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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/17/2023 and 12/19/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-5, 7-17, and 19-22 are pending and being examined,
Claim Objections
Claims 3, 12, and 13 are objected to because of the following informalities: claim 3 reads “isadapted” should read as “is adapted” in line 2; claim 12 reads “aprocess” should read as “a process” in line 3; and claim 13 reads “scanfrequency” should read as “scan frequency” in line 4. Appropriate correction is required.
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 8-10 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.
Claim 8 recites the limitation "the movement of multiple robotic entities" in line 2-3 and “the robotic entities” in line 3. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear. Specifically, the claim does not recite “robotic entities”. The applicant claims an automated system that moves and transports analysis vessels, but it is unclear which structure would be the “robotic entities”. Can any structure that moves be interpreted as a robotic entity? For purpose of prosecution, the examiner interprets that the robotic entity is any units that move within the system. Claims 9-10 are rejected by virtue of dependency on claim 8.
Claim 10 recites the limitation “the same 3-D space continuum” in line 3. The Applicant’s do not previously recite a “3-D space”, thus there is insufficient antecedent basis for this limitation in the claim and the limitation is unclear.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 5, 7, 11-17, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lemmo et al (US 20030123057 A1; hereinafter “Lemmo”; already of record on IDS filed 4/17/2023).
Regarding claim 1, Lemmo teaches 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), the analyser comprising;
a plurality of sample process stations adapted to receive sample vessels (Lemmo; para [12, 13]; plurality of containers, each of which contains a compound-of-interest and optionally one or more additional compounds; b) a block containing an array of holes for receiving said containers; Lemmo teaches moving the block of containers through “sample process stations” to be analyzed) and optionally heat inactivate samples (Lemmo; para [15]; a thermal processing system for heating and cooling multiple blocks simultaneously), transfer to analysis vessels and perform one or more processing or analysis steps on the samples retained in the analysis vessels (Lemmo; para [112]; a robotic arm 55 as shown in FIG. 5 can be used to removed the blocks 60 from the shelves 58 and transfer them to an imaging, or vision station, such as that which is described below in Section 4.3 and elsewhere);
said process stations comprising at least an incubation station (Lemmo; para [105]; This system comprises one or more shelves, preferably thermally conductive, onto which blocks can be placed, and heating and/or cooling means) adapted to:
receive a plurality of analysis vessels (Lemmo; para [105]; system comprises one or more shelves, preferably thermally conductive, onto which blocks can be placed);
provide illumination of the analysis vessels in the incubation field (Lemmo; para [125]; vial 50 is illuminated by a light 102 that can be placed in a variety of locations to light up different portions of the vial 50); and
maintain the plurality of analysis vessels at a predetermined incubation temperature or range of temperatures (Lemmo; para [106]; The thermal cycling system can be used to simply incubate an array of samples at a specific temperature for a particular time);
wherein the analyser further comprises:
an analysis vessel transfer system adapted to transfer analysis vessels between each of the process stations (Lemmo; para [112]; robotic arm 55 as shown in FIG. 5 can be used to removed the blocks 60 from the shelves 58 and transfer them to an imaging, or vision station, such as that which is described below in Section 4.3 and elsewhere herein);
an imaging system adapted to image the illuminated samples in the analysis vessels retained in the incubation field (Lemmo; Fig. 7A; para [124]; A block 60 containing an array of vials 50 is placed before an imaging device 104); and
a resource controller (Lemmo describes a computer that is adapted to control the different structures described below) 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 (Lemmo; para [112]; robotic arm 55 as shown in FIG. 5 can be used to removed the blocks 60 from the shelves 58 and transfer them to an imaging, or vision station, such as that which is described below in Section 4.3 and elsewhere);
control the imaging system to optically scan the analysis vessels retained in the incubation field according to a predetermined incubation period and scan frequency (Lemmo; Fig. 7B; para [121]; the image capture is rapid (on the order of 30 milliseconds with current digital camera technology);
receive optical image information from the imaging system of the scanned analysis vessels (Lemmo; para [125]; the camera 104 then takes a picture of the vial 50. The picture is then stored on a computer); and
instruct an image processor to process the image information (Lemmo; para [161]; The computer software is used to analyze, identify and categorize groups of samples having similar physical forms, thus identifying a group from which the operator, or scientist, can then select a few samples for further analysis);
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 (Lemmo; para [112]; Lemmo teaches that the blocks are removed for processing and the shelves hold a plurality of blocks as seen in Fig. 1 and 4A, thus the samples continue to be incubating while a block is being processed).
