DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/2026 has been entered.
Status of Claims
Claims 21-30 and 33-41 are pending with claims 21-29 and 41 under examination and claims 30 and 33-40 withdrawn from consideration.
Claims 1-20 and 31-32 have been canceled.
Response to Amendment
The claim amendments, received 02/26/2026, have overcome the 112(b) rejection(s). Therefore, the rejection(s) have been withdrawn.
Based on the claim amendments and remarks received on 02/26/2026, the 101 rejection(s) have been withdrawn.
New double patenting rejection(s) have been set forth.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 21-29 and 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,428,367; hereinafter ‘367, in view of Brown et al. (US 2015/0346149; already of record – hereinafter “Brown”).
Regarding claim 21, ‘367 disclose a method, comprising:
receiving nucleic acid identity data from a plurality of portable detectors via a connection (‘367 disclose a remote processing system in communication with a plurality of portable detectors and comprises communications circuity configured to receive sample and location information from each of the portable detectors; claim 1), wherein the nucleic acid identity data is generated by each portable detector of the plurality of portable detectors operating on respective biological samples wherein the biological samples are different from one another (‘367 disclose each detector comprise a sample receiving component that receives a biological sample that is different from other biological samples, a reader to detect nucleic acids of interest in the biological sample, and a processor programmed to assemble a nucleic acid sequence of at least one biological sample based on the sample data; claim 1),
wherein each portable detector of the plurality of portable detectors comprise a communication circuitry and processing circuitry (‘367 disclose a transceiver configured to output the sample data generated by the reading component, a remote processing system in communication with each of the plurality of portable detectors, and communications circuity configured to receive the sample data and location information from each of the plurality of portable detectors; claim 1);
receiving location data from each of the plurality of portable detectors, via the connection, wherein the location data is associated with the nucleic acid identity data (‘367 disclose a transceiver configured to output the sample data generated by the reading component, a remote processing system in communication with each of the plurality of portable detectors, and communications circuity configured to receive the sample data and location information from each of the plurality of portable detectors; claim 1);
processing the nucleic acid identity data and the location data for each of the plurality of portable detectors (‘367 disclose a processor programmed to assemble a nucleic acid sequence of at least one biological sample based on sample data including nucleic acids of interest and location information from a locator, where the communications circuity receives the sample data and location information from each of the plurality of portable detectors; claim 1);
assembling a nucleotide sequence of at least one biological sample of the respective biological samples based on the processing of the nucleic acid identity data (‘367 disclose the processor programmed to assemble a nucleic acid sequence of at least one biological sample based on the sample data; claim 1);
determining that the nucleotide sequence is a match to a signature of interest based at least in part on the location data (‘367 disclose determining a sequence coverage based on a threshold that is 10x sequence coverage for one or more regions of a genome and associated with predetermined data quality score wherein the location data is associated with the nucleic acid sequence; claims 1-2 and 5-6); and
sending, via the connection, instructions to the communication circuitry of each of the portable detectors of the plurality of portable detectors that cause the processing circuitry of plurality of portable detectors (‘367 disclose the processor configured to provide instructions to each of the plurality of portable detectors; claims 1-4 and 6) to:
stop a flow of one or more reagents of each of the portable detectors of the plurality of portable detectors operating on the respective biological samples after determining that the nucleotide sequence of the at least one biological sample of the respective biological samples is the match (‘367 disclose the instructions stop operation of the reader before the reader has completed a sequence run or before at least one of the portable detectors has consumed available sequencing reagents; claims 1-4);
determine an additional biological sample to process that is different than the respective biological samples (‘367 disclose the processor configured to determine and provide new instructions to analyze new biological samples; claim 1); and
generate additional nucleic acid identity data using the additional biological sample (‘367 disclose the processor configured to analyze new biological samples; claim 1).
‘367 does not teach the connection is wireless and one or more flow control devices.
However, Brown teach the analogous art of a method, comprising receiving nucleic acid identity data from a plurality of portable detectors (Brown; figs. 1-2 & 11, [0024, 0045, 0088, 0098, 0133, 0240]), wherein the plurality of portable detectors receive the nucleic acid identity data via a wireless connection (Brown; [0088]), and one or more flow control devices (Brown; fig. 8, #60, [0180]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of portable detectors to be configured with a wireless connection and one or more flow control devices, as taught by Brown, because Brown teach the wireless connection provides a connection to a data network and the one or more flow control devices provides control of the fluidics system in the device (Brown; [0088, 0157]).
