Prosecution Insights
Last updated: April 19, 2026
Application No. 17/437,232

MICROBIAL TEST KIT, MICROBIAL TEST METHOD AND MICROBIAL TEST DEVICE

Final Rejection §103
Filed
Sep 08, 2021
Examiner
JONES-FOSTER, ERICA NICOLE
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hitachi High-Tech Corporation
OA Round
4 (Final)
52%
Grant Probability
Moderate
5-6
OA Rounds
3y 3m
To Grant
97%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allow Rate
36 granted / 69 resolved
-7.8% vs TC avg
Strong +45% interview lift
Without
With
+44.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
63 currently pending
Career history
132
Total Applications
across all art units

Statute-Specific Performance

§101
7.6%
-32.4% vs TC avg
§103
33.8%
-6.2% vs TC avg
§102
22.4%
-17.6% vs TC avg
§112
24.7%
-15.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 69 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Support for the amendments is within the instant application specification. Applicant’s amendment to the claims filed on 1/22/2024 in response to the Non-Final Rejection mailed on 9/22/2023 is acknowledged. This listing of claims replaces all prior listings of claims in the application. Claims 1-20 are pending. Claims 1-10, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) Claims 11-16 are pending and examined on the merits. Applicant’s remarks filed on 12/24/2025 in response to the Non-Final Rejection mailed on 9/8/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied. The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action. Withdrawn Rejections The rejection of claims 11-16 under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, are withdrawn in view of Applicant’s amendment of claim 11 to recite, ‘A microbial test method, for determining a presence of microorganisms in a specimen…’ and ‘…to create a luminescence reaction; measuring an amount of light generated by the luminescence reaction; and determining the presence of the microorganisms in the luminescence reaction when an amount of ATP in the luminescence reaction is greater than a threshold.’ The rejection of claims 12 and 16 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), is withdrawn in view of the term “threshold” being part of the phrase, which is a standard that has been set. Maintained Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. 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 rejection of claims 11-16 under 35 U.S.C. 103 as being unpatentable over Noda et al. (2011. Patent No: US 7,879,290 B2, Date of Patent: Feb. 1, 2011, cited on IDS filed 9/8/2021) {herein Noda} in view of Hou et al (2018, Available online 15 November 2018. Journal of Microbial Methods, cited on PTO-892 mailed 8/9/2024) {herein Hou} is maintained. The rejection has been modified in view of Applicant’s amendment of claim 11 to recite ‘A microbial test method, for determining a presence of microorganisms in a specimen…’ and ‘…to create a luminescence reaction; measuring an amount of light generated by the luminescence reaction; and determining the presence of the microorganisms in the luminescence reaction when an amount of ATP in the luminescence reaction is greater than a threshold…’ As amended, claims 11-16 are drawn to a microbial test method, for determining a presence of microorganisms in a specimen, comprising: preparing a microbial test kit including a first syringe having a first syringe needle, a second syringe containing an ATP extraction reagent and having a second syringe needle, a sealed reaction container including a first opening, a first sealing member fitted to the first opening, a nozzle, a nozzle cap covering the nozzle, and a filter disposed so as to partition the first opening and the nozzle, a waste liquid container including a second opening, a second sealing member fitted to the second opening, and sealed under a reduced pressure, and a luminescence measurement container including a third opening, a third sealing member fitted to the third opening and the luminescence measurement container contains a luminescent reagent that emits light in a presence of ATP, and sealed under a reduced pressure; collecting the specimen with the first syringe; penetrating the first sealing member with the first syringe needle and introducing the specimen into the sealed reaction container; penetrating the second sealing member with the nozzle, introducing the specimen into the liquid waste container, filtering the specimen with the filter by a pressure difference between the sealed reaction container and the waste liquid container, and capturing, in the filter, the microorganisms from the specimen, and collecting a remainder of the specimen in the waste liquid container; penetrating the first sealing member with the second syringe needle and introducing the ATP extraction reagent into the sealed reaction container, and extracting ATP from the microorganisms; penetrating the third sealing member with the nozzle, introducing the extraction liquid of ATP into the luminescence measurement container by a pressure difference between the sealed reaction