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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2020-206444, filed on 12/14/2020.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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.
Claims 9-13, 14-15 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.
Regarding claim 9, it is unclear what the information reading device is doing after it reads the identification information on the sample containers and rack. In claim 9, “Where” in the statement “[…] and the information reading device reads container identification information of the plurality of mixed sample containers and rack identification information of the first rack in a state where the plurality of mixed sample containers are accommodated in the first rack […]” is not clear whether it is simply calling reference to the rack, or referring to a specific location that the containers should be positioned on the rack, or that the containers are being relocated in general, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The accommodation of the containers in a rack are rendered indefinite by the use of this term. The examiner is using broadest reasonable interpretation for this claim for the term "where" and "accommodated" to mean the general location of where the sample containers are housed.
Claim 10-13 are additionally rejected as they are dependent on claim 9.
Claim 15 is additionally rejected as it is dependent on claim 14.
Claim 17-18 is additionally rejected as it is dependent on claim 16
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.
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.
Claims 1, 4-8, 10, 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McNally et al. (“Pooled testing for SARS-CoV-2 could provide the solution to UK’s testing strategy”, as cited in the IDS), in view of Tajima et al. (JP 2004264044 A, as cited in the IDS).
Regarding claim 1, McNally et al. teaches mass diagnostic testing for infectious diseases, by performing sample pooling, wherein 100 individual samples are pooled in a 10x10 matrix, where each row may be pooled as 10 sample pools in two different sets for analysis. The sample pool consists of a mixture of 10 samples on a given row, in a vertical direction numbered from 1 to 10, and a lateral direction lettered from A to J. A one-way pool testing may also be considered. While not explicitly taught, the given figure for two-way pooled testing shows that a row of individual samples may be positioned in a different direction from the sample pool's first direction (see McNally et al., para. 1 and 5, Fig. "Two-way pooled testing").
McNally et al. fails to teach a first rack, a plurality of second racks, and a plurality of dispensation nozzles that move in the second direction in order to dispense a plurality of individual samples in the plurality of individual sample containers to the plurality of mixed sample containers, respectively, wherein the plurality of individual sample containers accommodated in one of the plurality of second racks, and one of the plurality of mixed sample containers accommodated in the first rack align in the second direction.
However, In the analogous art of dispensing apparatus with monitor function and method for monitoring, Tajima et al. teaches a mechanism section 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function. The mechanism section 1 further includes a X-axis member 11 and a Y-axis member 12 that operably supports the dispensing unit 2, where a container arrangement area 9 is provided below and supported by a frame 13 (see Tajima et al., [0061]-[0062], Fig. 2-3). The dispensing unit 2 is further supported by a Z-axis slider 16 to allow movement upwards and downwards, where a plurality of translucent disposable pipette tips 17 attached to a plurality of nozzles 18, powered by a cylinder 19 and plunger 20 for performing suction and discharging of a liquid and the like to the pipette tip 17 (see Tajima et al., [0063], Fig. 2-3, Fig. 5). Additionally, Tajima et al. teaches container group 72 arranged in the container arrangement area 9. The container group 72 is formed by bundling six cartridge-shaped containers 74 in accordance with the number of nozzles of the dispensing unit 2 with a six-fold holder 75 (i.e. a rack) to accommodate the bundled cartridge-shaped containers 74 (see Tajima et al. [0088], Fig. 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the individual sample matrix and sample pooling of McNally et al. to incorporate the mechanism section containing the dispensing unit, and bundling containers into groups with a cartridge (as taught by Tajima et al.) or rack, for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Regarding claim 4, McNally et al. fails to teach wherein the sample pooling device further includes a movement unit that moves the plurality of dispensation nozzles in the second direction.
However, Tajima et al. teaches that the mechanism section 1 containing the dispensing unit 2 includes a X-axis member 11 and a Y-axis member 12 that operably supports the dispensing unit 2, allowing it to move in two given directions (a first or a second direction) (see Tajima et al., [0061]-[0062], Fig. 2-3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate a movement member in either the X-axis or Y-axis for the dispensing unit (as taught by Tajima et al.), for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Regarding claim 5, McNally et al. teaches a row of 10 pooled samples, taken from multiple rows of individual samples in a 10x10 matrix (see McNally para. 5, Fig "Two-way pooled testing").
