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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Acknowledgment is made of applicants' claim for foreign priority to Korean application KR 10-2021-0094298 filed on 07/19/2021. Certified copies of the foreign priority document(s) are present in the application file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/16/2025 and 12/20/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
It is submitted that Applicant has failed to adhere to the proper rules of presenting claim amendments according to 37 CFR 1.121. It is submitted that strikethrough of entire claim is not permitted. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment. 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by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered). 37 CFR 1.121(c). Claims 1, 4-13 have this deficiency and must be corrected. In the interest of compact prosecution, the claims are being examined and are subject to the rejections listed below.
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 5-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The term “overexpressed” of “overexpression” in claims 5-7 are a relative terms which render the claims indefinite. The term “overexpressed” 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.
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 4-13 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 written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim encompasses all recombinant microorganisms comprising the recombinant vector of claim 1. The specification however, describes recombinant microorganisms as exclusively E. coli. The disclosure provides working examples and experimental data only for E. coli host strains. The specification does not describe, yeast, fungi, algae, or other bacterial genera comprising the claimed vector or any structural features common to a broader genus of microorganisms. It is not conceivable that experimental data in E. coli can be used to demonstrate possession for all the enormous numbers of known microorganisms.
Because claim 4 encompasses a broad genus of recombinant microorganisms, yet the specification discloses only a single species (E. coli), without representative examples or identifying characteristics common to the claimed genus, the specification does not reasonably convey to one of ordinary skill in the art that the inventors had possession of the full scope of the claimed genus. Claims 5-13 are similarly rejected for the same reason stated above.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 1-3, it is noted that SEQ ID NOs 1 and 2 are novel and unobvious over prior art from the sequence search results. It is indicated that SEQ ID NO: 1 codes for CimA variant with I47V/E114V/H126Q/T204A/L238S mutations, which was well-known before the filing date of the instant application. (See Atsumi et al (Appl Environ Microbiol. 2008 Dec; PTO-892)). However, use of Mii with E24G/F163L/M184V mutations appears novel and unobvious over prior art.
Conclusion
Claims 4-13 have written description and indefiniteness deficiencies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633