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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/26/2025 has been entered.
Response to Amendment
Applicant amendments filed 11/26/2025 have been entered.
Status of Claims
Claims 1-2, 5-6, and 9-11 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-6, and 9-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “the first sample placement position being a fixed position defined on the first sample placement section, at which one of the first plurality of sample containers is placed, and the second sample placement position being a fixed position defined on the second sample placement section, at which one of the second plurality of sample containers is placed,” on lines 21-26 where it is not seen in the instant specification where there is support for this limitation.
[14] describes that a sample container identifier management unit allocates a same sample container identifier to one sample container in a sample placement section of the preprocessing unit and a sample container placed in the sample placement section of the analysis device, and [18] of the instant specification describes where the sample container identifier management unit allocates identifiers so that the same identifier is allocated to samples derived from the same sample for a sample container identifier of each sample container placed in the sample placement section of the preprocessing device and a sample container identifier of each sample container placed in the sample placement section of the analysis device.
However, it is not seen in the instant specification where it describes that the placement positions are fixed. While Figure 2 does show a device status display screen showing the sample placement section in the preprocessing device and the sample placement section of the auto-sampler, there is nothing in the instant specification that describes these components as being fixed or stationary in any way.
Claims 2, 5-6, 9-11 are rejected by virtue of being dependent on a rejected claim.
Claim 11 has been similarly amended such that lines 5-10 describe a third and fourth sample placement position being fixed positions, and are similarly rejected for the reasons described above.
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.
Claim(s) 1-2, 5, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokunaga (US-2013/0009988-A1) in view of Bierre (WO-0138882-A1) and Sun (US-2016/0238623-A1) and as evidenced by Zahniser (WO-2013/016038-A1).
Regarding claim 1, Tokunaga teaches an automatic analysis system (automatic analyzing device main body 1) for performing predetermined preprocessing on a plurality of samples and then performing a predetermined analysis on the plurality of samples that has been preprocessed, the system (1) comprising ([0031], Figure 1):
a) a preprocessing device (pretreatment disk 21) configured to perform the predetermined preprocessing on the plurality of samples ([0033], Figure 1);
b) an analysis device (reaction disk 24) configured to perform the predetermined analysis on the plurality of samples that have been preprocessed ([0033], Figure 1); and
c) a controller (control unit 2) ([0034], Figure 1),
wherein the preprocessing device (21) comprises a first sample placement section on which a first plurality of sample containers (reaction cells 22) each containing one of the plurality of samples is placed, and performs the predetermined preprocessing on one of the plurality of samples contained in one of the first plurality of sample containers (22) placed in the first sample placement section ([0033] see the samples for which pretreatment such as dilution has been completed are dispensed as samples into reaction cells 25 of reaction disk 24. It is understood that dilution is a predetermined preprocessing),
wherein the analysis device (24) comprises a second sample placement section on which a second plurality of sample containers (reaction cells 25) each containing one of the plurality of samples that has been preprocessed is placed, and comprises a sampling unit (second conveying arm 23) for collecting one of the plurality of samples that has been preprocessed by a predetermined amount from one of the second plurality of sample containers (25) and introducing the collected sample into an injector ([0033], and see [0033] samples for which a pretreatment such as dilution has been completed are dispensed as samples into reaction cells 25 of a reaction disk 24 through second conveying arm 23, [0045]. It is understood that the second conveying arm 23 (sampling unit) will comprise an injector that is able to aspirate and dispense the sample from the pretreatment disk 21 to the reaction disk 24),
wherein the controller displays a first sample arrangement image, the first sample arrangement image showing an arrangement of the first plurality of sample containers (22) in the first sample placement section ([0042] describes Figures 5-8 that show an information display screen that has a disk display area 58, [0047] further describes where disk display area 58 shows the states of the samples in all reaction cells on pretreatment disk 21), and
wherein one of the plurality of samples that has been preprocessed is delivered from the first sample placement position to the second sample placement position ([0033], where it is understood that the samples for which a pretreatment such as dilution has been completed and are dispensed as samples into reaction cells 25 of reaction disk 24 is delivering a preprocessed sample from a reaction cell 22 (first placement position) to a reaction cell 25 (second placement position)).
Tokunaga does not teach wherein the controller allocates an identical number to a first sample placement position and a second sample placement position, the first sample placement position being a fixed position defined on the first sample placement section, at which one of the first plurality of sample containers is placed, and the second sample placement position being a fixed position defined on the second sample placement section, at which one of the second plurality of sample containers is placed,
In the same problem solving area of processing samples, Bierre teaches a known cell washing method (Bierre; abstract, page 2 lines 19-26).