McNally et al. fails to teach wherein: the sample pooling device further includes a first tray to be disposed in the sample pooling device; and the first tray accommodates the first rack, the plurality of second racks, and a plurality of dispensing tips to be attached to the plurality of dispensation nozzles.
However, Tajima et al. teaches container disposition area 9 (i.e. a tray), which accommodates the container groups 72 held in cartridge shaped containers 74, bundled in the holder 75. The Container disposition area may further accommodate large diameter tip container group 66, for storing unused large diameter translucent disposable pipette tips 17 and a small diameter pipette tip container 67 for storing unused small diameter pipette translucent disposable tips (see Tajima et al. [0086], [0088], Fig. 6-7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate the an container disposition area, accommodating container groups held in cartridges, and a storage container for unused pipette tips (as taught by Tajima et al.), for the benefit of being able to use a fluid sensor to optically identify the state and type of fluid that’s being held within a pipetting device because of the translucent tip (see Tajima et al. [0002]).
Regarding claim 6, McNally et al. fails to teach wherein the sample pooling device further includes a plurality of lanes that accommodate the plurality of dispensing tips to be attached to the plurality of dispensation nozzles.
However, while not explicitly taught, Tajima et al. shows in Fig. 6 that the translucent disposable pipette tips 17 are arranged in rows at large diameter tip container group 66 and small diameter pipette tip container 67, and further taught that the dispensing unit 2 that the six nozzles 18 of the dispensing unit may be simultaneously lowered onto the pipette container group so that six pipette tips 17 are mounted onto the nozzles 18 (see Tajima et al., [0092], Fig. 3-4, Fig. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate the pipette tip arrangement, and the mounted of pipette tips onto nozzles (as taught by Tajima et al.), for the benefit of being able to use a fluid sensor to optically identify the state and type of fluid that’s being held within a pipetting device because of the translucent tip (see Tajima et al. [0002]).
Regarding claim 7, the examiner is interpreting the PCR devices to be similar to the sampling pool device earlier claimed, based on the specifications and drawings provided by the instant application.
McNally et al. teaches performing pooling samples from rows of individual samples using a matrix of 10x10 to produce 20 pools in a two-way pool testing method, where they can then be directly tested with PCR tests (see McNally et al., para. 3 and 5, Fig "Two-way pooled testing").
McNally et al. fails to teach the sample pooling device; a first PCR device that executes a PCR test of the mixed sample; and a second PCR device that executes a PCR test of the individual samples.
However, Tajima et al. teaches a dispensing device as mechanism 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function (see Tajima et al. [0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling and PCR tests of McNally to be performed on one or more of the dispensing devices of Tajima (as taught by Tajima et al.), for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Regarding claim 8, McNally et al. teaches performing pooling samples from rows of individual samples using a matrix of 10x10 to produce 20 pools in a two-way pool testing method, or 10 pools in a one-way pool testing method following a first direction where they can then be directly tested with PCR tests (see McNally et al., para. 3 and 5, Fig "Two-way pooled testing").
McNally et al. fails to teach the sample pooling device, a first PCR device that executes a PCR test of the mixed sample; and a second PCR device that executes a PCR test of the individual samples, wherein the first PCR device and/or the second PCR device further includes an information reading unit that is movable in the first direction and the second direction in order to read rack identification information from the rack information display portion.
However, Tajima et al. teaches a dispensing device as mechanism 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function (see Tajima et al. [0061], Fig. 2-3). Tajima et al. additionally teaches a barcode reader 44 provided with a photometric unit, that can read the barcodes attached to a container in the container arrangement area 9. A reversing motor 46 for reversing the reading unit 45 in the direction in accordance with the direction of the attached barcode, where it may move horizontally or vertically (see Tajima et al. [0076], Fig 5.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling and PCR tests of McNally to be performed on one or more of the dispensing devices of Tajima et al, as well as provide a barcode reader to scan an identifying barcode on the containers (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit (see Tajima et al., [0054], [0056]).
Regarding claim 10, McNally et al. fails to teach wherein the information reading device determines an order or a position of the plurality of mixed sample containers in a state where the plurality of mixed sample containers is accommodated in the first rack or determines an order or a position of the plurality of individual sample containers in a state where the plurality of individual sample containers is accommodated in the second rack.
