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 .
Response to Amendment
The Amendment filed 08/06/2025 has been entered. Claims 1-5, 8-9, 11, 14-15, and 17-21 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
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 18-21 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 18, claim 18 recites “plate slots (110)” in line 2. It is unclear if the plate slots of claim 18 is the same or different from the plate slot of a working deck established in claim 1. How are the plate slots of claim 18 related to the plate slot of claim 1? Claims 19-21 are rejected by virtue of their dependency on claim 18.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-9, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ito (US 20160304821 A1) in view of Chernomorskey et al. (US 20140196550 A1), in view of Tang et al. (US 20130050692 A1), Uematsu et al. (US 20120309104 A1), Honkanen et al. (US 20040151628 A1), and Ahlfors (WO 2017221155 A1; cited in the office action filed 03/29/2024).
Regarding claim 1, Ito teaches a system (abstract, “subject moving device”) for a cell culture process performed in a biological laboratory system (“for a cell culture process…” is interpreted as an intended use of the system; Ito’s device, see abstract and Figs. 1-4, is capable of a cell culture process at a later time since the system comprises a microplate 90 that can be used for cell culture at a later time), the system comprising:
a plurality of components (see below) that are selected from a set of lab-ware (note that the BRI of “plurality of components” requires only two components from the set of lab-ware described below) comprising:
a second plate (Fig. 4, dispensing tip stocking section 22) suitable for holding a plurality of pipette tips (Fig. 4 and paragraph [0089] teaches dispensing tip stocking section 22 is capable of holding tips 80);
a lidded bottle (Fig. 4, paragraph [0057], interpreted as subject stocking section 21, which comprises box 211, tube 212, and a lid 213; paragraph [0057] teaches subject stocking section 21 stores liquid in which a cellular aggregate is dispersed, thus is interpreted as a bottle) for bulk supply of a solution or cell culture medium (paragraph [0057] teaches subject stocking section 21 stores liquid, thus is capable of bulk supply of a solution or cell culture medium at a later time);
a sixth plate (Fig. 4, cell selection section 23 comprising a dish 60) having a single well (paragraph [0061] and Figs. 4-5 teaches dish 60 includes a well plate 31 including a well formed from inclined plates 64 that has well plate 61 within the well);
a seventh plate (Fig. 4, cell transferring section 26 comprising microplate 90) comprising one or more storage wells holding said solution or cell culture medium (paragraph [0082] teaches the microplate has small wells, i.e. storage wells; paragraph [0112] teaches microplate is filled with cell culture solution and a reagent; paragraph [0130] teaches cellular aggregate is carried by microplate 90), being sealed by a foil and/or covered by a lid (paragraph [0082] teaches table lid member 262 is a lid member for covering and hiding the upper surfaces of the microplate 90; Fig. 28 shows an instance where a first black cover 271 covers microplate 90); and
wherein the plurality of selected components that are selected comprise at least the second plate (see above; Fig. 4, dispensing tip stocking section 22), the lidded bottle (Fig. 4, paragraph [0057], interpreted as subject stocking section 21, which comprises box 211, tube 212, and a lid 213), and the seventh plate (see above; Fig. 4, cell transferring section 26 comprising microplate 90), and
a process module (Figs. 1-2, interpreted as the overall moving device 1) having a liquid handling robot (Figs. 2 and 4, head unit 30; paragraph [0100] teaches head unit 30 functions to suctioning and dispensing),
wherein the lidded bottle (Fig. 4, paragraph [0057], interpreted as subject stocking section 21, which comprises box 211, tube 212, and a lid 213) is storable in a plate slot of a working deck of the process module (Fig. 4, shows subject stocking section 21 is storable in a slot between elements 12S, which is interpreted as part of a working deck of the overall moving device 1).
While Ito teaches there are demands for highly automated operations (paragraph [0005]), and it appears that Ito teaches the components have a similar size (Fig. 4 shows elements 22, 21, 23, and 26 within positioning members 12S having a relatively similar size), and a microplate (microplate 90), Ito fails to teach: wherein all of the plurality of components that are selected have a uniform footprint of a microplate having a width of 84.5 - 86.5 mm and a length of 126.8 - 128.8 mm; wherein the plurality of components that are selected comprise a fifth plate comprising a second plurality of compartments that hold one or more reagent bottles; a storage module with a first transfer interface that is in communication with a second transfer interface of the process module; and a robotic handling device configured to transfer the fifth plate with the one or more reagent bottles between the storage module and the process module; the lidded bottle has a volume of 50-500 mL and the uniform footprint of the microplate such that the lidded bottle is storable in the plate slot of the working deck of the process module.
