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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 February 2026 has been entered.
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 (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 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.
Claims 1, 4-17, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasson et al (US 20160124009 A1).
With regards to claim 1, Wasson et al teaches;
The claimed “a treatment chamber configured to receive the sample” has been read on the taught ([0393], “A sample processing device is provided in accordance with an aspect of the invention. A sample processing device may comprise one or more components. The sample processing device may be configured to receive a sample...”; A sample processing device reads on a treatment chamber.);
The claimed “a movement device movably arranged in a first spatial direction of the treatment chamber” has been read on the taught ([0588], “…robots, such as a robotic arm, may be provided within a device housing... They may permit movement of components within a device, between tracks, between modules, or within modules.”; [0595], “The robots may be capable of moving in any direction. The robots may be capable of moving in a lateral direction (e.g., horizontal direction)…”; A robot which permits the movement of components within a device and which is capable of moving in a lateral direction reads on a movement device movably arranged in a first spatial direction of the treatment chamber.);
The claimed “an analysis unit arranged in the treatment chamber and configured to analyze the sample” has been read on the taught ([0390], “Sample processing devices may comprise one, two or more modules…”; [0481], “One or more assay stations may be provided to a module.”; [1133]”…an assay station, or any other portion of a module or device, may include one or more assay units. An assay unit may be configured to perform a biological or chemical reaction that yields a detectable signal indicative of the presence or absence of one or more analyte, and/or a concentration of a one or more analyte.” An assay station reads on an analysis unit. The assay unit provided as a module of a sample processing device reads on the analysis unit arranged in a treatment chamber.);
The claimed wherein “the analysis unit [is] configured to be received by the movement device and moved to the sample by the movement device” has been read on the taught ([0588], “The robots may move one or more component, including but not limited to […] assay station or system, or any other component described elsewhere herein. The components may be movable within a module, within a rack, or within the device.”; The robot reads on the movement device. The robot which may move an assay station within the device reads on the analysis unit being configured to be received by the movement device and moved to the sample device; [1139], “The assay units may be independently movable relative to one another, or another portion of the device or module.”; The assay units being movable within the device supports the analysis unit being configured to be received and moved.);
The claimed wherein “the analysis unit being a wireless analysis unit with an energy storage device” has been read on the taught ([0089], “…a system, alone or in combination, includes a plurality of modules, and each individual modules of the plurality of modules is in wireless communication with a controller of the system.”; The module in wireless connection reads on the analysis unit being a wireless analysis unit; [1460], “Each module may be connected to or have its own local power source.”; [1459], “A device may optionally have an internal power source. For example, a local energy storage may be provided on the device… the local energy storage may be one or more battery or ultracapacitor.”; The module connected to a local power source, and wherein the local energy storage is a battery or ultracapacitor reads on the analysis unit having an energy storage device.);
The claimed “an electronic controller signal-connected to the movement device and the analysis unit“ has been read on the taught ([0394], "The device may have one or more controllers, including one or both of device-level and module-level controllers (e.g. where the device level controller is configured to direct certain procedures to be performed on certain modules and where the module level controller is configured to direct the components or stations to execute particular steps for sample preparation, sample assaying, or sample detection. In an alternative, a device-level controller may be connected to modules and components of the module, to perform both of these functions)."; The controller configured to direct components to execute steps reads on an electronic controller connected to the movement device and analysis unit.);
The claimed “a charging station arranged in the treatment chamber configured to store the analysis unit and charge the energy storage device“ has been read on the taught ([0617], “In one embodiment, a shared module may be a recharging station for wireless or wired peripherals that are used in conjunction with the device.”);