However, Tajima et al. teaches a barcode attached to each container in the container arrangement area 9, as an identifier for identifying the container itself, or a substance contained in the container (see Tajima et al. [0076], Fig 5.). The barcodes 82 may additionally contain arrangement data, where it can be used to confirm the arrangement of the containers via the position coordinates from the identifier readout before the mechanism 1 can begin operations in dispensing (see Tajima et al., [0090]-[0091], [0113], Fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. by incorporating a barcode affixed on the containers on the container arrangement area, and arrangement data within the barcodes with position readouts (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit and stored in a storage unit, allowing it to continue performing operations without any manual intervention (see Tajima et al., [0054], [0056]).
Regarding claim 14, the examiner is using broadest reasonable interpretation for this claim for the term "where" and "accommodated" to mean the general location of where the sample containers are housed. The examiner is additionally interpreting the PCR devices to be similar to the sampling pool device earlier claimed, based on the specifications and drawings provided by the instant application.
McNally et al. teaches performing pooling samples from rows of individual samples using a matrix of 10x10 to produce 20 pools in a two-way pool testing method, or 10 pools in a one-way pool testing method following a first direction where they can then be directly tested with PCR tests (see McNally et al., para. 3 and 5, Fig "Two-way pooled testing").
McNally et al. fail to teach the sample pooling system, further comprising a second tray disposed in the first PCR device, wherein the second tray accommodates the first rack such that the plurality of mixed sample containers aligns in the first direction in a state where the plurality of mixed sample containers are accommodated in the first rack.
However, Tajima et al. teaches a dispensing device as mechanism 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function (see Tajima et al. [0061], Fig. 2-3). Tajima et al. additionally teaches container disposition area 9 (i.e. a tray), which accommodates the container groups 72 held in cartridge shaped containers 74 (i.e. a rack), bundled in the holder 75. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling, PCR testing and alignment of rows in one direction of McNally et al. to incorporate the an dispensing device and container disposition area (as taught by Tajima et al.), for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Regarding claim 16, the examiner is using broadest reasonable interpretation for this claim for the term "where" and "accommodated" to mean the general location of where the sample containers are housed. The examiner is additionally interpreting the PCR devices to be similar to the sampling pool device earlier claimed, based on the specifications and drawings provided by the instant application.
McNally et al. teaches performing pooling samples from rows of individual samples using a matrix of 10x10 to produce 20 pools in a two-way pool testing method, or 10 pools in a one-way pool testing method following a first direction where they can then be directly tested with PCR tests (see McNally et al., para. 3 and 5, Fig "Two-way pooled testing").
McNally et al. fails to teach the sample pooling system, further comprising a third tray disposed in the second PCR device, wherein the third tray accommodates the second rack such that the plurality of individual sample containers align in the first direction in a state where the plurality of individual sample containers are accommodated in the second rack.
However, Tajima et al. teaches a dispensing device as mechanism 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function (see Tajima et al. [0061], Fig. 2-3). Tajima et al. additionally teaches container disposition area 9 (i.e. a tray), which accommodates the container groups 72 held in cartridge shaped containers 74 (i.e. a rack), bundled in the holder 75. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling, PCR testing and alignment of rows in one direction of McNally et al. to incorporate the dispensing device and container disposition area (as taught by Tajima et al.), for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Regarding claim 18, the examiner is interpreting the PCR devices to be similar to the sampling pool device earlier claimed, based on the specifications and drawings provided by the instant application.
McNally et al. teaches a method of sample pooling, involving a two-way pooled testing using a 10x10 matrix grid of individual samples, and pooling each row horizontally and vertically to obtain two separate rows of mixed pools, of 20 sample pools total. If a pooled sample is found to have yielded a positive result in one row of a pool, another pool should also return positive in the second row. An intercept can be made between the rows of both mixed pools, and a confirmatory PCR test can be run on the identified individual sample sitting in the intersection can be made (see McNally et al., para 2 and 5, Fig. "Two-way pooled testing").
McNally et al. fails to teach a control unit of the first PCR device; and the sample pooling device further includes a positive display portion.
