Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 11/29/2025 has been entered. Claims 1-7, 9-17, and 19-20 remain pending in the application. Claims 11-17 and 19-20 are withdrawn. Applicant’s amendments to the specification and claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 09/03/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites the limitations “determine a presence of bacteria…by comparing…determining…identifying…; and assess…”.
In accordance with MPEP 2106, the claims are found to recite statutory subject matter (Step 1: YES) and are analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A: Prong 1).
In the instant application, the limitations of “determine a presence of bacteria…by comparing…determining…identifying…; and assess…” covers performance of a limitation in the mind, i.e. mental process or mathematical calculation. Other than a memory and processor, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components (e.g. memory and processor), then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No). In claim 1, once the processor “determine a presence of bacteria…by comparing…determining…identifying…; and assess…”, no further action is performed. Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The processor limitations are recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Additionally, the preceding steps and limitations are used for data gathering in the abstract idea; wherein, data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Further, the consideration of whether the claim as a whole includes an improvement to a computer or to a technological field requires an evaluation of the specification and the claim to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. See MPEP 2106.04(d)(1). The specification, paragraphs [0016]-[0029] discusses specific detailed steps (e.g. pre-incubation phase 302, incubation phase 304, post-incubation phase 306; step 322 of staining samples and AT well) that appear to provide the improvement of the technology, which are not reflected in the claims. Thus, the claims do not reflect all of the elements that lead to the improvement of the technology (MPEP 2106.04(d)(1) and 2106.05(a)). Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
The claims 1-7 and 9-10 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding the abstract idea, claim 1 merely recites a memory and processor, wherein the claimed limitations of the computing device amount to no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 and dependent claims 2-7 and 9-10 further recite limitations, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)), which alone or in combination do not amount to significantly more. Claims 3, 7, and 10 further includes additional abstract ideas (e.g. enumerating, comparing, determining). Additionally, the limitations of claims 1-7 and 9-10 are well-understood, routine and conventional activities as evidenced by the prior art of over Super et al. (US 20150064703 A1; cited in the IDS filed 01/19/2024), Covey et al. (US 20100105074 A1), Shamsheyeva et al. (US 20140278136 A1; cited in the IDS filed 01/19/2024), Nogami (US 20010006783 A1), and Cheng et al. (US 20160334396 A1) . See MPEP 2106.05(d). The additional elements of the claims 1-7 and 9-10 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). The claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Super et al. (US 20150064703 A1; cited in the IDS filed 01/19/2024) in view of Covey et al. (US 20100105074 A1) and Shamsheyeva et al. (US 20140278136 A1; cited in the IDS filed 01/19/2024).
Regarding claim 1, Super teaches a system for automated testing of a sample of a body fluid for the presence of bacteria (abstract teaches kits and system for determination of antibiotic susceptibility of a microbe in a sample; paragraph [0028], “detect microbial infection of blood…bacteremia”; paragraph [0104] teaches determining the presence of a microbe in a sample; paragraph [0169] teaches automated imaging and analysis; paragraph [0195] teaches an automated system), the system comprising:
an incubator (paragraph [0150], incubator shaker) configured to culture the plurality of fluid samples in the well plate (paragraph [0150]);
a flow cytometer (paragraphs [0032] and [0394], “a system” comprising microfluidic devices to carry out methods described; paragraph [0155] teaches the assay is capable of flow cytometry, which implies a flow cytometer to perform flow cytometry) configured to enumerate cell counts in the plurality of fluid samples (paragraph [0155] teaches microbe growth is determined by flow cytometry, wherein the number of microbes are counted; therefore, the implied flow cytometer that perform flow cytometry is structurally capable of enumerating cell counts in the samples).
