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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ground guide rail, air guide rail and automatic guided vehicle recite in claim 3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Applicant discloses that claimed liquid operation system “may” include a storage compartment 301, a central operation compartment 302, and at least one liquid operation compartment 303.
In an embodiment according to the present disclosure, the liquid operation system 3 may be a full-automatic liquid operation system.
For purposes of examination the liquid operation system will be interpreted as any structural element(s) or combination of structural elements that can manage liquids in a system for evaluating biological drugs.
Applicant discloses that the sample detection platform “may” be provided with: a high performance liquid chromatograph 501 to perform HPLC detection; a mass spectrometer 504 to
perform mass spectrometry detection; an ELISA analyzer 503 to perform ELISA analyzer detection; and a capillary electrophoresis apparatus or gel electrophoresis apparatus 502 to perform capillary electrophoresis or gel electrophoresis detection.
For purposes of examination the sample detection platform will be interpreted as including any one or more of a high performance liquid chromatograph; a mass spectrometer; an ELISA; and a capillary electrophoresis apparatus or gel electrophoresis apparatus 502.
The claimed transfer platform is disclosed as is used for transferring the biological samples between the incubator and the liquid operation system and/or between the liquid operation
system and the sample detection platform, and comprising at least one of a cultured material transfer platform for transferring cultured biological samples between the incubator and the liquid operation
system and a test sample transfer platform for transferring biological samples to be detected between the liquid operation system and the sample detection platform
For purposes of examination the transfer platform will be interpreted as any structural element(s) or combination of structural elements that can transport/move samples between different areas of a system for evaluating biological drugs.
Applicant discloses that the laminar flow unit “may” be configured to form a laminar flow environment inside the liquid operation system 3 with a pressure difference, and “may” may include a laminar air-supply unit.
For purposes of examination the laminar flow unit will be interpreted as any structural element(s) or combination of structural elements that can provide laminar flow of liquid operation system (interpreted above).
Applicant discloses that the laminar air-supply unit “may” include an air-supply device, such as a blower or a centrifugal fan, which can send gases from an environment or a dedicated gas source into the interior of the liquid operation system 3 in the form of laminar flow.
For purposes of examination the laminar air-supply unit will be interpreted as any structural element(s) or combination of structural elements that can supply a gas to provide laminar flow of liquid operation system (interpreted above).
The claimed laminar air-return unit is disclosed as filtering and recycling gases within the liquid operation system.
For purposes of examination the laminar air-return unit will be interpreted as any structural element(s) or combination of structural elements that can filter and recycle gas to the liquid operation system (interpreted above).
The claimed consumable loading channel is shown in Figs. 7, 8a and 10, but not structurally described in detail.
For purposes of examination the consumable loading channel will be interpreted as any structural element(s) or combination of structural elements that provide for moving consumables (e.g., shake flasks, shake tubes, orifice plates, etc.) in a test sample transfer platform for transferring biological samples to be detected between the liquid operation system and the sample detection platform
The claimed sample loading channel is shown in Figs. 8a and 9 but not structurally described in detail.
For purposes of examination the sample loading channel will be interpreted as any structural element(s) or combination of structural elements that provide for moving biological samples in a test sample transfer platform for transferring biological samples to be detected between the liquid operation system and the sample detection platform
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1, 2, 10, 15 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chinese Patent Application Publication No. CN108611271 to Zhu (cited by applicant)
Zhu teaches full-closed type intelligent biological production system and a production method. The system comprises a shell, wherein a central motion bin (“transfer platform”), a liquid operation bin (“system”), a culture unit, a production quality detection bin (sample detection platform), a material feeding bin and a material discharging bin are arranged in the shell. (Abstract)
Zhu teaches a culture unit that comprises an incubator and a culture container storage module. (page 4, 1st paragraph, English Translation)
Zhu teaches a detection module that comprises an image detecting device and a flow cytometer, wherein the image detecting device acquires an image of the biological culture and performs image analysis; and the flow cytometer acquires the biological culture for analysis and sorting. (page 4, 7th paragraph, English Translation) This teaching reads on detection and screening of biological products. Note, Zhu teaches producing new drugs. (page 2, 2nd paragraph, English translation)
Zhu teaches that the system comprises a server (automatic control system) for storing data and controlling the flow of the flow between the isolation unit, the culture unit, the centrifugal transfection unit and the collection unit. (page 4, last paragraph, English translation).
