DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments and remarks, filed on 12/29/2025, has been entered. The claim amendments overcome the previous claim objections of claims 3, 12, and 13 and 112(b) rejection of claims 8 and 10.
The amendments and remarks, filed on 12/29/2025, has been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-5, 7-17, and 19-22 are pending and being examined.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3, 5, 7, 11-16, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao et al (US 20140045186 A1; hereinafter “Gubatayao”) in view of Kochar et al (US 20190391170 A1; hereinafter “Kochar”).
Regarding claim 1, Gubatayao teaches an automated analyser for high-throughput assay testing for the presence of a biological or biochemical substance (Gubatayao; Abstract; Systems and methods for performing simultaneous nucleic acid amplification and detection), the analyser comprising;
a plurality of sample process stations adapted to receive sample vessels and optionally heat inactivate samples (Gubatayao; para [63]; Receiving trays 520 a and 520 b may be located beneath or within the housing of the heater/ optical modules 500 a, 500 b), transfer to analysis vessels and perform one or more processing or analysis steps on the samples retained in the analysis vessels (Gubatayao; Fig. 3A; para [56, 72]; these measurements may be taken from separate reaction chambers within a microfluidic cartridge, e.g., comprising a chamber layer (the chamber layer referring herein to that portion of the microfluidic cartridge containing the reaction chambers)…the lanes may provide inlet ports 1705 in a convenient location near the user…the examiner notes that the “sample vessel” is interpreted as the inlet portion of the cartridge and is the “analysis vessel” is interpreted as the reaction chambers);
said process stations comprising at least an incubation station (Gubatayao; para [63]; Receiving trays 520 a and 520 b may be located beneath or within the housing of the heater/optical modules 500 a), the incubation station comprises an incubation field having a plurality of analysis vessel positions (Gubatayao; para [69]; The receiving tray 520 may be aligned so that various components of the apparatus that can operate on the microfluidic cartridge 200 (such as, heat sources, detectors, force members, and the like) are positioned to properly operate on the microfluidic cartridge 200 while the cartridge 200 is received in the recessed bay 524 of the receiving tray 520), each position providing both thermal and optical access, configured to allow for simultaneous temperature maintenance and imaging of light from within analysis vessels (Gubatayao; para [63]; Receiving trays 520 a and 520 b may be located beneath or within the housing of the heater/ optical modules 500 a, 500 b), the incubation station adapted to:
receive a plurality of analysis vessels (Gubatayao; para [69]; The receiving tray 520 may be aligned so that various components of the apparatus that can operate on the microfluidic cartridge 200);
provide illumination of the analysis vessels in the incubation field (Gubatayao; para [105]; The illumination optics may be designed so that the excitation light falling on the reaction chamber); and
maintain the plurality of analysis vessels at a predetermined incubation temperature or range of temperatures (Gubatayao; para [115]; the thermal trajectory for both heating and cooling may be determined for the entirety of the reaction prior to the start of the run);
wherein the analyser further comprises:
an imaging system adapted to image the illuminated samples in the analysis vessels retained in the incubation field (Gubatayao; para [92]; The detector head 700 may be configured to optically excite and/or monitor fluorescence emitted in connection with detection of from one or more polynucleotides present in the reaction chambers 1703); and
a resource controller (Gubatayao; para [121]; the process may be implemented in any of an FPGA, a microcontroller, or software running on a computer processor) adapted to:
control the imaging system to optically scan the analysis vessels retained in the incubation field according to a predetermined incubation period and scan frequency (Gubatayao; para [92, 94]; Each detector pair 726 can be comprised of a light source 726 a, such as a light-emitting diode (LED), and a corresponding light detector 726 b, such as a photodiode. The light source 726 a may selectively emit light in an absorption band of a fluorescent probe);
receive optical image information from the imaging system of the scanned analysis vessels (Gubatayao; para [92, 94]; The light detector 726 b may selectively detect light in an emission band of the fluorescent probe, wherein the fluorescent probe corresponds to a polynucleotide probe or a fragment thereof); and
instruct an image processor to process the image information (Gubatayao; para [99]; Plotted are the detected fluorescent levels for each light emitter-photodetector pair 801-805 over time for a single reaction chamber (or reactor) associated with a single lane);
wherein incubation of samples is performed simultaneous with the optical imaging and analysing of the samples for the presence of the biological or biochemical substance (Gubatayao; para [103]; thickness of the aperture plate must be appropriately selected to facilitate a proper light path between each reaction chamber and the light sources and photodetectors while still ensuring proper heating and cooling of the chamber layer; Gubatayao describes that the heating and cooling of the chamber provides precise and accurate results for the photodetector, thus teaching that the incubation and optical imaging is simultaneous).
