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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
DETAILED ACTION
Claims 6, 15, and 21 are canceled. Claims 1-5, 7-14, 16-20 and 22-23 are pending and under consideration.
All claims of the instant application are entitled to the effective filing date of 04/06/2020.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “based on the determining that” in line 31 or the fourth line from the bottom of the claim, which should be replaced with “based on the determination that” because the basis is a previous determination, not an active determining step.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7-14, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment filed on 02/17/2026 has introduced new matter into the claims.
Claim 1, as filed on 02/17/2026, recites a process for screening a microorganism in a microbial population from a biological sample for selecting at least one antimicrobial for a targeted prescription in managing a patient's infection, or as a candidate therapeutic solution in a research and development application, wherein the process comprises:
providing at least one microbial population from a biological sample;
treating a portion of each microbial population with the at least one antimicrobial, the other portion being untreated with the at least one antimicrobial;
incubating the at least one microbial population either with or without the at least one antimicrobial, thereby obtaining the treated analytical sample(s) and the control analytical sample(s), respectively;
eluting the analytical sample(s) from the previous step in a field-flow fractionation device;
obtaining elution profiles of the treated analytical sample(s) and the control analytical sample(s) for each microbial population;
quantifying the variation of the signals contained in the elution profiles of the control analytical sample(s) and the analytical sample(s) treated with the at least one antimicrobial, and comparing the variation of the signals to a significance threshold;
determining that the microorganism of the microbial population is sensitive to the at least one antimicrobial based on a determination that the variation of the signals contained in the elution profiles of the analytical sample(s) treated with the at least one antimicrobial compared to the elution profiles of the control analytical sample(s) is greater than the significance threshold; and
selecting the at least one antimicrobial, based on the determining that the microorganism is sensitive, for a targeted prescription in managing a patient's infection, or as a candidate therapeutic solution in a research and development application.
Claim 1 and dependent claims 2-5, 7-14, and 18-20 contain new matter because of the underlined limitation that requires selecting the at least one antimicrobial, based on a determination that the microorganism is sensitive, for a targeted prescription in managing a patient’s infection or as a candidate therapeutic solution in a research and development application.
Applicant’s amendment, filed 02/17/2026, directs to support to the specification, specifically page 1 lines 10-14 and 30-35, page 2 lines 1-6, page 3 lines 20-27, and page 4 lines 10-26. See the remarks filed 02/17/2026, specifically page 7 paragraph two to page 8 paragraph two.
The specification filed 10/05/2022 and the original claims do not provide support for the above underlined limitations. The specification discloses that methods for determining antimicrobial sensitivity/resistance profiles are essential diagnostic tools for the management of patients in human or veterinary medicine. Indeed, the prescription of targeted molecules enables an effective treatment of the infection while limiting the emergence of resistant strains linked to the misuse of antimicrobials and in particular of antibiotics. See page 1 lines 23-29. The invention can be used in industry, in research laboratories or in certifying agencies during the research and development phases of new therapeutic solutions, by demonstrating the antibacterial potentials thereof. See page 3 lines 20-23. As such, the specification describes the technical fields to which the invention is related to, but the specification is silent regarding a selection step in which an antimicrobial is selected based on a determination that the microorganism is sensitive to the antimicrobial.
Such limitations recited in the instant claim 1 (and dependent claims), which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claims. Applicant can remove the new matter limitations from the claims to obviate this rejection.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
§ 112(a) new matter rejection
Applicant asserts that the specification provides support for amended claim 1. The specification states that “the invention relates to the field of biological diagnosis…as part of the research for antimicrobial resistance” (page 1 lines 5-7 of the spec. filed 10/05/2022). See the second paragraph on page 7 of the remarks. Applicant argues that the specification provides support for the research and development/candidate therapeutic purpose in amended claim 1, because the specification teaches that the invention can be used during research and development phases of new therapeutic solutions (spec. filed 10/05/2022 page 3 lines 20-23). See the last paragraph on page 7 of the remarks.
This argument is not persuasive because Applicant has not pointed to support for an active selecting step that is based on a sensitivity determination.
