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 .
Notice to Applications
This communication is in response to the Application filed on April 27, 2023.
Claims 1-19 are pending.
Information Disclosure Statement
The information disclosure statement(s) (IDS(s)) submitted on April 28, 2023, June 09, 2023, June 27, 2023, June 11, 2024, July 09, 2025, and April 17, 2026 are in compliance with the provisions of 27 CFR 1.97. Accordingly, the information disclosure statements are being considered and attached by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable of Mathuis et al., US 20210142472 A1, (hereinafter “Mathuis”) in view of Battrell et al., US 20120115214 A1, (hereinafter “Battrell”) in further view of Wu et al., US 20200376488 A1, (hereinafter “Wu”).
Regarding claim 1, Mathuis teaches a system comprising: one or more cell culture containers, wherein each of the one or more cell culture containers comprises one or more closed cell culture chambers, each of the one or more cell culture chambers comprising ([0067] “The support substrate is used in adherent cell culture, wherein cells are cultured in a suitable medium and adhere to and spread over the support substrate, typically in a monolayer. Adherent cell culture is used to propagate certain animal (e.g. mammalian) cells that are anchorage dependent.”):
([0067] “The support substrate is used in adherent cell culture, wherein cells are cultured in a suitable medium and adhere to and spread over the support substrate, typically in a monolayer. Adherent cell culture is used to propagate certain animal (e.g. mammalian) cells that are anchorage dependent.”); and
an imaging system shared by the one or more cell culture containers, the imaging system comprising ([0066] “The DHM may be provided with a sample holder configured to receive the support substrate in the requisite form (e.g. as a microscope slide or container). The sample holder may be moveable (e.g. displaceable and/or rotatable) to allow different regions of the support substrate to be acquired. In FIG. 4, an exemplary DHM (100) is depicted comprising a stationary sample holder that is a stage (104) onto which the container is placed and a window (106) for the passage of light, for instance from the sample to the image sensor or of light emitted by the light source.”):
a light source configured to illuminate at least one closed cell culture chamber of each of the one or more cell culture containers ([0066] “The DHM may be provided with a sample holder configured to receive the support substrate in the requisite form (e.g. as a microscope slide or container). The sample holder may be moveable (e.g. displaceable and/or rotatable) to allow different regions of the support substrate to be acquired. In FIG. 4, an exemplary DHM (100) is depicted comprising a stationary sample holder that is a stage (104) onto which the container is placed and a window (106) for the passage of light, for instance from the sample to the image sensor or of light emitted by the light source.”);
([0067] “The support substrate is used in adherent cell culture, wherein cells are cultured in a suitable medium and adhere to and spread over the support substrate, typically in a monolayer. Adherent cell culture is used to propagate certain animal (e.g. mammalian) cells that are anchorage dependent.”);
a sensor configured to acquire a plurality of images from the at least one closed cell culture chamber of each of the one or more cell culture containers based at least in part on the captured light ([0061] “The DHM (100) may be provided with a docking element (102) configured to receive the dismountable conduit (150) for the passage of a sample flow, which docking element (102) is configured to position a transparent part (152, FIG. 3) of the dismountable conduit in relation to the DHM image sensor and/or DHM light source for acquisition of the holographic information. The transparent part (152) is configured for the passage of light emitted by the DHM light source.”) ([0067] “The support substrate is used in adherent cell culture, wherein cells are cultured in a suitable medium and adhere to and spread over the support substrate, typically in a monolayer. Adherent cell culture is used to propagate certain animal (e.g. mammalian) cells that are anchorage dependent.”); and
a computer processor programmed to generate quantitative phase images of the one or more cells based at least in part on the plurality of images ([0130] “Generally, a DHM comprises a light source that emits coherent light or at least partially coherent light such as a LASER or LED, an interferometer which may comprise a set of mirrors and/or beam splitters, and an image sensor such as a CCD or CMOS, and a processor and a computer-readable storage medium (e.g. solid state drive, flash card, or magnetic recording device).”) ([0069] “In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”).
Mathuis does not specifically disclose a first transparent window and a second transparent window opposite the first transparent window and wherein the first transparent window is configured to allow one or more cells inside.
However, Battrell teaches a first transparent window and a second transparent window opposite the first transparent window and wherein the first transparent window is configured to allow one or more cells inside ([Claim 1] “the microfluidic cartridge having a plastic flexible body enclosing a detection chamber, the detection chamber having a first optical window and a second optical window oppositely disposed thereon; wherein, a) the second optical window is a thermo-optical window formed of a compliant thermo-optical film;”) ([0086] “Each window is generally a thin layer of a flexible plastic film, may be less than 3 mils in thickness, and most commonly of a compliant transparent material such as polyethylene terephthalate (Mylar.RTM.),”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a dual transparent window compartment of Battrell in the cell culture imaging system of Mathuis to enable high-resolution imaging of the cells while maintaining optimal cell health and preventing contamination.
Mathuis in view of Battrell does not specifically disclose an objective configured to capture light from the light source transmitted through or reflected.
However, Wu teaches an objective configured to capture light from the light source transmitted through or reflected ([0039] “In some embodiments, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 30 degrees to about 60 degrees relative to the first channel. For example, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 40 degrees to about 50 degrees. Preferably, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 45 degrees.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an objective configured to capture light of Wu in the cell culture imaging system of Mathuis in view of Battrell to maximize precision, image quality, and flexibility of the cell imaging.
Regarding claim 2, Mathuis in view of Battrell and Wu teaches the system of claim 1, further comprising a laser source configured to manipulate the one or more cells based at least in part on the quantitative phase images (Wu - [0232] “The same laser or light source 249 is used for both first and second points of detection, which share a same detection Module 244. The detection signals are sent to the data acquisition and processing unit 255 for data analysis. Upon detecting a target droplet by the detection Module 244, the acquisition and processing unit 255 will deliver a trigger signal to the sorting controller 254 to activate the first sorting actuator 245, directing the target droplet into a collection channel 248. The acquisition and processing unit 255 will ignore undesired droplets and the non-target droplets will enter a waste channel 247.”) (Mathuis - [0069] “In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 3, Mathuis in view of Battrell and Wu teaches the system of claim 2, wherein manipulating the one or more cells comprises removing a subset of cells of the one or more cells from the first transparent window (Wu - [0232] “The same laser or light source 249 is used for both first and second points of detection, which share a same detection Module 244. The detection signals are sent to the data acquisition and processing unit 255 for data analysis. Upon detecting a target droplet by the detection Module 244, the acquisition and processing unit 255 will deliver a trigger signal to the sorting controller 254 to activate the first sorting actuator 245, directing the target droplet into a collection channel 248. The acquisition and processing unit 255 will ignore undesired droplets and the non-target droplets will enter a waste channel 247.”) (Battrell - [Claim 1] “the microfluidic cartridge having a plastic flexible body enclosing a detection chamber, the detection chamber having a first optical window and a second optical window oppositely disposed thereon; wherein, a) the second optical window is a thermo-optical window formed of a compliant thermo-optical film;”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 4, Mathuis in view of Battrell and Wu teaches the system of claim 2, wherein the objective is shared by the imaging system and the laser source (Wu - [0039] “In some embodiments, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 30 degrees to about 60 degrees relative to the first channel. For example, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 40 degrees to about 50 degrees. Preferably, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 45 degrees.”) (Mathuis - [0066] “The DHM may be provided with a sample holder configured to receive the support substrate in the requisite form (e.g. as a microscope slide or container). The sample holder may be moveable (e.g. displaceable and/or rotatable) to allow different regions of the support substrate to be acquired. In FIG. 4, an exemplary DHM (100) is depicted comprising a stationary sample holder that is a stage (104) onto which the container is placed and a window (106) for the passage of light, for instance from the sample to the image sensor or of light emitted by the light source.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 5, Mathuis in view of Battrell and Wu teaches the system of claim 2, wherein the first transparent window further comprises a semi- transparent film configured to absorb energy from the laser source and direct the absorbed energy to the one or more cells (Mathuis - [0061] “The DHM (100) may be provided with a docking element (102) configured to receive the dismountable conduit (150) for the passage of a sample flow, which docking element (102) is configured to position a transparent part (152, FIG. 3) of the dismountable conduit in relation to the DHM image sensor and/or DHM light source for acquisition of the holographic information. The transparent part (152) is configured for the passage of light emitted by the DHM light source.”) (Battrell - [Claim 4] “wherein the compliant thermo-optical film is a flexible plastic film having low resistance to heat transfer and optical transparency over a spectrum of excitation and emission wavelengths.”) (Wu - [0039] “In some embodiments, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 30 degrees to about 60 degrees relative to the first channel. For example, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 40 degrees to about 50 degrees. Preferably, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 45 degrees.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 6, Mathuis in view of Battrell and Wu teaches the system of claim 5, wherein the semi-transparent film further comprises a fiducial mark (Battrell - [Claim 4] “wherein the compliant thermo-optical film is a flexible plastic film having low resistance to heat transfer and optical transparency over a spectrum of excitation and emission wavelengths.”) (Battrell - [0096] “When the stage chassis is in the uppermost resting position, the microfluidic cartridge can be removed from the instrument. Mechanical fiducials and alignment pins are used to register the cartridge in the instrument docking bay during the assay.” wherein the film is a part of the microfluidic cartridge) (Mathuis - [0061] “The DHM (100) may be provided with a docking element (102) configured to receive the dismountable conduit (150) for the passage of a sample flow, which docking element (102) is configured to position a transparent part (152, FIG. 3) of the dismountable conduit in relation to the DHM image sensor and/or DHM light source for acquisition of the holographic information. The transparent part (152) is configured for the passage of light emitted by the DHM light source.