DETAILED CORRESPONDENCE
Application 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 are within the instant application specification.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/17/2026 has been entered.
Applicant’s amendment to the claims filed on 6/17/2026 in response to the Final Rejection mailed on 3/19/2026 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Claims 1-10, 17-20 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 11-16 are pending and examined on the merits.
Applicant’s remarks filed on 6/17/2026 in response to the Final Rejection mailed on 3/19/2026 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Withdrawn Rejections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. 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 Journal of Microbial Methods, cited on PTO-892 mailed 8/9/2024) {herein Hou} is withdrawn in view of Applicant’s amendment of claim 11 to recite ‘a microbial test method, for determining a presence of microorganisms in a specimen, comprising: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 inside the sealed reaction container in an internal flow path between the first opening and the nozzle, the filter dividing an internal space of the sealed reaction container into a first space communicating with the first opening and a second space communicating with 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 and a third sealing member fitted to the third opening , the luminescence measurement container containing a luminescent reagent that emits light in a presence of ATP and being 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 first space of the sealed reaction container through the first sealing member, wherein the nozzle communicates with the inside of the waste liquid container in a sealed state after penetrating the second sealing member while maintaining the sealed reaction container closed to ambient air; removing the nozzle cap from the nozzle after the specimen is introduced into the sealed reaction container penetrating the second sealing member with the nozzle, introducing liquid of the specimen from the sealed reaction container into the waste liquid container, filtering the specimen with the filter by a pressure difference between the sealed reaction container and the waste liquid container, capturing, on an upstream side of the filter, the microorganisms from the specimen, and collecting a remainder of the specimen as filtrate from which the captured microorganisms have been removed in the waste liquid container, wherein the pressure difference is produced by the reduced pressure of the waste liquid container after the nozzle penetrates the second sealing member; penetrating the first sealing member with the second syringe needle and introducing the ATP extraction reagent into the first space of the sealed reaction container through the first sealing member while the captured microorganisms remain on the upstream side of the filter, and extracting ATP from the microorganisms captured on the upstream side of the filter to produce an ATP extraction liquid in the sealed reaction container; penetrating the third sealing member with the nozzle, introducing the ATP extraction liquid into the luminescence measurement container by a pressure difference between the sealed reaction container and the luminescence measurement container, and bringing the ATP extraction liquid into contact with the luminescent reagent to create a luminescence reaction, wherein the pressure difference is produced by the reduced pressure of the luminescence measurement container after the nozzle penetrates the third sealing member; measuring an amount of light generated by the luminescence reaction; determining an amount of ATP based on the measured amount of light; and determining that microorganisms are present in the specimen when the determined amount of ATP is greater than a predetermined threshold, wherein the filtering of the specimen into the waste liquid container is performed after the nozzle penetrates the second sealing member such that the nozzle communicates with an inside of the waste liquid container in a sealed state, and wherein the introducing of the ATP extraction liquid into the luminescence measurement container is performed after the nozzle penetrates the third sealing member such that the nozzle communicates with an inside of the luminescence measurement container in a sealed state.’
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-16 are newly rejected under 35 U.S.C. 103 as being unpatentable over CN1871338A (Date Published: 2004, cited in IDS dated 9/8/2021, translated copy on PTO-892 within the instant office action) {herein ‘338} in view of JP2005229956A (Date Published: 2004, cited in IDS dated 9/8/2021, translated copy on PTO-892 within the instant office action) {herein ‘956}. The new rejection is necessitated by Applicant’s amendment of claim 11 to recite ‘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 inside the sealed reaction container in an internal flow path between the first opening and the nozzle, the filter dividing an internal space of the sealed reaction container into a first space communicating with the first opening and a second space communicating with 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 and a third sealing member fitted to the third opening , the luminescence measurement container containing a luminescent reagent that emits light in a presence of ATP and being 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 first space of the sealed reaction container through the first sealing member, wherein the nozzle communicates with the inside of the waste liquid container in a sealed state after penetrating the second sealing member while maintaining the sealed reaction container closed to ambient air; removing the nozzle cap from the nozzle after the specimen is introduced into the sealed reaction container penetrating the second sealing member with the nozzle, introducing liquid of the specimen from the sealed reaction container into the waste liquid container, filtering the specimen with the filter by a pressure difference between the sealed reaction container and the waste liquid container, capturing, on an upstream side of the filter, the microorganisms from the specimen, and collecting a remainder of the specimen as filtrate from which the captured microorganisms have been removed in the waste liquid container, wherein the pressure difference is produced by the reduced pressure of the waste liquid container after the nozzle penetrates the second sealing member; penetrating the first sealing member with the second syringe needle and introducing the ATP extraction reagent into the first space of the sealed reaction container through the first sealing member while the captured microorganisms remain on the upstream side of the filter, and extracting ATP from the microorganisms captured on the upstream side of the filter to produce an ATP extraction liquid in the sealed reaction container; penetrating the third sealing member with the nozzle, introducing the ATP extraction liquid into the luminescence measurement container by a pressure difference between the sealed reaction container and the luminescence measurement container, and bringing the ATP extraction liquid into contact with the luminescent reagent to create a luminescence reaction, wherein the pressure difference is produced by the reduced pressure of the luminescence measurement container after the nozzle penetrates the third sealing member; measuring an amount of light generated by the luminescence reaction; determining an amount of ATP based on the measured amount of light; and determining that microorganisms are present in the specimen when the determined amount of ATP is greater than a predetermined threshold, wherein the filtering of the specimen into the waste liquid container is performed after the nozzle penetrates the second sealing member such that the nozzle communicates with an inside of the waste liquid container in a sealed state, and wherein the introducing of the ATP extraction liquid into the luminescence measurement container is performed after the nozzle penetrates the third sealing member such that the nozzle communicates with an inside of the luminescence measurement container in a sealed state.’