Claim Rejections - 35 USC § 112(b)
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 1-5, 7-14, 16-20 and 22-23 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 “determining that the microorganism of the microbial population is sensitive to the at least one antimicrobial based on a determination…selecting the at least one antimicrobial, based on the determining that the microorganism is sensitive”, which renders the claim indefinite because it is unclear whether the selection step is conditional or required. The specification is silent regarding methods with such selection step. As such, one of ordinary skill in the art cannot ascertain whether claim 1 encompasses methods in which the microorganism is determined to not be sensitive to the at least one antimicrobial.
Claims 2-5, and 18-20 depend from claim 1 and are rejected for the reason set forth above.
Claim 13 recites “the elution profile(s)” in lines 3 and “the elution profile” at the end of line 7, which render the claim indefinite because claim 1, as amended, only recites “elution profiles”. Therefore, it is unclear whether claim 13 intends to further limit one or all of the elution profiles required in amended claim 1. Claim 13 recites the phrase “in particular” in line 4. This phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Claim 13 recites “Robs = trn/t0 or any other method of determination” in the last two lines, which renders the claim indefinite because the scope encompassed by “any other method of determination” is unclear. In one interpretation the methods of determination are limited to Robs determinations, and under an alternative interpretation the methods of determination are not limited.
Claim 16 recites “the analyzed microorganisms” in line 10. There is insufficient antecedent basis for this limitation in the claim. It is unclear which analyzed microorganisms are being referenced because there is no earlier recitation of analyzed microorganisms in the claim. In lines 1-2, claim 16 recites “a microorganism” in the singular form. However, since “the analyzed microorganisms” in line 10 are recited in the plural form, it is unclear whether the claim intends to reference the singular microorganism, or a separate plurality of analyzed microorganisms. To obviate this rejection, “the analyzed microorganisms” in line 10 can be replaced with “the microorganism”, so that the claim clearly refers back to the singular microorganism recited in lines 1-2.
Claim 22 depends from claim 16 and is rejected for the reason set forth above.
Claim 17 is missing a conjunction in front of the last listed component, i.e. in front of “the at least one separation channel”. It is unclear whether the claim is incomplete or whether both of the listed limitations are required, because there is no conjunction between the listed items. Furthermore, claim 17 recites “and the analyzed microorganisms”, which is indefinite because it is unclear how the recitation interrelates to the structure of the claimed kit composition. Consequently, there are multiple different reasonable claim interpretations. Specifically, claim 17 recites “at least one separation channel being a flow channel configured for an external field of gravitational nature to be applied thereon and the analyzed bacterial population”. In the first interpretation, claim 17 requires the kit to include at least one separation channel that is a flow channel configured for an external field of gravitational nature that can be applied to the flow channel, and can be applied to any analyzed bacterial population in the flow channel. In this first interpretation the kit does not require the presence of an analyzed bacterial population. In the second interpretation, claim 17 requires the kit to comprise at least one separation channel that is a flow channel configured for an external field of gravitational nature, and claim 17 requires the kit to comprise the analyzed bacterial population. As such, one of ordinary skill in the art cannot ascertain the metes and bounds of the kit required in claim 17.
Claim 23 depends from claim 17 and is rejected for the reason set forth above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-14 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each step described below is in reference to the subject matter eligibility test for products and processes (MPEP 2106).
Claim 1 recites “[a] process” which is one of the statutory categories (Step 1: Yes).
Claim 1 requires a step consisting of “quantifying the variation of the signals contained in the elution profiles of the control analytical sample(s) and the analytical sample(s) treated with the at least one antimicrobial, and comparing the variation of the signals to a significance threshold”. The terms “quantifying” and “comparing” are acts of evaluating information that can be practically performed in the human mind. The specification (filed 10/05/2022) discloses that the variation of the signals contained in the elution profiles is expressed in % and corresponds to a percentage of variation in Robs =PΔR; signifying a biological effect, i.e. the percentage of the variation in the retention factor [Math 1] PΔR= (| Robs | / Robs control)x 100. See page 10 lines 25-31. Furthermore, the instant specification discloses that the “significance threshold” to which the signal variations are compared, is the threshold from which the microbial population is considered to be sensitive or resistant to the antimicrobial. See page 10 line 32 to page 11 line 1. Thus, the instantly claimed quantification and comparison step recited in claim 1 and required by dependent claims 2-14 and 18-20 is an abstract idea in the “mental process” judicial exception grouping (MPEP 2106.04(a)(2)(III)) (Step 2A Prong 1: Yes).