Super fails to teach: a fluid handling device comprising a fluid handling system, wherein the fluid handling system comprises an automated pipetting system configured to distribute a plurality of fluid samples within a well plate comprising a plurality of wells; at least a processor; and a memory communicatively connected to the at least a processor, the memory containing instructions configuring the at least a processor to: distribute a portion of the plurality of fluid samples to at least a first well; divide the portion of the plurality of fluid samples from the at least a first well into at least two wells, wherein the at least two wells comprise: a time zero (T0) well; and a time one (T1) well; obtain a T0 enumerative baseline bacterial value relating to fluid samples in the T0 well at time T0 using the flow cytometer; culture the fluid samples in the T1 well using the incubator; obtain a T1 enumerative control bacterial value relating to fluid samples in the T1 well at time T1 using the flow cytometer; determine a presence of bacteria as a function of the T0 enumerative baseline bacterial value and the T1 enumerative control bacterial value by: comparing the T1 enumerative control bacterial value to the T0 enumerative baseline bacterial value; determining a growth ratio of the portion of the plurality of fluid samples as a function of the comparison; and identifying, based on a magnitude of the growth ratio, the bacteria as a pathogenic bacteria or a non-pathogenic bacteria; and assess, based on the identification, a disease state associated with the portion of the plurality of fluid samples.
Super teaches the assay or process can be adapted for use in a high-throughput platform, such as an automated system (paragraph [0195]). Super teaches multi well plates (paragraph [0195]). Super teaches that microbe growth or a functional response of microbes can be determined or monitored with flow cytometry (paragraph [0155]). Super teaches counting the number of microbes in the subsample, as compared to a control or reference; and total amount of microbes in the subsample, as compared to a control or reference (paragraph [0155]). Super teaches baseline measurement of a control or reference by determining the number of microbes in a subsample before incubation (paragraph [0156]). Super teaches it is desirable to determine the presence and/or initial number of microbes, prior to incubation, for evaluation of efficacy of an antibiotic agent to treat the microbe (paragraph [0104]). Super teaches counting the number of microbes (paragraphs [0155],[0158], [0171]) and detecting the concentration of microbes in a sample (paragraph [0190]). Super teaches dividing the sample into a plurality of subsamples before incubation steps (paragraph [0357]). Super teaches a process including detection of microbe or pathogen identity (paragraph [0032]). Super teaches identifying the microbe before incubating with antibiotic agents can reduce the number of antibiotic agents that need to be tested (paragraph [0107]). Super teaches known microbes or pathogens that causes diseases (paragraphs [0318],[0320]). Super teaches a subject can be one who is suspected of or at risk of having a disease or disorder caused by any microbes or pathogens described herein (paragraph [0414]). Super teaches when physicians suspect that a patient is suffering from bacteremia they must act quickly: since bacteria can divide very rapidly, every hour lost before the correct treatment is administered can make a crucial difference in patient outcome (paragraphs [0006],[0009],[0424]).
Covey teaches systems for automated processing of biological samples and analysis using a flow cytometer (abstract). Covey teaches a highly controlled automated process can increase throughput, reduce the potential for introducing variability into the results, and ensure that meaningful results are generated (paragraph [0004]). Covey teaches a system that facilitates automated and high-throughput processing of cell samples for flow cytometry includes: one or more robotic liquid handling instruments capable of performing sample transfer, reagent addition, mixing, aspiration, incubation, and centrifugation on a plurality of microplates or cartridges containing biological materials (paragraph [0006]). Covey teaches the system includes automated pipetting devices (paragraph [0028]). Covey teaches high throughput pipetting and dispensing (paragraph [0082]). Covey teaches the system includes computers with software including instructions (paragraph [0007]), which may operate various instrumentation components, liquid handling or micropipetting equipment, analysis instruments or analysis software (paragraph [0035]). Covey teaches an operating protocol comprising counting cells (claims 27,34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Super to incorporate Covey’s teachings of automated and high-throughput processing of cell samples for flow cytometry that includes automated pipetting devices (paragraphs [0004],[0006],[0028],[0082]) and a computer with software including instructions for micropipetting