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 .
Response to Arguments
In response to Applicant’s statement that a Terminal Disclaimer will be filed, the Double Patenting Rejection of 4/9/2025 is maintained until the Terminal Disclaimer is filed and accepted.
Applicant’s arguments, see Pages 9-10, filed 10/25/2025, with respect to the priority rejection of claims 21, 28, 35 (and their respective independent claims) have been fully considered and are persuasive. The priority rejection of 4/9/2025 has been withdrawn.
Applicant’s arguments, see Page 10, filed 10/25/2025, with respect to the 112(a) rejections of claims 21-40 have been fully considered and are not persuasive. The Examiner notes that the Office Action dated 4/9/2025 states that “reference is made to the electrodes being functionalized with RNA/DNA virus primers and bacterial pathogens aptamers materials 1510 in Figure 15 and [0062], but the specification does not point to a corresponding device or structure that is capable of performing this function,” so it is unclear how the inclusion of the solution compartment within claim 22 overcomes the rejection on record. The solution compartment is used for receiving an oral fluid sample and is not used to functionalize the electrodes and is therefore not enough to show that there is support within the instant specification for overcoming the 112(a) rejection on record.
Applicant's arguments, see Pages 11-16 filed 10/25/2025 have been fully considered but they are not persuasive.
On Page 11, the Applicant asserts that Applicant's claimed invention is a modular system to detect a group of singular targeted RNA/DNA viruses or bacterial pathogens, and that the reference of Duong teaches the analysis of multiple analytes using a single device.
In response to this argument, the Examiner respectfully disagrees as Duong et al. clearly states that the invention may also comprise a single capture ligand and that the substrate composition of the electrodes can be identical (see [0045]).
In response to the Applicant’s argument that the cited references fail to teach a functionalization mechanism using deposition of a coating of RNA/DNA virus primers or bacterial pathogens aptamers material to selectively target RNA or DNA viruses or bacterial pathogens, an electrical impedance measurement device adapted for real-time signal detection from selectively functionalized electrodes, and a modular architecture allowing distinct cartridges preconfigured for pathogen class-based detection, the Examiner neither agrees nor disagrees as these limitations have not been claimed within the invention. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Taslim is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the invention of Taslim is drawn to the AC impedance detection of a sensor used to identify and quantify a constituent in a liquid sample. While the detection of Taslim is directed to food, the device is used to monitor proteins and antibodies which are the same detected analytes of the instant invention. Further, the invention of Taslim is drawn generally to detecting analytes, but the detection of gluten is one analyte of interest for the system. While the instant invention is drawn to a system for the detection of a target analyte, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both the inventions of Taslim and Duong are used to measure the AC response of an analyte within a fluidic circuit. Modifying the reference of Duong to include the smart phone communication ability as exemplified by Taslim would have had the benefit of providing the AC detection and analysis results directly to a user, bypassing the need for a user to visit an expert for results interpretation, see [0121] – [0124] and [0209] – [0212].
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-27, 28, 30-31, 34-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8-9 of U.S. Patent No. 11,819,323. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding claim 21 of the instant application, Claim 1 of the reference application also teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample, comprising a conductive sensor having a plurality of printed electrodes on the conductive sensor, a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets and having a measurement device configured to record measurements of changes in an electrical field, and ionic strength of targets within the sample, at least one digital analytical device (referred to as the digital memory testing protocol identification activator) coupled to the platform and therefore the biosensors, configured to use the measurements to identify an existence and a type of the predetermined analytical targets in the sample, and at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets in the sample to a remote device (referred to as a sensing platform smartphone app). Claim 2 of the reference application teaches the limitation of the electrodes being functionalized with genetic information comprising primers and aptamers of viral and bacterial pathogens.
Regarding claim 22 of the instant application, Claim 2 of the reference application also teaches a functional device configured to functionalize the plurality of electrodes with RNA/DNA virus primers and bacterial pathogens aptamers materials.
Regarding claim 23 of the instant application, Claim 1 of the reference application also teaches that the measurement device is further configured to measure predetermined changes in impedance of the sample for detecting an existence of a predetermined analytical target in the sample.
Regarding claim 24 of the instant application, Claim 4 of the reference application also teaches a heater coupled to a solution compartment configured for incubating fluid of the samples in preparation for testing.
Regarding claim 25 of the instant application, Claim 1 of the reference application also teaches that the remote device is a sensing app operating on a mobile device that includes an interpretation processor wirelessly coupled to the measurement device.
