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 12/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1-17 in the reply filed on 04/21/2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/2026.
Claim Rejections - 35 USC § 102
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 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuysuzoglu et al. (hereinafter Tuysuzoglu) WO 2021/015881 cited in the IDS filed 12/02/2025.
Regarding claim 1, Tuysuzoglu discloses a molecular detection system, comprising a main control device (controller 110) and a plurality of molecular detection devices (laboratory analyzers 104i through 104n; [0029 and 0039]); wherein the main control device communicates with each of the plurality of molecular detection devices; the main control device is configured to control each of the plurality of molecular detection devices to perform detection (Typically, each of the analyzers 104i through 104.sub.n includes a dedicated computer or workstation therewith (designated as analyzer controller 245 in Figs 2A-2C), that can control the specific operation of each of the analyzers 104i through 104n. Thus, system controller 1 10 may interface and communicate with the various analyzer controller 245 by way of communication channels 147i through 147.sub.n. [0042]); the main control device comprises a display module configured to display detection data of each of the plurality of molecular detection devices (System controller 1 10 may include an operator interface 1 12 configured to enable an operator 1 14 to provide input and intervention to the diagnostic laboratory system 100 when desired. Operator interface 1 12 may include a user input device (e.g., keyboard- not shown) for entering, e.g., data, requests for status, operational and control commands, etc., to system controller 1 10. Operator interface 1 12 may also include a display device (not shown) configured to display status of each of the analyzers 104i through 104.sub.n, menus, data, and/or messages received from the analyzers 104i through 104.sub.n. [0041]); and detection performed by the plurality of molecular detection devices at least comprises nucleic acid extraction, amplification and detection [0031-0032, 0059-0060 and 0113-0114]. Also see whole document.
Regarding claim 2, Tuysuzoglu discloses wherein the main control device regulates detection parameters of each of the plurality of the molecular detection devices to control each of the plurality of the molecular detection devices to perform detection; each molecular detection device comprises a control module (analyzer controller 245); and the control module regulates the detection parameters of the molecular detection device to control the molecular detection device to perform detection (Typically, each of the analyzers 104i through 104.sub.n includes a dedicated computer or workstation therewith (designated as analyzer controller 245 in Figs 2A-2C), that can control the specific operation of each of the analyzers 104i through 104n. Thus, system controller 1 10 may interface and communicate with the various analyzer controller 245 by way of communication channels 147i through 147.sub.n. [0042]).
As to wherein a priority that the main control device regulates the detection parameters of each molecular detection device is higher than a priority that each molecular detection device’s own control module regulates the detection parameters of each molecular detection device, the system controller which includes a memory (e.g., RAM, ROM, other, or combinations) configured to store programming instructions and other information/data, disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the system controller of Tuysuzoglu is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraph 0044.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 3, wherein the main control device is further configured to: in response to receiving a networking command, broadcast a device searching command, receive reply information returned by the molecular detection device according to the device searching command, and add device information of the molecular detection device to a list of devices to be confirmed, wherein the reply information carries the device information of the molecular detection device; and broadcast a command for distribution network confirmation, receive distribution network confirmation information returned by the molecular detection device according to the command for distribution network confirmation; and store a device configuration list according to the list of devices to be confirmed in response to receiving the distribution network confirmation information from each of the plurality of molecular detection devices in the list of devices to be confirmed, the system controller which includes a memory (e.g., RAM, ROM, other, or combinations) configured to store programming instructions and other information/data, disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the system controller of Tuysuzoglu is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraph 0044.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claims 4-6, the system controller disclosed by Tuysuzoglu includes a memory (e.g., RAM, ROM, other, or combinations) configured to store programming instructions and other information/data. The system controller is structurally the same as the instantly claimed main control device. Thus, in the absence of further positively recited structure the system controller of Tuysuzoglu is capable of providing the operating conditions as listed in the intended use section of claims 4-6 in view of paragraph 0044.
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 7, Tuysuzoglu discloses wherein the main control device communicates with each of the plurality of molecular detection devices in a wireless manner; or the main control device communicates with each of the plurality of the molecular detection devices by means of a Registered Jack 45 (e.g., an ethernet port connected to a local area network) or a Controller Area Network via a wired network [0044].