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 7, Mathuis in view of Battrell and Wu teaches the system of claim 5, wherein the semi-transparent film is further configured to transmit incident light from the light source within a first range of wavelengths and absorb incident light from the laser source within a second range of wavelengths (Battrell - [Claim 4] “wherein the compliant thermo-optical film is a flexible plastic film having low resistance to heat transfer and optical transparency over a spectrum of excitation and emission wavelengths.”) (Mathuis - [0061] “The DHM (100) may be provided with a docking element (102) configured to receive the dismountable conduit (150) for the passage of a sample flow, which docking element (102) is configured to position a transparent part (152, FIG. 3) of the dismountable conduit in relation to the DHM image sensor and/or DHM light source for acquisition of the holographic information. The transparent part (152) is configured for the passage of light emitted by the DHM light source.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 8, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein each of the one or more cell culture containers is stationary while the plurality of images are acquired, and wherein the system further comprises an actuator configured to perform movement of the light source and the objective relative to each of the one or more cell culture containers (Mathuis - [0066] “The sample may comprise cells on a support substrate, incorporated into a glass or plastic container, or microscope slide. Suitable container include multi-plate well, T-flask. The support substrate is determined such that the front focal plane of the DHM automatically falls within the cell sample, without the need of refocusing the DHM for each sample.”) (Wu - [0154] “Upon detecting a signal indicative of a positive droplet (i.e., “target droplet”), the acquisition and processing unit 126 may deliver a trigger signal to a sorting controller 125. The sorting controller 125 may then activate the sorting actuator 115 to redirect a moving target droplet 117 to a target collection channel in the microfluidic device.”) (Wu - [0171] “FIG. 4A illustrates the use of RF to modulate a beam of laser energy at a detection point of any of the systems described herein. FIG. 4B illustrates the use of NBD beams to modulate a beam of laser energy at a detection point of any of the systems described herein. In both embodiments, a beam of light may be passed through a cylindrical optical element focusing the light into the back aperture of the objective lens (304/314) aimed at the sample, in this case delivered through a point of detection along a channel (302/312) of a microchip (301/311) comprising supporting substrate (303/313). In an exemplary embodiment, the microchip 301/311 can be made of PDMS on a glass substrate 303/313.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 9, Mathuis in view of Battrell and Wu teaches the system of claim 8, wherein the movement of the light source and the objective relative to each of the one or more cell culture containers allows the plurality of images to be acquired at each of a plurality of different focal planes along an axis perpendicular to a horizontal plane of the first transparent window (Wu - [0130] “In one aspect, one, two, or more points of detection may be used, the points of detection comprising at least one point of optical detection that is based on at least one laser or at least one laser-like source. In some embodiments, the laser may be provided through a unique optical configuration that comprises a remote focusing module (e.g., a tunable acoustic gradient (TAG) index lens), and two objectives provided at an angle of about 60 to about 120 degree, or of about 90 degree, at two corners of a prism, to provide an optical focal plane that crosses passing droplets in a channel of a microfluidic device at a point of detection.”) (Battrell - [Claim 1] “the microfluidic cartridge having a plastic flexible body enclosing a detection chamber, the detection chamber having a first optical window and a second optical window oppositely disposed thereon; wherein, a) the second optical window is a thermo-optical window formed of a compliant thermo-optical film;”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 10, Mathuis in view of Battrell and Wu teaches the system of claim 9, wherein the objective is tilted at an angle with respect to the axis (Wu - [0130] “In one aspect, one, two, or more points of detection may be used, the points of detection comprising at least one point of optical detection that is based on at least one laser or at least one laser-like source. In some embodiments, the laser may be provided through a unique optical configuration that comprises a remote focusing module (e.g., a tunable acoustic gradient (TAG) index lens), and two objectives provided at an angle of about 60 to about 120 degree, or of about 90 degree, at two corners of a prism, to provide an optical focal plane that crosses passing droplets in a channel of a microfluidic device at a point of detection.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 11, Mathuis in view of Battrell and Wu teaches the system of claim 8, wherein the movement of the light source and the objective relative to each of the one or more cell culture containers allows the plurality of images to be acquired at each of a plurality of different illumination angles relative to the first transparent window (Wu - [0130] “In one aspect, one, two, or more points of detection may be used, the points of detection comprising at least one point of optical detection that is based on at least one laser or at least one laser-like source. In some embodiments, the laser may be provided through a unique optical configuration that comprises a remote focusing module (e.g., a tunable acoustic gradient (TAG) index lens), and two objectives provided at an angle of about 60 to about 120 degree, or of about 90 degree, at two corners of a prism, to provide an optical focal plane that crosses passing droplets in a channel of a microfluidic device at a point of detection.”) (Wu - [0039] “In some embodiments, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 30 degrees to about 60 degrees relative to the first channel. For example, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 40 degrees to about 50 degrees. Preferably, the first objective or the second objective may be configured to direct the modulated laser energy at an angle of about 45 degrees.