Specifically, Bierre teaches that in the known cell washing method, collected blood samples are transferred by a lab technician from their collection tubes into respective sample tubes “marked with proper identification information corresponding to that on the collection tubes.” (Bierre; page 2 lines 19-26).
Tokunaga is silent with regards to how the sample is tracked from the pretreatment disk 21 to the reaction disk 24, therefore it would have been necessary and thus obvious to look to the prior art for conventional sample tracking methods. Bierre provides this conventional teaching showing that it is known in the art that when transferring sample from one tube to another, the receiving tube is marked with proper identification that corresponds to the starting tube. Therefore, it would have been obvious to one having ordinary skill in the art to modify the control unit of Tokunaga such that it identifies the reaction cell 25 that receives pretreated sample from reaction cell 22 with proper identification that corresponds to the reaction cell 22 because it is taught by Bierre that having identification information that corresponds to each other is effective for sample tracking when transferring samples from one tube to another.
It is evidenced by Zahniser that a particular blood sample tube can be identified with a bar code number (Zahniser; page 25 lines 30-31), where it is therefore understood that the “proper identification information” described by Bierre that are associated with both the initial and destination reaction cells will be identical numbers.
By assigning identification to the reaction cells in their respective disks, this is allocating an identical number to a first and second placement position. The placement position on the pretreatment disk and the placement position of the reaction disk will be fixed relative to their respective disks. Therefore, even though the disks are rotating the identification information will “follow” the sample as it rotates.
While Tokunaga does teach a display screen as seen in Figures 3-8, Tokunaga does not teach wherein the control unit displays a second sample arrangement showing an arrangement of the second plurality of the sample containers in the second sample placement section.
In the analogous art of systems and methods for managing workflow related to processing one or more microfluidic devices, Sun teaches a system for automated preparation, processing, imaging analysis, and control of microfluidic devices used to perform biological and chemical reactions (Sun; [0008]).
Specifically, [0035] of Sun describes a graphical user interface device for a fluidic micro chip analysis system that includes a first portion provided on a display of a representation of an array of well regions, a second portion provided on the display of a list of addresses, and a third portion provided on the display of a representation of a microfluidic chip. Figure 6C of Sun shows an Experiment Manager GUI that has in worksheet area 640 a reagent dispensing mapping is illustrating, including a mapping for a reagent plate and a microfluidic chip.
It would have been obvious to one skilled in the art to modify the information display screen of Tokunaga such that it includes an image of the reaction disk 24 because it is taught by Sun that by showing both the initial location and end location through a GUI allows mapping to be viewed and edited (Sun; [0561]).
Regarding claim 2, modified Tokunaga teaches the automatic analysis system as recited in claim 1. Tokunaga further teaches:
wherein the first sample arrangement image includes a first plurality of display regions corresponding to the arrangement of the first plurality of sample containers (Tokunaga; [0047] please see where reference numeral 58 denotes a pretreatment disk display area on the sample tracking display screen 51, Figure 5 where there are circles seen in pretreatment disk display that correspond to the reaction cells 22),
wherein the controller (2) is configured to receive information indicating a state of progress of respective operations from the preprocessing device (21) and the analysis device (24) and change a display mode in one of the first plurality of display regions according to the state of progress (Tokunaga; [0035] see the display unit 3 can display under the control of the control unit 2 various screen such as a pretreatment disk screen. [0047] describes where pretreatment disk display area 58 has the states of samples in the respective reaction cells are shown using a sample legend 583 so that the operator can easily understand the states of the samples).
Tokunaga has been modified by Sun such that the information display screen now has an image of the reaction disk 24 which will include display regions corresponding to the arrangement of the reaction cells 25 similar to how it is seen in Figure 5, where it is understood that one skilled in the art would find it obvious to modify the display showing the reaction disk 24 such that it includes similar status indicators as the indicators for pretreatment disk 21 as taught by Tokunaga because Tokunaga teaches that the status indicators allow the operator to easily understand the states of the samples (Tokunaga; [0047]).
Regarding claim 5, modified Tokunaga teaches the automatic analysis system as recited in claim 2. Tokunaga further teaches:
wherein the controller (2) is further configured for a user to identify one or more of the first plurality of display regions (Tokunaga; [0050] see if the operator selects a sample display area 577 corresponding to the sample 4, the sample display area 577 is highlighted and arrow marks 581 and 582 are displayed in the pretreatment disk display area 58 to indicate the reaction cells of the pretreatment disk 21 in which the corresponding samples exist, Figure 6), and
wherein the controller (2) is further configured to display an input setting screen which allows the user to input sample information of a sample from among the plurality of samples accommodated in one of the first plurality of sample containers (22) associated with the one or more of the first plurality of display regions when the one or more of the first plurality of display regions are identified via the controller (2) ([0035] see input unit 4 is used by an operator inputting various information such as analysis conditions and maintenance and giving an operation instruction. Tokunaga does not show a figure that depicts the screen that allows the operator to input information, however it is understood that one skilled in the art would recognize that an input screen would need to be shown in order for the user to input such information), and
wherein the automatic analysis system (1) further comprises a sample information storage unit (storage unit 5) configured to store the sample information input by an operation of the user on the input setting screen displayed by the controller in association with the number allocated (Tokunaga; [0010], [0031], [0035] see storage unit 5 stores programs that includes display control, sequence programs, data such as analysis items and measured results, [0064] see storage unit stores data related to the samples).
