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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/09/2026 has been entered.
Priority
This application is a 371 of PCT/JP2021/009831 filed 03/11/2021. Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Status of the Claims
Claims 11 is amended.
Claims 11, 13 and 14 are pending (claim set filed 06/09/2026) and are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 06/09/2026 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
Claim Rejections - 35 USC § 103
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 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 11, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (WO 2016153247 A1 on record in IDS) in view of Takahashi (Takahashi et al. FEMS Immun. Med. Microbiol., 2004, 41, 219-226) as evidenced by Lazear (Lazear et al. Immunity, 2019, 50, 907-923).
Regarding claim 11, Chang teaches Clostridium butyricum strains having immune enhancement, anti-viral and anti-bacterial activities and compositions containing the strain or culture thereof as active ingredient (Abstract). Chang discloses isolation and identification of two Clostridium butyricum strains, i.e. Fb5-3 and S-45-5 strains, with excellent antiviral activities (p. 5, 6th paragraph). Chang describes the probiotic compositions containing effective amount of Fb5-3 strain, S-45-5 strain or a culture medium thereof (p. 5, 12th paragraph). Chang provides example (Example 8) of oral administration of Clostridium butyricum S-45-5 strain in the effective amount of 1 x 103 for 10 or 21 days to mice followed by infection with influenza virus after pretreatment. Chang discloses induction of INF-β in serum, bronchoalveolar lavage fluid and small intestine of mice detected 12-36 hours after influenza virus infection for groups of mice pretreated for 10 or 21 days with Clostridium butyricum composition (p. 8, 10th paragraph, p. 11, 1st paragraph, Figure 15). INF-β is a type I interferon as evidenced by Lazear (Lazear et al. Immunity, 2019, 50, 907-923, Abstract). Chang describes monitoring body weights and survival of mice for 13 days after infection and demonstrates that after influenza virus attack all of the control mice died within 9 days, whereas only 20% of the group administered with Clostridium butyricum composition died and the body weights of survived treated mice recovered. Chang concludes that the composition showed excellent efficacy in the survival of mice by inhibiting influenza virus infection and proliferation (p. 10, last paragraph, Figure 14). Chang mentions that the strains can be used for prevention, health or therapeutic treatment (p. 6, 8th paragraph), however, provides working example of prevention rather than therapeutic treatment.
Chang does not teach Clostridium butyricum MIYAIRI 388 strain and does not teach administration of the strain after the virus infection.
Takahashi teaches effect of probiotic treatment with Clostridium butyricum on enterohemorrhagic Escherichia coli (EHEC) O157:H7 infection in mice. The probiotic agent is Clostridium butyricum MIYAIRI 588 (the claimed strain) (Abstract). Takahashi discloses that the MIYAIRI 588 strain of C. butyricum has been used as a probiotic for the treatment and prevention of non-antimicrobial induced diarrhea as well as antimicrobial-associated diarrhea in human and animal and has been approved for human clinical use since 1968 in Japan (p. 220, left column, 2nd paragraph). Takahashi describes oral administration of C. butyricum composition either 4 days before the infection with EHEC O157:H7 for prophylactic treatment or 2 days after infection for therapeutic treatment (p. 221, right column, 2nd paragraph). All infected mice died 7 days post infection. In contrast, the survival rate of the therapeutically treated mice (treated after infection) was 50% at 14 days after infection and the survival rate of the prophylactically treated mice was 100% at 14 days after infection (p. 223, right column, 2nd paragraph).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to test Clostridium butyricum MIYAIRI 588 strain from Takahashi teaching for production of interferons and treatment of virus infection as described in Chang teaching. One would have been motivated to do so since Takahashi and Chang teach strains of the same species, Clostridium butyricum, Takahashi describes strain approved for human clinical use and being able to prevent or treat bacterial infection. Besides, production of interferons type I and/or type Ill is inherent property of Clostridium butyricum MIYAI RI 588 strain. Pursuant to MPEP 2112.01(11 ), "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present." Therefore, Clostridium butyricum strain of Takahashi teaching can be used in Chang composition as interferon type I and/or type Ill promoter for treatment of virus infection.
Second, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Clostridium butyricum MIYAIRI 588 strain from Takahashi teaching for therapeutic treatment administering the strain composition after virus infection. One would have been motivated to do so since Chang mentions that the C. butyricum strains of his teaching can be used for prevention or therapeutic treatment and Takahashi demonstrates that MIYAIRI 588 strain increases survival of mice when used as therapeutic treatment and administered 2 days after infection and teaches that MIYAIRI 588 strain has preventative and therapeutic effects on bacterial infection. A skilled artisan would have reasonably expected success in that combination because Chang and Takahashi teach administration of Clostridium butyricum composition to prevent or treat infections. Thus, Chang and Takahashi teachings as evidenced by Lazear render claim 11 obvious.
Regarding claim 13, Chang teaches production of INF-β in mice pretreated with Clostridium butyricum composition and infected with influenza virus (p. 8, 10th paragraph, p. 11, 1st paragraph, Figure 15). Thus, Chang and Takahashi teachings as evidenced by Lazear render claim 13 obvious.
Regarding claim 14, Chang teaches treatment of influenza virus infection as described above. Chang mentions that the composition showed excellent efficacy in the survival of mice by inhibiting influenza virus infection and proliferation (p. 10, last paragraph, Figure 14). Thus, Chang and Takahashi teachings as evidenced by Lazear render claim 14 obvious.
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive. Applicant argues that Chang and Tabata do not teach or suggest administering the interferon
production promoter after the virus infection. These arguments are not persuasive because: (i) the new ground of rejection does not rely on prior art of Tabata and (ii) current rejection is based on combination of prior art of Chang and Takahashi as described above. Although Chang does not explicitly teach administering the Clostridium butyricum strain after the infection, Chang provides method of treating a virus infection with Clostridium butyricum strains causing induction of INF-β (type I interferon) (p. 8, 10th paragraph, p. 11, 1st paragraph, Figure 15) and mentions that the strains can be used for prevention or therapeutic treatment (p. 6, 8th paragraph) and Takahashi describes strain of the same species, i.e. claimed MIYAIRI 588 Clostridium butyricum strain, able to treat bacterial infection when administered post-infection (p. 221, right column, 2nd paragraph) providing motivation to use Clostridium butyricum MIYAIRI 588 strain from Takahashi teaching for therapeutic treatment of virus infection administering the strain composition after virus infection.
Applicant’s explanation of instant Examples wherein promoter was administered to mice already infected, i.e. after the virus infection is acknowledged.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
