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
Applicant’s amendment filed on 08 October 2025 is entered. Claims 1-8, 11-12 and 26 are amended, claims 13-19 and 25 are canceled, and claims 27-28 are new. Claims 1-8, 11-12, 24, and 26-28 are pending and under examination.
Response to Amendment
The amended claim listing filed 08 October 2025 does not comply with 37 CFR 1.121(c) because canceled claims 9-10 are omitted from the claims listing.
Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
Claim Objections
Claim 6 is objected to because of redundant and convoluted limitation: wherein the genes encoding proteins that function in cell wall and capsule biosynthesis encode one or more protein selected from the group consisting of the following (1) to (7). This limitation may to amended to: wherein the encoded proteins are selected from the group consisting of: (1)…. Appropriate correction is required.
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.
(Maintained, modified to address claim amendment) Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Qiu et al. (Faecalibacterium prausnitzii upregulates regulatory T cells and anti-inflammatory cytokines in treating TNBS-induced colitis, Journal of Crohn's and Colitis (2013) 7, 558–568) in view of Ferreira et al. (Action and function of Faecalibacterium prausnitzii in health and disease, Best Practice & Research Clinical Gastroenterology 31 (2017) 643-648).
The broadest reasonable interpretation of the limitation “…a supernatant of the culture of the strain…” recited in claim 24 includes any molecule or metabolite produced or utilized by Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP, but does not include the cells themselves.
Qiu teaches the administration of probiotic Faecalibacterium prausnitzii strain ATCC 27766 and its supernatant to human peripheral blood mononuclear cells (PBMCs) and TNBS-induced colitis rat models, and that both the strain and its supernatant clearly induced anti-inflammatory cytokines IL-10 and TGF-β1 in both PBMCs and TNBS-induced colitis models, thereby ameliorating TNBS-induced colitis (Qiu abstract, figs. 1-2 and 7-8). Qiu teaches that the species Faecalibacterium prausnitzii is a potent anti-inflammatory probiotic bacterium capable of treating TNBS-induced colitis, and suggests Faecalibacterium prausnitzii is suitable for treatment and management of inflammatory bowel disease and colitis (Qiu pg. e566 para. 1). Qiu teaches that the administered F. prausnitzii strain ATCC 27766 was a centrifuged culture of the strain where the cells were washed and resuspended in PBS (reads on the suspension of instant claim 18) (Qiu pg. e559 sec. 2.1), and that the F. prausnitzii supernatant was obtained by centrifugation of a F. prausnitzii ATCC 27766 culture and subsequent filtration of the supernatant through a 0.22 µm sterility filter, thereby removing the F. prausnitzii ATCC 27766 cells (Qiu pg. e559 sec. 2.1). Qiu teaches that the supernatant contained some unidentified metabolites (Qiu pg. e563 Discussion para. 1).
However, Qiu does not teach the specific strain Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP, nor anti-inflammatory effects of any molecules/metabolites known to be produced or utilized by the specific strain Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP.
Ferreira teaches strains of the bacterial species Faecalibacterium prausnitzii produce butyrate and salicylic acid, and that Faecalibacterium prausnitzii is the most important butyrate-producing bacteria in the human colon. Ferreira also teaches that butyrate and salicylic acid have strong anti-inflammatory effects by suppressing pro-inflammatory IL-8 production, and that Faecalibacterium prausnitzii cell components induce anti-inflammatory IL-10 production (Ferreira sec. 1.1 para. 3 sent. 7-15 and Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to apply butyrate and/or salicylic acid produced by strains of the bacterial species Faecalibacterium prausnitzii, and/or cell components thereof, to treat inflammatory bowel diseases such as ulcerative colitis. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Qiu teaches that administration of the bacterial species Faecalibacterium prausnitzii and its supernatant comprising metabolites of the species treats and manages inflammatory bowel disease and colitis in a subject in need thereof (Qiu abstract and pg. 566 para. 1), and Ferreira teaches butyrate and salicylic acid, metabolites of the species Faecalibacterium prausnitzii, have strong anti-inflammatory effects by suppressing pro-inflammatory IL-8 production, and that Faecalibacterium prausnitzii cell components induce anti-inflammatory IL-10 production.
(New necessitated by amendment) Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Qiu in view of Ferreira as applied to claims 24 and 26 above, and further in view of Bicalho (US 20200268017 A1, published 27 August 2020, effectively filed 20 June 2017).
Qiu and Ferreira do not teach the Faecalibacterium prausnitzii strain, culture of the strain, lysate of the strain, or supernatant of the strain formulated as a pharmaceutical, food, or probiotics composition in the form of a tablet, pill, troche, lozenge, aerosol, emulsion, syrup, or elixir.
