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 .
Power of Attorney
There is no Power of Attorney on file and it is recommended that applicant submits one to facilitate prosecution.
Priority
The instant application is a national stage entry of PCT/US2022/024071 (filed on 4/08/2022), which claims priority benefit of U.S. Provisional Application No. 63/172321 (filed on 4/08/2021), under 35 U.S.C. 119(e).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/15/2023 is in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all cited references have been fully considered.
Drawings
The drawings are objected to because of improper label: Figure 8A presents two gels scans that are split among two pages, one of which is identified as “Fig. 8A-cont’d”. According to 37 C.F.R. 1.84(u)(i), “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.””. See MPEP § 608.02(V). It is recommended that applicant corrects this issue by deleting Fig. 8A and Fig. 8A-con’td (pages 9-10, Drawings) and replacing them with a new figure showing the two gel scans together in one page and labeled as “Fig. 8A”.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objections
Claim 2 is objected to because of the following informalities: “a substituted or unsubstituted aryl” is recited twice in three different paragraphs (lines 4-6 in the first wherein clause; lines 11-13 in the second wherein clause; lines 17-19 in the third wherein clause). Appropriate correction is required.
Claim 3 is also objected to due to the repetition of “a substituted or unsubstituted aryl” (lines 4-6).
Claims 4, 6-7, and 12 are objected to since each of these claims do not end with a period. MPEP § 608.01(m) states “Each claim begins with a capital letter and ends with a period”. 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.
Claims 6-7 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.
Claim 6 refers to “the dual caged N-cephalosporin-caged 3,7-diesterphenoxazine beta-lactamase-cleavable probe”, while claim 7 refers to “the dual caged carbapenem-caged 3,7-diesterphenoxazine beta-lactamase-cleavable probe”. However, the parent claim does not recite any of these particular probes.
In the interest of compact prosecution, claims 6-7 are interpreted as depending on claim 5 instead of claim 2.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Yang et al. (Pub. No. WO 2020/057592 A1).
Yang et al. discloses beta-lactam compounds containing a chemical probe, as well as methods of making and using said compounds for detecting carbapenemase or microbial carbapenem resistance (Abstract; lines 11-18, page 2).
The disclosed compounds have the structure CP-A-D, wherein “CP” is an azabicyclo moiety composed of a beta-lactam ring and an unsaturated five-membered hetero-ring having a C-C double bond, “A” is a conjugated system attached to the hetero-ring at a carbon atom of the double bond and is at meta-position relative to the nitrogen atom, and “D” is connected to “A” via a methylene bridge and comprises a chemical probe (lines 32-33, page 2; lines 1-4, page 3).
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Examples of “A” include optionally substituted vinylene groups, phenylene groups, and heterocycles (lines 10-15, page 23).
In some embodiments, “D” contains a self-immolative linker between the methylene bridge and the rest of “D”. It is spontaneously separated from the rest of “D” after the release of “D” from the compounds (lines 15-17, page 7).
The chemical probe “D” can be a luminescence probe (lines 18 and 25, page 7), which can be a fluorescence probe that is non-fluorescent prior to carbapenemase hydrolysis and becomes fluorescent after being released (lines 8-16, page 39). Applicable luminescence probes include phenoxazines (lines 16-18, page 23; see structures below) like resorufin (line 11, page 39; claim 7, page 122).
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The beta-lactam ring can be hydrolyzed by one or more carbapenemases and leads to the release of “D” (lines 1-6, page 3). Thus in the method of use, Yang et al. teaches (a) contacting a sample containing bacteria with one or more of the disclosed compounds and (b) detecting the release of “D” from the disclosed compounds. Detection of “D” indicates the presence of carbapenemases, which denotes the presence of carbapenem resistance (lines 32-33, page 7; lines 1-4, page 8).
Yang et al. reads on the following claims:
Regarding claim 1: the beta-lactam compounds having the structure CP-A-D and being cleavable are equivalent to “A dual caged cleavable probe”.
The “CP” or azabicyclo moiety (ex. Formula Ia) is cleavable by carbapenemases and meets the requirement that the claimed probe comprises “a b-lactamase or carbapenemase-cleavable moiety”.
The embodiment of “D” comprising a self-immolative linker, thus satisfying “a self-immolative linker”.
The self-immolative linker being attached to the rest of “D”, which comprises a chemical probe such as a fluorescent probe that can be detected, is the same as “wherein the self-immolative linker is conjugated to a fluorescently detectable label”.
Hence, claim 1 is anticipated by Yang et al..
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651