Besides the judicial exception, claim 1 recites “[a] process for screening a microorganism in a microbial population from a biological sample for selecting at least one antimicrobial for a targeted prescription in managing a patient’s infection, or as a candidate therapeutic solution in a research and development application” in lines 1-5. This recitation does not meaningfully limit the claim, because the recitation does not structurally limit the method, and because the recitation merely serves to generally link the judicial exception to a particular technological environment. Before the quantification and comparison abstract idea step, claim 1 requires: “providing at least one microbial population from a biological sample; treating a portion of each microbial population with the at least one antimicrobial, the other portion being untreated with the at least one antimicrobial; incubating the at least one microbial population either with or without the at least one antimicrobial, thereby obtaining the treated analytical sample(s) and the control analytical sample(s), respectively; eluting the analytical sample(s) from the previous step in a field-flow fractionation device; obtaining elution profiles of the treated analytical sample(s) and the control analytical sample(s) for each microbial population”. These pre-solution activities are all data gathering steps, because the purpose of each step is to obtain the information necessary for the abstract idea. Although the steps require the use of a “field-flow fractionation device”, this element is merely a tool used to obtain the concept of an elution profile for the purpose of performing the abstract idea. After the quantification and comparison step, claim 1 requires “determining that the microorganism of the microbial population is sensitive to the at least one antimicrobial based on a determination that the variation of the signals contained in the elution profiles of the analytical sample(s) treated with the at least one antimicrobial compared to the elution profiles of the control analytical samples is greater than the significance threshold; and selecting the at least one antimicrobial, based on the [determination] that the microorganism is sensitive, for a targeted prescription in managing a patient’s infection, or as a candidate therapeutic solution in a research and development application”. These post-solution activities are insignificant, because the steps are recited with a high level of generality such that the steps are merely instructions to apply the judicial exception. Thus, the additional elements of claim 1 do not integrate the judicial exception into a practical application.
Claims 2-5, 7-14 and 18-20 depend from claim 1, but do not significantly limit the judicial exception as to integrate it into a practical application. Claim 2 requires the microorganism to be one selected from bacteria, fungi, yeasts and protozoa. Claims 3 and 18 require the at least one antimicrobial to be one selected from antibiotics, antifungals and antiparasitic agents. Claims 4 and 19-20 require the microorganism to be a bacterium. Claim 5 requires the at least one antimicrobial to be an antibiotic. Claim 7 requires the biological sample to be from a human, animal or environment. Claim 8 requires the biological sample to be urine, stool, sputum, broncho-alveolar water, pus, cerebrospinal fluid or blood. Claim 9 requires the biological sample to comprise a reference strain. Claim 10 requires the incubation step to last 30-120 minutes. Claims 2-5, 7-10 and 18-20 do not integrate the abstract idea into a practical application because the limitations merely serve to link the abstract idea to the technical field of determining antibiotic resistance in biological samples. Claims 11-12 entail a multigravitational field-flow fraction device. Such element does not integrate the abstract idea into a practical application because the device is merely a tool for obtaining the concept of an elution profile for the purpose of performing the abstract idea. Claim 13 limits the signal or signals contained in the elution profiles. However, the signals encompass mathematical values obtained by observing an output graph from a field-flow fractionation device, such as a tr (i.e. retention time) measured at a peak in the graph. Thus, claim 13 does not add any element to the abstract idea, because claim 13 merely indicates that the quantified and compared signals are obtained by observing an output of a field-flow fractionation device. Claim 14 requires defining a significance threshold for each microorganism/antimicrobial pair. The way in which the significance threshold is to be defined is recited with a high level of generality, such that the step encompasses mentally defining a significant threshold. Thus, the additional limitations of claims 1-5, 7-14 and 18-20 do not integrate the abstract idea into a practical application (Step 2A Prong 2: No).