Regarding claim 8, Tuysuzoglu discloses wherein each molecular detection device comprises a loading station (mounting spaces 216) and an amplification detection station (receptacles 244R) that are arranged at intervals in a first direction [0047 and 0053; Figs. 2A, 2B and 2C]; and the molecular detection device comprises: a pushing module (robot 226) controllably movable in the first direction between the loading station and the amplification detection station, the pushing module being configured to receive or unload a reagent device when moving to the loading station [0054-0055 and 0060]; a pipetting module (pipette 225) arranged corresponding to a position between the loading station and the amplification detection station, wherein the pipetting module is configured to pipet a sample between respective reagent chambers in the reagent device when the pushing module moves between the loading station and the amplification detection station [0048 and 0054; Figs. 2A, 2B and 2C]; an amplification detection module (incubation member 244/244A) arranged corresponding to the amplification detection station, wherein the amplification detection module is configured to perform amplification and detection on a reagent containing the sample in the reagent device when the pushing module moves to the amplification detection station [0053 and 0059]; and a communication module (communication line 147i) electrically connected to the pushing module, the pipetting module, and the amplification detection module, and communicating with the main control device [0042, 0053 and 0059].
Regarding claim 9, Tuysuzoglu discloses wherein the pipetting module comprises a connecting part (aspiration/dispense system 227) configured to connect with or disconnect from a pipette tip (pipette tip 225T) [0048 and 0055].
As to during a movement of the pushing module between the loading station and the amplification detection station, the connecting part is capable of being alternately aligned with a plurality of reagent chambers of the reagent device in a second direction; the plurality of reagent chambers are configured to preload the sample and/or reagents; the second direction intersects the first direction; and when the pushing module moves until the connecting part is aligned with any one of the reagent chambers in the second direction, the pipetting module is controllably movable in the second direction to drive the pipette tip on the connecting part to be inserted into or withdraw from a current reagent chamber, the robot disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the robot of Tuysuzoglu is capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0048, 0054-0055, 0057 and 0060].
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 10, wherein during the movement of the pushing module between the loading station and the amplification detection station, the connecting part is capable of being aligned in the second direction with a tip chamber of the reagent device that is configured to preload the pipette tip; and when the pushing module moves until the connecting part is aligned with the tip chamber in the second direction, the pipetting module is controllably movable in the second direction, so as to drive the connecting part to be inserted into or withdraw from the tip chamber, so that the connecting part picks up the pipette tip in the tip chamber or release the pipette tip on the connecting part into the tip chamber, the robot and the aspiration/dispense system, disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the robot and the aspiration/dispense system of Tuysuzoglu are capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0048, 0054-0055, 0057 and 0060].
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 11, wherein during the movement of the pushing module between the loading station and the amplification detection station, the connecting part is capable of being alternately aligned with an injection chamber and a plunger chamber configured to load a plunger of the reagent device in the second direction; when the pushing module moves until the connecting part is aligned with the plunger chamber in the second direction, the pipetting module is controllably movable in the second direction, thereby driving the connecting part to be inserted into or withdraw from the plunger chamber, to pick up the plunger; and when the pushing module moves until the connecting part is aligned with the injection chamber in the second direction, the pipetting module is controllably movable in the second direction, thereby driving the plunger on the connecting part to be inserted into the injection chamber, to inject the reagent containing the sample in the injection chamber into a reaction tube of the reagent device, the robot and the aspiration/dispense system, disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the robot and the aspiration/dispense system of Tuysuzoglu are capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0048, 0053-0055, 0057 and 0060].
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 12, wherein when the pushing module moves to the amplification detection station, the reaction tube of the reagent device is mated with the amplification detection module; and the amplification detection module is configured to perform amplification and detection on the reagent containing the sample in the reaction tube of the reagent device, the robot and the aspiration/dispense system, disclosed by Tuysuzoglu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the robot and the aspiration/dispense system of Tuysuzoglu are capable of providing the operating conditions as listed in the intended use section of the claim in view of paragraphs [0031, 0046, 0048, 0053-0055, 0057 and 0059-0060].
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 13, Tuysuzoglu discloses wherein each molecular detection device further comprises a first driving module (sample transporter 106 and/or motor), wherein the first driving module is drivingly connected to the pipetting module to drive the pipetting module to move in the second direction; and the first driving module is electrically connected to the communication module (Fig. 1:147n). See paragraphs [0040, 0042, 0053, 0055 and 0059].
Claim Rejections - 35 USC § 103
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 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tuysuzoglu) WO 2021/015881 as applied to claims 1-13 above, and further in view of Handique et al. (hereinafter Handique) US 2021/0139951.
