DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on June 1, 2026. Claims 16-35 are pending in the application.
Status of Objections and Rejections
All rejections under 35 U.S.C. §112 from the previous office action are withdrawn in view of Applicant’s amendment.
All rejections under 35 U.S.C. §103 are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz (US 2020/0108385) in view of Kim (US 2018/0143209).
Regarding claim 16, Temiz teaches a biomarker sensor (Fig. 1: microfluidic device; ¶7: analytes are biomarkers), wherein the sensor has a multielectrode array structure (Fig. 1-2) which comprises a carrier substrate (Fig. 1; ¶56: substrate 12) on which at least two separate electrode sets are arranged (Fig. 1-2; ¶57: a set of electrodes 31, 32, 40-42), each electrode set comprising one or more electrodes (e.g. Fig. 2A: eight pairs of electrodes 41, 42), and each electrode set being divided into, in the following order
(i) an incubation zone (Fig. 1-2: the exposed parts of electrodes 41, 42 inside the flow path on the surface 20; ¶60: the electrode sensing portions are naked electrode, i.e., not passivated) in which at least one specific receptor is bound to the one or more electrodes (¶117: surface-immobilized receptors, the function of which is to bind a specific analyte in a sample; e.g., antibodies),
(ii) a passivation zone in which a passivation layer covers the one or more electrodes (Fig. 1-2: the portion of the electrodes 41, 42 outside of the flow path on the surface 20; ¶60: other electrode portions (those portions that are not meant to be exposed to the liquid, because they are located outside of the flow path) could be passivated),
(iii) a contact zone in which the one or more electrodes are configured to be electrically contacted (Fig. 1-2; ¶57: electrical contacts 51,52), and
contact zones of the individual electrode sets together forming a common contact zone (Fig. 1-2; ¶57: a set of or more electrical contacts 50-52; e.g., the right part of Fig. 1, electrical contacts 51, 52 on wafer 14, is a common contact zone).
Temiz does not explicitly disclose the receptor is aptamer.
However, Kim teaches an aptasensor using an aptamer which is bound to the female-specific trace of blood (¶1). The application of the aptamer in the diagnosis and analysis is very natural because the aptamer has a target affinity comparable to that of antibodies, a size much smaller than that of antibodies, and an ability to bind to various target molecules with high binding force (¶9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz by substituting the antibody receptor with aptamer as taught by Kim because the aptamer does not only have a target affinity comparable to that of antibodies, but a size much smaller than that of antibodies, and an ability to bind to various target molecules with high binding force (Kim, ¶9).
Further, the designation “incubation zones of individual electrode sets or incubation zones and a part of up to 95% of a length of passivation zones of the individual electrode sets being configured to be movable, in each case independently of those of the other electrode sets” is functional limitations in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Even if it does, it would be obvious to one of ordinary skill in the art to modify Temiz and Kim by making the incubation zones or the incubation zones and a part of the passivation zones of an individual electrode set to be separable from other electrode sets because making the parts separable, like a attachable module, without changing the functions of all components are prima facie obvious. MPEP 2144.04(V)(C).
Regarding claim 19, Temiz teaches wherein the sensor comprises two separate electrode sets (Fig. 2A: the electrode 31 is deemed to be the first electrode set and the electrode 32 is deemed to be the second electrode set).
Regarding claims 20-21, Temiz teaches wherein teach electrode set comprises at least two electrodes or at least four electrodes (Fig. 2A: the electrode 31 having eight electrodes 41 and the electrode 32 having eight electrode 42).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Esfandyarpour (US 2015/0376692).
Regarding claims 17-18, Temiz and Kim disclose all limitations of claim 1, but fail to teach wherein the carrier substrate is polydimethylsiloxane (PDMS) (claim 17) or wherein the carrier substrate is a flexible material (claim 18).
However, Esfandyarpour teaches an integrated microfluidic devices may be formed from a substrate wherein a plurality of microfluidic channels may be embedded into the substrate (¶332). The substrate material may be PDMS (¶228: polydimethylsiloxane), and depending on the particular application, the substrate material may be rigid or it may be flexible (¶332).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by substituting the substrate with PDMS or a flexible substrate as taught by Esfandyarpour because PDMS is a suitable material of the substrate of microfluidic devices and a flexible substrate would be suitable for particular applications (¶332). The suggestion for doing so would have been that the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Mohapatra (US 2008/0023325).
