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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, Claims 1-6, 9-10, and 15-18, with traverse in the reply filed on 07/31/2026 is acknowledged.
The traversal is on the ground(s) that “Fritsch’s primary embodiment separates the biological capture surface from the detection electrode and a separate bar electrode performs electrochemical detection. Even if Fritsch’s LTCC ceramic embodiment, where rough gold surfaces may serve a dual capture-and-detection role, the system operates my measuring current generated by enzymatically-produced redox species under and externally applied potential via a potentiostat. The present claims reciting capturing surface that immobilize an analyte or particle complex at a detection electrode, thereby assembling part of a measurable Galvanic cell through electrochemical reaction which is a fundamentally different electrochemical mechanism from Fritsch’s potentiostat-driven amperometric detection. The claims also independently satisfy unit because Group I claims a product and Groups II and III claim processes of use of that product. The examiner has not established a search burden were required. This is not found persuasive because Fritsch does teach the electrodes 12 comprise a capturing surface capable of capturing an analyte (Fig.1 shows the electrodes 12 have monolayer regions 18 to capture/bind analyte binding material antibodies 20, which is an antibody specific to analyte 22 [para. 0061]). The “Galvanic” and/or “amperometric” detection are intended use of the device, and does not further limit the structures of the device. Furthermore, as outlined for the second set of rejection of claim 1 below, Lv teaches a galvanic detection device. As applicant noted that Group I claims a product, while Groups II and III claim processes of use of said products, thus they are different inventions. Note that the restriction is 371 unity restriction instead of 121 restriction. The claims of the present application contain distinct inventions. A search of these inventions may overlap, but the search of one invention does not include all the areas required for the others. A serious burden does exist, as different searches are required for each invention. Therefore, in order to ensure the quality of the search and examination, these inventions should be searched separately to account for their differences.
The requirement is still deemed proper and is therefore made FINAL, and claims 20-27 are withdrawn.
Claim Objection
Claims 1-6 and 9 are objected to because of the following informalities:
Claim 1: please amend “at least one detection electrode” to -- at least one detection electrode of the at least one pair of detection electrodes --; “an analyte and/or particle to at least one detection electrode” to – [[an]] the analyte and/or particle to the at least one detection electrode--.
Claim 2: please amend “the device” to -- the galvanic detection device--.
Claim 3: please amend “the pair of detection electrodes” to --the at least one pair of detection electrodes--; “is be selected” to -- is [[be]] selected--.
Claim 4: please amend “capturing system” to – the capturing surface system--.
Claim 5: please amend “capturing system” to – the capturing surface system--; “an aptamer a nucleotide” to -- an aptamer, and a nucleotide--.
Claim 6: please amend “capturing system” to – the capturing surface system--; “a detection electrode” to – a detection electrode of the at least one pair of detection electrodes--.
Claim 9: please amend “the device” to -- the galvanic detection device--; “an analyte” to –[[an]] the analyte--; “the capturing system” to – the capturing surface system--; “a detection electrode” to -- a detection electrode of the at least one pair of detection electrodes--; “the influence” to –[[the]] an influence--; “configured to move towards” to -- configured to move the analyte and/or particle towards--.
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 2 and 9 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 2, claim 2 recites “wherein the device comprises multiple pairs of detection electrodes, optionally wherein the galvanic detection device comprises two pairs of detection electrodes”, and claim 1 recites “A galvanic detection device comprising at least one pair of detection electrodes”. It is unclear if “multiple pairs of detection electrodes” and “two pairs of detection electrodes” are part of the at least one pair of detection electrodes, or the device further comprises “multiple pairs of detection electrodes” and “two pairs of detection electrodes” in addition to the at least one pair of detection electrodes. Thus, the scope of claim 2 is indefinite.
Regarding claim 9, claim 9 recites “a detection particle” which is unclear if it is the same as or different than “particle” recited in claim 1. Claim 9 further recites “a capturing surface”, which is unclear if it is the same as or different than the capturing surface of the at least one detection electrode recited in claim 1. Therefore, the scope of claim 9 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, 3-6, and 16-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fritsch et al. (US20030108922A1). Fritsch was provided in IDS filed on 11/21/2024.
Regarding claim 1, Firtsch teaches a galvanic detection device (a detection device as shown in Fig.1 [para. 0060]; “galvanic” is an intended use limitation. 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, Firtsch teaches the detection device comprising substantially the same elements or components as that of the application, as outlined in the rejection of claim 1 below. It is contented that the detection device can be operated as a galvanic detection device) comprising at least one pair of detection electrodes (gold layers 12 as shown in Fig.1 [para. 0064] and electrode 16 in Fig.1 [para. 0064]), wherein at least one of:
a) at least one detection electrode comprises a capturing surface capable of capturing an analyte and/or particle (Fig.1 shows each gold electrode comprises monolayer regions 18, and primary analyte binding material antibodies 20 are then attached to monolayer regions 18, and the antibody 20 is specific to analyte 22 [para. 0061]; the complex of the monolayer 18/primary antibody 20 is deemed as the capturing surface, which is capable of capturing an analyte 22); and/or
b) the galvanic detection device comprises a capturing surface system configured to actively deliver an analyte and/or particle to at least one detection electrode (this limitation is optional).