Chernomorskey teaches a system for processing samples by a robotic platform comprising a tray that defines a well (abstract). Chernomorskey teaches automated robotic processes are utilized extensively in laboratory settings to improve accuracy, reliability, processing times, and allow an operator to be free to perform other tasks (paragraph [0001]). Chernomorskey teaches a tray and basket system for automatic robotic processing of embryos, such as loading and removing a tray and basket (paragraph [0031]). Chernomorskey teaches that the trays are typically configured to be similar or identical in outside dimensional size (length, width, thickness) to a standard microtiter plate, which allows the basket and tray system to be used easily with existing laboratory robotic processing systems (paragraph [0058]).
Since Chernomorskey teaches automated sample processing systems, similar to Ito, 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 the components of Ito to incorporate the teachings of identical dimensions of components of Chernomorskey (paragraph [0058]) and the teachings of components having a similar size of Ito (Fig. 4 shows elements 22, 21, 23, and 26 within positioning members 12S having a relatively similar size), to provide wherein all of the plurality of components that are selected have a uniform footprint of a microplate; and the lidded bottle has the uniform footprint of the microplate such that the lidded bottle is storable in the plate slot of the working deck of the process module. Doing so would have a reasonable expectation of successfully allowing for components to have a standard, identical size, to allow each component to be easily used with robotic processing systems for improved automation of the overall system as taught by Chernomorskey (paragraph [0058]).
Modified Ito fails to teach: wherein the plurality of components that are selected have the uniform footprint of the microplate having a width of 84.5 - 86.5 mm and a length of 126.8 - 128.8 mm; wherein the plurality of components that are selected comprise a fifth plate comprising a second plurality of compartments that hold one or more reagent bottles; a storage module with a first transfer interface that is in communication with a second transfer interface of the process module; and a robotic handling device configured to transfer the fifth plate with the one or more reagent bottles between the storage module and the process module; and the lidded bottle has a volume of 50-500 mL.
Tang teaches a presentation system for a sample for use in an analysis system (abstract), such as in conjunction with laboratory robotics for automated processing (paragraph [0014]). Tang teaches that it is desired for structures to be compatible with automated handlers, such as microplate stackers that use grippers (paragraph [0004]). Tang teaches the presentation system is suitable for use with existing analysis systems, in particular, automated systems having robotic components designed to transport microplates conforming to the standardized dimensions (paragraph [0044]). Tang teaches an adaptor of the presentation system is configured to receive standardized microplates, wherein the adapter has a rectangular microplate-like shape and may have dimensions around 127.8 mm long, 85.5 mm wide, and 14.4 mm thick (paragraph [0019]).
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 the components of modified Ito to incorporate the teachings of dimensions of microplates of Tang (paragraph [0019]), to provide wherein all of the plurality of components that are selected have the uniform footprint of the microplate having a width of 84.5 - 86.5 mm and a length of 126.8 - 128.8 mm. Doing so would utilize known dimensions of standard microplates, as taught by Tang, which would have a reasonable expectation of successfully being capable of being used for automated systems having robotic components, thus improving automation of the overall system.
Modified Ito fails to teach: wherein the plurality of components that are selected comprise a fifth plate comprising a second plurality of compartments that hold one or more reagent bottles; a storage module with a first transfer interface that is in communication with a second transfer interface of the process module; and a robotic handling device configured to transfer the fifth plate with the one or more reagent bottles between the storage module and the process module; and the lidded bottle has a volume of 50-500 mL.
Uematsu teaches a sample processing device capable of efficiently recovering biological molecules (abstract). Uematsu teaches the device comprises different plates or racks (Fig. 1), such as a reagent rack (3) comprising a plurality of compartments that hold multiple reagent bottles (Fig. 1 and paragraph [0057] shows multiple reagent bottles held in the reagent rack, which is interpreted as having multiple compartments or regions for each reagent bottle). Uematsu teaches the reagent rack accommodates different reagent bottles depending on specific types of processing performed on the samples (paragraph [0068]).
