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 .
Claim Status
Claims 1-2, 5 and 15-16 were canceled.
Claims 17-24 were added.
Claims 3-4, 6-14 and 17-24 are pending and under consideration.
Withdrawn Rejections
Objection of Specification is withdrawn. Applicant amended the Title, thereby obviating this rejection/objection.
Rejection of Claim 4 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn. Attorney of record, over his or her signature and registration number, made a statement “Applicant notes that Bifidobacterium animalis subsp. lactis CNCM I-3446 was deposited by Applicant and has been accepted by an International Depository Authority under the provisions of the Budapest Treaty (as mentioned in the Specification). Applicant submits that all restrictions upon public access to the deposits will be irrevocably removed upon grant of a patent on this application and that the deposits will be replaced if viable samples cannot be dispensed by the depository.
Applicant further submits that Bifidobacterium animalis subsp. lactis B112, Bifidobacterium animalis subsp. lactis BLC1, Bifidobacterium animalis subsp. lactis DSM10140, Bifidobacterium animalis subsp. lactis V9, Bifidobacterium animalis subsp. lactis B1-04, Bifidobacterium animalis subsp. lactis Bi-07, Bifidobacterium animalis subsp. lactis B420, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium animalis subsp. lactis AD011, Bifidobacterium animalis subsp. lactis HN019, Bifidobacterium animalis subsp. lactis DN-173 010, Bifidobacterium animalis subsp. lactis ATCC 27536, and Bifidobacterium animalis subsp. lactis VTT E-012010 are publicly available.” (Applicant’s response filed 7/16/2026, page 8).
Rejection of Claim(s) 3-4 and 12-14 under 35 U.S.C. 102(a)(1) as being anticipated by Benyacoub et al (US10501530) is withdrawn.
Rejection of Claims 3-4 and 7-14 under 35 U.S.C. 103 as being unpatentable over Benyacoub et al (US10501530; published 12/10/2019; PTO-892) in view of David et al (US2014/0294789) is withdrawn.
Rejection of Claims 3-14 under 35 U.S.C. 103 as being unpatentable over Benyacoub et al (US10501530) in view of David et al (US2014/0294789) as applied to claims 3-4 and 7-14 above, and further in view of WO2020/063553 is withdrawn.
Applicant amended the claim 3 to recite “culture media comprising sugar and yeast extract, and sodium ascorbate and/or polysorbate” which was not previously recited in canceled claim 5, thereby obviating this rejection/objection.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 3-4, 6-14 and 17-24 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.
Claim 3 recites “culture medium comprising sugar and yeast extract, and sodium ascorbate and/or polysorbate” in line 5. Because conjunction “and/or” contains both “and” and “or”, claim 3 encompasses “culture medium comprising sugar and yeast extract, and sodium ascorbate or polysorbate”. In this case, due to mixed use of conjunction “and” and “or”, it is unclear what component is required in the culture medium. For example, is the “culture medium comprising sugar and yeast extract, and polysorbate” encompassed due to conjunction “or” between last two components?
Claim 24 recites “substantially all the Bifidobacterium lactis cells” in line 3. The limitation “substantially all the Bifidobacterium lactis cells” is a relative term which renders the claim indefinite. The term “substantially all the Bifidobacterium lactis cells” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of cells is allowed to be present after removing cells by the term.
Dependent claims depend from claim 3 and do not remedy the deficiency.
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 3-4, 10-12, 14, 18, and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-12, 14, and 17-26 of copending Application No. 18/294358 (hereinafter application’358; US2024/0335484). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 3 and 21-23, claim 1 of application’358 claims “A method for enhancing expression of anti-inflammatory cytokines and/or reducing expression of protein-inflammatory chemokines in the gastrointestinal tract of a subject having or at risk of an overactive immune system disorder comprising administering a Bifidobacterium lactis supernatant to the subject.” Furthermore, claim 3 of application’358 claims “A method for use in treating or preventing an IL-10 mediated disease by enhancing expression of IL-10 in the gastrointestinal tract of a subject comprising administering a Bifidobacterium lactis supernatant to the subject.” Claim 5 of application’358 claims that the Bifidobacterium lactis supernatant is obtained or obtainable by culturing Bifidobacterium lactis in a culture media comprising 1-6% sugar, 1-10% yeast extract, 0-0.5% sodium ascorbate, and 0-1% polysorbate.
The limitation “for treating or preventing a gastrointestinal disease by enhancing the growth of bifidobacteria in the gastrointestinal tract of a subject” of instant claim 3 is the expected result of the active process step. Because application’358 claims the same active process step “administering a Bifidobacterium lactis supernatant to the subject”, the application’358 will have same expected result.
Regarding claim 4, claim 4 of application’358 claims that the Bifidobacterium lactis is selected from the group consisting of: Bifidobacterium animalis subsp. lactis CNCM I-3446, Bifidobacterium animalis subsp. lactis B112, Bifidobacterium animalis subsp. lactis BLC1, Bifidobacterium animalis subsp. lactis DSM10140, Bifidobacterium animalis subsp. lactis V9, Bifidobacterium animalis subsp. lactis B1-04, Bifidobacterium animalis subsp. lactis Bi-07, Bifidobacterium animalis subsp. lactis B420, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium animalis subsp. lactis ADO11, Bifidobacterium animalis subsp. lactis HNO19, Bifidobacterium animalis subsp. lactis DN-173 010, Bifidobacterium animalis subsp. lactis ATCC 27536, and Bifidobacterium animalis subsp. lactis VTT E-012010.
Regarding claim 10, claim 10 of application’358 claims that compared to Bifidobacterium lactis culture media the Bifidobacterium lactis supernatant has: (i) a decreased concentration of total sugar; (ii) an increased concentration of total acids; and (iii) a decreased concentration of total amino acids.
Regarding claim 11, claim 11 of application’358 claims that the Bifidobacterium lactis supernatant comprises: (i) about 4 wt% or less total sugars; (ii) about 0.5 wt% or more total acids; and (iii) about 3.5 wt% or less total amino acids.
Regarding claim 12, claim 12 of application’358 claims that the Bifidobacterium lactis supernatant is used in combination with one or more probiotics, prebiotics, or synbiotics.
Regarding claim 14 and 20, claim 14 of application’358 claims that the IL-10 mediated disease is inflammatory bowel disease (IBD) or colorectal cancer. Therefore, claim 14 of application’358 claims treating same disease (i.e. inflammatory bowel disease (IBD) or colorectal cancer) by same active process step (i.e. administering a Bifidobacterium lactis supernatant to the subject) as instant claim 14.
Regarding claim 18, wherein-clause of claim 18 describes characteristics of supernatant, not the active process step of claimed method. Because application’358 claims that Bifidobacterium lactis is cultured in the same culture medium as instant invention, the supernatant of application’358 will have same characteristics as instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is 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 CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights