DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 21 November 2025. Claim 1 has been amended. Claims 4, 8, 9, and 17 have been cancelled. Claims 1-3, 5-7, 10-16, and 18 are currently pending and under examination.
The present application claims priority to European Patent Application No. 22163966.9, filed March 24, 2022.
Withdrawal of Rejections:
The rejection of claims 1-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification of Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-7, 10-16, and 18 are rejected 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. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically the sporulation-negative Bacillus subtilis strain deposited at the Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures Inhoffenstr (Braunschweig, Germany) (DSMZ) under accession number DSM 33181, and a sporulation-negative mutant thereof. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Although Applicant has noted on p. 18 of the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
Response to Arguments
Applicant urges that the claims as amended overcome the current rejection.
Applicant’s arguments have been fully considered, but have not been found persuasive. As noted above, although Applicant has noted on p. 18 of the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
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.
Claims 1-3, 5-7, 10-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cantor et al. (WO 2020/038931; Published 2020 – Previously Presented).
With regard to claims 1-3, 5-7, 10-12, 16, and 18, Cantor et al. teach inoculation of a sporulation-negative Bacillus subtilis subsp. natto strain into a milk substrate, which is a food substrate, at the start of fermentation to produce a fermented dairy product (Abs.; p. 11, line to 38 to p. 12, line 2). The sporulation-negative Bacillus subtilis strain comprising one or more species selected from the Bacillus subtilis subsp. natto strains deposited at the Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures Inhoffenstr (DSMZ) under accession number DSM 33181, and mutants thereof (p. 7, line 20 to p. 8. Line 13; p. 33, line 10 to p. 34, line 14; Examples 1-4), wherein the Bacillus subtilis strain DSM 33181 and mutants thereof are necessarily capable of iron scavenging, as they are, or are derived from, the same species as claimed.
The Bacillus subtilis strain is inoculated into the milk substrate at concentrations including 107 to 109 CFU/ml, 107 to 108 CFU/ml, and at least about 104, 105, 106, 107, or 108 CFU/ml of the milk substrate (p. 14, line 9-23), all of which are fully encompassed within 104 to 109 CFU/ml. Thus, Cantor et al. teach adding an “effective amount” of a sporulation negative Bacillus subtilis strain to a food substrate, which provides the result of inhibiting or delaying growth of yeast in the fermented food product.
Cantor et al. teach that the sporulation-negative Bacillus subtilis strain is determined to form no spores when subjected to the following method: i) inoculating 1% of a culture of the strain to be tested, grown over night in Veal Infusion Broth (VIB) at 37°C, 180 rpm, into 50 ml of a standard sporulation inducing medium contained in a 500 ml baffled shake flask; ii) allowing the inoculated medium to grow overnight at 37°C while subjecting it to
shaking at 200 rpm; and iii) testing for spores the next day (p. 23, line 1-8; claim 1).
Cantor et al. teach the steps of the method as claimed, and include all the components as claimed. As the components cannot be separated from their functions, the results of: reducing the amount of free iron in the fermented food product, including to less than 0.4 ppm, as compared to an otherwise identical method where an effective amount of a sporulation-negative Bacillus subtilis strain is not added to the food substrate; and inhibiting or delaying the growth of yeast including Torulaspora spp., Cryptococcus spp., Saccharomyces spp., Yarrowia spp., Debaryomyces spp., Candida spp., Rhodoturola spp., Yarrowia lipolytica, Rhodotorula mucilaginosa, Cryptococcus fragicola, and Debayomyces hansenii, the method being effective to reduce the amount of the yeast in the food product by at least 25%, after 5 days of incubation at 17°C with the Bacillus subtilis strain, as compared to a food product not containing the Bacillus subtilis strain, would naturally and necessarily flow from performance of the method as taught by Cantor et al.
With regard to claims 13-15, Cantor et al. teach that the fermented dairy product includes: buttermilk, sour milk, cultured milk, smetana, sour cream, Kefir, and fresh cheese, such as quark, tvarog and cream cheese; and yogurt, including set yogurt, stirred yogurt, and drinking yogurt (p. 6, line 15-19; claim 6).
Response to Arguments
Applicant urges that the claims as amended overcome the current rejection.
Applicant’s arguments have been fully considered, but have not been found persuasive. The amended claims are addressed in the modified rejection above.
Conclusion
No claims are allowable.
Previously Presented Art of Record:
Cantor et al., WO 2019/043085; published 2019 (producing a fermented dairy product by fermenting a milk substrate with Bacillus subtilis subsp. natto).
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653