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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, in the reply filed on 01/02/2026 is acknowledged.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/02/2026.
Claim Objections
Claim 4 is objected to because of the following informalities: It is suggested to remove the extraneous period at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1, 2 and 4-5 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rothberg et al. (US 20230109581 A1; effectively filed 10/01/2021).
Regarding claim 1, Rothberg teaches a device (abstract; Fig. 1; [0002]) comprising:
a well ([0020] teaches a device that houses a reaction tube, such as a chimney-shaped component, i.e. well; Fig. 7 and [0081], central well of heater 240) configured to receive a reaction tube containing an analyte (interpreted as a functional limitation, see MPEP 2114; [0020] teaches the chimney-shaped component is designed to receive the reaction tube; Fig. 1 teaches reaction tube 10 comprises contents 13; [0018] teaches test tubes containing reagents and target nucleic acid sequences; note that “reaction tube containing an analyte” is not positively recited structurally);
a receiver ([0038]-[0039], “receiving component of the visual result detection device”) configured to receive wirelessly transmitted data from a chip coupled to the reaction tube (interpreted as a functional limitation, see MPEP 2114; [0038]-[0039] teaches the receiving component wirelessly receives transmitted information from a RFID tag or NFC tag disposed on the reaction tube or cap of the reaction tube), the wirelessly transmitted data including information for determining a parameter associated with a type of test to be performed on the analyte by the device (interpreted as a functional limitation, see MPEP 2114; [0038]-[0040],[0055] teaches the information of the physical encoding includes test instructions to configure the visual result detection device to illuminate and/or image the reaction tube and/or other information of interest; therefore, the receiver is capable of receiving the claimed data);
a light emitting source (Fig. 1, illumination source 14) configured to emit an excitation light at a wavelength to illuminate the analyte in the reaction tube (Fig. 1; [0028]-[0028]);
an optical detector (Fig. 1, detector 16) configured to receive an emission light in response to the analyte being illuminated by the excitation light (Fig. 1; [0028],[0030]); and
a processor (Fig. 6, [0036], processor 610) operably coupled to the receiver and the light emitting source (Fig. 6; [0036],[0038]-[0039]), the processor configured to select the wavelength of the emission light based on the parameter ([0036] teaches the processor controls behavior of the visual result detection device, such as the illumination sources; [0029] teaches a programmable illumination source that provides wavelengths; [0044] teaches the visual result detection device configured to provide illumination at different wavelengths to detect the presence of different probes; [0038]-[0040],[0055] teaches the information of the physical encoding includes test instructions to configure the visual result detection device to illuminate and/or image the reaction tube and/or other information of interest; [0043] teaches test instructions are customized based on the fluorescent probes or dyes; [0055] teaches the test instructions including information on dye behaviors when subject to illumination, and illuminating for a test for a certain virus using a certain type of chemistry; therefore, it is implied that the processor is configured to select or provide the wavelength of emission light based on the test instructions in order to properly follow the test instructions based on the fluorescent probes or dyes related to a type of test to be performed).
In an alternative interpretation, if it is determined that Rothberg fails to explicitly teach: the processor configured to select the wavelength of the emission light based on the parameter, Rothberg teaches: the processor controls behavior of the visual result detection device, such as the illumination sources ([0036]); a programmable illumination source that provides wavelengths ([0029]); the visual result detection device configured to provide illumination at different wavelengths to detect the presence of different probes ([0044]); the information of the physical encoding includes test instructions to configure the visual result detection device to illuminate and/or image the reaction tube and/or other information of interest ([0038]-[0040],[0055]); test instructions are customized based on the fluorescent probes or dyes ([0043]); the test instructions including information on dye behaviors when subject to illumination, and illuminating for a test for a certain virus using a certain type of chemistry ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Rothberg to incorporate the information of controlling and programming the illumination sources, illumination at different wavelengths for different probes, test instructions customized based on the fluorescent probes or dyes, and information of illumination based on dye behavior and virus type of Rothberg to provide: the processor configured to select the wavelength of the emission light based on the parameter. Doing so would have a reasonable expectation of successfully improving automation and optimization of the illumination wavelength when performing a particular type of test for a desired analyte.
Regarding claim 2, Rothberg further teaches the device of claim 1, further comprising:
a heat block defining the well (Fig. 7 and [0081] teaches a header block 240 that defines a well for the reaction tube);
the processor operably coupled to the heat block and configured to control the temperature of the analyte ([0036] teaches the processor controls the heating mechanisms, therefore is coupled to the heat block and configured to control temperature of the analyte; [0082] teaches the reaction tube is heated).
Regarding claim 4, Rothberg further teaches wherein the light emitting source includes one or more light emitting diodes ([0029]).
Regarding claim 5, Rothberg further teaches wherein the light emitting source is configured to illuminate a bottom part of the reaction tube (Fig. 1 shows illumination source 14 illuminating a relative bottom part of tube 10).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg as applied to claim 2 above, and further in view of Courtney et al. (US 20150233828 A1).
Regarding claim 3, Rothberg fails to teach: wherein the heat block includes a first opening configured to create an optical path from the light emitting source to a transparent portion of the reaction tube.
Rothberg teaches the visual detection component is incorporated within the heater for visual reading of the reaction tube ([0082]).
