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 .
Response to Restriction Requirement
Applicant’s election without traverse of Group I (claims 1-4 and 7) in the reply filed on 8/17/26 is acknowledged. Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Status of the Claims
Claims 1-7 are pending.
Claims 5-6 are withdrawn as non-elected claims.
Claims 1-4 and 7 are under consideration.
Abstract
The abstract of the disclosure is objected to because it contains the trademark/tradename Alamar blue. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification
The disclosure is objected to because of the following informalities: .
Appropriate correction is required.
The use of the term AlamarBlue, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Rejection(s)
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.
Claim 4 is 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. The term alamarBlue is a registered trademark.
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Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a reagent and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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) 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0074831 A1 (BECTON DICKINSON AND COMPANY) 03 October 2022 (hereinafter: “BD”) and
US 2018/0088141 A1 (SELUX DIAGNOSTICS, INC.) 29 March 2018 (hereinafter: “SELUX”).
Regarding claim 1, BD teaches a method for rapid diagnosis and antibiotic susceptibility testing of urinary tract infections (para [0003], For example, the presence or absence of bacterial or fungal pathogens in biological samples can be used to diagnose conditions such as sepsis or urinary tract infections in a patient/ subject.; [0007], the target pathogen is a bacterium that is isolated and collected for identification testing or susceptibility testing.), comprising the steps of:
a. collecting a urine sample from a patient (para [0071], Bacteria Recovery and Concentration from Urine Sample.; [0053], Concentrating the bacteria directly from the patient sample delivers quicker results by improving the detectability or reducing the incubation time.),
b. transferring the urine sample into a fluidic cartridge (para [0031; 0043], The membrane-based technology can be implemented with tangential flow processing of a biological sample in liquid form. Such a tangential fluid flow may pass (e.g., repeatedly) the sample over a specified membrane surface that has a trans- membrane pressure characteristic that is engineered to allow a target constituent to pass through the membrane as a permeate or to be retained by the membrane as a retentate.; [0104], The operation of one example of such a disposable cartridge is described in FIG. 14A-K. As illustrated, the cartridge 800, which is formed on a cartridge substrate (not illustrated), has a fluid pathway 805 for drawing sample from a syringe or culture bottle (not illustrated) into the cartridge and subsequently processing the sample. The sample is drawn from a syringe or culture bottle through port 810.), c. performing a buffer exchange to isolate and concentrate bacteria present in the urine sample (para [0072]. The following example illustrates how tangential flow extraction can be applied to a urine sample for bacteria extraction In the test, urine samples were spiked with E. coli at a concentration of 56 CFU/10 mL prior to the concentration process with a membrane device. A pressure control system (e.g. a system obtained from Fluigent) was used to provide 1 and 4 psi pressures on the input side (first chamber of the membrane device) to drive the multi-pass tangential flow. A 10 mL sample was thereby processed on a TEM device until the remaining volume reached 0.5 mL, which was recovered and plated on an EMB plate and cultured overnight the initial E coli concentration in the urine sample was 5.6 CFU/mL and the final E. coli concentration was 87 CFU/mL after the concentration process through the membrane device.; [0086]. The bacteria remaining in the first or upper chamber can be recovered for next step testing such as detection, identification or antimicrobial susceptible test The washing buffer or other suitable liquid can be introduced at the beginning, during or at the end of concentration process. The concentration process can be repeated after addition of buffer solution to reach a targeted concentration factor.), and determining antibiotic susceptibility (para [0090], The AST results are based on an average of three biological replicates. AST EA is the antibiotic susceptibility essential agreement and refers to the percent of conditions in which the minimum inhibitory concentration (MIC) is within one doubling dilution of the reference method MIC. AST CA is the antibiotic susceptibility testing categorical agreement and refers to the percent of conditions in which the susceptible, intermediate, or resistant interpretation agrees with the reference method. For both AST EA and CA, the reference method uses was the Becton Dickinson Phoenix method utilizing an 18-24 subculture step.).