Regarding claim 22, modified ‘367 teach the method of claim 21 above, wherein the instructions to at least one of the portable detectors of the plurality of portable detectors stops the flow of one or more reagents operating before an entire genome of a biological sample among the respective biological samples is assembled (The modification of ‘367 to be configured with a wireless connection and one or more flow control devices, as taught by Brown, has previously been discussed above. ‘367 disclose the instructions stop operation of the reader before the reader has completed a sequence run or before at least one of the portable detectors has consumed available sequencing reagents; claims 1-4).
Regarding claim 23, modified ‘367 teach the method of claim 21 above, comprising receiving the signature of interest from a signature repository (‘367 disclose the sequence represents a predetermined sequence coverage; claim 2).
Regarding claim 24, modified ‘347 teach the method of claim 21 above, wherein each portable detector of the plurality of portable detectors is distinct from one another (‘347 disclose a plurality of portable detectors; claim 1).
Regarding claim 25, modified ‘347 teach the method of claim 21 above, comprising sending instructions to at least one of the portable detectors of the plurality of portable detectors to be loaded with new respective biological samples including the additional biological sample (‘367 disclose the processor configured to determine and provide new instructions to analyze new biological samples; claim 1).
Regarding claim 26, modified ‘347 teach the method of claim 25 above, wherein the new respective biological samples are assigned to the at least one of the portable detectors of the plurality of portable detectors based on the location data (367 disclose the processor configured to determine and provide new instructions to analyze new biological samples based on the location information; claim 1).
Regarding claim 27, modified ‘347 teach the method of claim 21 above, wherein the biological sample of each of the plurality of portable detectors corresponds to a different candidate sample of a plurality of candidate samples (‘347 disclose each biological sample is a different biological sample; claim 1).
Regarding claim 28, modified ‘347 teach the method of claim 21 above, wherein the instructions to each of the portable detectors of the plurality of portable detectors to stop the flow of one or more reagents via the one or more flow control devices of each of the portable detectors of the plurality of portable detectors operating on the respective biological samples cause a reader of the plurality of portable detectors to stop operation (The modification of ‘367 to be configured with a wireless connection and one or more flow control devices, as taught by Brown, has previously been discussed above. ‘367 disclose the instructions stop operation of the reader before the reader has completed a sequence run or before at least one of the portable detectors has consumed available sequencing reagents; claims 1-4).
Regarding claim 29, modified ‘347 teach the method of claim 21 above, wherein the location data indicates where the respective biological sample was obtained (‘347 disclose a locator configured to generate location information; claim 1).
Regarding claim 41, modified ‘347 teach the method of claim 21 above.
Modified ‘347 does not teach wherein the instructions indicate an order of biological samples to process, and wherein the instructions cause the plurality of portable detectors to determine the additional biological sample to process based on the order.
However, Brown teach the analogous art of a method, comprising receiving nucleic acid identity data from a plurality of portable detectors (Brown; figs. 1-2 & 11, [0024, 0045, 0088, 0098, 0133, 0240]), wherein the plurality of portable detectors are configured to determine an additional biological sample to process that is different than the respective biological samples and generate additional nucleic acid identity data using the additional biological sample (Brown teach loading a new well plate for analysis and automated registration for analysis [0148, 0211])
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of portable detectors to be configured with instructions indicating an order of biological samples to process, and wherein the instructions cause the plurality of portable detectors to determine the additional biological sample to process based on the order, as taught by Brown, because Brown teach the instructions allow additional biological sample in an automated manner (Brown; [0148, 0211]).
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10 and 12-13 of U.S. Patent No. 11,634,746; hereinafter ‘746, in view of Brown et al. (US 2015/0346149; already of record – hereinafter “Brown”).
