DETAILED ACTION
Status of claim rejections
The objections to the drawings are withdrawn in view of Applicant’s filing of replacement drawings in the response filed 05/22/2026.
The objections to the specification are withdrawn in view of Applicant’s filing of replacement specification in the response filed 05/22/2026.
The rejections of record under 35 USC 112(b) are withdrawn in view of Applicant’s amendments to the claims in the response filed 05/22/2026.
The rejections of record under 35 USC 102/103 are maintained in view of Applicant’s amendments to the claims in the response filed 05/22/2026. Please note that the rejections have been recast to the newly added claims 21-28 and 34.
Examiner’s Note Regarding Election/Restrictions
The examiner notes that previous instant claims 1-20 (which were subject to a restriction requirement on 10/06/2025) were cancelled. Claims 21-28 and 34 are directed to the elected invention; claims 29-33 and 35-36 are directed to inventions derived from previously withdrawn claims 9-13 and 19-20.
Note that the claim identifier status for withdrawn claims 29-33 and 35-36 are incomplete, as it reads “(New).”
Claims 29-33 and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) and consistent with the original Restriction/Election Requirement of 10/06/2025 as being drawn to a nonelected invention, there being no allowable generic or linking claim.
New Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 contains a comma after the colon in line 2. Appropriate correction is required.
Maintained Claim Rejections - 35 USC § 102/103
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.
First rejection
Claims 21-28 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 22, Geisberg teaches the antibody is monoclonal.
Regarding claim 23, Geisberg teaches placing the sample in contact with the intact beta-lactam antibiotic that may or may not be labelled (i.e., the beta lactam ring can be unlabelled as in step d); see paragraph 0009), immobilization of the antibody on a solid support (as in step e); see paragraph 0010; claim 8) before detection (as in step f and g) see paragraph 0005 and 0010).
Regarding claim 24, Geisberg teaches steps h) and i) (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 j) and k) (as above).
Regarding claim 25, Geisberg teaches steps l) and m) (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 (as in steps n and o).
Regarding claim 26, Geisberg teaches the sample contains bacteria (see abstract, claim 1, paragraph 0007-8).
Regarding claim 27, Geisberg teaches the surface of the support can be a test strip (see paragraphs 0067, 0068).
Regarding claim 28, 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 34 is rejected under 35 U.S.C. 103 as being unpatentable over Geisberg as applied to claim 21-28 above, and further in view of Nordmann et al (WO2013072494A1; cited in 12/13/2023 IDS; hereinafter “Nordmann”; prior art of record).
As discussed above, claims 21-28 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.
Response to Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive.
On pg. 9-12 of the remarks, Applicant argues that in Geisberg, a labelled antibody specific for the hydrolyzed antibiotic is brought into contact with the bacteria in the sample and the resulting mixture is deposited onto the strip on which the hydrolyzed antibiotic is immobilized. Applicant argues that if the sample contains antibiotic-resistant bacteria, a large quantity of hydrolyzed antibiotic is present in the sample, saturating the labelled antibodies such that the antibodies are no longer available to bind to the antibiotic on the strip and no signal is observed in the test zone. Applicant argues the claimed method relies on the antibiotic having intact non-hydrolyzed beta lactam ring and not the hydrolyzed form and the antibiotic of Geisberg and the claimed invention’s employ a fundamentally different class of antibodies. Applicant then argues the claims are unobvious because Geisberg provides no motivation to replace the disclosed antibodies that detect hydrolyzed beta-lactam antibiotics with a different class of antibodies designed to bind intact beta lactam rings. Applicant then argues that the invention makes possible the correlation of the presence of antibiotic-resistant bacteria with a positive signal instead of with the absence of a signal as required in Geisberg, which resulted in improved quantification and provides a test that is easier to read and interpret, as a genuine technical advantage. Applicant argues much of the same for the rejection using the Nordmann reference.
In response, the examiner disagrees. First, regarding Applicant’s arguments regarding “if the sample contains antibiotic-resistant bacteria, a large quantity of hydrolyzed antibiotic is present in the sample, saturating the labelled antibodies such that the antibodies are no longer available to bind to the antibiotic on the strip and no signal is observed in the test zone”, arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.") (MPEP 2145(I)). Applicant must provide empirical evidence to support the above assertion that “a large quantity of hydrolyzed antibiotic is present in the sample, saturating the labelled antibodies such that the antibodies are no longer available to bind to the antibiotic on the strip and no signal is observed in the test zone”.
Second, the examiner notes that while Geisberg does discuss the use of hydrolyzed beta-lactams, the examiner points Applicant to paragraph 0045 of Geisberg with explicitly teaches “It will be evident to those of ordinary skill that many possible substances may possess structures that render them adequate substrates for β-lactamases. Such substances include β-lactam antibiotics that are known to be hydrolyzed by β-lactamases as well as other existing or yet-to-be-conceived substances containing the required β-lactam ring. Such substances may contain as the core structure a penam, cepham, penem, cephem, carbapenem (i.e., at least one of the substnaces contemplated by the instant claims), carbacephem, oxapenem, oxacephem, or monobactam.” Geisberg thus contemplates the use of substances containing intact beta-lactam ring and the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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