BD does not specifically teach steps d-h (e.g. anti-biotic susceptibility test or AST).
Selux teaches a method for rapid diagnosis and antibiotic susceptibility testing of urinary tract infections (abstract, automated rapid antimicrobial susceptibility testing systems for performing a multi-assay testing sequence can include an automated incubation assembly having a nest assembly adapted to house at least one test panel having a plurality of wells for receiving a sample comprising microorganisms originating from a clinical sample a robotic handling assembly.; para [0068], Example biological samples can include whole blood, plasma, serum, sputum, urine.), d. introducing a panel of antibiotics to the concentrated bacterial suspension (para [0068], cartridges can include a plurality of test cartridge chambers (e.g., wells), each containing a liquid or dried form of an antimicrobial. In some cases, each well can contain a different antimicrobial type and/or concentration.; [0074], Upon determining sufficient growth of the sample in the growth well, the systems and methods described herein can initiate one or more end point assays. The end point assays can include one or more liquid handling, sample separation (e.g., centrifugation, magnetic separation, or vacuum filtration), and aspiration steps during which an amplifier is bound to the surface of the microorganism, unbound reagent can be washed away, and finally an optical signal can be measured and correlated to antimicrobial dilutions and MIC and/or QSR can be determined.), c. incubating the bacteria-antibiotic mixtures for a predetermined period (para [0081], A loading device (e.g., drawer) 300 can be used for loading cartridges (e.g., cartridges 700, 701) into the system. Once loaded, the robotic transfer system 200 can move the cartridges to the incubation subassembly 400 to begin processing. The incubation subassembly 400 is configured to provide controlled heating and shaking of the samples and cartridges to perform the various assays.), f. introducing a reagent to assess bacterial metabolic activity (para [0128], the optical detectors can measure fluorescence at excitation and emission wavelengths and bandwidths compatible with one or more commercially available reagents, such as resazurin and/or Thermo Fisher AlamarBluc Cell Viability Reagent, when dissolved in suitable solvents and then metabolically reduced to form Resorufin (i.e., a metabolic assay).), g. determining bacterial concentration in the original urine sample based on fluorescence readings (para [0073], Indirect measurements can include fluorometric measurements of wells where a reporter can be a redox dye that is converted into a fluorescent form via microorganism metabolism (e.g., resazurin).), and h. determining antibiotic susceptibility by comparing fluorescence intensities with predetermined threshold values (para [0157], Therefore, for each antimicrobial-microorganism pair being analyzed, the system can read the optical signals from each well being tested and send an array of data to the algorithm to be processed The algorithm can also correct and normalize each dataset using control wells and find a relative minimum inhibitory concentration (MIC) and/or a qualitative susceptibility result (QSR) for at least one antimicrobial that reduces defined cost function.). It would have been obvious to one of ordinary skill in the art to have applied the method of determining antibiotic susceptibility assay of Selux to the method of BD, in the process of routine practice.
Regarding claim 2, BD and Selux teach the method of claim 1, wherein the buffer exchange process involves passing the urine sample through a series of filters and buffer solutions to separate bacteria from other cellular debris and contaminants (BD, para [0086], The bacteria remaining in the first or upper chamber can be recovered for next step testing such as detection, identification or antimicrobial susceptible test The washing buffer or other suitable liquid can be introduced at the beginning, during or at the end of concentration process. The concentration process can be repeated after addition of buffer solution to reach a targeted concentration factor.).
Regarding claim 3, BD and Selux teach the method of claim 1, wherein the panel of antibiotics includes a range of antibiotics commonly used to treat urinary tract infections (Selux, para [0068], cartridges can include a plurality of test cartridge chambers (e.g., wells), each containing a liquid or dried form of an antimicrobial. In some cases, each well can contain a different antimicrobial type and/or concentration.).
