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 .
DETAILED ACTION
Claims 1-8, 10-11 and 16-18 are pending and under examination on their merits. Claims 9, 12-15, and 19-20 are cancelled.
Response to Arguments
Applicant's arguments filed 3/5/2026 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims under 35 U.S.C. 101 on the grounds that claim 1 recites physical steps including preparing a sample, introducing the sample into a container and that these steps cannot be performed in the human mind (Arguments, bottom paragraph on page 17).
However, this argument is unpersuasive because claim 1 recites the judicial exception of a natural correlation (law of nature: the change in a dielectric constant of water surrounding the microorganism as the microorganism grows) and the physical steps are merely insignificant extra-solution activity (data-gathering).
Applicant argues further against the rejection of claims under 35 U.S.C. 101 on the grounds that the test method requires a specific machine (Arguments, paragraph 4 on page 18).
However, the claims do not require a specific machine. Claim 1 recites “a sensor configured to detect a microorganism in the sample by detecting a change in the dielectric constant of water surrounding the microorganism, the change in the dielectric constant corresponding to a change in a ratio of bulk water to the water surrounding the microorganism.” Such sensors are taught by the prior art: for example, Narang injects bacterial samples into a biosensor comprising a microfluidic channel and a resonator (paragraph bridging pages 8-9, Figure 1). Narang teaches that resonator devices translate a variation in dielectric properties of adjacent materials into quantifiable electrical signals such as resonant frequency and resonant amplitude in a remote non-contact manner (paragraph 3 on page 2). Narang measures the shift in resonance frequency that occurs with cell growth (Figure 4) and calculates a linear relationship between the resonance frequency and OD600 (degree of growth): see Figure 4 caption. Independent claim 2 only adds a generic “insertion tool,” which fails to specify a specific machine. Thus, none of the claims require a specific machine.
Applicant argues against the rejection of claims under 35 U.S.C. 103 on the grounds that Narang and Shiraga do not teach (i) detecting a change in a dielectric constant of water surrounding the microorganism, the change in the dielectric constant corresponding to a change in a ratio of bulk water to the water surrounding the microorganism; (ii) covering the sample with a hydrophobic capping solvent while the sample is in the container; (iii) measuring an output from the sensor while the sample is covered with the hydrophobic capping solvent in the container; or (iv) detecting a degree of growth of the microorganism based on the output from the sensor (Arguments, paragraph 2 on page 20).
In response, this argument is unpersuasive. With respect to (i), Narang injects bacterial samples into a biosensor comprising a microfluidic channel and a resonator (paragraph bridging pages 8-9, Figure 1). Thus, Narang teaches a resonator device and Narang also teaches that resonator devices translate a variation in dielectric properties of adjacent materials into quantifiable electrical signals such as resonant frequency and resonant amplitude in a remote non-contact manner (paragraph 3 on page 2). Since Narang’s MH medium comprises water, as evidenced by Millipore (2018 website; page 1, Directions), changes in the dielectric properties (such as the dielectric constant) necessarily correspond to a change in a ratio of bulk water to the water surrounding the microorganism. With respect to (ii), Applicant has not provided any special definition for “covering” and thus the broadest reasonable interpretation of the claim includes simply injecting a hydrophobic capping solvent into the container while the sample is in the container. With respect to (iii)-(iv), Narang in view of Shiraga teaches these claim limitations (see the rejection below under 35 U.S.C. 103).
Claim Objections
Claim 18 is objected to because of the following informalities: “the sample is one of plural samples.” Plural is an adjective and samples is already a plural noun. Applicant may consider amending to “the sample is one of a plurality of samples.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
(New Rejection Necessitated by Amendment) Claims 4-5 and 16-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “the sensor is configured to detect a shift of an oscillation frequency of the oscillator.” Claim 4 ultimately depends from claim 1, which recites the sensor is configured to detect a microorganism in the sample by detecting a change in a dielectric constant of water surrounding the microorganism. It is unclear whether these are two separate configurations or whether the configuration in claim 4 is further limiting the configuration already recited in claim 1.
Claim 5 recites the limitation "the calculating" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 1, which does not recite any calculating step.
Claim 16 is indefinite for “at least one of Mycobacterium tuberculosis, Escherichia coli, or Staphylococcus epidermidis.” The claim is indefinite because it combines alternatives (Mycobacterium tuberculosis, Escherichia coli, or Staphylococcus epidermidis) with the limitation “at least one of” (includes combinations), leading to ambiguity in the claim scope as it is uncertain whether the claim scope is “at least one of Mycobacterium tuberculosis, Escherichia coli, and Staphylococcus epidermidis” or whether the claim scope is Mycobacterium tuberculosis, Escherichia coli, or Staphylococcus epidermidis.”
