CTNF 18/002,438 CTNF 97142 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026 has been entered. DETAILED ACTION Claims 3, 7-8, 10-11, 13-19, 22-24, 26-28, 30 and 33 are canceled. Claims 1-2, 4-6, 9, 12, 20-21, 25, 29, and 31-32 are pending and under consideration. Claim Rejections - 35 USC § 112(a) 07-30-01 AIA 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 1-2, 4-6, 9, 12, 20-21, 25, 29, and 31-32 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 03/17/2026 has introduced new matter into the claims. Claim 1 , as filed on 03/17/2026, recites a method of performing digital antibiotic susceptibility testing (AST), the method comprising: collecting a first multiplicity of images of a first sample that comprises uncultured bacterial cells over a first length of time using a forward scattering optical imaging apparatus configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; determining a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the first sample over the first length of time; and determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time; collecting, from a second sample provided to the imaging apparatus, a second multiplicity of images of the second sample over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic; determining a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the second sample over the second length of time; determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time; determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. Claim 32 , as filed on 03/17/2026, recites a system comprising: a light source; optics configured to focus light from the light source on a liquid sample that comprises uncultured bacterial cells in a container; a forward scattering imaging device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; and a controller operably coupled to the light source and the forward scattering imaging device and configured to: collect a first multiplicity of images of a first sample that comprises the uncultured bacterial cells over a first length of time using the forward scattering optical imaging device; determine a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the first sample over the first length of time; determine, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time; collect, from a second sample provided to the forward scattering imaging device, a second multiplicity of images of the second sample over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic; determine a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the second sample over the second length of time; determine, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time; determine a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; define a susceptibility threshold; compare the susceptibility ratio to the susceptibility threshold; and identify the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. Applicant’s amendment, filed 03/17/2026, directs to support to paragraphs [0016], [0027]-[0029], [0035], [0038], [0039], [0042], [0055] and [0057] and [0028] of the specification, and asserts that no new matter has been added. See the first paragraph on page 7 of the remarks filed 03/17/2026. However, the specification as filed does not provide sufficient written description of the above underlined limitations. Claims 1 and 32 (and dependent claims) contain new matter because of the limitation that requires (1) a forward scattering optical imaging apparatus or device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; and because of the limitation that requires (2) identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. (1) The specification as filed and the original claims do not provide support for the claimed forward scattering optical imaging apparatus or device. Paragraph [0027] contains the only reference to forward scattering optical imaging. The paragraph describes rapid antimicrobial susceptibility testing (AST) systems and methods that implement large volume scattering imaging (LVSi) for real-time imaging of single cells with sensitivity and precision. These systems and methods work directly on urine samples in glass vials or cuvettes to image, track, and count the individual division events of single bacterial cells in clinical samples. “Too precisely track and count single division events of bacterial cells in the presence of various particles (e.g., crystals and dead skin cells) in a sample, a forward scattering optical imaging configuration and an imaging processing algorithm are implemented”. See paragraph [0027]. As such, the specification indicates the LVSi system can be configured into a forward scattering optical imaging configuration to precisely track and count single division events of bacterial cells in the presence of various particles in the sample. However, the instant claims encompass any forward scattering optical imaging apparatus or device configuration that can collect light transmitted and forward-scattered through the sample in a free solution, without using microfluidics channels, pumps, or valves. Furthermore, the specification teaches that the elimination of microfluidics and associated pumps and valves simplifies the setup, removes clogging of microfluidic channels by air bubbles and impurities in real urine samples, and allows simultaneous tracking of multiple cells in parallel in free solution. See [0028]. Therefore, the original disclosure merely suggests the benefits of eliminating microfluidics and associated pumps and valves, without pointing to any apparatus or device configuration that does not use microfluidics channels, pumps, or valves. (2) The specification as filed and the original claims do not provide support for the claimed identification step. The specification teaches obtaining urine samples from a clinical microbiology laboratory. Clinical samples are transported in an ice box and kept at 4°C after receiving. The refrigerated urine samples are pre-warmed for 30 min before use. The urine samples are passed through a filter, diluted and added to microplates with or without the antibiotic ciprofloxacin. After mixing, the samples are transferred to cuvettes and subjected to large volume solution scattering imaging (LVSi). See paragraph [0041]. The specification teaches imaging a diluted sample with LVSi for 60 min. Division events are counted for the entire 60 min. See [0047]. In paragraph [0055], the specification teaches comparing the D ABX /D C ratio to the susceptibility threshold to determine whether samples are resistant or susceptible to ciprofloxacin. With 30 min detection the accuracy is ~87%, while the 45 min detection increased accuracy to 94%. At 60 min, the accuracy is 100%. See [0055]. As such, the original disclosure does not provide support for any such identification within 60 min of obtaining the first and second samples from the common source with at least 97% accuracy. Such limitations recited in the instant claims 1 and 32 (and required by 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 03/17/2026 have been fully considered to the extent that they apply to the new grounds for rejection but they are not persuasive. Rejection of claims 1-2, 4-6, 9, 10, 12-14, 16-18, 20-21, 25, 29, and 31-33 under 35 U.S.C. § 112(a) Applicant argues that the specification provides support for the forward-scattering optical imaging apparatus configured to collect transmitted and forward scattered light in free solution, without microfluidic channels, pumps, or valves, as required in instant claims 1 and 32. Applicant argues that paragraph [0028] ( sic. [0027] of the specification filed 12/19/2022) explicitly teaches the use of “a forward scattering optical imaging configuration and an imaging processing algorithm” to “precisely track and count single division events of bacterial cells in the presence of various particles (e.g., crystals and dead skin cells) in a sample”. Figure 1A, as described in paragraph [0043] ( sic. [0042] of the specification filed 12/19/2022), depicts this configuration: light from 780 nm IR LEDs is focused through the sample in a cuvette, the transmitted and forward scattered light is collected directly by CMOS camera. Applicant asserts that the paragraph further confirms that the imaging apparatus records “wide-view and deep field depth scattering imaging” using standard optics (collimating/focusing lenses, 2x variable zoom lens) and CMOS camera at 10 fps- exactly the apparatus recited in amended claims 1 and 32. See p.8 first paragraph. This argument is not persuasive because it is not commensurate in scope with the instant claims. Neither paragraph [0042] nor paragraph [0043] disclose that forward scattered light is collected directly by CMOS, as argued. Applicant asserts that the imaging apparatus that records wide-view and deep field depth scattering imaging using standard optics and CMOS camera at 10 fps is the apparatus recited in amended claims 1 and 32. However, the forward scattering optical imaging apparatus of claim 1 (line 4) and the forward scattering optical imaging device of claim 32 (line 5) are not limited to the any specific imaging apparatus or imaging device structure, such as the CMOS camera disclosed in the specification. Applicant argues that the specification makes it clear that this is not a novel or undisclosed structure but a specific optical configuration of the LVSi system that captures transmitted and forward-scattering light in free solution. Applicant asserts that amended one of ordinary skill in the art would immediately recognize that the inventors possessed this exact apparatus and configuration. See p. 8 paragraph 2 of the remarks. This argument is not persuasive because the instant claims are not limited to an exact apparatus or configuration. Rather, the claims encompass any structure that can serve as a forward scattering optical imaging apparatus or device configured to collect any light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves. Applicant argues that the phrase “without using microfluidic channels, pumps, or valves” is supported. Paragraph [0029] (sic. [0028]) states that the systems and methods operate “without DNA primers, reagents, incubation, immobilization or microfluidics” and that “the elimination of microfluidics and associated pumps and valves simplifies the setup, removes clogging of microfluidic channels.” Applicant asserts that paragraph [0017] confirms that large sample volumes are used “in glass vials or cuvettes… without additional reagents or microfluidics”. Paragraph [0030] (sic. [0029]) adds that the sample volume is typically 1 µl to 50 µL. See p. 8 last paragraph of the remarks. Applicant argues that the specification avoids microchannels, pumps and valves altogether, using instead static cuvettes/vials containing free solution. The microliter volumes recited in the specification and in amended claims do not transform a cuvette into a microfluidic device; they are simply the sample volume imaged in free solution. See p. 9 first paragraph of the remarks. This argument is not persuasive, because the instantly claimed “without using microfluidic channels, pumps, or valves” limitation is an attempt to claim the invention by excluding what the inventors did not invent rather than distinctly and particularly pointing out what they did invent. In paragraph [0028] the