The additional elements fail to amount to an inventive concept in view of the routine, well understood and conventional activities in the art of determining antibiotic resistance in biological samples. For example, Saenton (Separation Science and Technology, 2000, 35(11), as provided with the IDS filed 10/05/2022), teaches using field flow fractionation to separate living P. putida cells from dead P. putida cells that died in response to an 1% ethanol aqueous solution containing 0.15% 2-methylthiazalone and 0.15% bromo-nitro-dioxane (e.g. a treated analytic sample). See the paragraph spanning pages 1765 to 1766 and figure 4(a). Evidentiary reference Cayman (5-bromo-5-nitro-1,3-Dioxane (CAS 30007-47-7). (2025)) discloses that 5-bromo-5-nitro-1,3- Dioxane is an antimicrobial compound effective against Gram-positive and Gram-negative bacteria (e.g. an antibiotic) and fungi including yeast. See the product description of Cayman. Saenton teaches comparing the elution profiles and retention times of live bacteria (e.g. control analytic sample) injected into a FFF channel to their dead counterparts (e.g. treated analytic sample). See the first paragraph on page 1771. Figure 4(a) shows the elution profile of the live and dead P. putida eluted from the sedimentation FFF. Although Saenton does not teach bacteria obtained from a biological sample, Vaz teaches a method for detecting in a biological sample comprising microorganisms the presence of microorganisms resistant to a predetermined therapeutic agent comprising the following steps: a. inoculating the sample on a first tube with and on a second tube without at least one such therapeutic agent and incubating it. See claim 1. Thus, the instantly claimed field-flow fractionation element was well-known in the art prior to the effective filing date (Step 2B: No).
For all these reasons, claims 1-5, 7-14 and 18-20 are not patent eligible.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
§ 101 rejection of claims 1-5, 7-14 and 18-20
Applicant argues that amended claim 1 recites a specific, structured laboratory screening process for antimicrobial susceptibility, including physical steps of preparing treated and control analytical samples, incubating with/without the antimicrobial, eluting the samples in a FFF device and obtaining treated and controlled elution profiles. Those steps are not data gathering. See the paragraph spanning pages 8-9 of the remarks.
This argument is not persuasive because the steps recited before the mental process steps of “quantifying” and “comparing” amount to insignificant pre-solution activities. The physical steps referenced by Applicant are data gathering steps for two reasons. First, the purpose of each step is merely to obtain information necessary for the judicial exception. Second, the steps are recited with a high level of generality, such that each step is a nominal or tangential addition to the claim. For example, claim 1 requires providing at least one microbial population from a biological sample (line 8), and treating a portion of each microbial population with at least one antimicrobial (line 9-10) . However, these steps are recited with a high level of generality because structure of the microbial population and the antimicrobial are not limited in anyway. As such, physical steps referenced by Applicant cannot integrate the judicial exception into a practical application in step 2A prong 2.
Applicant argues that claim 1 integrates any such mental concept into a practical application because the claim requires a definitive determination of antimicrobial sensitivity based on the quantified comparison, and then an affirmative selecting step that uses that determination to select at least one antimicrobial for targeted prescription and/or as a candidate therapeutic solution. See page 9, the first full paragraph.
This argument is not persuasive because such steps are insignificant post-solution activities. After the quantifying and comparing step, claim 1 requires determining that the microorganism of the microbial population is sensitive to the at least one antimicrobial based on the mathematical outcome from the quantifying and comparing step, and selecting the at least one antimicrobial based on such determination for the purpose of managing a patient’s infection, or for the purpose of being used as a candidate for therapeutic research. These post-solution activities are insignificant because the activities amount to instructions for applying the mathematical outcome. The claim does not require an active method step of treating a patient’s infection, nor does the claim require actively using an antimicrobial for therapeutic research. Rather, post-solution activities are merely ideas of solutions or outcomes pertaining to medicine and research.