equipment and analysis (paragraph [0035]) and Super’s teachings of high-throughput automated systems (paragraph [0195]) and multi well plates (paragraph [0195]) to provide: a fluid handling device comprising a fluid handling system, wherein the fluid handling system comprises an automated pipetting system configured to distribute a plurality of fluid samples within a well plate comprising a plurality of wells; at least a processor; and a memory communicatively connected to the at least a processor, the memory containing instructions. Doing so would have a reasonable expectation of successfully improving automated sample processing and increasing throughput, reduce the potential for introducing variability into the results, and ensure that meaningful results are generated (Covey, paragraph [0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and memory of modified Super to incorporate Super’s teachings of the process adapted for use in a high-throughput platform, such as an automated system (paragraph [0195]), counting microbes in a subsample as compared to a control or reference (paragraph [0155]), baseline measurement of the number of microbes before incubation (paragraph [0104],[0156]), dividing the sample into subsamples before incubation (paragraph [0357]), and determining the presence of a microbe in a sample (paragraph [0104]) to provide: the memory containing instructions configuring the at least a processor to: distribute a portion of the plurality of fluid samples to at least a first well; divide the portion of the plurality of fluid samples from the at least a first well into at least two wells, wherein the at least two wells comprise: a time zero (T0) well; and a time one (T1) well; obtain a T0 enumerative baseline bacterial value relating to fluid samples in the T0 well at time T0 using the flow cytometer; culture the fluid samples in the T1 well using the incubator; obtain a T1 enumerative control bacterial value relating to fluid samples in the T1 well at time T1 using the flow cytometer; and determine a presence of bacteria as a function of the T0 enumerative baseline bacterial value and the T1 enumerative control bacterial value. Doing so would have a reasonable expectation of successfully improving automation of sample processing and analysis and thus allow for determination of the bacteria based on the number of bacteria of an incubated subsample as compared to a control or reference in a subsample before incubation as desired by Super. Additionally, doing so would have a reasonable expectation of successfully improving determination of a bacteria which can reduce the number of antibiotic agents that need to be tested (Super, paragraph [0107]), and ultimately improving correct treatment of a subject as desired by Super (paragraphs [0006],[0009],[0424]).
Modified Super fails to teach: determine the presence of bacteria as the function of the T0 enumerative baseline bacterial value and the T1 enumerative control bacterial value by: comparing the T1 enumerative control bacterial value to the T0 enumerative baseline bacterial value; determining a growth ratio of the portion of the plurality of fluid samples as a function of the comparison; and identifying, based on a magnitude of the growth ratio, the bacteria as a pathogenic bacteria or a non-pathogenic bacteria; and assess, based on the identification, a disease state associated with the portion of the plurality of fluid samples.
Super teaches counting the number of microbes in the subsample, as compared to a control or reference; and total amount of microbes in the subsample, as compared to a control or reference (paragraph [0155]). Super teaches baseline measurement of a control or reference by determining the number of microbes in a subsample before incubation (paragraph [0156]). Super teaches it is desirable to determine the presence and/or initial number of microbes, prior to incubation, for evaluation of efficacy of an antibiotic agent to treat the microbe (paragraph [0104]). Super teaches that a number of microbes or functional response level in the subsample can be determined before incubation (paragraph [0156]). Super teaches counting the number of microbes (paragraphs [0155],[0158], [0171]) and detecting the concentration of microbes in a sample (paragraph [0190]). Super teaches determining the growth of a microbe (paragraph [0026], [0107],[0155]). Super teaches identifying the microbe before incubating with antibiotic agents can reduce the number of antibiotic agents that need to be tested (paragraph [0107]). Super teaches known microbes or pathogens that causes diseases (paragraphs [0318],[0320]). Super teaches a subject can be one who is suspected of or at risk of having a disease or disorder caused by any microbes or pathogens described herein (paragraph [0414]). Super teaches when physicians suspect that a patient is suffering from bacteremia they must act quickly: since bacteria can divide very rapidly, every hour lost before the correct treatment is administered can make a crucial difference in patient outcome (paragraphs [0006],[0009],[0424]).
