DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/2024 and 3/19/2026 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I and Species II, Claims 1-11 and 13, in the reply filed on 03/19/2026 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 Objection
Claims 1-2, 7-11 and 13 are objected to because of the following informalities:
Claim 1: please amend “a sample fluid” in Ln4 to – [[a]] the sample fluid--; “the analyte” to –the at least one analyte--; “the affinity-based probes” to -- the plurality of affinity-based probes--; “an analyte” to – [[an]] the at least one analyte--; “analyte binding to the affinity-based probe” to – the at least one analyte binding to the plurality of affinity-based probes--; “ the redox tags” to -- the plurality of redox tags--.
Claim 2: please amend “the affinity-based probe” to -- the plurality of affinity-based probes--.
Claim 7: please amend “the redox tags” to -- the plurality of redox tags--.
Claim 8: please amend “the other redox tags” to -- the other redox tags of the plurality of redox tags--.
Claim 9: please amend “the redox tags” to -- the plurality of redox tags--; “the electrode” to –the at least one electrode--; “redox tags” to – the plurality of redox tags--.
Claim 10: please amend “the redox tags” to -- the plurality of redox tags--; “the electrode” to –the at least one electrode--.
Claim 11: please amend “the electrode” to –the at least one electrode--.
Claim 13: please amend “The device of claim 1 wherein” to – The device of claim 1, wherein --; “the affinity-based probes” to -- the plurality of affinity-based probes --.
Appropriate correction is required.
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 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 8, claim 8 recites “wherein each redox tag comprises at least one molecule that is distinct from the other redox tags”, and it is unclear if there are two distinct redox tags or more than two distinct redox tags. Thus, the scope of claim 8 is indefinite.
Regarding claim 9, claim 9 recites “the redox tags with further position from the electrode have a redox peak voltage when free in solution that is less than the redox peak voltage for redox tags in closer position to the electrode”, and claim 1 recites “wherein the affinity-based probes each carry a plurality of redox tags”. Since the plurality of redox tags are carried by each affinity-based probe, they are not free in solution. Thus, it is unclear if the plurality of redox tags are attached to each affinity-based probe or free in solution. Therefore, the scope of claim 9 is indefinite.
Regarding claim 10, claim 10 recites “the measured signal”, which lacks antecedent basis. Therefore, the scope of claim 10 is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9-11 and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rozenblum et al. (US20230031265A1). Plaxco et al. ( US20190209063A1) is used as an evidence for claim 9. Rozenblum was provided in the previous Restriction/Election office action.
Regarding claim 1, Rozenblum teaches a device (a biosensor device 100 in Fig.1 [para. 0038]); “for detecting or measuring at least one analyte in a sample fluid” is an intended use limitation [see MPEP 2111.02]. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Rozenblum teaches the biosensor device comprising working electrode 108 functionalized with an aptamer probe 106 that may be designed to bind specifically to a particular target molecule 109 in a sample fluid 104, act as a non-specific binding control, or to perform some other assay function [para. 0038, 0040, 0046, 0059]. Thus, the disclosed biosensor device is configured to perform the intended use of detecting or measuring at least one analyte 109 in a sample fluid 104. The device comprising:
at least one electrode (working electrodes 108 in Fig.1 [para. 0038]);
the sample fluid (a liquid solution such as liquid buffer solution 104 in Fig.1 containing analytes to be detected [para. 0059]); and
a plurality of affinity-based probes (one or more probes 112 in Fig.1 [para. 0038]) capable of binding to the analyte (Each working electrode 108 may be functionalized with an aptamer probe 106 that may be designed to bind specifically to a particular target molecule 109 [para. 0040]), wherein the affinity-based probes each carry a plurality of redox tags (one or more redox molecules 105 in Fig.1 [para. 0038]; the one or more redox labels comprise Methyl Blue. In some embodiments, the probe comprises at least 3 redox molecules [para. 0011]);
wherein the detection or measurement of the analyte is caused by the analyte binding to the affinity-based probe (Each working electrode 108 may be functionalized with an aptamer probe 106 that may be designed to bind specifically to a particular target molecule 109 [para. 0040; claim 6]) which further causes a change in electron transfer from the redox tags (wherein the one or more electrical current signals is generated by a change in the surface potential of a first working electrode of one or more working electrodes due to a change in distance between the one or more redox molecules of a first probe of the one or more probes and the first working electrode caused by a change in structure of the aptamer upon binding with a target of the one or more targets. Redox molecule denotes a molecule capable of accepting or donating an electron thereby changing its redox state. [claim 11, para. 0009]).