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 the system of modified Ito to incorporate the teachings of a reagent rack comprising a plurality of compartments that hold multiple reagent bottles of Uematsu (Fig. 1; paragraphs [0057],[0068]) to provide: wherein the plurality of components that are selected comprise a fifth plate comprising a second plurality of compartments that hold one or more reagent bottles. Doing so would have a reasonable expectation of successfully improving versatility of the system to perform specific types of processing on samples as discussed by Uematsu (paragraph [0068]).
Modified Ito fails to teach: a storage module with a first transfer interface that is in communication with a second transfer interface of the process module; and a robotic handling device configured to transfer the fifth plate with the one or more reagent bottles between the storage module and the process module; and the lidded bottle has a volume of 50-500 mL.
Honkanen teaches a high-throughput system for automatic retrieval of microplates from a carousel, i.e. a common storage module, and spotting biological materials on a substrate (title; abstract). Honkanen teaches duplicates of microplates stored in a carousel (Fig. 7 shows a microplate carousel comprising duplicates of microplates 721), wherein the carousel has a first transfer interface (interface of the control chamber 715 coupled to the frame 710) that is in communication with a second transfer interface (microplate end effector 755, microplate retainer 780 are coupled to the frame and in communication with the environmental control chamber via the frame 710 and the microplate robot 730) of a process module (gantry system 780 with a print assembly 790) to transfer microplates between the carousel to the process module (paragraph [0062]). Honkanen a robotic handling device (microplate robot 730) configured to transfer a plate between the storage module and the process module (paragraph [0062]). Honkanen teaches parallel engagement of multiple slides in parallel (paragraph [0063]). Honkanen teaches one or more environmental control chambers may be provided and be maintained at a temperature and/or humidity suitable for relatively longer term storage and prevent evaporation and degradation of probe materials (paragraph [0062]). Honkanen teaches the carousel and chamber are structurally connected to other elements (paragraph [0062]). Honkanen teaches a demand for devices capable of making larger number of spotted arrays in a reasonable time and an increase demand for greater automation of processes to increase reliability and accuracy (paragraph [0003]).
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 the system of modified Ito to incorporate the teachings of high-throughput systems including a storage module and robotic handling device of Honkanen (Fig. 7; paragraphs [0061]-[0063]) to provide: a storage module with a first transfer interface that is in communication with a second transfer interface of the process module; and a robotic handling device configured to transfer the fifth plate with the one or more reagent bottles between the storage module and the process module. Doing so would utilize known structures of systems for storage and manipulation of plates, as taught by Honkanen (Fig. 7; paragraphs [0061]-[0063]), which would have a reasonable expectation of successfully increasing and improving throughput of the overall system, allowing for improved automation to increase reliability and accuracy of processing of plates, such as between a storage module and process module, and improve storage of the one or more reagent bottles.
Modified Ito fails to teach: the lidded bottle has a volume of 50-500 mL.
Ahlfors teaches a system for automated cell processing of biological samples (abstract). Ahlfors teaches robotically transports materials into and out of the enclosure (paragraph [0032]), robotic aspirators and dispensers (paragraph [0035]), autoclavable tip holders with system-closable lids, i.e., lids that can be opened and closed using robotic systems (paragraph [0042]), and robotic handling of various types of cell processing containers 314 including trays, flasks, bottles, tubes and vials (paragraph [00152]). Ahlfors teaches that various holders for tubes, bottles, pipettes, plates, etc. are specially designed to allow their manipulation (such as transport, decapping and capping) by universal gripping by several types of robotic arms (paragraph [00167]). Ahlfors teaches lidded bottles (Fig. 16; paragraph [00247]). Ahlfors teaches a 50mL tube (paragraphs [00321]-[00325]), and decapping a container, such as 50 mL tubes, 100mL or 125 mL flasks, and the like, to retrieve a desired volume using a robotic pipettor (paragraph [00377]).
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 the lidded bottle of modified Ito to incorporate the teachings of lidded containers volumes for automated cell processing of Ahlfors (paragraphs [00321]-[00325],[00377]) to provide: the lidded bottle has a volume of 50-500 mL. Doing so would have a reasonable expectation of successfully allowing for a desired of volume to be fluid to be stored, handled, and processed by the analysis device as taught by Ahlfors (paragraph [00377]).