container and the luminescence measurement container, and bringing the extraction liquid of ATP into contact with the luminescent reagent to create a luminescence reaction; measuring an amount of light generated by the luminescence reaction; and determining the presence of the microorganisms in the luminescence reaction when an amount of ATP in the luminescence reaction is greater than a threshold. With respect to claim 11, Noda teaches a method wherein an ATP extracting reagent, and a chemiluminescence solution are introduced into a specimen collection container containing a specimen solution with an antigen used as a specimen via a nozzle connected to a tip so that the amount of microbes can be measured using a luminescence intensity of ATP within living microbes (column 4, lines 41-45, fig. 9). Examiner is interpreting the nozzle as being synonymous to a needle as both are designed to deliver material from one environment to another. Examiner is interpreting the specimen collection container to be the reaction container (Noda: fig. 5A #4). Examiner is interpreting the chemiluminescence solution to be the luminescent reagent. Examiner is interpreting the ATP extracting reagent to be within a second syringe having a second needle (Noda: fig. 9 #23 and #20). Said reagents (ATP extracting agent and chemiluminescence reagent) were added to 3 dispensing containers (column 12, lines 44-46, fig.9 #23 and #20). The sample was added to a sample preparation container (column 12, lines 37-38, fig. 9 #53). Each of the reagents were connected to the sample preparation container via 3 separate nozzles to allow the delivery of the reagents to the sample preparation container (column 12, lines 46-47). Examiner is interpreting the sample preparation container to be a sealed reaction container as Noda teaches the reagents are delivered to said container along with the sample in preparation for measuring chemiluminescence (column 12, lines 37-40) and O-rings were used to prevent leakage of vacuum apparatuses (column 13, lines 6-7). It would be obvious to one of ordinary skill in the art at the effective time of filing to seal the containers under reduced pressure as said limitation would allow for the aseptic flow of reagents and samples. Furthermore, Noda teaches a ‘vacuum apparatus’ of which is known by those of ordinary skill in the art to rely on removing air to create a seal. Additionally, it would be obvious to one of ordinary skill in the art that the containers would have a sealing member fitted to the opening of the containers as said sealing member would allow for the efficient transfer of materials from one environment to another. Furthermore, it would be obvious to one of ordinary skill in the art at the effective date of filing that one would need to penetrate the apparatus in order to add the sample for testing as well as a syringe to be used for the method. Additionally, it would be obvious to one of ordinary skill in the art that said containers would have an opening to receive and remove content. It would be obvious to one of ordinary skill in the art that the dispensing nozzles (needles) would have a cap to ensure the materials within the nozzles do not become contaminated within intervals of experimentation, oxygen is not introduced into the syringe causing the inadvertent cleavage of ATP and to ensure the contents within the nozzles do not leak out. A chemiluminescence reagent is added to the chemiluminescence detection container (column 12, lines 39-40) to create a luminescence reaction and measure ATP levels. It is known by those of ordinary skill in the art that chemiluminescence is the emission of ‘cold light’ generated by the chemical reaction. As such, absent evidence otherwise, it is the Examiner’s position that the chemiluminescence reaction would necessarily generate an amount of light that would be measured by the luminescence reaction. Examiner is interpreting the chemiluminescence detection container to be a luminescence measurement container as that is where luminescence takes place. The assay is used for the detection and counting of living microbes (column 12, lines 7-9). The detection method detects only ATP present within living microbes and measures the amount of ATP (column 12, lines 10-11). Examiner contends that the recitation ‘when an amount of ATP in the luminescence reaction is greater than a threshold’ within the instant application claim 11 is indefinite as one of ordinary skill is the art is unable to ascertain the phrase ‘greater than a threshold.’ As such, since Noda teaches ‘the detection method detects only ATP present within living microbes and measures the amount of ATP (column 12, lines 10-11),’ then Noda necessarily teaches ‘determining the presence of the microorganisms in the luminescence reaction when an amount of ATP in the luminescence reaction is greater than a threshold’ as recited in the instant application claim 11. With respect to claim 12, Noda teaches a method wherein an ATP-eliminating reagent is introduced into a specimen collection container via a nozzle connected to a tip so that the amount of microbes can be measured using a luminescence intensity of ATP in living microbes (column 4, lines 41-45). Examiner is interpreting the nozzle to be the third syringe and the tip to be the third needle as both allow for delivery of reagent to the container. Additionally, it would be obvious to one of ordinary skill in the art that the containers would have a sealing member fitted to the opening of the containers as said sealing member would allow for the efficient transfer of materials from one environment to another. Furthermore, it would be obvious to one of ordinary skill in the art at the effective date of filing that one would need to penetrate the apparatus in order to add the sample for testing as well as a syringe to be used for the method. Said reagent is added to a dispensing container (column 12, lines 44-46). It would be obvious to one of ordinary skill in the art at the effective time of filing to include a waste liquid container with a sealing member in order to ensure when waste is removed, oxygen is not introduced into the environment with the specimen. With respect to claim 13, Noda teaches a method wherein the experiment is stored in a storing medium (column 11, lines 63-64) and a sample suspension of microbes is within a sample preparation container (column 15, lines 45-46). Examiner is interpreting the cell suspension to be a liquid culture medium. An ATP eliminating reagent is dispensed from the nozzle into the cell suspension in the specimen preparation container (column 15, lines 48-49). Examiner is interpreting the ATP eliminating reagent and cell suspension to be a mixture. As said mixture is within a container, examiner is interpreting the cell to be undergoing culturing for a predetermined period of time as it is within the container. It would be obvious to one of ordinary skill in the art to seal the container to reduce and/or eliminate the risk of contamination and exposure to oxygen. With respect to claim 14, Noda teaches a method wherein an ATP extracting reagent is introduced into a specimen collection container via a nozzle connected to a tip to measure the luminescence intensity of ATP within living microbes (column 4, lines 41-45, fig. 9, fig. 10). It would be obvious to one of ordinary skill in the art at the effective time of filing to utilize a powder for the ATP extract reagent as it is readily understood in the art that when reagents are in powder form, they maintain a longer shelf life. Additionally, it would be obvious to one of ordinary skill in the art that said powder reagent would have to be reconstituted before utilization for experimentation as it is common knowledge in the art that powder reagent are reconstituted with a diluent before being utilized. It is the Examiner’s position that introducing the reagent before the specimen into the reaction container does not bear any patentable weight as Noda teaches adding only the ATP reagents and the specimen to said container before the chemiluminescence reagent (fig. 10). Additionally, it would be obvious to one of ordinary skill in that art at the effective time of filing that a fourth syringe and needle would be needed to introduce the solvent into the reaction container. Furthermore, it would be obvious to one of ordinary skill in the art at the effective date of filing that one would need to penetrate the apparatus in order to add the sample for experimentation. However, Noda does not teach the method of claim 11, wherein, a sealed reaction container including a first opening, a first sealing member fitted to the first opening, a nozzle, a nozzle cap covering the nozzle, and a filter disposed so as to partition the first opening and the nozzle (claim 11). The method of claim 12, wherein after filtering the specimen with the filter to capture microorganisms in the specimen, causing the third syringe needle to penetrate the first sealing member and introducing the ATP eliminating reagent into the reaction container; and causing the nozzle to penetrate the second sealing member to discharge the ATP eliminating reagent to the waste liquid container by a pressure difference between the reaction container and the waste liquid container (claim 12). The method of claim 14, wherein the reagent is in a powder form, and the microbial test kit further includes a fourth syringe containing a solvent of the reagent and having a fourth syringe needle, the microbial test method further comprising: causing the fourth syringe needle to penetrate the first sealing member and introducing the solvent into the reaction container before introducing the specimen into the reaction container (claim 14). The method of claim 15, wherein the microbial test kit further includes a fifth syringe containing a washing reagent and having a fifth syringe needle, the microbial test method further comprising: filtering the specimen with the filter to capture microorganisms in the specimen, then causing the fifth syringe needle to penetrate the first sealing member, and introducing the washing reagent into the reaction container; and causing