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 12, Mathuis in view of Battrell and Wu teaches the system of claim 11, wherein the light source emits light at a plurality of different wavelengths, and wherein the plurality of different wavelengths illuminates the at least one closed cell culture chamber at a plurality of different angles (Mathuis - [0061] “The transparent part (152) is configured for the passage of light emitted by the DHM light source.”) (Mathuis - [0128] “In a DHM system, where the object wave front is recorded from multiple angles, it is possible to fully characterize the optical characteristics of the object and create tomography images of the object.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 13, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the computer processor is further programmed to perform a machine learning analysis of the plurality of images or the quantitative phase images (Mathuis - [0134] “The machine learning method learns how to discriminate between a virally-infected cell and a non-virally infected cell based on the holographic information, in particular on the cellular parameter data, thereby creating the predictive model.”) (Mathuis - [0069] “In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 14, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the imaging system is further configured to automatically acquire the plurality of images based on a schedule (Mathuis - [0069] “Holographic information refers to information, generally being phase and amplitude information, which can be obtained through a digital holographic microscope (DHM) from the cell sample. In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”) (Mathuis - [0056] “The viral status may be provided in “real time”. By “real-time” is a means that the status is regularly updated (e.g. 1-5 times/min) to reflect changes in virus load as cells in the sample are incubated. The sample may be a flowing suspension. The sample may be a flowing suspension pumped from and returned to a bioreactor.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 15, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the one or more cell culture containers comprise a closed cassette (Mathuis - [0066] “The sample may comprise cells on a support substrate, incorporated into a glass or plastic container, or microscope slide. Suitable container include multi-plate well, T-flask.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 16, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the imaging system is further configured to acquire the plurality of images over a period of time (Mathuis - [0069] “Holographic information refers to information, generally being phase and amplitude information, which can be obtained through a digital holographic microscope (DHM) from the cell sample. In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 17, Mathuis in view of Battrell and Wu teaches the system of claim 16, wherein the computer processor is further programmed to store, for the at least one closed cell culture chamber of each of the one or more cell culture containers, a set of time-series image data from the plurality of images or the quantitative phase images (Mathuis - [0122] “Digital Holographic Microscopy (DHM) is a technique which allows a recording of three dimensional information of a sample or object without the need of scanning the sample layer-by-layer. In this respect DHM is a superior technique to confocal microscopy in terms of acquisition speed. In DHM, a holographic representation is recorded by an image sensor such a CCD or CMOS. The holographic representation may be subsequently be stored or processed on a computer.”) (Mathuis - [0069] “In particular, said holographic information may include a digital hologram acquired by the DHM, an intensity image derived from the digital hologram, a quantitative phase contrast image derived from the digital hologram, or a combination of these. The intensity image and quantitative phase contrast image may be obtained from the digital hologram by hologram reconstruction.”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 18, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the light source is further configured to direct incident light onto the first transparent window (Mathuis - [0061] “The transparent part (152) is configured for the passage of light emitted by the DHM light source.”) (Battrell - [Claim 1] “the microfluidic cartridge having a plastic flexible body enclosing a detection chamber, the detection chamber having a first optical window and a second optical window oppositely disposed thereon; wherein, a) the second optical window is a thermo-optical window formed of a compliant thermo-optical film;”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Regarding claim 19, Mathuis in view of Battrell and Wu teaches the system of claim 1, wherein the light source is further configured to direct incident light on the second transparent window (Mathuis - [0061] “The transparent part (152) is configured for the passage of light emitted by the DHM light source.”) (Battrell - [Claim 1] “the microfluidic cartridge having a plastic flexible body enclosing a detection chamber, the detection chamber having a first optical window and a second optical window oppositely disposed thereon; wherein, a) the second optical window is a thermo-optical window formed of a compliant thermo-optical film;”).
The motivation for combining Mathuis, Battrell, and Wu is the same motivation as used for claim 1.
Conclusion
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/AMANDA H PEARSON/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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