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 .
Election/Restrictions
Applicant’s election of Group I, claims 1 – 9 in the reply filed on June 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1 – 20 are pending; claims 10 – 20 are withdrawn; claims 1 – 9 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 6, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 – 9 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Britton et al. (US 2020/020261) as evidenced by Sequence Search for SEQ ID NOs: 1, 2, 4, 5.
Regarding claim 1, Britton teaches engineered bacterial biosensors comprising a bacteria (bacterial host) expressing direct calprotectin-sensor sequences or indirect calprotectin-sensor sequences (calprotectin responsive promotor) operably linked to expression of a detectable readout product (reporter molecule) (abstract, 0007).
Regarding claim 2, the detectable readout product (reporter molecule) produces a detectable signal when calprotectin levels containing the biosensor reaches ≥100 ug/mL, or above a threshold level (0009).
Regarding claims 3 – 5, the bacterial host is Escherichia coli Nissle 1917 (0007).
Regarding claim 6, the readout product (reporter molecule) may be colorimetric or fluorescent such as green fluorescence protein, yellow fluorescent protein, blue fluorescent protein, or cyan fluorescent protein (0008).
Regarding claims 7 – 8, the calprotectin-sensor sequences (calprotectin responsive promotor) may be ykgMO (0046, prior art SEQ ID NO:1) which shares 92.1% with claimed SEQ ID: 1; 100% with claimed SEQ ID: 2; 84.3% with claimed SEQ ID: 4; and 96.8% with claimed SEQ ID: 5, or at least 80% identity with each of the claimed sequences (Seq Search for SEQ ID NOs 1, 2, 4, 5).
Regarding claim 9, the biosensors may be used to identify inflammatory bowel disease or Clostridium difficile infection (0006, 0027).
The reference anticipates the claimed subject matter.
Claims 1 – 9 are rejected under 35 U.S.C. 102a2 as being anticipated by Britton et al. (WO 2023/201243 OR US 2025/0237648, cited by US 2025/0237648) as evidenced by Sequence Search for SEQ ID NOs: 1, 2, 4, 5.
Regarding claim 1, Britton teaches engineered bacterial biosensors comprising a bacteria (bacterial host) expressing calprotectin responsive sequences (promotor) operably linked to expression of a detectable readout product (reporter molecule) (abstract, 0007).
Regarding claim 2, the detectable readout product (reporter molecule) produces a detectable signal when calprotectin levels reach > 50 ug/mL, or above a threshold level (0054).
Regarding claims 3 – 5, the bacterial host is Escherichia coli Nissle 1917 (0007).
Regarding claim 6, the readout product (reporter molecule) may be colorimetric or fluorescent such as green fluorescence protein, yellow fluorescent protein, blue fluorescent protein, or cyan fluorescent protein (0011).
Regarding claims 7 – 8, the calprotectin-sensor sequences (calprotectin responsive promotor) may be ykgMO (0008, 0013, 0016, prior art SEQ ID NO:1) which shares 100% identity with claimed SEQ ID: 2; 84.3% with claimed SEQ ID: 4; and 92.1% with claimed SEQ ID: 1(Seq Search for SEQ ID NOs 1, 2, 4, 5). Additional disclosed sequences 9 – 19 may also be included (0090), which includes sequences having greater than 80% to each of the claimed sequences (See Seq Search results).
Regarding claim 9, the biosensors may be used to identify inflammatory bowel disease, gut inflammation, infection (abstract, 0005).
The reference anticipates the claimed subject matter.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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