specification describes the benefits of eliminating microfluidics and associated pumps and valves, but the paragraph does not provide support for the structure of a forward scattering optical imaging apparatus or device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps or valves. Furthermore, to the extent that Applicant is arguing that the specification provides support for the “without using microfluidic channels” limitation because the specification teaches glass vials or cuvettes, it is unpersuasive. The claimed apparatus or device is not required to include a glass vial or cuvette. Applicant argues that the timing and accuracy limitations are directly supported by the working examples. Paragraph [0039] ( sic. [0038] of the specification filed 12/19/2022) states "For real samples, the technique was applied to 60 clinical urine samples and predicts 97% of the bacterial existence for the infection positive samples with 60 min. AST is also performed on these patient samples with ciprofloxacin, and achieved 100% categorical agreements within 60 min (sample-to-results)." Applicant asserts that paragraph [0056] ( sic. [0055]) confirms that "At 60 min, all susceptibility profiles are determined, showing an accuracy of 100%." See the remarks p. 9 last passage. This argument is not persuasive because it is not germane to the instant claims. Predicting “97% of the bacterial existence for infection positive samples with 60 min” and achieving “100% categorical agreement within 60 min”, as described in paragraph [0038], are not equivalent or germane to the instantly claimed limitation that requires “at least 97% accuracy” (claim 1 last line, and claim 32 second to last line). Paragraph [0055] teaches an accuracy of 100% at 60 min, however “at 60 min” is one time point, whereas the instant claims encompass times “within 60 minutes” of obtaining the first and second samples from the common source. Applicant asserts that the phrase "within 60 minutes of obtaining the first and second samples from the common source" is supported because the specification expressly measures performance from the point the clinical samples (obtained from the common source) are received and processed-"sample-to-results" within 60 minutes-exactly as claimed. The "at least 97% accuracy" is expressly disclosed (97% for detection, 100% for categorical AST agreements). See the remarks p. 10 first passage. Applicant asserts that the disclosure is explicit regarding the timeline. The amendments clarify the starting point as “obtaining the first and second samples from the common source” (directly from paragraph [0011]), eliminating any ambiguity regarding transport time. See the remarks p. 10 first full paragraph. This argument is not persuasive because it is not commensurate in scope with the instant claims. The example in the specification teaches obtaining urine samples (see [0041]), pre-warming the urine samples for 30 min before use (see [0041]) and counting cumulative division events for 60 min (see [0046]). According to paragraph [0034] the cumulative division (division events integration, D c ) in a control sample without antibiotics at the 60 min point is used for infection detection. Sample pairs that yield a D ABx /D c ratio above a selected susceptibility threshold are called resistant. See [0034]. The instant claims require identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source. However, the susceptibility ratio, as disclosed in [0034], requires counting cumulative division events in a sample for 60 min in order to arrive at the D c input for the ratio. Therefore, the specification does not reasonably provide support for an identification within 60 minutes of obtaining the first and second samples from the common source. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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. 07-34-01 Claims 1-2, 4-6, 9, 12, 20-21, 25, 29, and 31 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. Claims 1, 2 and 21 recite “the imaging apparatus” (claim 1 line 11, claim 2 line 2, claim 21 second to last line), which render the claims indefinite because it is unclear whether the claims intended to reference the forward scattering optical imaging apparatus (claim 1 line 4) or a separate imaging apparatus. Since “the imaging apparatus” is a broader recitation, it is unclear whether claims 2 and 13 intend to limit the imaging apparatus to the forward scattering optical imaging apparatus of claim 1. Claim 1 recites “the sample in free solution” in line 5, which rends the claim indefinite because it is unclear whether the claim is referring to the first sample recited earlier in the claim in line 3, or a separate sample in free solution. Claims 2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 depend from claim 1 and are rejected for the reason set forth above. Claim 9 recites “the length of time”, which renders the claim indefinite because it is unclear whether the length of time is required to be the first length of time, the second length of time, a separate length of time, or a combination of both the first and second lengths of time. Claim 21 recites “a volume of the first and second samples is in the range of 1 µL to 50 µL”, which renders the claim indefinite because there are multiple reasonable interpretations for this limitation. Since the claim recites “a volume… is”(singular), in one interpretation the limitation is requiring one volume of the first or second sample to be in the range of 1 µL to 50 µL. Under a second interpretation, the limitation requires the total volume of the first and second samples to be in the range of 1 µL to 50 µL. Under a third interpretation, the claim requires each of the first and second samples to separately have a volume in the range of 1 µL to 50 µL. Claim 21 further recites “a number of particles in the first and second samples is less than 2 x 10 5 particles/mL”, which further renders the claim indefinite because in one interpretation the limitation requires either the first or second sample to have a particle number less than 2 x 10 5 particles/mL; in a second interpretation the total number of particles for both the first and second sample is required to be less than 2 x 10 5 particles/mL; and in a third interpretation each of the first and second samples are separately required to have a particle number less than 2 x 10 5 particles/mL. Claim 21 recites “the sample” in line 4, which is indefinite because it is unclear whether the sample is required to be the first or second sample. Claim 25 recites “the multiplicity of images”, which renders the claim indefinite because it is unclear whether the limitation intends to reference the first multiplicity of images, the second multiplicity of images, or both. To obviate this rejection, “the multiplicity of images” can be amended to “the first and second multiplicity of images”. Claim 29 recites “the number of bacterial cell divisions”, which renders the claim indefinite because in one interpretation the recitation is referring to the bacterial cell divisions that occur in the first sample during the first length of time, and under an alternative interpretation the recitation is referring to the bacterial cell divisions that occur in the second sample during the second length of time. Claim 31 recites “the length of time”, which renders the claim indefinite because it is unclear whether the length of time is referring to the first length of time, the second length of time, or both the first and second lengths of time. To obviate this rejection, “the length of time” can be amended to “the first and second lengths of time”. Claim 32 requires “a controller operably coupled to the light source and the forward scattering imaging device and configured to: collect…determine a trajectory a trajectory… determine a trajectory…define a susceptibility ratio…define a susceptibility threshold; compare… and identify the first sample as resistant or as susceptible”, which renders the claim indefinite because it is unclear how the recitation (after “configured to:”) structurally limits the claimed system. Response to Arguments Applicant’s arguments, see the remarks p. 12 first full paragraph, filed 03/17/2026, with respect to the rejection of claims 1 and 32 (and dependent claims) under 35 U.S.C. §112(b) have been fully considered and are persuasive. The rejection of claims 1 and 32, and dependent claims, for reciting a broad limitation together with a narrow limitation that falls within the broad range or limitation (in the same claim) has been withdrawn. However, new grounds for rejection are applied above. Claim Rejections - 35 USC § 112(d) 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 31 depends from claim 1. Claim 1, as amended, requires collecting a first multiplicity of images of a first sample over a first length of time; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source. Claim 31 requires the length of time to be in a range between 20 minutes and 120 minutes. Therefore, claim 31 improperly broadens the scope of claim 1 because claim 31 encompasses timeframes up to 120 minutes. and fails to further limit the subject matter of the claim upon which it depends . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each step mentioned below is in reference to the patent subject matter eligibility flowchart in MPEP 2106. Claim 1 recites “a method”. Therefore claims 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 are directed to a method, which is one of the statutory categories (Step 1: Yes). Claim 1 further recites “comparing the susceptibility ratio to the susceptibility threshold ”, which is an act of evaluation that can be practically performed in the human mind. Accordingly, this “comparing” step is an abstract idea categorized as a mathematical concept judicial exception (MPEP 2106.04(a)(2)(I)) (Step 2A Prong 1: Yes). Besides the “comparing” abstract idea, claim 1 recites the purpose or intended use of the method in the preamble and requires nine additional active method steps. The recitation “performing digital antibiotic susceptibility testing (AST)” is the intended use of the invention and cannot integrate the judicial exception into a practical application because it merely serves to link the judicial exception to a field of use. For the first step, claim 1 requires collecting a first multiplicity of images of a first sample that comprises uncultured bacterial cells over a first length of time using a forward scattering optical imaging apparatus configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps or valves. However, this first step is recited at a high level of generality because the “forward scattering optical imaging apparatus” encompasses any structure capable of collecting light as it deflects or forward scatters through a sample in free solution, as long the apparatus does not include microfluidic channels, pumps or valves. This provides insufficient specificity to add anything of significance to the judicial exception and at most this “collecting” method step constitutes as a step of gathering data for the purpose of performing the “comparing” abstract idea. For the second step, claim 1 requires determining a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the sample over the first length of time. For the third step, claim 1 requires determining based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time. These second and third determination steps encompass visually determining a bacterium’s trajectory from the first multiplicity of images and based on that determination mentally counting a first number of cell divisions, which at most constitutes as data gathering steps for the purpose of performing the “comparing” abstract idea. MPEP 2106.04(II)(B) indicates that for claims reciting multiple judicial exceptions, the eligibility analysis should be conducted for one selected exception, which in this case is the “comparing” abstract idea. For the fourth step, claim 1 requires collecting, from a second sample provided to the imaging apparatus, a second multiplicity over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic. This fourth step is recited at a high level of generality, because the common source of the first and second samples is not described, and the antibiotic in the first sample is not limited in anyway. As such, this fourth step is a data gathering pre-solution activity. For the fifth and sixth steps, claim 1 requires determining a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the sample over the second length of time; and determining based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time. These fifth and sixth determination steps encompass visually determining a bacterium’s trajectory from the first multiplicity of images and based on that determination mentally counting a second number of cell divisions, which at most constitutes as data gathering steps for the purpose of performing the “comparing” abstract idea For the seventh step, claim 1 requires determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions. For the eighth step, claim 1 requires defining a susceptibility threshold. As such, the seventh and eight steps are data gathering steps necessary for performing the abstract idea of comparing the susceptibility ratio to the susceptibility threshold. For the ninth step, claim 1 requires identifying the first samples as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. This ninth step is an insignificant post-solution activity, because the step is merely an instruction to apply the judicial exception. Claim 2 requires providing the first and second samples to the imaging apparatus; and/or collecting the first and second samples from a subject. These limitations are recited at a high level of generality because the way in which the samples are provided to the imaging apparatus is not limited and the subject from which the samples are collected is not limited. As such, the limitation of claim 2 merely serves to generally link the judicial exception to a particular technological environment, i.e. medical diagnostics. Claims 4 limits the first and second samples to comprise a bodily fluid from a subject and claim 5 limits the samples to urine. The limitations of claims 4 and 5 fail to integrate the judicial exception into a practical application because the limitations merely serve to generally link the use of the judicial exception to a particular technological environment, i.e. medical diagnostics. Claim 6 requires combining the first and second sample with a culture medium; further comprising diluting the first and second samples; and/or filtering the first and second samples. These limitations are recited at a high level of generality because the “culture medium”, the dilution mode and the filtration mode are not limited in anyway. As such, the additional limitations of claim 6 amount to data gathering pre-solution activities, because the purpose of the activities is to obtain input for the “comparing” abstract idea. Claim 9 requires defining an infection threshold as a number of cell divisions; and comparing the number of bacterial cell divisions that occur in the first and second samples during the length of time with the infection threshold. The additional steps of claim 9 encompass the mathematical concept of comparing the number of observed bacterial cell divisions to any arbitrary infection threshold number associated with cell divisions. Claim 12 depends from claim 9 and requires the infection threshold to be between 2 to 10 cell divisions. At most, the additional steps of claim 9 and the additional limitation of claim 12 are attempts to link the use of the judicial exception to a particular technological environment, i.e. medical diagnostics. Claim 20 requires the susceptibility threshold to be between 0.4-0.6, corresponding to inhibition of 40% to 60% of the bacterial cells, respectively. This limitation is insignificant, because it is merely an instruction for applying the mathematical concept judicial exception. Claim 21 requires a volume of the first and second samples to be in a range of 1-50 µL; a number of particles in the first and second samples to be less than 2 x 10 5 particles/mL; assessing the trajectory of each bacterial cell in the sample to comprise monitoring a position of each bacterial cell in a sequence of images; and/or a magnification of the imaging apparatus to be in a range of 0.5-10X. The limitations of claim 20 and 21 are insignificant, because the limitations are merely instructions for applying the mathematical concept judicial exception. Claim 25 requires the step of collecting the multiplicity of images to comprise irradiating the sample with infrared light. This limitation is an insignificant pre-solution activity because the purpose of the step is to collect the image inputs necessary for performing the abstract idea. Claim 29 recites “[t]he method of claim 1, further comprising, based on the number of bacterial cell divisions, administering an antibiotic to a subject”. This conditional administration step is recited with a high level of generality because the antibiotic in anyway way. Furthermore, claim 29 does not limit the number of bacterial cell divisions that must occur in the sample prior to the antibiotic administration, nor does claim 29 explicitly require the sample to be from the subject to whom the antibiotic is administered. Therefore, claim 29 does not require an additional antibiotic administration. Rather, claim 29 merely serves as an insignificant post-solution activity, which cannot integrate the abstract idea into a practical application. Claim 31 depends from claim 1 and limits the length of time to between 20 minutes and 120 minutes. This limitation is merely an instruction for applying the judicial exception. As such, claim 31 does not integrate the abstract idea into a practical application. The additional elements of claim 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 separately and accumulatively do not integrate the abstract idea into a practical application because the elements either constitute as insignificant extra-solution activities, or the limitations merely serve to generally link the judicial exception to a technological environment (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 diagnosing infections. Wichselbaum (US 2016/0299067) teaches determining the susceptibility of bacteria to antibiotics. See the abstract. Wichselbaum teaches a method of detecting bacteria suspended in a biological fluid comprising: placing filtered biological fluid in at least one cuvette aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; repeatedly receiving forward-scattered signals at the light detector; and using the forward-scattered signals to determine a change in bacterial count over a period of time. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. forward scattering optical imaging apparatus). See [0052]. Wichselbaum does not teach or suggest microfluidic channels, pumps or valves. Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images (i.e. a multiplicity of images over a period of time). The speckles images are processed for counting bacteria. See [0036]. Tomaras (US 2020/0249148, filed 02/05/2019) teaches antibacterial susceptibility testing for a patient’s fluid sample. See [0056]. Tomaras teaches a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic (i.e. second sample free of added antibiotic). Tomaras further teaches the same patient’s liquid sample (i.e. common source), but mixed with an antibiotic (i.e. a first sample). See [0055]. Furthermore, Tomaras an overall time-to-result of three hours or less. See [0071]. Tomaras teaches samples and cuvettes illuminated by optical or infrared (IR) light sources. See [0051]. Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174) discloses that the only information that is needed to determine antibiotic susceptibility is whether the pathogen is dividing after the antibiotic is administered. See p. 1 right column first passage. Choi teaches examining the accuracy of clinical interpretations and category agreement (see p. 9 left column second paragraph). Mo ( Analytical chemistry , 2019 91 (15), 10164-10171) teaches setting an infection threshold to 1.24. Mo teaches comparing the N t ÷ N 0-- of -urine samples to the infection threshold to classify the sample as infection positive if the number exceeds the threshold or negative if not. See the paragraph spanning pages 10169-10170, figure 1 and S3. Mo comparing the N t /N- 0 of a first sample without ampicillin and without ciprofloxacin to the N t /N- 0 values of with ampicillin and with ciprofloxacin. See figure 3. Mo teaches defining a susceptibility threshold as 0.88 and comparing the N ABX /N C overtime to the threshold and classifying resistant samples if they exceed the threshold. See the paragraph spanning pages 10169 to 10170 and figure 5. Froim (US 2006/0193924) teaches a method of treating an antibiotic-resistant bacterial infection in a subject, the method comprising administering to a subject suspected of having an antibiotic-resistant bacterial infection a therapeutically effective combination of an antibiotic and a toxic compound. See claim 1 of Froim. Thus, the additional elements in claims 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 do not amount to an inventive concept because the elements provide instructions for implementing the abstract idea, such that elements amount to a recitation of the words “apply it” (Step 2B:No). Response to Arguments Applicant's arguments filed 03/17/2026 have been fully considered to the extent that they apply to the new grounds for rejection, but they are not persuasive. Rejection of claims 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31 under 35 U.S.C. § 101 Applicant’s arguments with respect to the § 101 rejection include claim 32 (Remarks p. 14 second para.). Claim 32 however is not rejected under 35 U.S.C. §101. Applicant argues that forward-scattered light at small angles is not visible to the naked eye; it requires the precise optical configuration shown in figure 1A and described in paragraph [0028] and [0043] (780 nm IR LEDs, collimating/focusing optics, CMOS camera at 10 fps through a 2x variable zoom lens). The specification emphasizes that this configuration is essential to precisely track and count single division events in the presence of various particles. The naked-eye observation cannot capture the required multiplicity of images, trajectories or division events. See the remarks p. 14 last paragraph. Applicant argues that the claims as a whole recite a specific physical process rooted