Additionally, since Ahlfors teaches volumes of containers of 50mL, 100mL and 125 mL (paragraphs [00321]-[00325],[00377]), wherein the claimed range of 50-500 mL overlap with the volumes disclosed by Ahlfors, it would have been obvious to one of ordinary skill in the art to have modified the lidded bottle of modified Ito to provide the lidded bottle has a volume of 50-500 mL. I.e., it would have been prima facia obvious to have selected the overlapping portion of the range from the taught range of volumes of Ahlfors (paragraphs [00321]-[00325],[00377]) (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05 (I)).
Note that the BRI of “plurality of components” requires only two components from the set of lab-ware claimed, wherein the claim requires the plurality of components to include at least the second plate, lidded bottle, fifth plate, and the seventh plate. Therefore, the first plate, third plate, fourth plate, and sixth plate are interpreted as not required under BRI of the “plurality of components”.
Regarding claim 2, Ito further teaches wherein one or more of the first, second, third, fourth, fifth, sixth and seventh plates are placed into respective plate slots (Figs. 2 and 4 teaches elements 22, 23, and 26 placed into spaces between positioning members 12S, which are interpreted as plate slots) of a working deck (Fig. 2 shows a cell moving line 20 comprising the positioning members 12S, where the cell moving line 20 is interpreted as the working deck) of the process module (Figs. 1-2, interpreted as the overall moving device 1).
Note that the BRI of “two or more components” of claim 1 requires only two components from the set of lab-ware claimed. As discussed above, Ito teaches the two or more components comprising at least the “a second plate”, “a sixth plate”, and “a seventh plate”.
Regarding claim 3, modified Ito fails to teach wherein a plurality of duplicates of at least one of the first, second, third, fourth, fifth, sixth and seventh plates are stored in the storage module having the first transfer interface that is in communication with the second transfer interface of the process module for transfer of at least one of the first, second, third, fourth, fifth, sixth and seventh plates between the storage module and the process module.
Honkanen teaches a high-throughput system for automatic retrieval of microplates from a carousel, i.e. a common storage module, and spotting biological materials on a substrate (title; abstract). Honkanen teaches duplicates of microplates stored in a carousel (Fig. 7 shows a microplate carousel comprising duplicates of microplates 721), wherein the carousel has a first transfer interface (interface of the control chamber 715 coupled to the frame 710) that is in communication with a second transfer interface (microplate end effector 755, microplate retainer 780 are coupled to the frame and in communication with the environmental control chamber via the frame 710 and the microplate robot 730) of a process module (gantry system 780 with a print assembly 790) to transfer microplates between the carousel to the process module (paragraph [0062]). Honkanen a robotic handling device (microplate robot 730) configured to transfer a plate between the storage module and the process module (paragraph [0062]). Honkanen teaches parallel engagement of multiple slides in parallel (paragraph [0063]). Honkanen teaches a demand for devices capable of making larger number of spotted arrays in a reasonable time and an increase demand for greater automation of processes to increase reliability and accuracy (paragraph [0003]).
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 the system of modified Ito to incorporate the teachings of high-throughput systems comprising duplicates of plates of Honkanen (Fig. 7; paragraphs [0062]-[0063]) to provide: wherein a plurality of duplicates of at least one of the first, second, third, fourth, fifth, sixth and seventh plates are stored in the storage module having the first transfer interface that is in communication with the second transfer interface of the process module for transfer of at least one of the first, second, third, fourth, fifth, sixth and seventh plates between the storage module and the process module. Doing so would have a reasonable expectation of successfully increasing and improving throughput of the overall system while allowing for improved automation to increase reliability and accuracy of processing of various plates.
Regarding claim 4, note that the BRI of “plurality of components that are selected from a set of lab-ware” of claim 1 requires only two components from the set of lab-ware claimed. Thus, since Ito teaches the two or more components being “a second plate”, “a lidded bottle”, “a sixth plate”, and “a seventh plate” as discussed above, the following limitations are interpreted as not being required: an eighth plate with a surface treated for cell adhesion, wherein the eighth plate is a single well plate, or has a growth area of at least 60cm2.
If applicant desires for the eighth plate to be positively recited structurally, it is suggested to recite “the plurality of components that are selected further comprise the eighth plate…”
Regarding claim 5, Ito further teaches wherein the sixth plate (Fig. 4, cell selection section 23 comprising a dish 60; paragraph [0061] and Figs. 4-5 teaches dish 60 includes a well plate 31 including a well formed from inclined plates 64 that has well plate 61 within the well) is used as a reservoir for a liquid medium (Figs. 4-5 and paragraph [0117] teaches the dish 60 has a structural well, and a solution is dispensed into dish 60, thus the dish 60 is capable of being used as a reservoir for a liquid medium at a later time).