I.) Regarding applicant’s claim 1 Zhu teaches all the elements of claim 1.
Therefore Zhu anticipates claim 1.
II.) Regarding applicant’s claim 2, as noted above Zhu anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the transfer platform comprises at least one of a cultured material transfer platform for transferring cultured biological samples between the incubator and the liquid operation system and a test sample transfer platform for transferring biological samples to be detected between the liquid operation system and the sample detection platform.
Zhu teaches an “operations unit” that performs transportation of patient cell sample between different work modules. (page 7, 3rd full paragraph, English translation).
Therefore, Zhu anticipates claim 2.
III.) Regarding applicant’s claim 10, as noted above Zhu anticipates claim 1 from which claim 10 depends.
Claim 10 recites liquid operation system is placed in a controlled laminar flow environment, so that an internal environment of the liquid operation system is isolated from its external environment.
Zhu teaches laminar flow systems of each compartment and housings (cabins) for each compartment. (page 7, last paragraph; page 3, 3rd paragraph, English translation)
Therefore, Zhu anticipates claim 10.
IV.) Regarding applicant’s claim 15, as noted above Zhu anticipates claim 1 from which claim 15 depends.
Claim 15 recites a storage compartment, a central operation compartment and at least one liquid operation compartment, wherein the storage compartment is used for storing consumables to support continuous operations of the system for expression, purification, and detection and screening of biological drugs, and the central operation compartment and the liquid operation compartment are used for implementing different operations on the biological samples.
Zhu teaches a liquid operating compartment and a waste storage module is configured to store used consumables and medicaments. (page 13, 2nd paragraph and page 4, 6th paragraph, English translation)
Therefore, Zhu anticipates claim 15.
V.) Regarding applicant’s claim 41, as noted above Zhu renders claim 1 obvious from which claim 41 depends.
Claim 41 recites that the sample detection platform is configured to perform at least one of following operations: chromatographic sample preparation, high performance liquid chromatography detection, mass spectrometry detection, gel electrophoresis detection, ELISA analyzer detection, and endotoxin detection, and wherein the sample detection platform is equipped with at least one of following detection devices: a high performance liquid chromatograph, a mass spectrometer, a ELISA analyzer, a gel electrophoresis apparatus, an endotoxin detector, a counter, an imager and a real-time fluorescence quantitative analyzer.
Zhu teaches detecting the obtained cells and classifying and transferring the cells which renders the use of an analyzer obvious. (English Abstract).
Zhu further teaches that the detection module comprises an image detecting device and a flow cytometer, wherein the image detecting device acquires an image of the biological culture and performs image analysis; and the flow cytometer acquires the biological culture for analysis and sorting. (page 4, 7th paragraph, English translation)
Therefore, Zhu anticipates claim 41.
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.
2. Claims 3, 16, 19, 21, 25, 29, 31, 32 and 37 are rejected under 35 USC 103 as being unpatentable over Zhu.
I.) Regarding applicant’s claim 3, as noted above Zhu anticipates claim 2 from which claim 3 depends.
Claim 3 recites at least one of the cultured material transfer platform and the test sample transfer platform comprises a robot, and wherein the robot is disposed on any one of a ground guide rail, an air guide rail and an automatic guided vehicle.
Zhu teaches that the operation unit includes six degrees of freedom A GMP-compliant robot, a linear motor module, and a jaw connected to the six-degree-of-freedom GMP-compliant robot, the linear motor module being coupled to the six-degree-of-freedom GMP-compliant robot. (page 3, last paragraph, English translation).
While Zhu does not specifically teach that the robot is disposed on any one of a ground guide rail, an air guide rail and an automatic guided vehicle.
Zhu’s teaching of a linear motor module renders it obvious to provide a guide rail for linear motion of the robot in the form of a ground guide rail or an air guide rail. (page 3, last paragraph, English translation)
Therefore, Zhu renders claim 3 obvious.