Courtney teaches a device for optically measuring fluorescence (abstract; Figs. 1-4) including wells (32) for receiving a sample tube (16) made of a transparent material (abstract). Courtney teaches the device includes a heat block (Fig. 2 and [0047]-[0048], thermally conductive block 34) that includes a first opening (36) configured to create an optical path from the light emitting source to a transparent portion of the reaction tube (Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat block of Rothberg to incorporate Rothberg’s teachings of a visual detection component is incorporated within the heater for visual reading of the reaction tube ([0082]) and Courtney’s device including a heat block with an opening that provides an optical path for the light emitting source (Figs. 1-2; [0047]-[0048]) to provide: wherein the heat block includes a first opening configured to create an optical path from the light emitting source to a transparent portion of the reaction tube. Doing so would have a reasonable expectation of successfully improving transmission of desired excitation light from the light emitting source, through the heat block, and to the analyte inside of the reaction tube.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg as applied to claim 1 above, and further in view of Maracas et al. (US 5772966 A).
Regarding claim 6, Rothberg fails to teach: the device of claim 1, further comprising: a hinged cover configured to be movable to cover a top portion of the reaction tube, the receiver located within the hinged cover.
Rothberg teaches an RFID tag or NFC tag can be integrated with or adhered to the cap of the reaction tube ([0038]-[0039]).
Maracas teaches an assay dispensing apparatus (abstract). Maracas teaches the apparatus includes a cover, which selectively covers and uncovers a top face of a body and is pivotably-connected using a hinge (column 15, lines 37-42); and the cover is placed in an uncovered state for dispensing samples into ports and a covered state that seals the samples within the apparatus for storage and use of the device (column 15, lines 42-46). Maracas teaches a cover plate can include a transmitter for wirelessly transmitting a signal from a sensor, the transmitter including a radio frequency tag or transponder integrated with the cover plate (column 20, lines 15-22). Maracas teaches the device includes a wireless receiver to receive the signal from the transmitter (column 20, lines 23-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rothberg to incorporate Rothberg’s teachings of an RFID tag or NFC tag can be integrated with or adhered to the cap of the reaction tube ([0038]-[0039]) and Maracas’ teachings of an assay device with a hinged cover and a wireless receiver to receive a signal from a cover plate (column 15, lines 37-46; column 20, lines 15-30) to provide: the device of claim 1, further comprising: a hinged cover configured to be movable to cover a top portion of the reaction tube, the receiver located within the hinged cover. Doing so would have a reasonable expectation of successfully improving sealing of the reaction tube for storage or during use and allowing for receiving transmitted data from the chip when the chip is on the top or cap of the reaction tube. Additionally, providing the receiver located within the hinged cover is an obvious matter of design choice that would have an expected result of aligning the receiver with the chip of the reaction tube when the chip is at the top of the reaction tube (MPEP 2144.04(VI)(C); In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Regarding claim 7, Rothberg further teaches wherein the receiver is further configured to emit or receive a near-field communication signal (interpreted as a functional limitation, see MPEP 2114; [0038]-[0039] teaches the receiving component wirelessly receives transmitted information from a NFC tag disposed on the reaction tube or cap of the reaction tube).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dodgson (US 20120029832 A1) teaches systems for handling biological materials (abstract), the system comprising a hinged lid that covers a vial (Fig. 3c).
Parnaby (US 20230101253 A1; effectively filed 09/01/2021) teaches a system for nucleic acid sequencing using a light source and detector (abstract). Parnaby teaches the computer system 106 may automatically determine which optical frequency should be output from the light source, e.g., by scanning labels and/or barcodes attached to a sample vial and determining the particular fluorophores to be used in a sequencing reaction based on the labels and/or barcodes, or by retrieving information stored in the memory relating to previous sequencing reactions, and then control the light source to select and output the desired optical frequency ([0033]). Parnaby teaches the computer system may automatically determine which wavelength or which range of wavelengths should be output from the light source, e.g., by scanning labels and/or barcodes attached to a sample vial and determining the particular fluorophores used in a sequencing reaction based on the labels and/or barcodes, or by retrieving information stored in the memory relating to previous sequencing reactions, and then control the light source to select and output the desired wavelength or range of wavelengths ([0040]).
Bonecker (US 20090155923 A1) teaches a mixing container for a photometric measuring device (abstract). Bonecker teaches an RFID chip which is readable in a contactless way is arranged on the mixing container for identifying the samples ([0024],[0049]). Bonecker teaches the RFID chip can contain the type, number and calibration data and expiration date of the tests, thus ensuring automation in the test recognition and increased security in making the findings ([0049]). Bonecker teaches the device automatically choosing the correct test software on the basis of the data stored on the RFID chip ([0055]).
Tidd et al. (US 20210155978 A1; effectively filed 08/10/2017) teaches systems for performing nucleic acid amplification assays in an automated analyzer (abstract). Tidd teaches a method including (a) inputting, into a computer system, user-defined assay parameters that at least partially define the nucleic acid amplification assay to be performed on a sample positioned in the analyzer; the inputting may include (i) selecting one or more detection parameters, where each detection parameter is indicative of a wavelength of fluorescence data that will be recorded by the analyzer during the nucleic acid amplification assay ([0046]). Tidd teaches containers may include an RFID transponder that wirelessly transmits information related to the container to an RFID reader ([0179]). Tidd teaches an RFID reader transmits information about a container to a controller, the information can include (1) a receptacle identifier that identifies each receptacle 1940 supported in container 1920; (2) a holder identifier that identifies container 1920; and (3) a process identifier that identifies the processes (e.g., assays) to be performed using reconstitution fluids ([0183]). Tidd teaches based on the information received from RFID reader, the controller may determine the process to be performed ([0184]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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