the nozzle to penetrate the second sealing member to discharge the washing reagent to the waste liquid container by a pressure difference between the reaction container and the waste liquid container (claim 15). The method of claim 16, wherein the microbial test kit further includes a fifth syringe containing a washing reagent and having a fifth syringe needle, the microbial test method further comprising: after discharging the ATP eliminating reagent into the waste liquid container, causing the fifth syringe needle to penetrate the first sealing member and introducing the washing reagent into the reaction container; and causing the nozzle to penetrate the second sealing member to discharge the reagent to the waste liquid container by a pressure difference between the reaction container and the waste liquid container (claim 16). With respect to claims 11-12, Hou teaches a method, wherein a syringe with a filter capable of collecting a specimen is under pressure, thereby allowing for filtration of microbial cells (page 1, column 2, para 2). Examiner is interpreting said syringe to be a first syringe having a first syringe needle. Examiner is interpreting the filter to be within the first syringe, partitioning the first opening and the nozzle. Furthermore, It would be obvious to one of ordinary skill in the art at the effective time of filing to isolate a sample via filtration in a syringe with a sealing member in a vacuum sealed environment because doing so would inhibit/reduce contaminants and prevent the inadvertent cleavage of ATP due to the presence of oxygen within the environment. Absent evidence otherwise, it is the Examiner’s position that the syringe needle under pressure taught by Hou would necessarily penetrate the first sealing member and introduce the ATP eliminating reagent into the reaction container as Hou teaches a syringe that is under pressure, of which Examiner is interpreting and it is well understood in the art that the difference in pressure between the reaction container and syringe taught by Hou would passively allow for the movement of materials from one environment to another. Since the Office does not have the facilities for examining and comparing applicants’ method of delivering reagents to a container with the methods of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the claimed method). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. ‘ With respect to claim 15, Hou teaches a syringe with a filter capable of collecting a specimen (abstract). It would be obvious to one of ordinary skill in the art at the effective time of filing to include a waste liquid container with a sealing member in order to ensure when waste is removed, oxygen is not introduced into the environment with the specimen. One of ordinary skill in the art would wash the specimen on the filter with a washing reagent to remove contaminants that might interfere with experimentation. It would be obvious that said washing reagent would be in a syringe with a needle as said syringe and needle would allow for the effective delivery of materials to the specimen. Examiner is interpreting said syringe to be a fifth syringe and said needle to be a fifth needle. One of ordinary skill in the art at the effective time of filing would want to seal the syringe under reduced pressure because doing so would allow for the movement of solutions into the tube without exerting any external forces and introducing contaminants and oxygen to the reaction. It would be obvious to one of ordinary skill in the art at the effective date of filing that one would need to penetrate the apparatus it in order to add the washing reagent so it could be used for the method. Absent evidence otherwise, it is the Examiner’s position that the syringe needle under pressure taught by Hou would necessarily penetrate the second sealing member to discharge the washing reagent into the washing liquid container as Hou teaches a syringe that is under pressure, of which is well understood in the art that the difference in pressure between the reaction container and syringe taught by Hou would passively allow for the movement of materials from one environment to another. Since the Office does not have the facilities for examining and comparing applicants’ method of delivering reagents to a container with the methods of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the claimed method). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. ‘ With respect to claim 16, Hou teaches a syringe with a filter capable of collecting a specimen (abstract). It would be obvious to one of ordinary skill in the art to add a needle to the syringe in order to ensure the specimen is efficiently added to the containers. It would be obvious to one of ordinary skill in the art at the effective time of filing to isolate the sample via filtration in a syringe with a sealing member in a vacuum sealed environment because doing so would remove/reduce contaminants and prevent the inadvertent cleavage of ATP due to oxygen within the environment. It would be obvious to one of ordinary skill in the art at the effective time of filing to include a waste liquid container with a sealing member in order to ensure when waste is removed, oxygen is not introduced into the environment with the specimen. One of ordinary skill in the art would wash the specimen on the filter with a washing reagent to remove contaminants that might interfere with experimentation. It would be obvious that said washing reagent would be in a syringe with a needle as said syringe and needle would allow for the effective delivery of materials to the specimen. Examiner is interpreting said syringe to be a fifth syringe and said needle to be a fifth needle. One of ordinary skill in the art at the effective time of filing would want to seal the syringe under reduced pressure because doing so would allow for the movement of solutions into the tube without exerting any external forces and reduce the likelihood of introducing contaminants and oxygen into the sample. It would be obvious to one of ordinary skill in the art at the effective date of filing that one would need to penetrate the apparatus it in order to add the reagents so it could be used for the method. It would be obvious to one of ordinary skill in the art at the effective time of filing to wash the reaction container after discharging the ATP eliminating reagent because do so helps eliminate the likelihood of cross reactivity between the free ATP and intracellular cellular ATP. Absent evidence otherwise, it is the Examiner’s position that the syringe needle under pressure taught by Hou would necessarily penetrate the second sealing member to discharge the washing reagent into the washing liquid container as Hou teaches a syringe that is under pressure, of which is well understood in the art that the difference in pressure between the reaction container and syringe taught by Hou would passively allow for the movement of materials from one environment to another. Since the Office does not have the facilities for examining and comparing applicants’ method of delivering reagents to a container with the methods of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the claimed method). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. ‘ Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Noda et al of a method wherein an ATP extracting reagent, and a chemiluminescence solution are introduced into a specimen collection container via a nozzle connected to a tip so that the amount of microbes can be measured using a luminescence intensity of ATP within the living microbes (column 4, lines 41-45, fig. 9) or combine the teachings of Hou et al of a method wherein a syringe with a filter capable of collecting a specimen that is under pressure, thereby allowing for filtration of microbial cells (page 1, column 2, para 2). One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would be motivated to combine the teachings of Noda and Hou because Hou provides the motivation for Noda to utilize a syringe with a filter disposed so as to partition the first opening and the nozzle under pressure as doing so would allow for the movement of solutions into containers without exerting any external forces and would reduce the risk of contamination and would allow for a more cost effective mechanism for dispensing material from a syringe as it would not be dependent upon an outside energy source. Furthermore, it would be obvious to one of ordinary skill in the art at the effective time of filing to isolate the sample via filtration in a syringe with a sealing member in a vacuum sealed environment because doing so would remove contaminants and prevent the inadvertent cleavage of ATP due to the lack of oxygen within the environment. Additionally, it would be obvious to one of ordinary skill in the art at the effective time of filing to include a waste liquid container with a sealing member in order to ensure when waste is removed, oxygen is not introduced into the environment with the specimen. In all, having differences in pressure between the reaction container and waste container would ensure proper retention of the sample and removal of contaminants. One of ordinary skill in the art knowing the benefit of reducing the risk of contamination during experimentation and synthetic based on the teachings of Noda and Hou would have a reasonable expectation of success to combine both a method of measuring cell counts of living microbes with a vacuum sealed filter syringe because one of ordinary skill in the art would expect them both to increase the efficiency of the cell counting by reducing the risk of ATP hydrolysis in the absence of the ATP extracting reagent. One of skill in the art would have a reasonable expectation of success to make and use the claimed fusion protein because Noda provides the method of measuring microbial cell count via ATP level in live cells while Hou provides the motivation for using a vacuum sealed syringe with a filter and needle Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. RESPONSE TO REMARKS: Beginning on p. 12 of Applicant’s remarks, Applicant contends that the