Regarding claim 22, Temiz and Kim disclose all limitations of claim 16, and Temiz further discloses metallic electrodes are patterned in channels of the device (¶3). Temiz and Kim fail to teach the one or more electrodes are made of noble metal or carbon.
However, Mohapatra teaches a microfluidic sensor for detection of biomarkers ([Abstract]). The materials of electrode is preferably comprise noble metals, and most preferably comprises gold, platinum, and carbon (¶21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by substituting the metallic electrode with one made of noble metal or carbon as taught by Mohapatra (¶21). The suggestion for doing so would have been that the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Cheung (Y-W Cheung, Aptamer-mediated Plasmodium-specific diagnosis of malaria, Biochimie 2018(145), pp. 131-136).
Regarding claim 23, Temiz and Kim disclose all limitations of claim 16, but fails to teach wherein the at least one specific aptamer is 2008s aptamer.
However, Cheung teaches a DNA aptamer, 2008s, that targets P. falciparum lactate dehydrogenase (PfLDH) and a sensitive aptamer-tethered enzyme capture (APTEC) assay ([Abstract]). The 2008s aptamer can be used as bio-recognition molecules for aptamer-based biosensing with advantages including ease of manipulation, ease of synthesis, high stability, high sensitivity and tailored specificity (p. 131, col. 2, para. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by substituting the aptamer with 2008s as taught by Cheung because aptamer 2008s has specific target affinity (Kim, ¶9) for biosensing with tailored specificity, ease of manipulation, ease of synthesis, high stability, and high sensitivity (Cheung, p. 131, col. 2, para. 2). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). The substitution of one specific aptamer for its specific target for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Torabi (R. Torabi, Aptamers, the bivalent agents as probes and therapies for coronavirus infections: A systematic review, Molecular and Cellular Probes 2020(53), 101636, pp. 1-8).
Regarding claim 24, Temiz and Kim disclose all limitations of claim 16, but fails to teach wherein the at least one specific aptamer is NG1 aptamer.
However, Torabi teaches aptamers are multipotent biological probes for design of sensitive and specific biosensors and therapeutics to treat coronavirus, e.g., for the SARS-CoV-2 ([Abstract]). For example, NG1 aptamer (p. 6, Table 2) is a therapeutic for the target SARS-CoV Helicase because the drug can bind to the helicase and inhibit its activity through blocking the binding to nucleic acids (p. 5, col. 2, para. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by substituting the aptamer with NG1 aptamer as taught by Torabi because aptamer has specific target affinity (Kim, ¶9) and NG1 is one aptamer against coronavirus by binding the target, SARS-CoV Helicase (Torabi, Table 2). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). The substitution of one specific aptamer for its specific target for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Xiao (US 2007/0154909).
Regarding claim 25, Temiz and Kim disclose all limitations of claim 16, but fails to teach wherein different aptamers or aptamer mixtures are bound in each electrode set.
However, Xiao teaches aptamer-based detector (¶15) including an array of microelectrode in the format of N “pixels” with each pixel containing a unique oligonucleotide structure and with all microelectrodes electrochemically addressable, thereby enabling detection of N different targets (¶55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by using different aptamers bound to each electrode set as taught by Xiao because it would enable detection of multiple different target detection (¶55). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim and Xiao, and further in view of Torabi
Regarding claim 26, Temiz, Kim and Xiao disclose all limitations of claim 25, but fails to teach wherein the different aptamers or aptamer mixtures bound in each electrode set are (1) in a first electrode set 2008s aptamer and in a second electrode set 2106s aptamer and in a third electrode set pL1 aptamer and in a fourth electrode set LDHp11 aptamer or (2) in a first electrode set C7 aptamer and in a second electrode set C11 aptamer or (3) in at least two electrode sets aptamers selected from one or more of C5 aptamer, C7 aptamer, C9 aptamer, C11 aptamer, C15 aptamer or Il aptamer, IH1 aptamer, SG1 aptamer, HCS1 aptamer, and NG1 aptamer.