Regarding claim 8, modified Ito fails to teach wherein one or more of said components comprise means for identifying said components or reagents stored therein, the means for identifying comprising a radio frequency identification (RFID)-tag or a Barcode.
Honkanen teaches automatic retrieval of a plurality of well plates from a carousel (paragraph [0006]). Honkanen teaches using a bar code reader, the system ensures that user has correctly loaded the identified microplate into a corresponding carousel slot prior to depositing probes from the microplate onto slides; wherein, a barcode on a surface of a microplate allows a microplate to be uniquely identified to executables (paragraph [0060]). Honkanen teaches employing a barcode or other machine-readable indicators for identifying microplates for processing (paragraph [0068]). Honkanen teaches a demand for devices capable of making larger number of spotted arrays in a reasonable time and an increase demand for greater automation of processes to increase reliability and accuracy (paragraph [0003]).
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 the one or more said components of modified Ito to incorporate the teachings of barcodes for identifying elements of a system of Honkanen (paragraphs [0060],[0068]) to provide wherein one or more of said components comprise means for identifying said components or reagents stored therein, the means for identifying comprising a radio frequency identification (RFID)-tag or a Barcode. Doing so would have a reasonable expectation of successfully increasing and improving throughput of the overall system while allowing for improved automation to increase reliability and accuracy of microplate processing via employing indicators for identifying and tracking the components (Honkanen, paragraphs [0003],[0060],[0068]).
Regarding claim 9, Ito further teaches wherein the at least one of the first, second, third, fourth, fifth, sixth and seventh plates further comprise one or more recesses or protrusions in a side wall, an end face or an underside (Fig. 4, the sixth plate, interpreted as cell selection section 23 that comprising a dish 60 comprises a recesses or protrusion under element 631, see below annotated Fig. 5).
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Annotated Fig. 5 of Ito: Arrows pointing to the claimed “recess” or “protrusion” in a side wall, end face, or an underside of dish 60, which is interpreted as part of the “sixth plate”.
Regarding claim 17, modified Ito further teaches wherein the system comprises four, five, six, seven or eight of the components that are selected from the set of lab-ware (see above claim 1; modified Ito teaches “a second plate”, “a lidded bottle”, “fifth plate”, “a sixth plate”, and “a seventh plate” from the set of lab-ware listed, i.e. five of the components that are selected from the set of lab-ware).
Regarding claim 18, modified Ito fails to teach the system further comprising modules comprising racks with plate slots, the modules being configured to store the plurality of components that are selected.
Honkanen teaches a high-throughput system for automatic retrieval of microplates from a carousel, i.e. a common storage module, and spotting biological materials on a substrate (title; abstract). Honkanen teaches modules (Fig. 7, interpreted as chamber 715 and carousel 720, which comprises multiple levels of racks) comprising racks with plate slots (Fig. 7, paragraph [0067] teaches a carousel with slots for microplates) for storing one or more of the first, second, third, fourth, fifth, sixth and seventh plates (Fig. 7). Honkanen teaches microplates stored in a carousel (Fig. 7 shows a microplate carousel comprising microplates 721), wherein the carousel has a first transfer interface (interface of the control chamber 715 coupled to the frame 710) that is in communication with a second transfer interface (microplate end effector 755, microplate retainer 780 are coupled to the frame and in communication with the environmental control chamber via the frame 710 and the microplate robot 730) of a process module (gantry system 780 with a print assembly 790) to transfer microplates between the carousel to the process module (paragraph [0062]). Honkanen teaches automatic retrieval of a plurality of well plates from a carousel (paragraph [0006]). Honkanen teaches a demand for devices capable of making larger number of spotted arrays in a reasonable time and an increase demand for greater automation of processes to increase reliability and accuracy (paragraph [0003]).
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 the system of modified Ito to incorporate the teachings of high-throughput systems having racks with plate slots of Honkanen (Fig. 7; paragraphs [0006],[0062],[0067]) to provide: the system further comprising modules comprising racks with plate slots, the modules being configured to store the plurality of components that are selected. Doing so would have a reasonable expectation of successfully increasing and improving throughput of the overall system while allowing for storage of a plurality of plates to improved automation and to increase reliability and accuracy of plate processing.