Shamsheyeva teaches system and method for rapid determination of microorganism growth and antimicrobial agent susceptibility and/or resistance (abstract). Shamsheyeva teaches determination of the growth rate of a microorganism may further be used to identify that the microorganism is, for example, expressing a virulence factor or hypervirulent; wherein a microorganism may demonstrate an altered growth rate due to expression of one or more virulence factors that may be associated with enhanced pathogenicity (paragraph [0087]). Shamsheyeva teaches identification algorithms for each microorganism exhibiting growth and determined growth rate, and microorganisms were classified as Staphylococcus aureus (STAU), i.e. pathogenic, Pseudomonas aeruginosa (PSAE), i.e. pathogenic, or non-target, i.e. nonpathogenic (paragraph [0242]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate Super’s teachings of determining microbe growth by counting the number of microbes in a subsample as compared to the number of microbes in a subsample before incubation (paragraphs [0104],[0155],[0156]) and known pathogens that causes disease in a subject (paragraphs [0318],[0320],[0414]) and Shamsheyeva’s teachings of identification algorithms that use determined growth rate to classify microorganisms as pathogens or non-targets (paragraphs [0087],[0242]) to provide: determine the presence of bacteria as the function of the T0 enumerative baseline bacterial value and the T1 enumerative control bacterial value by: comparing the T1 enumerative control bacterial value to the T0 enumerative baseline bacterial value; determining a growth ratio of the portion of the plurality of fluid samples as a function of the comparison; and identifying, based on a magnitude of the growth ratio, the bacteria as a pathogenic bacteria or a non-pathogenic bacteria; and assess, based on the identification, a disease state associated with the portion of the plurality of fluid samples. Doing so would have a reasonable expectation of successfully improving automation of sample processing and analysis and thus allow for determination of bacteria growth based on the number of bacteria of an incubated subsample as compared to a control or reference in a subsample before incubation as desired by Super. Additionally, doing so would have a reasonable expectation of successfully improving determination of disease state based on the identification of the bacteria, which can reduce the number of antibiotic agents that need to be tested (Super, paragraph [0107]), and ultimately improving correct treatment of a subject as desired by Super (paragraphs [0006],[0009],[0424]).
Regarding claim 2, note that the “well plate” is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“well plate”) worked upon by a structure (fluid handling system; incubator) being claimed does not impart patentability to the claims (see MPEP 2115).
However, for compact prosecution purposes, Super further teaches wherein the well plate comprises a multi-well cassette (paragraph [0121] teaches multi-well plates, which are interpreted as multi-well cassettes; paragraph [0150] teaches 96-well plates or 384-well plates, i.e. multi-well cassettes).
Regarding claim 3, Super fails to teach: wherein distributing the portion of the plurality of fluid samples to the at least a first well comprises determining a total bacteria count of the portion of the plurality of fluid samples by enumerating the portion of the plurality of fluid samples using the flow cytometer.
Super teaches microbe growth can be assessed by counting the microbes in the subsample and the total amount of microbes in the subsample, as compared to a control or reference (paragraph [0155]), wherein microbe growth can be determined or monitored in real-time by flow cytometry (paragraph [0155]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of assessing microbe growth by counting microbes and the total amount of microbes, and flow cytometry, of Super (paragraph [0155]) to provide: wherein distributing the portion of the plurality of fluid samples to the at least a first well comprises determining a total bacteria count of the portion of the plurality of fluid samples by enumerating the portion of the plurality of fluid samples using the flow cytometer. Doing so would have a reasonable expectation of successfully improving automation of enumeration and assessing of microbe growth as discussed by Super (paragraph [0155]).
Regarding claim 5, modified Super fails to teach: wherein obtaining the T0 enumerative baseline bacterial value comprises enumerating the fluid samples in the T0 well at time T0.
Super teaches counting the number of microbes in the subsample, as compared to a control or reference; and total amount of microbes in the subsample, as compared to a control or reference (paragraph [0155]). Super teaches baseline measurement of a control or reference by determining the number of microbes in a subsample before incubation (paragraph [0156]). Super teaches it is desirable to determine the presence and/or initial number of microbes, prior to incubation, for evaluation of efficacy of an antibiotic agent to treat the microbe (paragraph [0104]). Super teaches that a number of microbes or functional response level in the subsample can be determined before incubation (paragraph [0156]). Super teaches counting the number of microbes (paragraphs [0155],[0158], [0171]) and detecting the concentration of microbes in a sample (paragraph [0190]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of counting the number of microbes in a subsample as compared to the number of microbes in a subsample before incubation of Super (paragraphs [0104],[0155],[0156]) to provide: wherein obtaining the T0 enumerative baseline bacterial value comprises enumerating the fluid samples in the T0 well at time T0. Doing so would have a reasonable expectation of successfully improving automation of sample processing and analysis and thus allow for determination of the bacteria based on the number of bacteria of an incubated subsample as compared to a control or reference in a subsample before incubation as desired by Super.
