googDETAILED 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 .
The amendment filed 03/13/2025 has been entered. Claims 1, 5-11, and 24-28 remain pending in the application. Amendments to claims 1, 5-11 and 14-18 and cancellation of claims 2-4, 12-13, and 29 are acknowledged. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 12/17/2024.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-7, 11, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pressman et al. (US 20030092186 A1), hereinafter Pressman, in view of Yamakawa et al. (US 20160061851 A1), hereinafter Yamakawa, in view of Braun et al. (US 20200269236 A1), hereinafter Braun.
Regarding claim 1, Pressman discloses a urinalysis method ([0239], processing of a urine sample) by a urinalysis system ([0011]: “specimen processing apparatus”) configured to analyze urine specimen accommodated in a specimen container ([0010]: “This self-contained vial and processing assembly arrangement minimizes human operator exposure to biohazards, such as tuberculosis or other pathogens in sputum or in other specimens types, such as urine,”), the method comprising: removing, by an uncapping device ([0010]: “a simple uncapping device”), a cap from the specimen container at a first position (Fig 11 element 400) on a transport path ([0017]: “Each vial is transported through the LBP device on a computer-controlled conveyor, in its own receptacle.”, Fig 11 stations 1-10), sealing, by a sealing device an opening of the specimen container ( [0113]: “so that the manifold 46 can receive and seat the filter assembly F, with the membrane filter 205 facing down,”, Fig 5, Fig 10, wherein the opening of container 20 is sealed at manifold 46 by the filter) with a filter at a second position that is downstream of the first position on the transport path (Fig 11 element 600), measuring the urine specimen by aspirating the urine specimen in the specimen container at a third position that is downstream of the second position on the transport path ([0218]: “specimen acquisition station 700 has a suction head 702 that descends to engage the upper portion of the stirrer 40…. Then suction is applied through suction line 750 to aspirate specimen liquid from the container 20 through suction tube 43, into the particulate matter separation chamber (manifold) 46 and through the filter assembly F,” wherein station 700 is after 600).
Pressman fails to disclose a first analyzer, observing a change of color of a test paper upon applying the aspirated urine specimen on the test paper, measuring the urine specimen, by a second analyzer, by aspirating the urine specimen in the specimen container at a fourth position that is downstream of the third position on the transport path, and measuring formed elements of urine particles in the aspirated urine specimen, wherein the second analyzer penetrates, with an aspiration tube to aspirate the urine specimen, the film which has been penetrated by the first analyzer.
Yamakawa discloses a urinalysis method including a first analyzer ([0006]: “a first test device”) measuring the urine specimen and observing a change of color of a test paper upon applying the aspirated urine specimen on the test paper ([0176]: “of the first test type (see FIG. 15) includes measurement unit 650 for detecting colors on a test strip.”), measuring the urine specimen, by a second analyzer (Fig 10 element 20), by aspirating the urine specimen in the specimen container ([0140]: “Test device 20 aspirates the samples out of the respective sample containers in stowed rack 500”) at a fourth position that is downstream of the third position on the transport path ([00138]: “of test device 20 on a downstream side performs the assignment of samples to test device 20 on the downstream side and test device 30 on an upstream side”, wherein the second analyzer is downstream of the first analyzer, [0040]: “transport unit”), and measuring formed elements of urine particles in the aspirated urine specimen ([0153]: “which perform the tests of the second test type are each a test device configured to perform measurement of particles in a urine sample by flow cytometry.”).
As Pressman discloses withdrawing samples for analysis ([0023]: “to remove preprocessed specimen fluid from any container presented to it for subsequent analytical testing or evaluation”) but does not specify the test performed, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to include the first and second analyzers disclosed by Yamakawa in order to automate the tests within a single system and obtain data about the presence of biomarkers within the urine sample (Yamakawa ([0176]). Additionally, the elements disclosed in Pressman and Yamakawa function the same separately as they do in combination. Pressman discloses a transport system wherein a specimen vial is loaded and a sample is withdrawn for analysis. Yamakawa discloses a system wherein an opened specimen vial is loaded into a transport system and a sample is withdrawn and analyzed. As each element completes the same functions disclosed by the claimed invention with the only difference being the lack of combination, it would have been obvious to a person of ordinary skill in the art to have combined the elements in a single method.