Regarding claim 14, Tuysuzoglu discloses a first driving module (the rejection of claim 13 above is relied upon) however, Tuysuzoglu does not expressly disclose wherein the first driving module comprises a first mounting base, a first driving member, a driving wheel, a driven wheel, and a transmission belt; wherein the pipetting module is movably connected to the first mounting base in the second direction; the first driving member is mounted on the first mounting base, and is electrically connected to the communication module; the driving wheel is drivingly connected to an output shaft of the first driving member; the driven wheel is rotatably connected to the first mounting base and is arranged spaced apart from the driving wheel in the second direction; and the transmission belt is sleeved between the driving wheel and the driven wheel, and is fixedly connected to the pipetting module.
While Tuysuzoglu does not expressly disclose wherein the first driving module comprises a first mounting base, a first driving member, a driving wheel, a driven wheel, and a transmission belt, Tuysuzoglu does disclose a functionally equivalent means. Therefore, it would have been an obvious matter of design choice to provide a first mounting base, a first driving member, a driving wheel, a driven wheel, and a transmission belt, wherein the pipetting module is movably connected to the first mounting base in the second direction; the first driving member is mounted on the first mounting base, and is electrically connected to the communication module; the driving wheel is drivingly connected to an output shaft of the first driving member; the driven wheel is rotatably connected to the first mounting base and is arranged spaced apart from the driving wheel in the second direction; and the transmission belt is sleeved between the driving wheel and the driven wheel, and is fixedly connected to the pipetting module, since applicant has not disclosed that the elements of claim 14 solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the driving module of Tuysuzoglu.
Regarding claim 15, Tuysuzoglu does not expressly disclose wherein the molecular detection device further comprises a second driving module; wherein the second driving module is drivingly connected to the pushing module to drive the pushing module to move in the first direction; and the second driving module is electrically connected to the communication module. However, Tuysuzoglu does disclose a first driving module (i.e., a sample transporter and motor(s)) electrically connected to the communication module (Fig. 1:147n). See paragraphs [0040, 0042, 0053, 0055 and 0059].
However, absent unexpected results, it would have been prima facie obvious to provide a second driving module drivingly connected to the pushing module to drive the pushing module to move in the first direction; and the second driving module is electrically connected to the communication module, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP §2144.04 (VI-B).
Regarding claim 16, Tuysuzoglu discloses a first driving module (the rejection of claim 15 above is relied upon) however, Tuysuzoglu as modified does not expressly disclose wherein the second driving module comprises a second mounting base, a second driving member, a screw rod, and a screw rod nut; wherein the pushing module is movably connected to the second mounting base in the first direction; the screw rod is rotatably connected to the second mounting base around its own axis, and an axis of the screw rod is parallel to the first direction; the second driving member is drivingly connected to the screw rod and is electrically connected to the communication module; and the screw rod nut is threadedly connected to the screw rod and is fixedly connected to the pushing module.
While Tuysuzoglu as modified does not expressly disclose wherein the second driving module comprises a second mounting base, a second driving member, a screw rod, and a screw rod nut, Tuysuzoglu does disclose a functionally equivalent means. Therefore, it would have been an obvious matter of design choice to provide second driving module comprises a second mounting base, a second driving member, a screw rod, and a screw rod nut; wherein the pushing module is movably connected to the second mounting base in the first direction; the screw rod is rotatably connected to the second mounting base around its own axis, and an axis of the screw rod is parallel to the first direction; the second driving member is drivingly connected to the screw rod and is electrically connected to the communication module; and the screw rod nut is threadedly connected to the screw rod and is fixedly connected to the pushing module, since applicant has not disclosed that the elements of claim 16 solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the driving module of Tuysuzoglu.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tuysuzoglu) WO 2021/015881 as applied to claims 1-16 above, and further in view of Handique et al. (hereinafter Handique) US 2021/0139951.
Regarding claim 17, Tuysuzoglu does not expressly disclose wherein each of the plurality of molecular detection devices further includes a casing, the pushing module, the pipetting module, and the amplification detection module are accommodated in the casing.
Handique discloses a microfluidic system (system 100/981) comprising a plurality of molecular detection devices (cartridge 200/994), a pushing module (a robotic dispenser), the pipetting module (pipette 10), and the amplification detection module (read head 300/detector 999) are accommodated in the casing (housing 2002). See paragraphs [0062, 0069, 0078, 0084-0085, 0093, 0148, 0186 and 0204-0205].
It would have been prima facie obvious to one of ordinary skill in the art to modify Tuysuzoglu such that each of the plurality of molecular detection devices, the pushing module, the pipetting module, and the amplification detection module are housed in a casing as taught by Handique, in order to maintain an aseptic environment and avoid contamination of the test samples.
Conclusion
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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