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 08/27/2026 has been considered by the examiner.
Status of the Claims
The Amendment filed May 11th, 2026 has been entered. Claims 1, 3, 9-10, 13, 15, 18, and 20 have been amended. Claims 2 and 5 have been canceled. Claims 1, 3-4, and 6-20 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action dated 02/11/2026.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of Applicant’s amendments.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the Applicant’s amendments as outlined below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 6-12, and 17-20 is rejected under 35 U.S.C. 103 as being unpatentable by Mahari (eCovSens-Ultrasensitive Novel In-House Built Printed Circuit Board Based Electrochemical Device for Rapid Detection of nCovid-19 antigen, a spike protein domain 1 of SARS-CoV-2 bioRxiv, 2020, pages 1-20, provided in IDS dated 07/14/2024) in view of Arad (US 2023/0090502 A1, provided in IDS dated 10/14/2024).
Regarding Claim 1, Mahari teaches an electrode (FTO/AuNPs/nCovid-10 Ab modified electrode [Section 2.5 Fabrication of FTO electrode with AuNPs/nCovid 19- Ab, page 4]) having attached thereto an agent (nCovid-19 Ab is immobilized on different FTO/AuNPs [Section 2.5 Fabrication of FTO electrode with AuNPs/nCovid 19- Ab, page 4]) that specifically binds to a biomarker of a viral infection (nCovid-19 Ab binds with nCovid-19 Ag [first and second para., page 3]).
Mahari is silent on the biomarker is a proteolytic enzyme indicative of said viral infection; and the biomarker is found in a saliva of a subject having said viral infection.
Arad teaches methods and kits for testing SARS-CoV-2 via determining the presence of viral 3CL protease (abstract), and teaches the biomarker is a proteolytic enzyme indicative of said viral infection (biomarker 3CL-protease is detected in a sample by contact with a composition comprising an agent, wherein a presence of the 3CL-protease in the sample is indicative of a SARS-CoV-2 infection [para. 0015]); and the biomarker is found in a saliva of a subject having said viral infection (sample comprises saliva [paras. 0110 and 0112]).
Mahari and Arad are considered analogous art to the claimed invention because they are in the same field of SARS-CoV-2 biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the biomarker of Mahari to be SARS-CoV-2 3CLpro, which is a proteolytic enzyme indicative of said viral infection; and the biomarker is found in a saliva of a subject having said viral infection, as taught by Arad, as detecting the presence of 3CL-protease in saliva is indicative of a SARS-CoV-2 infection (Arad, [para. 0015]).
Regarding Claim 3, modified Mahari teaches the electrode of claim 1.
Mahari teaches wherein said agent that specifically binds to said biomarker is an antibody specific to said proteolytic enzyme (nCovid-19 antibody specifically binds with its protein biomarker counterpart [first and second para., page 3]).
Regarding Claim 4, modified Mahari teaches the electrode of claim 1, and teaches wherein said biomarker is a SARS-CoV-2-specific proteolytic enzyme (as outlined in the claim 1 rejection above, Arad teaches the biomarker is SARS-CoV-2 3CL-protease [para. 0015]).
Regarding Claim 6, modified Mahari teaches the electrode of claim 4.
Mahari teaches wherein said agent that specifically binds to said proteolytic enzyme is an antibody specific to said SARS-CoV-2-specific proteolytic enzyme (immobilized nCovid-Ab is specific to target protein biomarker [abstract]).
Regarding Claim 7, modified Mahari teaches the electrode of claim 4, and teaches wherein said SARS-CoV-2-specific proteolytic enzyme is 3CLpro (SARS-CoV-2 3CLpro) (as outlined in the claim 1 rejection above, Arad teaches the biomarker is SARS-CoV-2 3CLpro [para. 0015]).
Regarding Claim 8, modified Mahari teaches the electrode of claim 7.
Mahari is silent on wherein said 3CLpro comprises an amino acid sequence as set forth in SEQ ID NO:2.
Arad teaches wherein said 3CLpro comprises an amino acid sequence as set forth in SEQ ID NO:2 (protease used in the positive control comprises an amino acid sequence as set forth in SEQ ID NO: 34 [para. 0242], which Examiner notes is identical to SEQ ID NO:2 of the instant application).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the 3CLpro in the method of modified Mahari to comprise an amino acid sequence as set forth in SEQ ID NO:2, as taught by Arad, as a 3CL-protease with this sequence can detect the presence of SARS-CoV-2 in a subject (Arad, [paras. 0241-0242]).