Regarding claim 26 of the instant application, Claim 5 of the reference application also teaches an interpretation processor coupled to the electrochemical platform, and therefore to the measurement device, and configured to determine a concentration of a virus or a bacterial pathogen in the predetermined analytical target in the sample.
Regarding claim 27 of the instant application, Claim 1 of the reference application also teaches the plurality of electrodes are made of an electrically conductive electrode material deposited on a substrate (the electrodes of claim 1 are able to be energized, and are therefore able to conduct electricity).
Regarding claim 28 of the instant application, claim 6 of the reference application also teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample, comprising a conductive sensor having a plurality of printed electrodes on the conductive sensor, where the electrodes are functionalized with DNA molecules, or genetic information, wherein the plurality of electrodes are composed of an electrically conductive electrode material (electrodes are inherently conductive as they carry an electrical signal), a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets and having a measurement device configured to record measurements of changes in an electrical field, and ionic strength of targets within the sample, at least one digital analytical device (referred to as the digital memory testing protocol identification activator) coupled to the platform and therefore the biosensors, configured to use the measurements to identify an existence and a type of the predetermined analytical targets in the sample, and at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets in the sample to a remote device (referred to as a sensing platform smartphone app).
Regarding claim 30 of the instant application, Claim 8 of the reference application also teaches one communication device including a short-range wireless technology, coupled to the electrochemical sensing platform for transmitting testing data including measurements, cloud analysis, and results to a user a smartphone.
Regarding claim 31 of the instant application, Claim 9 of the reference application also teaches one multiple test cartridge reader configured for reading multiple detection cartridge test data simultaneously.
Regarding claim 34 of the instant application, Claim 6 of the reference application also teaches that the measuring device is configured to measure changes in impedance for impedimetric biosensors detection testing.
Regarding claim 35 of the instant application, Claim 1 of the reference application also teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample, comprising a conductive sensor having a plurality of printed electrodes on the conductive sensor, a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets and having a measurement device configured to record measurements of changes in an electrical field, and ionic strength of targets within the sample, at least one digital analytical device (referred to as the digital memory testing protocol identification activator) coupled to the platform and therefore the biosensors, configured to use the measurements to identify an existence and a type of the predetermined analytical targets in the sample, and at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets in the sample to a remote device (referred to as a sensing platform smartphone app). Claim 2 of the reference application teaches the limitation of the electrodes being functionalized with genetic information comprising primers and aptamers of viral and bacterial pathogens.
Regarding claim 36 of the instant application, Claim 1 of the reference application also teaches the plurality of electrodes are composed of an electrically conductive electrode material (the electrodes of claim 1 are able to be energized, and are therefore able to conduct electricity using its material).
Regarding claim 37 of the instant application, Claim 2 of the reference application also teaches a functional device configured to functionalize the plurality of electrodes with RNA/DNA virus primers and bacterial pathogens aptamers materials.
Regarding claim 38 of the instant application, Claim 5 of the reference application also teaches an interpretation processor coupled to the electrochemical platform, and therefore to the measurement device, and configured to determine a concentration of a virus or a bacterial pathogen in the predetermined analytical target in the sample.
Regarding claim 40 of the instant application, Claim 4 of the reference application also teaches that the incubation heater is further configured to prepare a sample for testing.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22, 29, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation of the “inkjet-printed sensor electrode,” in Line 6, however no inkjet electrode has been recited in claim 21. It is unclear whether the sensor electrode is referring to the conductive sensor or the impedimetric biosensors. Appropriate correction is required as there is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation of the “inkjet-printed sensor electrode,” in Line 6, however no inkjet electrode has been recited in claim 28. It is unclear whether the sensor electrode is referring to the conductive sensor or the impedimetric biosensors. Appropriate correction is required as there is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation of the “inkjet-printed sensor electrode,” in Line 6, however no inkjet electrode has been recited in claim 35. It is unclear whether the sensor electrode is referring to the conductive sensor or the impedimetric biosensors. Appropriate correction is required as there is insufficient antecedent basis for this limitation in the claim.
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 21- 24, 26-29, 31-38 and 40 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over Duong et al. (US 2007/0189921).