Gubatayao does not teach an analysis vessel transfer system adapted to transfer analysis vessels between each of the process stations; and the resource controlled adapted to control the analysis vessel transfer system to transfer the plurality of analysis vessels to respective process stations for preparation and analysis of the biological or biochemical substance in accordance with a predetermined analysis process schedule.
However, Kochar teaches an analogous art of an assay system (Kochar; Abstract) comprising an analysis vessel transfer system (Kochar; para [155]; the system comprising a robotic gripper arm) adapted to transfer analysis vessels between each of the process stations (Kochar; para [292]; a robotic subsystem (902) configured to access and move one or more consumables, e.g., multi-well assay plates, from one subsystem of the assay system to another); and a resource controlled adapted to control the analysis vessel transfer system to transfer the plurality of analysis vessels to respective process stations for preparation and analysis of the biological or biochemical substance in accordance with a predetermined analysis process schedule (Kochar; para [292, 415]; The robotic subsystem is configured to move one or more plates to and/or from the plate preparation platform, the plate washing subassembly, the orbital shaking subasssembly, the assay reader, and the consumable storage unit… Therefore, once the assay is conducted by the system, the controller can be used to write the results of the assay to the identifier. Such information includes, but is not limited to a schedule of events to be conducted on an assay consumable or a test site and/or domain within an assay consumable). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the automated analyzer of Gubatayao to comprise the analysis vessel transfer system as taught by Kochar, because Kochar teaches that the assay system is automated to execute without human assistance (Kochar; para [813]). Thus, the modification of incorporating the analysis vessel transfer system would result in the resource controller being adapted to control the analysis vessel transfer system as taught by modified Gubatayao.
Regarding claim 2, modified Gubatayao teaches the analyser of claim 1 wherein each analysis vessel is a microplate assay (Gubatayao; para [61]; the reaction chambers within the microfluidic cartridge(s) includes one or more reagents, buffers, etc., used in the nucleic amplification assay).
Regarding claim 3, modified Gubatayao teaches the analyser of claim 1, wherein the imaging system is adapted to record images comprising colorimetric or fluorescent signals arising from the illuminated samples in the analysis vessels located within the incubation field (Gubatayao; para [99]; Plotted are the detected fluorescent levels for each light emitter-photodetector pair 801-805 over time for a single reaction chamber (or reactor) associated with a single lane).
Regarding claim 5, modified Gubatayao teaches the analyser of claim 1, wherein the analyser is configured to accept analysis vessels with fresh samples whilst in operation to permit continuous analysis operations (Gubatayao; para [66]). Gubatayao teaches cartridges are tested indivudally, thus a new/fresh sample could be added after the prior cartridge is finished. The limitation is directed to the function and/or the manner of operating the analyser, all the structural limitations of the claim has been disclosed by modified Gubatayao and the analyser of modified Gubatayao is capable of “accept[ing] analysis vessels with fresh samples whilst in operation to permit continuous analysis operations”. As such, it is deemed that the claimed analyser is not differentiated from the analyser of modified Gubatayao (see MPEP §2114).
Regarding claim 7, modified Gubatayao teaches the analyser of claim 1, wherein the analyser is operable as a queueing system to maximise the utilization of the resources within the analyser for processing the analysis vessels with samples within the analyser. The limitation is directed to the function and/or the manner of operating the analyser, all the structural limitations of the claim has been disclosed by modified Gubatayao and the analyser of modified Gubatayao is capable of “queueing system to maximise the utilization of the resources within the analyser for processing the analysis vessels with samples within the analyser”. As such, it is deemed that the claimed analyser is not differentiated from the analyser of modified Gubatayao (see MPEP §2114).