Regarding claim 21, ‘746 disclose a method, comprising:
receiving nucleic acid identity data from a plurality of portable detectors via a wireless connection (‘746 disclose a remote processing system in communication with a plurality of portable detectors via a wireless connection and comprises communications circuity configured to receive sample and location information from each of the portable detectors; claims 1 and 13), wherein the nucleic acid identity data is generated by each portable detector of the plurality of portable detectors operating on respective biological samples wherein the biological samples are different from one another (‘746 disclose each detector comprise a sample receiving component that receives a biological sample that is different from other biological samples, a reader to detect nucleic acids of interest in the biological sample, and a processor programmed to assemble sequencing data of at least one biological sample based on the sample data; claim 1),
wherein each portable detector of the plurality of portable detectors comprise a communication circuitry and processing circuitry (‘746 disclose a transceiver configured to output the sample data generated by the reading component, a remote processing system in communication with each of the plurality of portable detectors, communications circuity configured to receive the sample data and location information from each of the plurality of portable detectors, and a processor with programming instructions; claims 1 and 13);
receiving location data from each of the plurality of portable detectors, via the wireless connection, wherein the location data is associated with the nucleic acid identity data (‘746 disclose a transceiver configured to output the sample data generated by the reading component, a remote processing system in communication with each of the plurality of portable detectors, and communications circuity with a processor configured to receive the sample data and location information from each of the plurality of portable detectors; claims 1 and 13);
processing the nucleic acid identity data and the location data for each of the plurality of portable detectors (‘746 disclose a processor programmed to assemble a nucleic acid sequence of at least one biological sample based on sample data including nucleic acids of interest and location information associated with the biological sample, where the communications circuity receives the sample data and location information from each of the plurality of portable detectors; claims 1 & 13);
assembling a nucleotide sequence of at least one biological sample of the respective biological samples based on the processing of the nucleic acid identity data (‘746 disclose the processor programmed to assemble a sequence of at least one biological sample based on the sample data; claims 1-5, 10 and 12);
determining that the nucleotide sequence is a match to a signature of interest based at least in part on the location data (‘746 disclose determining a sequence coverage matches a signature from a group of predefined signatures; claims 1-2 and 6-7); and
sending, via the wireless connection, instructions to the communication circuitry of each of the portable detectors of the plurality of portable detectors that cause the processing circuitry of plurality of portable detectors (‘746 disclose the processor configured to provide instructions to each of the plurality of portable detectors; claims 1-5, 7, 9 and 13) to:
stop a flow of one or more reagents of each of the portable detectors of the plurality of portable detectors operating on the respective biological samples after determining that the nucleotide sequence of the at least one biological sample of the respective biological samples is the match (‘746 disclose the instructions stop operation of the reader when the biological sample matches the signature of the group; claims 1-2 and 6-7).
‘367 does not teach one or more flow control devices or determine an additional biological sample to process that is different than the respective biological samples and generate additional nucleic acid identity data using the additional biological sample.
However, Brown teach the analogous art of a method, comprising receiving nucleic acid identity data from a plurality of portable detectors (Brown; figs. 1-2 & 11, [0024, 0045, 0088, 0098, 0133, 0240]), wherein the plurality of portable detectors comprise one or more flow control devices (Brown; fig. 8, #60, [0180]), and are configured to determine an additional biological sample to process that is different than the respective biological samples and generate additional nucleic acid identity data using the additional biological sample (Brown; [0148])
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of portable detectors to comprise one or more flow control devices and to be configured to determine an additional biological sample to process and generate additional nucleic acid identity data on the additional sample, as taught by Brown, because Brown teach the one or more flow control devices provides control of the fluidics system in the device and the additional biological sample allows the device to continue analysis (Brown; [0148, 0157]).
Response to Arguments
Applicant’s arguments, filed 02/26/2026, have been fully considered.
Applicant argues, see pages 9-14 of their remarks, that the claim amendments “sending, via the wireless connection, instructions to the communication circuitry of each of the portable detectors of the plurality of portable detectors that cause the processing of the plurality of portable detectors to: stop a flow of one or more reagents via the one or more flow control devices of each of the portable detectors of the plurality of portable detectors operating on the respective biological samples after determining that the nucleotide sequence of the at least one biological sample of the respective biological samples is the match” recites a practical application by providing one or more remedial actions to reduce unnecessary or unwanted consumption of sequencing reagents (step 2A prong 2), similar to example 47 in the July 2024 Subject Matter Eligibility Examples, and therefore recites patent eligible subject matter. The examiner agrees with applicant’s arguments and has withdrawn the 101 rejection.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Sohl, III et al. (US 2004/0241045) discloses an a detector with a communication link that transfers data to a database for analytical/computational analysis.
Fernandez (US 2005/0043894) discloses a biosensor with wireless communications and data analysis system for providing diagnostic guidance.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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