in a particular machine. See the remarks p. 15 paragraph 2. This argument is not persuasive because MPEP 2111.01(II) states that “[t]hough understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitationGive that are not part of the claim." The instant claims do not limit the forward-scattering optical imaging apparatus to any particular structure. Furthermore, the “light transmitted and forward-scattered through the sample in free solution” (claim 1 line 5) is not limited to 780 nm IR LEDs. Applicant argues, with respect to step 2A prong 2, that the additional elements integrate any alleged abstract idea into a practical application by improving the functioning of AST technology itself. Applicant argues that the amended claims require the use of forward scattering imaging apparatus, parallel imaging of two samples from a common source, identification of resistance or susceptibility within 60 minutes of obtaining samples with at least 97% accuracy; and application to uncultured bodily fluids. See the remarks the paragraph spanning p. 15-16. Applicant argues that these features provide a technical improvement over conventional AST methods, which require overnight culturing, DNA primers/reagents, microfluidics and hours-to-days turnaround with lower accuracy. Applicant asserts that this is not mere data gathering or field-of-use linking; it is a specific unconventional process that solves the long-standing problem of rapid, reagent-free, single-cell-precision AST directly from patient samples. See the remarks p. 16 first full paragraph. This argument is not persuasive because it is not commensurate in scope with the instant claims. The claims do not require parallel imaging of the first and second samples, as argued. Furthermore, Applicant argues that the additional elements integrate the abstract idea in step 2A prong 2 by improving the functioning of AST technology itself. However, whether an additional element represents only well-understood, routine and conventional activities is a consideration in step 2B. As discussed above, Tomaras teaches an overall time-to-result of three hours or less (see [0071]), and Choi teaches examining the accuracy of clinical interpretations and category agreement (see p. 9 left column second paragraph). Therefore, the claimed identification step does not integrate the abstract idea into an inventive concept in step 2B. Applicant argues, with respect to step 2B, that examiner has provided no evidence that the specific combination of the forward-scattering optics, free-solution imaging without microfluidics, dual-sample ratio calculation, and 60 minutes/97%-accuracy performance on uncultured clinical samples is well-understood, routine or conventional. See the remarks p. 16 last passage. This argument is not persuasive because of the new grounds for rejection discussed above. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1, 2, 4-6, 21, 25, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Wichselbaum (US 2016/0299067) in view of Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174) . Regarding claim 1 , Wichselbaum teaches determining the susceptibility of bacteria to antibiotics. See the abstract. Wichselbaum teaches a method of detecting bacteria suspended in a biological fluid comprising: placing filtered biological fluid in at least one cuvette aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; repeatedly receiving forward-scattered signals at the light detector; and using the forward-scattered signals to determine a change in bacterial count over a period of time. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. forward scattering optical imaging apparatus). See [0052]. Wichselbaum does not teach or suggest microfluidic channels, pumps or valves, which meets the instantly claimed limitation that requires “without using microfluidic channels, pumps or valves”. Furthermore, Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images (i.e. a multiplicity of images over a period of time). The speckles images are processed for counting bacteria. See [0036]. In figures 10A, Wichselbaum teaches scattering angle-time profiles induced by particles having constant unidirectional velocity (i.e. trajectory). See [0021]. Wichselbaum teaches analyzing speckles images to study the dynamics of bacteria. Wichselbaum suggests that by inducing chemotactic or thermotactic motion (i.e. trajectory) the sensitivity for detecting and measuring the concentration of motile bacteria suspended in the examined fluid, as well as for determining their susceptibility to antibiotic agents is enhanced. See [0061]. Wichselbaum does not teach a first sample that comprises uncultured bacterial cells. Wichselbaum does not teach a second sample, wherein the first sample and the second sample are obtained from a common source, and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic. Tomaras teaches antibacterial susceptibility testing for a patient’s fluid sample. See [0056]. Tomaras teaches liquid samples contained in optical chambers of cuvette assemblies between a light source and a sensor. See [0049]. Tomaras teaches a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic (i.e. second sample free of added antibiotic). Tomaras further teaches the same patient’s liquid sample (i.e. common source), but mixed with an antibiotic (i.e. a first sample). See [0055]. Furthermore, Tomaras teaches cuvette-based systems that detect urinary tract infection (UTI) pathogens directly from urine specimens (i.e. uncultured), without the need for initial processing and provides an overall time-to-result of three hours or less See [0071]. 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 substitute Tomaras’s first and second liquid samples for Wichselbaum’s biological fluid. One of ordinary skill in the art would have been motivated to do so because Wichselbaum teaches determining the antibiotic susceptibility of motile bacteria suspended in examined fluid (see [0061]). There would have been a reasonable expectation of success because Wichselbaum demonstrates collecting speckles images of particles suspended in synthetic urine moving in uniform directions (i.e. trajectory) (see [0050]). Wichselbaum and Tomaras do not teach determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time. However, Wichselbaum suggests analyzing images for bacteria velocity or motion (i.e. trajectories) and counting bacteria. Wichselbaum and Tomaras do not teach determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during second first length of time. However, Wichselbaum suggests analyzing images for bacteria velocity or motion (i.e. trajectories) and counting bacteria. Wichselbaum and Tomaras do not teach determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold. Choi discloses that the only information that is needed to determine antibiotic susceptibility is whether the pathogen is dividing after the antibiotic is administered. See p. 1 right column first passage. Choi teaches automated image-processing and data interpretation. Choi teaches dividing the value of bacterial occupancy area in third images at 4 hours (A 3 ) by those of first image at 0 hours (A 1 ) and comparing the calculated value with a threshold value. If A 3 / A 1 (i.e. a susceptibility ratio) is larger than the threshold value, the case may be determined as resistant. See p. 8 the caption of figure 4, specifically the left column. As such if the bacterial area in the images is increased, the case is determined as resistant. See p. 2 right column second paragraph. 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 apply the image-processing of Choi to the scatter images of Wichselbaum and Tomaras, such that the second sample without antibiotics is A 1 and the first sample with antibiotics is A 3. One of ordinary skill in the art would have been motivated to do so because Choi suggests that cell division is the only information needed to determine antibiotic susceptibility; and Choi further suggests that the area (A) is indicative of cell division. There would have been a reasonable expectation of success because Choi demonstrates defining a threshold, comparing a ratio to the threshold and identifying a sample as resistant or susceptible. Wichselbaum, Tomaras and Choi do not teach identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility ratio within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. However, Tomaras teaches cuvette-based systems that detect pathogens directly from urine specimens, without the need for initial processing and provides an overall time-to-result of three hours or less. See [0071]. 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 optimize the method of Wichselbaum, Tomaras and Choi by adjusting the three hours or less timeframe taught by Tomaras, and the accuracy. One of ordinary skill in the art would have been motivated to adjust the time frame of Tomaras because Tomaras suggests that the results may be achieved in less than three hours. There would have been a reasonable expectation of success because Tomaras provides a time frame that overlaps with the instantly claimed within 60 minutes. One of ordinary skill in the art would have been motivated to adjust the accuracy, because Choi teaches examining the accuracy of clinical interpretations and category agreement (see p. 9 left column second paragraph). There would have been a reasonable expectation of success because Choi demonstrates a 91.5% category agreement, from which one could optimize (see p. 9 left column second paragraph). Regarding claim 2 , Wichselbaum teaches placing filtered biological fluid in at least one cuvette (i.e. providing the sample) aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; and repeatedly receiving forward-scattered signals at the light detector. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. imaging apparatus). See [0052]. Regarding claim 4-5, Tomaras teaches a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic (i.e. second sample free of added antibiotic). Tomaras further teaches the same patient’s liquid sample (i.e. common source), but mixed with an antibiotic (i.e. a first sample). See [0055]. Regarding claim 6 , Tomaras discloses that each sample may undergo some type of filtering. See [0034]. Regarding claim 21 , Choi teaches inoculating microplates with a bacterial stock solution of 10 µL. See p. 11 last full paragraph. Regarding claim 25 , Tomaras teaches samples and cuvettes illuminated by optical or infrared (IR) light sources. See [0051]. Regarding claim 31 , Tomaras teaches a period of time, e.g. 1-6 hours, preferably 1-3 hours, which overlaps with the instantly claimed length of time between 20 minutes and 120 minutes. See [0029]. Regarding claim 32 , Wichselbaum teaches a system comprising light source. Light emitted from light source passes through collimator (i.e. optics configured to focus light) and the collimated beam entered a cuvette (i.e. container). See [0027]. Wichselbaum teaches fluid contained in cuvette. See [0023]. The sample of the fluid, need not be cultured. See [0022]. Wichselbaum teaches a light detector for receiving light forwardly scattered from the biological fluid. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as a light detector. See [0052]. Wichselbaum does not teach microfluidic channels, pumps or valves, which meets the instantly claimed requirement. Wichselbaum teaches a processing and control unit that provides for powering light source and receiver unit. The receiver unit controls the detector (i.e. the forward scatter imaging device). See [0027]. Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images (i.e. a multiplicity of images over a period of time). The speckles images are processed for counting bacteria. See [0036]. In figures 10A, Wichselbaum teaches scattering angle-time profiles induced by particles having constant unidirectional velocity (i.e. trajectory). See [0021]. Wichselbaum does not explicitly teach a first sample that comprises uncultured bacterial cells. Wichselbaum does not teach a second sample, wherein the first sample and the second sample are obtained from a common source, and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic. Tomaras teaches antibacterial susceptibility testing for a patient’s fluid sample. See [0056]. Tomaras teaches liquid samples contained in optical chambers of cuvette assemblies between a light source and a sensor. See [0049]. Tomaras teaches a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic (i.e. second sample free of added antibiotic). Tomaras further teaches the same patient’s liquid sample (i.e. common source), but mixed with an antibiotic (i.e. a first sample). See [0055]. Furthermore, Tomaras teaches cuvette-based systems that detect urinary tract infection (UTI) pathogens directly from urine specimens (i.e. uncultured), without the need for initial processing and provides an overall time-to-result of three hours or less See [0071]. 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 substitute Tomaras’s first and second liquid samples for Wichselbaum’s biological fluid. One of ordinary skill in the art would have been motivated to do so because Wichselbaum teaches determining the antibiotic susceptibility of motile bacteria suspended in examined fluid (see [0061]). There would have been a reasonable expectation of success because Wichselbaum demonstrates collecting speckles images of particles suspended in synthetic urine moving in uniform directions (i.e. trajectory) (see [0050]). Wichselbaum and Tomaras do not teach determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time. However, Wichselbaum suggests analyzing images for bacteria velocity or motion (i.e. trajectories) and counting bacteria. Wichselbaum and Tomaras do not teach determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during second first length of time. However, Wichselbaum suggests analyzing images for bacteria velocity or motion (i.e. trajectories) and counting bacteria. Wichselbaum and Tomaras do not teach determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold. Choi discloses that the only information that is needed to determine antibiotic susceptibility is whether the pathogen is dividing after the antibiotic is administered. See p. 1 right column first passage. Choi teaches automated image-processing and data interpretation. Choi teaches dividing the value of bacterial occupancy area in third images at 4 hours (A 3 ) by those of first image at 0 hours (A 1 ) and comparing the calculated value with a threshold value. If A 3 / A 1 (i.e. a susceptibility ratio) is larger than the threshold value, the case may be determined as resistant. See p. 8 the caption of figure 4, specifically the left column. As such if the bacterial area in the images is increased, the case is determined as resistant. See p. 2 right column second paragraph. 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 apply the image-processing of Choi to the scatter images of Wichselbaum and Tomaras, such that the second sample without antibiotics is A 1 and the first sample with antibiotics is A 3. One of ordinary skill in the art would have been motivated to do so because Choi suggests that cell division is the only information needed to determine antibiotic susceptibility; and Choi further suggests that the area (A) is indicative of cell division. There would have been a reasonable expectation of success because Choi demonstrates defining a threshold, comparing a ratio to the threshold and identifying a sample as resistant or susceptible. Wichselbaum, Tomaras and Choi do not teach identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility ratio within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy. However, Tomaras teaches cuvette-based systems that detect pathogens directly from urine specimens, without the need for initial processing and provides an overall time-to-result of three hours or less. See [0071]. 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 optimize the method of Wichselbaum, Tomaras and Choi by adjusting the three hours or less timeframe taught by Tomaras, and the accuracy. One of ordinary skill in the art would have been motivated to adjust the time frame of Tomaras because Tomaras suggests that the results may be achieved in less than three hours. There would have been a reasonable expectation of success because Tomaras provides a time frame that overlaps with the instantly claimed within 60 minutes. One of ordinary skill in the art would have been motivated to adjust the accuracy, because Choi teaches examining the accuracy of clinical interpretations and category agreement (see p. 9 left column second paragraph). There would have been a reasonable expectation of success because Choi demonstrates a 91.5% category agreement, from which one could optimize (see p. 9 left column second paragraph) . 07-22-aia AIA Claim s 9, 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wichselbaum (US 2016/0299067) Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174) , as applied to claim s 1, 2, 4-6, 21, 25, 31 and 32 above, and further in view of Mo ( Analytical chemistry , 2019 91 (15), 10164-10171; previously cited) Regarding claim 9 , Choi discloses that the only information that is needed to determine antibiotic susceptibility is whether the pathogen is dividing after the antibiotic is administered. See p. 1 right column first passage. Wichselbaum, Tomaras and Choi do not teach defining an infection threshold as a number of cell divisions; and comparing the number of bacterial cell divisions that occur in the first and second sample during the length of time with the infection threshold. Mo teaches a large volume light scattering microscopy (LVM) technique that tracks phenotypic features of single bacterial cells directly in clinical urine samples. The technique demonstrates rapid (90 min) detection of E. coli in clinical urine samples. See the abstract. Mo teaches determining a threshold based on counting errors of a [light scattering microscopy (LVM)] system. The statistical counting error was estimated by 1÷ √N, where N is the spots count (i.e. number of bacteria). The maximum counting error among all experimental data is ±6% for infection identification. To establish a 95% confidence interval, the error is multiplied by 2. Therefore, the infection threshold, T I (N 90 / N 0 ) is set at 1.24. See the paragraph spanning pages 10169-10170. Moreover, Mo teaches analyzing LVM images to determine spot counts vs time. The ratio of the spot count at time t (N t ) to that at 0 min (N 0 ) is measured and compared with an infection threshold (T I ) to determine if infection is positive or negative. See the caption of figure 1 and figure S3. Mo teaches classifying clinical urine samples as “infection positive” or “infection negative” via LVM-AST testing. See the left column on page 10168 and figure 4 (a). Thus, Mo indicates that the 1.24 infection threshold is the number of cell divisions between 0 and 90 min (N 90 / N 0 ); and Mo teaches comparing the N t ÷ N 0-- of -urine samples to the infection threshold to classify the sample as infection positive or negative. 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 apply Mo’s infection threshold and bacterial cell division comparison of Mo to the first and second samples of Wichselbaum, Tomaras and Choi. One of ordinary skill in the art would have been motivated to do so because Mo suggests that the calculation can be used for identifying resistant or susceptible bacteria directly in clinical urine samples; and Tomaras teaches urine samples. There would have been a reasonable expectation of success because Mo demonstrates classifying samples based on the infection threshold defined. Regarding claim 12 , Mo teaches setting an infection threshold set at 1.24. The threshold is determined based on counting errors. The maximum counting error is ±6% or ±0.06 for infection identification. To establish a 95% confidence interval, the error is multiplied by 2 thereby revealing a ±12% or ±0.12 confidence range of infection identification. Therefore, the 1.24 threshold is set as the upper boundary of 1.12 ±0.12, which gives >95% confidence. See the paragraph spanning pages 10169-10170. Wichselbaum, Tomaras, Choi and Mo do not teach an infection threshold that is between 2 to 10 cell divisions. 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 optimize the threshold by adjusting the confidence interval. One would be motivated to do so because a person of ordinary skill in the art has good reason to pursue the known options within their technical grasp. There would be a reasonable expectation of success because Mo teaches infection positive urine samples with an N t /N- 0 =2. Thus, one could reasonably set the threshold in view of those samples. In the process, one would arrive at a threshold equivalent to 2 cell divisions. MPEP 2144.05(II) states that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Regarding claim 20 , Mo teaches a 0.88 susceptibility threshold. See paragraph spanning pages 10169 and 10170. Mo teaches setting the susceptibility threshold based on counting errors of the system. Moreover, Mo teaches a 95% confidence interval. See paragraph spanning pages 10169 and 10170. Wichselbaum, Tomaras, Choi and Mo do not teach a susceptibility threshold in a range of 0.4 to 0.6. 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 optimize the susceptibility threshold of Mo. One would be motivated to do so because Mo suggests setting the susceptibility threshold based on counter errors and a confidence interval of 95%. As such, one would be motivated adjust the susceptibility threshold for different counter systems or confidence intervals. There would be a reasonable expectation of success because Mo demonstrates setting a susceptibility threshold at 0.88. MPEP 2144.05(II) states that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) . 07-22-aia AIA Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wichselbaum (US 2016/0299067), Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174) , as applied to claim s 1, 2, 4-6, 21, 25, 31 and 32 above, and further in view of Froim (US 2006/0193924) . Regarding claim 29 , Wichselbaum teaches determining the susceptibility of bacteria to antibiotics in order to devise a treatment schedule if an infection is detected. See [0002]. Tomaras teaches a liquid sample of urine from a patient suspected of having a urinary tract infection. See [0056]. Choi suggests that the only information that is needed to determine antibiotic susceptibility is whether the pathogen is dividing after the antibiotic is administered. See p. 1 right column first passage. Wichselbaum, Tomaras, and Choi do not teach a method further comprising, based on the number of cell divisions, administering an antibiotic to a subject. Froim teaches a method of treating an antibiotic-resistant bacterial infection in a subject, the method comprising administering to a subject suspected of having an antibiotic-resistant bacterial infection a therapeutically effective combination of an antibiotic and a toxic compound. See claim 1 of Froim. 