Regarding claim 21, Duong et al. teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample (biochips, see [0002], [0010] and [0042]), comprising:
a conductive sensor (monolayer comprising conductive oligomers, see [0078] and [0085]) having a plurality of printed electrodes on the conductive sensor (the monolayer is attached to a plurality of detection electrodes, see [0386] and [0050]), wherein the plurality of electrodes is configured to be functionalized with genetic information (nucleic acids) associated with RNA/DNA virus primers or bacterial pathogen aptamers materials (the detection electrodes are attached to nucleic acid probes, see [0074] and [0386], where the probes are viral or bacterial pathogenic material, see [0394] – [0396]);
wherein a DNA primer coating is bound to the electrically conductive electrode to form a functionalized printed electrode (covalently attached nucleosides or nucleic acids bound to the electrode, see [0148]);
an impedance measurement device coupled to the plurality of electrodes configured to measure changes in impedance of current passing through the plurality of electrodes after deposition of an incubated patient oral fluid sample on the plurality of electrodes to detect the presence of viruses and bacterial pathogens (the prior art teaches a device for measuring electron transfer across the electrode using AC detection, see [0342], but does not explicitly teach that the ETMs are measured using the Faradaic impedance. However, another embodiment within the prior art teaches a list of possible forms of detection including Alternating Current methods, see [0347], where the Faradaic impedance is sensitive to changes in an electrical field and ionic strength of a sample fluid, see [0384]. Additionally, the prior art references teach that it is known that there were design incentives for implementing the claimed variation. Specifically, the nucleic acids being detected have different concentrations and electronic properties within different solutions that impact the Faradaic impedance and not the bulk or dielectric impedance. Therefore, the use of the Faradaic impedance measurements would have been recognized as predictable to one of ordinary skill in the art),
a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets (a plurality of ETMs, electron transfer moieties, are coupled to the electrode that display a change in AC voltage and are electronically detected, see [0347] and [0332] - [0334], where impedance is an inherent part of AC systems) and having an impedance measurement device configured to record measurements of changes in impedance, an electrical field, and ionic strength of current passing through the plurality of printed electrodes when in contact with the predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens (the prior art teaches a device for measuring electron transfer across the electrode using AC detection, see [0342], where the Faradaic impedance is sensitive to changes in an electrical field and ionic strength of a sample fluid, see [0384], where the electrode has one probe for one analyte, see [0210]);
at least one digital analytical device coupled to the plurality of impedimetric biosensors (device board coupled to electronic impedance analyzers, see [0325] and [0348]) and configured to use the measurements to identify an existence and a type of the predetermined analytical targets in the sample (the device board is used to perform signal recognition and sample identification based on the different current values, see [0344] – [0348]) ; and
at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens in the sample to a remote device (processor/CPU coupled to the device board that wirelessly transmits the signal recognition results to a remote device, see [0326] – [0329], [0308]).
Regarding claim 22, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 21, further comprising a solution compartment coupled to the inkjet printed sensor electrode (chamber coupled to electrodes, see [0385]) configured to deposit a coating of at least one singular RNA/DNA virus primers or bacterial pathogens aptamers material on at least one inkjet printed sensor electrode to form at least one functionalized inkjet printed sensor electrode (the test chamber deposits the sample solution comprising the target viral/bacterial material, see [0022] and [0395], onto electrodes where the electrodes comprise a nucleic acid probe and conductive oligomer for detecting the analyte within the sample, see [0383]-[0386]).
Regarding claim 23, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 21, wherein the measurement device is further configured to measure predetermined changes in impedance of the sample for detecting an existence of a predetermined analytical target in the sample (device for measuring electron transfer using AC detection, or by monitoring changes in current and Faradaic impedance of the sample, see [0347]- [0350]).
Regarding claim 24, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 21, further comprising a heater coupled to a solution compartment (station) configured for incubating fluid of the samples in preparation for testing (thermal controller used to heat each the sample in a station, see [0295] – [0297], where incubating fluid of the samples is a functional usage limitation of the heater. A function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the function, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963)).
Regarding claim 26, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 21, further comprising an interpretation processor coupled to the measurement device and configured to determine a concentration of a virus or a bacterial pathogen in the predetermined analytical target in the sample (a computer program, located within the processor coupled to the device board, see [0326] – [0329], [0308], is used to detect the amount of molecules present within the sample, see [0403] – [0407]).
Regarding claim 27, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 21, wherein the plurality of electrodes are made of an electrically conductive electrode material deposited on a substrate (electrodes are made of gold, a conductive material deposited on a substrate, see [0046] – [0048]).