Regarding Claim 9, modified Mahari teaches the electrode of claim 1.
Mahari is silent on the electrode being a carbon electrode, optionally a carbon fiber electrode.
However, in another embodiment, Mahari teaches the electrode being a carbon electrode (screen printed carbon electrode [abstract]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrode of modified Mahari to be a carbon electrode, as taught by Mahari, as electrodes made of carbon are suitable for immobilization of immobilizing Covid antibodies for sensing (Mahari, [abstract]).
Regarding Claim 10, modified Mahari teaches an electrochemical system comprising the electrode of claim 1 (see claim 1 rejection above);
the limitation “the electrochemical system being configured such that when said biomarker is contacted with said electrode, a detectable change in an electrochemical parameter is generated” 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, cyclic voltammetry is used to measure the electrical current difference via the binding of nCovid-19 Ag [third para. page 6]. Thus, the electrochemical system of modified Mahari is capable of performing the claimed function above.
Regarding Claim 11, modified Mahari teaches the electrochemical system of claim 10.
Mahari teaches wherein said electrode forms a part of an electrochemical cell (as illustrated in Scheme 1 (B), FTO working electrode is part of an electrochemical cell [page 7]) and the electrochemical cell is operable by electrically connecting said electrode to a power source (electrochemical cell is connected to a potentiostat as illustrated in Scheme 1 (B) [page 7]).
Regarding Claim 12, modified Mahari teaches the electrochemical system of claim 11.
Mahari teaches wherein the electrochemical cell is operable by contacting said electrode with an electrolyte (electrolyte is comprised of K3[Fe(CN)6]/K4[Fe(CN)6] (1:1) solution with 100 mM KCl [see Scheme 1 (B) page 7]).
Regarding Claim 17, modified Mahari teaches the electrode of claim 1.
Mahari teaches a method of determining a presence and/or amount of a viral biomarker in a sample (detect the presence of nCovid-19 spike Ag [first para. page 3]), the method comprising contacting the sample with the electrode of claim 1 (as outlined in the claim 1 rejection above, modified Mahari teaches the electrode recited in claim 1), and determining a change in an electrochemical parameter (variation in current as judged by cyclic voltammetry [first para. 10]; illustrated in cyclic voltammetry graphs on page 10) generated upon operating an electrochemical system comprising the electrode of claim 1 (Scheme 1 sensor is an electrochemical system that uses the FTO immunosensor outlined in claim 1 above [third para. page 6]; also illustrated in Scheme 1 (B), page 7), wherein said change is indicative of the presence and/or amount of the viral biomarker in the sample (as shown in Fig. 3A, current is varied based on concentration of nCovid-19 Ag [page 12]).
Regarding Claim 18, modified Mahari teaches the method of claim 17, and teaches wherein the sample is a biological sample drawn from a subject (as outlined in the claim 1 rejection above, Arad teaches the sample comprises saliva [paras. 0110 and 0112]), the method being for determining the presence and/or amount of the viral infection in the subject (as outlined in the claim 17 rejection above, Mahari teaches detection of nCovid-19 Ag [first para. page 14]).
Regarding Claim 19, modified Mahari teaches the method of claim 18, and teaches wherein said biological sample is a saliva sample of the subject (as outlined in the claim 18 rejection above, Arad teaches the sample is saliva [paras. 0110 and 0112])).
Regarding Claim 20, modified Mahari teaches the method of claim 17, and teaches wherein said biomarker is SARS-CoV-2 3CLpro (as outlined in the claim 1 rejection above, Arad teaches the biomarker is SARS-CoV-2 3CLpro [para. 0015]).
Mahari teaches the method being of determining a presence and/or amount of a viral infection caused by SARS-CoV-2 in the subject (as shown in Fig. 3A, current is varied based on concentration of nCovid-19 Ag [page 12]).
Claims 13-16 is rejected under 35 U.S.C. 103 as being unpatentable by Mahari and Arad, as applied to claim 12 above, and in view of Biloivan (Development of Enzyme Biosensor Based on ISFETs for Quantitative Analysis of Serine Proteinases. Electroanalysis 2004; 16(22), pages 1883-1889).
Regarding Claim 13, modified Mahari teaches the electrochemical system of claim 12.
Mahari is silent on wherein said electrolyte comprises a substance that is capable of interacting with said biomarker, wherein a detectable change is an electrochemical parameter is generated in response to an interaction between said biomarker and said substance.