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 modify the method of Wichselbaum, Tomaras and Choi by administering an antibiotic to a subject, as taught by Froim. One of ordinary skill in the art would have been motivated to do so because Wichselbaum suggests that the susceptibility determination can be used to devise a treatment schedule. There would have been a reasonable expectation of success because Choi suggests that cell division is the only information needed to determine susceptibility; and Froim further suggests administering an antibiotic to a subject to treat a bacterial infection determined to be antibiotic-resistant . Response to Arguments With respect to the previous rejections under 35 U.S.C. §103, Applicant's arguments filed 03/17/2026 have been fully considered but they do not apply to the new grounds of rejection set forth above. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/494,225 (hereafter Nongijan ‘225 ) in view of Wichselbaum (US 2016/0299067), Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174), Mo ( Analytical chemistry , 2019 91 (15), 10164-10171), and Froim (US 2006/0193924). Co-pending claim 1 recites a method for deep learning video microscopy-based antimicrobial susceptibility testing (DLVM-AST) of a bacterial strain in a sample including non-immobilized bacterial cells and an antibiotic, the method comprising: acquiring an image sequence of individual bacterial cells of the bacterial strain in a subject sample with a phase contrast microscope before, during, and after exposure to each antibiotic at different concentrations; wherein the acquiring of the image sequence comprises capturing one or more phenotypic features including a motion feature of the non-immobilized bacterial cells in the image sequence; compressing the image sequence into static images while preserving essential phenotypic features; inputting data representing the static images into a pre-trained deep learning (DL) model which generates output data; and determining antimicrobial susceptibility for the bacterial strain from the output data. Co-pending claim 3 recites the method of claim 1 wherein the subject sample is a urine sample from a human patient. Co-pending claim 6 recites the method of claim 1 wherein said capturing of phenotypic features further comprises capturing one or more of a division feature , and a morphological feature. The co-pending claims lack: a first sample that comprises uncultured bacterial cells, using a forward scattering optical imaging apparatus configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; determining a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the first sample over the first length of time; and determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time; collecting, from a second sample provided to the imaging apparatus, a second multiplicity of images of the second sample over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic; determining a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the second sample over the second length of time; determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time; determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy (relevant to instant claim 1); further comprising providing the first and second samples to the imaging apparatus, and/or further comprising collecting the first and second samples from a subject (relevant to instant claim 2); and a length of time is in a range between 20 minutes and 120 minutes, or between 30 minutes and 60 minutes (relevant to instant claim 31). Furthermore, a system comprising: a light source, optics to focus light on the liquid sample comprising uncultured bacterial cells in a container; a forward scattering imaging device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps or valves; and a controller operably coupled to the light source and forward scattering imaging device configured to: [the method steps of instant claim 1] (relevant to instant claim 32) However, Wichselbaum teaches placing filtered biological fluid in at least one cuvette aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; repeatedly receiving forward-scattered signals at the light detector; and using the forward-scattered signals to determine a change in bacterial count over a period of time. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. forward scattering optical imaging apparatus). See [0052]. Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images. See [0036]. Tomaras a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic and the same patient’s liquid sample may be mixed with an antibiotic. See [0055]. Furthermore, Tomaras an overall time-to-result of three hours or less. See [0071]. Choi teaches defining a threshold value (T 1 ) and if the bacterial occupancy area at 4 hours (A 3 ) is divided by that of the first image at 0 hours (A 0 ) and greater than the threshold the case is determined as resistant. See the caption of figure 4 (relevant to instant claim 1). Wichselbaum teaches providing biological fluid in at least one cuvette aligning the at least one cuvette in the system. See claim 18 of Wichselbaum (relevant to instant claim 2). Tomaras an overall time-to-result of three hours or less. See [0071] (relevant to instant claim 31). Wichselbaum teaches a system comprising light source. Light emitted from light source passes through collimator (i.e. optics configured to focus light) and the collimated beam entered a cuvette (i.e. container). See [0027]. Wichselbaum teaches fluid contained in cuvette. See [0023]. The sample of the fluid, need not be cultured. See [0022]. Wichselbaum teaches a light detector for receiving light forwardly scattered from the biological fluid. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as a light detector. See [0052]. Wichselbaum does not teach microfluidic channels, pumps or valves, which meets the instantly claimed requirement. Wichselbaum teaches a processing and control unit that provides for powering light source and receiver unit. The receiver unit controls the detector (i.e. the forward scatter imaging device). See [0027] (relevant to instant claim 32). 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 substitute the urine sample recited in co-pending claim 3 for the biological fluid of Wichselbaum, to further use that urine sample as a first with an antibiotic and second sample without an antibiotic as suggested by Tomaras, and to further apply the resistance determination of Choi in order to determine antibiotic susceptibility. The copending claims lack: filtering the first and second samples (relevant to instant claim 6); defining an infection threshold as a number of cell divisions; and comparing the number of the bacterial cell divisions that occur in the first and second samples sample during the length of time with the infection threshold (relevant to instant claim 9); an infection threshold that is between 2 to 10 cell divisions (relevant to instant claim 12); a threshold of 0.4 to 0.6 (relevant to instant claim 20); first and second samples in a range of 1 µl to 50 µl (relevant to instant claim 21); irradiating the sample with IR (relevant to instant claim 25); based on the number of bacterial cell divisions, administering an antibiotic to a subject (relevant to instant claim 29). However, Tomaras discloses that each sample may undergo some type of filtering. See [0034] (relevant to instant claim 6). Mo teaches setting an infection threshold to 1.24 (relevant to instant claims 9, 12 and 20). Choi teaches inoculating microplates with a bacterial stock solution of 10 µL. See p. 11 last full paragraph (relevant to instant claim 21). Tomaras teaches samples and cuvettes illuminated by optical or infrared (IR) light sources. See [0051] (relevant to instant claim 25). Froim (administering to a subject suspected of having an antibiotic-resistant bacterial infection a therapeutically effective combination of an antibiotic. See claim 1 of Froim (relevant to instant claim 29). 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 apply the filtering and IR illumination of Tomaras to the urine sample recited in co-pending claim 3, optimize the volume of the sample based on Choi’s 10 µL suggestion, and to further apply the infection threshold determination of Mo in order to test for antibiotic susceptibility. 08-36 AIA Claim s 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-12 of U.S. Patent No. 12049662 (hereafter Wang ‘662 ) , in view of Wichselbaum (US 2016/0299067), Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174), Mo ( Analytical chemistry , 2019 91 (15), 10164-10171), and Froim (US 2006/0193924) . Patent claim 1 recites a method of assessing the presence of microbes in a liquid sample, the method comprising: directing light from a light source toward a reservoir containing the liquid sample; obtaining, with a video camera , a series of images of the liquid sample over a length of time, wherein incident light from the light source is prevented from directly entering the camera, and objects in the liquid sample appear as bright spots in the images of the sample; removing background noise from the images of the liquid sample to yield modified images of the sample, wherein removing the background noise comprises averaging frames of raw images to reduce noise and data size to produce a local stack average, subtracting a stack local minimal from the local stack average to remove static and drifting background noises to produce a subtracted stack local minimal, subtracting a stack median of all frames from the subtracted stack local minimal to remove dynamic background noises to produce a median subtracted stack local minimal, and subtracting a local spatial background from the median subtracted stack local minimal to remove spatial optical noises to produce the modified images of the sample; assessing, from the modified images of the liquid sample, an initial integrated scattering intensity of the objects (I C0 ) and an integrated scattering intensity of the objects at a time t (I Ct ); and identifying the sample as comprising microbes for (I Ct )/(I C0 ) above a predefined infection threshold T I , wherein a portion of the sample comprising microbes is treated with an antibiotic to yield a treated liquid sample. Patent claim 2 recites a method of claim 2, further comprising identifying the microbes as resistant to the antibiotic for a ratio of ΔI ABX to ΔI C that exceeds a predefined resistant threshold T R . Patent claim 4 recites the method of claim 2, further comprising identifying the microbes as susceptible to the antibiotic for a ratio of ΔI ABX to Δ IC that is less than or equal to a predefined resistant threshold T R . Patent claim 5 recites the method of claim 1, wherein the microbes comprise bacteria . Patent claim 6 recites the method of claim 1, wherein the liquid sample