameters”.
Claim 23: Temesvari et al disclose comparing the level of the metabolites in the sample from the subject to a reference value no LPS treatment. See p, 183 column 2 first paragraph under results “cardiovascular and blood chemistry parameters”.
Claim 26, 28, 29: Temesvari et al disclose the same method step of determining the level of the metabolite in a subject who has received the lipopolysaccharide, thus the method is a method of modulating one or more metabolite in the subject, is a method of characterizing the metabolome of the subject and is a method of treating or ameliorating experimental neonatal meningitis induced in the piglets by the lipopolysaccharide, wherein the experimental neonatal meningitis is associated with the metabolic acidosis metabolites.
Claim(s) 1-5, 7-8, 12, 15-24 and 26-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry. US 2016/0271188 9/22/16 cited in IDS.
Claims 1-3: Berry et al disclose a method comprising determining a level of one or more metabolites in a blood or fecal sample from a mammalian/human subject, wherein the subject has received a composition comprising ten or more microbial strains.
See paragraph 1192: To evaluate the effect of administered bacterial composition, optionally with one or more prebiotics, on SCFA, fecal pellets are collected to quantify SCFA levels, particularly acetate, propionate, or butyrate. SCFAs, creatines, and hydroxy-SCFAs are quantified by alkalinizing stool samples, obtaining fingerprints of the metabolic composition of the sample using 1D 1H NMR on a Bruker Avance-600 MHz Spectrometer, and analyzing with supervised multivariate statistical methods using Chenomx NMR Suite software.
See paragraph 1223: the blood is also submitted for metabolomics with the pure prebiotic composition administered as a control to demonstrate appropriate utilization and production of specific bacterial metabolites not present in compositions containing the combination of bacteria and prebiotic.
See paragraph 1026: In some aspects, the pharmaceutical composition, dosage form, or kit comprises at least one type of microbe and at least one type of prebiotic such that the composition, dosage form, or kit is capable of increasing the level of one or more immunomodulatory SCFA (e.g., acetate, propionate, butyrate, or valerate) in a mammalian subject.
See paragraphs 1012 and claims 1-7.
Claims 4-5: Berry et al disclose that microbiome strains are from a mammalian/human microbe. See paragraphs 1102-1112.
Claim 7, 8, 12: Berry et al disclose that the ten or more microbial strains comprise Gluconacetobacter hansenii, Terrisporobacter glycolicus (aka Clostridium glycolicum in table 1), Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, and Acidaminococcus sp.
See table 1, paragraph 15 and 20.
Claim 15: one of the metabolite is creatine which is listed in table 4. See paragraph 1192.
Claim 16-17: Berry et al disclose the metabolites are associated with inflammation since short chain fatty acids have many positive impacts on the health of the subject, by, for example, reducing a condition such as inflammation, or improving intestinal barrier integrity. See paragraph 642.
Claims 18-20: Berry et al disclose the sample is blood (which comprises blood cells) or feces. See paragraph 1192 and 1223.
Claim 21, 23, 24,: Berry et al disclose quantifying the level of one or more metabolites in the sample from the subject and comparing the level of metabolites in the sample to samples from a subject administered prebiotic composition alone. See paragraph 1192 and 1223.
Claim 22: Berry et al disclose further administering to the subject the composition comprising the ten or more microbial strains:
See paragraph 845 disclosing in preferred embodiments, metabolite profiles are taken at different time points during a patient's disease and treatment in order to better evaluate the patient's disease state including recovery or relapse events. In some embodiments, metabolite profiles inform subsequent treatment, including but not limited to alterations in dosage of therapeutic compositions, formations of prebiotic, or the administration of a particular prebiotic or bacterial population, in order to promote the growth, proliferation, colonization, and/or engraftment of a desired microbial population in the host.
Claim 26-29: Berry et al disclose the same method step of determining the level of the metabolite in a subject who has received the ten or more microbial strains; thus the method is a method of modulating one or more metabolite in the subject, is a method of characterizing the ability of ten or more microbial strains to modulate the one or more metabolite, is a method of characterizing the metabolome of the subject and is a method of treating or ameliorating inflammation in the subject. See paragraph 642.
Status of Claims
Claims 1-5, 7-8, 12-29 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645