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 11/5/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, Claims 1-9, with traverse in the reply filed on 06/10/2026 is acknowledged.
The traversal is on the ground(s) that “the search for these groups substantially overlaps. As such, it is submitted that examination of both would not be considered an undue burden”. This is not found persuasive because for purposes of the initial requirement, a serious burden on the Examiner may be prima facie shown if the Examiner shows by appropriate explanation of separate classification, or separate status in the art, or a different field of search (as defined in MPEP § 808.02). The restriction requirement clearly meets this requirement. While that prima facie showing may be rebutted by appropriate showings or evidence by the Applicant, an unsupported statement by Applicant that no serious burden would exist in the examination of all pending claims does not qualify as an “appropriate showing” or “evidence”. See MPEP § 803. As stated in the prior Office Action, 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.
Claim Objection
Claims 1 and 8 are objected to because of the following informalities:
Claim 1: please amend “the working electrode and” to -- the working electrode [[and]]--; “the CRP detection sensitivity” to – [[the]] a CRP detection sensitivity--; “the range of “ to – [[the]] a range of --.
Claim 8: please amend “the detection time” to – [[the]] a detection time--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1, “a current signal recorder … the current signals from the current signal recorder” is being interpreted under 35 U.S.C. 112(f) . Prong 1: a current signal recorder (uses the generic placeholder), prong 2: record current signals (inherent functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). The specification does not disclose the structure of the current signal recorder to perform the function of recording current signals.
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 1-9 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 1, claim 1 recites “a data processor for receiving the current signals from the current signal recorder”, wherein “the current signals” lack antecedent basis. Therefore, the scope of claim 1 is indefinite. Claims 2-9 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 1, claim 1 recites “a current signal recorder” for recording current signals, which invoke 112(f) and the specification does not provide the corresponding structures for performing the functions above. Therefore, the scope of claim 1 is indefinite. Claims 2-9 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (US20110139636A1), and in view of Jarczewska et al. (Development of DNA aptamer-based sensor for electrochemical detection of C-reactive protein, Talanta, 2018, 189, 45-54), Kendall et al. (US20230053962A1), and Folch et al. (US20240369511A1).
Regarding claim 1, Lai teaches a single-step, reagentless and reusable electrochemical biosensor system (a gold-plated screen-printed electrode for use as an electrochemical sensor [para. 0004, Figs. 1-2]), comprising:
a working electrode (working electrode 124 in Fig.1B; a gold film can be electrodeposited onto the WE 124 [para. 0024]) with redox-tagged analyte-targeting aptamer immobilized on the surface of the working electrode (FIG. 2A shows an E-DNA sensor includes a redox-tagged stem-loop DNA probe covalently attached to the gold pixel on the electrode [para. 0027]; FIG. 2B illustrates an example of an electrochemical sensor in which the binding ligand for detecting a target analyte is an aptamer. An aptamer-based electrochemical sensor (E-AB) can include a redox tagged aptamer covalently attached to an electrode [para. 0029]);
a counter-electrode (counter electrode 104 in Fig.1A [para. 0023]; claims 1, 5 and 7);
a flat substrate surface for mounting the electrodes and the specimen (The electrodes are screen-printed onto a substrate using conductive inks. The substrate of a screen-printed electrode can be paper, plastic, or ceramic [para. 0023]; Figs. 1 -2 show a flat substrate surface for mounting the electrodes and the specimen);
a current signal recorder connected to the working electrode and the counter-electrode (screen-printed electrochemical biosensors can be configured as voltammetric electrochemical biosensors that utilize alternating current voltammetry in a solution or buffer that includes a sample. The use of voltammetry allows control of the potential (voltage) of an electrode in contact with an analyte while the resulting current is measured. For example, a voltammetric scan can obtain information about a target analyte from an electrochemical biosensor by measuring current at a first electrode (e.g., a working electrode), where the current results from the transfer of electrons between the electrode and the analyte. A second electrode (e.g., a reference electrode) generally is a half cell with a known reduction potential (voltage), which does not pass any current between it and the analyte and acts as a reference in measuring and controlling the potential at the first electrode. A third electrode (e.g., a counter electrode) can pass the current needed to balance the current observed at the first electrode (e.g., the counter electrode) [para. 0034]; thus, it must have a current signal recorder connected to the working electrode and the counter-electrode to measure the resulting current as shown in Fig.3. Note that the current signal recorder will be further rejected in view of Jarczewska in the following).