comprises urine . Patent claim 7 recites the method of claim 1, wherein the length of time is at least 60 minutes. Patent claim 8 recites the method of claim 1, wherein the light source comprises a light emitting diode (LED). Patent claim 9 recites the method of claim 1, wherein a volume of the liquid sample is in a range between 1 μL and 10 μL . Patent claim 10 recites the method of claim 1, further comprising magnifying the objects in the liquid sample in a range of 1X-5X before obtaining the series of images. Patent claim 11 recites the method of claim 1, further comprising maintaining a temperature of the liquid sample between about 35° C. and about 37° C. while obtaining the series of images. The patent claims lack: a first sample that comprises uncultured bacterial cells, using a forward scattering optical imaging apparatus configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; determining a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the first sample over the first length of time; and determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time; collecting, from a second sample provided to the imaging apparatus, a second multiplicity of images of the second sample over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic; determining a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the second sample over the second length of time; determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time; determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy (relevant to instant claim 1); further comprising providing the first and second samples to the imaging apparatus, and/or further comprising collecting the first and second samples from a subject (relevant to instant claim 2); and a length of time is in a range between 20 minutes and 120 minutes, or between 30 minutes and 60 minutes (relevant to instant claim 31). Furthermore, a system comprising: a light source, optics to focus light on the liquid sample comprising uncultured bacterial cells in a container; a forward scattering imaging device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps or valves; and a controller operably coupled to the light source and forward scattering imaging device configured to: [the method steps of instant claim 1] (relevant to instant claim 32). However, Wichselbaum teaches placing filtered biological fluid in at least one cuvette aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; repeatedly receiving forward-scattered signals at the light detector; and using the forward-scattered signals to determine a change in bacterial count over a period of time. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. forward scattering optical imaging apparatus). See [0052]. Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images. See [0036]. Tomaras a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic and the same patient’s liquid sample may be mixed with an antibiotic. See [0055]. Furthermore, Tomaras an overall time-to-result of three hours or less. See [0071]. Choi teaches defining a threshold value (T 1 ) and if the bacterial occupancy area at 4 hours (A 3 ) is divided by that of the first image at 0 hours (A 0 ) and greater than the threshold the case is determined as resistant. See the caption of figure 4 (relevant to instant claim 1). Wichselbaum teaches providing biological fluid in at least one cuvette aligning the at least one cuvette in the system. See claim 18 of Wichselbaum (relevant to instant claim 2). Tomaras an overall time-to-result of three hours or less. See [0071] (relevant to instant claim 31). Wichselbaum teaches a system comprising light source. Light emitted from light source passes through collimator (i.e. optics configured to focus light) and the collimated beam entered a cuvette (i.e. container). See [0027]. Wichselbaum teaches fluid contained in cuvette. See [0023]. The sample of the fluid, need not be cultured. See [0022]. Wichselbaum teaches a light detector for receiving light forwardly scattered from the biological fluid. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as a light detector. See [0052]. Wichselbaum does not teach microfluidic channels, pumps or valves, which meets the instantly claimed requirement. Wichselbaum teaches a processing and control unit that provides for powering light source and receiver unit. The receiver unit controls the detector (i.e. the forward scatter imaging device). See [0027] (relevant to instant claim 32). 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 substitute the series of images recited in patent claim 1 for Wichselbaum’s multiplicity of images, and to substitute the urine sample recited in patent claim 6 for Tomaras’s first and second sample in order to determine antibiotic susceptibility. The patent claims lack: filtering the first and second samples (relevant to instant claim 6); defining an infection threshold as a number of cell divisions; and comparing the number of the bacterial cell divisions that occur in the first and second samples sample during the length of time with the infection threshold (relevant to instant claim 9); an infection threshold that is between 2 to 10 cell divisions (relevant to instant claim 12); a threshold of 0.4 to 0.6 (relevant to instant claim 20); first and second samples in a range of 1 µl to 50 µl (relevant to instant claim 21); irradiating the sample with IR (relevant to instant claim 25); based on the number of bacterial cell divisions, administering an antibiotic to a subject (relevant to instant claim 29). However, Tomaras discloses that each sample may undergo some type of filtering. See [0034] (relevant to instant claim 6). Mo teaches setting an infection threshold to 1.24 (relevant to instant claims 9, 12 and 20). Choi teaches inoculating microplates with a bacterial stock solution of 10 µL. See p. 11 last full paragraph (relevant to instant claim 21). Tomaras teaches samples and cuvettes illuminated by optical or infrared (IR) light sources. See [0051] (relevant to instant claim 25). Froim (administering to a subject suspected of having an antibiotic-resistant bacterial infection a therapeutically effective combination of an antibiotic. See claim 1 of Froim (relevant to instant claim 29). 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 substitute Tomaras’s IR for the LED light recited in patent claim 8, optimize the volume of the sample based on Choi’s 10 µL suggestion, and to further apply the infection threshold determination of Mo in order to test for antibiotic susceptibility . 08-36 AIA Claim s 1-2, 4-6, 9, 12, 16-18, 20-21, 25, 29, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-12 of U.S. Patent No. 11834696 (hereafter Tao ‘696 ) , in view of Wichselbaum (US 2016/0299067), Tomaras (US 2020/0249148, filed 02/05/2019) and Choi (Sci Transl Med. 2014 Dec 17;6(267):267ra174), Mo ( Analytical chemistry , 2019 91 (15), 10164-10171), and Froim (US 2006/0193924) . Patent claim 1 of Tao ‘696 recites a method for determining susceptibility of bacterial cells to at least one selected drug, the method comprising: (a) preparing a set of test samples from a patient sample, where each test sample of the set of test samples includes a plurality of bacterial cells; (b) preparing at least one negative control sample from the patient sample; (c) adding a different dose of the at least one selected drug in each test sample of the set of test samples; (d) selecting a first test sample having a first dose of the selected drug from the set of test samples; (e) subjecting the selected test sample to large-volume light scattering imaging (LLSi) utilizing a light source and optics to produce a light slab to illuminate a test sample view volume of at least 1 mm 3 , and utilizing a camera (e.g. imaging device) configured to collect light scattered by transit through at least a portion of the test sample view volume; (f) producing, from the LLSi imaging, a video (e.g. a multiplicity of images over a length of time) of at least a portion of the plurality of bacterial cells in the selected test sample; (g) generating a training data set comprising at least 6000 bacterial cell traces including at least 3000 bacterial cell traces inhibited by an antibiotic, and at least 3000 controls, and thereafter processing the video with a deep learning (DL) algorithm to provide an output signal for the selected test sample; (h) selecting a next test sample from the set of test samples; (i) repeating steps (e) through (h) so as to provide a plurality of output signals; and (j) determining drug susceptibility of the plurality of bacterial cells to the at least one selected drug from the plurality of output signals as compared against a control output signal generated from the at least one negative control sample. Patent claim 2 of Tao ‘696 recites the method of claim 1 wherein the at least one selected drug includes at least one antibiotic, the method further comprising: (k) for each of the at least one selected drug, repeating steps (a) to (i) for each of the at least one selected drug to obtain an inhibition curve for each of said at least one selected drug thereby generating a set of inhibition curves; and (l) determining drug susceptibility of the plurality of bacterial cells for each of the at least one selected drug from the set of inhibition curves. Patent claim 3 of Tao ‘696 recites the method of claim 1 wherein the patient sample is selected from the group consisting of a urine sample , a blood sample, a sample including bacterial cells and combinations thereof. Patent claim 4 of Tao ‘696 recites the method of claim 1 wherein processing the video with a deep learning (DL) algorithm comprises: compressing an LLSi video into a trace image; transmitting the trace image into a convolutional neural network as an input; and processing the input using a plurality of hidden layers in a neural network to provide an output. Patent claim 5 of Tao ‘696 recites the method of claim 1 wherein the act of processing the video with a deep learning (DL) algorithm comprises detecting action of the at least one selected drug on the plurality of bacterial cells for each selected test sample that leads to changes in various phenotypic features of the plurality of bacterial cells including features selected from the group consisting of division , metabolic driven motion, morphology and combinations thereof. Patent claim 6 of Tao ‘696 recites the method of claim 1 wherein processing the video with a deep learning (DL) algorithm comprises differentiating antibiotic susceptible bacterial cells in the plurality of bacterial cells of each test sample from antibiotic resistant cells in the plurality of bacterial cells of each test sample automatically by detecting differences in the videos of individual bacterial cells . Patent claim 7 of Tao ‘696 recites the method of claim 6 wherein the act of detecting differences includes detecting differences in characteristics selected from the group consisting of cell division , morphology change, motion associated with metabolic activities, changes in the LLSi images, ATP, redox markers, and combinations thereof. Patent claim 8 of Tao ‘696 recites the method of claim 1 wherein the act of processing the video with a deep learning (DL) algorithm comprises: transforming each bacterial cell in the video into a trace image; and detecting cell