Regarding claim 3, Firtsch teaches the galvanic detection device of claim 1, wherein the at least one pair of detection electrodes comprises a non-reactive conductor electrode (gold electrodes 12 in Fig.1) and a redox reactive electrode (electrode 16 in Fig.1; Ag/AgCl [saturated KCl] reference electrode [para. 0076]) incorporating a redox active substance (Ag/AgCl reference electrode incorporating a redox active substance of silver).
optionally wherein the non-reactive conductor electrode is configured to receive a redox active substance during an assay to form a galvanic cell (this limitation is optional; furthermore, the gold electrode is configured to receive a redox active substance during an assay to form a galvanic cell. Examiner further notes that in instant application, the non-reactive conductor electrode may be selected from a carbon electrode or a noble metal electrode (e.g., a gold electrode, or a platinum electrode) [para. 0040] in PG-Pub of instant specification. The disclosed gold electrode is the same as the gold electrode adopted in instant application), and
optionally wherein the redox active substance is be selected from the group consisting of zinc, silver, nickel, aluminium, copper, manganese, and salts and oxides thereof (this limitation is optional; furthermore, Firtsch teaches Ag/AgCl electrode incorporating a redox active substance of silver).
Regarding claim 4, Firtsch teaches the galvanic detection device of claim 1,
wherein the capturing surface or capturing system is present on one or more of: an electrical conductor, an electrode, and/or a particle (the complex of the monolayer 18/primary antibody 20 is present on conductor layer 20 of each electrode 12 as shown in Fig.1 [para. 0061]).
Regarding claim 5, Firtsch teaches the galvanic detection device of claim 1, wherein the capturing surface comprises a capturing agent comprising an antibody (self assembled monolayer has primary antibodies covalently attached [claim 25]; the primary antibody attached on the monolayer 18 is specific to analyte 22 [para. 0061]).
Regarding claim 6, Firtsch teaches the galvanic detection device of claim 1, wherein the capturing surface is stationary (Fig.1 shows the capturing surface is stationary on the conductive layer 20 of each electrode 12).
Regarding claim 16, Firtsch teaches the galvanic detection device of claim 1, wherein the detection device is a microfluidic test device capable of receiving a liquid sample for analysis (In the present invention, a Au screen printed LTCC platform is used as a substrate for a sandwich type ELISA using mouse IgG. The ceramics can be used for the construction of microfluidic channels for the delivery of small volumes of samples. Therefore, this platform is suitable for high throughput analysis and μTAS chips in biosensor technology that may be automated [para. 0114]).
Regarding claim 17, Firtsch teaches the galvanic detection device of claim 1, wherein the detection device further comprises at least one electrolyte reagent (a solution containing 4 mM K 3Fe(CN)6 in 0.1 M KCl and 4 mM PAPR in 0.1 M Tris, pH 9.0 [para. 0102]).
Regarding claim 18, Firtsch teaches the galvanic detection device of claim 1, further comprising an electronic measuring device (A BAS-100B potentiostat and a PA-1 preamplifier with BAS-100W electrochemical software (Bioanalytical Systems, Lafayette, Ind.) and a CH Instruments Electrochemical Workstation Model 650A potentiostat with a Picoamp booster and Faraday cage (CH Instruments, Inc, Austin, Tex.), controlled by a PC with CHI-650A software [para. 0102]).
Claims 1-2, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lv et al. (Magnetic-field-driven extraction of bioreceptors into polymeric membranes for label-free potentiometric biosensing, Angew. Chem. Int. Ed., 2021, 60, 2609-2613).
Regarding claim 1, Lv teaches a galvanic detection device (a detection device as shown in Scheme 1 on page 2610; “galvanic” is an intended use limitation. 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, Lv teaches the detection device comprising substantially the same elements or components as that of the application, as outlined in the rejection of claim 1 below. It is contented that the detection device can be operated as a galvanic detection device. Furthermore, Lv does teach wherein the detection device is operated as a galvanic detection device, and Fig.1 shows the potential responses of the peptide S5 on the ISE measured in the galvanic cell [caption of Fig.1]) comprising at least one pair of detection electrodes (three working electrodes and one reference electrode are shown in Scheme 1; Fig.5 shows a sensor array for 4 peptides x 8 bacteria x 5 replicates [the first paragraph in Col. 2 on page 2612]), wherein at least one of:
a) at least one detection electrode comprises a capturing surface capable of capturing an analyte and/or particle (Scheme 1 and Fig.5 show each WE comprises MBs-peptides as the bioreceptors for the potentiometric detection of antimicrobial peptides [the 1st and 2nd paragraphs in Col. 1 on page 2610]); and/or
b) the galvanic detection device comprises a capturing surface system configured to actively deliver the particle to the at least one detection electrode (by applying a magnetic field, MBs-peptide can be assembled and reconfigured on the membrane surface efficiently [the 2nd paragraph in Col. 1 on page 2610]).