Regarding claim 4, BD and Selux teach the method of claim 1, wherein the reagent for assessing bacterial metabolic activity is alamarBlue (Selux, para [0128], the optical detectors can measure fluorescence at excitation and emission wavelengths and bandwidths compatible with one or more commercially available reagents, such as resazurin and/or Thermo Fisher AlamarBlue Cell Viability Reagent, when dissolved in suitable solvents and then metabolically reduced to form Resorufin i.e. a metabolic assay.
antimicrobial. In some cases, each well can contain a different antimicrobial type and/or concentration.).
Regarding claim 7, BD and SELUX teach the method of claim 1, but do not specifically teach wherein filtration, incubation and analysis takes place within a total duration of less than 60 minutes.
Given that BD teaches that the filtration process of urine samples takes about 15 to 30 minutes (para [0099], i.e. a solution that isolates the sample of interest from the PBC in a short period of time, such as less than about 15 to 30 minutes, in combination with the automated rapid SELUX anti-biotic susceptibility test (AST) it would have rendered it obvious to one of ordinary skill in the art to have determined the time needed for filtration, incubation and analysis, which would reasonably be expected to be completed in under an hour as required in instant claim 7.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0074831 A1 (BD) and US 2018/0088141 A1 (SELUX) as applied to claims 1-4 and 7 above, and further in view of Chen et al. “Toward Decentralizing Antibiotic Susceptibility Testing via Ready-to-Use Microwell Array and Resazurin-Aided Colorimetric Readout”; Anal. Chem. (2021) 93 (3): 1260–1265 (hereinafter: CHEN).
Regarding claim 7, BD and SELUX teach the method of claim 1, but do not explicitly teach wherein filtration, incubation and analysis takes place within a total duration of less than 60 minutes.
However, BD teaches that the filtration process of urine samples takes about 15 to 30 minutes (para [0099].
Assuming arguendo, the SELUX teaching of steps d-h (e.g. anti-biotic susceptibility test or AST) fails to achieve the completion of the AST method steps d-h, within the 60 minutes required, the substitution of the CHEN Ready-to-Use” AST method based on microwell array-based resazurin-aided colorimetric antibiotic susceptibility test (marcAST) can be substituted.
The CHEN marcAST is a ready-to-use microwell array device that is preassembled with custom titers of various antibiotics and splits bacterial samples upon a simple syringe injection step to initiate AST against all antibiotics. Resazurin is used which changes from blue to pink in the presence of growing bacteria, to accelerate and enable colorimetric readout in the CHEN automated AST method. Even with its simplicity, marcAST can accurately measure the minimum inhibitory concentrations of reference bacterial strains against common antibiotics and categorize the antibiotic susceptibilities of clinically isolated bacteria. See e.g. Abstract.
Accordingly, it would have been obvious to substitute the CHEN marcAST ready-to-use microwell array device as a functional equivalent means for the SELUX anti-biotic susceptibility test or AST to use in conjunction with the US 2022/0074831 A1 (BD) apparatus to achieve a combined “system” of filtration, incubation and analysis within a total duration of less than 60 minutes as in instant claim 7 with a reasonable expectation of success.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yuen et al. “A Multiple Fluidic Chip for Rapid Phenotypic Antibiotic Susceptibility Testing”; mBio.2020 Feb 25: 11(1): e03109-19.
Yuen et al., teaches an anti-biotic susceptibility test (AST) method that enable starting targeted treatment within a few hours to improve patient outcome and reduce the overuse of broad-spectrum antibiotics. The multiplex fluidic chip for phenotypic AST described in the present study may enable data on antimicrobial resistance within 2 to 4 h, allowing for an early initiation of appropriate antibiotic therapy. See e.g. Abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENNETT CELSA whose telephone number is (571)272-0807. The examiner can normally be reached Monday-Friday 7-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Zachariah Lucas can be reached at 571-272-0905. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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