division. Patent claim 9 of Tao ‘696 recites the method of claim 1 wherein the plurality of bacterial cells for at least one selected test sample comprises E. Coli cells. The patent claims lack: a first sample that comprises uncultured bacterial cells, using a forward scattering optical imaging apparatus configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps, or valves; determining a trajectory of each bacterial cell in the first sample from the first multiplicity of images of the first sample over the first length of time; and determining, based on the trajectory of each bacterial cell in the first sample, a first number of bacterial cell divisions that occur in the first sample during the first length of time; collecting, from a second sample provided to the imaging apparatus, a second multiplicity of images of the second sample over a second length of time, wherein the first sample and the second sample are obtained from a common source and wherein the first sample comprises an antibiotic and the second sample is free of added antibiotic; determining a trajectory of each bacterial cell in the second sample from the second multiplicity of images of the second sample over the second length of time; determining, based on the trajectory of each bacterial cell in the second sample, a second number of bacterial cell divisions that occur in the second sample during the second length of time; determining a susceptibility ratio, wherein the susceptibility ratio comprises a ratio of the first number of bacterial cell divisions to the second number of bacterial cell divisions; defining a susceptibility threshold; comparing the susceptibility ratio to the susceptibility threshold; and identifying the first sample as resistant or as susceptible to the antibiotic if the susceptibility ratio exceeds the susceptibility threshold within 60 minutes of obtaining the first and second samples from the common source with at least 97% accuracy (relevant to instant claim 1); further comprising providing the first and second samples to the imaging apparatus, and/or further comprising collecting the first and second samples from a subject (relevant to instant claim 2); and a length of time is in a range between 20 minutes and 120 minutes, or between 30 minutes and 60 minutes (relevant to instant claim 31). Furthermore, a system comprising: a light source, optics to focus light on the liquid sample comprising uncultured bacterial cells in a container; a forward scattering imaging device configured to collect light transmitted and forward-scattered through the sample in free solution, without using microfluidic channels, pumps or valves; and a controller operably coupled to the light source and forward scattering imaging device configured to: [the method steps of instant claim 1] (relevant to instant claim 32). However, Wichselbaum teaches placing filtered biological fluid in at least one cuvette aligning the at least one cuvette in the system, illuminating a portion of the filtered biological fluid with a light beam to create forward-scattering light; repeatedly receiving forward-scattered signals at the light detector; and using the forward-scattered signals to determine a change in bacterial count over a period of time. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as the light detector (i.e. forward scattering optical imaging apparatus). See [0052]. Wichselbaum discloses that the system repeatedly receives for a first predefined time interval T 1 a number of discrete speckles images. See [0036]. Tomaras a liquid sample, e.g. urine from a patient suspected of having a urinary tract infection, that may serve as a control with no antibiotic and the same patient’s liquid sample may be mixed with an antibiotic. See [0055]. Furthermore, Tomaras an overall time-to-result of three hours or less. See [0071]. Choi teaches defining a threshold value (T 1 ) and if the bacterial occupancy area at 4 hours (A 3 ) is divided by that of the first image at 0 hours (A 0 ) and greater than the threshold the case is determined as resistant. See the caption of figure 4 (relevant to instant claim 1). Wichselbaum teaches providing biological fluid in at least one cuvette aligning the at least one cuvette in the system. See claim 18 of Wichselbaum (relevant to instant claim 2). Tomaras an overall time-to-result of three hours or less. See [0071] (relevant to instant claim 31). Wichselbaum teaches a system comprising light source. Light emitted from light source passes through collimator (i.e. optics configured to focus light) and the collimated beam entered a cuvette (i.e. container). See [0027]. Wichselbaum teaches fluid contained in cuvette. See [0023]. The sample of the fluid, need not be cultured. See [0022]. Wichselbaum teaches a light detector for receiving light forwardly scattered from the biological fluid. See claim 18 of Wichselbaum. Wichselbaum teaches a CMOS sensor that serves as a light detector. See [0052]. Wichselbaum does not teach microfluidic channels, pumps or valves, which meets the instantly claimed requirement. Wichselbaum teaches a processing and control unit that provides for powering light source and receiver unit. The receiver unit controls the detector (i.e. the forward scatter imaging device). See [0027] (relevant to instant claim 32). 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 substitute the forward-scattering imaging of Wichselbaum for the LLSi imaging recited in patent claim 1, to substitute Tomara’s first and second urine samples for the urine sample recited in patent claim 3, and to further apply Choi’s resistance determination calculation in order to determine antibiotic susceptibility. The patent claims lack: filtering the first and second samples (relevant to instant claim 6); defining an infection threshold as a number of cell divisions; and comparing the number of the bacterial cell divisions that occur in the first and second samples sample during the length of time with the infection threshold (relevant to instant claim 9); an infection threshold that is between 2 to 10 cell divisions (relevant to instant claim 12); a threshold of 0.4 to 0.6 (relevant to instant claim 20); first and second samples in a range of 1 µl to 50 µl (relevant to instant claim 21); irradiating the sample with IR (relevant to instant claim 25); based on the number of bacterial cell divisions, administering an antibiotic to a subject (relevant to instant claim 29). However, Tomaras discloses that each sample may undergo some type of filtering. See [0034] (relevant to instant claim 6). Mo teaches setting an infection threshold to 1.24 (relevant to instant claims 9, 12 and 20). Choi teaches inoculating microplates with a bacterial stock solution of 10 µL. See p. 11 last full paragraph (relevant to instant claim 21). Tomaras teaches samples and cuvettes illuminated by optical or infrared (IR) light sources. See [0051] (relevant to instant claim 25). Froim (administering to a subject suspected of having an antibiotic-resistant bacterial infection a therapeutically effective combination of an antibiotic. See claim 1 of Froim (relevant to instant claim 29). 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 apply the filtering and IR illumination of Tomaras to the urine samples, to optimize the volume of the sample based on Choi’s 10 µL suggestion, and to further apply the infection threshold determination of Mo in order to test for antibiotic susceptibility. Response to Arguments With respect to the double patenting rejections, Applicant's arguments filed 03/17/2026 have been fully considered but they do not apply to the new grounds of rejection set forth above. 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 Application/Control Number: 18/002,438 Page 2 Art Unit: 1657 Application/Control Number: 18/002,438 Page 3 Art Unit: 1657 Application/Control Number: 18/002,438 Page 4 Art Unit: 1657 Application/Control Number: 18/002,438 Page 5 Art Unit: 1657 Application/Control Number: 18/002,438 Page 6 Art Unit: 1657 Application/Control Number: 18/002,438 Page 7 Art Unit: 1657 Application/Control Number: 18/002,438 Page 8 Art Unit: 1657 Application/Control Number: 18/002,438 Page 9 Art Unit: 1657 Application/Control Number: 18/002,438 Page 10 Art Unit: 1657 Application/Control Number: 18/002,438 Page 11 Art Unit: 1657 Application/Control Number: 18/002,438 Page 12 Art Unit: 1657 Application/Control Number: 18/002,438 Page 13 Art Unit: 1657 Application/Control Number: 18/002,438 Page 14 Art Unit: 1657 Application/Control Number: 18/002,438 Page 15 Art Unit: 1657 Application/Control Number: 18/002,438 Page 16 Art Unit: 1657 Application/Control Number: 18/002,438 Page 17 Art Unit: 1657 Application/Control Number: 18/002,438 Page 18 Art Unit: 1657 Application/Control Number: 18/002,438 Page 19 Art Unit: 1657 Application/Control Number: 18/002,438 Page 20 Art Unit: 1657 Application/Control Number: 18/002,438 Page 21 Art Unit: 1657 Application/Control Number: 18/002,438 Page 22 Art Unit: 1657 Application/Control Number: 18/002,438 Page 23 Art Unit: 1657 Application/Control Number: 18/002,438 Page 24 Art Unit: 1657 Application/Control Number: 18/002,438 Page 25 Art Unit: 1657 Application/Control Number: 18/002,438 Page 26 Art Unit: 1657 Application/Control Number: 18/002,438 Page 27 Art Unit: 1657 Application/Control Number: 18/002,438 Page 28 Art Unit: 1657 Application/Control Number: 18/002,438 Page 29 Art Unit: 1657 Application/Control Number: 18/002,438 Page 30 Art Unit: 1657 Application/Control Number: 18/002,438 Page 31 Art Unit: 1657 Application/Control Number: 18/002,438 Page 32 Art Unit: 1657 Application/Control Number: 18/002,438 Page 33 Art Unit: 1657 Application/Control Number: 18/002,438 Page 34 Art Unit: 1657 Application/Control Number: 18/002,438 Page 35 Art Unit: 1657 Application/Control Number: 18/002,438 Page 36 Art Unit: 1657 Application/Control Number: 18/002,438 Page 37 Art Unit: 1657 Application/Control Number: 18/002,438 Page 38 Art Unit: 1657 Application/Control Number: 18/002,438 Page 39 Art Unit: 1657 Application/Control Number: 18/002,438 Page 40 Art Unit: 1657 Application/Control Number: 18/002,438 Page 41 Art Unit: 1657 Application/Control Number: 18/002,438 Page 42 Art Unit: 1657 Application/Control Number: 18/002,438 Page 43 Art Unit: 1657 Application/Control Number: 18/002,438 Page 44 Art Unit: 1657 Application/Control Number: 18/002,438 Page 45 Art Unit: 1657 Application/Control Number: 18/002,438 Page 46 Art Unit: 1657 Application/Control Number: 18/002,438 Page 47 Art Unit: 1657 Application/Control Number: 18/002,438 Page 48 Art Unit: 1657 Application/Control Number: 18/002,438 Page 49 Art Unit: 1657 Application/Control Number: 18/002,438 Page 50 Art Unit: 1657 Application/Control Number: 18/002,438 Page 51 Art Unit: 1657 Application/Control Number: 18/002,438 Page 52 Art Unit: 1657 Application/Control Number: 18/002,438 Page 53 Art Unit: 1657 Application/Control Number: 18/002,438 Page 54 Art Unit: 1657 Application/Control Number: 18/002,438 Page 55 Art Unit: 1657 Application/Control Number: 18/002,438 Page 56 Art Unit: 1657 Application/Control Number: 18/002,438 Page 57 Art Unit: 1657 Application/Control Number: 18/002,438 Page 58 Art Unit: 1657 Application/Control Number: 18/002,438 Page 59 Art Unit: 1657
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