Regarding claim 28, Duong et al. teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample (biochips, see [0002], [0010] and [0042]), comprising:
a conductive sensor (monolayer comprising conductive oligomers, see [0078] and [0085]) having a plurality of printed electrodes on the conductive sensor (the monolayer is attached to a plurality of detection electrodes, see [0386] and [0050]), wherein the plurality of electrodes is configured to be functionalized with genetic information (nucleic acids) associated with RNA/DNA virus primers or bacterial pathogen aptamers materials (the detection electrodes are attached to nucleic acid probes, see [0074] and [0386], where the probes are viral or bacterial pathogenic material, see [034] – [0396]);
wherein the plurality of electrodes are composed of an electrically conductive material (electrodes are made of gold, a conductive material deposited on a substrate, see [0046] – [0048]),
wherein a DNA primer coating is bound to the electrically conductive electrode to form a functionalized printed electrode (covalently attached nucleosides or nucleic acids bound to the electrode, see [0148]);
an impedance measurement device coupled to the plurality of electrodes configured to measure changes in impedance of current passing through the plurality of electrodes after deposition of an incubated patient oral fluid sample on the plurality of electrodes to detect the presence of viruses and bacterial pathogens (the prior art teaches a device for measuring electron transfer across the electrode using AC detection, see [0342], but does not explicitly teach that the ETMs are measured using the Faradaic impedance. However, another embodiment within the prior art teaches a list of possible forms of detection including Alternating Current methods, see [0347], where the Faradaic impedance is sensitive to changes in an electrical field and ionic strength of a sample fluid, see [0384]. Additionally, the prior art references teach that it is known that there were design incentives for implementing the claimed variation. Specifically, the nucleic acids being detected have different concentrations and electronic properties within different solutions that impact the Faradaic impedance and not the bulk or dielectric impedance. Therefore, the use of the Faradaic impedance measurements would have been recognized as predictable to one of ordinary skill in the art),
a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets (a plurality of ETMs, electron transfer moieties, are coupled to the electrode that display a change in AC voltage and are electronically detected, see [0347] and [0332] - [0334], where impedance is an inherent part of AC systems) and having an impedance measurement device configured to record measurements of changes in impedance, an electrical field, and ionic strength of current passing through the plurality of printed electrodes when in contact with the predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens (the prior art teaches a device for measuring electron transfer across the electrode using AC detection, see [0342], where the Faradaic impedance is sensitive to changes in an electrical field and ionic strength of a sample fluid, see [0384], where the electrode has one probe for one analyte, see [0210]);
at least one digital analytical device coupled to the plurality of impedimetric biosensors (device board coupled to electronic impedance analyzers, see [0325] and [0348]) and configured to use the measurements to identify an existence and a type of the predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens in the sample (the device board is used to perform signal recognition and sample identification based on the different current values, see [0344] – [0348]); and
at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens in the sample to a remote device (processor/CPU coupled to the device board that wirelessly transmits the signal recognition results to a remote device, see [0326] – [0329], [0308]).
Regarding claim 29, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising a solution compartment coupled to the inkjet printed sensor electrode (chamber coupled to electrodes, see [0385]) configured to deposit a coating of at least one singular RNA/DNA virus primers or bacterial pathogens aptamers material on at least one inkjet printed sensor electrode to form at least one functionalized inkjet printed sensor electrode (the test chamber deposits the sample solution comprising the target viral/bacterial material, see [0022] and [0395], onto electrodes where the electrodes comprise a nucleic acid probe and conductive oligomer for detecting the analyte within the sample, see [0383]-[0386]).
Regarding claim 31, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising at least one multiple test cartridge reader configured for reading multiple detection cartridge test data simultaneously (analysis device comprises two stations for the simultaneous detection of target nucleic acids, see Claim 24).
Regarding claim 32, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising an interpretation processor coupled to the at least one electrochemical sensing platform configured for determination of the concentration of any detected virus and bacterial pathogen (a computer program, located within the processor coupled to the device board, see [0326] – [0329], [0308], is used to detect the amount of molecules present within the sample, see [0403] – [0407]).
Regarding claim 33, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising a device configured for functionalizing the plurality of electrodes with virus primers and bacterial pathogens aptamers materials (the attachment linker covalently attaches, or functionalizes, the electrode with the nucleic acid probe, see [0171] – [0174], [0386], and [0392], where the probe belongs to a viral or bacterial pathogen, see [0021]- [0022]).