Pressman as modified by Yamakawa fails to disclose sealing, by a sealing device an opening of the specimen container with a film, a first analyzer, wherein the first analyzer penetrates the film with an aspiration tube to aspirate the urine specimen, and the second analyzer penetrates, with an aspiration tube, the film which has been penetrated by the first analyzer
Braun discloses a system for handling samples (abstract) including sealing, by a sealing device (Fig 1) an opening of the specimen container ([0022]: “a region of a capping material dispensed by the dispenser is positionable on or about an opening of an analytical sample vessel held by the holder.”) with a film ([0021]: “film”), a and measuring the urine specimen by a first analyzer ([0070]: “analysing a sample in an analytical sample tube”), wherein the first analyzer penetrates the film with an aspiration tube to aspirate the urine specimen ([0095]: “the capped tube can be pieced by a sampling needle of an automated sample handling or analysis apparatus”), and the second analyzer penetrates, with an aspiration tube to aspirate the urine specimen, the film which has been penetrated by the first analyzer ([0069]: “the biological sample has been previously contacted by an analytical apparatus… previous contact in this context is therefore contact of the sample with an analytical apparatus (such as a sampling needle of the analytical apparatus) in the course of the first analysis.”, wherein any sample that is withdrawn after the first analysis and puncture a seal that has been punctured by the first analyzer and wherein the purpose of the seal is to facilitate multiple samples being withdrawn)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the filter application station and aspiration through suction as disclosed by Pressman as modified by Yamakawa to the sealing station and puncturing of the applied seal to withdraw a specimen sample as disclosed by Braun for the predictable result of withdrawing a sample, and in order to prevent loss of the sample during transport through the system and further prevent contamination of the samples between withdrawals (Braun [0005]).
Regarding claim 6, Pressman further discloses re-sealing the opening of specimen container ([0017]: “and a re-capping station”), from which the urine specimen has been aspirated by the aspiration tube penetrating the film ((Fig 11 element 700/station 5 specimen acquisition 800/ station 10, as modified by Braun), with a seal through which the aspiration tube can penetrate ([0021]: “pierceable by the needle of a samplinge apparatus”).
Regarding claim 7, Pressman further discloses acquiring identification information for identifying the specimen container, wherein the re-sealing of the specimen container is selectively performed on the basis of the identification information acquiring identification information for identifying the specimen container ([0017]: “vial bar code is read, and then proceed stepwise through the following processing stations of the LBP device”) wherein the re-sealing of the specimen container is selectively performed on the basis of the identification information ([0017]: “and a re-capping station”).
Regarding claim 11, Pressman discloses a urinalysis system ([0011]: “specimen processing apparatus”) comprising: an uncapping device configured to remove a cap ([0010]: “a simple uncapping device”) from a specimen container containing a urine specimen at a first position (Fig 11 element 400) on a transport path ([0017]: “Each vial is transported through the LBP device on a computer-controlled conveyor, in its own receptacle.”, Fig 11 stations 1-10), and a transport device configured to transport the sealed specimen container to the third and fourth positions ([0123]: “device further includes a transport mechanism 240 for moving the specimen containers to the various operating stations.”); sealing, by a sealing device an opening of the specimen container ( [0113]: “so that the manifold 46 can receive and seat the filter assembly F, with the membrane filter 205 facing down,”, Fig 5, Fig 10, wherein the opening of container 20 is sealed at manifold 46 by the filter) with a filter at a second position that is downstream of the first position on the transport path (Fig 11 element 600), measuring the urine specimen, by aspirating the urine specimen in the specimen container at a third position that is downstream of the second position on the transport path ([0218]: “specimen acquisition station 700 has a suction head 702 that descends to engage the upper portion of the stirrer 40…. Then suction is applied through suction line 750 to aspirate specimen liquid from the container 20 through suction tube 43, into the particulate matter separation chamber (manifold) 46 and through the filter assembly F,” wherein station 700 is after 600).
Pressman as fails to disclose a first analyzer, observing a change of color of a test paper upon applying the aspirated urine specimen on the test paper, measuring the urine specimen, by a second analyzer, by aspirating the urine specimen in the specimen container at a fourth position that is downstream of the third position on the transport path, and measuring formed elements of urine particles in the aspirated urine specimen, wherein the second analyzer penetrates, with an aspiration tube to aspirate the urine specimen, the film which has been penetrated by the first analyzer.
