DETAILED ACTION
Notice of 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 .
Status of Application
Claims 1-20 are pending and subject to examination on the merits.
Priority
The instant application is a 371 of PCT/CN2023/106980 filed 12 July 2023 which claims benefit of US provisional application 63368373 filed 14 July 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05 January 2026 has been considered by the examiner. See initialed and signed PTO/SB/08.
Compliance with Sequence Rules
The sequence listing, filed in computer readable form (.xml) on 13 January 2025, has been received and entered. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.831(b). However, this application fails to fully comply with the requirements of 37 C.F.R. 1.831-1.839.
The following Figures/parts of the specification contain sequences that contain four or more specifically defined amino acids or ten or more specifically defined nucleotides without any corresponding SEQ ID NO: and/or no reference to any SEQ ID NO: in the Brief Description of the Drawings. Reference to the specification is made to the as-filed 20 page specification (see below).
In Figures 4A (x2), 4B (x2) and 4C (x1), amino acid sequences are identified without any corresponding sequence identity in the Figures themselves or in the Brief Description of the Drawings.
In paragraph 0041, an amino acid peptide fragment is shown without any sequence identifier.
In paragraph 0054, a peptide fragment is shown without any sequence identifier.
In paragraph 0078, a peptide fragment is shown without any sequence identifier.
* If the noted sequences are in the sequence listing as filed, Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO:. If the noted sequences are not in the sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (.xml), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify the identified sequences by SEQ ID NO: and (5) an updated incorporation by reference statement with the new date of creation, sequence file name and size. – See also MPEP 2422.
Specification
The disclosure is objected to because of the following informalities: there are no page numbers for the submitted 20 page specification.
In addition, two different specifications have been submitted on the same day; one that is 19 pages and has 106 paragraphs and one that is 20 pages but which abruptly ends mid sentence of paragraph 0086. Clarification and corrections are required.
Appropriate correction is required.
Claim Objections
Claim 10 is objected to because of the following informalities: the first time an acronym is utilized the full name should be spelled out with the acronym following in parenthesis. This is directed to the acronym BADAN.
Claim 11 is objected to because of the following informalities: the claim can be improved with respect to grammar by deleting “any” before “claim 5” in the first line of the claim. Appropriate correction is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 and 14 recite a protein comprising a polypeptide having at least 95% sequence homology with an amino acid selected from the group consisting of SEQ ID NOs: 1-5, and wherein the amino acid at position 70 of SEQ ID NOs: 1-5 must be Cys (it is noted, position 70 in SEQ ID NOs: 1-5 is occupied by a Phe). However, it is not clear if the polypeptide has at least 95% sequence identity to SEQ ID NOs: 1-5 before or after the Phe at position 70 has been replaced by Cys.
This confusion carries over to claims 4/8/17 and 9 which recite, on the one hand, the polypeptide comprises SEQ ID NO: 1, which has a Phe at position 70 (claims 4/8/17) or the polypeptide comprises SEQ ID NO: 6 which has a Cys at position 70 (e.g. it is SEQ ID NO: 1 having a Phe70Cys replacement).
Clarification is requested.
References of Interest – Not Relied Upon
Sun et al. (Nature Communications, 2018 – cited herein) teach the state of the art and numerous site-directed mutagenesis studies on NDM-1 (e.g. instant SEQ ID NO: 1). None involved Phe70.
Khan et al. (BMC Microbiology, 2017 – cited herein) the structure and differences between NDM beta-lactamase variants 1-13.
Thoden et al. (JBC, 2023 – cited herein) is post-filing art teaching the X-ray crystal structure of NDM-4 (e.g. instant SEQ ID NO: 4, which differs from NDM-1/SEQ ID NO:1 by a single substitution at M154L substitution). They teach the structure is basically like others determined for NDM-1; where L1 (loop 1) which is inclusive of Phe70 is involved in hydrophobic interactions of substrates. It would not be obvious to substitute an amino acid which is so close to the substrate with a cysteine which is then labeled with a fluorophore for fear of destroying or altering catalytic properties (See Computational Studies, p. 7).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 30 August 2026
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