Regarding claim 2, Rozenblum teaches the device of claim 1, wherein the affinity-based probe is an aptamer (each working electrode 108 is functionalized with an aptamer probe 106 and one or more redox molecules 105 [para. 0038]).
Regarding claim 3, Rozenblum teaches the device of claim 1, “wherein the device has a redox signal strength, and the redox signal strength, when compared to a probe with a singular redox tag, is at least 1.5 times greater” is a functional recitation of the device. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Rozenblum teaches the biosensor device 100 configured for amperometric sensing utilizing aptamer probes immobilized onto the working electrodes 108 and labeled with redox molecules 105 for current signal amplification. The probe may contain one or more redox molecules such as Ferrocene or Methyl Blue, for example. The number of redox molecules attached to one probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0038, 0041]. In order to increase the signal upon ligand binding, a branched phosphoramidite can be added during synthesis to increase the number of redox molecules in each probe molecule [para. 0089]. In some embodiments, synthesis of aptamers with enhanced redox reporters to enhance the signal upon target-ligand binding is achieved by adding several redox molecules [para. 0091]. The instant specification discloses: The present invention is capable of 2, 3, 5, or even 10 redox tags, or more, improving redox signal strength compared to a singularly tagged aptamer by at least one of 1.5×, 2×, 3×, 10× [para. 0037 ] in PG-Pub. Therefore, the disclosed biosensor device comprising substantially the same elements or components as that of the instant device wherein each probe is an aptamer carrying a plurality of redox tags for increasing the redox signal strength, it is contended that the biosensor device of the prior art is capable of providing the same redox signal strength as the instant device. Note that the redox signal strength is proportional to the number of redox tags, since the number of redox molecules attached to the disclosed probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0041], the disclosed device is capable of providing a redox signal strength, when compared to a probe with a singular redox tag, is at least 1.5 times greater.
Regarding claim 4, Rozenblum teaches the device of claim 1, “wherein the device has a redox signal strength, and the redox signal strength, when compared to a probe with a singular redox tag, is at least 2 times greater” is a functional recitation of the device. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Rozenblum teaches the biosensor device 100 configured for amperometric sensing utilizing aptamer probes immobilized onto the working electrodes 108 and labeled with redox molecules 105 for current signal amplification. The probe may contain one or more redox molecules such as Ferrocene or Methyl Blue, for example. The number of redox molecules attached to one probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0038, 0041]. In order to increase the signal upon ligand binding, a branched phosphoramidite can be added during synthesis to increase the number of redox molecules in each probe molecule [para. 0089]. In some embodiments, synthesis of aptamers with enhanced redox reporters to enhance the signal upon target-ligand binding is achieved by adding several redox molecules [para. 0091]. The instant specification discloses: The present invention is capable of 2, 3, 5, or even 10 redox tags, or more, improving redox signal strength compared to a singularly tagged aptamer by at least one of 1.5×, 2×, 3×, 10× [para. 0037 ] in PG-Pub. Therefore, the disclosed biosensor device comprising substantially the same elements or components as that of the instant device wherein each probe is an aptamer carrying a plurality of redox tags for increasing the redox signal strength, it is contended that the biosensor device of the prior art is capable of providing the same redox signal strength as the instant device. Note that the redox signal strength is proportional to the number of redox tags, since the number of redox molecules attached to the disclosed probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0041], the disclosed device is capable of providing a redox signal strength, when compared to a probe with a singular redox tag, is at least 2 times greater.
Regarding claim 5, Rozenblum teaches the device of claim 1, “wherein the device has a redox signal strength, and the redox signal strength, when compared to a probe with a singular redox tag, is at least 3 times greater” is a functional recitation of the device. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Rozenblum teaches the biosensor device 100 configured for amperometric sensing utilizing aptamer probes immobilized onto the working electrodes 108 and labeled with redox molecules 105 for current signal amplification. The probe may contain one or more redox molecules such as Ferrocene or Methyl Blue, for example. The number of redox molecules attached to one probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0038, 0041]. In order to increase the signal upon ligand binding, a branched phosphoramidite can be added during synthesis to increase the number of redox molecules in each probe molecule [para. 0089]. In some embodiments, synthesis of aptamers with enhanced redox reporters to enhance the signal upon target-ligand binding is achieved by adding several redox molecules [para. 0091]. The instant specification discloses: The present invention is capable of 2, 3, 5, or even 10 redox tags, or more, improving redox signal strength compared to a singularly tagged aptamer by at least one of 1.5×, 2×, 3×, 10× [para. 0037 ] in PG-Pub. Therefore, the disclosed biosensor device comprising substantially the same elements or components as that of the instant device wherein each probe is an aptamer carrying a plurality of redox tags for increasing the redox signal strength, it is contended that the biosensor device of the prior art is capable of providing the same redox signal strength as the instant device. Note that the redox signal strength is proportional to the number of redox tags, since the number of redox molecules attached to the disclosed probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0041], the disclosed device is capable of providing a redox signal strength, when compared to a probe with a singular redox tag, is at least 3 times greater.