The claimed wherein “the movement device comprises a sample processing device configured to perform a processing step on the sample“ has been read on the taught ([0588], “The robots may move one or more component, including but not limited to a sample handling system...”; [0491], “Any description herein of a fluid handling system may also apply to other sample handling systems, and vice versa… “; [0490], “The fluid handling system may permit the movement of a sample, reagent, or a fluid. The fluid handling system may permit the dispensing and/or aspiration of a fluid. The fluid handling system may pick up a desired fluid from a selected location and/or may dispense a fluid at a selected location. The fluid handling system may permit the mixing and/or reaction of two or more fluids.”; A robot comprising a sample handling system, wherein the sample/fluid handling system is capable of mixing two fluids reads on the movement device comprising a sample processing device configured to perform a processing step on the sample.);
The claimed “the sample processing device comprises a receiving element configured to receive the analysis unit, so that the analysis unit is capable of being moved to the sample by the movement device in an operating state“ has been read on the taught ([0491], “A sample handling system may be capable of accepting, depositing, and/or moving a container (e.g., assay unit, reagent unit)…”; [0483], “a system, device, or module provided herein may have an assay station/cartridge receiving location. The assay station receiving location may be configured to receive a removable or insertable assay station.”; The sample handling system capable of accepting, depositing, or moving an assay unit, and which may have an assay station receiving location reads on the sample processing device comprising a receiving element configured to receive the analysis unit.);
The limitation “the analyzing unit is movable by the movement device through the treatment chamber from the sample to the charging station after analyzing the sample” is functional language describing the intended use of the device. As described above, the analyzing unit is capable of being moved to the sample, and is capable of being received by the charging unit. Accordingly, this limitation does not further define the claimed invention over the prior art of Wasson et al.
With regards to claim 4, the apparatus of claim 1 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the analysis unit is a detection device” has been read on the taught ([0478], “Devices may comprise one or more modules… A module may comprise […] two or more… of a sample preparation station 310, and/or an assay station 320, and/or a detection station 330.”; [0488], "A detection station may contain one or more detection units..."; [1160] An assay unit may be shaped and/or sized to permit detection by a detection unit.”; Taken together, Wasson et al teaches that a module may comprise an assay station and a detection station, that the detection station may include a detection unit, and that an assay unit may work with a detection unit. Accordingly, a module comprising an assay station of claim 1 and detection unit reads on the analysis unit being a detection device.);
The claimed “a detection device comprising a radiation source configured to irradiate the sample with a primary radiation“ has been read on the taught ([1377], “An optical detector can also comprise a light source…”);
The claimed “a detector configured to receive a secondary radiation source originating from the sample“ has been read on the taught ([1370], “A detection unit may include one or more optical or visual sensor…”).
With regards to claim 5, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the detector is a diode“ has been read on the taught ([0488], “A detection station may contain […] a photodiode…”).
With regards to claim 6, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the radiation source is a deuterium lamp, a halogen lamp, or a LED“ has been read on the taught ([1855], “Sources of light for exciting fluorophores are well known in the art, including but not limited to xenon lamps, lasers, LEDs…”; An LED for exciting fluorophores reads on a radiation source being and LED; See also [0860] for a list of light sources.).
With regards to claim 7, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the detection device comprises a plurality of detectors or radiation sources“ has been read on the taught ([0862], “One or more of a plurality of light sources may be provided.” A plurality of light sources reads on a plurality of radiation sources. See also [0488], "A detection station may contain one or more detection units…” More than one detection units reads on a plurality of detectors or radiation sources.).
With regards to claim 8, the apparatus of claim 1 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the analysis unit is designed as an infrared photometer configured to measure optical temperature, a pH meter, a camera, an ultrasonic sensor, a laser, a laser interferometer, or a UVC unit for local decontamination of the treatment chamber“ has been read on the taught ([1400], “Cameras may be useful as detection units.”; A camera as a detection unit reads on the analysis unit being designed as a camera.).
With regards to claim 9, the apparatus of claim 1 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the energy storage device is a capacitor, a battery, or an accumulator“ has been read on the taught ([1460], “Each module may be connected to or have its own local power source.”; [1459], “A device may optionally have an internal power source. For example, a local energy storage may be provided on the device… the local energy storage may be one or more battery or ultracapacitor.”; A power source being a batter or ultracapacitor reads on wherein an energy storage device is a capacitor or a battery.).