Regarding claim 34, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising the measuring device is configured to measure changes in impedance for impedimetric biosensors (ETMs) detection testing (device for measuring electron transfer using AC detection, or by monitoring changes in current and Faradaic and non-Faradaic impedance of the ETMs and electrodes, see [0347]- [0350] and [0384]).
Regarding claim 35, Duong et al. teaches an electrochemical sensing platform for detecting predetermined analytical targets of a sample (biochips, see [0002], [0010] and [0042]), comprising:
a conductive sensor (monolayer comprising conductive oligomers, see [0078] and [0085]) having a plurality of printed electrodes on the conductive sensor (the monolayer is attached to a plurality of detection electrodes, see [0386] and [0050]), wherein the plurality of electrodes is configured to be functionalized with genetic information (nucleic acids) associated with virus primers and bacterial pathogen aptamers materials (the detection electrodes are attached to nucleic acid probes, see [0074] and [0386], where the probes are viral or bacterial pathogenic material, see [034] – [0396]);
wherein a DNA primer coating is bound to the electrically conductive electrode to form a functionalized printed electrode (covalently attached nucleosides or nucleic acids bound to the electrode, see [0148]);
a plurality of impedimetric biosensors coupled to the plurality of printed electrodes and the predetermined analytical targets (a plurality of ETMs, electron transfer moieties, are coupled to the electrode that display a change in AC voltage and are electronically detected, see [0347] and [0332] - [0334], where impedance is an inherent part of AC systems) and having an impedance measurement device coupled to the plurality of electrodes configured to measure changes in impedance of current passing through the plurality of electrodes after deposition of an incubated patient oral fluid sample on the plurality of electrodes to detect the presence of viruses and bacterial pathogens; (the prior art teaches a device for measuring electron transfer across the electrode using AC detection, see [0342], but does not explicitly teach that the ETMs are measured using the Faradaic impedance. However, another embodiment within the prior art teaches a list of possible forms of detection including Alternating Current methods, see [0347], where the Faradaic impedance is sensitive to changes in an electrical field and ionic strength of a sample fluid, see [0384]. Additionally, the prior art references teach that it is known that there were design incentives for implementing the claimed variation. Specifically, the nucleic acids being detected have different concentrations and electronic properties within different solutions that impact the Faradaic impedance and not the bulk or dielectric impedance. Therefore, the use of the Faradaic impedance measurements would have been recognized as predictable to one of ordinary skill in the art);
and further configured to record measurements of changes in impedance of current passing through the plurality of printed electrodes when in contact with the predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens (the values obtained after analysis are stored within a database to determine electricity and impedance, see [0321]- [0322] and [0345]-[0348])
an incubation heater coupled to a solution compartment configured to heat and prepare a fluid sample for impedance testing (thermal controller used to heat each the sample in a station, see [0295] – [0297]);
at least one digital analytical device coupled to the plurality of impedimetric biosensors (device board coupled to electronic impedance analyzers, see [0325] and [0348]) and configured to use the measurements to identify an existence and a type of the predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens in the sample (the device board is used to perform signal recognition and sample identification based on the different current values, see [0344] – [0348]); and
at least one communication device coupled to the digital analytical device and configured to transmit the existence and the type of predetermined analytical targets selected from a group of singular targeted RNA/DNA viruses or bacterial pathogens in the sample to a remote device (processor/CPU coupled to the device board that wirelessly transmits the signal recognition results to a remote device, see [0326] – [0329], [0308]).
Regarding claim 36, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 35, wherein the plurality of electrodes are composed of an electrically conductive material (electrodes are made of gold, a conductive material deposited on a substrate, see [0046] – [0048]).
Regarding claim 37, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 35, further comprising a solution compartment coupled to the inkjet printed sensor electrode (chamber coupled to electrodes, see [0385]) configured to deposit a coating of at least one singular RNA/DNA virus primers or bacterial pathogens aptamers material on at least one inkjet printed sensor electrode to form at least one functionalized inkjet printed sensor electrode (the test chamber deposits the sample solution comprising the target viral/bacterial material, see [0022] and [0395], onto electrodes where the electrodes comprise a nucleic acid probe and conductive oligomer for detecting the analyte within the sample, see [0383]-[0386]).
