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). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-8, 10, 17-19, 21 and 22 are pending.
Claims 1, 6 are amended.
Claims 9 and 11 are canceled.
Claims 12, 13, 14, 15, 16, and 20 are withdrawn.
Claims 21 and 22 are new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
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 1-8, 17-19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ito (WO 2017110005 A1), machine translation and original for figures, and further in view of Rolf et. al. (JP 2018136329 A), machine translation.
Regarding claim 1, Ito teaches “A fluid handling unit” (Pages 2, 10 and Fig 1, cell transfer device, The target objects are liquids such as organic or inorganic fragments. The cell aggregate C together with the medium L is sucked into the tubular passage 60 of the chip 6 by these liquid flows LF1 and LF2.)” Therefore, the fluid handling unit is taught by the target objects being organic and inorganic liquids in addition to the medium L and the cell aggregate flow with liquid. Below the image system is used to determine the opening of the well which would make the unit “ridge” in order to extract liquid from the well. Further taught “for handling a fluid contained or to be contained in a receptacle” (Page 4, The microplate 4 is a container to which the cell aggregate C is moved); “the fluid handling unit comprising: a needle comprising an elongated shape with an open end and configured to aspirate the fluid from the receptacle; and/ or dispense the fluid into the receptacle;” (Abstract and page 4, A pick-up method for target objects, whereby a tip (6) having a tip opening (6H) is inserted into and suctions inside a well (3). The chip 6 is a tube-shaped member having a tip opening 6H, and sucks and discharges the medium L including the cell aggregate C); “wherein the receptacle comprises a body for containing the fluid” (Page 3, The plate body 2 is made of a flat plate member having a predetermined thickness, and has an upper surface 21 and a lower surface 22. The upper surface 21 is provided with a plurality of wells 3 that carry cell aggregates C.); and an opening for reaching into the receptacle, and the receptacle bears a marking” (Fig 7 and Page 8, hole 34)).
Ito does not teach “and wherein the marking is a separate component positioned on or applied to the receptacle”.
Rolf teaches automated sample operation using a syringe, syringe pump, barcode reader and “and wherein the marking is a separate component positioned on or applied to the receptacle” (Page 14, By identifying the marking on the top or by visualizing the barcode contained on the sample container (102, 210, 211) or sample rack (103).
210, 211) and / or the type of sample contained in the input rack (103).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ito to incorporate the teachings of Rolf wherein the marking is separate component and positioned on or applied to the receptacle. Doing so would allow the barcode to be removed and a new one affixed to the sample container in order to update sample information contained within the container.
Ito further teaches “in a spatially defined relationship to the opening into the receptacle; (Fig 7 and Page 8, hole 34); “a needle drive configured to position the needle with respect to the receptacle;” (Page 5, a head unit axis driving unit 64 (a part of nozzle driving means) as a mechanism for horizontally moving the head unit 61, and a head 63. Head drive unit 65 (a part of the nozzle drive means) and the head unit 61 for positioning raising and lowering the head 63 for the suction and discharge operations of the cell aggregate C by the head 63.); ”a detection unit” (Page 3 and 5, camera 5); “configured to detect the marking of the receptacle;” (Page 8 and figure 5, The well plate 10 is imaged by the camera unit 5, and the obtained image of the well plate 10 is subjected to image processing, and the boundary portion 35 (opening edge) that is an individual frame of the well 3 on the upper surface 21 of the well plate 10. Figure 5 shows the photograph of the wells were the taper and bottom center are visible).
Further taught by Ito is “a control unit configured to control an operation comprising:” (Page 5, control unit 7 (calculation means) that controls); “analyzing the detected marking to determine at least one feature being part of the marking or the marking itself,” (Page 9, the coordinate calculation unit 74 performs processing for obtaining the center coordinates of the well 3 (bottom portion 32) based on the recognition information of the well frame 35A (boundary portion 35) obtained in step 1.) “and determine a target position based on the determined at least one feature,” (Page 9, setting the x-axis coordinate and the y-axis coordinate so as to obtain the center of the square.); “wherein the target position is selected to be in spatial relationship to a center point of the opening” (Page 9, Since the hole 34 is located at the center of the bottom 32, the center coordinate formed by the intersection of the x-axis coordinate and the y-axis coordinate is located in the hole 34.); “and operating the needle drive to position the open end of the needle relative to the determined target position.” (Abstract and Page 2, in a state in which the tip (6) is positioned above an axial line for the central coordinates in a space above the well (3). Conventionally, at the time of the suction, the tip opening of the tip and the cell aggregate of the suction target are aligned with each other over the well plate, the tip is lowered.).
