DETAILED ACTION
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 .
In this Action, references to the instant specification will be cited using the Pre-Grant Publication US 2023/0407243 A1.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 17 September 2025 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 September 2025. Claims 1-10 will be examined on the merits herein.
Priority
The instant application claims priority to US Provisional Appl. 63/352,569 (filed 15 June 2022). Therefore, the effective filing date of claims 1-10 is 15 June 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 August 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 4 recites, “a nucleic acid having the sequence as shown in SEQ ID NO: 255.” The term “having” is interpreted as open claim language. See MPEP 2111.03(IV).
Claim 6 recites, “optionally under the control of a constitutive promoter.” MPEP 2111.04(I) states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Thus, this optional limitation has been interpreted as not required by the claim.
Claim Rejections - 35 USC § 112(b)
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 and 8-9 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.
Regarding claim 5 (upon which claims 8-9 depend), where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Claim 5 recites, “an open variant of outer membrane ferric siderophore transporter FhuA.” The instant specification does not define the term “open variant” on its own or in the context of the FhuA transporter. Krishnamoorthy et al. (2016, Antimicrob. Agents Chemother.) teaches “an open variant of FhuA”, in which the N-terminal plug domain that prevents leakage is removed, creating a large hole in the transporter (pg. 7373, left col., para. 1). However, the phrase “an open variant” in both the art and the instant specification suggests more than one structure of open variant; thus, it is unclear what scope of FhuA structures is encompassed by the claim.
Claim Rejections - 35 USC § 112(a)
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.
Claim 4 is 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(s) 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.
It is apparent that the Escherichia coli strain deposited under IDAC accession number 310522-01 or 070623-01 is required to practice the claimed invention. As such, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the claimed E. coli strains.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The claimed E. coli strains were generated in part using the λ-Red recombineering system for deletion of some of the target genes (see specification, para. 160-162); however, the λ-Red system can result in “unintended genomic deletions” following the removal of the genes (para. 186). Because of these unpredictable, unintended genomic deletions, the process of obtaining the claimed E. coli strains (i.e., having identical genome sequences) described in the specification is not repeatable.
It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the 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 enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Allowable Subject Matter
Claims 1-3, 6-7, and 10 are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baba et al. (2006, Mol. Syst. Biol.; cited in IDS) teaches single gene knockouts of 33 of the 35 recited genes (does not teach mdtO or mdfA) (see Table S2), but does not teach any strain comprising deletions of at least 20 of the recited genes. Baba et al. also teaches that none of the claimed genes are essential to E. coli viability (Table S6).
Sulavik et al. (2001, Antimicrob. Agents Chemother.) teaches several efflux pump deletion E. coli strains: ΔacrEF, ΔacrAB, ΔyhiUV, ΔacrD, ΔyegMNO; ΔemrKY, ΔemrAB, ΔemrD, ΔmdfA; and ΔemrE. However, Sulavik et al. does not teach an E. coli strain comprising at least 20 of the recited genes, nor does it teach a motivation or rationale for combining the gene deletions taught in a single E. coli strain with other claimed drug efflux pump gene deletions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674