Regarding claim 19, modified Ito further teaches wherein the racks are situated on a carousel (see above claim 18; Honkanen, Fig. 7, teaches microplates in slots, i.e. racks, on a carousel 720), wherein a center of the carousel is open and forms a center well (Honkanen, Fig. 7 shows the center of carousel 720 is open and forms a center well), and wherein the plate slots are arranged such that respective edges of the plate slots all face towards the center well (Honkanen, Fig. 7).
Claims 11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ito in view of Chernomorskey ,Tang, Uematsu, Honkanen, and Ahlfors as applied to claim 1 above, and further in view of Fritchie et al. (US 20090117620 A1; cited in the IDS filed 02/27/2024) and Vansickler et al. (WO 2017184244 A1).
Regarding claim 11, while Ito teaches demands for highly automating series of operations (paragraph [0005]), modified Ito fails to teach: wherein the robotic handling device includes an end effector having at least two parallel fingers being movable in a horizontal direction towards each other, or a handling means comprising a gripper plate , wherein the fingers or the gripper plate have one or more protrusions or recesses that match with recesses or protrusions of the first, second, third, fourth, fifth, sixth or seventh plates, wherein the one or more protrusions or recesses of the fingers or the gripper plate are conical or pyramidal in shape.
Fritchie teaches a laboratory automation system capable of carrying out assays employing microwell plates (abstract). Fritchie teaches the system further comprising a robotic handling device (paragraph [0091] teaches a robotic system) that includes: an end effector (Fig. 9B and paragraph [0091] teaches gripping devices 92) having at least two parallel fingers (Figs. 9A-9B, gripping devices 92) being movable in a horizontal direction towards each other (paragraph [0091]), or a handling means comprising a gripper plate (Figs. 9A-9B, interpreted as the gripping devices 92, which are plate shaped) , wherein the fingers or the gripper plate have one or more protrusions or recesses (Figs. 9A-9B shows elements 92 has conical or pyramidal protrusions), wherein the one or more protrusions or recesses of the fingers or the gripper plate are conical or pyramidal in shape (Figs. 9A-9B shows elements 92 has conical or pyramidal protrusions). Fritchie teaches the robotic system is capable of gripping containers and microwell plates (paragraph [0091]). Fritchie teaches the robotic mechanism can grip a micro-well plate, raise and lower the micro-well plate vertically, and rotate the micro-well plate while it is being transported (paragraph [0095]). Fritchie teaches the system with a gripping device can enhance the automated features of the system (paragraph [0144]). Fritchie teaches typically, such a robotic device selects a micro-well plate, grips the micro-well plate, raises the micro-well plate, transfers the micro-well plate to the area where it is required to be placed, and then places the micro-well plate in the appropriate position (paragraph [0209]). Fritchie teaches transfer of containers can be effected with little difficulties by an automated robotic mechanism (paragraph [0015]).
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 the system of modified Ito to incorporate the teachings of automated structures of robotic devices of Fritchie (paragraphs [0091],[0095],[0209]; Figs. 9A-9B) to provide: wherein the robotic handling device includes an end effector having at least two parallel fingers being movable in a horizontal direction towards each other, or a handling means comprising a gripper plate , wherein the fingers or the gripper plate have one or more protrusions or recesses that match with recesses or protrusions of the first, second, third, fourth, fifth, sixth or seventh plates, wherein the one or more protrusions or recesses of the fingers or the gripper plate are conical or pyramidal in shape. Doing so would have a reasonable expectation of successfully allowing for automated transferring and positioning of components of the system, thus improving overall efficiency and automation of the system (Fritchie, paragraphs [0015],[0144]).
Modified Ito fails to teach the one or more protrusions or recesses match with recesses or protrusions of the first, second, third, fourth, fifth, sixth or seventh plates.
Vansickler teaches an automated analyzer comprising a robotic arm comprising an end effector with fingers, wherein the fingers comprises engagement features that project from the fingers and are configured to engage recesses of an article such that the robotic arm can carry the article when the engagement features engage with the article (abstract). Vansickler teaches the engagement features are sized to fit within engagement notches of plates (paragraph [0110]). Vansickler teaches engagement features extend into the notches or openings of the corresponding consumable item preventing the consumable item from falling while fingers clamp to the consumable item and helps prevent inadvertent rotation of the consumable item within the fingers' grasp (paragraph [0110]). Vansickler teaches automatically handling consumables such as pipette tips, sample containers, sample container shuttles, processing plates, dry reagent plates, liquid reagent plates, and amplification cartridges (paragraph [0058]).