rejection has been addressed by amendment. In summary, Applicant contends Noda, or Hou, or their combinations fail to teach at least the features of amended claim 11. Instead, the combination of Noda and Hou are silent regarding sealing containers under reduced pressure and performing filtration or dispensing can be completed simply by inserting the needle into the sealing of the container, without the need for suction pumps or pipettes. This argument is found to be not persuasive. Examiner contends that Hou in view of Noda teaches the limitations of the instant application claims as taught in the 103 rejection. Examiner contends that Hou teaches a method, wherein a syringe with a filter capable of collecting a specimen is under pressure, thereby allowing for filtration of microbial cells (page 1, column 2, para 2). Absent evidence otherwise, it is the Examiner’s position that said syringe to be a first syringe having a first syringe needle. Additionally, it is the Examiner’s position that the filter is within the first syringe, partitioning the first opening and the nozzle. Furthermore, It would be obvious to one of ordinary skill in the art at the effective time of filing to isolate a sample via filtration in a syringe with a sealing member in a vacuum sealed environment because doing so would inhibit/reduce contaminants and oxygen that prevent the inadvertent cleavage of ATP due to the presence of oxygen within the environment. Absent evidence otherwise, it is the Examiner’s position that the syringe needle under pressure taught by Hou would necessarily penetrate the first sealing member and introduce the ATP eliminating reagent into the reaction container as Hou teaches a syringe that is under pressure, of which Examiner is interpreting and it is well understood in the art that the difference in pressure between the reaction container and syringe taught by Hou would passively allow for the movement of materials from one environment to another. Applicant contends that Hou teaches away from the filtration syringe or containers being under reduced pressure. Additionally, the "[syringe filters used pressure to push Campylobacter through the filter." (Emphasis added). Hou at pg. 80, §4. While Hou uses the term "pressure" here, it is obvious to one of ordinary skill in the art that this "pressure" is an external force being applied to the syringe's plunger, as described by earlier stating that the "plunger was depressed" in @2.1.3. Further, based on the use of the word "push" it would be obvious to one of ordinary skill in the art in order to push the sample through the filter, that there is not a pressure difference as described in amended claim 11. This argument is found to be not persuasive. Examiner contends that Applicant has not shown any evidence that Hou’s teaching of “pressure” is an external force being applied to the syringe. Examiner contends that Hou teaches a method, wherein a syringe with a filter capable of collecting a specimen is under pressure, thereby allowing for filtration of microbial cells (page 1, column 2, para 2). Applicant contends that the Office Action fails to provide any comparison in either Noda or Hou to the "waste liquid container" of amended claim 11. This argument is found to be not persuasive. Examiner contends that it would be obvious to one of ordinary skill in the art at the effective time of filing to include a waste liquid container with a sealing member in order to ensure when waste is removed and oxygen is not introduced into the environment with the specimen. Additionally, it is well-known in the field that oxygen significantly interferes with many forms of luminesce as it acts as a powerful quenching agent that reduces the intensity and lifetime of the emitted light. As such, it would be obvious to include a waste liquid container with a sealing member as to ensure oxygen does not have deleterious effects on the luminescence assay. Conclusion Claims 11-16 are pending and examined on the merits. Claims 1-10, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) Claims 11-16 are rejected. No claims are in condition for allowance. 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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p. 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, Manjunath Rao can be reached at 571-272-0939. 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. /ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656 /MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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Prosecution Timeline

Sep 08, 2021
Application Filed
Aug 02, 2024
Non-Final Rejection — §103
Dec 03, 2024
Response Filed
Feb 24, 2025
Final Rejection — §103
Aug 04, 2025
Request for Continued Examination
Aug 07, 2025
Response after Non-Final Action
Sep 03, 2025
Non-Final Rejection — §103
Dec 24, 2025
Response Filed
Mar 13, 2026
Final Rejection — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
52%
Grant Probability
97%
With Interview (+44.8%)
3y 3m
Median Time to Grant
High
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