II.) Regarding applicant’s claim 16, as noted above Zhu anticipates claim 15 from which claim 16 depends.
Claim 16 recites that the liquid operation system comprises two liquid operation compartments disposed at two sides of the central operation compartment respectively and configured to be able to perform operation independent of each other as well as perform operation in parallel; wherein the storage compartment comprises a consumable loading channel and a sample loading channel independent of each other, so as to realize parallel loading of consumables and the biological samples; and wherein the consumable loading channel and the sample loading channel extend in directions perpendicular to each other respectively.
As noted above Zhu teaches a liquid operation compartment and a storage compartment for consumables, but does not teach two liquid operation compartments disposed at two sides of the central operation compartment respectively and configured to be able to perform operation independent of each other as well as perform operation in parallel; wherein the storage compartment comprises a consumable loading channel and a sample loading channel independent of each other, so as to realize parallel loading of consumables and the biological samples; and wherein the consumable loading channel and the sample loading channel extend in directions perpendicular to each other respectively.
It would have been obvious to one of ordinary skill in the art to modify Zhu to include two liquid operation compartment, since mere duplication of parts has no patentable significance unless a new and unexpected result is produced. (See MPEP2144.04 (VI)(B)).
Further, it would have been obvious to arrange the two liquid operation compartments and storage for consumable in any convenient manner in relationship to loading areas (channels) for each since the arrangement of parts has been held to be an obvious matter or design choice. (See MPEP 2144.04 (VI)(C)).
Therefore, Zhu renders claim 16 obvious.
III.) Regarding applicant’s claim 19, as noted above Zhu renders claim 16 obvious from which claim 19 depends.
Claim 19 recites that the consumable loading channel is provided therein with a robot transfer unit including a transfer robot, and wherein the transfer robot is arranged on a slide rail extending along the consumable loading channel and is slidable on the slide rail.
As noted above, Zhu teaches that the operation unit includes six degrees of freedom A GMP-compliant robot, a linear motor module. Zhu further teaches a consumable storage module, a material transfer compartment, a material entry compartment and a material delivery compartment. (page 13, 2nd paragraph; page 3, 3rd paragraph, English translation)
It would have been obvious to modify Zhu to provide a consumable loading area (“channel”) with the robot transfer unit including a transfer robot, and arrange the transfer robot on a slide rail (in view of Zhu teaching a linear motion module for the robot) extending along the consumable loading channel and is slidable on the slide rail.
Therefore, Zhu renders claim 19 obvious.
IV.) Regarding applicant’s claim 21, as noted above Zhu renders claim 19 obvious from which claim 21 depends.
Claim 21 recites a continuous loading unit is provided in the vicinity of the consumable loading channel, and the continuous loading unit is constructed in the form of a continuous loading turntable to realize continuous loading and unloading of the consumables, and wherein the continuous loading unit comprises an annular transmission element and consumable transfer trays disposed on the annular transmission element, and the transfer robot is configured to transfer the consumables onto the consumable transfer trays and/or transfer the consumables from the consumable transfer trays to other locations wherein the storage compartment comprises a plurality of storage drums for storing consumables, and each storage drum comprises a plurality of spaces arranged in a plurality of layers and columns for storing the consumables, and wherein the transfer robot is configured to transfer the consumables to corresponding spaces of corresponding storage drums for storage, and wherein the plurality of storage drums are arranged adjacent to the central operation compartment and the liquid operation compartments, so that the transfer robot in the storage compartment is capable of transferring the consumables in the storage drums to at least one of the central operation compartment and the liquid operation compartment.
Zhu teaches consumables, a storage module for consumables and a transfer unit, but does not teach loading unit is provided in the vicinity of the consumable loading channel, and the continuous loading unit is constructed in the form of a continuous loading turntable to realize continuous loading and unloading of the consumables, and wherein the continuous loading unit comprises an annular transmission element and consumable transfer trays disposed on the annular transmission element, and the transfer robot is configured to transfer the consumables onto the consumable transfer trays and/or transfer the consumables from the consumable transfer trays to other locations wherein the storage compartment comprises a plurality of storage drums for storing consumables, and each storage drum comprises a plurality of spaces arranged in a plurality of layers and columns for storing the consumables, and wherein the transfer robot is configured to transfer the consumables to corresponding spaces of corresponding storage drums for storage, and wherein the plurality of storage drums are arranged adjacent to the central operation compartment and the liquid operation compartments, so that the transfer robot in the storage compartment is capable of transferring the consumables in the storage drums to at least one of the central operation compartment and the liquid operation compartment.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to provide a consumable loading area (channel) with a suitable conveying platform, including a turntable as a matter of design choice.