Regarding claim 11, modified Gubatayao teaches the analyser of claim 1 (Gubatayao is modified to comprise the analysis vessel transfer system as taught by Kochar discussed above in claim 1), wherein the analysis vessel transfer system is a microplate crane system (Kochar; para [292]; a robotic subsystem (902) configured to access and move one or more consumables, e.g., multi-well assay plates, from one subsystem of the assay system to another).
Regarding claim 12, modified Gubatayao teaches the analyser of claim 1, wherein the resource controller is adapted to process the image information using an image processor to determine a positive determination of the biological or biochemical substance under test (Gubatayao; para [76]; one assay chamber could include template nucleic acids from a test sample, positive control template nucleic acids, one or more primer pairs for the amplification of specific target sequences, one or more probes for the detection of target amplicons, and one or more primer pairs and a probe for the detection of positive control amplicons).
Regarding claim 13, modified Gubatayao teaches the analyser of claim 1, wherein the controller is arranged to control the imaging system to optically scan the analysis vessels retained in the incubation field according to a predetermined incubation period and scan frequency (Gubatayao; para [12, 13]; The method can include the steps of determining or providing or accessing a detection cycle time for each of the plurality of reactors).
Regarding claim 14, modified Gubatayao teaches the analyser of claim 1, comprising a sample carrier tray for receiving a plurality of analysis vessels (Gubatayao; para [56]; plurality of reaction chambers within the cartridge).
Regarding claim 15, modified Gubatayao teaches the analyser of claim 1, wherein the incubation station is adapted to provide uniform back illumination (Gubatayao; para [105]; The illumination optics may be designed so that the excitation light falling on the reaction chamber, or reactor, is incident along an area that is similar to the shape of the reactor). The limitation is directed to the function and/or the manner of operating the incubation station, all the structural limitations of the claim has been disclosed by modified Gubatayao and the incubation station of modified Gubatayao is capable of being “adapted to provide uniform back illumination”. As such, it is deemed that the claimed incubation station is not differentiated from the incubation station of modified Gubatayao (see MPEP §2114).
Regarding claim 16, modified Gubatayao teaches the analyser of claim 1, wherein each analysis vessel is processed according to a unique analysis process schedule, for assay testing for the presence of different biological or biochemical substances in each microplate assay (Gubatayao; para [114]; the system in operation may comprise many different protocols of many different durations operating simultaneously in different reaction chambers). The limitation is directed to the function and/or the manner of operating the analysis vessel, all the structural limitations of the claim has been disclosed by modified Gubatayao and the analysis vessel of modified Gubatayao is capable of being “processed according to a unique analysis process schedule”. As such, it is deemed that the claimed analysis vessel is not differentiated from the analysis vessel of modified Gubatayao (see MPEP §2114).
Regarding claim 20, modified Gubatayao teaches the analyser of claim 1, wherein the imaging system is adapted to image the complete area of the incubation field at a rate of at least once per minute (Gubatayao; para [130]; “Intra-cycle adjustments” comprise adjustments to step or substep intervals, as may have been specified by a user or received from a database, so that the step as a whole is an integer multiple of a predetermined duration). The limitation is directed to the function and/or the manner of operating the imaging system, all the structural limitations of the claim has been disclosed by modified Gubatayao and the imaging system of modified Gubatayao is capable of being “adapted to image the complete area of the incubation field at a rate of at least once per minute”. As such, it is deemed that the claimed imaging system is not differentiated from the imaging system of modified Gubatayao (see MPEP §2114).
Regarding claim 21, modified Gubatayao teaches the analyser of claim 1, wherein the imaging system is adapted to scan the incubation field in a 2-dimensional scan path (Gubatayao; para [94]; Optionally, the detector and emitter of a pair are aligned with the reaction chamber along lines that substantially intersect at an acute angle at the reaction chamber. The angle can be, for example, between about 5 and 70 degrees, preferably between about 8 and 60 degrees, more preferably between about 10 and 50 degrees). The examiner notes that the camera is positioned relative to the light, thus if the angle of the light is at 45 degrees then the photedetector will be used at an angle showing 2-dimensions. The limitation is directed to the function and/or the manner of operating the imaging system, all the structural limitations of the claim has been disclosed by modified Gubatayao and the imaging system of modified Gubatayao is capable of being “adapted to scan the incubation field in a 2-dimensional scan path”. As such, it is deemed that the claimed imaging system is not differentiated from the imaging system of modified Gubatayao (see MPEP §2114).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao in view of Kochar, and in further view of Lemmo et al (US 20030123057 A1; hereinafter “Lemmo”; already of record on IDS filed 4/17/2023).
