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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/21/2026 is acknowledged.
Claims 1, 4-6, 8, 10, 13-14, 16, 18, 21-23, 25, 27, 30-32, 34, and 36-37 are pending. Claim 37 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 4-6, 8, 10, 13-14, 16, 18, 21-23, 25, 27, 30-32, 34, and 36 are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 5/21/2026 has been considered. A signed copy is enclosed.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on at least pages 6 and 9. 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 Objections
Claims 8, 25, and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12589123. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claim is drawn to a method of increasing gut biodiversity in a subject by administering C. butyricum MIYAIRI 588.
The patented claims are drawn to methods of treating cancer in a subject by administering C. butyricum MIYAIRI 588. If the method works as applicant claims, this would necessarily increase gut biodiversity in the subject. Therefore, the claim is anticipated.
Claim 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 19559903 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claim is drawn to a method of increasing gut biodiversity in a subject by administering C. butyricum MIYAIRI 588.
The patented claims are drawn to methods of treating cancer in a subject by administering C. butyricum MIYAIRI 588. If the method works as applicant claims, this would necessarily increase gut biodiversity in the subject. Therefore, the claim is anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 30 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 30 recites the limitation that the subject is undergoing allogeneic hematopoietic stem cell transplantation. However, the parent claim already requires this. Therefore, the claim does not further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tatarowicz et al (US Patent Application Publication 2013/0224164IDS filed 5/21/2026).
The instant claim is drawn to a method of increasing gut biodiversity in a subject by administering C. butyricum MIYAIRI 588.
Tatarowicz et al disclose methods where C. butyricum MIYAIRI 588 is administered to subjects (see paragraph 0013 and 0019) . If the method works as applicant claims, this would necessarily increase gut biodiversity in the subject. Therefore, the claim is anticipated.
Claims 1, 4-6, 10, 13-14, 16, 18, 21-23, 27, 30-32, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lobacki et al (WO2019/165285).
The instant claims are drawn to methods of treating or preventing GVHD, increasing gut biodiversity, or improving clinical outcomes in subjects undergoing allogeneic hematopoietic stem cell transplantation by administering C. butyricum MIYAIRI 588.
Lobacki et al disclose treatment or prevention of oncology-treatment induced conditions by administering live C. butyricum MIYAIRI 588 (see page 2, lines 11-15, page 8, lines 29-30, page 37, lines 14-19, page 62, lines 10-12). The subject can have GVHD (see page 5, line 4). The subject can be undergoing an allogeneic hematopoietic stem cell transplant (see page 18, lines 9-10 and page 19, lines 1-2). The subject can be a leukemia patient (see page 4, lines 1-6). The dosage of the composition can be 150mg per day, which is considered “about” 160 (see page 50, lines 12-35). The composition can be administered once daily and can be administered for at least 14 or 28 days (see page 52, lines 1-3 and 21-25).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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