However, Tajima et al. teaches a dispensing device as mechanism 1, with the function of performing the process of transferring, extracting, separating, isolating, stirring, washing and the like, where a dispensing unit 2 is included on this mechanism 1 with a monitoring function (see Tajima et al. [0061], Fig. 2-3). A control unit 4 may be responsible for controlling operation instructions to the mechanism unit 1 and the monitoring of each operation in response to an external instruction, and an input for inputting data, operation instructions, and the like, where the control unit 4 may further comprise an input unit 5, and an output unit 6, for outputting a monitoring result of each operation instruction (see Tajima et al. [0054], Fig. 1). The output unit 6 may further include a display unit such as a liquid crystal display or a CRT, a printer, a CD drive, a DVD drive, or a communication line (see Tajima et al., [0059], Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling, and determination of a positive reading based on the mixed samples intercept with the individual of McNally et al. to incorporate the dispensing device, control unit, and display of Tajima et al., for the benefit of the dispensing device providing high-precision inspection, and processing with high quantitativeness, in fields that require such results such as chemistry, medicine, engineering, agriculture, livestock, and fisheries (see Tajima et al., [0001]).
Claims 2-3, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over McNally et al. and Tajima et al. as applied to claim 1 and 7 above, and further in view of Okumura (JP H0943248 A, as cited in the IDS).
Regarding claim 2, McNally et al. fails to teach wherein: the first rack and/or the second rack includes a rack information display portion; and the sample pooling device further includes an information reading unit that is movable in the first direction and the second direction in order to read rack identification information from the rack information display portion.
However, Tajima et al. teaches a barcode attached to each container in the container arrangement area 9, as an identifier for identifying the container itself, or a substance contained in the container. A barcode reader 44 is provided with a photometric unit, and can read the barcodes attached to a container in the container arrangement area 9. A reversing motor 46 for reversing the reading unit 45 in the direction in accordance with the direction of the attached barcode, where it may move horizontally or vertically (see Tajima et al. [0076], Fig 5.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate a barcode affixed on the containers on the container arrangement area, and a motor driven barcode reader (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit and stored in a storage unit (see Tajima et al., [0054], [0056]).
Furthermore, the combination of McNally et al. and Tajima et al. fails to teach that the information display portion is on a rack.
However, in the analogous art of specimen conveying system, Okumura teaches a sample transportation system, where it comprises a rack which collectively includes a predetermined number of sampled, and of which a rack identification code is attached (i.e. a bar code) (see Okumura, [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling, an barcode affixed on the containers on the container arrangement area, and a motor driven barcode reader from the combination of McNally et al. and Tajima et al., to further incorporate the application of the barcode onto a rack (as taught by Okumura), for the benefit of performing automated, and rapid sample processing and distribution (see Okumura, [0001]).
Regarding claim 3, McNally et al. fails to teach wherein the rack information display portion is disposed on an upper surface of the first rack and/or the second rack.
However, Tajima et al. teaches that the bar code is applied to the upper part of each container of the container arrangement area 9 (see Tajima et al. [0076], Fig 5.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate a barcode affixed on the upper part of the containers (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit and stored in a storage unit (see Tajima et al., [0054], [0056]).
Furthermore, the combination of McNally et al. and Tajima et al. fails to teach that the information display portion is on a rack on an upper surface.
However, Okumura teaches a sample transportation system, where it comprises a rack which collectively includes a predetermined number of sampled, and of which a rack identification code is attached (i.e. a bar code) (see Okumura, [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling and the barcode being applied to an upper part from the combination of McNally et al. and Tajima et al., to further incorporate the application of the bar code onto a rack (as taught by Okumura), for the benefit of performing automated, and rapid sample processing and distribution (see Okumura, [0001]).
Regarding claim 9, The examiner is using broadest reasonable interpretation for this claim for the term "where" and "accommodated" to mean the general location of where the sample containers are housed.
McNally et al. fails to teach wherein: the first rack and/or the second rack includes a rack information display portion that displays rack identification information; the mixed sample container and/or the individual sample container includes at least one container information display portion that displays container identification information; the sample pooling system further includes an information reading device; and the information reading device reads container identification information of the plurality of mixed sample containers and rack identification information of the first rack in a state where the plurality of mixed sample containers are accommodated in the first rack, or reads container identification information of the plurality of individual sample containers and rack identification information of the second rack in a state where the plurality of individual sample containers are accommodated in the second rack.