Regarding claim 6, modified Super fails to teach: wherein culturing the fluid samples in the T1 well comprises: delivering, using a plate transport device, the fluid samples in the T1 well to the incubator; and returning, using the plate transport device, the fluid samples from the incubator to the fluid handling device after culturing.
Covey teaches robotic elements are used to transport microplates form thermoregulating components to any other component (paragraph [0088]). Covey teaches automated retrieval and incubation of microplates, wherein methods includes step of retrieving selected microplates, performing specified steps of the assay on the plate, and returning the completed microplate to the plate holder (paragraph [0010]). Covey teaches the robotic arm may remove microplates containing cell samples from an incubator or plate holder, the plates would be placed on a deck as a working surface to interact with other instruments and to accept the appropriate reagents (paragraph [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of robotic elements for automated retrieval and incubation of microplates between thermoregulating components to other components of Covey (paragraphs [0010],[0028],[0088]) to provide: wherein culturing the fluid samples in the T1 well comprises: delivering, using a plate transport device, the fluid samples in the T1 well to the incubator; and returning, using the plate transport device, the fluid samples from the incubator to the fluid handling device after culturing. Doing so would have a reasonable expectation of successfully improving automation of transporting desired samples between various components of the system for proper sample processing, such as incubation and analysis.
Regarding claim 7, modified Super fails to teach: wherein obtaining the T1 enumerative control bacterial value comprises enumerating the fluid samples in the T1 well at time T1.
Super teaches counting the number of microbes in the subsample, as compared to a control or reference; and total amount of microbes in the subsample, as compared to a control or reference (paragraph [0155]). Super teaches baseline measurement of a control or reference by determining the number of microbes in a subsample before incubation (paragraph [0156]). Super teaches it is desirable to determine the presence and/or initial number of microbes, prior to incubation, for evaluation of efficacy of an antibiotic agent to treat the microbe (paragraph [0104]). Super teaches that a number of microbes or functional response level in the subsample can be determined before incubation (paragraph [0156]). Super teaches counting the number of microbes (paragraphs [0155],[0158], [0171]) and detecting the concentration of microbes in a sample (paragraph [0190]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of counting the number of microbes in a subsample as compared to the number of microbes in a subsample before incubation of Super (paragraphs [0104],[0155],[0156]) to provide: wherein obtaining the T1 enumerative control bacterial value comprises enumerating the fluid samples in the T1 well at time T1. Doing so would have a reasonable expectation of successfully improving automation of sample processing and analysis and thus allow for determination of the bacteria based on the number of bacteria of an incubated subsample as compared to a control or reference in a subsample before incubation as desired by Super.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Super in view of Covey and Shamsheyeva as applied to claim 3 above, and further in view of Nogami (US 20010006783 A1).
Regarding claim 4, modified Super fails to teach: wherein distributing the portion of the plurality of fluid samples to the at least a first well comprises adjusting a dilution of the portion of the plurality of fluid samples using a growth media to a predetermined concentration as a function of the total bacteria count.
Super teaches dilution of a biological sample (paragraph [0354]). Super teaches preprocessing of a sample includes dilution of a sample (paragraph [0039]). Super teaches a sufficient amount of growth medium can be added to a subsample for incubation (paragraph [0143]).
Nogami teaches an apparatus for detecting bacteria (abstract). Nogami teaches effectively detecting bacteria, and in many cases where any useful bacterium is to be detected, the step of diluting a solution having a high bacterium concentration at a suitable dilution ratio must often be taken (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of diluting a solution having a high bacterium concentration to properly detect bacterium of Nogami (paragraph [0036]) and preprocessing and dilution of a sample with growth medium of Super (paragraphs [0039],[0143],[0354]) to provide: wherein distributing the portion of the plurality of fluid samples to the at least a first well comprises adjusting a dilution of the portion of the plurality of fluid samples using a growth media to a predetermined concentration as a function of the total bacteria count. Doing so would have a reasonable expectation of successfully adjusting and optimizing the concentration of a bacteria sample for effective detection as taught by Nogami (paragraph [0036]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Super in view of Covey and Shamsheyeva as applied to claim 1 above, and further in view of Cheng et al. (US 20160334396 A1).