Regarding claim 2, Lemmo teaches the analyser of claim 1 wherein each analysis vessel is a microplate assay (Lemmo; para [7]; In addition, there are systems consisting of blocks with multiple wells for performing reactions for different applications such as combinatorial chemistry. Examples of such system include the TITAN™ Reactor Clamp and TITAN™ PTFE MicroPlates).
Regarding claim 3, Lemmo 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 (Lemmo; para [141]; spectroscopic techniques that can be used to bin or analyze samples are numerous, and will be readily apparent to those skilled in the art. Some specific examples include, but are not limited to, optical absorption (e.g. UV, visible, or IR absorption), optical emission (e.g., fluorescence or phosphorescence)).
Regarding claim 5, Lemmo 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 (Lemmo; para [112]; Depending on the result of the imaging, the block can then be replaced onto a shelf in the thermal cycling system, or its containers can be separated, rearranged into new blocks, or removed entirely for more detailed). 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 Lemmo and the analyser of Lemmo 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 Lemmo (see MPEP §2114).
Regarding claim 7, Lemmo 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 Lemmo and the analyser of Lemmo 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 Lemmo (see MPEP §2114).
Regarding claim 11, Lemmo teaches the analyser of claim 1, wherein the analysis vessel transfer system is a microplate crane system (Lemmo; para [112]; a robotic arm 55 as shown in FIG. 5 can be used to removed the blocks 60 from the shelves 58).
Regarding claim 12, Lemmo 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 (Lemmo; para [118]; Samples can be imaged at any time after their preparation. Consequently, imaging information can be used to determine whether or not a sample should be processed, how it should be processed, and whether or not it should be subjected to more detailed, (e.g., spectroscopic) analysis).
Regarding claim 13, Lemmo 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 (Lemmo; para [121, 127]; the image capture is rapid (on the order of 30 milliseconds with current digital camera technology)…an area of the width of roughly 72 mm is observed when 8 tubes (a row at a time) are pushed out of a block for vision analysis, although, for instance, tubes may be viewed in groups of fewer than 8 such as single tubes or two tubes per captured image).
Regarding claim 14, Lemmo teaches the analyser of claim 1, comprising a sample carrier tray for receiving a plurality of analysis vessels (Lemmo; para [89]; a specific block 60 is made of aluminum, and has 96 holes 61 into which containers will fit).
Regarding claim 15, Lemmo teaches the analyser of claim 1, wherein the incubation station is adapted to provide uniform back illumination (Lemmo; para [125]; vial 50 is illuminated by a light 102 that can be placed in a variety of locations to light up different portions of the vial 50). 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 Lemmo and the incubation station of Lemmo 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 Lemmo (see MPEP §2114).
Regarding claim 16, Lemmo 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 (Lemmo; para [108]; each block contains a plurality of sample containers, each of which is identifiable by is location in the block and/or the use of a bar code or other identifier, the conditions to which each sample in a given hotel is exposed is recorded and tracked by computer).
Regarding claim 17, Lemmo teaches the analyser of claim 1, 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 (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).
Regarding claim 19, Lemmo teaches the analyser of claim 1, 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 (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).
Regarding claim 20, Lemmo 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 (Lemmo; para [121]; the image capture is rapid (on the order of 30 milliseconds with current digital camera technology).
Regarding claim 21, Lemmo teaches the analyser of claim 1, wherein the imaging system is adapted to scan the incubation field in a 2-dimensional scan path (Lemmo; Fig. 7A; para [132]; the invention utilizes laser light at an angle different from 90 degrees (e.g., at a 45 degree angle) relative to the camera lens). The examiner notes that the camera is positioned relative to the laser light, thus if the angle of the light is at 45 degrees then the camera 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 Lemmo and the imaging system of Lemmo 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 Lemmo (see MPEP §2114).
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.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lemmo in view of Cohen et al (US 6374982 B1; hereinafter “Cohen”).
Regarding claim 8, Lemmo teaches the analyser of claim 1, with the controller.
Lemmo 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 Lemmo 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, Lemmo teaches the analyser of claim 8 (the controller of Lemmo 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, Lemmo teaches the analyser of claim 9 (the controller of Lemmo 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 Lemmo in view of Johns (US 20140305227 A1; hereinafter “Johns”), and in further view of Cohen.
Regarding claim 4, Lemmo teaches the analyser of claim 1, with the imaging system.
Lemmo 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 Lemmo 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 Lemmo 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 Lemmo 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 Lemmo 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 (Lemmo; para [112]; robotic arm 55 as shown in FIG. 5 can be used to removed the blocks 60 from the shelves 58 and transfer them to an imaging, or vision station, such as that which is described below in Section 4.3 and elsewhere herein) 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 Lemmo in view of Johns.
Regarding claim 22, Lemmo teaches the analyser of claim 1, with the imaging system.
Lemmo 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 Lemmo 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]).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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