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 .
Claims 3, 8, and 10 are canceled.
Claims 1, 2, 4-7, and 9 are pending and examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
(1) Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. In particular, the size of the XML file is in kilobytes in the amendment to the specification filed August 2, 2024. As highlighted above, the size of the file should be in bytes.
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 incorporation by reference paragraph, 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.
(2) Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). In particular, the sequences in Table 1 on page 12 of the specification are not referenced by their sequence identifiers.
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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The embedded hyperlink is on page 6, line 25 of the specification.
Claim Objections
Claims 7 and 9 are objected to because of the following informalities:
Claim 7 is objected to because the recitation “Corynebancterium” in line 3 is a misspelling of the term “Corynebacterium.”
Claim 9 is objected to because it recites a period at the end of the second-to-last line, after the recitation of “metabolite.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4, 6, 7, and 9 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 4 is indefinite because it recites a use but fails to recite steps. See MPEP 2173.05(q). Claim 4 does not set forth how the promoter is used in improving the production or yield of a microbial metabolite, or in constructing a production strain for a microbial metabolite.
The term “strong promoter” in claim 6 is a relative term which renders the claim indefinite. The term “strong promoter” 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 is required for a promoter to be considered “strong.”
Claim 7 recites the limitation "The recombinant microorganism of claim 4" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 4 do not recite a recombinant microorganism.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the recombinant microorganism is a Corynebacterium glutamicum.
Claim 9 is indefinite because it recites a use but fails to recite steps. See MPEP 2173.05(q). Claim 9 does not set forth how the recombinant microorganism is used in any one of (1)-(3), so no steps are recited.
Also, claim 9 recites the limitation "the recombinant microorganism of claim 4" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 4 do not recite a recombinant microorganism.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 4 recites a use of the promoter of claim 1 without any active, positive steps delimiting how this use is actually practiced; and claim 9 recites a use of a recombinant microorganism without any active, positive steps delimiting how this use is actually practiced. Therefore, claims 4 and 9 do not properly set forth a process. See MPEP 2173.05(q)(I).
Claim Interpretation
Claim 7 is being interpreted as: A recombinant microorganism that is a Corynebacterium species.
Claim 9 is being interpreted as: Use of a recombinant microorganism in any one of:
producing a microbial metabolite or a derivative thereof;
selecting a strain for producing a microbial metabolite or a derivative thereof; and
increasing the production and/or yield of a microbial metabolite;
optionally, wherein the microbial metabolite is threonine.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
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 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogt (Appl. Microbiol. Biotechnol. 2015. 99: 791-800. Listed on IDS filed 3/16/26).
Vogt discloses strains created using promoter mutations of synthesized fragments in pK19mobsacB to achieve allelic replacement in the genome of MH20-22B in two rounds of positive selection (page 792, right column, third paragraph). The strain is shown in Table 1 on page 793 as Corynebacterium glutamicum MH20-22B. A mutated strain of C. glutamicum MH20-22B created by Vogt is directed to a recombinant strain that is a Corynebacterium species. Therefore, instant claim 7 is anticipated.
The mutated strains produce L-isoleucine, and Vogt found that the best combination of genomic mutations was found in their K2P55 strain, where 53 mM L-isoleucine could be obtained (abstract). L-isoleucine is directed to a microbial metabolite. Therefore, Vogt discloses use of a recombinant microorganism (e.g., K2PP strain) in producing a microbial metabolite (L-isoleucine). Therefore, instant claim 9 is anticipated.
Conclusion
The closest prior art to the claimed invention is Vogt discussed above. Vogt discloses a mutated dapA promoter (page 792, right column, last paragraph; Table 1 on page 793). The promoter of Vogt differs from the promoter of the instant claims (in particular, instant claim 1) in that the promoter of Vogt does not have a nucleotide sequence of SEQ ID NO.1 of the instant claims. Therefore, Vogt does not disclose the invention of claims 1, 2, and 4-6.
Claims 1, 2, and 5 are allowed.
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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