Claim 17 recites the limitation "the calculating" in line 8. There is insufficient antecedent basis for this limitation in the claim. Claim 17 is further indefinite because it is unclear whether “evaluating sensitivity of the microorganism to the drug” is an additional method step.
Claim 18 is indefinite for the limitation “the samples are prepared, each of the samples further comprising a drug at a concentration different than each other for evaluating sensitivity of the microorganism to the drug” because it is unclear how the samples are prepared or whether this step is further limiting the existing step of preparation recited in claim 1, from which claim 18 ultimately depends. Additionally, it is unclear whether “evaluating sensitivity of the microorganism to the drug” is an additional method step.
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.
(New Rejection Necessitated by the Amendment) Claims 1-8, 10-11 and 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more.
The rationale for this determination is explained below.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature, or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 recites a method of testing for a microorganism comprising preparing a sample by mixing a specimen with a liquid culture medium, introducing the sample into a container which includes a sensor configured to detect a microorganism in the sample by detecting a change in a dielectric constant of water surrounding the microorganism, the change in the dielectric constant corresponding to a change in a ratio of bulk water to the water surrounding the microorganism, and detecting a degree of growth of the microorganism based on the output from the sensor. Claim 1 is drawn to a process (Step 1: Yes). Claim 1 recites the judicial exception of a natural phenomenon: the change in a dielectric constant of water surrounding the microorganism as the microorganism grows (Step 2A Prong One: Yes). Claim 1 is not integrated into a practical application because the output of the method is purely information (the degree of growth of a microorganism in a sample). The additional elements of the method are all well-understood, routine, and conventional: preparing a sample, introducing the sample, and measuring output from a sensor are insignificant, extra-solution activity (mere data-gathering). Covering the sample with a hydrophobic capping solvent while the sample is in the container is also well-understood, routine, and conventional activity. For example, Shiraga et al. (JP2019060609(A); cited in the IDS filed on 11/28/2022) teaches a method for evaluating cells comprising transmitting terahertz waves to a region that interacts with a cell in a non-polar liquid medium, such as fluorocarbons or mineral oils (“hydrophobic capping solvent”) ([0009]). Claim 2 recites the same natural phenomenon judicial exception as claim 1: the change in a dielectric constant of water surrounding the microorganism as the microorganism grows. Claims 3-8, 10-11 and 16-18 depend from claim 1 and thus also recite the judicial exception of a natural phenomenon.
Additionally, claim 5 recites “the calculating includes displaying a growth curve for evaluating a shift with time in the growth of the microorganism, based on the output from the sensor,” which is the judicial exception of an abstract idea.
Claim 17 recites “the calculating includes: calculating the oscillation frequency of the oscillator for the sample; and displaying a growth curve indicating the shift of the oscillation frequency of the oscillator with time,” which is also the judicial exception of an abstract idea.
Claim 18 recites “calculating the shift of the oscillation frequency of the oscillator with time for each of the samples; and displaying the shift of the oscillation frequency with time for each of the samples,” which are both abstract ideas.
Claims 1-8, 10-11 and 16-18 do not recite additional elements that integrate the judicial exception into a practical application (Step 2A Prong Two: No). Each of the claims is drawn to a generic “microorganism test method” and the output of each of the claims is purely the information gathered, with no specific action taken based on the information gathered.
Each of the additional elements recited in the claims do not amount to significantly more than the judicial exception (Step 2B: No).