Regarding claim 9, while Covey teaches calibration data and experiment data may be stored in system memory, such as values associated with fluorescent labels (paragraph [0042]), modified Super fails to teach: wherein the memory further contains instructions configuring the at least a processor to adjust a test enumerative bacterial value as a function of a compensator factor.
Cheng teaches a method of quantitative and qualitative detection of compounds in fluids (abstract), wherein the compound may include bacteria (paragraph [0011]). Cheng teaches measuring a concentration of the compound in the fluid comprises counting using a flow cytometer (paragraph [0012]). Cheng teaches a calibration or reference curve may be prepared for a target compound showing the volume fraction and/or number fraction of aggregates found using reference solutions having known concentrations of the target compound being tested; wherein the concentration of that target compound in the sample can then be found by comparing the measured volume fraction and/or number fraction of these aggregates in the sample to the calibration curve (paragraphs [0040],[0074]). Cheng teaches the present invention enable reliable detection of target macromolecular biomarkers or other target compounds in samples at very low concentrations (paragraph [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate the teachings of using calibration curves to calculate concentration of a target compound of Cheng (paragraphs [0040],[0074]) to provide: wherein the memory further contains instructions configuring the at least a processor to adjust a test enumerative bacterial value as a function of a compensator factor. Doing so would have a reasonable expectation of successfully improving correction or calibration of a measured value and thus improving detection of target compounds, i.e. bacteria, in samples (Cheng, paragraph [0040]).
Regarding claim 10, modified Super fails to teach: wherein adjusting the test enumerative bacterial value comprises:
including a known concentration of a test-enumerative compensator (TEC) particles in the fluid sample to be enumerated, wherein the TEC particles comprise known flow cytometric scatter and fluorescence characteristics;
enumerating the TEC particles with the sample enumeration by the flow cytometer; and
determining the compensator factor as a function of a comparison of the test enumerative bacterial value of the TEC particles to the known concentration of the TEC particles.
Cheng teaches a method of quantitative and qualitative detection of compounds in fluids (abstract), wherein the compound may include bacteria (paragraph [0011]). Cheng teaches measuring a concentration of the compound in the fluid comprises counting using a flow cytometer (paragraph [0012]). Cheng teaches a calibration or reference curve may be prepared for a target compound showing the volume fraction and/or number fraction of aggregates found using reference solutions having known concentrations of the target compound being tested; wherein the concentration of that target compound in the sample can then be found by comparing the measured volume fraction and/or number fraction of these aggregates in the sample to the calibration curve (paragraphs [0040],[0074]). Cheng teaches the present invention enable reliable detection of target macromolecular biomarkers or other target compounds in samples at very low concentrations (paragraph [0040]). Cheng teaches fluorescent microparticles are used to count the number of aggregates (paragraph [0069]). Cheng teaches the number and size of the compound-microparticle aggregates for each of the target compounds may be measured by a fluorescent microscope or flow cytometer and the volume or number fraction of the compound-microparticle aggregates for each target compound calculated (paragraph [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory and processor of modified Super to incorporate Cheng’s teachings of determining a calibration curves using reference solutions having known concentrations of a target compound and a concentration is found by comparing measured values to the calibration curve (paragraphs [0040],[0074]) and teachings of fluorescent particles used to count aggregates and using a flow cytometer to measure the number of aggregates (paragraphs [0069],[0088]), to provide: wherein adjusting the test enumerative bacterial value comprises: including a known concentration of a test-enumerative compensator (TEC) particles (e.g. fluorescent particles) in the fluid sample to be enumerated, wherein the TEC particles comprise known flow cytometric scatter and fluorescence characteristics; enumerating the TEC particles with the sample enumeration by the flow cytometer; and determining the compensator factor as a function of a comparison of the test enumerative bacterial value of the TEC particles to the known concentration of the TEC particles. Doing so would have a reasonable expectation of successfully improving correction or calibration of a measured value and thus improving detection of target compounds, i.e. bacteria, in samples (Cheng, paragraph [0040]).
