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
The claim set filed 8/28/2024 is acknowledged.
Claims 1-20 are cancelled.
Claims 21-32 will be examined on the merits herein.
Priority
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.
Information Disclosure Statement
There is no English translation provided for all foreign references, accordingly these references have not been considered further than an English title or abstract. If the applicant wishes to have them further considered the applicant needs to provide a full English translation.
Claim Objections
Claims 22 and 25 are objected to because of the following informalities: The claims contain two periods at the end of the claim. Appropriate correction is required.
Claim 22 recites “necphalomyelitis” which is an apparent typographical error for encephalomyelitis. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 21, 25, 27, and 30 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 21, 25, and 30, are indefinite the claims recite “a vesicle derived from the strains, a lysis solution of the strains, a culture solution of the strains” since strains is plural it appears to refer to more than 1, however if is not clear if all five of the strains are part of the limitation or just 2 or more, or if it was meant to only be one or any combination thereof.
In the interest of compact prosecution, the examiner will interpret this as each of these components being of one or more of the aforementioned strains.
Claim 27 recites “wherein the infection caused by gram-negative bacteria” however claim 25 from which it depends does not recite an infection caused by gram-negative bacteria. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 is indefinite as it recites “wherein the infection caused by gram-negative bacteria is caused by bacteria belonging to the Clostridium sp.” Clostridium are gram-positive, not gram-negative bacteria.
Claim 27 can be corrected by writing it as follows. The method of claim 25, wherein the infection is caused by gram-negative bacteria belonging to the Helicobacter sp., the Escherichia sp., or the Salmonella sp., or the infection is caused by gram-positive bacteria belonging to the Clostridium sp.
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)(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 25, 27, 28, and 30-31 are rejected under 35 U.S.C. 102 (a)(1) and 102(a)(2) as being anticipated by US 20180169157 A1 (Publication 2018-06-21) hereinafter 157 as evidenced by Wikipedia (Blautia obeum – Wikipedia.pdf) hereinafter WikiObeum and Baxter et al (Dynamics of Human Gut Microbiota and Short-Chain Fatty Acids in Response to Dietary Interventions with Three Fermentable Fibers. mBio. 2019 Jan 29;10(1):e02566-18. doi: 10.1128/mBio.02566-18. PMID: 30696735; PMCID: PMC6355990).
Regarding claims 25, 27, and 28, 157 teaches compositions for treating Clostridium difficile infection comprising Rumminococcus obeum which is Blautia obeum par.8-9. 157 teaches a composition F comprising Rumminococcus obeum having SEQ ID NO: 32 in fig.13 and used this composition to treat mice infected with C. difficile in Example 4, 157 teaches the data demonstrate Composition F protect against and/or treat C. difficile infection par.255-257 and allows 100% survival as indicated by the gem shaped markers on the graph in fig.16.
It is noted that Rumminococcus obeum is a synonym for Blautia obeum WikiObeum p.1 bottom of the informational box on the right.
Regarding claim 30 amelioration of intestinal health is the result of the treatment since C. difficile infects the intestine, 157 par.4, and outcomes in mice were improved as detailed above.
Regarding claim 31, the rejection of claim 30 details inhibition of harmful bacteria, furthermore growth of beneficial bacteria is also the outcome of the method of treatment with B. obeum as evidenced by Baxter. Baxter discloses “short-chain fatty acids (SCFAs) are major end products of bacterial fermentation in the human colon and are known to have wide-ranging impacts on host physiology. Butyrate in particular is important for maintaining health via regulation of the immune system” p.1 par.3. Ruminococcus was more likely to yield higher butyrate concentrations, especially when their microbiota were replete with populations of the butyrate-producing species Eubacterium rectale p.1 abstract. Eubacterium rectale can grow on degradation products of resistant starch released by R. bromii p.2 last paragraph and p.3 first paragraph. Therefore R. bromii promotes growth of E. rectale which is a beneficial bacterium because they increase SCFA production which maintains health and regulation of the immune system.
Claims 25 and 26 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hsiao et al. (Members of the human gut microbiota involved in recovery from Vibrio cholerae infection. Nature. 2014 Nov 20;515(7527):423-6. doi: 10.1038/nature13738. Epub 2014 Sep 17. PMID: 25231861; PMCID: PMC4353411) as evidenced by Wikipedia (Vibrio cholerae – Wikipedia.pdf) hereinafter WikiCholerae.
Regarding claims 25 and 26, Hsiao teaches a treatment of mice infected with the gram-negative bacterial pathogen Vibrio cholerae with Ruminococcus obeum which is Blautia Obeum p.1 title and fig.1a black bars. This graph demonstrates that R. obeum restricts V. cholerae colonization.
It is noted that V. cholerae is a gram-negative bacterium, WikiCholerae p.1 par.1.
It is noted that Ruminococcus obeum is a synonym for Blautia obeum WikiObeum p.1 bottom of the informational box on the right.
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.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over KR20190011806A (Published 11/18/2019, machine translation provided) hereinafter 806 as evidenced by CDC (Crohn's Disease Basics _ IBD _ CDC.pdf) hereinafter CDCCrohns.
Regarding 21-23 claims , 806 teaches compositions comprising bacterial strains isolated from mammalian digestive tracts and to the use of such compositions in the treatment of diseases p.2 par.2 after Description. 806 teaches a preferred embodiment the composition of the present invention is used for the treatment or prevention of IBS, Crohn's disease, ulcerative colitis p.3 par.6. Crohn’s disease is an inflammatory disease, instant specification p.7 last paragraph. 806 teaches “a further embodiment of the present invention, the bacterial strain in the composition has Blautia wexlerae”
Regarding claim 23 it is noted that Crohn’s disease is a disease of the digestive track CDCCrohns p.1 Key Points.
It would have been obvious to a person having ordinary skill in the art to try treatment of Crohn’s disease with Blautia wexlerae because 806 only listed 3 choices of species in their disclosure to try from.
There would have been reasonable expectation of success because 806 teaches their use in compositions for treating multiple inflammatory diseases p.6 par.4.
Allowable Subject Matter
The examiner has noted that searching the art of the SEQ ID NO: 1-5 did not yield any prior art, therefore SEQ ID NO: 1-5 are free of the prior art.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/JOANNE HAMA/ Supervisory Patent Examiner, Art Unit 1647
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