Biosensors that utilize shift of an oscillation frequency of the oscillator to calculate the degree of growth of a microorganism are well-understood, routine, and conventional. See, for example, Mitsunaka et al. ("CMOS biosensor IC focusing on dielectric relaxations of biological water with 120 and 60 GHz oscillator arrays." IEEE Journal of Solid-State Circuits 51.11 (2016): 2534-2544; cited in the Non-Final Action mailed on 11/6/2025; paragraph bridging pages 2540-2541, B. Biosensing Demonstration), as well as the Abstract of Narang et al. (Scientific reports 8.1 (2018): 15807; cited in the Requirement for Restriction mailed on 7/18/2025). Claim 2 recites the additional element of “inserting an insertion tool into the hydrophobic capping solvent and introducing the sample onto the sensor via the insertion tool such that the sample is covered with the hydrophobic capping solvent in the container.” The term “insertion tool” is recited at a high level of generality and common laboratory equipment including pipettes and syringes are “insertion tools.” Thus, claim 2 as a whole does not amount to significantly more than the judicial exception of a natural phenomenon (Step 2B: No). Claims 8 and 16 merely limit the type of bacteria and each of the bacteria recited in the claims is well-understood, routine, and conventional (e.g. the Abstract of Narang teaches E. coli and Mashabela et al. (Microbiology spectrum 7.4 (2019): 10-1128; cited in the Non-Final Action mailed on 11/6/2025) teaches M. tuberculosis (Abstract). Furthermore, the use of a “hydrophobic capping solvent” is taught by the prior art (see Shiraga et al. JP2019060609(A); cited in the IDS filed on 11/28/2022, [0017]). The use of an oscillator in the GHz band (claims 10-11) is also well-understood, routine, and conventional (see, for example, the Abstract of Narang). Regarding the additional element of an array sensor (claim 3), this element is also well-understood, routine, and conventional: Shiraga teaches an array sensor in which a plurality of sensor elements are arranged adjacently in a matrix pattern (Figure 1(b)). The additional element of including a drug in the sample (claims 17-18), such as an antibiotic for antimicrobial susceptibility testing, is also well-understood, routine, and conventional. See the Abstract of Narang et al. (Scientific reports 8.1 (2018): 15807; cited in the Requirement for Restriction mailed on 7/18/2025).
Therefore, none of the claims are eligible under 35 U.S.C. 101.
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.
The following rejections are necessitated by the amendment.
Claims 1-5, 7, 10-11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Narang et al. (Scientific reports 8.1 (2018): 15807; cited in the Requirement for Restriction mailed on 7/18/2025) in view of Shiraga (JP2019060609(A); cited in the IDS filed on 11/28/2022) as evidenced by Millipore (2018, website).
Regarding claims 1, Narang teaches diluting (mixing) bacterial samples (specimen) in MH medium (liquid culture medium): page 8, Bacterial Sample Preparation, paragraph 1. Narang injects bacterial samples into a biosensor (“container”) comprising a microfluidic channel and a resonator (paragraph bridging pages 8-9, Figure 1). Narang measures the shift in resonance frequency that occurs with cell growth (Figure 4) and calculates a linear relationship between the resonance frequency and OD600 (degree of growth): see Figure 4 caption. Narang’s resonator oscillates at a frequency of 2.576 GHz (paragraph 2 on page 3). Narang teaches that resonator devices translate a variation in dielectric properties of adjacent materials into quantifiable electrical signals such as resonant frequency and resonant amplitude in a remote non-contact manner (paragraph 3 on page 2). Since Narang’s MH medium comprises water, as evidenced by Millipore (page 1, Directions), the measured shift in resonance frequency necessarily corresponds to changes in the dielectric properties of the water surrounding the cells. Thus, Narang’s sensor is necessarily “configured” to detect changes in dielectric constant corresponding to a change in a ratio of the bulk water to the water surrounding the microorganism.
Narang does not teach covering the sample with a hydrophobic capping solvent while the sample is in the container.
Shiraga teaches a method for evaluating cells comprising transmitting terahertz waves to a region that interacts with a cell in a non-polar liquid medium, such as fluorocarbons or mineral oils (“hydrophobic capping solvent”) ([0009]). Shiraga teaches detecting an interaction between the cell and the terahertz wave ([0009]). Shiraga’s cell is in the non-polar liquid medium ([0009]), so the cell is covered by the non-polar liquid medium (“hydrophobic capping solvent’). Shiraga teaches that the method may further include culturing the cells in a culture medium and may include a step of replacing the culture medium with the non-polar liquid medium ([0032]).
Shiraga teaches that in some cases most of the terahertz waves are absorbed by water contained in the extracellular medium, so information on water in cells cannot be sufficiently obtained ([0006]). Shiraga then presents the technical solution including the non-polar liquid medium ([0009]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace at least a portion of the culture medium of Narang with the non-polar liquid medium of Shiraga in order to improve the sensitivity of the method in detecting changes in resonance frequency. The person of ordinary skill in the art would have been motivated by the teachings of Shiraga, which suggest that replacing the extracellular medium with a non-polar liquid medium increases the sensitivity of the method in detecting changes in the water in cells. The person of ordinary skill in the art would have had a reasonable expectation of success in adding the non-polar liquid of Shiraga to the microbial cells of Narang.
Regarding the timing of adding the non-polar liquid of Shiraga to the microbial cells of Narang, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add the non-polar liquid medium while the sample is loaded into the biosensor. The person of ordinary skill in the art would have been motivated to use the existing syringe pump in Narang’s biosensor (Figure3(b) caption). The person of ordinary skill in the art would have had a reasonable expectation of success in adding Shiraga’s non-polar liquid medium to the biosensor, which necessarily covers the sample with Shiraga’s non-polar liquid medium.