Further, it would have been obvious to provide suitable containers for the consumables, including containers of any desired shape, including drums, that can store consumables in layers and columns, and trays to hold the consumables during transfer. The arrangement of the consumables transfer system in relationship with the other elements of Zhu would have been an obvious manner of design choice. (See MPEP2144.04 (VI)(C)).
Therefore, Zhu renders claim 21 obvious.
V.) Regarding applicant’s claim 25, as noted above Zhu anticipates claim 15 from which claim 25 depends.
Claim 25 recites that the central operation compartment comprises an operation table-board mounted with at least one of following devices: a consumable lid opening/closing unit, a centrifuge unit, a vacuum filtration unit, a metal bath unit, a sample oscillation unit, a consumable storage rack, a secondary storage rack for secondary storage of materials, and a multi-degree-of-freedom robot.
As noted above, Shu teaches a multi-degree-of-freedom robot but does not specifically teach that operation unit comprises an operation table-board mounted with the robot.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to provide the operation unit in Zhu with any suitable support, including a table-board mounted with the robot as a matter of design choice.
Therefore, Zhu renders claim 25 obvious.
VI.) Regarding applicant’s claim 29, as noted above Zhu anticipates claim 15 from which claim 25 depends.
Claim 29 recites that the central operation compartment is configured to perform at least one of following operations: vacuum filtration operation, centrifugal separation, centrifugal enrichment, vibration mixing operation, consumable lid opening/closing operation, and metal bath incubation operation, and wherein the liquid operation compartment is configured to perform at least one of following operations: plasmid preparation and frozen tube lid opening/closing operation, culture and replenishment of the biological samples, transfection expression of biological samples, magnetic bead sorting, magnetic bead purification, and pretreatment of the biological samples to be detected.
Zhu teaches centrifugal transfection.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to culture and replenishment of the biological samples to maintain processing.
Therefore, Zhu renders claim 29 obvious.
VII.) Regarding applicant’s claim 31, as noted above Zhu anticipates claim 29 from which claim 31 depends.
Claim 31 recites that the liquid operation compartment comprises at least one pipetting unit configured to transfer liquid required in a process to perform corresponding operations.
Zhu does not teach the liquid operation compartment comprises at least one pipetting unit configured to transfer liquid required in a process to perform corresponding operations.
It would have been obvious to one of ordinary skill in the art to modify Zhu to provide the liquid operation compartment with at least one pipetting unit configured to transfer liquid required in a process to perform corresponding operations, inasmuch as pipetting units are conventional in biological production systems.
Therefore, Zhu renders claim 31 obvious.
VIII.) Regarding applicant’s claim 32, as noted above Zhu renders claim 31 obvious from which claim 32 depends.
Claim 32 recites that the pipetting unit is configured to be movable along a X axis and comprises one or more pipetting heads each of which is configured to be movable independently along a Y axis and a Z axis inside the pipetting unit, wherein the Y axis is in a horizontal plane and perpendicular to the X axis, and the Z axis is in a vertical plane and perpendicular to the X axis and the Y axis; wherein the pipetting unit comprises one or more movers mounted along a direction of the Y-axis, so that each pipetting head is movable along the direction of the Y-axis under driving of the movers.
Zhu does not teach that the pipetting unit is configured to be movable along a X axis and comprises one or more pipetting heads each of which is configured to be movable independently along a Y axis and a Z axis inside the pipetting unit, wherein the Y axis is in a horizontal plane and perpendicular to the X axis, and the Z axis is in a vertical plane and perpendicular to the X axis and the Y axis; wherein the pipetting unit comprises one or more movers mounted along a direction of the Y-axis, so that each pipetting head is movable along the direction of the Y-axis under driving of the movers.