Regarding claim 6, Rozenblum teaches the device of claim 1, “wherein the device has a redox signal strength, and the redox signal strength, when compared to a probe with a singular redox tag, is at least 10 times greater” is a functional recitation of the device. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Rozenblum teaches the biosensor device 100 configured for amperometric sensing utilizing aptamer probes immobilized onto the working electrodes 108 and labeled with redox molecules 105 for current signal amplification. The probe may contain one or more redox molecules such as Ferrocene or Methyl Blue, for example. The number of redox molecules attached to one probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0038, 0041]. In order to increase the signal upon ligand binding, a branched phosphoramidite can be added during synthesis to increase the number of redox molecules in each probe molecule [para. 0089]. In some embodiments, synthesis of aptamers with enhanced redox reporters to enhance the signal upon target-ligand binding is achieved by adding several redox molecules [para. 0091]. The instant specification discloses: The present invention is capable of 2, 3, 5, or even 10 redox tags, or more, improving redox signal strength compared to a singularly tagged aptamer by at least one of 1.5×, 2×, 3×, 10× [para. 0037 ] in PG-Pub. Therefore, the disclosed biosensor device comprising substantially the same elements or components as that of the instant device wherein each probe is an aptamer carrying a plurality of redox tags for increasing the redox signal strength, it is contended that the biosensor device of the prior art is capable of providing the same redox signal strength as the instant device. Note that the redox signal strength is proportional to the number of redox tags, since the number of redox molecules attached to the disclosed probe is 3 to 20, 4 to 5, 4 to 10, 4 to 20, 5 to 10, 5 to 20, or 10 to 20 [para. 0041], the disclosed device is capable of providing a redox signal strength, when compared to a probe with a singular redox tag, is at least 10 times greater.
Regarding claim 7, Rozenblum teaches the device of claim 1, wherein the redox tags comprise the same molecule (the probe may contain one or more redox molecules such as Ferrocene or Methyl Blue, for example [para. 0041]; the nucleotide on the opposite end of the linker end, is labeled with a sequence of three Methyl Blue redox molecules [para. 0094]).
Regarding claim 9, Rozenblum teaches the device of claim 1, wherein the redox tags have an average position relative to the electrode during measurement (Fig.1 shows the redox tags 105 have an average position relative to the electrode 108 during measurement), and
“the redox tags with further position from the electrode have a redox peak voltage when free in solution that is less than the redox peak voltage for redox tags in closer position to the electrode” is an inherent characteristic of the electrochemical aptamer-based (E-AB) sensor. Since the prior art does disclose E-AB biosensor device comprising substantially the same elements or components as that of the applicant, it is contended that the redox tags of the prior art with further position from the electrode have a redox peak voltage when free in solution that is less than the redox peak voltage for redox tags in closer position to the electrode. Furthermore, Rozenblum teaches wherein Fig.1 shows the redox tags 105 with a further position from the electrode 108 when the probe is not binding to the target molecule 109 and the redox tags 105 with a closer position to the electrode 108 when the probe is binding to the target molecule 109 (the complimentary probe-target binding, causing the aptamer to change conformation 110, places the redox molecules in closer proximity to the working electrode 108 [para. 0101]). This decrease in distance between the redox molecules and the working electrode causes an increase in the electrical current [para. 0101]. As further evidenced by Plaxco wherein Fig.2A shows the electrical current caused by the redox tag Methylene blue (MB) increases as the aptamer probe binding to the target analyte and the redox peak voltage for the MB redox tag in closer position to the electrode (for 0.1 mM and 1.0 mM target analyte concentrations in Fig.2A) is higher than the redox peak voltage for the MB redox tag in a further position from the electrode (no target in Fig.2A since the redox tag is brought in closer proximity to the working electrode when the aptamer binds to the target) [para. 0010 in Plaxco]. Note that Rozenblum teaches wherein the one or more redox molecules comprises Methyl Blue [para. 0041, 0094], and the redox tags of MB is the same as the MB redox tag of Plaxco. Thus, the disclosed redox tags of Rozenblum with further position from the electrode have a redox peak voltage when free in solution (corresponding to the redox peak voltage with No target as shown in Fig.2A in Plaxco and the redox tags 105 with further position from the electrode 108 with no target as shown in Fig.1 in Rozenblum) that is less than the redox peak voltage for redox tags in closer position to the electrode (corresponding to the redox peak voltage with 0.1 mM and 1 mM target as shown in Fig.2A in Plaxco and the redox tags 105 in closer position to the electrode 108 when the aptamer binds to the target 109 as shown in Fig.1 in Rozenblum).