Applicant argues that the result is not merely an abstract conclusion. The claim requires that the susceptibility determination be used to select an antimicrobial for a specific downstream, real-world purpose in the clinical and/or R&D context. This is not insignificant post-solution activity but rather is the operative end of the screening method as claimed. See the second paragraph on page 9 of the remarks. Applicant asserts that the selecting limitation is not properly dismissed as non-limiting intended use. The Federal Circuit has held that purpose-limiting language in a claim limitation – not merely an intended use- when it is the essence or a fundamental characteristic of the claimed invention and provides criteria by which the previously recited steps are analyzed. See the last paragraph on page 9 of the remarks.
This argument is not persuasive because generally linking an abstract idea to its technical field of use in clinical and/or R&D context(s) cannot integrate the judicial exception into a practical application. The claim requires “selecting the at least one antimicrobial, based on the [determination] that the microorganism is sensitive, for a targeted prescription in managing a patient’s infection, or as a candidate therapeutic solution”. This selection step does not require any particular structure, because composition of the at least one antimicrobial is not limited, and the presence of a patient is not required. Applicant asserts that such selection step is more than a recitation of an intended use. However, it is unclear, based on Applicant’s argument, how such recitation alters the structure of the method, or its mode of operation.
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.
Claims 1-5, 7-14, 16-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Saenton, (Separation Science and Technology, 2000, 35(11), 1761-1775) in view of Vaz (US 2014/0199703), with evidence from Cayman (5-bromo-5-nitro-1,3-Dioxane (CAS 30007-47-7). (2025)).
PNG
media_image1.png
208
383
media_image1.png
Greyscale
Regarding claim 1, Saenton teaches preparing bacteria samples from a culture by centrifuging cells to obtain cell pellets. The cell pellet is diluted in 2% ammonium chloride (NH4Cl) (i.e. control analytical sample). Dead bacteria are prepared by suspending (i.e. incubating) viable cells in 1% ethanol aqueous solution containing 0.15% 2-methylthiazalone and 0.15% bromo-nitro-dioxane (i.e. treated analytic sample). See the paragraph spanning pages 1765 to 1766. Evidentiary reference Cayman discloses that 5-bromo-5-nitro-1,3- dioxane is an antimicrobial. See the product description of Cayman. For sedimentation field-flow fractionation (FFF), Saenton teaches using a system (i.e. device) similar to a Model S101 Fractionator. See page 1766 first full paragraph. Saenton indicates that live and dead Pseudomonas putida elute from the sedimentation FFF device, such that fractograms (i.e. elution profiles) are obtained. See figure 4a provided below. Saenton teaches comparing the elution profiles and retention times of live bacteria (i.e. control analytic sample) to their dead counterparts (i.e. treated analytic sample). See page 1771 first paragraph. Saenton discloses that live cells always elute first. See page 1771 first full paragraph. Thus, Saenton suggests that the treated cells are dead (i.e. sensitive) if their retention time is greater than the retention time of the live cells (significance threshold).
Saenton does not teach providing at least one microbial population of microorganisms from a biological sample.
Saenton does not teach selecting the at least one antimicrobial, based on the determination that the microorganism is sensitive, for a targeted prescription in managing a patient’s infection, or as a candidate therapeutic solution in a research and development application.