Regarding claim 2, modified Ito teaches all of claim 1 as above in addition to teaching “wherein the control unit is configured to correct for a deviation of an actual position of the open end of the needle from the determined target position by determining the deviation, and operating the needle drive to correct for the determined deviation.” (Page 5, 7 and 11, The cell moving device S includes a control unit 7 (calculation means) that controls the movement of the head unit 61 (which includes the tip opening), the positioning and raising/ lowering of the head 63, the suction and discharge operations of the cell aggregate C by the head 63, and the operation of the camera unit 5. The tip opening 6H of the chip 6 enters the well 3 having a small opening size, and the cell aggregate C is sucked. Therefore, very accurate positioning of the chip 6 is required. On the other hand, even if the setting position of the sorting container 1 on the stage is determined, the position of the well plate 10 varies depending on the deviation at the time of setting, the assembled state to the sorting container 1 and the like. Therefore, after the sorting container 1 is actually set on the stage, that is, after the installation position of the well plate 10 is determined, it is necessary to acquire an image of the well plate 10 and obtain the center coordinates of the well 3. The method for recognizing the top of a cell aggregate.)
Regarding claim 3, modified Ito teaches all of claim 1 as above in addition to “wherein the at least one feature has a defined spatial relationship to the opening of the receptacle, or to the opening of the receptacle and to the center point of the opening.” (Page 9, Since the hole 34 is located at the center of the bottom 32, the center coordinate formed by the intersection of the x-axis coordinate and the y-axis coordinate is located in the hole 34.). Therefore, the target position has a defined special relationship to the opening of the receptacle.
Regarding claim 4, modified Ito teaches all of claim 1 as above in addition to “wherein the target position is selected to be the center point of the opening.” (Page 9, Since the hole 34 is located at the center of the bottom 32, the center coordinate formed by the intersection of the x-axis coordinate and the y-axis coordinate is located in the hole 34.).
Regarding claim 5, modified Ito teaches all of claim 1 as above in addition to “comprising at least one of: the receptacle comprises at least one of: a container; a vial; a vessel; a tube; and a microtiter plate; the receptacle comprises a plurality of individual wells each for receiving and storing a fluid.” (Page 3,. The upper surface 21 is provided with a plurality of wells 3 that carry cell aggregates C.).
Regarding claim 6, modified Ito teaches all of claim 1 as above in addition to “comprising at least one of the marking is located on a surface of the receptacle; the marking is located on an upper surface of the receptacle; the marking is located on at least one of: a cap; a lid; a flap; a coverage; a foil; and a seal; the marking is located on a lower surface of the receptacle; the marking is located on a lateral surface of the receptacle.” (Fig 3, lines and square). The line and squares are on the receptacle which teaches to the markings are located on the receptacle.
Regarding claim 7, modified Ito teaches all of claim 1 as above in addition to “comprising at least one of: the detection unit comprises at least one of: an optical detection unit; a fluorescence detection unit; a phosphorescence detection unit; a magnetic detection unit; and a microwave detection unit; the detection unit is configured to detect the marking by providing at least one of: an image recognition; fluorescence imaging; reading dielectric barcodes; and reading magnetic structures; the detection unit is configured to detect the marking of the receptacle when the receptacle is located in a dedicated detection area of the fluid handling unit where the detection unit is capable of detecting the receptacle.” (Page 3 and 5, camera 5).The camera is an optical detection unit.