Response to Arguments
Applicant’s arguments, see pages 10, filed 11/29/2025, with respect to the specification objections, claim objections, and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The specification objections, claim objections, and rejections under 35 U.S.C. 112(b) of 09/03/2025 have been withdrawn.
Applicant's arguments, see pages 10-18, filed 11/29/2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
In response to applicant’s argument that claim 1 recites limitations that are not directed to an abstract idea (Remarks, page 13), the examiner disagrees. In the instant application, the limitations of “determine a presence of bacteria…by comparing…determining…identifying…; and assess…” covers performance of a limitation in the mind, i.e. mental process or mathematical calculation. Other than a memory and processor, if the claim limitations, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components (e.g. memory and processor), then the claim limitations fall within the “Mental Processes” grouping of abstract ideas (MPEP 2106.05(f)). Accordingly, the claims recite abstract ideas (Step 2A: Prong 1: Yes).
In response to applicant’s argument that claim 1 is integrated into a practical application and meaningfully limit the exception (Remarks, pages 13-14), the examiner disagrees. This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that reflects an improvement to technology or applies or uses the judicial exception in some other meaningful way (Step 2A, Prong 2: No). In claim 1, once the processor “determine a presence of bacteria…by comparing…determining…identifying…; and assess…”, no further action is performed. Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The processor limitations are recited at a high-level of generality (i.e., as generic computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Additionally, the preceding steps and limitations are used for data gathering in the abstract idea; wherein, data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
In response to applicant’s argument that claim 1 provides an improvement in technology, and therefore is integrated into a practical application or amounts to significantly more than the judicial exception itself (Remarks, pages 14-17), the examiner disagrees. The consideration of whether the claim as a whole includes an improvement to a computer or to a technological field requires an evaluation of the specification and the claim to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. See MPEP 2106.04(d)(1). The specification, paragraphs [0016]-[0029] discusses specific detailed steps (e.g. pre-incubation phase 302, incubation phase 304, post-incubation phase 306; step 322 of staining samples and AT well ) that appear to provide the improvement of the technology, which are not reflected in the claims. Thus, the claims do not reflect all of the elements that lead to the improvement of the technology (MPEP 2106.04(d)(1) and 2106.05(a)). Therefore, the claimed limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claims are directed to an abstract idea that is not integrated into a practical application (Step 2A, Prong 2: No).
In response to applicant’s argument that claim 1 recites an inventive concept and includes limitations amounting to significantly more than any alleged judicial exception (Remarks, pages 17-18), the examiner disagrees. The claims 1-7 and 9-10 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding the abstract idea, claim 1 merely recites a memory and processor, wherein the claimed limitations of the computing device amount to no more than mere instructions to apply the exception using a generic computer component; wherein a general purpose computer is not a particular machine (MPEP 2106.05(b)). Claim 1 and dependent claims 2-7 and 9-10 further recite limitations, however these limitations generally link the judicial exception to a particular field of use (MPEP 2106.05(h)) and are used for data gathering, wherein data gathering to be used in the abstract idea is an insignificant extra-solution activity, and not a practical application (see MPEP 2106.05(g)), which alone or in combination do not amount to significantly more. Claims 3, 7, and 10 further includes additional abstract ideas (e.g. enumerating, comparing, determining). Additionally, the limitations of claims 1-7 and 9-10 are well-understood, routine and conventional activities as evidenced by the prior art of over Super et al. (US 20150064703 A1; cited in the IDS filed 01/19/2024), Covey et al. (US 20100105074 A1), Shamsheyeva et al. (US 20140278136 A1; cited in the IDS filed 01/19/2024), Nogami (US 20010006783 A1), and Cheng et al. (US 20160334396 A1) . See MPEP 2106.05(d). The additional elements of the claims 1-7 and 9-10 do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No).
Applicant’s arguments, see pages 18-21, filed 11/29/2025, with respect to the rejections of claims 1-10 under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Super et al. (US 20150064703 A1; cited in the IDS filed 01/19/2024) in view of Covey et al. (US 20100105074 A1) and Shamsheyeva et al. (US 20140278136 A1; cited in the IDS filed 01/19/2024).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758