Biloivan teaches a potentiometric biosensor for quantitative determination of proteinases (abstract), and teaches wherein said electrolyte comprises a substance (electrolyte includes substrate BAEE [second para. col. 2, page 1885]) that is capable of interacting with said biomarker wherein a detectable change is an electrochemical parameter is generated in response to an interaction between said biomarker and said substance (substrate BAEE interacts with immobilized trypsin-like proteinases to determine amount of proteinase via hydrolysis with water [fourth and fifth paras. col. 2, page 1885 and Scheme 1 page 1885] to create a pH dependent reaction [see Figure 4, page 1888]).
Modified Mahari and Biloivan are considered analogous art to the claimed invention because they are in the same field of biosensors using immobilized proteolytic enzymes. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute said biomarker of modified Mahari to be a trypsin-like proteinase and modify the electrolyte to include BAEE so that said electrolyte comprises a substance that is capable of interacting with said biomarker wherein a detectable change is an electrochemical parameter is generated in response to an interaction between said biomarker and said substance, as taught by Biloivan, as BAEE interacts with trypsin to create hydrogen ions to measure the activity of trypsin (Bioloiva, [fourth and fifth paras. col. 2, page 1885; also Figures 1 and 4 pages 1885 and 1888, respectively).
Regarding Claim 14, modified Mahari teaches the electrochemical system of claim 13, and teaches wherein said electrolyte further comprises an electroactive agent that undergoes an electrochemically detectable reaction in response to said interaction to thereby generate said change in said electrochemical parameter (as outlined in the claim 13 reaction above, Biloivan teaches water is contained in the electrolyte and used in the hydrolysis of BAEE [fourth and fifth paras. col. 2, page 1885; illustrated in Figure 1 page 1885]).
Regarding Claim 15, modified Mahari teaches the electrochemical system of claim 14, and teaches wherein said biomarker, said substance, and said electroactive agent are selected such that said interaction between said biomarker and said substance generates a moiety or species (as outlined in the claim 13 reaction above, Biloivan teaches hydrolysis of BAEE generates and hydrogen ion [Figure 1 page 1885]), and said electroactive agent undergoes an electrochemically detectable reaction in response to a presence of said chemical moiety or species (as outlined in the claim 13 reaction above, generating a hydrogen ion allows for detection of change in pH [fourth and fith paras. col. 2, page 1885; illustrated in Figure 1 page 1885]).
Regarding Claim 16, modified Mahari teaches the electrochemical system of claim 15, and teaches wherein said interaction between said biomarker and said substance results in a pH change (as outlined in the claim 13 reaction above, Biloivan teaches water is contained in the electrolyte and used in the hydrolysis of BAEE [fourth and fifth paras. col. 2, page 1885; illustrated in Figure 1 page 1885]) and wherein said electroactive agent undergoes a pH-dependent electrochemically detectable reaction (as outlined in the claim 13 reaction above, Biloivan teaches water is used in the hydrolysis of BAEE [fourth and fith paras. col. 2, page 1885; illustrated in Figure 1 page 1885].
Response to Arguments
Applicant's arguments, see Remarks pgs. 6-10, filed 05/11/2026, with respect to the 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant traverses the 35 U.S.C 103 prior art rejection for Claim 1 by amending claim 1 to define and recite the biomarker is both a proteolytic enzyme indicative of the viral infection and is found in a saliva of a subject having the viral infection. In addition, Applicant argues that Examiner states that O’Brien teaches “detecting SARS-CoV-2 using 3C-like protease” and that “the biomarker is a proteolytic enzyme indicative of said viral infection”, which are factually incorrect and misrepresent the content of O’Brien, as O’Brien explicitly states that the authors “describe a luminescence-based biosensor assay for evaluating small molecule inhibitors of SARS-CoV-2 3CLpro/main protease for antiviral drug discovery, which is not analogous to the invention or to Mahari. In fact, the present inventors were the first to demonstrate the presence of 3CLpro in salivary samples from SARS-CoV-2 patients.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection. In addition, although the Applicant asserts that they may have been the first to demonstrate the presence of 3CLpro in salivary samples from SARS-CoV-2 patients, for patentability under U.S.C 103, 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.
Applicant’s Argument #2:
Applicant traverses the 35 U.S.C 103 prior art rejection for Claims 13-16 as claim 1 has been amended. As claims 13-16 ultimately depends on claim 1, they are therefore patentable by virtue of their dependency of the allowable claims, regardless of the teaches of Biloivan.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive as Claim 1 remains rejected under 35 U.S.C 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
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