Vaz teaches a method for detecting in a biological sample comprising microorganisms the presence of microorganisms resistant to a predetermined therapeutic agent comprising: inoculating the sample, on a first tube with, and on a second tube without, at least one such therapeutic agent and incubating it ; and performing flow cytometric analysis to obtain one or more flow cytometric parameters for each of the two tubes. See claim 2 of Vaz. Vaz teaches biological samples selected from urine, a blood culture, water or a suspension of microorganisms obtained from pure cultures. See claim 6 of Vaz. Vaz teaches microorganisms including, for example Pseudomonas aeruginosa. See claim 19 of Vaz. In example 2, Vaz teaches evaluating the susceptibility of P. aeruginosa (see [0107]) to meropenem (see [0108]). Vaz suggests that flow cytometry can be used to show cell death as a result of incubation with a specific drug. Furthermore, Vaz teaches identifying the type of microorganism in the biological sample and according to such identification selecting the therapeutic agent. See claim 5(i) of Vaz. Vaz suggests that appropriate therapy can be based on a susceptibility profile. See [0002].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention substitute the sedimentation field-flow fractionation step of Saenton for the flow cytometry step in the method taught by Vaz. One of ordinary skill in the art would have been motivated to do so, because Saenton suggests that flow cytometry has a lower size limit that excludes the detection of small size bacteria (see p. 1763, second paragraph , fifth sentence). There would be a reasonable expectation of success because Saenton and Vaz separately demonstrate combining Pseudomonas bacteria with an antimicrobial agent prior to an analysis that detects differences in cells, such as cell death.
Regarding claims 2, 4 and 19, Saenton teaches Pseudomonas putida. See the caption of figure 4(a).
Vaz teaches detecting resistant microorganisms including bacteria, to a therapeutic agent in a biological sample. See [0012].
Regarding claim 3, 5, and 18, Saenton teaches suspending (e.g. incubating) viable cells in 1% ethanol aqueous solution containing 0.15% 2-methylthiazalone and 0.15% bromo-nitro-dioxane (e.g. a treated analytic sample). See the paragraph spanning pages 1765 to 1766. Evidentiary reference Cayman discloses that 5-bromo-5-nitro-1,3- dioxane is an antimicrobial compound effective against bacteria (e.g. antibiotic). See the product description of Cayman.
Vaz teaches incubating Pseudomonas aeruginosa with meropenem (e.g. antibiotic). See paragraphs [0107]-[0116]. Vaz discloses that meropenem is a bactericide (e.g. antibiotic). See paragraph [0117].
Regarding claims 7 and 8, Vaz teaches biological samples including urine (i.e. human or animal origin), a blood culture (i.e. human or animal origin). See claim 6 of Vaz.
Regarding claim 9, Vaz teaches inoculating a sample with a carbapenem and incubating it (see [0025]), removing the microorganism of the biological sample (see [0026]), and adding a strain with a known behavior- a control strain with a known dose-effect curve, for example incubating a serial concentration of a carbapenem with a microorganism as E. coli ATCC strain 25922 (i.e. reference strain) by flow cytometry (see [0027]).
Regarding claim 10, Vaz, in example 2, teaches incubating Pseudomonas aeruginosa with or without meropenem for thirty minutes at 35˚C prior to performing flow cytometry. See [0115].
Regarding claims 11 and 12, Saenton teaches sedimentation field-flow fractionation (FFF), which is synonymous with multi-gravitation field flow fractionation. Saenton teaches using a sedimentation FFF system similar to the Model S101 Fractionator. See page 1766 the first full paragraph.
Regarding claim 13, Saenton teaches obtaining a retention ratio from a fractogram (also referred to as an elution profile) using the relationship R=t0/tr where t0 is the void time and tr is the retention time. See page 1765 equation (2). Thus, Saenton indicates that a retention time ( tr ) -signal is contained in the elution profile of figure 4a. Moreover, figure 4a, as shown above, includes peak apexes corresponding to specific retention times.
Regarding claim 14, Saenton teaches comparing the elution profiles and retention times (i.e. tr ) of live bacteria injected into a FFF channel to their dead counterparts. See page 1771 the first paragraph.
Regarding claim 16, Saenton teaches a thin, ribbonlike, open channel in which the separation is induced and controlled by an external field acting in a direction perpendicular to laminar flow in the channel. See page 1763 the third paragraph. Furthermore, Saenton teaches an ethanol aqueous solution bromo-nitro-dioxane (e.g. antibiotic). See the paragraph spanning pages 1765 to 1766.
Saenton does not teach a kit.
