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 with traverse of Group I, 1-8 and 18 in the reply filed on 12/05/2025 is acknowledged. The traversal is on the ground(s) that “Correy et al. only refers in general terms to primary or secondary antibodies conjugated to a ß-lactamase enzyme (paragraphs [0013]-[0014] in particular). In contrast, both Groups of claims recite the common technical feature of at least one monoclonal antibody specifically recognising an antibiotic molecule containing an intact ß-lactam ring, said antibody not recognising the same antibiotic molecule when hydrolysed. It is not possible to derive from Correy et al. that the antibody referred to is a monoclonal antibody that specifically recognizes an antibiotic molecule containing an intact ß-lactam ring, said antibody not recognizing the same antibiotic molecule when it is hydrolyzed. In this case, the Examiner did not take into account the functional characteristics of the monoclonal antibody recited in the claims, which are not explicitly stated in Correy et al. Thus, the invention groups I and II is linked by a new and inventive common concept.” This is not found persuasive because the technical feature under consideration was detection of beta-lactamase in a sample using antibodies, which was disclosed by the Correy reference teaching methods of detecting beta-lactamase enzyme activity from samples using monoclonal antibodies (see Fig. 2-3; paragraph 0013-14, 0195, 0214; see claims 31-32). Thus, the claims lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-13 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/05/2025.
Priority
The instant application claims benefit to PCT/FR2022/050133 filed on 01/25/2022 and FR2100708 filed 01/26/2021 and is acknowledged. The instant claims herein are examined using the effective filing date of 01/26/2021 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/13/2023 and 12/05/2025 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Specification
The disclosure is objected to because of the following informalities: the specification refers to the drawings as “Figure” instead of “FIG.”
Appropriate correction is required.
Drawings
The drawings are objected to because the drawings recite “Figure” instead of “FIG.”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1, 4-8, and 18 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.
Claim 1 recites: “A method for detecting the presence of a beta-lactamase enzyme in a sample, said method using at least one monoclonal antibody specifically recognising an antibiotic molecule containing an intact p-lactam ring, said antibody not recognising the same antibiotic molecule when hydrolysed, and the antibiotic molecule containing an intact ring specifically recognised by said antibody.” The claim essentially recites a use for the antibody without any active, positive steps delimiting how this use is actually practice (see MPEP 2173.05(q)). Thus, the claim is indefinite. Please note claims 6-8 and 18 are also indefinite for dependency on indefinite claim 1 (the claims do not recite any steps).
Claims 4 and 5 recite the limitation "c) placing the solution of step b) in contact with said antibiotic molecule". There is insufficient antecedent basis for this limitation in claim 4 because there is no recitation of any solution earlier in claim 4, or claim 2 (which claim 4 is dependent on). Furthermore, it is unclear which “step b)” both claims are referring to (is it referring to the step b) recited in claim 2, or claim 4, or claim 5?). Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting each “step b)” to be referring to the step b) recited in each individual claim (e.g., “step c)” in claim 4 is referring to “step b)” in claim 4).
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated, or in the alternative, under 35 U.S.C. 103 as obvious over Geisberg (US 20180156796 A1; cited in 12/13/2023 IDS).
Geisberg teaches a method of detecting the presence of antibiotic-resistant bacteria in a sample, comprising: (a) contacting the sample with a substrate for one or more bacterial enzymes, wherein the bacterial enzymes are capable of conferring antibiotic resistance upon bacteria possessing the enzymes; and (b) using one or more antibodies, antibody fragments, or aptamers to detect the presence of one or more products of enzymatic reactions carried out by the bacterial enzymes upon the substance (see abstract, claim 1), and the bacterial enzyme is beta-lactamase (see claim 2). Geisberg teaches the substrate is a molecule containing a beta-lactam moiety (i.e., contacting a sample with an antibiotic molecule containing an intact beta-lactam ring; see claim 4). Geisberg teaches the antibody can be monoclonal (see claim 12 and paragraph 0009), and recognition of antibiotics having an intact beta-lactam ring (see paragraph 0038) and that hydrolysis of the antibiotics by beta-lactamase enzymes destroys the beta-lactam ring and deactivates the drug (see paragraph 0038 and 0042; i.e., the antibody will not recognize the antibiotic when hydrolyzed as in claim 1). Geisberg further teaches detecting beta-lactamase protein using antibody binding (i.e., complexing of the antibody with the antibiotic; see paragraph 0005, 0010).