With regards to claim 10, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the detection device is a photometer“ has been read on the taught ([0394], “ Components and stations of a module may include […] spectrophotometers…”; A spectrophotometer reads on a photometer.).
With regards to claim 11, the apparatus of claim 1 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the movement device is configured to be moved in a second spatial direction of the treatment chamber, the second spatial direction orthogonal to the first spatial direction and in a third spatial direction of the treatment chamber, the third spatial direction orthogonal to the first spatial direction and the second spatial direction.“ has been read on the taught ([0595], “The robots may be capable of moving in any direction. The robots may be capable of moving in a lateral direction (e.g., horizontal direction) and/or a vertical direction. A robot may be capable of moving within a horizontal plane, and/or a vertical plane. A robot may be capable of moving in an x, y, and/or z direction wherein an x-axis, y-axis, and z-axis are orthogonal to one another.”);
With regards to claim 12, the apparatus of claim 2 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the sample processing device is a pipetting device configured to receive and dispense a fluid“ has been read on the taught ([0491], “Any description herein of a fluid handling system may also apply to other sample handling systems, and vice versa… “; [0697], “…the fluid handling system may use a pipette or similar device.”; [0490], “The fluid handling system may permit the movement of a sample, reagent, or a fluid. The fluid handling system may permit the dispensing and/or aspiration of a fluid.”; The fluid handling device which may permit the dispensing and/or aspiration of a fluid reads on pipetting device.);
The claimed “the receiving element is configured to receive a pipette tip“ has been read on the taught ([0699], “A fluid handling device may include […] one or more tip.”; [1158], “An assay unit may be picked up and/or removed from a fluid handling mechanism. For example, an assay tip or other assay unit may be picked up by a pipette nozzle.”; An assay unit which may be an assay tip reads on the analysis unit. The receiving element configured to receive the analysis unit being further configured to receive a pipette tip reads on a fluid handling device including one or more tip.).
With regards to claim 13, Wasson et al teaches;
Wasson et al additionally teaches;
The claimed “providing the automated laboratory apparatus according to claim 1“ has been read on the taught ([0034], “…said method comprising: providing the sample to systems above or elsewhere herein…”; providing the sample to the systems herein reads on providing the automated laboratory apparatus.);
The claimed “introducing the sample into the treatment chamber “ has been read on the taught (Claim 5, “…the method comprising: a) introducing a biological […] into a sample processing device…” introducing the biological sample into a sample processing device reads on introducing the sample into the treatment chamber.);
The claimed “receiving the analysis unit by the movement device through the treatment chamber to the sample “ has been read on the taught ([1159], “An assay unit may be moved within a device and/or module using a fluid handling mechanism.”);
The claimed “analyzing the sample by the analysis unit” has been read on the taught (Claim 5, “…with the aid of the detection station or cytometry station, obtaining data measurements of the assay performed in each of the first, second, and third, and fourth assay units.”).
With regards to claim 14, the method of claim 13 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “the analysis unit is received by the receiving element of the sample processing device and is transported by the movement device through the treatment chamber from the charging station to the sample” has been read on the taught ([0497], “A module may be brought into electrical connection with a device when a module is inserted/attached to the device. The device may provide power (or electricity) to the module. A module may be disconnected from the electrical source when removed from the device.”; [1381], “…the device or controller may receive or store a protocol which contains instructions for directing a sample handling apparatus within a device or module to move assay units to different detection units (or vice versa),”; The detection unit which is moved to the assay unit by a sample handling apparatus reads on the detection device being transported by the movement device to the sample.).
With regards to claim 15, the method of claim 14 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “comprising moving the detection device by the movement device through the treatment chamber from the sample to the charging station after analyzing the sample“ has been read on the taught ([0598], “In some cases, the module is removably detachable—that is, the module may be removed from the mounting station and returned to its original position on the mounting station.”; [0611], “The rechargeable battery module may be recharged... The dedicated recharging station may be the device or be operatively connected to the device (e.g., recharging can be done via induction without direct physical contact).”; A module which is returned to its original position in a device which has a dedicated recharging station reads on moving the detection device to the charging station after analyzing the sample.).