However, Tajima et al. teaches a barcode attached to each container in the container arrangement area 9, as an identifier for identifying the container itself, or a substance contained in the container. A barcode reader 44 is provided with a photometric unit, and can read the barcodes attached to a container in the container arrangement area 9. A reversing motor 46 for reversing the reading unit 45 in the direction in accordance with the direction of the attached barcode, where it may move horizontally or vertically (see Tajima et al. [0076], Fig 5.). The barcodes 82 may additionally contain arrangement data, where it can be used to confirm the arrangement of the containers before the mechanism 1 can begin operations in dispensing (see Tajima et al. [0090]-[0091], Fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling of McNally et al. to incorporate a barcode affixed on the containers on the container arrangement area, a motor driven barcode reader, and arrangement data within the barcodes (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit and stored in a storage unit, allowing it to continue performing operations without any manual intervention (see Tajima et al., [0054], [0056]).
Furthermore, the combination of McNally et al. and Tajima et al. fails to teach that the information display portion is on a rack.
However, Okumura teaches a sample transportation system, where a component being moved within the system comprises a rack which collectively includes a predetermined number of samples, and of which a rack identification code is attached (i.e. a bar code) onto said rack (see Okumura, [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling and the barcodes affixed on the containers on the container arrangement area, a motor driven barcode reader, and arrangement data within the barcodes from the combination of McNally et al. and Tajima et al., to further incorporate the application of the bar code onto a rack (as taught by Okumura), for the benefit of performing automated, and rapid sample processing and distribution (see Okumura, [0001]).
Regarding claim 11, McNally et al. fails to teach wherein the information reading device includes: a first information reading unit that reads sample identification information from a side surface of the plurality of mixed sample containers or the plurality of individual sample containers; a second information reading unit that reads rack identification information from a place above the first rack or the second rack; and a guide portion that guides the first rack or the second rack to the first information reading unit and the second information reading unit.
However, Tajima et al. teaches a barcode reader 44 that’s provided with a photometric unit, and can read the barcodes attached to a container in the container arrangement area 9 (see Tajima et al. [0076], Fig 5.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling method of McNally et al. to incorporate a barcode reader (as taught by Tajima et al.), for the benefit of automatically determining and confirming the type and arrangement of the container scanned, with the scanned information inputted onto a control unit and stored in a storage unit, allowing it to continue performing operations without any manual intervention (see Tajima et al., [0054], [0056]).
Furthermore, the combination of McNally et al. and Tajima et al. fails to teach a guide portion that guides the first rack or the second rack to the first information reading unit and the second information reading unit.
However, Okumura teaches a transportation system, with a code reading unit for reading the sample identification code and the rack identification code, which can hold a plurality of racks to be loaded onto the sample transport system. The barcode reading mechanism is installed on the transport line, where the racks are moved through the line for reading. The barcode reader 133 may read from the side of the transport line, or move in a position above the racks to also read the rack identifier (see Okumura, [0010], [0017], Fig. 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barcode reader for containers from the combination of McNally et al. and Tajima et al., to further incorporate a code reading device along a transport line for moving and scanning containers and racks (as taught by Okumura), for the benefit of performing automated, and rapid sample processing and distribution (see Okumura, [0001]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over McNally et al., Tajima et al. and Okumura as applied to claim 11 above, and further in view of Koch et al. (US PG-Pub 20100049358 A1).
Regarding claim 12, the combination of McNally et al. and Tajima et al. does teach a barcode reading device (see Tajima et al. [0076], Fig 5.), but fails to teach wherein: the information reading device includes a gate portion having a rack passing port through which the first rack or the second rack is able to pass; and the first information reading unit and the second information reading unit are disposed in the gate portion.
However, Okumura teaches a code reading unit that’s installed at an input port of the transport line that reads rack identification code of a rack. The barcode reader 133 may read from the side of the transport line, or move in a position above the racks to also read the rack identifier (see Okumura, [0020], Fig. 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barcode reader for containers from the combination of McNally et al. and Tajima et al., to further incorporate a code reading device along a transport line for moving and scanning containers and racks (as taught by Okumura), for the benefit of performing automated, and rapid sample processing and distribution (see Okumura, [0001]).
Furthermore, the combination of McNally et al., Tajima et al. and Okumura does not teach a gate portion having a rack passing port through which the first rack or the second rack is able to pass; and the first information reading unit and the second information reading unit are disposed in the gate portion.