In the alternative, it would have been prima facie obvious to one of ordinary skill at the time of filing to use the method of Geisberg with a reasonable expectation of success. One of ordinary skill would have been motivated to use the method of Geisberg to effectively detect the presence of functional beta-lactamases in a sample.
Regarding claim 3, Geisberg teaches placing the sample in contact with the intact beta-lactam antibiotic that may or may not be labelled (as in step a); see paragraph 0009), immobilization of the antibody on a solid support (as in step b); see paragraph 0010; claim 8) before detection (as in step c and d); see paragraph 0005 and 0010).
Regarding claim 4, Geisberg teaches steps a) and b) (as above) and that the antibodies placed in contact with the sample can be labelled using biotin, enzyme, latex particle, metal colloid particle, fluorescent dye, etc. (see paragraph 0009), as well as steps c) and d) (as above).
Regarding claim 5, Geisberg teaches steps a) and b) (including using antibodies that specifically recognize beta-lactamase like penam, cepham, penem, cephem, carbapenem, carbacephem, oxapenem, oxacephem, or monobactam antibiotics (see paragraph 0038), labelling of the antibodies (as above), immobilization of the antibiotics onto a solid support, and detection of antibodies bound to the antibiotics
Regarding claim 6, Geisberg teaches the sample contains bacteria (see abstract, claim 1, paragraph 0007-8).
Regarding claim 7, Geisberg teaches the surface of the support can be a test strip (see paragraphs 0067, 0068).
Regarding claim 8, teaches detection using antibodies that detect cefotaxime (see paragraph 0086).
Accordingly, the claimed invention was anticipated, or in the alternative, rendered prima facie obvious by Geisberg.
Claim Rejections - 35 USC § 103
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Geisberg as applied to claim 1-8 above, and further in view of Nordmann et al (WO2013072494A1; cited in 12/13/2023 IDS; hereinafter “Nordmann”).
As discussed above, claims 1-8 were anticipated, or in the alternative, rendered prima facie obvious by the teachings of Geisberg.
Geisberg does not explicitly teach the enzyme is an extended spectrum beta-lactamase enzyme.
However, Nordmann teaches a method for detecting the presence of an expanded spectrum β-lactamase (ESBLs) in a sample using E-test® strips (see abstract, pg. 1-2). Nordmann teaches patients with infections due to ESBL-producing enterobacteria tended to have less satisfactory outcomes than those infected with pathogens that do not produce ESBLs, it is important to detect as early as possible those ESBL producers (see pg. 4, paragraph 4). Nordmann teaches to facilitate the detection of expanded-spectrum B-lactamase (ESBL in particularly) producers in the field of clinical microbiology using a simple acido-colorimetric technique based on the concept that by hydrolysing the beta-lactam ring of an expanded-cephalosporin substrate, the enzymes generate a carboxyl group which in turn acidifies a medium. The acidity resulting from this hydrolysis is then identified by a color change of a pH color indicator. (see pg. 4, last paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of Geisberg to detect functional ESBL as taught by Nordmann to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Nordmann teaches that ESBLs can be successfully detected for advantageous early detection of enterobacteria to reduce poor patient outcomes.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tarlton NJ, Satoorian TS, Panchal A, Borges CA, Geisberg M, Riley LW. Monoclonal antibody-mediated detection of CTX-M β-lactamases in Gram-negative bacteria. J Microbiol Methods. 2018 Jan;144:37-43. doi: 10.1016/j.mimet.2017.09.017. Epub 2017 Sep 29: discussed the development of an anti-CTX-M sandwich ELISA based on a pair of monoclonal antibodies (mAbs)—mAb 6101-33 and mAb 6101-19—used as the capture and detection antibody, respectively. This antibody pair detected CTX-M variants from group 1 (CTX-M-15), group 2 (CTX-M-2), group 8 (CTX-M-8), and group 9 (CTX-M-14) that were expressed by a training set of clinical GNB isolates.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672