As noted above, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to provide the liquid operation compartment in Zhu with at least one pipetting unit configured to transfer liquid required in a process to perform corresponding operations.
It would have further been obvious to one of ordinary skill in the art before applicant’s effective filing date to configured the pipetting unit to be movable along a X axis and comprises one or more pipetting heads each of which is configured to be movable independently along a Y axis and a Z axis inside the pipetting unit, wherein the Y axis is in a horizontal plane and perpendicular to the X axis, and the Z axis is in a vertical plane and perpendicular to the X axis and the Y axis; wherein the pipetting unit comprises one or more movers mounted along a direction of the Y-axis, so that each pipetting head is movable along the direction of the Y-axis under driving of the mover, for purposes of selectively transferring liquids and samples during various processes of the biological production system of Zhu.
Therefore, Zhu renders claim 32 obvious.
IX.) Regarding applicant’s claim 37, as noted above Zhu renders claim 31 obvious from which claim 37 depends.
In one alternative, claim 37 recites that the liquid operation compartment comprises at least one of the following items: a unit for pumping and replenishing liquid and a pump set, wherein the unit for pumping and replenishing liquid is used for providing required process fluid to the pipetting unit, and the pump set is used for pumping the process fluid into pipes of the unit for pumping and replenishing liquid.
Zhu teaches a pump set. (page 9, 2nd paragraph, English translation).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to use the pump set of Zhu to pump and replenish liquid, wherein the unit for pumping and replenishing liquid is used for providing required process fluid to the pipetting unit, and the pump set is used for pumping the process fluid into pipes of the unit for pumping and replenishing liquid.
Therefore, Zhu renders claim 37 obvious.
3. Claims 5 and 48 are rejected under 35 USC 103 as being unpatentable over Zhu as applied to claim 1 above and further in view of U.S. Patent Application Publication No. 2015/0147819 to Pedrazzini and Spanish Patent Publication No. ES2253889 to Ammann et al.
I.) As noted above, Zhu anticipates claim 1 from which claim 5 depends.
Claim 5 recites that the incubator comprises a housing and a culture assembly accommodated in the housing, and the culture assembly is provided on an automatic sliding table element to enable the culture assembly to slide out of or into the housing in a controlled manner; wherein the incubator is configured to automatically control temperature and humidity of the biological samples, wherein a temperature inside the incubator is controlled between 16-38°C and a humidity inside the incubator is controlled between 70-95%; and wherein the incubator comprises at least one of the following items: a heating film for automatically heating the incubator to control the temperature inside the incubator between 16-38 °C; a humidifying unit, which includes an automatic water supply unit configured to supply water to the incubator in a controlled manner and an atomizer configured to atomize water from the automatic water supply unit to control the humidity in the incubator; a refrigeration compressor configured to control a temperature of the biological samples between 2-8°C when sedimentation and enrichment of the biological samples are needed.
Zhu teaches that the environmental control unit 6 includes laminar flow systems of each compartment, H2O2 sterilization of each unit, isolation doors of each compartment, temperature and humidity sensors, rendering it obvious to control the temperature and humidity in the incubator at desired ranges, including a temperature of between 16-38°C. (page 8, last paragraph, English translation)
Zhu does on teach that the incubator includes a sliding table element that slides out of or into the housing of the incubator in a controlled manner.
Pedrazzini teaches an interfacing apparatus between a laboratory automation system and a platform for handling consumables and liquids in the field of molecular biology. Pedrazzini teach a mechanism for moving the various shelves which form it), when needed, to the consumable handling system 14, to then be collected by the second robot 8 and positioned on platform 1. [0033]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to include a sliding shelf or table element that slides out of or into the housing of the incubator in a controlled manner as taught by Pedrazzini for purposes of inserting or removing cultures to be incubated into and then out of the incubator.
Zhu in view of Pedrazzini does not teach that the incubator includes a heating film, a humidifying unit and a refrigeration compressor.
