DETAILED ACTION
Status of the Application
Claims 1-6 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment filed on 11/11/2024 amending the specification is acknowledged.
Priority
This application is a 371 of PCT/KR2023/006403 filed on 05/11/2023 and claims
foreign priority under 35 U.S. C. 119(a)-(d) to KR10-2022-0057992 filed on 05/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/11/2024 is acknowledged.
The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the
information disclosure statement is being considered by the examiner.
Specification
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification in Table 1 (pages 19-21) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: The claims lack the article "A" in front of recombinant. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jennewein et al. (EP3141610A1, published on 03/15/2017, cited in IDS filed on 11/11/2024, #6).
Claim 1 is directed to a recombinant Corynebacterium glutamicum transformed such that exogenous genes, including genes encoding lactose permease, genes encoding β-1,3-N- acetylglucosaminyltransferase, and genes encoding β-1,3- galactosyltransferase are expressed in Corynebacterium glutamicum, the recombinant Corynebacterium glutamicum transformed such that one or more genes selected from endogenous genes in Corynebacterium glutamicum, including genes encoding glutamine-fructose-6-phosphate aminotransferase, genes encoding phosphoglucosamine mutase, genes encoding glucosamine-1-phosphate N-acetyltransferase, genes encoding UDP-N-acetylglucosamine pyrophosphorylase, genes encoding phosphoglucomutase, genes encoding UTP-glucose-1-phosphate uridylyltransferase, and genes encoding UDP-glucose-4- epimerase are overexpressed. Claim 2 is directed to a recombinant Corynebacterium glutamicum transformed such that exogenous genes, including genes encoding lactose permease, genes encoding β-1,3-N- acetylglucosaminyltransferase, and genes encoding β-1,4- galactosyltransferase are expressed in Corynebacterium glutamicum, the recombinant Corynebacterium glutamicum transformed such that one or more genes selected from endogenous genes in Corynebacterium glutamicum, including genes encoding glutamine-fructose-6-phosphate aminotransferase, genes encoding phosphoglucosamine mutase, genes encoding glucosamine-1-phosphate N-acetyltransferase, genes encoding UDP-N-acetylglucosamine pyrophosphorylase, genes encoding phosphoglucomutase, genes encoding UTP-glucose-1-phosphate uridylyltransferase, and genes encoding UDP-glucose-4- epimerase are overexpressed. Claim 3 is directed to a method for producing lacto-N-tetraose comprising culturing the recombinant Corynebacterium glutamicum according to claim 1 in a medium containing lactose. Claim 4 is directed to the method according to claim 3, wherein the medium further contains glucose. Claim 5 is directed to a method for producing lacto-N-neotetraose comprising culturing the recombinant Corynebacterium glutamicum according to claim 2 in a medium containing lactose. Claim 6 is directed to the method according to claim 5, wherein the medium further contains glucose.
Jennewein et al. teaches a genetically modified microbial host cell comprising (i) a heterologous expressed β-1,3-N-acetylglucosaminyltransferase and (ii) a heterologous expressed β-1,3-galactosyltransferase or a heterologous expressed β-1,4-galactosyltransferase as glycosyltransferases (see claims 18 and 19). Jennewein et al. teaches that the genetically modified microbial host can be Corynebacterium glutamicum (see paragraph [0060]). Jennewein et al. teaches that the host cell can have a nucleic acid sequence coding for a functional lactose permease protein, LacY (see paragraph [0034]). Jennewein et al. teaches increased UDP-N-acetylglucosamine and UDP-galactose production capability comprises the overexpression of one or more genes encoding for proteins comprising the following activities for a: L-glutamine: D-fructose-6-phosphate aminotransferase, N-acetyl glucosamine-1-phosphate uridyltransferase/glucosamine-1-phosphate acetyl transferase, phosphoglucosamine mutase, UDP-galactose-4-epimerase, phosphoglucomutase, glucose-1-phosphate uridylyltransferase (see paragraph [0036]).
Jennewein et al. teaches the genetically modified microbial host cell comprising the characteristics as set forth herein are cultured in the presence of glucose, sucrose, glycerin or a combination thereof - using these substrates as carbon- and energy sources - as well as in the presence of lactose or oligosaccharides larger than disaccharides, e.g., LNT-II (see paragraph [0021]). Jennewein et al. teaches the β-1,3-galactosyltransferase or said β-1,4-galactosyltransferase, respectively, have the activity to galactosylate lacto-N-triose II thus generating lacto-N-tetraose or lacto-N-neotetraose, respectively (see paragraph [0028]). Therefore, the teachings of Jennewein et al. anticipate the instant claims as written/interpreted.
Conclusion
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON KIEFER, PhD whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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, Robert Mondesi can be reached at (408)918-7584. 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.
/DALTON EDWARD KIEFER/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
Prosecution Insights