Vaz teaches the concept of a kit for carrying out a method. See claim 23 of Vaz. Vaz teaches a kit for detecting the resistant microorganisms to a therapeutic agent. See [0041].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to organize the bromo-nitro-dioxane (e.g. antibiotic) and the channel of Saenton into a kit, as suggested by Vaz. One would be motivated to organize the components into a kit because Vaz suggests that kits may be useful for carrying out a method. There would be a reasonable expectation of success because Saenton teaches components of a sedimentation FFF system, and Vaz teaches the concept of a kit.
Regarding claim 17, Saenton teaches a sedimentation FFF (SdFFF) system that includes a channel. See page 1766 first full paragraph. For SdFFF, Saenton discloses that the channel is inserted into a centrifuge basket and spun to generate the centrifugal field (i.e. external field). See page 1765 the fifth paragraph. Furthermore, Saenton teaches an ethanol aqueous solution bromo-nitro-dioxane (e.g. antibiotic). See the paragraph spanning pages 1765 to 1766.
Saenton does not teach a kit.
Vaz teaches the concept of a kit for carrying out a method. See claim 23 of Vaz. Vaz teaches a kit for detecting the resistant microorganisms to a therapeutic agent. See [0041].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to organize the bromo-nitro-dioxane (e.g. antibiotic) and the SdFFF channel of Saenton into a kit, as suggested by Vaz. One would be motivated to organize the components into a kit because Vaz suggests that kits may be useful for carrying out a method. There would be a reasonable expectation of success because Saenton teaches components of a sedimentation FFF system, and Vaz teaches the concept of a kit.
Regarding claim 20, Saenton teaches Pseudomonas putida. See the caption of figure 4(a).
Vaz teaches detecting resistant microorganisms including bacteria, to a therapeutic agent in a biological sample. See [0012].
Regarding claim 22, Saenton teaches a FFF channel that uses a semipermeable membrane. See page 1773 the first full paragraph. Saenton teaches a carrier solution with deionized water containing surfactant and bactericide sodium azide (i.e. at least one solution for cleaning). Saenton teaches flushing the channel after each sample injection to clean it. See page 1766 the first full paragraph.
Regarding claim 23, Saenton teaches a carrier solution with deionized water containing surfactant and bactericide sodium azide (i.e. at least one solution for cleaning). Saenton teaches flushing the channel after each sample injection to clean it. See page 1766 the first full paragraph.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
§ 103 rejection
Applicant argues that the prior art rejections treat the prior claim preamble as a non-limiting intended use. Amended claim 1 now recites, in the body of the claim, a concluding step of selecting at least one antimicrobial, based on the sensitivity determination, for targeted prescription and/or as a candidate therapeutic solution. See page 10 of the remarks, the last full paragraph.
This argument is not persuasive because the concluding selection step may reasonably be interpreted as a conditional step. The specification does not teach an active method step that involves selecting at least one antimicrobial based on a sensitivity determination. Therefore, it is unclear how the step structurally affects the method.
Applicant argues that Saenton does not teach or suggest the claimed screening and selection process. Saenton does not teach susceptibility screening workflow culminating in selection of an antimicrobial for targeted prescription in managing a patient infection, nor does Saenton teach selecting an antimicrobial as a candidate therapeutic solution in an R&D application. See the paragraph spanning pages 10-11 of the remarks. Vaz is directed to flow cytometry and dos not teach or suggest modifying Saenton’s FFF-based separation/viability approach. The conclusion to substitute the biological sample of Vaz into Saenton system is based on impermissible hindsight. See page 11 of the remarks, the first paragraph.
This argument is not persuasive because Saenton in view of Vaz teach every active method step. Vaz further teaches a method in which a therapeutic agent is selected. See claim 5(i) of Vaz. Therefore, Vaz, not Saenton, is relied upon for teaching a therapeutic selection step (see claim 5(i) of Vaz). Applicant asserts that the conclusion to substitute the biological sample of Vaz into the system of Saenton is based on impermissible hindsight. However, the previous obviousness rationale is no longer applicable, because the rejection was modified to address the claim amendment and, consequently, the obviousness rationale was modified.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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, LOUISE HUMPHREY can be reached at (571)272-5543. 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.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
Prosecution Insights