Regarding claim 10, Rozenblum teaches the device of claim 1, wherein the redox tags contributing to the measured signal each have a redox potential measured by the electrode (the one or more redox molecules is Methyl Blue [para. 0041, 0094], each MB redox tag has a redox potential) and the redox potentials are within 0.125 V or less of each other (the nucleotide is labeled with a sequence of three Methyl Blue redox molecules [para. 0094]; since the redox tags are the same, the redox potentials of the redox tags are the same, thus are within 0.125 V or less of each other).
Regarding claim 11, Rozenblum teaches the device of claim 2, wherein the aptamer is bound to a material that itself is directly or indirectly attached to the electrode (a probe composition has the formula: [[A]n[X]m]y-L-S, wherein each A independently comprises a monomer linked to one or more redox molecules, each X independently comprises a monomer, L comprises a linker, S comprises a substrate. In some embodiments, the linker comprises a thiol end group. In some embodiments, the substrate comprises gold [para. 0011]; the nucleotide sequence is attached to the gold surface of the working electrode by the reaction product of the linker 1-0-Dimethoxytrityl-hexyldisulfide,r-[(2-cyanoethyl)-(N,N-diisopropyl)]-phosphoramidite as seen in Fig.7 [para. 0094]; thus the aptamer is bound to a material [a linker] that itself is directly attached to the electrode).
Regarding claim 13, Rozenblum teaches the device of claim 1, wherein the affinity-based probes each carry at least three redox tags (wherein the probe comprises at least 3 redox molecules [claim 26; para. 0011]).
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 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rozenblum, as applied to claim 1 above, and further in view of Plaxco et al. ( US20190209063A1).
Regarding claim 8, Rozenblum teaches the device of claim 1, and is silent to wherein each redox tag comprises at least one molecule that is distinct from the other redox tags.
Plaxco teaches an electrochemical aptamer-based (E-AB) sensor (abstract, Fig.1 and [para. 0009]), and Fig.1 shows the E-AB sensor comprising an aptamer 102 functionalized with a sensing MB redox reporter 105 and a reference AQ redox reporter 103 [para. 0009]. Plaxco further teaches in the sensors of the invention, the recognition elements of the sensor are functionalized with at least two different redox reporters [para. 0026].
Rozenblum and Plaxco are considered analogous art to the claimed invention because they are in the same field of E-AB sensors comprising an aptamer probe functionalized with a plurality of redox tags/reporters. Given the teaching of Plaxco regarding the probe is functionalized with at least two different redox reporters [para. 0026], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different redox reporters as the plurality of redox tags such that each redox tag comprises at least one molecule that is distinct from the other redox tags, as taught by Plaxco, since it would allow to provide a reference signal generated by a reference redox reporter that is insensitive to the target analyte(s) and the other sensing signals generated by the other distinct sensing redox reporters sensitive to the target analytes (claim 1 and [para. 0014] in Plaxco).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Zhu et al. (Employing an Intercalated Redox Reporter in Electrochemical Aptamer-Based Biosensors to Enable Calibration-Free Molecular
Measurements in Undiluted Serum, Analytical Chemistry, 2020, 92, 12437-12441) teach an E-AB sensor comprising a probe attached MB reporter and DOX reporter. Ford et al. (US20230042710A1) teaches E-AB sensor comprising an aptamer coupled to a plurality of redox tags. Larson et al. (US20210140956A1) teaches E-AB sensor using a plurality of different redox moieties on active sensor elements or companion reference sensing elements. Bertrand et al. (US20200041437A1) teaches E-AB sensors configured with a plurality of different redox moieties [para. 0065].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V. Van can be reached on (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795
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