As the control unit of Tokunaga has been modified by Bierre such that the reaction cell 22 will have the same identification information as the receiving reaction cell 25, it is understood that the storage unit 5 will contain this information as well.
Regarding claim 9, modified Tokunaga teaches the automatic analysis system as recited in claim 1. Tokunaga further teaches:
wherein the first sample arrangement image includes a first plurality of display regions corresponding to the arrangement of the first plurality of sample containers (Tokunaga; [0047] please see where reference numeral 58 denotes a pretreatment disk display area on the sample tracking display screen 51, Figure 5 where there are circles seen in pretreatment disk display that correspond to the reaction cells 22),
Tokunaga has been modified by Sun such that the information display screen now has an image of the reaction disk 24 which will include display regions corresponding to the arrangement of the reaction cells 25 similar to how it is seen in Figure 5. Further it is understood that the shape of the envelope of the first plurality of display regions will be different from a shape of an envelope of the second plurality of display regions because the pretreatment disk 21 is seen in Figure 1 to be two concentric circles of reaction cells and the reaction disk 24 is seen to be a single circle, therefore the shapes of their envelopes are different because one will have two boundaries and the other will only have a single boundary.
The “envelopes” are being interpreted as the shape that encloses the arrangement of containers, where this is best seen in Figure 2 of the instant specification where on the left side the containers are enclosed in a circle, and on the right containers are enclosed by a rectangle.
Regarding claim 10, modified Tokunaga teaches the automatic analysis system as recited in claim 1. Bierre teaches proper identification information, where it has been evidenced by Zahniser that sample tubes can be identified with a bar code number. It is therefore understood that the number allocated to both reaction cell 22 and receiving reaction cell 25 will be a vial number.
Regarding claim 11, modified Tokunaga teaches the analysis system as recited in claim 1. Modified Tokunaga further teaches:
wherein the controller displays the first sample placement position and the second sample placement position, which have been allocated the identical number, in a manner different from that used for a third sample placement position and a fourth sample placement position, the third sample placement position being a fixed position defined on the first sample placement section, at which another one of the first plurality of sample containers is placed, and the fourth sample placement position being a fixed position defined on the second sample placement section, at which another one of the second plurality of sample containers is placed.
Tokunaga has been modified by Sun such that the information display screen shows both an image of the reaction disk 24 and pretreatment disk 21, where Tokunaga has also been modified by Bierre such that the reaction cell 25 that receives sample from reaction cell 22 has the same proper identification information to allow for sample tracking. This will occur for all samples in the pretreatment disk 21, where another reaction cell 22 in pretreatment disk 21 and corresponding reaction cell 25 in reaction disk 24 will have their own unique identification information assigned which is different from the one used for the previous sample.
Further, as described above the placement position on the pretreatment disk and the placement position of the reaction disk will be fixed relative to their respective disks. Therefore, even though the disks are rotating the identification information will “follow” the sample as it rotates.
Claim(s) 5 is/are alternatively rejected and claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tokunaga (US-2013/0009988-A1), Bierre (WO-0138882-A1) and Sun (US-2016/0238623-A1), and in further view of Moschell (US-2017/0176480-A1).
Regarding claim 5, modified Tokunaga teaches the automatic analysis system as recited in claim 2. Tokunaga further teaches:
wherein the controller (2) is further configured for a user to identify one or more of the first plurality of display regions (Tokunaga; [0050] see if the operator selects a sample display area 577 corresponding to the sample 4, the sample display area 577 is highlighted and arrow marks 581 and 582 are displayed in the pretreatment disk display area 58 to indicate the reaction cells of the pretreatment disk 21 in which the corresponding samples exist, Figure 6), and
wherein the automatic analysis system (1) further comprises a sample information storage unit (storage unit 5) configured to store the sample information input by an operation of the user on the input setting screen displayed by the controller in association with the number allocated (Tokunaga; [0010], [0031], [0035] see storage unit 5 stores programs that includes display control, sequence programs, data such as analysis items and measured results, [0064] see storage unit stores data related to the samples).