Lai further teaches the particular binding ligand used will depend on the target analyte being detected [para. 0025].
Lai is silent to: (1) wherein the analyte is CRP, and the redox-tagged analyte-targeting aptamer is CRP-targeting aptamer; (2) the counter electrode is back-filled with a backfilling reagent to prevent non-specific adsorption; (3) a data processor for receiving the current signals from the current signal recorder and processing the current signals; and (4) wherein the CRP detection sensitivity of the electrochemical biosensor system is in the range of 1 to 500 nanomolar.
Jarczewska teaches E-DNA aptamer-based sensor for electrochemical detection of C-reactive protein wherein the redox-tagged analyte-targeting aptamer is CRP-targeting aptamer (title, Fig.1, DNA probes in Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the redox-tagged aptamer ligands in Lai to redox-tagged CRP-targeting aptamer for the detection of CRP, as taught by Jarczewska, since CRP is a crucial biomarker of cardiovascular diseases and the modified E-DNA sensor would allow for detection of CRP (abstract in Jarczewska).
Jarczewska further teaches cyclic voltammetry and square-wave voltammetry were performed with a CHI 660A electrochemical workstation (section 2.1). Although Lai does not explicitly teach the current signal recorder to record the resulting current of voltammetry, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use CHI 660 electrochemical workstation as the current signal recorder, as taught by Jarczewska, since Jarczewska teaches CHI 660A electrochemical workstation would be suitable to perform CV and SWV measurements of the E-DNA sensor for the detection of CRP (section 2.1).
Modified Lai is silent to: (2) the counter electrode is back-filled with a backfilling reagent to prevent non-specific adsorption; (3) a data processor for receiving the current signals from the current signal recorder and processing the current signals; and (4) wherein the CRP detection sensitivity of the electrochemical biosensor system is in the range of 1 to 500 nanomolar.
Jarczewska further teach as nonspecific adsorption of target protein or interfering molecules on gold electrodes was likely to occur an additional blocking agent was selected. To limit the surface fouling alkanethiols]: 2-mercapto-1-
ethanol (MCE), 6-mercapto-1-hexanol (MCH), 11-mercapto-1-undecanol (MCU) and bovin serum albumin (BSA) [45] were applied for Au modification (section 3.1.3).
Kendall teaches an E-DNA aptamer sensor, wherein the counter electrode is back-filled with a backfilling reagent to prevent non-specific adsorption (50 μL of 1 mM 6-mercaptohexanol (MCH) in PBS was dropped onto the aptamer functionalized electrode, covering both the working and counter electrode, and the electrode was incubated for 40 mins at room temperature in the dark [para. 0611]). Thus, Kendall teaches both the working electrode and the counter electrode are back-filled with a backfilling reagent of MCH.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the counter electrode to be back-filled with a backfilling reagent of MCH, as taught by combined Kendall and Jarczewska, since it would prevent non-specific adsorption of target protein or interfering molecules (section 3.1.3 in Jarczewska).
Modified Lai is silent to: (3) a data processor for receiving the current signals from the current signal recorder and processing the current signals; and (4) wherein the CRP detection sensitivity of the electrochemical biosensor system is in the range of 1 to 500 nanomolar.