Regarding claim 17, modified Gubatayao teaches the analyser of claim 1, with the analyser.
Modified Gubatayao does not teach wherein the analyser comprises a plurality of optical fibre bundles, each optical fibre bundle being associated with a respective microplate slot of the incubation field.
However, Lemmo teaches an analogous art of an automated analyser for high-throughput assay testing for the presence of a biological or biochemical substance (Lemmo; Abstract; Systems and methods are described that allow the high-throughput preparation, processing, and study of arrays of samples) comprising a plurality of optical fibre bundles, each optical fibre bundle being associated with a respective microplate slot of the incubation field (Lemmo; para [95]; This lighting of the samples in the containers though the septa can be accomplished through the use of light sources such as fiber optic light guides or light-emitting diodes). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the analyser of modified Gubatayao to comprise the plurality of optical fibre bundles as taught by Lemmo, because Lemmo teaches the fiber optic light guides are an alternative to the light-emitting diode (Lemmo; para [95]).
Regarding claim 19, modified Gubatayao teaches the analyser of claim 1, with the imaging system.
Modified Gubatayao does not teach wherein the imaging system is a scanning imaging system comprising at least one optical camera adapted for imaging of analysis vessels located in the incubation field
However, Lemmo teaches an analogous art of an automated analyser for high-throughput assay testing for the presence of a biological or biochemical substance (Lemmo; Abstract; Systems and methods are described that allow the high-throughput preparation, processing, and study of arrays of samples) comprising a scanning imaging system further comprising at least one optical camera adapted for imaging of analysis vessels located in the incubation field (Lemmo; para [119]; A suitable camera can be any unit capable of yielding photographic images of the contents of containers, e.g., the presence or absence of solids or solid forms, but is preferably capable of digital capture). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the imaging system of modified Gubatayao to comprise the at least one optical camera as taught by Lemmo, because Lemmo teaches that the camera allows for video capture and frame grabbing of the sample as it is being analyzed (Lemmo; para [200]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao in view of Kochar, and in further view of Cohen et al (US 6374982 B1; hereinafter “Cohen”; already of record).
Regarding claim 8, modified Gubatayao teaches the analyser of claim 1, with the controller.
Modified Gubatayao does not teach wherein the controller is arranged to operate in accordance with a predictive method for coordinating the movement of multiple robotic entities to avoid collisions between the robotic entities.
However, Cohen teaches an analogous art of a robotic arm for transporting containers (Cohen; Abstract) comprising a controller (Cohen; col 8, line 20-22; controlling the operation of instrument 10 are multiple controllers) wherein the controller is arranged to operate in accordance with a predictive method for coordinating the movement of multiple robotic entities to avoid collisions between the robotic entities (Cohen; col 18, line 20-23; A collision avoidance protocol for avoiding collisions between robotic arms 100, 600 must be incorporated into software on the sample handler controller). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the controller of modified Gubatayao to prevent collisions between robotic entities as taught by Cohen, because Cohen teaches the test tubes may spill or disturb the samples (Cohen; col 13, line 49-51).
Regarding claim 9, Modified Gubatayao teaches the analyser of claim 8 (the controller of modified Gubatayao is modified to execute the predictive method as taught by Cohen discussed in claim 8) wherein the predictive method coordinates the movement of multiple robotic entities operating in a shared time and space environment ("Coordination function"), to avoid collisions between subsystems, whilst maximising system throughput and minimising overall analysis vessel processing delay through the system (Cohen; col 18, lines 24-64). Cohen describes the collision avoidance protocol to prevent future collisions.
