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 .
Preliminary Amendments
Applicant’s preliminary amendment filed on February 3, 2026 is acknowledged. Claims 28-35 is withdrawn from consideration. Claims 16-27 are currently pending.
Election/Restrictions
Applicant’s election of Group I, claims 16-27 in the reply filed on September 29, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim(s) 20-22 is/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 pre-AIA the applicant regards as the invention.
Claim 20 recites the limitation "the sensor sets" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “each electrode set.”
Claim 21 recites the limitation "the sensor sets" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “each electrode set.”
Claim 22 recites the limitation "the electrodes" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “each electrode is” or “the one or more electrodes are.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 the sensor sets comprise at least two electrodes each or at least four electrodes each (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, Exfandyarpour 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 Exfandyarpout 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 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 Mohapartra (¶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 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) 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) 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).
Conclusion
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