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 .
Status of Claims
Receipt of Arguments/Remarks filed on 4/7/2026 is acknowledged. Claims 1-2, 10, 12, 15-19, 22-23, 28-32, and 42-45 are pending. Claims 1-2, 10, 12, 15-18, 22, 28-30, and 42-45 were amended. Claims 3-9, 11, 13-14, 20-21, 24-27, and 34-41 were canceled. Claims 28-33 are withdrawn as being directed to a non-elected invention.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 1/12/2026 and 5/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Objections/Rejections
The objections to the drawings and to claims 17-19 has been withdrawn in view of amendments.
The rejection of claims 1-16, 22-23, 25-26, and 42-45 under 35 U.S.C. § 101 are withdrawn in view of amendments to the claims.
The rejections on the grounds of non-statutory double patenting over 18/569,805, 17/787,258, and 17/604,284 are withdrawn.
New and modified rejections necessitated by amendment
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 10, 15-19, 22-23, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernalier-Donadille US 2018/0214496 A1 (hereinafter Bernalier).
Regarding claim 1, Bernalier teaches a composition comprising Blautia sp., wherein the Blautia sp. is lyophilized (Bernalier p. 1 para. 8, p. 2 para. 16). Bernalier teaches that the composition may comprise an enteric coating (Bernalier p. 10 para. 140-141) or a preservative (Bernalier p. 10 para. 132).
Regarding claim 10, Bernalier teaches that the Blautia sp. is Blautia hydrogenotrophica (Bernalier p. 1 para. 11) or Blautia producta (Bernalier p. 3 para. 43).
Regarding claims 15-16, the limitations “reduces visceral motor reflex in the colon of subject treated with the composition” and “reduces pain in response to colorectal distension in a subject treated with the composition” are functional limitations of the claimed product. Any product having the same structure as claimed, i.e. the composition of claim 1, must necessarily have these same functions. Further, Bernalier teaches that the composition comprising Blautia is useful for treating or preventing visceral hypersensitivity, which is measured via visceral motor reflection (see instant specification para. 346; Bernalier p. 5 para. 61) and for reducing the response to colorectal distension, which is a manifestation of visceral hypersensitivity (Bernalier p. 5 para. 66).
Regarding claim 17, Bernalier teaches that the subject suffers from Crohn's disease, ulcerative colitis, functional dyspepsia, infantile colic, or inflammatory bowel disease/IBS (Bernalier p. 5 para. 67).
Regarding claims 18-19, Bernalier teaches that the composition may be administered to a mammal, including a human (Bernalier p. 7 para. 89).
Regarding claim 22, Bernalier teaches that the composition may include a prebiotic (Bernalier p. 7 para. 101).
Regarding claim 23, Bernalier teaches that prebiotics include non-digestible carbohydrate such as an oligo- or polysaccharide, sugar alcohol, inulin and transgalactooligosaccharides (Bernalier p. 8 para. 107).
Regarding claim 42, Bernalier teaches that the composition may be formulated as a pharmaceutical (Bernalier p. 8 para. 109).
Regarding claim 43, Bernalier teaches that the composition may be formulated as a nutritional supplement (Bernalier p. 8 para. 110).
Regarding claim 44, Bernalier teaches that the composition may be formulated as a dietary supplement, i.e. a food product (Bernalier p. 8 para. 110).
Regarding claim 45, Bernalier teaches that the composition may be formulated as a medical food, i.e. a food that provides therapeutic benefit (Bernalier p. 8 para. 110).
Claims 1-2, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Culler et al., WO 2019/178542.
Regarding claim 1, Culler teaches a composition comprising Blautia sp. (Culler p. 5 lines 18-24). Culler teaches that the bacteria of the composition can be lyophilized (Culler p. 29 lines 4-8) and that the composition may comprise an enteric coating (Culler p. 58 lines 6-10) or preservative (Culler p. 29 lines 18-20).
Regarding claim 2, Culler teaches that the composition further comprises microbes of Akkermansia, Bacteroides, Bifidobacterium, Clostridium, and/or Ruminococcus (Culler p. 5 lines 18-24) as well as Anaerostipes, Collinsella, and/or Coprococcus (Culler p. 11 lines 9-26).
Regarding claim 10, Culler teaches that the Blautia sp. may be B. hydrogenotrophica or B. producta (Culler p. 6 lines 2-5).
Regarding claim 12, Culler teaches that the composition further comprises Collinsella aerofaciens and Bifidobacterium longum (Culler p. 11 lines 9-26).
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.
Claims 1-2, 10, 12, 15-19, 22-23, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 10-12, and 14-15 of U.S. Patent No. US11583558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claim 14 of ‘558 recites a microbial composition comprising Akkermansia muciniphila as a primary fermenter, Bifidobacterium infantis as a primary fermenter, Eubacterium hallii as a secondary fermenter, Clostridium beijerinckii as a secondary fermenter, and Clostridium butyricum as a secondary fermenter. Claim 15 of ‘558 recites that the composition comprises Blautia hydrogenotrophica. Claim 5 of ‘558 recites that the composition comprises an enteric coating.
Regarding claims 15-19, these claims recited intended use limitations. Any product having the claimed structure is capable of performing the intended use. As set forth above, ‘558 teaches the product of claim 1.
Regarding claims 2, 10, 12, 22-23, and 42, the limitations of these dependent claims are recited in claims 1, 5, 7, 10-12, and 14-15 of US Patent ‘558.
Claims 1-2, 10, 12, 15-19, 22-23, and 42-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 7, 10, 12-14, 17, and 19 of copending Application No. 18/847,148 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claim 6 of ‘148 recites a composition comprising Blautia hydrogenotrophica and/or Blautia producta. Claim 10 of ‘148 recites that the composition comprises an enteric coating, a preservative, or lyophilized bacteria.
Regarding claims 15-19, these claims recited intended use limitations. Any product having the claimed structure is capable of performing the intended use. As set forth above, ‘148 teaches the product of claim 1.
Regarding claims 2, 10, 12, 22-23, and 42-45, the limitations of these dependent claims are recited in claims 5, 7, 10, 12-14, 17, and 19 of copending ‘148.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In light of amendments to the claims, the rejection of claims 1-16, 20-25, and 42-45 under 35 U.S.C. § 102 as anticipated by Cutcliffe; the rejection of claims 1, 6, 10, 15-16, 22-23, 26-27, and 42-45 under 35 U.S.C. § 102 as anticipated by Cani, and the rejection of claims 1, 10, 15-16, 25, and 42-45 as anticipated by Johnson; have been withdrawn. However, upon further consideration, new grounds of rejection of claims 1, 10, 15-19, 22-23 and 42-45 are made under 35 U.S.C. § 102 in view of Bernalier, and new grounds of rejection of claims 1-2, 10, and 12 are made under 35 U.S.C. § 102 in view of Culler as set forth above. Given these new grounds of rejection, the arguments presented regarding claims rejected under 35 U.S.C. § 102 in view of Cutcliffe, Cani, or Johnson are moot.
In light of amendments to the claims, the rejections on the grounds of non-statutory double patenting have been modified as set forth above.
Conclusion
Claims 1-2, 10, 12, 15-19, 22-23, and 42-45 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila 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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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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