With respect to claims 11-12, 14-16, ‘338 teaches a method of using a microbial test kit for detecting microorganisms in a liquid sample (page 1, para 2). The method entails, according to figure 3 taught by ‘338, a prescribed amount of the aggregating agent #3 is drawn into the first syringe #2, a liquid sample is added to the sample cup #14 and the prescribed amount is drawn into the first syringe #2, and air is charged with finger pressure to stir the front end of the first syringe #2 for about 5 seconds, wherein the first syringe is capable of taking a sample with a first syringe needle (page 10, para 9 and page 11, para 1, Figure 3a). An ATP-eliminating agent can also be added in the detection of microorganisms (page 2, para 5). A person skilled in the art would conceive to provide a third syringe with a third syringe needle containing the ATP-depleting agent and to keep the first sealing member penetrating through the third syringe needle in a closed state of the reaction vessel. ‘338 further teaches immediately after stirring, the device connecting the primary filter #5 and the secondary filter #6 is installed at the front end of the first syringe #2. The mixed liquid #15 is filtered by slowly pressing the syringe core of the 1st syringe #2 (page 11, para 2, Figure 3b). Next, the 1st syringe #2 is removed after filtration and air is sucked in again by feeding it through the device connecting the 1st filter #5 and the 2nd Filter #6, completely filtering the sample inside the filter membrane; as shown in Fig. 3c (page 11, para 2, figures 3b and 3c). Then the washing liquid #8 is sucked in advance with the 2nd syringe #7, two filters #6 are installed at the front end of the 2nd syringe #7, the syringe core of the 2nd syringe #7 is squeezed, the two filters #6 are washed with the washing liquid #8, the 2nd syringe #7 is removed after filtration (page 11, para 2 and 3, figure 3c). Air is sucked in shortly, and the washing liquid #8 inside the two filters #6 is completely removed, installing it on the two filters #6 (page 11, para 4, figure 3d). Next, pre-aspirating a prescribed amount of a bacteriolytic #9 (i.e. ATP extraction reagent (fig 3e)) with a second syringe #7, filter #6 is installed 2 times, the 2nd syringe #7 is inverted upside down, feeding lysate #9 into the 2 pass filter #6 from below, filling the 2 pass filter #6 with lysate #9, then rotating the 2 pass filter #6 or letting it flow into the 2 pass membrane filter #6 without filling with lysate #9 with gentle shaking for about 30 seconds (i.e., with a second syringe containing ATP extraction reagent, as seen in figure 3e with a second syringe needle) (page 11, para 4, figure 3e). It is the Examiner’s position that the microorganisms would necessarily remain captured in the upstream side of the filter as said filter is designed to ‘trap’ the microorganisms in order to subsequently extract the ATP. Since said filter is internal (fig 3, #6) it is the Examiner’s position that the filter is disposed inside the ’sealed reaction container,’ which is depicted in fig 3e #6, within an internal flow between the first opening and the nozzle (location where syringe is attached); and with a first opening and a sealing member fitted to the first opening as ‘338 does not teach any leaking from the #6. Said filter (within #6 of fig 3e) divides an internal space of the sealed reaction container into a first space communicating with the first opening and a second space communicating with the nozzle. Furthermore, it would be obvious to one of ordinary skill in that art to have a nozzle cap on the nozzle of fig 3e #6 as doing so prevents the liquid from drying out or clogging and protects the internal tip from physical damage. 338’ would be motivated to collect the flow through from fig 3b-3d within a waste container and one would desire to filter the specimen into the waste liquid container after the nozzle penetrates the second sealing member such that the nozzle communicates with an inside of the waste liquid container in a sealed state as doing so would reduce the likelihood of contaminating the microbe on the filter (fig 3 #6) by the inadvertent introduction of contaminants from the air as opposed to the method depicted by the waste product flow through in fig 3b-3c. MPEP 2143.I.D states ‘the rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.’ While both liquid and powdered are common forms of the reagent containing the medium component, when the reagent is powdered, it is also conceivable for a person skilled in the art that the kit is provided with a fourth syringe having a solvent containing said reagent and having a fourth syringe needle. ‘338 further teaches the liquid is collected after the reaction by extruding the reaction liquid #16 into the test tube #10 (page 11, para 4, figured 3d). The reaction liquid remaining on the secondary membrane filter #6 is also squeezed with air so that said reaction liquid is completely collected in the test tube nozzle #10 (i.e., a light emission measurement vessel having a third opening and a third sealing member connector fitted into the third opening, as seen in figure 3, and containing a light emission reagent that emits light in the presence of ATP) (page 11, para 4, figure 3). On this basis, it is conceivable to provide