Regarding claim 2, Narang does not teach inserting an insertion tool into the hydrophobic capping solvent and introducing the sample onto the sensor via the insertion tool such that the sample is covered with the hydrophobic capping solvent in the container.
However, Narang teaches that the bacterial cultures are injected via a syringe pump (Figure3(b) caption). Narang also teaches that it is important for the bacteria to not adhere to the walls of the microfluidic channel (paragraph 1 on page 4).
It would have also been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to inject Shiraga’s non-polar liquid medium via the syringe pump (“insertion tool’) into the sensor before Narang’s sample in order to coat the walls of the microfluidic channel, thus reducing the likelihood of bacterial adherence of the bacteria to the microfluidic walls in addition to increasing the method sensitivity. The person of ordinary skill in the art would also have had a reasonable expectation of success in this modification (injecting Shiraga’s non-polar liquid medium into the sensor first and then inserting the syringe into the non-polar liquid medium and injecting the sample).
Regarding claim 3, Narang does not teach an array sensor in which sensor elements are arranged adjacently in a matrix pattern.
Regarding claim 4, an oscillator is given its broadest reasonable interpretation as any device that produces an oscillation. A resonator is a device that oscillates at specific frequencies, so a resonator is also an oscillator.
Although Narang teaches sensor elements that include a resonator that oscillates in a gigahertz band (Abstract), Narang does not teach that the sensor elements are arranged adjacently in a matrix pattern.
Shiraga teaches an array sensor in which a plurality of sensor elements are arranged adjacently in a matrix pattern (Figure 1(b)).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Narang’s biosensor by including multiple resonators arranged adjacently in a matrix pattern per the teaching of Shiraga. The person of ordinary skill in the art would have been motivated to test multiple samples in parallel. The person of ordinary skill in the art would have had a reasonable expectation of success in this modification given that Shiraga’s sensor is also based on the same principle (detecting a shift in the resonance frequency).
Regarding claim 5, Narang teaches calculating a growth curve based on a shift in resonance frequency and displaying the shift in resonance frequency (Figure 1 and paragraph bridging pages 8-9).
Narang does not teach that the growth curve is displayed.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to display the calculated growth curve in addition to the shift in resonance frequency. The person of ordinary skill in the art would have been motivated to introduce the capability to monitor the growth of the bacteria in real time in order to further improve the utility of the microfluidic platform. The person of ordinary skill in the art would have had a reasonable expectation of success in introducing this capability.
Regarding claim 7, Shiraga teaches that the non-polar liquid medium is either fluorocarbons (“fluorine-based inert solvent”) or mineral oil ([0009]).
Regarding claim 10, Narang does not teach that the gigahertz band is greater than or equal to 10 GHz and less than or equal to 600 GHz.
Regarding claim 11, Narang does not teach that the gigahertz band is greater than or equal to 30 GHz and less than or equal to 300 GHz.
However, Shiraga teaches the optimization of the resonance frequency ([0030]) and Narang teaches transmitting a resonance frequency in the GHz range for the evaluation of cell growth (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the resonance frequency of the resonator in order to detect changes in the growth of different microorganisms in the method of Narang modified by Shiraga. The person of ordinary skill in the art would have had a reasonable expectation of success in a range of resonance frequencies depending on the cell type and cell medium.
Regarding claim 16, Narang detects the growth of E. coli (page 8, paragraph 2).
Regarding claim 17, an oscillator is given its broadest reasonable interpretation as any device that produces an oscillation. A resonator is a device that oscillates at specific frequencies, so a resonator is also an oscillator.
Narang does not teach that the sample further comprises a drug.
However, Narang teaches that antibiotic susceptibility testing is a time-consuming and often laborious clinical microbiology practice and presents the resonator biosensor as a means to increase the efficacy of clinical microbiology practices (Abstract). Narang also specifically suggests utilizing a planar microwave resonator in conjunction with microfluidics as a biosensor to assist in infection diagnosis and AST (antimicrobial susceptibility testing) analysis to increase clinical efficiency and decrease infectious fatalities (page 2, paragraph 3).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include an antibiotic (drug) within the sample in order to test the susceptibility of a microorganism to the antibiotic. The person of ordinary skill in the art would have had a reasonable expectation of success given that Narang suggests this application for the biosensor. Furthermore, the method of Narang measures the growth of a microorganism and antimicrobial susceptibility testing is merely measuring the growth of a microorganism in response to an antibiotic.