As the control unit of Tokunaga has been modified by Bierre such that the reaction cell 22 will have the same identification information as the receiving reaction cell 25, it is understood that the storage unit 5 will contain this information as well.
However, if it is determined that Tokunaga does not teach:
wherein the controller is further configured to display an input setting screen which allows the user to input sample information of a sample from among the plurality of samples accommodated in one of the first plurality of sample containers associated with the one or more of the first plurality of display regions when the one or more of the first plurality of display regions are identified via the controller, in the analogous art of user interfaces for an instrument, Moschell teaches a presentation unit display that has a similar appearance to the presentation unit of an instrument that allows a user to compare the presentation unit display with presentation unit containing samples (Moschell; [0004]).
Specifically, Moschell teaches where a carousel interface display region 302 includes a carousel display 116 and a data specifications grid 320 (Moschell; [0084], Figure 8). [0085] of Moschell describes where the interface display region 302 operates to receive inputs from the operator to allow the operator to provide details about the samples loaded onto the carousel 104 (carousel 104 seen in Figure 1 of Moschell), where the carousel interface display region 302 can do one or more of: identify which carousel positions contain a sample, give each sample a name, assign a protocol to each sample, link protocols, and make parameter specifications. It is seen in Figure 8 of Moschcell that the carousel display 116 includes body 322 and container positions 324, where body 322 is a graphical representation of body 180 (seen in Figure 3 of Moschell) with each container position 324 containing a number within the circular shape to identify the order of each position 324 (Moschell; [0086]). [0091] of Moschell describes that in one example, container positions 324 are selectable by providing an input onto the container position 324, such as the operator manipulating an input device to select a point on the container position 3242 (such as a click, double click, tap, double tap, or other input), this results in the instrument interface engine 112 recognizing the input and selects the corresponding container position 3242. Once selected, the carousel display 116 animates rotation of the carousel until the selected container position 3242 is positioned at the origin position 326 (Moschell; [0091]). [0092] of Moschell describes where when the operator provides an input to the container position 324, such as a right click or other input, a pop-up menu is displayed where the operator can create a new protocol or import a previously defined protocol. Once a protocol has been defined for the sample at the selected container position 324, the color of the container position 324 is changed from an initial color to a different color that indicates that a sample is expected to be present at that container position 324 during the acquisition, and that a protocol has been defined for the sample (Moschell; [0095]). [0097] of Moschell also describes where groups of protocols can be moved or copied simultaneously, for example if the operator wants to have a repeating pattern of Protocol A and Protocol B. It is also seen in Figure 8 of Moschell that there are labels 330 associated with container positions 3241 and 3242, where in the absence of meta information, labels 330 display names of the protocols such as Protocol A and Protocol B (Moschell; [0100]). One example describes where the operator can select labels 330 and then enter meta information such as a sample identifier, a description, or other desired information that will then be displayed in the respective label (Moschell; [0100]).
[0009] of Moschell describes a computer readable storage device that stores data instructions that when executed by at least one processing device, causes the at least one processing device to: generate a user interface on the display device, and receive inputs that define instructions for analysis of a sample by the instrument.
It would have been obvious to one skilled in the art to modify the control unit of Tokunaga such that the display includes an interface that would allow an operator to input information about a sample container and to modify the storage unit of Tokunaga such that it stores input protocols as taught by Moschell because Moschcell teaches that color coding allows the operator to visually identify container positions for which a protocol has and has not been defined without having to individually check settings of each container position, and that displayed information is helpful to the operator in properly setting up protocols and verifying protocols have been properly set up (Moschell; [0095], [0100]).
Regarding claim 6, modified Tokunaga teaches the automatic analysis system as recited in claim 5. Tokunaga has been modified with Moschell such that now in the display, when a specific reaction cell 22 is selected, additional information will be able to be associated with the reaction cell 22. It is described by [0092] of Moschell that once a protocol has been selected the color of the container portion 324 changes color, where [0100] of Moschell describes where when meta information is added for the container portion 324, a label 330 is displayed as seen in Figure 8 of Moschell.
It is therefore understood that this will change the display mode of the first plurality of display regions depending on whether or not sample information has been set.
Response to Arguments
Applicant’s arguments, see page 2, filed 11/26/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 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 Tokunaga (US-2013/0009988-A1), Bierre (WO-0138882-A1) and Sun (US-2016/0238623-A1) and as evidenced by Zahniser (WO-2013/016038-A1).
Please note that Tokunaga, Bierre, and Sun as evidenced by Zahniser were previously used in the Office Action mailed 08/26/2025. However, due to applicant amendments to the claims, the rejections in view of Tokunaga have been modified to address these amendments. In particular, a new interpretation of Tokunaga is being used for the sample placement sections being “fixed positions”.
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796