Ammann et al. teaches an incubator for an automatic analyzer that includes a film heater and a refrigeration unit. (page 31, 2nd paragraph, English translation)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu in view of Pedrazzini to provide the incubator with a film heater and refrigerating unit as taught by Ammann et al. It would further been obvious to use the refrigerating unit to control the temperature when sedimentation and enrichment of biological samples are need to a desire temperature range, including a range of 2-8°C.
It would further have been obvious to one of ordinary skill in the art to provide Zhu in view of Pedrazzini with a humidifying unit in view of Zhu teaching sensing humidify, for purposes of controlling the humidity as desired.
Therefore Zhu in view of Pedrazzini and Ammann et al. render claim 5 obvious.
II.) Regarding applicant’s claim 48, as noted above Zhu in view of Pedrazzini and Ammann et al. render claim 5 obvious from which claim 48 depends.
Claim 48 recites that the incubator is provided with a CO2 pipe for replenishing CO2 into the incubator and a CO2 sensor for measuring a concentration of CO2 in the incubator, so as to control the concentration of CO2 in the incubator, and wherein the incubator is further provided with a CO2 inflation valve for controlling the replenishment of CO2 and a CO2 pipe filter for removing impurities in CO2.
Zhu teaches that the culture chamber is a custom H2O2 self-cleaning CO2 incubator. (page 8, 1st paragraph, English translation)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to provide the CO2 incubator of Zhu with a valve for controlling the replenishment of CO2 and a CO2 pipe filter for removing impurities in CO2 for purpose of controlling the CO2 in the incubator.
Therefore, Zhu in view of Yamada et al. renders claim 48 obvious.
4. Claim 11 is rejected under 35 USC 103 as being unpatentable over Zhu as applied to claim 10 above and further in view of Chinese Patent No. CN 202852998 to Gao.
I.) Regarding applicant’s claim 11, as noted above Zhu anticipates claim 10 from which claim 11 depends.
Claim 11 recites that the liquid operation system is provided with a laminar flow unit configured to form the laminar flow environment in an interior of the liquid operation system by pressure difference; and wherein the laminar flow unit comprises at least one of the following items: a laminar air-supply unit including a centrifugal fan; a laminar air-return unit disposed at a bottom of the liquid operation system, wherein the laminar air-return unit comprises a filter screen configured to filter out particulate matters in laminar gases before the laminar gases enter the interior of the liquid operation system.
As noted above, Zhu teaches laminar flow, but does not teach a laminar air-supply unit including a centrifugal fan.
Gao teaches using a centrifugal fan, so as to effectively eliminate air turbulence so as to improve the air purifying effect of the laminar flow purification device. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to include a centrifugal pump as taught by Gao to provide the laminar flow taught by Zhu.
Therefore, Zhu in view of Gao renders claim 11 obvious.
5. Claim 26 is rejected under 35 USC 103 as being unpatentable over Zhu as applied to claim 25 above and further in view of Gao and Pedrazzini.
I.) Regarding applicant’s claim 26, as noted above Zhu renders claim 25 obvious from which claim 26 depends.
Claim 26 recites a laminar air-return mesh plate is provided on the operation table-board to allow a laminar returned-air to enter an internal space of the central operation compartment through the laminar air-return mesh plate; wherein the multi-degree-of-freedom robot is mounted on a linear motor module, which includes a cross beam extending in a horizontal direction and a linear motor mounted on the cross beam and driving the multi-degree-of-freedom robot in a direction along which the cross beam extends wherein a space is reserved in a middle portion of the operation table-board of the central operation compartment, and the space reserved is configured to receive a consumable stage sliding table of the liquid operation compartment.
As noted above, Zhu teaches laminar flow, but does not teach a laminar air-supply unit.
Gao teaches using a centrifugal fan, so as to effectively eliminate air turbulence so as to improve the air purifying effect of the laminar flow purification device. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to include a centrifugal pump as taught by Gao to provide the laminar flow taught by Zhu. The centrifugal fan of Gao would drive air to provide the laminar flow in Zhu and necessitate containment and return of compressed air.
It would have been obvious to one of ordinary skill in the art to provide a filter (mesh plate) through which to direct returned compressed air to remove any debris in the returned air.
As noted above Zhu teaches a linear motor module for the robot.
