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 .
DETAILED ACTION
Claims 1-22, 24, 26, and 42 remain cancelled. Claims 23, 25, 27-41, 43, and 44 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/09/2026 has been entered.
Response to Arguments
With respect to the rejection of claims 23, 25, 27-41, 43, and 44 under 35 USC 103, Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive. Applicant argues that there is nothing specific in Borody that specifically points to the use of Coprococcus comes, and that Borody teaches that this species may be present or absent from the composition. However, because Borody teaches that Coprococcus comes may be present, it would be obvious to one of ordinary skill in the art that a microbial composition comprising Coprococcus comes may be used to treat GI disorders such as inflammatory bowel disease, as stated. Applicant argues that Borody doesn’t teach that Coprococcus comes may have therapeutic activity on its own. However, the claim contains open language and therefore does not require that the composition contains only Coprococcus comes or a culture extract thereof.
Applicant argues that Borody does not teach using a culture extract of any bacterium to treat any disease. However, as stated, Borody teaches a method of centrifugation, wherein the supernatant separated during centrifugation is filtered to remove bacteria while keeping their secretions, such as antimicrobial bacteriocins, bacteria-derived cytokine-like products, and all accompanying biologically active molecules (para. [0128]). Borody teaches that the composition may comprise purified microbiota and a non-cellular fecal filtrate (para. [0130]). Therefore, it would be obvious to one of ordinary skill that a culture extract, in the form of a supernatant, containing biologically active molecules produced from Coprococcus comes may be used to treat a disorder such as a metabolic syndrome or an inflammatory bowel disease.
Applicant argues that the teaching of Marinelli has since been contradicted. However, the evidentiary reference is no longer relied on for the rejection presented in this Office action. Independent claim 23 recites: A method of treating a disease…comprising administering a composition comprising a culture extract of a Coprococcus comes bacterium optionally in combination with a Coprococcus comes bacterium exhibiting AhR agonist activity… Therefore, it is interpreted that a Coprococcus comes bacterium exhibiting AhR agonist activity is an optional, and thus not required, limitation of the instant claims.
Claim Rejections - 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.
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.
Claims 23, 25, 27-41, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Borody et al. (US2017/0348360 A1), previously cited, as evidenced by Liu et al., 2019 (Alterations in the gut microbiome and metabolism with coronary artery disease severity).
Regarding claims 23, 25, 27, and 28, Borody teaches compositions and methods for the treatment of GI disorders such as inflammatory bowel disease (Abstract). Borody teaches that the therapeutic composition comprises one or more isolated, purified, or cultured fecal microorganisms, which may include Coprococcus comes (Paragraph [0117]). Borody does not explicitly teach that the culture extract of Coproroccus comes may be used to treat disorders such a metabolic syndrome, IBS, etc. However, Borody teaches a method of centrifugation, wherein the supernatant separated during centrifugation is filtered to remove bacteria while keeping their secretions, such as antimicrobial bacteriocins, bacteria-derived cytokine-like products, and all accompanying biologically active molecules (para. [0128]). Borody teaches that the composition may comprise purified microbiota and a non-cellular fecal filtrate (para. [0130]). Therefore, it would be obvious to one of ordinary skill that a culture extract, in the form of a supernatant, containing biologically active molecules produced from Coprococcus comes may be used to treat a disorder such as a metabolic syndrome or an inflammatory bowel disease.
Regarding claim 29, Borody teaches that the microbial preparation comprises one or more live fecal microorganisms, which may include Coprococcus microorganisms (Paragraph [0117]).
Regarding claims 30 and 31, Borody teaches that the therapeutic composition may also comprise microorganisms selected from the group consisting of Eubacterium, Bacteroides, Lactobacillus, Ruminococcus, Faecalibaterium, or Escherichia coli (Paragraph [0116]). It is interpreted that the production of an AhR agonist is an inherent capability of the aforementioned bacterial genera.
Regarding claim 32, Borody teaches that the pharmaceutical composition may comprise Faecalibacterium prausnitzii A2-165 (Paragraph [0179]).
Regarding claim 33, as stated above, Borody teaches that the therapeutic composition may comprise one or more microorganisms (Paragraph [0116]).
Regarding claim 34, Borody teaches that the therapeutic composition may be administered orally or rectally (Paragraph [0287]).
Regarding claims 35, Borody teaches that the method may be used to treat metabolic syndrome, fatty liver, or type II diabetes (Paragraph [0014]).
Regarding claim 36, Borody teaches that the method may be used to treat disorders associated with dysfunctional intestinal microbiota (Abstract). Coronary artery disease is associated with gut microbiota alterations, as evidenced by Liu (Abstract). Therefore, it is considered that coronary heart disease may be treated using the invention of Borody.
Regarding claim 37, Borody teaches that the method may be used to treat fatty liver or type II diabetes (i.e., insulin resistance) (para. [0014]).
Regarding claim 38, Borody teaches that the method may be used to treat metabolic syndrome (para. [0014]).
Regarding claims 39 and 40, Borody teaches that the method may be used to treat Crohn’s disease or ulcerative colitis (para. [0014]).
Regarding claim 41, although Borody does teach that the therapeutic composition may be used to treat antibiotic-associated colitis (Paragraph [0261]), Borody teaches the treatment of a multitude of other disorders, as described above. Therefore, it would be obvious to one of ordinary skill that diseases other than antibiotic-associated colitis may be treated with the invention of Borody.
Regarding claim 44, as stated, Borody teaches a C. comes strain for the treatment of GI disorders. Because of the limitation “a mutant thereof”, any Coprococcus comes strain with an effect on the GI tract that shares any percent homology with C. comes strain DSM 33359 would be a mutant thereof.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Borody et al., (US2017/0348360 A1) as applied to claim 23 above, and further in view of Henn et al., (US 9,028,841 B2).
Borody teaches methods of treating disorders such as metabolic syndrome (para. [0014]), but does not teach the treatment of lipodystrophy.
However, Henn teaches therapeutic compositions for the treatment of symptoms associated with dysbiosis of a mammalian subject (Abstract). Henn teaches that the composition comprises at least a first type of an isolated bacterium capable of forming a spore and at least a second type of an isolated bacterium capable of forming a spore (Column 2, lines 51-55). Henn teaches that the bacteria are selected from Table 1 (Column 3, line 25). Table 1 (Page 46) includes Coprococcus comes. Henn teaches that Table 6 provides representative human diseases for which the bacterial compositions are useful. Table 6 (Page 266, Column 512) includes lipodystrophy.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have treated lipodystrophy, as taught by Henn, by administering a culture extract of Coprococcus comes, as taught by Borody. One of ordinary skill in the art would have been motivated to do so because Henn teaches that a bacterial composition that may comprise Coprococcus comes may be used to treat lipodystrophy, as discussed above. One of ordinary skill in the art would have been motivated to do so because Borody and Henn are in the same field of endeavor of probiotic development for the treatment of dysbiosis-associated disorders.
Allowable Subject Matter
There are no prior art references that teach a Coprococcus comes strain with accession number DSM 3359.
The following claim amendment, drafted by the examiner and considered to distinguish patentably over the art of record in this application, is presented to Applicant for consideration:
Cancel claims 25 and 44.
Claim 23. A method of treating or, comprising administering to a subject in need thereof a composition comprising a Coprococcus comes strain deposited with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) under accession number DSM 3359,
wherein the Coprococcus comes strain is capable of producing an AhR agonist.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657