However, Torabi teaches aptamers are multipotent biological probes for design of sensitive and specific biosensors and therapeutics to treat coronavirus, e.g., for the SARS-CoV-2 ([Abstract]). For example, NG1 aptamer (p. 6, Table 2) is a therapeutic for the target SARS-CoV Helicase because the drug can bind to the helicase and inhibit its activity through blocking the binding to nucleic acids (p. 5, col. 2, para. 2). Further, Kim teaches each aptamer exhibits specifically high affinity for its target substances with high affinity and specificity (¶¶7-8). Xiao teaches an array of microelectrode of the aptamer-based detector in the format of N “pixels” with each pixel containing a unique oligonucleotide structure and with all microelectrodes electrochemically addressable, thereby enabling detection of N different targets (¶55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz, Kim and Xiao by using different aptamers or aptamer mixtures bound in each electrode set, e.g., using NG1 aptamer in at least two electrode sets, as recited because all microelectrodes electrochemically addressable (Xiao, ¶55) and each electrode set would be individually used to detect the specific target. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Temiz in view of Kim, and further in view of Khattak (US 2015/0136599).
Regarding claim 27, Temiz and Kim disclose all limitations of claim 16, but fails to teach wherein the sensor further comprises collectively a reference electrode and a counter electrode.
However, Khattak teaches a microfluidic device for molecule detection (¶2), wherein a plurality of sensors 758 are disposed within the analysis channel 732 (Fig. 18A; ¶130). In this embodiment, each sensor 758 is formed of a working electrode 758a, a reference electrode 758b, and a counter electrode 758c (Fig. 18A; ¶130). In the other embodiment, two or more working electrodes configured to share a same reference electrode (claim 16) and share a same counter electrode (claim 17; also see claim 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Temiz and Kim by using a collective reference electrode and a counter electrode shared by all sensing electrodes as taught by Khattak because it would reduce the number of electrodes and provide a compact electrode configuration. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues the feature of the claimed sensor that the incubation zones of individual electrode sets or incubation zones and a part of up to 95% of a length of passivation zones of the individual electrode sets being configured to be movable, in each case independently of those of the other electrode sets and contact zones of the individual electrode sets together forming a common contact zone is not merely a functional limitation but implies a structure, i.e., a structural element having this functionality (Response, p. 10, para. 5-6). Examiner disagrees. This limitation uses the term “being configured to” which is typical term for functional limitation. Applicant is requested to amend the claim to explicitly recite the structural limitation for further consideration.
Applicant argues Temiz does not disclose electrodes having incubation zones and having aptamers bound to these incubation zones (p. 11, last two para.). This argument is unpersuasive. Temiz teaches an incubation zone (Fig. 1-2: the exposed parts of electrodes 41, 42 inside the flow path on the surface 20; ¶60: the electrode sensing portions are naked electrode, i.e., not passivated) of the test line, e.g., the rectangle area (¶117), i.e., the spot 61 (Fig. 2A-B: the spot 61 and the sensing portions are overlapping). This testing area comprises surface-immobilized receptors, the function of which is to bind a specific analyte in a sample (¶117), and thus being able to detect the target analyte inside the flow path of the device.
Applicant argues Temiz discloses individual electrodes (not sets) having incubation parts (sensing portions) and passivated parts, but not entire electrode sets (p. 12, para. 1). This argument is unpersuasive. Each electrode sets comprises individual electrodes, e.g., electrodes 41, 42, and the individual electrodes each having incubation parts and passivated parts. As a result, the collective of the incubation parts and passivated parts, respectively, of all electrode sets would together form an incubation zone and a passivation zone of the entire electrode sets.
Applicant argues the feature relating to the individually movable electrode sets is not disclosed by Temiz (p. 12, para. 2-3). Examiner agrees that Temiz does not explicitly disclose such structural limitation. However, Applicant claims such a feature as a functional limitation instead of a structural limitation. Further, even if Applicant claim it as a structural limitation, it would be obvious to one of ordinary skill in the art to modify Temiz by making the incubation zones or the incubation zones and a part of the passivation zones of an individual electrode set to be separable from other electrode sets because making the parts separable, like a attachable module, without changing the functions of all components are prima facie obvious. MPEP 2144.04(V)(C).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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