Yamakawa discloses a urinalysis method (abstract) including a first analyzer ([0006]: “a first test device”) measuring by applying the urine specimen on a test paper and observing a change of color of the test paper ([0176]: “of the first test type (see FIG. 15) includes measurement unit 650 for detecting colors on a test strip.”), a second analyzer (Fig 10 element 20), configured to aspirate the urine specimen in the specimen container ([0140]: “Test device 20 aspirates the samples out of the respective sample containers in stowed rack 500”) at a fourth position that is downstream of the third position on the transport path ([00138]: “of test device 20 on a downstream side performs the assignment of samples to test device 20 on the downstream side and test device 30 on an upstream side”, wherein the second analyzer is downstream of the first analyzer), and measure formed elements of urine particles in the aspirated urine specimen ([0153]: “which perform the tests of the second test type are each a test device configured to perform measurement of particles in a urine sample by flow cytometry.”).
As Pressman discloses withdrawing samples for analysis ([0023]: “to remove preprocessed specimen fluid from any container presented to it for subsequent analytical testing or evaluation”) but does not specify the test performed, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to include the first and second analyzers disclosed by Yamakawa in order to automate the tests within a single system and obtain data about the presence of biomarkers within the urine sample (Yamakawa ([0176]). Additionally, the elements disclosed in Pressman and Yamakawa function the same separately as they do in combination. Pressman discloses a transport system wherein a specimen vial is loaded and a sample is withdrawn for analysis. Yamakawa discloses a system wherein an opened specimen vial is loaded into a transport system and a sample is withdrawn and analyzed. As each element completes the same functions disclosed by the claimed invention with the only difference being the lack of combination, it would have been obvious to a person of ordinary skill in the art to have combined the elements in a single method.
Pressman as modified by Yamakawa fails to disclose sealing, by a sealing device an opening of the specimen container with a film, wherein the first analyzer penetrates the film with an aspiration tube to aspirate the urine specimen; wherein the second analyzer penetrates, with an aspiration tube to aspirate the urine specimen, the film which has been penetrated by the first analyzer.
Braun discloses a system for handling samples (abstract) including sealing, by a sealing device (Fig 1) an opening of the specimen container ([0022]: “a region of a capping material dispensed by the dispenser is positionable on or about an opening of an analytical sample vessel held by the holder.”) with a film ([0021]: “film”), and measuring the urine specimen by a first analyzer ([0070]: “analysing a sample in an analytical sample tube”), wherein each of the first and second analyzers comprises an aspiration tube to penetrate the film and aspirate the urine specimen ([0095]: “the capped tube can be pieced by a sampling needle of an automated sample handling or analysis apparatus”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the system disclosed by Pressman to substitute the filter application station and aspiration through suction as disclosed by Pressman as modified by Yamakawa to the sealing station and puncturing of the applied seal to withdraw a specimen sample as disclosed by Braun for the predictable result of withdrawing a sample, and in order to prevent loss of the sample during transport through the system and further prevent contamination of the samples between withdrawals (Braun [0005]).
As both Pressman and Braun disclose withdrawing samples for analysis but do not specify the test performed, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to include the urine sampling tests disclosed by Yamakawa in order to further clarify which tests are performed and obtain data about the presence of biomarkers within the urine sample (Yamakawa ([0176])) and additionally add a second analyzer downstream of the first analyzer in a fourth position in order to obtain additional data from a sample.
Regarding claim 15, Pressman further discloses a second sealing device configured to re-seal the opening of the specimen container ([0242]), from which the urine specimen has been aspirated, with a seal through which the aspiration tube can penetrate ([0249]: “easily punctured by a syringe or a pipette”).
Regarding claim 16, Pressman further discloses a plurality of urinalysis processing devices (claim 7: “path to a plurality of operating heads spaced so that the operating heads can operate simultaneously on different specimens”) and a plurality of the second sealing devices, wherein the plurality of second sealing devices perform re-sealing on specimen containers that have been subjected to aspiration in the urinalysis processing devices that are different from each other (claim 15).
Regarding claim 17, Pressman further discloses an information reader configured to read identification information for identifying the specimen container ([0017]); and a controller ([0017]: “computer-controlled”) configured to control the second sealing device so as to selectively perform re-sealing on the specimen container on the basis of the read identification information ([0017]).
Regarding claim 18, Pressman further discloses a controller ([0017]) configured to perform control of selecting a sealing method to be performed by the sealing device from among a plurality of sealing methods ([0123]: “All stations are computer-controlled.”).