Bicalho teaches a live or dead Faecalibacterium prausnitzii strain, a culture of the strain, and a supernatant of the strain formulated as administrable pharmaceutical or food compositions (Bicalho [0045]-[0046] and [0053]-[0054]), and the composition is in the form of a tablet, pill, troche, lozenge, aerosol, emulsion, syrup, or elixir (Bicalho [0055]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to administer Bicalho’s composition comprising a live or dead Faecalibacterium prausnitzii strain, a culture of the strain, or a supernatant of the strain in Qiu and Ferreira’s method of treating inflammatory bowel disease. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because one of ordinary skill in the art would recognize that Bicalho’s composition comprising a Faecalibacterium prausnitzii strain, a culture of the strain, or a supernatant of the strain is in a suitable, administrable form that can be used in a method of treating a subject, such as the method of Qiu in view of Ferreira. Notably, Bicalho’s composition also comprises the same bacteria Faecalibacterium prausnitzii that is administered in the method of Qiu in view of Ferreira. Thus, one of ordinary skill in the art would reasonably expect Bicalho’s Faecalibacterium prausnitzii composition to be in an ideal form for administration to a subject in the method of Qiu in view of Ferreira.
(New necessitated by amendment) Claims 1-8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bicalho (US 20200268017 A1, published 27 August 2020, effectively filed 20 June 2017) in view of Ferreira et al. (Action and function of Faecalibacterium prausnitzii in health and disease, Best Practice & Research Clinical Gastroenterology 31 (2017) 643-648).
The BRI of the limitation “…a supernatant of a culture of the strain…” recited in claim 1 includes any molecule or metabolite produced or utilized by Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP, but does not include the cells themselves because the cells are removed after centrifugation.
Regarding claim 1, Bicalho teaches a live or dead Faecalibacterium prausnitzii strain, a culture of the strain, and a supernatant of the strain formulated as administrable pharmaceutical or food compositions (Bicalho [0045]-[0046] and [0053]-[0054]), and the composition is in the form of a tablet, pill, troche, lozenge, aerosol, emulsion, syrup, or elixir (Bicalho [0055]).
Bicalho does not teach the specific strain Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP, nor any specific molecules/metabolites known to be produced or utilized by the specific strain Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP.
Ferreira teaches strains of the bacterial species Faecalibacterium prausnitzii produce butyrate and salicylic acid, and that Faecalibacterium prausnitzii is the most important butyrate-producing bacteria in the human colon. Ferreira also teaches that butyrate and salicylic acid have strong anti-inflammatory effects by suppressing pro-inflammatory IL-8 production, and that Faecalibacterium prausnitzii cell components induce anti-inflammatory IL-10 production (Ferreira sec. 1.1 para. 3 sent. 7-15 and Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to formulate a tablet, pill, troche, lozenge, aerosol, emulsion, syrup, or elixir composition comprising a supernatant of any Faecalibacterium prausnitzii culture in order to form an administrable anti-inflammatory composition. One of ordinary skill in the art would have had a reasonable expectation of success because Ferreira teaches that butyrate and salicylic acid are metabolites produced by the bacterial species Faecalibacterium prausnitzii, so, commensurate with the BRI of the claimed term “supernatant of a culture of the strain”, one of ordinary skill in the art would reasonably expect Bicalho’s composition comprising a supernatant of a culture of any Faecalibacterium prausnitzii strain to comprise butyrate and salicylic acid, metabolites that Ferreira teaches have strong anti-inflammatory effects by suppressing pro-inflammatory IL-8 production.
Regarding claims 2 and 4-7, since the supernatant of the culture of Faecalibacterium prausnitzii strain KBL1027 having accession number KCTC14231BP does not comprise any cells, any cellular components or properties of the strain, such as its 16s rRNA gene sequence (claim 2) or genes that the strain comprises (claims 4-7), do not structurally limit the supernatant composition. Thus, if a composition in the prior art teaches all of the structural limitations of the composition of claim 1, claims 2 and 4-7 will be considered to be rendered obvious. As stated above, Bicalho in view of Ferreira teaches all of the structural limitations of the claimed composition.
Regarding claims 3, 8 and 11-12, the claims recite desired effects or capabilities of the composition of claim 1, but they do not add any new structural limitations to the composition of claim 1. Thus, if a composition in the prior art teaches all of the structural limitations of the composition of claim 1, claims 3, 8 and 11-12 will be considered to be rendered obvious. As stated above, Bicalho in view of Ferreira teaches all of the structural limitations of the claimed composition.
Response to Arguments
Applicant’s arguments, see Remarks filed 08 October 2025, with respect to the 35 USC §112(a) enablement of biological materials have been fully considered and are persuasive. Applicant provided the required statement for Budapest Treaty deposits that any restrictions imposed by the depositor on the availability of the deposit to the public will be irrevocable removed upon grant of the patent. The rejection under 35 USC §112(a) for lack of enablement of the public availability of biological materials of claims 1-8, 11-19, and 24-26 has been withdrawn.
Applicant's arguments filed 08 October 2025 have been fully considered but they are not persuasive.
Applicant's arguments (Remarks pg. 11 para. 1) fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
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 Alexander M Duryee whose telephone number is (571)272-9377. 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, Louise Humphrey can be reached on (571)-272-5543. 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.
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657