However, in the analogous art of laboratory systems for handling sample tube racks, Koch et al. teaches a disposal unit 18, consisting of a gate opening 612 of which storage racks SR can be pushed along a guide into it. A loading interface or a refrigeration storage section 14 may additionally incorporate gates in storing racks within (see Koch et al., [0064]-[0066], Fig. 1, Fig. 3-4, Fig. 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barcode reader devices and transport lines of the combination of McNally et al., Tajima et al., and Okumura, and further incorporate a gate along a guided path (as taught by Koch et al.) that a rack may be pushed along into, where the barcode reading devices may be installed into, for the benefit of preventing congestion from the flow of sample racks moving between storages by restricting flow through a gate.
Regarding claim 13, the combination of McNally et al., Tajima et al. and Okumura fails to teach wherein: the guide portion is a guide groove in which the sample rack is slid; and the rack passing port is positioned above the guide groove.
However, Koch et al. teaches that the guide elements may be guide grooves formed by raised side edges, encompassing the lower edges of a storage rack when being slid in the pack position so that the protruding extensions 96 provided along longitudinal edges of the storage rack engages with the raised edge guide grooves of the platform 622. The guide grooves may travel along under a gate opening 612 to allow for racks to pass through it. (see Koch et al., [0064], Fig. 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample pooling system of the combination of McNally et al., Tajima et al., and Okumura, by incorporating the guide grooves (as taught by Koch et al.) on the transport lines, for the benefit of being able to keep the racks upright and in place during transportation along a path to prevent spills or otherwise disturb the contained sample.
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McNally et al. and Tajima et al. '044 (JP 2004264044, as cited in the IDS and from hereon, referred to as Tajima et al. '044) as applied to claims 14 and 16 above, and further in view of Tajima et al. '618 (US PG-Pub 20150218618 A1).
Regarding claim 15, the combination of McNally et al. and Tajima et al. '044 teaches the sample pooling system according to claim 14, a PCR device (see McNally et al., para. 3, and see Tajima et al. '044, [0061], Fig. 2-3) and a tray (see Tajima et al. '044, [0088], Fig. 7), but fails to teach wherein the first PCR device includes a plurality of PCR tubes and a plurality of thermal cyclers adjacent to the second tray.
However, in the analogous art of light measurement apparatus and method for reaction vessel, Tajima et al. '618 teaches a reaction vessel control system 901, which comprises of a plurality of PCR tubes 231subi representing the reaction vessels (see Tajima et al. '618, [0282], Fig. 21). Tajima et al. '618 additionally teaches a temperature controller, preferably a thermal cycler using a Peltier element, that either makes contact with or is adjacent to a portion or the entirety of the reaction vessel (see Tajima et al. '618, [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dispensing device, and container disposition area of the combination of McNally et al. and Tajima et al. '044 by incorporating a plurality of PCR tubes and a thermal cycler (as taught by Tajima et al. '618) placed adjacent of the tray, for the benefit of being able to detect and analyze products of DNA amplification in real time using PCR methods and apparatuses such as thermal cycling (see Tajima et al. '618, [0002]).
Regarding claim 17, the combination of McNally et al. and Tajima et al. '044 teach the sample pooling system according to claim 16, a PCR device (see McNally et al., para. 3, and see Tajima et al. 044, [0061], Fig. 2-3) and a tray (see Tajima et al. '044, [0088], Fig. 7), but fails to teach wherein the second PCR device includes a plurality of PCR tubes and a plurality of thermal cyclers adjacent to the third tray.
However, Tajima et al. '618 teaches a reaction vessel control system 901, which comprises of a plurality of PCR tubes 231subi representing the reaction vessels (see Tajima et al. '618, [0282], Fig. 21). Tajima et al. '618 additionally teaches a temperature controller, preferably a thermal cycler using a Peltier element, that either makes contact with or is adjacent to a portion or the entirety of the reaction vessel (see Tajima et al. '618, [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dispensing device, and container disposition area of the combination of McNally et al. and Tajima et al. '044 by incorporating a plurality of PCR tubes and a thermal cycler (as taught by Tajima et al. '618) placed adjacent of the tray, for the benefit of being able to detect and analyze products of DNA amplification in real time using PCR methods and apparatuses such as thermal cycling (see Tajima et al. '618, [0002]).
Conclusion
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797