Regarding claim 8, modified Ito teaches all of claim 1 as above in addition to “comprising at least one of: the control unit is configured to operate the needle drive to position the open end of the needle relative to the determined target position above the receptacle; the control unit is configured to move the needle towards the marking to contact the determined target position with the open end of the needle; the control unit is configured to operate the needle drive to position the open end of the needle relative to the determined target position above the receptacle, and to move the needle towards the marking to contact the determined target position with the open end of the needle; the control unit is configured to operate the needle drive to position the open end of the needle into the receptacle for aspirating and/or dispensing the fluid.” (Page 5, The cell moving device S includes a control unit 7 (calculation means) that controls the movement of the head unit 61 (which includes the tip opening), the positioning and raising/ lowering of the head 63, the suction and discharge operations of the cell aggregate C by the head 63, and the operation of the camera unit 5. (The head drive unit 65 (a part of the nozzle drive means) and the head unit 61 for positioning raising and lowering the head 63 for the suction and discharge operations of the cell aggregate C by the head 63.).
Regarding claim 17, modified Ito teaches all of claim 2 as above in addition to “wherein determining the deviation comprises using at least one of: an image recognition; an optical measurement; a capacitive measurement; an inductive measurement.” (Page 7, After the sorting container 1 is actually set on the stage, that is, after the installation position of the well plate 10 is determined, it is necessary to acquire an image of the well plate 10 and obtain the center coordinates of the well 3.). Therefore, the acquired image teaches to the image recognition in the deviation correction.
Regarding claim 18, modified Ito teaches all of claim 1 as above in addition to “comprising at least one of: the needle drive comprises at least one of: a linear stage; an xyz-robot; a robot arm; and a manipulator; the needle drive is configured to immerse the needle into the receptacle. (Fig 1 and Page 5 and 7,- The head unit shaft drive unit 64 includes a drive motor that moves the head unit 61 (head body 62) along the guide rail 61R. It is possible to drive the head unit shaft driving unit 64 based on the position coordinate information of the well plate 10 and move the head unit 61 to the sky of the sorting container 1 (well plate 10). However, in this embodiment, the tip opening 6H of the chip 6 enters the well 3 having a small opening size, and the cell aggregate C is sucked.) Therefore, the guide rail 61R is the linear stage in addition the head unit which has the tip on it which is controlled by the needle drive to move in and out of the receptacle teaches to the needle drive configured to immerse the needle into the receptacle.
Regarding claim 19, modified Ito teaches all of claim 1 as above in addition to “wherein the at least one feature to be determined by the control unit is at least one of: a point; a middle point; one or more edges of a geometric object; a geometrical shape; a circle; a square; a rectangle; and a triangle.” (Page 5 and 11, The cell moving device S includes a control unit 7 (calculation means) that controls the movement of the head unit 61, the positioning and raising / lowering of the head 63, the suction and discharge operations of the cell aggregate C. The cell agglomerate Ci s sucked back to the well 3 at the second suction point.).
Regarding claim 21, modified Ito teaches all of claim 1 as above but Ito does not teach “comprising at least one of: the marking comprises at least one of: a fiducial; a fiducial mark; a barcode; a 2D barcode; an Aztec code; and a machine-readable label or marking; the marking is provided as at least one of: a label; a sticker; a tag; an RFID antenna. the marking is applied by at least one of: printing; stamping; and laser marking.”.
Rolf teaches “comprising at least one of: the marking comprises at least one of: a fiducial; a fiducial mark; a barcode; a 2D barcode; an Aztec code; and a machine-readable label or marking; the marking is provided as at least one of: a label; a sticker; a tag; an RFID antenna. the marking is applied by at least one of: printing; stamping; and laser marking.” (Page 14, By identifying the marking on the top or by visualizing the barcode contained on the sample container (102, 210, 211) or sample rack (103). 210, 211) and / or the type of sample contained in the input rack (103).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Ito to incorporate the teachings of Rolf the marking is a barcode. Doing so would allow the barcode to be removed and a new one affixed to the sample container in order to update sample information contained within the container in addition would allow the barcode to contain information about the sample contained within the sample container.
Regarding claim 22, modified Ito teaches all of claim 1 as above but Ito does not teach “wherein the marking contains at least one material selected from the group consisting of: an ink; a dye; a fluorescent dye; a dielectric material; a metal; a magnetic material; a polymer; a polarizable material; a molten polymer printing; and a material of different color than a surface of the receptacle.”.