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 the one or more protrusions or recesses of modified Ito to incorporate the teachings of engaging corresponding notches of plates of Vansickler (paragraph [0110]) to provide: the one or more protrusions or recesses match with recesses or protrusions of the first, second, third, fourth, fifth, sixth or seventh plates. Doing so would have a reasonable expectation of successfully improving gripping and transferring of components by preventing a consumable from falling during gripping and helping to prevent inadvertent rotation of the consumable item within the fingers' grasp as taught by Vansickler (paragraph [0110]), thus improving automation of the overall system.
Regarding claim 14, modified Ito fails to teach wherein the fingers or the gripper plate extends at least half of a length of each of the lab-ware from the set of lab-ware and/or the robot handling device further comprises positioning means upwardly extending toward each of the lab-ware when in a handling position, the positioning means being shaped to orientate each of the lab-ware on the gripper plate being formed by a tray.
Fritchie teaches gripping devices, whereby a micro-well plate can be gripped between the paddle-shaped gripping devices, and the micro-well plate can be gripped via either the two longer sides of the micro-well plate or by the two shorter sides of the micro-well plate (paragraph [0093]). Fritchie teaches embodiments where the size and shape of the adapters can substantially conform to the shape of a container (paragraph [0093]). Fritchie teaches an embodiment of fingers extending at least half the length of a lab-ware (Figs. 9C-9D).
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 the fingers or gripper plate of modified Ito to incorporate the teachings of gripping devices of Fritchie (paragraph [0093]; Figs. 9C-9D) to provide: wherein the fingers or the gripper plate extends at least half of a length of each of the lab-ware from the set of lab-ware. Doing so would have a reasonable expectation of successfully improving conforming the shape of the gripper to a desired element to be gripped, thus improving gripping of a desired component.
Note that the limitation of “the robot handling device further comprises positioning means upwardly extending toward each of the lab-ware when in a handling position, the positioning means being shaped to orientate each of the lab-ware on the gripper plate being formed by a tray” is interpreted as an optional limitation due to the “and/or” statement. Since modified Ito teaches “wherein the fingers or the gripper plate extends at least half of a length of each of the lab-ware from the set of lab-ware”, modified Ito teaches the limitations of claim 14.
Regarding claim 15, modified Ito fails to teach the system of claim 11, further comprising a radio frequency identification (RFID)-reader or a proximity sensor.
Fritchie teaches radio frequency identification tags, conforming to the guidelines of ISO 14443 or ISO 15693 and ISO 18000, are positioned on the items of interest, such as, for example, reagent containers, sample containers, and micro-well plates (paragraph [0013]), and the use of radio frequency identification technology provides faster and more reliable readings than do barcodes, and further eliminates the hazards associated with laser scanning devices; thus enabling tracking of micro-well plates from the initial dispensing of samples and reagents to the final reading of results from the plates (paragraph [0013]).
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 the system of modified Ito to incorporate the teachings of identification tags of Fritchie (paragraph [0013]) to provide the system of claim 11, further comprising a radio frequency identification (RFID)-reader or a proximity sensor. Doing so would have a reasonable expectation of successfully improving automation of the overall system by allowing tracking of components of the system during processing (Fritchie, paragraph [0013]).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ito in view of Chernomorskey, Tang, Uematsu, Honkanen, and Ahlfors as applied to claim 19 above, and further in view of Haas (US 7013198 B2; cited in the IDS filed 12/15/2021).
Regarding claim 20, while Honkanen teaches a robotic device (Fig. 7, microplate robot 730) comprising a robot arm to transfer a microplate to and from a microplate retainer (Fig. 12; paragraph [0069]) and that numerous designs may be employed in other implementations of the carousel (paragraph [0067]), modified Ito fails to teach wherein the robotic handling device is positioned in the center well, and includes a robot arm with a grabber configured to reach into one or more of the plate slots.