a fifth syringe provided with a fifth syringe needle containing a washing agent. Subsequently, the luminescent reagent powder #11lb is added in advance to the luminescent reagent dissolution solution #11a and the conditioned specific amount of luminescent reagent #11 is added, and after gentle stirring with the connector #12, the amount of luminescence is measured by the photometer #13 (page 11, para 5, figure 3f). Next, as shown in Fig. 3 (f), luminescent reagent #11 prepared in advance is added, and the connector #12 is attached while gently stirring, and then the amount of luminescence is measured by a photometer #13 (fig 1 #13). Said photometer has a third opening (fig 1 #13). It is conceivable that said opening would also contain a sealing member as it would ensure the sample does not leak out during the transfer process. Additionally, sealing said third opening of the photometer would reduce the risk of contaminating the sample due to contaminants in the air. The relationship between the number of microorganisms obtained and the amount of luminescence was measured (page 13, para 4). It is noted that the recitation ‘determining that microorganisms are present in the specimen when the determined amount of ATP is greater than a predetermined threshold’ is a conditional limitation that does not require any active steps. Nevertheless, ‘338 teaches a good proportional relationship when the amount of luminescence (ATP concentration) and the number of bacteria are 10^4/ml or more (page 13, para 4).
However, ‘338 does not teach the method of claim 11 of preparing a microbial test kit using a sealed container… filtration under reduced pressure (claim 11). ‘338 does not teach the method of claim 13, wherein the sealed reaction container contains a reagent containing a liquid culture medium or a powder culture medium, and the microbial test method further comprises: after introducing the specimen into the sealed reaction container and creating a mixture, and before penetrating the second sealing member with the nozzle, culturing the mixture within the sealed reaction container for a predetermined period (claim 13).
With respect to claims 11, 13, ‘956 teaches a method for detecting microorganisms in a beverage, comprising a first step of filtering a beverage under reduced pressure (page 2, para 7), using a filtering material with filter paper layered on a membrane filter, a second step of washing the filter material with a washing liquid (under reduced pressure, page 2, para 8), a third process of culturing the filter material in a liquid medium or an agar plate medium, a fourth process of adding an ATP-depleting agent to the filter material and eliminating free ATP, a fifth process of adding an ATP-extractant to the filter material, extracting ATP originating from microorganisms, a sixth process of adding a luminescent reagent to the extract obtained in step 5, and measuring the amount of luminescent light produced; therein, the cultivation of microorganisms, the elimination of residual ATP, the extraction of ATP originating from microorganisms is carried out within a sealed reaction container under reduced pressure, thereby having the structure of the instant application claims 11, 13 (page 2, para 2, Fig. 1).
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 ‘338 of a microbial test kit for detecting microorganisms in a liquid sample (page 1, para 2) or combine the teachings of ‘956 because ‘956 teaches a method of detecting microbes within a ‘closed’ microbial test kit (page 2, para 2, Fig. 1).
One of ordinary skill in the art would be motivated to either use the teachings of ‘338 by itself or combine the teachings of ‘956 because ‘956 provides ‘338 the motivation to conduct the microbial testing method within a closed reaction vessel as ‘956 teaches the filtration unit used for the cultivation of microorganisms, the elimination of residual ATP, and the extraction of ATP derived from microorganisms within a closed reaction vessel, under reduced pressure, improves the elimination of residual ATP and the subsequent extraction of ATP for the detection of microorganisms (page 3, para 2). One of ordinary skill in the art knowing the benefit of a method for detecting microorganisms in samples based on the teachings ‘338 and ‘956 would have a reasonable expectation of success to try using a method of detecting microorganisms in samples within a closed system, under reduced pressure, because one would expect said method to result in reduced contaminants, thereby resulting in improved ATP detection. MPEP 2143.I.E states ‘the rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
One of skill in the art would have a reasonable expectation of success to make and use the claimed method for detecting microorganisms in samples because ‘338 provides the teaching of method of using a microbial test kit for detecting microorganisms in a liquid sample (page 1, para 2). Whereas ‘956 teaches a method of detecting microorganisms via ATP analysis utilizing a closed system under reduced pressure (page 2, para 2, 7,8, fig. 1). 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.
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.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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