Folch teaches electrochemical aptamer sensors (abstract) comprising one or more processors configured to detect the change in the electric current, and process the change in the electric current [para. 0058, 0144, claim 13].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrochemical aptamer biosensor system by providing a processor configured to receive the current signals from the current signal recorder and process the current signals, as taught by Folch, since it would allow to process the current signals and subsequently determine concentration of the analyte based on a change in an electric current [para. 0150 in Folch].
The limitation “wherein the CRP detection sensitivity of the electrochemical biosensor system is in the range of 1 to 500 nanomolar” is a functional recitation. 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, modified Lai teaches the electrochemical biosensor system comprising substantially the same sensing elements or components as those of the instant application, as outlined in the rejection above. Furthermore, Jarczewska teaches the electrochemical aptamer-based sensor for the detection of CRP with LOD of 1 pM and linear range of response is in a range of 1-100 pM (see the last row in Table 4). Therefore, it is contented that the disclosed electrochemical aptamer-based biosensor is capable of providing a CRP detection sensitivity in the range of 1 to 500 nanomolar.
Regarding claim 2, modified Lai teaches the system of claim 1, and Lai teaches wherein the working electrode is a gold electrode (gold deposited on the working electrode [para. 0005, 0007]).
Regarding claim 3, modified Lai teaches the system of claim 1, and Lai teaches a screen-printed carbon counter electrode [para. 0050], thus is silent to wherein the counter-electrode is a platinum electrode.
Kendall teaches wherein the electrochemical aptamer-based biosensor comprises a gold working electrode and a platinum counter electrode [para. 0606].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the carbon counter electrode to a platinum counter electrode, as taught by Kendall, since Kendall teaches platinum would be a suitable material for the counter electrode of an electrochemical aptamer-based biosensor [para. 0606].
Regarding claim 4, modified Lai teaches the system of claim 1, wherein the redox tag of the CRP-targeting aptamer is methylene blue (Lai teaches wherein the redox tag is Methelene Blue [para. 0061, 0064]; In the alternative, Jarczewska teaches wherein the redox tag is Methelene Blue [Number 6 in Table 1]).
Regarding claim 5, modified Lai teaches the system of claim 1, wherein the backfilling reagent comprises alkane-thiols (as outlined in the rejection of claim 1 above,
Kendall teaches wherein the backfilling reagent comprises MCH [para. 0611], which comprises alkane-thiols).
Regarding claim 6, modified Lai teaches the system of claim 1, and Lai teaches wherein the substrate is ceramic (The substrate of a screen-printed electrode can be ceramic [para. 0023]).
Regarding claim 7, modified Lai teaches the system of claim 1, wherein the redox-tagged CRP-targeting aptamer is immobilized on the surface of the working electrode by gold-thiol interaction (Lai teaches methods of attaching a binding ligand to a GPE as described herein are well-known in the art and include, without limitation, covalent linkers or, when the pixel is gold, sulfur groups [e.g., thiols] [para. 0025]).
Regarding claim 8, modified Lai teaches the system of claim 1, and the limitation “wherein the detection time for the CRP is no longer than 10 minutes” is a functional recitation. 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, modified Lai teaches the electrochemical biosensor system comprising substantially the same sensing elements or components as those of the instant application, as outlined in the rejection of claim 1 above. Therefore, it is contented that the disclosed electrochemical aptamer-based biosensor is capable of providing a detection time for the CRP no longer than 10 minutes.
Regarding claim 9, modified Lai teaches the system of claim 1, and the limitation “wherein the system is reusable for more than 1 time for dose-response assays” is a functional recitation. 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, modified Lai teaches the electrochemical biosensor system comprising substantially the same sensing elements or components as those of the instant application, as outlined in the rejection of claim 1 above. Therefore, it is contented that the disclosed electrochemical aptamer-based biosensor would be reusable for more than 1 time for dose-response assays.
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Mallires et al. (US20230301552A1) teaches an electrochemical aptamer biosensor comprising aptamer tethered to gold working electrode via a thiol link (claim 38). Plaxco et al. (US20210196161A1) teaches E-AB sensor as shown in Fig.1.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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