Haas teaches a storage carousel and retrieval apparatus including a robotic device capable of gripping items stored in the apparatus and delivering the item to a separate, proximate instrument (abstract; Figs. 1-3). Haas teaches the robotic device is located within a core of the carousel and is operable to access the microplates from racks to deliver them to selected workstations (column 3, lines 44-59). Haas teaches that conventional carousel apparatus for storage and an robotic device in the vicinity of the carousel has a disadvantage, such as requiring an additional degree of motion which create a designated area within a system where the robotic device can operate without interference, thus requiring additional space which is undesirable (column 1, lines 25-53). Haas teaches the object of the instant invention is to mitigate disadvantages of conventional carousel apparatus, and thus employs a robotic device within the core of a carousel (column 2, lines 21-39). Haas teaches the instant invention is a compact, flexible, and efficient storage carousel that can be easily integrated into a general system, wherein the overall footprint of installation is reduced (column 5, lines 5-19).
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 the robotic handling device of modified Ito to incorporate the teachings of a centrally located robotic device within a carousel of Haas (Figs. 1-3; column 3, lines 44-59; column 2, lines 21-39) to provide: wherein the robotic handling device is positioned in the center well, and includes a robot arm with a grabber configured to reach into one or more of the plate slots. Doing so would have a reasonable expectation of successfully allowing for transferring and processing of components while improving compactness, flexibility, and efficiency of storing plates as taught by Haas (column 2, lines 21-39; column 5, lines 5-19)
Regarding claim 21, modified Ito further teaches wherein the carousel is configured to rotate about a central axis (see above claim 19; Honkanen, Fig. 7, teaches microplates in slots, i.e. racks, on a carousel 720, wherein paragraph [0007] teaches the carousel is rotatable), and wherein the robotic handling device is further configured to face and move horizontally in a direction of the first transfer interface (see above claim 20; Haas, Fig. 5 shows robotic device 16 comprising an arm 64 that is capable of facing and moving horizontally in a direction of a transfer interface, e.g. element 18 or 22).
Response to Arguments
Applicant’s arguments, see pages 6-10, filed 08/06/2025, specifically regarding the new limitation of “the lidded bottle has a volume of 50-500 mL and the uniform footprint of the microplate…”, 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: Ito (US 20160304821 A1) in view of Chernomorskey et al. (US 20140196550 A1), in view of Tang et al. (US 20130050692 A1), Uematsu et al. (US 20120309104 A1), Honkanen et al. (US 20040151628 A1), and Ahlfors (WO 2017221155 A1; cited in the office action filed 03/29/2024).
In response to applicant’s argument that the stocking section 21 of Ito is not a “lidded bottle” (Remarks, pages 7-8), the examiner disagrees. The claimed “lidded bottle” does not exclude the presence of additional elements. Ito’s subject stocking section 21, which comprises box 211, tube 212, and a lid 213, reads on the BRI of a “lidded bottle”, i.e. the “lidded bottle” is interpreted as Ito’s subject stocking section 21, which comprises box 211, tube 212, and a lid 213.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, specifically in view of Chernomorskey, Tang, Uematsu, and Honkanen (Remarks, pages 8-9), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Chernomorskey provides teachings of trays are typically configured to be similar or identical in outside dimensional size (length, width, thickness) to a standard microtiter plate (paragraph [0058]). Chernomorskey provides motivation that the identical sized components allows the basket and tray system to be used easily with existing laboratory robotic processing systems (paragraph [0058]). Ito further provides suggestions of similar sized elements and microplate (Fig. 4 shows elements 22, 21, 23, and 26 within positioning members 12S having a relatively similar size).
Since Chernomorskey teaches automated sample processing systems, similar to Ito, it would have been obvious to one of ordinary skill in the art to have modified the components of Ito to incorporate the teachings of identical dimensions of components of Chernomorskey (paragraph [0058]) and the teachings of components having a similar size of Ito (Fig. 4 shows elements 22, 21, 23, and 26 within positioning members 12S having a relatively similar size), to provide wherein all of the plurality of components that are selected have a uniform footprint of a microplate; and the lidded bottle has the uniform footprint of the microplate such that the lidded bottle is storable in the plate slot of the working deck of the process module. Doing so would have a reasonable expectation of successfully allowing for components to have a standard, identical size, to allow each component to be easily used with robotic processing systems for improved automation of the overall system as taught by Chernomorskey (paragraph [0058]).
Therefore, there is at least some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed components, and the lidded bottle, having a uniform footprint of a microplate in view of Chernomorskey and Ito.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758