8. Claims 5 and 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pressman in view of Braun in view of Yamakawa in view of Kacian et. all (US 20020127147 A1), hereinafter Kacian.
Regarding both claim 5 and 14, Pressman as modified by Braun and Yamakawa discloses the method of claim 1 and system of claim 11. Braun further discloses the sealing device seals the opening of the specimen container with the film ([0054]: “urge a capping material dispensed by the dispenser onto and/or about an opening of an analytical sample vessel.”) and adheres a part of the film extending from an edge of the opening to an outer periphery of the specimen container ([0055]: “crimping means configured to crimp a capping material dispensed by the dispenser snugly onto the analytical sample vessel.”). but fails to disclose the film is a resin film having extensibility.
Kacian discloses a specimen container with a puncturable seal (abstract) wherein the seal is a resin film having extensibility ([0053]: “seal layer comprised of an epoxy resin.”)
It would have been obvious to a person of ordinary skill in the art to modify the seal disclosed by Pressman, Braun, and Yamakawa to be a resin film as disclosed by Kacian as resin has high mechanical strength (Kacian [0053]).
10. Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pressman in view of Braun in view of Yamakawa in further in view of Mitsui (JP2007061477A).
e. Regarding claims 9, Pressman as modified by Braun and Yamakawa discloses the methods of claim 1 but fail to disclose sealing with the seal includes: stretching the seal by pressing an opening edge of the specimen container against the seal; and winding the seal around the specimen container by rotating at least one of the seal in a stretched state and the specimen container around a center axis of the specimen container.
Mitsui discloses a specimen container (title) with a seal ([0020]: “The film 7 constituting the label 4”) wherein the sealing with the seal includes: pressing an opening edge of the specimen container against the seal ([0025]: “the one side end of the label 4 is placed on the body portion 21”); and winding the seal around the specimen container by rotating the film around a center axis of the specimen container ([0025]: “and rotating the container body 2”).
It would have been obvious to a person of ordinary skill in the art to substitute the known sealing method disclosed by Pressman, Braun, and Yamakawa with the known sealing method disclosed by Mitsui in order to obtain the predictable result of attaching a seal to a specimen container.
f. Regarding claims 10, Pressman as modified by Braun, Yamakawa, and discloses the method of claim 1, but fails to disclose the sealing with the film comprises :pressing an opening edge of the specimen container against the film to stretch the film; and winding of the seal around the specimen container is performed by rotating the film in a stretched state around a center axis of the specimen container.
Mitsui discloses a specimen container (title) with a seal ([0020]: “The film 7 constituting the label 4”) wherein the sealing with the film comprises: pressing an opening edge of the specimen container against the film to stretch the film (([0025]: “the one side end of the label 4 is placed on the body portion 21”); and the winding of the film around the specimen container ([0028]: “a winding-type label that is wound around the container body”) is performed by rotating the film in the stretched state ([0020]: “the film 7 used for the cylindrical label 4 is subjected to the stretching process”) around the center axis of the specimen container ([0028]).
It would have been obvious to a person of ordinary skill in the art to substitute the known sealing method disclosed by Pressman, Braun, and Yamakawa with the known sealing method disclosed by Mitsui in order to obtain the predictable result of attaching a seal to a specimen container.
Response to Arguments
Applicant’s arguments, see applicant’s reply, filed 03/13/2025, with respect to the rejection(s) of claim(s) 1-23 under USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pressman, Braun, and Yamakawa under USC 103 (see above). While applicant argues that Braun does not teach the limitations of claim 1 on pages 10-11 of applicant’s reply, these arguments are considered moot in light of the new grounds of rejection (see above).
Further, applicant argues on pages 11-12 of applicant’s reply that Braun does not explicitly disclose to solve the same problem as the present application as Braun does not seek to eliminate odor. However, Braun discloses one of the objectives of the system is to [0005]: “prevent contamination of the laboratory environment given the propensity for biological samples to form aerosols and be inhaled by laboratory personnel”). MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000). While Braun may not state that odor is reduced, a person of ordinary skill in the art would recognize that the seal as disclosed by Braun would effectively reduce odor while preventing inhalation of aerosols.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pavlovic et al. (US 20070034592 A1) – discloses a specimen container with an interior seal
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.
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/ Primary Examiner, Art Unit 3791