With regards to claim 16, the method of claim 14 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “irradiating the sample with a primary radiation by a radiation source of the detection device“ has been read on the taught ([1355], “To perform fluorescence assays […] a light source having a narrow emission wavelength profile may be used… an excitation filter may be placed between the light source and the sample, such that light of only a selected wavelength(s) reaches the sample.” A light source with a selected wavelength reaching a sample to perform fluorescence reads on irradiating the sample with a primary radiation by a radiation source of the detection device.);
The claimed “receiving an secondary radiation originating from the sample by a detector of the detection device“ has been read on the taught ([1355], “Furthermore, an emissions filter may be placed between the sample and the optical detector, such that only light of a selected wavelength (typically that which is emitted by the fluorescent compound) reaches the optical detector.”; Light emitted by the fluorescent compound reaching the optical detector reads on receiving a secondary radiation originating from the sample by a detector of the detection device.).
With regards to claim 17, the method of claim 16 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “determining a concentration of the sample based on the secondary radiation“ has been read on the taught ([1400], “For example, cameras may be useful for capturing changes of cell morphology, concentration and spatial distribution of entities in cells that are labeled with contrast agents (e.g. fluorescent dyes…”; Measuring the concentration of cells labeled with fluorescent dyes reads on determining a concentration of the sample based on the secondary radiation.).
With regards to claim 19, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the detection device is a spectrometer“ has been read on the taught ([0269], “Optionally, the sensors include at least two sensors selected from the group consisting of spectrometers…”).
With regards to claim 20, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the detection device is a fluorometer“ has been read on the taught ([0269], “Optionally, the sensors include at least two sensors selected from the group consisting of […] fluorescence detectors…”; A fluorescence detector reads on a fluorometer.).
With regards to claim 21, the apparatus of claim 1 is anticipated by Wasson et al.
Wasson et al additionally teaches;
The claimed “wherein the movement device is configured to move the analysis unit to a predeterminable well containing the fluid” has been read on the taught ([1369], “The detection unit may have a fixed position, or may be movable. The detection unit may be movable relative to a component from which a signal is to be detected.”; A component from which a signal is to be detected reads on a predeterminable well. The detection unit being movable reads to a component reads on the movement device being configured to move the analysis unit.).
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.
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wasson et al (US 20160124009 A1) in view of Godfrey (Godfrey, L. “Choosing the Detector for your Unique Light Sensing Application,” PerkinElmer, 2003. Please see NPL attached with this office action.).
With regards to claim 18, the apparatus of claim 4 is anticipated by Wasson et al.
Wasson et al teaches;
The claimed “wherein the detector is a silicon photodiode or a vacuum photodiode“ has been read on the taught ([0488], “A detection station may contain […] a photodiode…”).
However, Wasson et al fails to teach wherein the detector is a silicon or a vacuum photodiode.
In the analogous art of photodiode detectors, Godfrey teaches;
A silicon photodiode (Photodiodes, paragraph 6, “Silicon based photodiodes cover the wide range of wavelengths from 190 to 1100 nm (the lower limit is set by absorption of ultraviolet light in air).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detector including a photodiode as taught by Wasson et al with the silicon photodiode as taught by Godfrey, for the benefit of using a sensor which is lightweight, inexpensive, and which covers a wide range of detectable wavelengths (Photodiodes, paragraph 3, “They are small and light weight… They are inexpensive, with million piece pricing for small area detectors less than $0.25.”; Photodiodes, paragraph 6, “Silicon based photodiodes cover the wide range of wavelengths from 190 to 1100 nm (the lower limit is set by absorption of ultraviolet light in air).”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wenk et al (WO 2020173867 A1) teaches a pipetting device with a reaction chamber and a wireless sensing device.
Kim et al (WO 2015030368) teaches an automated laboratory device with a reaction chamber and a sensing device.
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/LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797