Narang teaches displaying the shift in resonance frequency (Figure 1), but Narang does not teach displaying a growth curve.
Narang teaches calculating a growth curve based on a shift in resonance frequency and teaches displaying the shift in resonance frequency (Figure 1 and paragraph bridging pages 8-9; Abstract: “The growth of bacteria analyzed over the resonator showed an exponential growth curve with respect to time”). Narang teaches that the resonator frequency changes linearly with bacterial concentration, as measured by OD600 (Figure 4 caption). Narang exemplifies a growth curve (OD600 vs time) in Figure S1.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to calculate a growth curve based on the change in resonance frequency over time and to display the calculated growth curve in addition to the shift in resonance frequency. The person of ordinary skill in the art would have been motivated to introduce the capability to monitor the growth of the bacteria in real-time in order to further improve the utility of the microfluidic platform. The person of ordinary skill in the art would have had a reasonable expectation of success in introducing this capability.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Narang et al. (Scientific reports 8.1 (2018): 15807; cited in the Requirement for Restriction mailed on 7/18/2025) in view of Shiraga (JP2019060609(A); cited in the IDS filed on 11/28/2022) as evidenced by Millipore (2018, website), as applied to claims 1-5, 7, 10-11, and 16-17 above, further in view of Mashabela et al. (Microbiology spectrum 7.4 (2019): 10-1128) as evidenced by Kubie (Journal of Biological Chemistry 72.2 (1927): 545-548; cited in the Non-Final Action mailed on 11/6/2025).
See discussion of Narang and Shiraga above, which is incorporated into this rejection as well.
Narang teaches that antibiotic susceptibility testing is a time-consuming and often laborious clinical microbiology practice and presents the resonator biosensor as a means to increase the efficacy of clinical microbiology practices (Abstract).
Regarding claim 6, Shiraga’s mineral oil necessarily has O2 gas solubility as evidenced by Kubie (Solubility in Mineral Oil, middle of page 547).
However, Narang and Shiraga do not teach that oxygen is dissolved in the non-polar liquid (“capping solvent”).
Regarding claim 8, Narang and Shiraga do not teach that the microorganism is Mycobacterium tuberculosis.
Mashabela teaches that Mycobacterium tuberculosis is an obligate aerobe (requires oxygen) responsible for causing tuberculosis (Abstract and page 10, right column, Respiration).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace Narang’s E. coli with Mycobacterium tuberculosis because M. tuberculosis is the causative agent for tuberculosis and is thus clinically relevant. It would have been further obvious to dissolve oxygen in the non-polar liquid medium (“capping solvent”) and growth medium in order to ensure Mycobacterium tuberculosis would have been capable of growing within Narang’s microfluidic channel. The person of ordinary skill in the art would have had a reasonable expectation of success in dissolving oxygen in Shiraga’s non-polar liquid medium.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Narang et al. (Scientific reports 8.1 (2018): 15807) in view of Shiraga (JP2019060609(A); cited in the IDS filed on 11/28/2022) as evidenced by Millipore (2018, website), as applied to claims 1-5, 7, 10-11, and 16-17 above, further in view of Shih et al. (US 2018/0335405 A1).
See discussion of Narang and Shiraga above, which is incorporated into this rejection as well.
Regarding claim 18, although Narang teaches calculating the shift of the resonance frequency and displaying the calculated shift (see Figure 1), Narang does not teach preparing a plurality of samples that contain drugs at different concentrations from each other and then performing these steps (calculating the shift and displaying the calculated shift) for each sample.
Shih teaches using a biosensor to perform antimicrobial susceptibility testing: Shih prepares samples with different concentrations of ampicillin (an antibiotic) and measures the growth of E. coli in response to the different concentrations of ampicillin (page 9, Table 2 and [0130]). Shih teaches that the minimum inhibitory concentration of an antibiotic is the lowest concentration of antibiotic that prevents growth of a bacteria (page 1, left column, bottom paragraph).
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare samples with different concentrations of an antibiotic per Shih and to perform the method of Narang modified by Shiraga on each sample in order to determine the growth of microorganisms exposed to each concentration of an antibiotic. The person of ordinary skill in the art would have been motivated to determine whether the antibiotic suppresses growth of the microorganism and if so, to also determine the minimum inhibitory concentration of the antibiotic. The person of ordinary skill in the art would have had a reasonable expectation of success, given that these modifications are the implementation of antimicrobial susceptibility testing, which is suggested by Narang as an application of the biosensor.
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 CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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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.
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/CANDICE LEE SWIFT/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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