Regarding claim 10, modified Gubatayao teaches the analyser of claim 9 (the controller of modified Gubatayao is modified to execute the predictive method as taught by Cohen discussed in claim 8) wherein the predictive method implements an algorithm to simultaneously predict a future position of a plurality of robotically controlled entities, all operating dynamically in the same 3-D space continuum (Cohen; col 18, lines 24-64). Cohen describes the collision avoidance protocol to prevent future collisions.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao in view of Kochar in further view of Johns (US 20140305227 A1; hereinafter “Johns”; already of record), and in further view of Cohen.
Regarding claim 4, modified Gubatayao teaches the analyser of claim 1, with the imaging system.
Modified Gubatayao does not teach wherein the imaging system is a scanning imaging system comprising components that move during scanning.
However, Johns teaches an analogous art of an analytical laboratory system and method for processing samples (Johns; Abstract) comprising an imaging system is a scanning imaging system (Johns; para [334]; a system 1800 comprising a camera unit (e.g., 2-D arrays or line scanners) comprising a camera 1802) wherein the imaging system is a scanning imaging system comprising components that move during scanning (Johns; para [334]; The camera 1802 and the illumination elements 1804 may be movable or stationary and may be mounted to a frame (not shown) in a processing module above racks with sample tubes). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the imaging system of modified Gubatayao to comprising components that move during scanning as taught by Johns, because Johns teaches that the camera moves to acquire 2-D images of the target object (Johns; para [334]).
Modified Gubatayao does not teach wherein the controller is adapted to coordinate a motion of the analysis vessel transfer system operation when transferring analysis vessels to and from the incubation field with the motion of the scanning imaging system to avoid collisions between the analysis vessel transfer system and the imaging system.
However, Cohen teaches an analogous art of a robotic arm for transporting containers (Cohen; Abstract) comprising a controller (Cohen; col 8, line 20-22; controlling the operation of instrument 10 are multiple controllers) wherein the controller is adapted to coordinate a motion to avoid collisions (Cohen; col 18, line 20-23; A collision avoidance protocol for avoiding collisions between robotic arms 100, 600 must be incorporated into software on the sample handler controller). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the controller of modified Gubatayao to prevent collisions as taught by Cohen, because Cohen teaches the test tubes may spill or disturb the samples (Cohen; col 13, line 49-51). Thus, modified Gubatayao teaches wherein the controller is adapted to coordinate a motion of the analysis vessel transfer system operation when transferring analysis vessels to and from the incubation field () with the motion of the scanning imaging system (Johns; para [334]; The camera 1802 and the illumination elements 1804 may be movable or stationary and may be mounted to a frame (not shown) in a processing module above racks with sample tubes) to avoid collisions between the analysis vessel transfer system and the imaging system (Cohen; col 18, line 20-23; A collision avoidance protocol for avoiding collisions between robotic arms 100, 600 must be incorporated into software on the sample handler controller).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao in view of Kochar, and in further view of Johns.
Regarding claim 22, modified Gubatayao teaches the analyser of claim 1, with the imaging system.
Modified Gubatayao does not teach wherein the imaging system comprises a plurality of imaging cameras adapted to provide a combined field of view across the full width of the incubation field, and wherein the imaging system is adapted to scan the incubation field in a 1-dimensional scan path.
However, Johns teaches an analogous art of an analytical laboratory system and method for processing samples (Johns; Abstract) comprising an imaging system is a scanning imaging system (Johns; para [335]; the camera unit 1808 (e.g., 2-D arrays or line scanners)) wherein the imaging system comprises a plurality of imaging cameras adapted to provide a combined field of view across the full width of the incubation field, and wherein the imaging system is adapted to scan the incubation field in a 1-dimensional scan path (Johns; para [335]; . The camera unit 1808 (e.g., 2-D arrays or line scanners) comprises a plurality of cameras 1810(a), 1810(b), 1810(c) and illumination elements 1812 to acquire one or more 2-D images of the target objects can be used in the laboratory automation system to detect the presence of and identify the target objects). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the imaging system of modified Gubatayao to comprise the plurality of imaging cameras as taught by Johns, because Johns teaches that the plurality of cameras captures multiple images of the sample rack to stitch a larger image together (Johns; para [335]).
Response to Arguments
Applicant’s arguments filed, 12/29/2025, have been considered and the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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