Regarding claim 38, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 35, further comprising an interpretation processor coupled to the at least one electrochemical sensing platform configured for determination of the concentration of any detected virus and bacterial pathogen (a computer program, located within the processor coupled to the device board, see [0326] – [0329], [0308], is used to detect the amount of molecules present within the sample, see [0403] – [0407]).
Regarding claim 40, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 35, wherein the incubation heater is further configured to prepare blood and serum for testing for measuring impedance (thermal controller used to heat each the sample in a station, see [0295] – [0297], where preparing the blood and serum sample is a functional limitation of the heater. A function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the function, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963)).
Claims 25, 30, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Duong et al. (US 2007/0189921) as applied to claims 21, 28, and 35 above respectively, and further in view of Taslim et al. (US 2016/0097764).
Regarding claim 25, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample claim 21, that includes an interpretation processor wirelessly coupled to the measurement device (a computer program, located within the processor coupled to the device board, see [0326] – [0329], [0308], is used to wirelessly detect the amount of molecules present within the sample, see [0403] – [0407]), but does not teach that the remote device is a sensing app operating on a mobile device.
However, in the analogous art of impedimetric sensing to detect compounds within a sample, Taslim et al. teaches a device where the impedimetric results and identification of a compound are determined by the system, stored in a computer’s database, then relayed to an application on a user’s mobile device, see [0121] – [0124].
While the computer program of Duong et al. does not specifically relay results to an application on a mobile phone, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention to transmit the obtained measurements of the prior art to an application on a user’s smartphone as exemplified by Taslim et al. for the benefit of providing the analysis results directly to a user, bypassing the need for a user to visit an expert for results interpretation, see [0121] – [124] and [0209] – [0212]. Moreover, the modification of the platform of Duong et al. to relay results to the application on the smartphone of Taslim et al. (instead of the more general computer) would have had the reasonable expectation of successfully facilitating the communication of results to an end-user of the aforementioned device and platform as a smartphone is a miniaturized data processor.
Regarding claim 30, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 28, further comprising at least one communication device including a short-range wireless technology, coupled to the electrochemical sensing platform for transmitting testing data including measurements, cloud analysis, and results to a user (processor/CPU coupled to the device board that uses technology to wirelessly transmit the signal recognition results to a remote device, or user, see [0326] – [0329], [0308]), but does not teach that the results are transmitted to a smartphone.
However, in the analogous art of impedimetric sensing to detect compounds within a sample, Taslim et al. teaches a device where the impedimetric results and identification of a compound are transmitted to a user’s mobile device, see [0121] – [0124].
While the computer program of Duong et al. does not specifically relay results to an application on a mobile phone, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention to transmit the obtained measurements of the prior art to an application on a user’s smartphone as exemplified by Taslim et al. for the benefit of providing the analysis results directly to a user, bypassing the need for a user to visit an expert for results interpretation, see [0121] – [124] and [0209] – [0212]. Moreover, the modification of the platform of Duong et al. to relay results to the application on the smartphone of Taslim et al. (instead of the more general computer) would have had the reasonable expectation of successfully facilitating the communication of results to an end-user of the aforementioned device and platform as a smartphone is a miniaturized data processor.
Regarding claim 39, Duong et al. teaches the electrochemical sensing platform for detecting predetermined analytical targets of a sample of claim 35, further comprising at least one communication device including a short-range wireless technology, coupled to the electrochemical sensing platform for transmitting testing data including measurements, cloud analysis, and results to a user a smartphone (processor/CPU coupled to the device board that uses technology to wirelessly transmit the signal recognition results to a remote device, or user, see [0326] – [0329], [0308]) , but does not teach that the results are transmitted to a smartphone.
However, in the analogous art of impedimetric sensing to detect compounds within a sample, Taslim et al. teaches a device where the impedimetric results and identification of a compound are transmitted to a user’s mobile device, see [0121] – [0124].
While the computer program of Duong et al. does not specifically relay results to an application on a mobile phone, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention to transmit the obtained measurements of the prior art to an application on a user’s smartphone as exemplified by Taslim et al. for the benefit of providing the analysis results directly to a user, bypassing the need for a user to visit an expert for results interpretation, see [0121] – [124] and [0209] – [0212]. Moreover, the modification of the platform of Duong et al. to relay results to the application on the smartphone of Taslim et al. (instead of the more general computer) would have had the reasonable expectation of successfully facilitating the communication of results to an end-user of the aforementioned device and platform as a smartphone is a miniaturized data processor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758