Pedrazzini teaches an interfacing apparatus between a laboratory automation system and a platform for handling consumables and liquids in the field of molecular biology. Pedrazzini teach a mechanism for moving the various shelves which form it), when needed, to the consumable handling system 14, to then be collected by the second robot 8 and positioned on platform 1. [0033]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu in view of Gao to include a sliding shelf or table element that slides the table-board as taught by Pedrazzini for loading and unloading consumables.
Therefore, Zhu in view of Gao and Pedrazzini renders claim 26 obvious.
6. Claim 34 is rejected under 35 USC 103 as being unpatentable over Zhu as applied to claim 31 above and further in view of U.S. Patent Application Publication No. 2009/0155123 to Williams et al.
I.) Regarding applicant’s claim 34, as noted above Zhu renders claim 31 obvious from which claim 34 depends.
Claim 34 recites that the pipetting unit is mounted on a linear motor gantry main frame structure, which includes two guide rail structures spaced from each other and a cross beam extending between the two guide rail structures, the pipetting unit being provided on the cross beam; wherein the guide rail structures are configured to extend along the X axis, and the cross beam is movable in a direction of the X-axis along the guide rail structures wherein the guide rail structures and the cross beam are components of a linear motor, wherein the guide rail structures constitute a stator of the linear motor and the cross beam constitutes a mover of the linear motor, and no mechanical connection is present between the guide rail structures and the cross beam.
Zhu does not teach that the pipetting unit is mounted on a linear motor gantry main frame structure, which includes two guide rail structures spaced from each other and a cross beam extending between the two guide rail structures, the pipetting unit being provided on the cross beam; wherein the guide rail structures are configured to extend along the X axis, and the cross beam is movable in a direction of the X-axis along the guide rail structures wherein the guide rail structures and the cross beam are components of a linear motor, wherein the guide rail structures constitute a stator of the linear motor and the cross beam constitutes a mover of the linear motor, and no mechanical connection is present between the guide rail structures and the cross beam.
Williams et al. teaches an automated pipetting apparatus that includes a liquid dispenser 976, mounted on a gantry that can move along horizontal sliding rails 2102, as further described herein. [0054].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to mount the pipetting unit on a linear motor gantry main frame structure, which includes two guide rail structures spaced from each other and a cross beam extending between the two guide rail structures, the pipetting unit being provided on the cross beam; wherein the guide rail structures are configured to extend along the X axis, and the cross beam is movable in a direction of the X-axis along the guide rail structures wherein the guide rail structures and the cross beam are components of a linear motor, wherein the guide rail structures constitute a stator of the linear motor and the cross beam constitutes a mover of the linear motor, and no mechanical connection is present between the guide rail structures and the cross beam, as taught by Williams et al. for purposes of enabling positioning of the pipette(s) in desired locations.
Therefore, Zhu in view of Williams et al. renders claim 34 obvious.
7. Claim 43 is rejected under 35 USC 103 as being unpatentable over Zhu as applied to claim 41 above and further in view of International Patent Application Publication No. WO 2006/040870 to Yamada et al.
I.) Regarding applicant’s claim 43, as noted above Zhu renders claim 41 obvious from which claim 43 depends.
Claim 43 recites in one alternative a man-machine cooperative robot which is used for transferring the biological samples to be detected to different detection locations on the sample detection platform, wherein the man-machine cooperative robot comprises a force feedback unit, and wherein the man-machine cooperative robot is provided on a linear module and movable along the linear module.
Zhu does not teach a man-machine cooperative robot which is used for transferring the biological samples to be detected to different detection locations on the sample detection platform, wherein the man-machine cooperative robot comprises a force feedback unit, and wherein the man-machine cooperative robot is provided on a linear module and movable along the linear module.
Yamada et al. teaches a cell incubator having the controller for driving and controlling each part of the single-cell operation support robot that is composed of a controller body and the controller has a first operation functioning as a man-machine interface. [0040]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Zhu to include a man-machine cooperative robot as taught by Yamada et al. as a simple substitute for Zhu’s robot and to include a force feedback system to monitor the robot to prevent inadvertent damage caused by the movement of the robot.
Therefore, Zhu in view of Yamada et al. renders claim 43 obvious.
Conclusion
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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