Regarding claim 2, Lv teaches the galvanic detection device of claim 1, wherein the device comprises multiple pairs of detection electrodes, optionally wherein the galvanic detection device comprises two pairs of detection electrodes (three Wes and one reference electrode as shown in Scheme 1; and Fig.5 shows a sensor array for 4 peptides x 8 bacteria x 5 replicates [the first paragraph in Col. 2 on page 2612]).
Regarding claim 10, Lv teaches the galvanic detection device of claim 1, wherein the capturing surface comprises streptavidin or biotin (the peptide serving as both the bioreceptor and signal reporter was linked to the MBs through the biotin-streptavidin reaction [the 1st paragraph in Col. 1 on page 2610]).
Regarding claim 15, Lv teaches the galvanic detection device of claim 1, wherein the particle is a magnetic particle (Magnetic particles [MBs] in Scheme 1 [the 1st paragraph in Col. 1 on page 2610]) and the galvanic detection device further comprises a magnet or magnetic field for attracting the magnetic particle (by applying a magnetic field, MBs-peptide can be assembled and reconfigured on the membrane surface efficiently [the 2nd paragraph in Col. 1 on page 2610]).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lv, as applied to claim 1 above.
Regarding claim 9, Lv teaches the galvanic detection device of claim 1, wherein the device comprises:
a detection particle functionalised with a peptide (MBs-peptide in Scheme 1) for capturing an analyte and forming a detection complex comprising the detection particle and the analyte (the peptide serving as both the bioreceptor and signal reporter was linked to the MBs for the potentiometric detection of antimicrobial peptides [scheme 1B; the 2nd paragraph in Col. 1 on page 2610]); and
a capturing surface for capturing the detection complex (scheme 1 shows a capturing surface on each SPE WE for capturing the detection complex [the 2nd paragraph in Col. 1 on page 2610]),
wherein the capturing system is configured to move the analyte and/or particle towards a detection electrode under the influence of a magnetic field (By applying a magnetic field, MBs-peptide can be assembled and reconfigured on the membrane surface efficiently [the 2nd paragraph in Col. 1 on page 2610]), and
wherein the detection particle is a magnetic particle (MBs in scheme 1) and the galvanic detection device further comprises one or more magnets for attracting the magnetic detection particle towards a detection electrode capturing surface (By applying a magnetic field, MBs-peptide can be assembled and reconfigured on the membrane surface efficiently [the 2nd paragraph in Col. 1 on page 2610]; Scheme 1 illustrate the magneto-controlled potentiometric sensing mechanism [the 1st paragraph in Col. 1 on page 2610]; The magnetic field was controlled with the number of the applied magnets [the 1st paragraph in Col. 2 on page 2611]).
Lv is silent to wherein the MBs are functionalized with an antibody for capturing the analyte in Scheme 1.
But Lv does teach bioreceptors such as antibodies and aptamers have been used for potentiometric detection of a broad range of different target molecules [the 1st paragraph in Col. 2 on page 2609]; and the proposed magneto-controlled sensing principle can be extended to other bioreceptors such as aptamers and antibodies [the 1st paragraph in Col. 1 on page 2613].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the peptide with antibody such as the detection particle of MBs is functionalized with an antibody for capturing the analyte, as taught by Lv, which teaches suitable alternative bioreceptors such as antibody for potentiometric detection of a broad range of different target molecules.
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Wu et al. (Bifunctional magnetic nanobeads for sensitive detection of avian influenza A (H7N9) virus based on immunomagnetic separation and enzyme-induced metallization, Biosensors and Bioelectronics, 2015, 68, 586-592) teaches bi-MBs functionalized with target recognition molecules for capturing H7N9 virus. Alvarez-Carulla et al. (Self-Powered Point-of-Care Device for Galvanic Cell-Based Sample Concentration Measurement, Sensors, 2021, 21, 2665) teaches Cu as inert electrode and Zn as the redox active electrode for galvanic cell. Chandler et al. (A time-dependent model for improved biogalvanic tissue characterization, Medical Engineering & Physics, 2015, 37, 956) teaches an Cu-Zn galvanic cell. Skiba et al. (US20200222687A1) teaches a plurality of galvanic cells comprising a plurality of first electrodes 6 and a plurality of second electrode 10 separated by a spacing 8 as shown in Fig.1.
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/Primary Examiner, Art Unit 1795