Rolf teaches “wherein the marking contains at least one material selected from the group consisting of: an ink; a dye; a fluorescent dye; a dielectric material; a metal; a magnetic material; a polymer; a polarizable material; a molten polymer printing; and a material of different color than a surface of the receptacle.” (Page 13, Examples of the barcode printing means include any known printing methods such as ink jet, direct thermal sensitivity, thermal transfer, impact, laser ablation, and laser dye change.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Ito to incorporate the teachings of Rolf wherein the marking is of a ink material. Doing so provides a durable marking which is resistant to harsh chemicals and environments.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Inoue et. al. (WO 2014162921 A1), machine translation, and further in view of Ito (WO 2017110005 A1), machine translation and original document for figures, and Rolf et. al. (JP 2018136329 A), machine translation..
Regarding claim 10, Inoue teaches an autosampler for automatically injecting into a sample injection part of various analyzers in addition to “A chromatography system, comprising:” (Page 1, Analyzing devices that use an autosampler include liquid chromatographs); a mobile phase drive; (Page 12, the pump unit 1 for feeding the mobile phase to the column 5) ,a separation unit, (Page 12, This high-performance liquid chromatograph collects a sample from the column 5 for separating the sample). The recitation “wherein the mobile phase drive is configured for driving a mobile phase through the separation unit” is capability of the mobile phase drive. Inoue discloses the positively claimed structural elements of the mobile phase drive as claimed, such mobile phase drive are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Inoue already taught on page 12 the pump unit feeds the mobile phase into the column of the separation unit. The recitation “and the separation unit is configured for chromatographically separating compounds of a sample fluid in the mobile phase;” is capability of the separation unit. Inoue discloses the positively claimed structural elements of the separation unit as claimed, such separation unit is said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Inoue teaches a high-performance liquid chromatograph collects a sample from the column (separation unit) for separating the sample on page 12.
Inoue does not explicitly teach “and the fluid handling unit of claim 1,”.
Modified Ito teaches a fluid handling unit including picking up target objects in addition to “and the fluid handling unit of claim 1,” (taught within the page numbers listed within claim 1 rejection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of modified Ito wherein the fluid handling unit is that of claim 1 which the target objects are inorganic and organic liquids. Inoue teaches to the entire system including the autosampler similar to claim 1 in that it has a needle drive and moves in the xyz direction in addition to teaching the system part by being connected to a chromatograph. Modifying Inoue to incorporate the teachings of Ito’s fluid handling unit would allow for a handling unit with more accuracy and be able to select the exact part of the fluid sample to be further analyzed by the system. In addition, the fluid handling unit would allow for varying type of receptacles placed onto it which increases the versatility of the system as a hole.
Inoue teaches to a sample injection port for a liquid chromatography that discharges the sample sucked by the needle into the system of the analyzer on page 4 but does not explicitly teach “wherein the fluid is at least one of: the sample fluid to be injected into the mobile phase; and separated compounds of the sample fluid.”.
Ito teaches “wherein the fluid is at least one of: the sample fluid to be injected into the mobile phase; and separated compounds of the sample fluid.” (Page 2, The target objects are small electronic parts and mechanical parts, liquids such as organic or inorganic fragments and particles, pellets, eggs used in in vitro fertilization and IVF (in vitro fertilization)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Inoue to incorporate the teachings of Ito wherein the wherein the fluid is at least one of: the sample fluid to be injected into the mobile phase; and separated compounds of the sample fluid. Doing so would allow the liquid that is from the fluid handling unit to flow into the other parts of the system including the mobile phase of the chromatography system making it a complete system and allowing the sample liquid to flow through the entire thing.
Specification Amendments
Examiner maintains that amendments to Para [0097] within the specification were not provided.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered.
Applicant traverses the 102 rejection for claim 1. Applicant argues that Ito does not teach a “detection unit” or “control unit” configured in the manner recited in claim 1. Examiner maintains the 102 rejection for claim 1. Examiner maintains that the “detection unit” taught by Ito is the camera within (Page 3 and 5) and it is configured in the manner recited in claim 1 on (Page 8 and Figure 5) within the rejection. Examiner maintains the that the “control unit” configured in the manner recited in claim 1 is taught by Ito. The control unit is taught within (Page 5) and the “configured in a manner” recited in claim 1 is taught within (Page 9, 2, and Abstract).
Applicant argues that based on the foregoing claim 1 Ito does not read on claim 1 and is not anticipated by Ito. Examiner has withdrawn the 102 rejection and made a new 103 rejection based on claim amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798